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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
July 30, 2023
NABRIVA THERAPEUTICS PLC
(Exact name of registrant as specified in its charter)
| Ireland |
|
001-37558 |
|
Not Applicable |
(State or other jurisdiction of
incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer
Identification No.) |
Alexandra House Office 225/227,
The Sweepstakes,
Ballsbridge, Dublin 4, Ireland |
|
Not Applicable |
| (Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including area code: (610) 816-6640
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which
registered |
| Ordinary
Shares, nominal value $0.01 per share |
|
NBRV |
|
The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If an emerging growth company, indicate
by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Introductory Note
As previously disclosed, on January 4, 2023,
the Board of Directors of Nabriva Therapeutics plc (the “Company”), after an assessment of the Company’s strategic options,
approved a plan to preserve the Company’s cash to adequately fund an orderly wind down of the Company’s operations (the “Cash
Preservation Plan”).
Item 1.01. Entry into a Material Definitive Agreement.
On July 30, 2023, Nabriva Therapeutics plc (the “Company”)
and its wholly-owned subsidiaries, Nabriva Therapeutics Ireland Designated Activity Company (“Nabriva Ireland”), Nabriva Therapeutics
US, Inc. and Nabriva Therapeutics GmbH (collectively, the “Sellers”) entered into an Asset Purchase Agreement (the “Asset
Purchase Agreement”) with Sumitomo Pharma Co., Ltd. (the “Purchaser”), pursuant to which the Purchaser agreed to
(i) purchase, among other things, the Seller’s assets and rights related to the development, manufacture, marketing and commercialization
of lefamulin in the People’s Republic of China, Hong Kong, Macau and Taiwan (the “Territory”) and (ii) assume certain
liabilities related to the acquired assets (the “Transaction”). The Sellers and the Purchaser completed the Transaction simultaneously
with the execution of the Asset Purchase Agreement.
Under the terms of the Asset Purchase Agreement, the Purchaser agreed
to pay to the Company an upfront cash payment of $15.0 million upon the closing of the Transaction, of which (i) $1.8 million was
held back by the Purchaser as security for potential indemnification claims by the Purchaser (the “Holdback Amount”) and (ii) $10.4
million was paid by the Purchaser, on behalf of the Company, to certain of the Company’s contract manufacturing organizations to
settle and discharge the remaining obligations under such agreements, including the supply agreement with Patheon UK Limited for intravenous
vials of XENLETA, the supply agreement with Almac Pharma Services Limited for XENLETA tablets, the supply agreement with Fresenius Kabi
Norge AS for sodium citrate buffer infusion bags for use with intravenous vials of XENLETA and the agreement with Hovione Limited for
the supply of XENLETA’s active pharmaceutical ingredient. For additional information regarding the Company’s agreements with
its contract manufacturing organizations, see the Company’s Annual Report on Form 10-K for the fiscal year ended December 31,
2022.
In addition, in connection with the closing of the Transaction and
as contemplated by the Asset Purchase Agreement, the Company terminated its license agreement and certain related agreements with certain
affiliates of the Purchaser, including Sumitomo Pharmaceuticals (Suzhou), pursuant to which the Sellers previously had granted an exclusive
license to develop and commercialize, and a non-exclusive license to manufacture, certain products containing lefamulin in the Territory.
The Asset Purchase Agreement provides that the Sellers and the Purchaser
will indemnify each other for losses arising from certain breaches of the Asset Purchase Agreement, including breaches of certain representations
and warranties, and for certain other matters and subject to certain limitations as more fully described in the Asset Purchase Agreement.
The Holdback Amount will be paid to the Sellers, subject to reduction for any indemnification claims by the Purchaser and pursuant to
the terms of the Asset Purchase Agreement, following an 18-month indemnification period.
Following the closing of the Transaction and for a period of time
that may extend to March 31, 2024 (the “Bridge Period”), the Sellers have agreed to provide various post-closing
support activities to the Purchaser, including to continue and maintain (i) the application for marketing approval for lefamulin
filed by Nabriva Ireland with the National Medical Products Administration of the People’s Republic of China (the “NMPA”), (ii) the
import drug license for lefamulin filed with the NMPA and (iii) the existing market approval for lefamulin in the United States (the
“Nabriva Bridge Period Obligations”). The Purchaser may also elect to extend the Bridge Period beyond March 31, 2024 to
a date not later than September 30, 2024. In exchange for these obligations, the Purchaser has agreed to reimburse the
applicable Seller(s) for their reasonable and documented expenses incurred by them in connection with such post-closing
obligations, up to an aggregate amount equal to $3.0 million (subject to further increase in the event that the Purchaser extends
the Bridge Period past March 31, 2024). Further, the parties at closing allocated $2.0 of the $15.0 upfront cash payment as
one-time pre-paid expense reimbursement to the Sellers for the Nabriva Bridge Period Obligations.
The Asset Purchase Agreement also contains customary representations
and warranties. The assertions embodied in those representations and warranties were made solely for purposes of the Asset Purchase Agreement
and may be subject to important qualifications and limitations. Moreover, the representations and warranties may be subject to a contractual
standard of materiality that may be different from what may be viewed as material to shareholders or may have been used for the purpose
of allocating risk between the Sellers and the Purchaser rather than establishing matters as facts. For the foregoing reasons, no person
should rely on such representations and warranties as statements of factual information at the time they were made or otherwise.
The description of the Asset Purchase Agreement does not purport to
be complete and is qualified in its entirety by reference to the full text of the Asset Purchase Agreement, a copy of which is filed as
Exhibit 2.1 hereto and incorporated herein by reference.
Item 1.02. Termination of a Material Definitive Agreement.
The disclosure in Item 1.01 above is incorporated by reference into
this Item 1.02.
Item 2.01. Completion of Acquisition or Disposition of Assets.
The disclosure in Item 1.01 above is incorporated
by reference into this Item 2.01.
Item 5.02. Departure of Directors or Certain Officers; Election
of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On July 30, 2023, immediately following the closing of the Transaction,
each of Colin Broom, Carrie Bourdow, Lisa Dalton and Mark Corrigan (collectively, the “Departing Directors”) resigned from
the Company’s Board of Directors and from all committees of the Board of Directors on which such directors served. The Departing
Directors resignations did not result from a disagreement with the Company or any of its officers or other directors on any matter relating
to the Transaction or the operations, policies or practices of the Company.
Item 8.01. Other Events.
Continuing Operations
Following the closing of the Transaction,
operational activities of the Company will consist solely of (i) complying with the Nabriva Bridge Period Obligations, (ii) identifying
and exploring strategic options, including the sale, license or other disposition of one or more of the Company’s remaining assets,
technologies or products, including XENLETA (lefamulin) outside of the Territory and CONTEPO; and (iii) the wind-down of its operations.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits:
* Portions of this exhibit have been
omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
Cautionary Note Regarding Forward-looking Statements
This Current Report on Form 8-K contains forward-looking statements
that involve substantial risks and uncertainties. Any statements in this Current Report on Form 8-K about the Company’s future
expectations, plans and prospects, including but not limited to statements about the Transaction, the Company’s ability to identify,
assess and execute a strategic transaction, its ability to preserve cash in order to adequately fund an orderly wind down, the ability
of shareholders and other stakeholders to realize any value or recovery as part of a wind down process, the potential expense reimbursement
from the Purchaser in connection with the Nabriva Bridge Period Obligations, the ability to comply with the Nabriva Bridge Period Obligations,
the sufficiency the Company’s existing cash resources and other statements about future expectations, estimates and other matters
that are dependent upon future events or developments, including statements containing the words “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,”
“target,” “potential,” “likely,” “will,” “would,” “could,” “should,”
“continue,” and similar expressions constitute forward-looking statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various
important factors, including: the occurrence of any event, change or other circumstance that could give rise to a claim for indemnification
under the Asset Purchase Agreement, negative effects of the announcement of the Transaction on the market price of the Company’s
ordinary shares, the risk of litigation and/or regulatory actions related to the Transaction, the sufficiency of the Company’s cash
resources to perform and satisfy the Nabriva Bridge Period Obligations and to fund an orderly wind down of its business and such other
important factors as are set forth under the caption “Risk Factors” in the Company’s annual and quarterly reports and
any other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this
Current Report on Form 8-K represent the Company’s views as of the date of this Current Report on Form 8-K. The Company
anticipates that subsequent events and developments will cause its views to change. However, while the Company may elect to update these
forward-looking statements at some point in the future, the Company specifically disclaim any obligation to do so. These forward-looking
statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this Current Report
on Form 8-K.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
| |
Nabriva Therapeutics plc |
| |
|
|
| |
|
|
| Date: July 31, 2023 |
By: |
/s/ Michael Hogan |
| |
|
Michael Hogan |
| |
|
Chief Executive Officer |
Exhibit 2.1
Certain identified information has been excluded
from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private
or confidential. Double asterisks denote omissions.
WARNING:
THE TAKING OF THIS DOCUMENT OR ANY CERTIFIED COPY THEREOF OR ANY OTHER DOCUMENT WHICH CONSTITUTES SUBSTITUTE DOCUMENTATION OF THIS DOCUMENT, INCLUDING
WRITTEN CONFIRMATIONS OR REFERENCES THERETO, INTO THE REPUBLIC OF AUSTRIA, AS WELL AS THE PRODUCTION IN, OR THE SENDING TO OR FROM,
THE REPUBLIC OF AUSTRIA OF ANY OF THE FOREGOING DOCUMENTS, AS WELL AS THE SENDING TO OR FROM THE REPUBLIC OF AUSTRIA OF FAX MESSAGES OR
E-MAILS CARRYING AN ELECTRONIC SIGNATURE (WHETHER DIGITALLY, MANUSCRIPT OR OTHERWISE TECHNICALLY REPRODUCED) WHICH REFER TO THIS DOCUMENT
OR TO WHICH A COPY OF THIS DOCUMENT IS ATTACHED, MAY CAUSE THE IMPOSITION OF AUSTRIAN STAMP DUTY. ACCORDINGLY, KEEP THE ORIGINAL
OF THIS DOCUMENT AS WELL AS ANY CERTIFIED COPY THEREOF AND WRITTEN AND SIGNED REFERENCES THERETO OUTSIDE OF THE REPUBLIC OF AUSTRIA AND
AVOID SENDING FAX MESSAGES OR E-MAILS CARRYING AN ELECTRONIC SIGNATURE (WHETHER DIGITALLY, MANUSCRIPT OR OTHERWISE TECHNICALLY REPRODUCED)
WHICH REFER TO THIS DOCUMENT OR TO WHICH A COPY OF THIS DOCUMENT IS ATTACHED TO OR FROM THE REPUBLIC OF AUSTRIA.
ASSET
PURCHASE AGREEMENT
by and among
NABRIVA THERAPEUTICS PUBLIC LIMITED COMPANY,
Nabriva Therapeutics Ireland Designated Activity
Company,
Nabriva Therapeutics US, Inc.,
Nabriva Therapeutics GmbH,
and
Sumitomo Pharma Co., Ltd.
Dated as of July 30, 2023
Table
of Contents
Page
| Article 1 |
SALE AND PURCHASE OF ASSETS; LIABILITIES |
1 |
| 1.1 | Purchased Assets; Excluded Assets |
1 |
| Article 2 |
REPRESENTATIONS AND WARRANTIES |
7 |
| 2.1 | Representations and Warranties of Sellers |
7 |
| 2.2 | Representations and Warranties of Purchaser |
18 |
| 2.3 | Exclusivity of Representations |
19 |
| 3.1 | Post-Closing Access and Information; Cooperation in Legal Proceedings and Investigations |
20 |
| 3.2 | Covenants Regarding Intellectual Property |
22 |
| 3.3 | Further Assurances; Non-Assignable Assets; Wrong Pockets |
23 |
| 3.6 | Delivery of Purchased Assets |
26 |
| 3.8 | Certain Tax Matters |
29 |
| 3.9 | Termination of Existing Nabriva Agreements |
31 |
| 3.12 | Right of Reference |
33 |
| 3.13 | PV-Related Activities |
34 |
| 3.14 | [Intentionally Omitted] |
34 |
| 3.15 | Sellers’ Obligations during Bridge Period; Expense Reimbursement |
34 |
| 3.16 | Transition Trademark License |
38 |
| 3.17 | M&A Qualified Beneficiaries |
38 |
| Article 4 | INDEMNIFICATION | 38 |
| 4.2 | Limitations on Indemnification |
40 |
Table
of Contents
(continued)
Page
| 4.4 | Tax Treatment of Indemnification Payments |
45 |
| 4.5 | Indemnification Holdback |
45 |
| 4.6 | Other Provisions Relating to Indemnification |
45 |
| 5.1 | Governing Law, Jurisdiction, Venue and Service |
46 |
| 5.3 | No Benefit to Third Parties |
49 |
| 5.4 | Waiver and Non-Exclusion of Remedies |
49 |
| 5.9 | Specific Performance |
50 |
| 5.11 | Bulk Sales Statutes |
51 |
| 5.12 | Counterparts; Electronic Signature |
51 |
| 5.13 | Disclosure Schedule |
51 |
| 5.14 | Interpretation of Agreement |
52 |
| 5.16 | Austrian Stamp Duty |
52 |
| 5.17 | Place of Performance |
53 |
TABLE OF SCHEDULES AND EXHIBITS
SCHEDULES
| Schedule A |
Individuals relevant for Sellers’ Knowledge |
| Schedule B |
Definition of Product |
| Schedule 1.3.1(b) |
Nabriva Parent’s Wire Information |
| Schedule 1.3.1(c) |
Settlement Amounts payable to CMOs |
| Schedule 1.3.1(d) |
Nabriva DAC’s Wire Information |
| Schedule 1.4.2(a)(v) |
CMO Agreements |
| Schedule 1.4.2(a)(vi) |
Counterparty to Confidentiality Amendment |
| Schedule 3.6.2 |
Delivery of Tangible Purchased Assets |
| Schedule 3.7.4 |
Regulatory Approval Applications |
| Schedule 3.8.2(a) |
Purchase Price Allocation |
| Schedule 3.13 |
PV Countries and Regions |
| Schedule 3.15.1(d) |
Counterparties to Relevant Agreements |
| Disclosure Schedule |
| EXHIBITS |
| |
| Exhibit A |
Certain Definitions |
| Exhibit B |
Form of Austrian Local Transfer Agreement |
| Exhibit C |
Budget Plan |
| Exhibit D |
Form of Termination Agreement regarding Existing Nabriva Agreements |
| Exhibit E |
Form of Intellectual Property License Agreement |
| Exhibit F |
Form of Intellectual Property Assignment Agreement |
ASSET
PURCHASE AGREEMENT
This
ASSET PURCHASE AGREEMENT (this “Agreement”) is made and executed as of July 30, 2023 (the “Execution
Date”), by and among Nabriva Therapeutics Public Limited Company, a public limited company organized under the laws of Ireland
(“Nabriva Parent”), Nabriva Therapeutics Ireland Designated Activity Company, a designated activity company formed
under the laws of Ireland and a direct wholly-owned subsidiary of Nabriva Parent (“Nabriva DAC”), Nabriva Therapeutics
US, Inc., a Delaware corporation and an indirect wholly-owned subsidiary of Nabriva Parent (“Nabriva US”), and
Nabriva Therapeutics GmbH, an Austrian company with limited liability and a direct wholly-owned subsidiary of Nabriva Parent (“Nabriva
Austria”) (Nabriva Parent, Nabriva DAC, Nabriva US, and Nabriva Austria, each a “Seller” and collectively,
the “Sellers”), and Sumitomo Pharma Co., Ltd., a company (Kabushiki Kaisha) organized under the laws of
Japan (“Purchaser”). Sellers and Purchaser are referred to collectively in this Agreement as the “Parties,”
and each individually as a “Party.” Certain capitalized terms used in this Agreement are defined in Exhibit A
attached hereto.
RECITALS
WHEREAS,
Sellers, together with their Affiliates (the “Seller Group”), own and operate the Product Business;
WHEREAS,
the Parties wish to provide for the purchase by Purchaser (or one or more of its designees) of certain assets and rights from the Seller
Group, and to provide for certain related transactions, on the terms and subject to the conditions and other provisions set forth in this
Agreement and in the Ancillary Agreements; and
WHEREAS,
at the Closing, Sellers (or such other member of the Seller Group identified in the Ancillary Agreements) and Purchaser (or Purchaser’s
designee(s)) intend to enter into and deliver the Ancillary Agreements.
AGREEMENT
NOW,
THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth and set forth in the
Ancillary Agreements, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties,
intending to be legally bound, do hereby agree as follows:
Article 1
SALE AND PURCHASE OF ASSETS; LIABILITIES
1.1 Purchased
Assets; Excluded Assets.
1.1.1 Sale
and Purchase of Purchased Assets. Upon the terms and subject to the conditions of this Agreement and the Ancillary Agreements, at
and effective as of the Closing, Sellers shall (and shall cause the other applicable members of the Seller Group to) and do hereby sell,
transfer, convey, assign and deliver to Purchaser, or Purchaser’s designee(s) (as determined in Purchaser’s sole discretion
and communicated by Purchaser to Nabriva Parent prior to the Closing), free and clear of all Encumbrances, except for Permitted Encumbrances,
and Purchaser (or Purchaser’s designee(s)), shall purchase and accept from Sellers or the other applicable members of the Seller
Group, all of the Seller Group’s right, title and interest in and to all assets, properties and rights specifically listed or described
below, free and clear of all Encumbrances, except for Permitted Encumbrances (collectively, the “Purchased Assets”):
(a) the
Purchased Regulatory Documentation;
(b) the
Purchased Product Records;
(c) all
Product Promotional Material;
(d) copies
of all medical affairs correspondence and other documentation that is reasonably available to and under the Control of the Seller Group
as of the Closing Date to the extent primarily related to or the Product in the Territory;
(e) the
Purchased Intellectual Property and the Patent Files; and
(f) all
transferable rights, claims, causes of actions, rights of recovery, and credits, including all guarantees, warranties, indemnities and
similar rights, in favor of any member of the Seller Group to the extent relating to any Purchased Asset or any Assumed Liability whether
arising from events or circumstances arising before, on or after the Closing Date.
Subject to the express terms of this Agreement,
to the extent permitted by applicable Law, title to the Purchased Assets which are capable of passing by delivery shall pass by delivery
at the Closing.
1.1.2 Excluded
Assets. Purchaser shall not acquire pursuant to this Agreement or any Ancillary Agreement, and Sellers shall retain following the
Closing, and the Purchased Assets shall not include, the following (collectively, “Excluded Assets”):
(a) all
rights of Sellers under this Agreement;
(b) all
Contracts;
(c) any
Clinical Trials;
(d) all
Regulatory Approvals and Regulatory Approval Applications;
(e) all
Regulatory Documentation, other than the Purchased Regulatory Documentation;
(f) all
Product Records other than the Purchased Product Records;
(g) all
Intellectual Property (including the Seller Retained Marks) other than the Purchased Intellectual Property;
(h) any
cash, cash equivalents, accounts receivable (including cash and accounts receivable relating to Product sold prior to the Closing in the
Territory), prepaid rents, certificates of deposit, and treasury bills;
(i) any
Tax records of the Seller Group (including all Tax returns) relating to the Purchased Assets;
(j) all
rights of the Seller Group to any refunds, or rights or claims to refunds, of Taxes, Tax deposits, Tax credits or other Tax assets attributable
to a Tax payment made or other Tax-related action taken by the Seller Group;
(k) the
Seller Group’s corporate books and records of internal corporate proceedings, work papers and books and records, except as specifically
included in the Purchased Assets;
(l) all
books, records, documentation and similar materials of the Seller Group that relate to the Transactions;
(m) all
equity or equity-linked securities or rights;
(n) any
insurance policies or the right to make claims under any insurance policy, subject to Article 4;
and
(o) all
rights, claims, causes of actions, rights of recovery, and credits, including all guarantees, warranties, indemnities and similar rights,
in favor of the Seller Group related to any of the foregoing items set forth in this Section 1.1.2
or any Excluded Liability, whether arising from events or circumstances arising before, on or after the Closing Date.
1.2 Liabilities.
1.2.1 Assumed
Liabilities. Upon the terms and subject to the conditions of this Agreement and any Ancillary Agreements, at the Closing, Sellers
shall assign to Purchaser, or Purchaser’s designee(s) (as determined in Purchaser’s sole discretion and communicated
by Purchaser to Nabriva Parent prior to the Closing), and Purchaser (or Purchaser’s designee(s), as applicable) shall assume from
Sellers or their Affiliates and agree to pay and discharge when due, to the extent not an Excluded Liability, all Liabilities to the extent
related to the Purchaser’s or its Affiliates’ ownership, use or operation of the Purchased Assets after the Closing, or the
operation or conduct of the Product Business after the Closing, including any product liability in respect of any Legal Proceeding instituted
by a Third Party to the extent arising out of or relating to the operation or conduct of the Product Business or the Purchased Assets
by Purchaser or its Affiliates, in each case, to the extent arising after the Closing (collectively, the “Assumed Liabilities”).
1.2.2 Excluded
Liabilities. Notwithstanding any provision of this Agreement or any Ancillary Agreement to the contrary, neither Purchaser nor any
of its Affiliates will assume or otherwise be responsible for and Sellers shall pay, perform or otherwise satisfy and discharge when due,
all Liabilities of the Seller Group, whether or not related to the Product Business and whether in or outside of the Territory, other
than the Assumed Liabilities (the “Excluded Liabilities”). For the avoidance of doubt, the Excluded Liabilities include
the following:
(a) any
Liability of the Seller Group (including any Liability to the extent resulting from any member of the Seller Group’s ownership,
use, operation, or Exploitation of the Purchased Assets prior to the Closing, or the operation or conduct of the Product Business prior
to the Closing);
(b) all
accounts payable of any member of the Seller Group for materials and services with respect to the Exploitation of a Product in the Territory
prior to the Closing;
(c) all
Liabilities for (i) Taxes of the Seller Group, (ii) Taxes that relate to or are attributable to the Purchased Assets, the Product
Business or the Assumed Liabilities for any taxable period that ends on or before the Closing Date or any Pre-Closing Straddle Tax Period
(a “Pre-Closing Tax Period”) (except as apportioned to Purchaser under Section 3.8.3(c)),
(iii) payments under any Tax allocation, sharing or similar agreement (whether oral or written) other than pursuant to this Agreement
entered into by any member of the Seller Group prior to the Closing Date to which any member of the Seller Group is subject, (iv) the
Covered Transfer Taxes as set forth in Section 3.8.3(a), and (v) any withholding
Taxes which were owed by Purchaser with respect to payments made by Purchaser on behalf of Sellers or any other member of the Seller Group
pursuant to Section 1.3.1(c);
(d) any
Liability pursuant to any Environmental Law arising from or related to any action, event, circumstance or condition occurring or existing
on or prior to the Closing;
(e) any
Liability pursuant to any Health Care Laws arising from or related to any action, event, circumstance or condition occurring or existing
on or prior to the Closing;
(f) any
Liability of any member of the Seller Group (i) relating to wages, bonuses, payroll, vacation, sick leave, workers’ compensation,
unemployment benefits, (ii) relating to any actual or alleged violation by any Seller or any of its Affiliates of any equal employment,
employment discrimination or other labor Laws, and (iii) otherwise relating to the employment of any former or current employees
of any of the members of the Seller Group;
(g) any
Liability based upon, arising out of or otherwise in respect of any Employee Plan;
(h) any
indebtedness for borrowed money incurred by a member of the Seller Group, or guarantees thereof (whether prior to or after the Closing);
and
(i) any
Liability of a member of the Seller Group to the extent relating to an Excluded Asset, including any Liability of a member of the Seller
Group to the extent relating to the operation of any business by a member of the Seller Group after the Closing, other than the Product
Business as conducted by Purchaser.
1.3 Consideration.
1.3.1 In
consideration of the sale, transfer, conveyance, assignment and delivery contemplated under Section 1.1
and Section 1.4, on the Closing Date,
Purchaser or an Affiliate of Purchaser (as designated by Purchaser) shall:
(a) assume
(and perform and pay when due) the Assumed Liabilities;
(b) initiate
a wire transfer of immediately available funds for the payment to Nabriva Parent, to the account (or accounts) designated by Nabriva Parent
and set forth on Schedule 1.3.1(b),
of an amount in cash equal to (i) the Purchase Price minus (ii) the Indemnification Holdback minus (iii) the
Aggregate CMO Settlement Amount (the amount resulting from clauses (i) through (iii), the “Closing Purchase
Price”);
(c) on
behalf of Sellers, initiate wire transfers of immediately available funds for the payment to each of the CMOs set forth on, and to the
accounts specified on, Schedule 1.3.1(c),
in cash of such portion of the Aggregate CMO Settlement Amount set forth opposite such CMO’s name on Schedule 1.3.1(c);
and
(d) initiate
a wire transfer of immediately available funds for the payment of the Bridge Period Pre-Funded Expenses Amount to Nabriva DAC, to the
account (or accounts) designated by Nabriva DAC and set forth on Schedule 1.3.1(d),
an amount in cash equal to the Bridge Period Pre-Funded Expenses Amount.
1.3.2 At
the Closing, Purchaser will retain, and not wire to Nabriva Parent (or the other Sellers), that portion of the Purchase Price as is equal
to the Indemnification Holdback. For the period specified in Section 4.5,
the Indemnification Holdback will be held by Purchaser as security for potential indemnification claims brought by Purchaser Indemnitees
pursuant to Article 4, and released to Nabriva
Parent or Purchaser, as the case may be, in accordance with, and subject to, the terms and conditions of this Agreement, including Section 4.5.
1.4 Closing.
1.4.1 Closing.
Pursuant to the terms and subject to the conditions of this Agreement, unless another time and place is agreed to by Purchaser and Nabriva
Parent in writing, the closing of the Transactions (the “Closing”) shall take place on the Execution Date remotely
via electronic transmission of documentation and signatures or other similar means. The Closing shall be deemed to have occurred at 11:59
p.m., Pacific Time, on the Closing Date, such that Purchaser (or its designee(s)) shall be deemed the owner of the Purchased Assets after
the Closing Date.
1.4.2 Closing
Deliveries.
(a) Except
as otherwise indicated below, at the Closing, Sellers shall deliver or cause to be delivered the following to Purchaser (or its designees):
(i) subject
to the provisions of Section 3.6, the
Purchased Assets;
(ii) each
of the Ancillary Agreements to which a member of the Seller Group is a party, validly executed by a duly authorized officer of such member
of the Seller Group in substantially the form attached hereto, or if a form thereof is not attached hereto, in a form and substance reasonably
acceptable to Purchaser;
(iii) a
properly completed and duly executed Internal Revenue Service Form W-9 of Nabriva US;
(iv) [Intentionally
Omitted];
(v) evidence
reasonably satisfactory to Purchaser that each relevant Seller or other member of the Seller Group, as applicable, has entered into settlement
and/or amendment agreements (reasonably satisfactory to Purchaser) in respect of the agreements listed on Schedule 1.4.2(a)(v) (the
“CMO Agreements”) with each of the counterparties to the CMO Agreements regarding the discharge of all outstanding
obligations of any member of the Seller Group under such agreements, and satisfied all obligations thereunder, other than the payment
to such counterparties of the relevant portion of the Aggregate CMO Settlement Amount which will be paid by Purchaser in accordance with
Section 1.3.1(c), in exchange for a
full, unconditional and irrevocable release of claims and obligations, in each case duly executed by such member of the Seller Group and
the relevant counterparty or counterparties to the CMO Agreements (all of the settlement agreements, and other documents referred to in
this clause collectively, the “Settlement Agreements”);
(vi) an
amendment to the confidentiality terms of the employment agreement of the person specified on Schedule 1.4.2(a)(vi) permitting
such person to share confidential information with respect to the Product Business, the Purchased Assets or the Assumed Liabilities with
Purchaser and its Affiliates and Representatives, in a form and substance reasonably acceptable to Purchaser;
(vii) a
certified copy of the resolutions, in agreed form, of the board of directors of each Seller authorizing the Transactions and the execution
and delivery of this Agreement, the Ancillary Agreements to which such Seller is a party and any other documents referred to in this Agreement
as being required to be delivered by such Seller;
(viii) the
original of any power of attorney under which this Agreement or any other document to be delivered to Purchaser under this Section 1.4.2(a) has
been executed.
(b) At
the Closing, Purchaser shall deliver, or cause to be delivered, the following to Sellers or perform the following actions:
(i) each
of the Ancillary Agreements to which Purchaser or a designee of Purchaser is a party, validly executed by a duly authorized officer of
Purchaser or such designee of Purchaser, as applicable, in substantially the form attached hereto, or if a form thereof is not attached
hereto, in a form and substance reasonably acceptable to Nabriva Parent;
(ii) [Reserved.]
(iii) Purchaser
shall have initiated (A) the wire in respect of the Closing Purchase Price in accordance with Section 1.3.1(b),
(B) the wires in respect of the Aggregate CMO Settlement Amount in accordance with Section 1.3.1(c),
and (C) the wires in respect of the Bridge Period Pre-Funded Expenses Amount in accordance with Section 1.3.1(d).
Article 2
REPRESENTATIONS AND WARRANTIES
2.1 Representations
and Warranties of Sellers. Except as set forth in the Disclosure Schedule, each Seller, jointly
and severally, hereby represents and warrants to Purchaser as follows:
2.1.1 Organization
and Qualification.
(a) Each
member of the Seller Group is duly incorporated or formed, validly existing and in good standing (to the extent such concept is recognized
by the applicable jurisdiction) under the Laws of the jurisdiction of incorporation or formation, and has all requisite corporate power
and authority to own, lease and operate the Purchased Assets owned by it and conduct its business as it is now being conducted.
(b) Each
member of the Seller Group is duly qualified, licensed or admitted to do business as a foreign corporation, and in good standing (to the
extent such concept is recognized by the applicable jurisdiction), in each jurisdiction in which the ownership of the Purchased Assets
or operation of the Product Business makes such qualification, licensing or admission necessary, except as would not, individually or
in the aggregate, have a Material Adverse Effect.
2.1.2 Authority.
(a) Each
Seller has all necessary power and authority to enter into this Agreement and the Ancillary Agreements to which it is a party, to perform
its obligations hereunder and thereunder and to consummate the Transactions. The execution, delivery and performance by Sellers of this
Agreement and the consummation by each Seller of the Transactions have been duly and validly authorized by all necessary corporate or
organizational action on behalf of such Seller. Neither the execution and delivery by Sellers of this Agreement, nor the consummation
of the Transactions, require any approval by the stockholders of any Seller that has not been obtained prior to the Execution Date. This
Agreement constitutes, and each Ancillary Agreement to which a Seller is a party, when executed and delivered by such Seller, assuming
the due authorization, execution and delivery by Purchaser, or Purchaser’s designee, as applicable, will constitute, the valid and
legally binding obligation of such Seller, enforceable against such Seller in accordance with its terms, subject to the Enforceability
Exceptions.
(b) Each
Affiliate of a Seller that will enter into an Ancillary Agreement has the requisite entity power and authority to perform its obligations
under each Ancillary Agreement to which it is a party and to consummate the transactions contemplated thereby. The execution and delivery
of the Ancillary Agreements to which any Affiliate of a Seller is a party and the consummation of the transactions contemplated thereby
have been duly authorized by all necessary organizational actions of such Seller Affiliate. Each Ancillary Agreement, when executed and
delivered by an Affiliate of a Seller that is a party thereto, assuming the due authorization, execution and delivery by Purchaser, or
Purchaser’s designee, as applicable, will constitute the valid and legally binding obligation of such Seller Affiliate, enforceable
against such Seller Affiliate in accordance with its terms, subject to the Enforceability Exceptions.
2.1.3 Non-Contravention.
The execution, delivery and performance by each Seller of this Agreement and each Ancillary Agreement to which it is a party and the execution,
delivery and performance by each Affiliate of a Seller of each Ancillary Agreement to which such Affiliate is a party do not and will
not (a) violate the certificate of formation or operating agreement or comparable organizational or constitutional documents of such
Seller or such Affiliate, as applicable, (b) violate any (i) Law applicable to such Seller or such Affiliate, as applicable,
the Product Business or the Purchased Assets, or (ii) Order to which such Seller or any of its Affiliates is subject relating to
the Product Business, or (c) subject to obtaining the Consents and Permits, or giving the notices and making the filings referred
to in Section 2.1.5(c), violate, breach
or constitute (with or without notice or lapse of time, or both) a default under, require any Consent of or notice to any Person pursuant
to, give to others any right of termination, amendment, modification, acceleration or cancellation of, allow the imposition of any fees
or penalties, require the offering or making of any payment or redemption, give rise to any increased, guaranteed, accelerated or additional
rights or entitlements of any Person or otherwise adversely affect any rights of such Seller, Affiliate or the Product Business under,
or result in the creation of any Encumbrance (other than Permitted Encumbrances) on any of the Purchased Assets pursuant to, any Contract
to which such Seller or any of its Affiliates is a party or to which such Seller or any of its Affiliates, the Product Business or the
Purchased Assets is subject, except, with respect to clause (c) of this Section 2.1.3,
as would not, individually or in the aggregate, be material to the Product Business, taken as a whole, or prevent or materially impair
the performance by the Seller Group of their respective obligations under this Agreement or the Ancillary Agreements or the consummation
of the Transactions.
2.1.4 No
Broker. There is no broker, finder, financial advisor, or other Third Party acting or who has acted on behalf of any member of the
Seller Group who is entitled to receive any brokerage or finder’s or financial advisory fee in connection with the Transactions.
2.1.5 No
Legal Proceedings; Consents.
(a) Since
the Lookback Date, there has been no Legal Proceeding pending or, to Sellers’ Knowledge, threatened against a member of the Seller
Group. There is no Legal Proceeding by any member of the Seller Group pending, or which such member of the Seller Group has commenced
preparations to initiate, against any other Person in connection with the Product Business or the Purchased Assets.
(b) There
is no Order or, to Sellers’ Knowledge, threatened investigation by any Governmental Entity to which any of the Sellers or any of
its Affiliates is subject.
(c) No
member of the Seller Group is required to provide, make, seek or obtain any notice to, filing with, or Permit or Consent of any Governmental
Entity or other Person in connection with the execution, delivery and performance by any Seller of this Agreement, or by any member of
the Seller Group of any Ancillary Agreement, or the consummation of the Transactions by any member of the Seller Group, except where the
failure to provide such notice, make such filing, or seek or obtain such Permit or Consent would not, individually or in the aggregate,
be material to the Product Business, taken as a whole, or prevent, or materially impair the performance by any member of the Seller Group
of its obligations under this Agreement or the Ancillary Agreements, or the consummation of the Transactions.
2.1.6 Purchased
Assets.
(a) The
applicable members of the Seller Group have, and at the Closing will transfer to Purchaser (or its designees) good and valid title to,
or valid Contract rights in, as applicable, the Purchased Assets, free and clear of all Encumbrances other than Permitted Encumbrances.
This Agreement, the Ancillary Agreements and the instruments and documents to be delivered by the members of the Seller Group at the Closing
shall be adequate and sufficient to transfer to Purchaser or one of its Affiliates the Seller Group’s entire right, title and interest
in and to the Purchased Assets free and clear of all Encumbrances (including Encumbrances resulting from any indebtedness of any member
of the Seller Group), other than Permitted Encumbrances.
(b) Subject
to Section 3.3.2 and Section 3.6,
except for (i) the Seller Retained Marks, (ii) Intellectual Property licensed to any member of the Seller Group pursuant to
non-exclusive licenses for software generally commercially available, (iii) services of employee matters relating to the Product
Business, (iv) all inventory, equipment, and other tangible assets related to the Product Business (other than as included in the
Purchased Assets), (v) any and all Regulatory Approvals, and (vi) general corporate services, the Purchased Assets constitute
in all material respects all of the assets, properties and rights necessary for the Exploitation of a Product in the Territory.
2.1.7 Absence
of Certain Changes. Since December 31, 2022, (a) there has not been any change, event or development that, individually
or in the aggregate, has had or is reasonably likely to have a Material Adverse Effect and (b) no member of the Seller Group has
experienced any material damage, destruction or loss (whether or not covered by insurance) of any asset or right that would constitute
a Purchased Asset.
2.1.8 Contracts.
(a) Except
as listed in Section 2.1.8 of the Disclosure
Schedule, there are no Contracts to which any member of the Seller Group is a party relating to and necessary for the conduct of the Product
Business by Purchaser or its Affiliates as currently proposed to be conducted of the following nature:
(i) any
Contract for the Exploitation of a Product in the Territory;
(ii) any
Contract with any Governmental Entity;
(iii) any
Contract relating to Clinical Trials, including any Clinical Trial Agreement, or Contract with a CRO or CMO;
(iv) any
Contract relating to Clinical Trials with any HCP or other consultant;
(v) any
Contract relating to pharmacovigilance related matters;
(vi) any
Contract that limits, or purports to limit, the ability of any member of the Seller Group or, from and after the Closing, Purchaser or
any of its Affiliates to operate the Product Business or Exploit a Product in the Territory or during any period of time, or that restricts
the ability of any member of the Seller Group or, from and after the Closing, Purchaser or any of its Affiliates to compete in any material
respect in the conduct of the Product Business;
(vii) any
Contract under which any member of the Seller Group has licensed, sublicensed, granted or conveyed to any Person any right, title or interest
in or to any Intellectual Property related to a Product with respect to the Territory (including the Purchased Intellectual Property);
(viii) any
Contract pursuant to which the Licensed Product IP has been licensed or otherwise granted by a Third Party to any member of the Seller
Group, other than Contracts licensing commercially available off-the-shelf software on non-exclusive terms;
(ix) any
Contract pursuant to which a member of the Seller Group has transferred (or agreed to transfer) ownership of, or granted (or agreed to
grant) any exclusive license of or exclusive right to use, or authorized the retention of any exclusive rights to use or joint ownership
of any Intellectual Property or Intellectual Property rights that would, but for such transfer or agreement to transfer, have been Purchased
Intellectual Property;
(x) any
Contracts for the sale by any Seller or any other member of the Seller Group of any Purchased Asset or the grant of any preferential rights
to purchase any Purchased Asset (including sales of a Product);
(xi) any
Contract requiring royalty, milestone or similar payments with respect to a Product in the Territory;
(xii) any
Contract or other instrument that includes any powers of attorney with respect to any Purchased Assets; or
(xiii) any
Contract establishing joint ventures or partnerships relating to the Product Business.
(b) Each
of the Settlement Agreements referred to in Section 1.4.2(a)(v) is
in full force and effect and accurate copies thereof have been made available to Purchaser. Under the terms of the Settlement Agreements,
upon payment of the applicable settlement amount, the applicable Seller (or other member of the Seller Group) will, among other things,
be fully and forever released and discharged from all minimum purchase commitments, outstanding payment obligations, and any other obligations
to purchase any amount of Product from any of the CMOs under the CMO Agreements, except as required by Nabriva DAC to continue the stability
studies conducted in respect of the Marketing Approvals for Lefamulin in the U.S. in accordance with Section 3.15.1(c).
2.1.9 Compliance
with Law.
(a) Each
Seller and each other member of the Seller Group, and to Sellers’ Knowledge, Persons acting on their behalf, with respect to the
operation of the Product Business or otherwise with respect to a Product (whether or not within the Territory), are and since the Lookback
Date have been in compliance in all material respects with all applicable Laws. Since the Lookback Date, with respect to the operation
of the Product Business, no Seller nor any other member of the Seller Group has received any written notice, or to Sellers’ Knowledge,
other notice, of any actual, potential or alleged violation of any Law applicable to the Product Business, a Product (whether or not within
the Territory), the Purchased Assets or the Assumed Liabilities from any Governmental Entity or other Person or filed or otherwise provided
any written notice or communication to any Governmental Entity or other Person regarding any actual, potential or alleged violation of,
or failure to comply with any provision of any Law applicable to the Product Business, a Product (whether or not within the Territory),
the Purchased Assets or the Assumed Liabilities, and to Sellers’ Knowledge, no self-disclosure to any Governmental Entity of any
material violation of Law is required.
(b) None
of the directors, officers, managers, employees, or, to the Sellers’ Knowledge, agents or other Representatives of any member of
the Seller Group or any other Person acting on behalf of any of the Seller Group has, with respect to the Purchased Assets, the Product
(whether or not within the Territory) or the Product Business (i) used any funds for unlawful contributions, gifts, entertainment
or other unlawful payments relating to any political activity, (ii) made any unlawful payment to any government official or employee
or any political party or campaign, HCP, healthcare organization, patient or patient organization or any other Party or (iii) violated
any provision of the U.S. Foreign Corrupt Practices Act of 1977, the U.K. Bribery Act of 2010, or the OECD Convention on Combating Bribery
of Foreign Public Officials in Business Transactions or any other Law applicable to the conduct of business with Governmental Entities.
(c) Section 2.1.9(c) of
the Disclosure Schedule sets forth a true and complete list of all material Permits required to operate the Product Business. Sellers,
or another member of the Seller Group, possess, and are in compliance with, all material Permits necessary for the conduct of the Product
Business as it is currently conducted. To Sellers’ Knowledge, all such Permits are valid and in full force and effect. Since the
Lookback Date, (i) no Governmental Entity has served written notice, or to Sellers’ Knowledge, any other notice, upon a Seller
or any other member of the Seller Group that such Seller or such other member of the Seller Group, the Product Business or the Purchased
Assets were, are or have been alleged to be in violation of any Law or Permit in any jurisdiction where the Product Business is conducted,
and (ii) no member of the Seller Group has received written notice from any Governmental Entity that there are any circumstances
existing which would lead to any loss of any material Permit.
(d) The
Seller Group has not, either expressly or by operation of law, assumed or undertaken, or agreed to indemnify, any Liability or corrective,
investigatory or remedial obligation of any other Person, relating to any Environmental Laws that would reasonably be expected to result
in a liability to Purchaser as a result of the consummation of the Transactions.
2.1.10 Certain
Regulatory Matters.
(a) The
Exploitation of Products in the Relevant Regulatory Territory, as such Exploitation has been conducted by any member of the Seller Group
since the Lookback Date, has been conducted in material compliance with all applicable Health Care Laws and Permits, including the Regulatory
Approvals. All Regulatory Documentation and Product Promotional Material have been prepared and maintained in material compliance with
applicable Law. Members of the Seller Group Control the Purchased Regulatory Documentation and the Purchased Product Records as necessary
to conduct the Product Business as currently conducted in all material respects. Each of the Regulatory Approvals and Regulatory Approval
Applications are in full force and effect. Since the Lookback Date, no member of the Seller Group has received any written communication
or notice from any Governmental Entity threatening to withdraw, suspend or modify any Regulatory Approval or Regulatory Approval Application
in the Relevant Regulatory Territory. No member of the Seller Group is in material violation of the terms of any Regulatory Approval or
Regulatory Approval Application for the Relevant Regulatory Territory.
(b) Since
the Lookback Date, there has not been any product recall, market withdrawal, field action, safety notice or replacement conducted by or
on behalf of any member of the Seller Group concerning Products (whether or not within the Territory) or any product recall, market withdrawal,
field action, safety notice or replacement conducted by or on behalf of any Third Party concerning Products (whether or not within the
Territory).
(c) All
Regulatory Documentation required to be maintained with respect to a Product in the Relevant Regulatory Territory or the Product Business,
by Sellers or other members of the Seller Group or filed or furnished to any Governmental Entity thereby or on any of their behalf, has
been so maintained, filed or furnished and no material deficiencies have been asserted with regard thereto by a Governmental Entity since
the Lookback Date. All Regulatory Documentation and conclusions derived therefrom, utilized as the basis for or submitted in connection
with any and all requests for a Regulatory Approval or Regulatory Approval Application, when submitted to the relevant Governmental Entity
were complete and correct in all material respects and did not omit any material information as of the date of submission and any necessary
or required updates, changes, corrections or modifications to such applications, submissions, information and data pursuant to applicable
Law, have been submitted to the relevant Governmental Entity. Each of Sellers and other members of the Seller Group, as applicable, has
prepared and filed or submitted all Regulatory Documentation in accordance with Law, in each case, in all material respects. None of them
has (i) made any untrue statement of material fact or fraudulent statement to any Governmental Entity; (ii) failed to disclose
a material fact required to be disclosed to any Governmental Entity; or (iii) committed an act, made a statement, or failed to make
a statement in each case that would reasonably be expected to provide a basis for any Governmental Entity to invoke the policy respecting
“Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10,
1991) or any similar policy.
(d) All
Clinical Trials, pre-clinical studies, and post-marketing studies and other post-marketing requirements, testing or investigations conducted
by or on behalf of any of Sellers or other members of the Seller Group with regard to a Product in the Relevant Regulatory Territory or
the Product are being, or have been, conducted in material compliance with applicable Health Care Laws and Permits, including applicable
Regulatory Approvals. None of the Clinical Trials conducted by or on behalf of any member of the Seller Group with respect to a Product
(whether or not within the Territory) or the Product Business is or has been the subject of a clinical hold or is or has been terminated
or suspended prior to completion, including for safety or non-compliance reasons.
(e) None
of Sellers or other members of the Seller Group, nor, to any Sellers’ Knowledge, any CRO, CMO, other service provider or other Person
acting on any Seller’s behalf, has received written notice from any Governmental Entity that a Marketing Approval with respect to
a Product (whether or not within the Territory) will not or is likely not to be issued or maintained in full force and effect.
(f) No
member of the Seller Group in connection with the Product Business, or otherwise with respect to a Product (whether or not within the
Territory), has received written notice of any alleged material violation of, or material non-compliance with, any applicable Health Care
Laws, or has received any written correspondence or notice of potential enforcement proceedings or similar correspondence or written notice
from any Governmental Entity, in each case, regarding any Clinical Trials for any Product, or any Exploitation of any Product, in each
case whether or not within the Territory, including any warning letter, untitled letter or inquiry letter. In the case of each such item
disclosed or required to be disclosed in Section 2.1.10(f) of
the Disclosure Schedule, any required corrective action has been conducted and satisfactorily concluded in accordance with applicable
Health Care Laws.
(g) None
of Sellers or other members of the Seller Group, nor to Sellers’ Knowledge, any of their respective CROs, CMOs or other service
providers or other Persons acting on their behalf in connection with the Product Business or otherwise with respect to a Product (whether
or not within the Territory), have been debarred, excluded, or suspended from participation in any health care program or by a Governmental
Entity. No Legal Proceeding (solely to Sellers’ Knowledge as it relates to any CROs, CMOs or other service providers or other Persons
acting on their behalf in connection with the Product Business) that would reasonably be expected to result in such a debarment, exclusion
or suspension are pending or, to Sellers’ Knowledge, threatened against any of the foregoing Persons.
(h) None
of Sellers or other members of the Seller Group, nor, to Sellers’ Knowledge, any of their respective CROs, CMOs, service providers
or other Persons acting on their behalf in connection with the Product Business or otherwise with respect to a Product (whether or not
within the Territory), has received written notice (i) of any alleged material noncompliance, major or critical findings or observations,
including as a result of any audit or inspection performed by or on behalf of a Governmental Entity in connection with any Product (whether
or not within the Territory) or the Product Business, (ii) of any alleged falsification or fraudulent activity regarding any Regulatory
Documentation generated or submitted by any of them to any Person in connection with any Product (whether or not within the Territory)
or the Product Business, or (iii) that any Regulatory Documentation generated by any of them or otherwise in connection with any
Product (whether or not within the Territory) or the Product Business will not be accepted by a Governmental Entity, including based on
data integrity or other compliance concerns.
(i) No
member of the Seller Group or, to Sellers’ Knowledge, any Persons acting on their behalf in connection with the Product Business
or otherwise with respect to a Product (whether or not within the Territory), is party to or bound by any Order or other formal or informal
agreements with or imposed by any Governmental Entity concerning compliance with applicable Health Care Laws, and, to Sellers’ Knowledge,
no such agreement or Order has been threatened against such Persons, nor, to Sellers’ Knowledge, have any Persons acting on their
behalf engaged in any voluntary disclosure or mandatory self-disclosure to any Governmental Entity concerning any alleged, potential or
actual non-compliance with any Laws.
(j) Section 2.1.10(j)(i) of
the Disclosure Schedule lists each of the Clinical Trials being conducted regarding a Product in any jurisdiction, and lists for each
such Clinical Trial, the applicable study title, protocol number, ClinicalTrials.gov identifier, indication, principal Investigator, site
jurisdiction, total number of subjects enrolled, applicable Clinical Trial Authorizations, identification of any related Clinical Trial
Agreements, agreements with CROs or CMOs or other Contracts related thereto, and the status of each such Clinical Trial. Section 2.1.10(j)(ii) of
the Disclosure Schedule lists each of the Regulatory Approvals relating to a Product in the Relevant Regulatory Territory. Section 2.1.10(j)(iii) of
the Disclosure Schedule lists each Regulatory Approval Application relating to a Product in the Relevant Regulatory Territory.
(k) There
is no pending, proposed or final national or local coverage determination, or equivalent determination under applicable Law, including
any Health Care Law, in any jurisdiction that, if finalized, would restrict coverage for a Product including any coverage, benefit, or
reimbursement guidance for a Product related to applicable Health Care Law or implementation guidance.
(l) The
Seller Group and all Persons acting on its behalf have complied in all material respects with the federal Anti-Kickback Statute codified
at 42 U.S.C. §1320a-7b and any state or foreign counterparts with respect to the pricing, bundling, rebating, and discounting of
Product and with respect to any offering of no charge or rebated or discounted goods or services, including product samples.
(m) Each
member of the Seller Group has disclosed to customers, Governmental Entities or other Persons, as applicable (A) any and all rebates,
discounts or other preferential pricing of Products in the Territory, (B) any and all no charge, rebated, or discounted goods and
services including product samples, and (C) option awards to HCPs or actual ownership of a member of the Seller Group by HCPs. Each
member of the Seller Group has also developed or maintained required Regulatory Documentation relating to (A)-(C), as applicable. All
product sample programs, speaker programs, scientific or strategic advisory board programs have been terminated as of the Closing Date.
(n) Any
patient assistance or patient support program that offers, provides or intends to provide free drug product (including any Product) or
any cost-sharing assistance, such as co-pay coupons or co-pay cards in relation to a drug product, to any patient, including any federal
healthcare program beneficiaries (each, a “Patient Assistance Program”) and the offering, making, or provision of any
grants, charitable contributions, donations, sponsorships or similar support (whether in cash or in kind) that relates to or otherwise
supports any third-party Patient Assistance Program (including any co-pay assistance foundation) has been offered, provided or otherwise
conducted in compliance all applicable Health Care Laws. All such activities have been terminated as of the Closing Date.
2.1.11 Intellectual
Property.
(a) A
member of the Seller Group is the sole owner of all of the right, title and interest in and to the Product IP, free and clear of any Encumbrances.
As of the Closing Date, any rights to any Purchased Intellectual Property granted to a member of the Seller Group pursuant to a Contract
between or among members of the Seller Group has been terminated. Following the Closing, no member of the Seller Group will retain or
otherwise have any rights to the Purchased Intellectual Property except for those rights granted by Purchaser pursuant to the Intellectual
Property License Agreement. To the Sellers’ Knowledge, the Owned Registered Purchased IP is valid, subsisting and enforceable and
to the Sellers’ Knowledge, there are no facts or circumstances that would be reasonably expected to render any item of Owned Registered
Purchased IP (including any pending application) invalid or unenforceable.
(b) Section 2.1.11(b) of
the Disclosure Schedule sets forth a true and complete list of all Purchased Intellectual Property (including the Purchased Patents) that
is the subject of a registration (including an application for registration, issuance or grant) (“Owned Registered Purchased
IP”), setting forth, as applicable, the name of the current owner, the title, the jurisdictions in which Patents have been issued
and Patent applications have been filed and Trademarks have been registered and Trademark applications have been filed, along with the
current owner, the respective application, registration or filing number, and the current status of such applications, registrations or
filings. All required maintenance fees, annuity fees or renewal fees for such Owned Registered Purchased IP that are due and payable prior
to the Closing Date have been paid. To the Sellers’ Knowledge, the ownership of the Owned Registered Purchased IP is accurately
recorded with the appropriate Governmental Entity in the Territory. To Sellers’ Knowledge and except as set forth in Section 2.1.11(b) of
the Disclosure Schedule, there are no actions (including the payment of late fees or penalties) that must be taken before the Closing
or within [**] thereafter, including the payment of any registration, maintenance or renewal fees or the filing of any responses to any
Governmental Entity of office actions, documents, applications or certificates for the purposes of obtaining, maintaining, perfecting
or preserving or renewing any of the Owned Registered Purchased IP.
(c) None
of the Product IP is (i) subject to any Legal Proceeding or outstanding Order or (ii) involved in any reissue, interference,
reexamination, opposition, or other pre-grant or post-grant inter partes proceeding or other proceeding initiated by a Person that
is not a Governmental Entity, including challenges to the validity or enforceability of any Product IP before any Governmental Entity.
(d) To
Sellers’ Knowledge, the conduct of the Product Business as currently conducted or contemplated to be conducted by the Seller Group
does not infringe, misappropriate or otherwise violate any Third Party’s Intellectual Property rights and as conducted by Sellers
since the Lookback Date has not infringed, misappropriated or otherwise violated any Third Party’s Intellectual Property rights.
No Legal Proceeding is pending or threatened in writing, or, to Sellers’ Knowledge, otherwise threatened, against any member of
the Seller Group (i) based upon, challenging or seeking to deny or restrict the use, validity or enforceability of any of the Product
IP, (ii) alleging that any Exploitation of any Product in the Territory, infringes, misappropriates or otherwise violates the Intellectual
Property of any Person, or (iii) challenging the right, title or interest of a member of the Seller Group in, to or under the Product
IP. No Seller has received any written notice, or to Sellers’ Knowledge, other notice from any other Person (A) alleging any
Exploitation of any Product, infringes, misappropriates or otherwise violates the Intellectual Property of any Person, (B) challenging
the ownership of any Product IP, (C) alleging any Product IP is invalid or unenforceable, or (D) offering to license any Intellectual
Property rights to a member of the Seller Group in connection with any Exploitation of any Product.
(e) To
Sellers’ Knowledge, no Person is engaging in any activity that infringes, misappropriates or otherwise violates any Product IP.
Seller Group has taken all commercially reasonable steps to protect the Trade Secrets that are Product IP. To the Sellers’ Knowledge,
there has been no misappropriation or unauthorized disclosure of any Trade Secrets that are Product IP, or breach of any obligations of
confidentiality with respect to the Purchased Assets.
(f) All
current or former employees or contractors of a member of the Seller Group who are or were involved in the design, creation, conception,
reduction to practice or development of the Product IP have executed written contracts (i) obligating them to protect the confidential
Product IP, and (ii) assigning all their rights in the Product IP to a member of the Seller Group.
(g) No
university, military, educational institution, research center, Governmental Entity or other similar organization has sponsored research
or development conducted in connection with a Product or the Product Business that has any claim or right to, ownership of or other lien
on any Product IP. No research and development conducted in connection with a Product or the Product Business was performed by a student,
employee, post-grad, professor, researcher or other representative of any university, military, educational institution, research center,
Governmental Entity or other similar organization that has any claim or right to, ownership of or other lien on any Purchased Intellectual
Property.
(h) (i) No
member of the Seller Group is obligated to pay to any Person any royalties, fees, commissions or other amounts for the use by a member
of the Seller Group of any Purchased Intellectual Property, and (ii) immediately after the Closing, all Purchased Intellectual Property
will be fully transferable, alienable and licensable by Purchaser without restriction and without payment of any kind to any Third Party,
other than as a result of actions taken or Contracts executed by Purchaser or its Affiliates.
(i) Neither
the execution, delivery or performance of this Agreement or the Ancillary Agreements nor the consummation of any of the Transactions will,
with or without notice or lapse of time, result in, or give any other Person the right or option to cause or declare: (i) a loss
of, or Encumbrance (other than a Permitted Encumbrance) on, any Product IP; (ii) the release, disclosure or delivery of any Product
IP by or to any escrow agent or other Person; (iii) the grant, assignment or transfer to any other Person of any license or other
right or interest under, to or in any of the Product IP; (iv) Purchaser granting to any Person any right to or with respect to any
Product IP; (v) Purchaser, being bound by or subject to, any exclusivity obligations, non-compete or other restriction on the operation
or scope of its business; or (vi) Purchaser being obligated to pay any royalties or other amounts to any Person in excess of those
payable by it in the absence of this Agreement or the Transactions contemplated hereby. Following the Closing, as between the Parties,
Purchaser will have and be permitted to exercise all of Seller Groups’ rights under the Product IP to the same extent that the relevant
member of the Seller Group would have had, and been able to exercise, had this Agreement, and any other contracts, documents and instruments
to be executed and delivered after the Execution Date, not been entered into, and the Transactions contemplated herein not consummated.
2.1.12 Taxes.
(a) To
the extent failure to do so could result in Liability to Purchaser or to which the Purchased Assets, the Product Business, or the Assumed
Liabilities will be subject, with respect to any Pre-Closing Tax Period (i) all Tax Returns required to be filed with respect to
the Purchased Assets, or for which Purchaser could be held liable under a successor liability or similar theory of Law, have been properly
completed and filed on a timely basis and in correct form in all material respects, (ii) as of the time of filing, such Tax Returns
correctly reflected in all material respects the facts regarding the income, business, assets, operations, activities, status and other
matters of the Purchased Assets and any other information required to be shown thereon, (iii) no extension of time has been requested
or granted within which to file any Tax Return with respect to the Purchased Assets, and (iv) with respect to amounts in respect
of Taxes imposed with respect to the Purchased Assets for any Pre-Closing Tax Period, all applicable Tax Laws and agreements have been
complied with in all material respects and all such amounts required to be paid by the applicable member of the Seller Group to Governmental
Entities or others have been paid.
(b) No
claim, to the extent that such claim could result in Liability to Purchaser, has been made in writing, and no member of the Seller Group
has received written notice of a proposed claim, by a Governmental Entity in any jurisdiction where a member of the Seller Group does
not file Tax Returns, that such member of the Seller Group is or may be subject to taxation by that jurisdiction with respect to the Purchased
Assets, the Product Business, or the Assumed Liabilities.
(c) To
the extent failure to do so could result in Liability to Purchaser, Sellers have withheld and timely paid all Taxes required to have been
withheld and paid in connection with amounts paid or owing to any employee, independent contractor, creditor, shareholder or other Third
Party with respect to any Tax period up to and including the Closing Date.
(d) There
are no Encumbrances for Taxes upon the Purchased Assets other than current Taxes not yet due and payable.
2.1.13 Product
Liability. No member of the Seller Group has received written notice of any material claim since the Lookback Date arising out of
any claim for injury to any Person which resulted from, or alleged to have resulted from, the use of Products (excluding Adverse Events
routinely reported to Governmental Entities which are not expected to result in claims against any member of the Seller Group).
2.1.14 Solvency;
Fair Value; No Fraudulent Conveyance. As of immediately after giving effect to the Transactions, (a) each member of the Seller
Group will be able to pay its debts as they become due and will own property which has a fair saleable value greater than the amounts
required to pay its debts (including a reasonable estimate of the amount of all contingent Liabilities), and (b) each member of the
Seller Group will have adequate capital to carry on its business. The transfer of the Purchased Assets to Purchaser as contemplated by
this Agreement and the other Ancillary Agreements is made in exchange for fair and equivalent consideration. No member of the Seller Group
is entering into this Agreement or consummating the Transactions with the intent to defraud, delay or hinder its creditors and the consummation
of the Transactions will not have any such effect. The Transactions will not give rise to any right of any creditor of a member of the
Seller Group to assert any claim for fraudulent conveyance against Purchaser, any of its Subsidiaries or any of the Purchased Assets in
the hands of Purchaser or any of their respective successors and assigns following the Closing.
2.1.15 Bulk
Transfer Laws. There are no current or past creditors of a member of the Seller Group to whom any Law requires the delivery of notice
or from whom any form of Consent is required in connection with the Seller Group’s undertaking the Transactions.
2.2 Representations
and Warranties of Purchaser. Purchaser hereby represents and warrants to Sellers as follows:
2.2.1 Organization
and Qualification.
(a) Purchaser
is a company (Kabushiki Kaisha) duly organized and validly existing under the laws of Japan and has all requisite corporate power
and authority to conduct its business as it is now being conducted.
(b) Purchaser
is duly qualified and licensed to do business as a foreign company in, and is in good standing (where such concept is applicable) in,
each jurisdiction where the character of the properties owned, leased, or operated by it or the nature of its activities makes such licensing
necessary, except, in each case, where the failure to be so qualified or in good standing would not, individually or in the aggregate,
have or reasonably be expected to have a Purchaser Material Adverse Effect.
2.2.2 Authority.
Purchaser has all requisite company power and authority to execute and deliver this Agreement and each of the Ancillary Agreements to
which it will be a party, to perform its obligations hereunder and to consummate the Transactions. The execution, delivery and performance
by Purchaser of this Agreement and the Ancillary Agreements to which it will be a party and the consummation of the Transactions have
been duly and validly authorized by all necessary company action on behalf of Purchaser. This Agreement has been, and upon their execution
each of the Ancillary Agreements to which Purchaser will be a party will have been, duly executed and delivered by Purchaser and, assuming
due execution and delivery by each of the other parties hereto and thereto, this Agreement constitutes, and upon their execution each
of the Ancillary Agreements to which Purchaser will be a party will constitute, the legal, valid and binding obligation of Purchaser,
enforceable against Purchaser in accordance with their respective terms, subject to the Enforceability Exceptions.
2.2.3 Non-Contravention.
The execution, delivery and performance by Purchaser of this Agreement and each of the Ancillary Agreements to which it is a party, and
the purchase of the Purchased Assets by Purchaser and the consummation of the other Transactions do not and will not: (a) conflict
with or violate the certificate of formation or operating agreement or comparable organizational documents of Purchaser; (b) conflict
with, violate or breach any Law or Order applicable to Purchaser; or (c) conflict with, result in any breach of, result in the loss
of any right or benefit of, cause acceleration of, or constitute a default (or an event that, with notice or lapse of time or both, would
become a default), or give rise to any right to terminate, cancel, amend or accelerate under, or require any Consent of or notice to any
Person pursuant to, any Contract of Purchaser, except, in each case of clauses (a) through (c), as would not, individually or
in the aggregate, have a Purchaser Material Adverse Effect.
2.2.4 No
Broker. There is no broker, finder, financial advisor, or other Third Party acting, or who has acted, on behalf of Purchaser or any
of its Affiliates, who is entitled to receive any brokerage, finder’s, or financial advisory fee from any member of the Seller Group
in connection with the Transactions.
2.2.5 Consents.
Purchaser is not required to provide, make, seek or obtain any notice to, filing with, or Permit or Consent of any Governmental Entity
or other Person in connection with the execution, delivery and performance by Purchaser of this Agreement or any Ancillary Agreement to
which Purchaser will be a party or the consummation of the Transactions, except where the failure to provide such notice, make such filing,
or seek or obtain such Permit or Consent would not, individually or in the aggregate, have a Purchaser Material Adverse Effect.
2.3 Exclusivity
of Representations.
2.3.1 PURCHASER
ACKNOWLEDGES AND AGREES THAT, EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES CONTAINED IN SECTION 2.1
OR IN ANY ANCILLARY AGREEMENT, (A) SELLERS HAVE MADE NO REPRESENTATION OR WARRANTY WHATSOEVER HEREIN OR OTHERWISE RELATED TO A PRODUCT,
THE PRODUCT BUSINESS OR THE TRANSACTIONS AND (B) PURCHASER HAS NOT RELIED ON ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, IN
CONNECTION WITH A PRODUCT, THE PRODUCT BUSINESS OR THE TRANSACTIONS. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, PURCHASER ACKNOWLEDGES
AND AGREES THAT, EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT OR IN ANY ANCILLARY AGREEMENT, PURCHASER IS ACQUIRING THE PURCHASED ASSETS
ON AN “AS IS, WHERE IS” BASIS WITHOUT ANY EXPRESS OR IMPLIED WARRANTIES, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE
OR OTHERWISE, INCLUDING ANY WARRANTY AS TO QUALITY, THE FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, MERCHANTABILITY, CONDITION
OF THE PURCHASED ASSETS OR AS TO ANY OTHER MATTER. PURCHASER ACKNOWLEDGES AND AGREES THAT IT HAS NOT RELIED ON ANY PROJECTIONS, COST ESTIMATES
OR OTHER FORWARD-LOOKING INFORMATION PROVIDED BY OR ON BEHALF OF SELLERS (INCLUDING CONTAINED IN ANY “DATA ROOMS” OR IN ANY
MANAGEMENT PRESENTATIONS).
2.3.2 SELLERS
ACKNOWLEDGE AND AGREE THAT, EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES CONTAINED IN SECTION 2.2
OR IN ANY ANCILLARY AGREEMENT, PURCHASER HAS MADE NO REPRESENTATION OR WARRANTY WHATSOEVER HEREIN OR OTHERWISE RELATED TO THE TRANSACTIONS
AND SELLERS HAVE NOT RELIED ON ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, IN CONNECTION WITH THE TRANSACTIONS CONTEMPLATED
HEREBY OR BY THE ANCILLARY AGREEMENTS.
Article 3
COVENANTS
3.1 Post-Closing
Access and Information; Cooperation in Legal Proceedings and Investigations.
3.1.1 For
the period commencing on the Closing Date and ending on the date on which the dissolution or liquidation of the relevant member of Seller
Group becomes effective, Sellers shall, and shall cause each other member of the Seller Group to (a) preserve and retain the books
and records of Sellers and each other member of the Seller Group that are or pertain to the Excluded Assets or Excluded Liabilities (the
“Excluded Books and Records”), and (b) provide Purchaser and its Affiliates, and their respective Representatives,
reasonable access, and the right to inspect and duplicate, during normal business hours, upon reasonable prior notice to Sellers or other
members of the Seller Group, to such books and records (including any Tax records) and the personnel of Sellers and other members of the
Seller Group, in each case, to the extent such access is reasonably necessary or desirable (i) in connection with the preparation
of Purchaser’s or its Affiliates’ accounting records, or with any financial reporting or filing obligations, or audits, (ii) in
connection with the preparation of any Tax Returns or with any tax audits, (iii) in connection with any Legal Proceeding or investigation
relating to the Purchased Assets, the Assumed Liabilities or the Product Business, (iv) any inspection of Purchaser’s or its
Affiliates’ facilities by a Governmental Entity or (v) in connection with any required regulatory filing or reporting obligation
or governmental inquiry relating to the Purchased Assets, the Assumed Liabilities or the Product Business; provided, however,
that (A) Purchaser shall reimburse Sellers or other members of the Seller Group, as applicable, for all reasonable and necessary
out-of-pocket costs and expenses incurred by Sellers or other members of the Seller Group in connection with any such request, (B) Sellers
may redact any information to the extent not related to the Purchased Assets, the Assumed Liabilities or the Product Business, and (C) any
access of Purchaser or its Representatives pursuant to this Section 3.1.1
shall be conducted in a manner as not to unreasonably interfere with the operation of Sellers or other members of the Seller Group. Notwithstanding
anything to the contrary contained in this Agreement, a Seller shall not be required to disclose any information or provide any such access
if such disclosure or access would (w) violate applicable Law, (x) violate the provisions of a binding Contract (including any
confidentiality agreement to which such Seller is a party), provided, that Sellers shall use good faith efforts to obtain the Consent
of any such Third Party to such disclosure, (y) result in the waiver of any attorney-client privilege or other established legal
privilege or (z) disclose any Trade Secrets not included in the Purchased Intellectual Property. If any material is withheld by a
Seller pursuant to the immediately preceding sentence, such Seller shall inform Purchaser as to the general nature of what is being withheld
and the basis for withholding such material and use commercially reasonable efforts to provide such information in a manner and to the
extent it would not result in the aforementioned effect (including, to the extent reasonably practicable, by redacting such portions of
documents that cause such effect). Promptly following the expiration of the Bridge Period, Sellers shall provide written notice to Purchaser,
reasonably in advance of the effectiveness of the liquidation, informing Purchaser of the anticipated date on which the liquidation of
a member of the Seller Group will be completed under the laws of its jurisdiction of formation or incorporation, and upon receipt of such
notice, [**]. Purchaser shall reimburse the relevant member of the Seller Group for all reasonable and necessary out-of-pocket costs and
expenses incurred by it in connection with the foregoing transfer of the Excluded Books and Records. The access and information provided
in accordance with this Section 3.1.1
shall not in any way diminish or otherwise affect any of the representations or warranties of Sellers hereunder or Purchaser’s right
to indemnification pursuant to Article 4
in respect of any breach thereof.
3.1.2 Notwithstanding
anything to the contrary set forth in Section 3.1.1
or any other provision of this Agreement or any of the Ancillary Agreements, following the Closing, to the extent reasonably requested
by Purchaser and at Purchaser’s sole expense, Sellers shall, and shall cause each other member of the Seller Group to, reasonably
cooperate with Purchaser and its Affiliates, and their respective Representatives, in the defense or prosecution of any Legal Proceeding,
examination or audit instituted prior to or after the Closing against or by any Party or their respective Affiliates to the extent relating
to or arising out of the conduct of the Product Business or the Exploitation of a Product prior to the Closing (other than Legal Proceedings,
if any, between Purchaser or its Affiliates, on the one hand, and a member of the Seller Group, on the other hand, arising out of the
Transactions, this Agreement, or the Ancillary Agreements) (a “Relevant Legal Proceeding”). In furtherance of the foregoing,
from and after the Closing, Sellers shall, and shall cause the other members of the Seller Group to, (a) make available to Purchaser
during normal business hours and upon reasonable prior written notice, but without unreasonably disrupting its business, all available
and accessible books and records to the extent relating to the Product Business, Purchased Assets or Assumed Liabilities and (b) use
commercially reasonable efforts to make its respective personnel reasonably available for interviews, depositions and testimony, in each
case, to the extent reasonably necessary to permit the defense or investigation of any such Relevant Legal Proceeding. In order to be
able to satisfy the foregoing obligations, Sellers shall, and shall cause the other members of the Seller Group to, preserve and retain
all such books and records for the length of time contemplated by Section 3.1.1.
[**]. Notwithstanding anything to the contrary contained in this Agreement, no member of the Seller Group shall be required to disclose
any information or provide any such access if such disclosure or access would (i) violate applicable Law, (ii) violate the provisions
of a binding Contract (including any confidentiality agreement to which such member of the Seller Group is a party), provided,
that Sellers shall use good faith efforts to obtain the Consent of any such Third Party to such disclosure, (iii) result in the waiver
of any attorney-client privilege or other established legal privilege, or (iv) disclose any Trade Secrets not included in the Purchased
Intellectual Property. If any material is withheld by a member of the Seller Group pursuant to the immediately preceding sentence, a Seller
shall inform Purchaser as to the general nature of what is being withheld and the basis for withholding such material and use commercially
reasonable efforts to provide such information in a manner and to the extent it would not result in the aforementioned effect (including,
to the extent reasonably practicable, by redacting such portions of documents that would cause such effect). The access and information
provided in accordance with this Section 3.1.2
shall not in any way diminish or otherwise affect any of the representations or warranties of Sellers hereunder or Purchaser’s right
to indemnification pursuant to Article 4
in respect of any breach thereof.
3.2 Covenants
Regarding Intellectual Property.
3.2.1 Following
the Closing, Purchaser shall have the sole right and discretion, at its sole cost and expense, to file, prosecute (including the defense
of any oppositions, interferences, reissue proceedings, re-examinations and other post-grant proceedings originating in a patent office,
including the filing of any patent term extensions) and maintain any Purchased Intellectual Property (collectively, “Prosecute
and Maintain”). Following the Closing, Sellers shall, and shall cause each other member of the Seller Group to, reasonably cooperate
with Purchaser and its Affiliates, as reasonably requested by Purchaser with respect to Purchaser’s efforts to Prosecute and Maintain
and enforce the Purchased Intellectual Property, and to provide reasonable additional information and execute any documents necessary
for Purchaser or its Affiliates to Prosecute and Maintain and enforce the Purchased Intellectual Property or to secure and perfect any
of Purchaser’s rights in the Purchased Intellectual Property. Sellers shall promptly notify Purchaser in writing if any of the Sellers
or any other member of the Seller Group is notified of any Legal Proceeding by any Third Party involving any Purchased Intellectual Property,
including any nullity, revocation, interference, reexamination or compulsory license proceeding (each, a “Third Party IP Action”).
Purchaser shall have the sole right, but not the obligation, to defend against any Third Party IP Action and any such defense will be
at Purchaser’s expense. Sellers will, and will cause each member of the Seller Group to, cooperate with Purchaser and its Affiliates
and Representatives in connection with any Third Party IP Action.
3.2.2 As
between Sellers and Purchaser, Purchaser shall be responsible for filing any instruments of transfer relating to the Purchased Intellectual
Property with applicable Governmental Entities following the Closing at Purchaser’s own cost and expense. As soon as reasonably
practical after the Closing, Sellers shall complete, validly execute, and, if required under applicable Law or by Governmental Entities,
have notarized and legalized (or, as applicable, cause other members of the Seller Group to execute and, if required under applicable
Law, have notarized and legalized), at Sellers’ cost, and deliver to Purchaser (or its designee), such intellectual property assignments
and other instruments of transfer as are prepared and reasonably requested by Purchaser to record and perfect the transfer to Purchaser
or its Affiliates, as applicable, of the Owned Registered Purchased IP.
3.2.3 As
reasonably requested by Purchaser in writing following the Closing and on or before [**], the applicable Seller shall file, with the appropriate
Patent authorities in the Territory, Patent applications claiming priority to US patent application number [**] and/or EP patent application
number [**] (each, such patent application a “Post-Closing Cooperation Patent”). Upon the filing of each such Post-Closing
Cooperation Patent (a) such Post-Closing Cooperation Patent shall automatically constitute a Purchased Patent and (b) such Post-Closing
Cooperation Patent shall be automatically assigned, and is hereby assigned, to Purchaser by the applicable Seller.
3.3 Further
Assurances; Non-Assignable Assets; Wrong Pockets.
3.3.1 Subject
to Section 3.6, (a) each of the
Sellers shall, and shall cause each other member of the Seller Group to, and (b) Purchaser shall, at any time or from time to time
after the Closing, execute and deliver all such conveyance, transfer or assignment instruments and documents as the other Party may reasonably
request in order to (i) vest in Purchaser (or its designee(s)) all of the Seller Group’s right, title and interest in and to
the Purchased Assets as contemplated hereby, (ii) effectuate Purchaser’s (or its delegatee(s)’s) assumption of the Assumed
Liabilities, (iii) grant to each Party all rights that are to be granted to such Party under this Agreement or the Ancillary Agreements
and (iv) otherwise make effective the Transactions; provided, however, that after the Closing, apart from the foregoing
further assurances, neither Sellers nor Purchaser shall have any other obligations except as specifically set forth in this Agreement
or in the Ancillary Agreements. For the avoidance of doubt, to effect the transfer, assignment and conveyance of the Purchased Assets
to, and the assumption of the Assumed Liabilities by, Purchaser (or its designee(s) or delegatee(s)), the Parties shall promptly
apply to the applicable Governmental Entity for any necessary Consents.
3.3.2 Without
limiting Sellers’ obligations under Sections 1.1.1,
1.4.2(a)(i) or 3.6,
to the extent that a Seller’s rights under any Purchased Asset may not be conveyed, transferred or assigned (a) under applicable
Law or (b) without the Consent of another Person and such Consent has not been obtained prior to the Closing, this Agreement shall
not constitute an agreement to convey, transfer or assign the same if an attempted conveyance, transfer or assignment would be unlawful
or constitute a breach of the underlying Contract which provides for the Consent. If (i) the Consents set forth on Section 2.1.5(c) of
the Disclosure Schedule shall not have been obtained prior to the Closing and (ii) the relevant Purchased Asset whose assignment,
transfer or conveyance requires such Consent is reasonably necessary for the conduct of the Product Business, then Sellers shall, and
shall cause each other member of the Seller Group to, until expiration of the Bridge Period, use their commercially reasonable efforts
to assist and cooperate with Purchaser and its Affiliates in order to obtain such Consent to the assignment, transfer or conveyance thereof;
provided, that neither Sellers nor any of their Affiliates shall be required to pay any amount of money to any Third Party, commence
any Legal Proceeding or offer or grant any non-de minimis accommodation (financial or otherwise) to any Third Party in connection with
such efforts or otherwise in complying with its obligations under this Section 3.3.2.
Until any such Consent is obtained and the related Purchased Asset is transferred, assigned and conveyed to Purchaser (or its designee(s)),
Sellers shall, and shall cause each other member of the Seller Group to, use their commercially reasonable efforts to (A) provide
to Purchaser substantially comparable benefits thereof and (B) enforce, at the request of and for the account and at the expense
of Purchaser, any rights of Sellers arising under any such Purchased Asset against any Person. To the extent that Purchaser or any of
its Affiliates is provided with benefits of any such Purchased Asset, Purchaser or such Affiliate shall perform the obligations of the
relevant Sellers associated with the benefits received by Purchaser or such Affiliate thereunder to the extent that such obligations would
constitute an Assumed Liability. Once any such Consent for the transfer, conveyance or assignment of any such non-assignable asset is
obtained, Sellers shall, and shall cause each other member of the Seller Group to, convey, assign, transfer and deliver such non-assignable
asset to Purchaser (or its designee(s)) at no additional cost to Purchaser. To the extent that the Parties are not successful in providing
the economic claims, rights and benefits under a Purchased Asset that is not transferred, assigned or conveyed to Purchaser (or its designee(s))
as a result of this Section 3.3.2 prior
to the expiration of the Bridge Period, such asset will cease to be a Purchased Asset and all Liabilities with respect to such asset shall
constitute Excluded Liabilities.
3.3.3 In
the event that, within the Bridge Period, Purchaser or an Affiliate of Purchaser receives any invoices from any Third Party with respect
to any account payable of the Product Business outstanding, and to the extent attributable to the period prior to the Closing, then Purchaser
shall, within [**] of receipt of such invoice, provide a copy of such invoice to Nabriva Parent, and Sellers shall solely be responsible
to pay and discharge or challenge such invoice. In the event that, within the Bridge Period, Sellers or any of their Affiliates receive
any invoices from any Third Party with respect to any account payable of Purchaser or any of its Affiliates for any period after the Closing,
then Sellers shall, within [**] of receipt of such invoice, provide a copy of such invoice to Purchaser, and Purchaser shall solely be
responsible to pay and discharge or challenge such invoice.
3.3.4 Subject
to Section 3.3.2 and Section 3.6,
if during the Bridge Period either Purchaser or any Affiliate of Purchaser, on the one hand, or any of the Sellers or any other member
of the Seller Group, on the other hand, becomes aware that any of the Purchased Assets has erroneously not been transferred, assigned
or conveyed to Purchaser or its Affiliates (as applicable) at the Closing or that any of the Excluded Assets has erroneously been transferred
or assigned to Purchaser or its Affiliates at the Closing, it shall promptly notify the other and the Parties shall, as soon as reasonably
practicable, ensure that such property is transferred, at the expense of the Party that is seeking the assets to be transferred to it,
to (a) Purchaser or its Affiliates (as applicable), in the case of any Purchased Asset which was erroneously not transferred, assigned
or conveyed to Purchaser or such Affiliate at the Closing; or (b) the relevant Seller, in the case of any Excluded Asset which was
erroneously transferred, assigned or conveyed to Purchaser at the Closing.
3.4 Publicity.
Purchaser will not and will cause its controlled Affiliates not to, and Sellers will not and will cause each member of the Seller Group
and their Affiliates not to, make any public announcement related to this Agreement or the Transactions without the mutual approval of
Nabriva Parent and Purchaser, except any public disclosure which either Purchaser or Nabriva Parent, in its good faith judgment, believes
is required by applicable Law or by any stock exchange on which its securities or those of its Affiliates are listed; provided,
that each of Purchaser and its Affiliates and Sellers, members of the Seller Group and their Affiliates may make any public statement
in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst calls, or issue
press releases, so long as any such public statement or press release is consistent with prior public disclosures, press releases or
public statements approved by the other party pursuant to this Section 3.4
and which do not reveal non-public information about the other Parties. If a Party, in its good faith judgment, believes such disclosure
is so required, such Party shall use its commercially reasonable efforts (to the extent reasonably practicable) to consult with the other
Parties and their Representatives, and to consider in good faith any revisions proposed by the other Parties or their Representatives,
as applicable, prior to making (or prior to any of its Affiliates making) such disclosure, and shall limit such disclosure to only that
information which is legally required to be disclosed. Notwithstanding the foregoing, (a) Purchaser and its Affiliates, on the one
hand, and members of the Seller Group, on the other hand, may make internal announcements to their respective employees, Representatives
and Affiliates and public announcements that are consistent with a communications plan agreed upon by Nabriva Parent and Purchaser, (b) each
Party may communicate with government officials, customers and suppliers regarding this Agreement and the Transactions (to the extent
that, in the case of customers and suppliers, such communications are consistent with a communications plan agreed upon by Nabriva Parent
and Purchaser), and (c) following the Closing, Purchaser and its Affiliates may make such disclosures and announcements regarding
their use and operation of the Product Business, Purchased Assets and Assumed Liabilities as they determine in their sole discretion,
and any member of the Seller Group may make such disclosures and announcements regarding the Excluded Assets and Excluded Liabilities
as it may determine in its sole discretion. Neither Purchaser nor any member of the Seller Group may issue a press release announcing
the execution and delivery of this Agreement or the Closing without the prior written consent of the other Party, and provided that the
content of such press release must be consented to by Nabriva Parent and Purchaser prior to its issuance (such consent not to be unreasonably
withheld, conditioned or delayed).
3.5 Confidentiality.
3.5.1 From
and after the Closing, each of the Parties (a) shall hold, and shall direct its respective Affiliates and Representatives to hold,
in strict confidence from any Person all Confidential Information furnished to it by or on behalf of the other Parties in connection with
the Transactions, (b) shall not, directly or indirectly, disclose, divulge or make any use of, and will cause its respective Affiliates
and their Affiliates’ respective Representatives to not, directly or indirectly, disclose, divulge or make any use of, any Confidential
Information, including disclosure to journalists, customers, vendors, employees and consultants of such Party, participants or analysts
in the industry in which the Product Business or the retained businesses of the Seller Group, as applicable, are conducted or through
social media, except that such Party may disclose Confidential Information solely to the extent required to (i) perform its obligations
or exercise its rights under this Agreement or any Ancillary Agreement, (ii) comply with applicable Law or the rules or orders
of any stock exchange on which its securities or those of its Affiliates are listed, (iii) prepare accounting records or in connection
with any audits, (iv) prepare any Tax Returns or in connection with any tax audits, or (v) with respect to the Seller Group,
comply with the applicable member of the Seller Group’s specific obligations under the Extraterritorial Agreements, and for no other
purpose, and (c) shall, and shall cause its Affiliates and Representatives to, protect Confidential Information from disclosure using
the same degree of care as the applicable Party used to protect its own proprietary and confidential information from unauthorized use
or disclosure, but in no event less than a reasonable degree of care. Each Party acknowledges and agrees that the Confidential Information
is proprietary and confidential in nature and that such Party shall be responsible for any breach of the confidentiality obligations set
forth in this Section 3.5 by any of
its Affiliates or Representatives. Notwithstanding anything to the contrary set forth herein, this Section 3.5
does not prohibit any disclosure permitted by Section 3.4,
or any disclosure required to be made by applicable Law so long as, to the extent legally permissible, the disclosing Party provides to
the other Parties with reasonable prior notice of such disclosure and a reasonable opportunity (at such other Parties’ sole cost
and expense) to contest such disclosure and the disclosing Party shall use its reasonable best efforts to obtain assurance that confidential
treatment will be accorded to such Confidential Information.
3.5.2 For
purposes of this Agreement, “Confidential Information” means (a) with respect to the obligations of Sellers pursuant
to Section 3.5.1, all information included
in the Purchased Product Records, Product Promotional Material or relating to a Product, the Purchased Assets or Assumed Liabilities,
Purchaser, Purchaser’s Affiliates or their respective Representatives, contractors, suppliers, vendors, distributors or similar
Third Parties, or their respective businesses (including all Patent Files and Trade Secrets within the Purchased Intellectual Property)
and the existence and terms of this Agreement and the Ancillary Agreements, and (b) with respect to the obligations of Purchaser
pursuant to Section 3.5.1, all information
provided to Purchaser or any of its Affiliates or Representatives relating to any of the Sellers, other members of the Seller Group, or
their respective Affiliates or businesses, except to the extent such information relates to the Purchased Product Records, Product Promotional
Material, a Product in the Territory, the Product Business, Purchased Assets or Assumed Liabilities. Notwithstanding the foregoing, Confidential
Information shall not include information that, in each case as demonstrated by written documentation: (i) was generally available
to the public or otherwise part of the public domain at the time of its disclosure; (ii) became generally available to the public
or otherwise part of the public domain after its disclosure other than through any act or omission in breach of this Agreement or any
other confidentiality obligation; (iii) is subsequently disclosed by a third party without obligations of confidentiality with respect
thereto; or (iv) is subsequently independently developed without the aid, application or use of Confidential Information.
3.6 Delivery
of Purchased Assets.
3.6.1 Sellers
will deliver, or will cause to be delivered, to Purchaser (or its applicable designee(s)), through the method of delivery reasonably determined
by Purchaser and communicated to Sellers in advance of the Closing, the Purchased Intellectual Property, any Regulatory Documentation,
any Purchased Product Records, and any other items included in the Purchased Assets, in each case to the extent in electronic format,
through (a) Electronic Delivery or (b) to the extent communicated by Purchaser to Sellers in advance of the Closing, delivery
through one or more USB flash drives or similar portable data storage devices by or on behalf of Sellers to the address(es) designated
by Purchaser in advance of the Closing. The Parties agree that the delivery pursuant to this Section 3.6.1
shall be made (i) if through Electronic Delivery, at the Closing and (ii) if through the delivery of USB flash drives or similar
portable data storage devices in accordance with the provisions of this Section 3.6.1,
promptly, and in no event later than [**], following the Closing. The Parties agree that Sellers will include in the delivery pursuant
to this Section 3.6.1, among other items,
(A) all Lab Notebooks that are in electronic form as of the Closing Date, and (B) to the extent the original Lab Notebooks are
in physical form, any electronic copies thereof that Sellers or any other member of the Seller Group has as of immediately prior to the
Closing.
3.6.2 Except
as expressly set forth in this Section 3.6
or elsewhere in this Agreement and unless Nabriva Parent and Purchaser otherwise mutually agree in writing, delivery of any tangible assets
or property, including any Purchased Regulatory Documentation, Purchased Product Records, Product Promotional Material and Patent Files
that are not in electronic format that are included in the Purchased Assets shall be made by the respective member of the Seller Group
to Purchaser (or one or more of its designees) in the manner, to the locations and at the times set forth in Schedule 3.6.2.
On or as promptly as reasonably practicable (but in no event later than [**]) after the Closing Date, Nabriva Parent shall notify all
of Seller Group’s agents and other Third Parties that hold files or other tangible assets, including any Regulatory Documentation,
included in the Purchased Assets that, effective as of the Closing, Purchaser (or one or more of its designees) owns, with directions
to deliver such Purchased Assets to Purchaser (or its designees) in accordance with Purchaser’s reasonable instructions. Sellers
shall pay for any costs or expenses associated with the delivery of the Purchased Assets to Purchaser or any of its designees in accordance
with this Agreement.
3.6.3 Subject
to Section 3.5, Sellers may retain copies
of the Regulatory Documentation and the Product Records included within the Purchased Assets to the extent necessary for Taxes or accounting
matters; provided that access to such information shall be restricted to legal counsel of the Seller Group and such employees of
the Seller Group who have a “need to know” such information in connection therewith.
3.6.4 Notwithstanding
anything to the contrary set forth in this Agreement, Sellers expressly agree that all Purchased Assets which are not delivered on the
Closing Date in accordance with the terms of this Agreement are deemed to be held in trust and to the order of Purchaser pending delivery
thereof to Purchaser pursuant to this Agreement.
3.7 Regulatory
Matters.
3.7.1 After
the Closing, as requested by Purchaser from time to time, qualified personnel from the Seller Group familiar with the books and records
and other documents and materials included within the Purchased Assets or the Purchased Intellectual Property will reasonably cooperate
with Purchaser and its Affiliates and their respective Representatives, upon reasonable advance notice and during reasonable hours, and
exchange knowledge, including by meeting or participating in telephone conference calls with personnel from Purchaser or Purchaser’s
designee at such agreed upon times, all as reasonably necessary to ensure a prompt transition of all of the Purchased Assets and Purchased
Intellectual Property to Purchaser and its Affiliates. Sellers shall designate a transition manager to act as the primary contact person
with respect to all matters relating to this Section 3.7.
Purchaser shall designate a transition manager to act as the primary contact person with respect to all matters relating to this Section 3.7.
3.7.2 Notwithstanding
anything to the contrary in this Section 3.7,
for as long as the marketing authorization application filed with the NMPA and the import drug license application filed with NMPA (such
applications together, the “Pending NMPA Applications”) are pending, [**].
3.7.3 Each
of Sellers shall use commercially reasonable efforts to, and shall cause each other member of the Seller Group to use commercially reasonable
efforts to, deliver all Purchased Regulatory Documentation (including Governmental Transfer Consents for the transfer to Purchaser of
data deriving from or relating to Clinical Trials) and, to the extent applicable, technology export recordals or approvals with respect
to technical information (including pursuant to People’s Republic of China Technology Import and Export Administration Regulation)
to Purchaser at the Closing, except to the extent a recordal with, or an approval by, a Governmental Entity for such transfer (“Governmental
Transfer Consent”) is required, in which case, Sellers shall furnish evidence of having applied to relevant Governmental Entities
to obtain such Governmental Transfer Consent at the Closing, and Sellers shall use their reasonable best efforts to obtain such Governmental
Transfer Consent as promptly as practical following the Closing. To the extent that any Purchased Regulatory Documentation or technology
export recordal or approval is not delivered at the Closing in accordance with the immediately preceding sentence, Sellers shall, and
shall cause each other member of the Seller Group to, deliver all such Purchased Regulatory Documentation and technology export recordals
or approvals to Purchaser at the latest within [**] after Closing. Delivery to Purchaser of Purchased Regulatory Documentation pursuant
to this Section 3.7 shall be effected
(i) for electronic files, in accordance with Section 3.6.1,
with the electronic files contained therein appropriately named and organized in a reasonably logical and functional order with a separate
index provided, and (ii) for all files submitted to a Governmental Entity, in the original format in which they were submitted to
such Governmental Entity (e.g., paper, electronic, eCTD, Nees) and in their entirety, with all electronic source files provided
for such submission files (e.g., Microsoft Word, working files) in accordance with Sections 3.6.1
and 3.6.1. Concurrent with such transfer, Sellers
shall, and shall cause each other member of the Seller Group to, provide Purchaser or an Affiliate of Purchaser (as determined in Purchaser’s
sole discretion and communicated by Purchaser to Sellers) with all associated datasets using SAS transport files and metadata (e.g.,
programs, user guides), including the datasets used for all reports (e.g., CSR, ISE, ISS) including SDTM and ADAM datasets.
3.7.4 With
respect to each Regulatory Approval Application set forth on Schedule 3.7.4,
for the period of time from the Closing until the earliest of (a) acceptance by the applicable Governmental Entity in the Territory,
(b) denial by the applicable Governmental Entity in the Territory or (c) voluntary withdrawal, termination or transfer to Purchaser
(in each case, at the direction of Purchaser) of such Regulatory Approval Application, the members of the Seller Group shall take all
steps that are reasonably necessary to obtain the acceptance or transfer to Purchaser of such Regulatory Approval Application.
3.7.5 During
the Bridge Period, Sellers shall reasonably cooperate with Purchaser in good faith to reasonably (determined in light of Sellers’
then operations, infrastructure, and employees), in each case at Purchaser’s cost, (a) support Purchaser’s communications
and meetings with Governmental Entities as reasonably requested to support Purchaser’s Clinical Trial Authorization Applications,
Marketing Approval Applications and obligations under Regulatory Approvals with respect to a Product in the Territory (provided that Purchaser
shall be solely responsible for the preparation of any materials submitted in connection with any such communications or meetings) and
Sellers shall cause Nabriva Parent and Nabriva DAC to remain in existence to the extent necessary to comply with the foregoing and consistent
with their obligations set forth in Section 3.15,
and (b) consult with Purchaser regarding the status of development of a Product in the Territory, including ongoing discussions with
regulators, partners, sites and vendors and the content of the Purchased Product Records and Purchased Regulatory Documentation.
3.7.6 Notwithstanding
anything in this Agreement to the contrary, Sellers shall be permitted to delegate any obligations set forth in this Section 3.7
to any of its Affiliates or Third Parties; provided that Sellers shall remain responsible for the performance of such delegated
obligations.
3.8 Certain
Tax Matters.
3.8.1 Withholding
Taxes. The amounts payable by one Party (the “Payer”) to another Person (the “Payee”) pursuant
to this Agreement (“Payments”) shall not be reduced on account of any Taxes unless required by applicable Law. The
Payee alone shall be responsible for paying any and all Taxes (other than withholding Taxes required to be withheld and filed by the Payer)
levied on account of, or measured in whole or in part by reference to, any Payments it receives. The Payer shall deduct or withhold from
the Payments any Taxes that it is required by applicable Law to deduct or withhold; provided that in the case of any amount required
to be deducted or withheld by the Payer from any Payment under applicable Law, such amount shall be treated for all purposes of this Agreement
as having been paid to the Payee. Other than with respect to wages or compensation related to employment, in the event that Payer determines
that such withholding and deduction is required, the Payer shall (a) provide the Payee with reasonable notice of such determination
(at least [**] prior to the proposed payment date), (b) consult with the Payee to determine whether the withholding Tax is legally
required, and (c) cooperate with the Payee as reasonably requested by the Payee to reduce the amount of any such withholding to the
extent permitted under applicable Law. The Payee shall co-operate with the Payer in completing any procedural formalities, including delivering
any completed documentation or providing any information as may be reasonably requested by the Payer, necessary for the Payer to make
any payment without withholding or subject to a reduced rate of withholding or to comply with any obligation on the Payor to file or hold
such documentation. If the Payee is entitled under any applicable Tax treaty to a reduction of rate of, or the elimination of, or recovery
of, applicable withholding Tax, it shall deliver to the Payer or the appropriate Governmental Entity (with the assistance of the Payer
to the extent that this is reasonably required and is expressly requested in writing) the prescribed forms necessary to reduce the applicable
rate of withholding or to relieve the Payer of its obligation to withhold Tax, and the Payer shall apply the reduced rate of withholding,
or dispense with the withholding, as the case may be. If, in accordance with the foregoing, the Payer withholds any amount, it shall make
timely payment to the proper taxing authority of the withheld amount, and send to the Payee proof of such payment within [**] following
that payment.
3.8.2 Allocation
of Purchase Price.
(a) The
Parties agree that the Purchase Price will be allocated amongst the Purchased Assets, the Assumed Liabilities and, to the extent appropriate,
the Ancillary Agreements, as set forth in Schedule 3.8.2(a) (the
“Allocation”).
(b) The
Allocation will be conclusive and binding upon the Parties for Tax purposes, and no Party will make any statement or declaration to any
taxing authority that is inconsistent with the Allocation. No Party will take or permit any of its Affiliates or Representatives to take
any position on any tax return with any taxing authority or in any judicial Tax proceeding that is inconsistent with the Allocation. Each
Party will timely notify the other Parties, and will timely provide the other Parties with assistance, in the event of an examination,
audit or other proceeding regarding the Allocation.
3.8.3 Transfer
Taxes and Apportioned Obligations.
(a) All
amounts payable hereunder or under any Ancillary Agreement are exclusive of all recordation, transfer, documentary, excise, sales, value
added, use, stamp, conveyance or other similar Taxes, duties or governmental charges, and all recording or filing fees or similar costs,
imposed or levied by reason of, in connection with or attributable to this Agreement and the Ancillary Agreements or the Transactions
(collectively, “Transfer Taxes”). All Transfer Taxes payable in the United States (to the extent applicable), Ireland
or Austria shall be borne by Sellers (collectively, “Covered Transfer Taxes”). All Tax Returns with respect to Covered
Transfer Taxes shall be timely filed by the member of the Seller Group responsible for such filing under applicable Law. To the extent
Purchaser would be the Person responsible for making a Tax Return in respect of Covered Transfer Taxes, Sellers shall prepare such Tax
Returns for execution by Purchaser, unless otherwise agreed between the Parties. Purchaser shall sign and file such Tax Returns (with
any changes that Purchaser determines are necessary to comply with applicable Law) and Sellers shall provide Purchaser with funds sufficient
to pay such Covered Transfer Taxes. Each Party shall use their commercially reasonable efforts to obtain any available exemption from
such Covered Transfer Taxes and to cooperate with the other Parties in providing any information or documentation that may be necessary
to obtain such exemptions.
(b) If
any part of the Covered Transfer Taxes is VAT which is, or becomes, chargeable on the transfer of the Purchased Assets from a Seller to
Purchaser then: (i) where Seller is the Person required to account to the relevant Governmental Entity for the VAT, the Seller shall
pay the VAT to the relevant Governmental Entity and provide Purchaser with a valid VAT invoice evidencing the amount of the VAT paid,
and to the extent Purchaser has a right to recover this VAT from the relevant Governmental Entity, Purchaser shall use best endeavors
to do so and promptly pay to the Seller an amount equal to any credit or repayment Purchaser receives from the relevant Governmental Entity;
and (ii) where Purchaser is the Person required to account to the relevant Governmental Entity for the VAT, the Seller shall promptly,
following demand from Purchaser, pay to Purchaser an amount equal to the VAT chargeable but only to the extent that Purchaser reasonably
determines that it is not entitled to credit or repayment from the relevant Governmental Entity in respect of that VAT. In all cases,
if VAT arises on the Transactions, Sellers will issue a valid VAT invoice to Purchaser in accordance with applicable Laws.
(c) All
personal property and similar ad valorem obligations levied with respect to the Purchased Assets for a taxable period which includes
(but does not end on) the Closing Date (collectively, the “Apportioned Obligations”) shall be apportioned between members
of the Seller Group, on the one hand, and Purchaser, on the other hand, based on the number of days of such taxable period ending on the
day prior to the Closing Date (such portion of such taxable period, the “Pre-Closing Straddle Tax Period”) and the
number of days of such taxable period on and after the Closing Date (such portion of such taxable period, the “Post-Closing Straddle
Tax Period”). The Seller Group shall be liable for the proportionate amount of such Apportioned Obligations that is attributable
to the Pre-Closing Straddle Tax Period, and Purchaser shall be liable for the proportionate amount of such Apportioned Obligations that
is attributable to the Post-Closing Straddle Tax Period.
(d) Notwithstanding
anything to the contrary set forth in this Agreement, Sellers and their Affiliates shall remain solely and fully liable for any and all
Taxes incurred by Purchaser or any of its Affiliates as a result of the Parties’ non-compliance with any applicable bulk sales,
bulk transfer or similar Laws.
(e) Apportioned
Obligations, Covered Transfer Taxes and Taxes as a result of non-compliance with bulk sales, bulk transfer or similar Laws shall be timely
paid, and all applicable filings, reports and returns shall be filed, as provided by applicable Law. The paying Party shall be entitled
to reimbursement from the non-paying Party in accordance with Section 3.8.3(a) or
Section 3.8.3(c), as the case may be.
Upon payment of any such Apportioned Obligation or Transfer Tax, the paying Party shall present a statement to the non-paying Party setting
forth the amount of reimbursement to which the paying Party is entitled under Section 3.8.3(a) or
Section 3.8.3(b), as the case may be,
together with such supporting evidence as is reasonably necessary to calculate the amount to be reimbursed. The non-paying Party shall
make such reimbursement promptly but in no event later than [**] after the presentation of such statement.
3.8.4 Cooperation
and Exchange of Information. Each of Sellers and Purchaser shall (a) provide the other with such assistance as may reasonably
be requested by the other in connection with the preparation of any Tax Return, audit or other examination by any taxing authority or
judicial or administrative proceeding relating to Liability for Taxes in connection with the Product Business or the Purchased Assets,
(b) retain and provide the other with any records (or copies of such records) or other information that may be relevant to such Tax
Return, audit or examination, proceeding or determination, and (c) inform the other of any final determination of any such audit
or examination, proceeding or determination that affects any amount required to be shown on any Tax Return of the other for any period.
3.9 Termination
of Existing Nabriva Agreements. Sellers will, and will cause each other member of the Seller
Group to, and Purchaser will, and will cause each of its relevant Affiliates to, execute and deliver to the other Parties, prior to Closing,
the Termination Agreement regarding the Existing Nabriva Agreements in the form attached hereto as Exhibit D.
3.10 Non-Competition.
3.10.1 Sellers
understand that Purchaser shall be entitled to protect and preserve the going concern value of the Product Business following the Closing
to the extent permitted by Law and that Purchaser would not have entered into this Agreement absent the provisions of this Section 3.10
and, therefore, for a period of [**] following the Closing Date, Sellers shall not, and shall cause their Affiliates, successors and permitted
assigns and their respective Representatives not to, directly or indirectly, whether as principal, agent, partner, stockholder or otherwise,
alone or in association with any other Person, (a) engage in Exploiting a Competing Product in the Territory (other than the Manufacture
of a Competing Product in the Territory solely for Development or Commercialization outside of the Territory), (b) own, operate or
control any Person engaged in Exploiting a Competing Product in the Territory (other than the Manufacture of a Competing Product in the
Territory solely for Development or Commercialization outside of the Territory), or (c) grant or transfer any right or license to
or enter into any collaboration or consultation with any Person, by Contract or otherwise, specifically to Exploit a Competing Product
in the Territory (other than the Manufacture of a Competing Product in the Territory solely for Development or Commercialization outside
of the Territory). As used herein, “Competing Product” means, with respect to any Product, any drug product that (i) is
a Product or is substitutable for such Product (by virtue of being deemed by any Governmental Entity in the Territory as therapeutically
equivalent to such Product) or (ii) contains the same therapeutic moiety, or its precursor, a salt, prodrug, metabolite, enantiomer,
polymorph, analog, racemate, diastereomer, tautomer, solvate, hydrate or ester (but not necessarily in the same amount or dosage form)
as such Product.
3.10.2 Purchaser
understands that Sellers shall be entitled to protect and preserve the going concern value of the Seller Product Business following the
Closing to the extent permitted by Law and that Sellers would not have entered into this Agreement absent the provisions of this Section 3.10
and, therefore, for a period of [**] following the Closing Date, Purchaser shall not, and shall cause their Affiliates and its and their
respective Representatives not to, directly or indirectly, whether as principal, agent, partner, stockholder or otherwise, alone or in
association with any other Person, (a) engage in Exploiting a Competing Product outside of the Territory (other than the Manufacture
of a Product outside of the Territory solely for Development or Commercialization within the Territory), (b) own, operate or control
any Person engaged in Exploiting a Competing Product outside of the Territory (other than the Manufacture of a Product outside of the
Territory solely for Development or Commercialization within the Territory), or (c) grant or transfer any right or license to or
enter into any collaboration or consultation with any Person, by Contract or otherwise, specifically to Exploit a Competing Product outside
of the Territory (other than the Manufacture of a Product outside of the Territory solely for Development or Commercialization within
the Territory). Notwithstanding anything to the contrary set forth in this Section 3.10.2
or elsewhere in this Agreement, Purchaser and its Affiliates shall not be restricted from Exploiting a Competing Product outside of the
Territory to the extent that Purchaser or an Affiliate of Purchaser is permitted to do so by the terms of a license for the Exploitation
of such Product granted by any of the Sellers, any other member of the Seller Group, or any sublicensee thereof.
3.10.3 The
restrictions in this Section 3.10 shall
be deemed to consist of a series of separate covenants, one for each line of business included within the Product Business or the Seller
Product Business, respectively, and each country, state or other region included within the Territory or outside the Territory, respectively.
Each of the Parties acknowledges that this Section 3.10
has been negotiated by the Parties and that the character, duration, geographic area and subject matter scope of this Section 3.10
are fair and reasonable in light of the circumstances as they exist upon the Closing Date, including Purchaser’s plans for the Purchased
Assets and the Product Business and Sellers’ plans for the Seller Product Business, and (in respect of Purchaser) are necessary
to accomplish the full transfer of the goodwill and other intangible assets contemplated hereby. However, if a court of competent jurisdiction
determines at a later date that the character, duration, geographical area or subject matter scope of this Section 3.10
exceeds that permitted by applicable Law in a particular jurisdiction, then the Parties agree that this Section 3.10
will be reformed to the maximum character, duration, geographical area and subject matter scope, as the case may be, permitted by applicable
Law in such jurisdiction, without affecting the enforceability of any provisions of Section 3.10
in other jurisdictions within the Territory, in respect of Purchaser, or outside of the Territory, in respect of Sellers. If, in any judicial
proceeding, a court shall refuse to enforce all of the separate covenants deemed included in this Section 3.10
because, taken together, they are more extensive (after giving effect to any reformation contemplated
by the preceding sentence) than necessary or appropriate to assure Purchaser or Sellers, as applicable, of the intended benefit of this
Section 3.10, it is expressly understood
and agreed among the Parties hereto that those of such covenants that, if eliminated, would permit the remaining separate covenants to
be enforced in such proceeding shall, for the purpose of such proceeding, be deemed eliminated from the provisions hereof in that jurisdiction.
3.11 Insurance.
In the event that prior to the Closing Date any Purchased Asset suffers any damage, destruction or other loss as a result of a casualty
event or otherwise, Sellers shall, after the Closing Date, to the extent legally permissible, assign to Purchaser all rights of Sellers
and or other members of the Seller Group against Third Parties with respect to any causes of action, whether or not a Legal Proceeding
has commenced as of the Closing Date, in connection with such damage, destruction or other loss; provided, however, that
the proceeds of such insurance shall be subject to (and recovery thereon shall be reduced by the amount of) any applicable deductibles
and co-payment provisions or any payment or reimbursement obligations of Sellers in respect thereof.
3.12 Right
of Reference.
3.12.1 Purchaser
will have a perpetual, irrevocable right of reference to any Regulatory Documentation that is Controlled by the Seller Group and that
is reasonably required for the Exploitation of any Product in the Territory. Sellers shall provide to Purchaser and to any Governmental
Entity specified by Purchaser a letter, in the form reasonably acceptable to Purchaser or the relevant Governmental Entity, acknowledging
that Purchaser has the rights of reference to such Regulatory Documentation granted pursuant to this Section 3.12.
Sellers shall use their reasonable best efforts to procure that their obligations set forth in this Section 3.12
will also apply to any Third Party that acquires (whether through merger or business combination, asset acquisition, stock acquisition,
or otherwise) the relevant rights to Exploit a Product outside of the Territory, such that the Third Party will be subject to Purchaser’s
right of reference pursuant to this Section 3.12.
Following the Bridge Period, Sellers shall provide written notice to Purchaser informing Purchaser of the anticipated date on which the
liquidation or dissolution of a member of the Seller Group will be completed or become effective. Purchaser shall have the right to acquire
the Regulatory Documentation related to conduct outside of the Territory owned by such liquidating or dissolving member of the Seller
Group and have such Regulatory Documentation transferred to Purchaser (or one of its designees) at Purchaser’s expense. Purchaser
may exercise such right by written notice to Nabriva Parent, which notice shall include the desired method of delivery and the location
to which delivery shall be made, and upon Purchaser so exercising its right, Sellers shall, and shall cause the relevant member of the
Seller Group to, promptly transfer the acquired Regulatory Documentation of the applicable dissolving or liquidating member of the Seller
Group, for no additional consideration, in accordance with Purchaser’s exercise notice but such purchase may be subject to Purchaser
assuming a member of the Seller Group’s obligations under the Existing Nabriva License Agreements to provide access or a right of
reference to such Regulatory Documentation. Purchaser shall reimburse the relevant member of the Seller Group for all reasonable and necessary
out-of-pocket costs and expenses actually incurred by it in connection with the foregoing transfer.
3.12.2 Sellers
will have a right of reference to any Regulatory Documentation transferred to Purchaser or one of its Affiliates hereunder, but only to
the extent reasonably necessary to permit Sellers to fulfill their then-existing contractual obligations outside of the Territory.
3.13 PV-Related
Activities. After the Closing and at least until the expiration of the Bridge Period, Sellers
shall continue to (a) maintain the global safety data base for a Product and (b) be responsible for the coordination of all
global pharmacovigilance-related activities related to a Product and for the collection of any safety information under and in accordance
with that certain Safety Data Exchange Agreement, dated as of August 2, 2019, by and between Nabriva DAC and Sumitomo Pharma (Suzhou)
Co., Ltd. (formerly: Sumitomo Pharmaceuticals (Suzhou) Co., Ltd.) (“SMPC”). In accordance with all applicable
Laws and applicable guidelines, at least until the expiration of the Bridge Period, the Parties agree to monitor, exchange and report
safety information for a Product in the Territory and the countries and regions set forth in Schedule 3.13.
Sellers will use their reasonable best efforts to procure that the obligations set forth in this Section 3.13
will also apply to any Third Party that acquires (whether through merger or business combination, asset acquisition, stock acquisition,
or otherwise) the relevant rights to Exploit a Product outside of the Territory. Purchaser covenants and agrees that if Purchaser (or
any of its Affiliates) sells or transfers to a Third Party any rights related to the Product Business within the Territory prior to each
Seller having been liquidated, Purchaser will either (i) make available to Sellers (or such other member of the Seller Group designated
by Nabriva Parent) pharmacovigilance-related information received by Purchaser from the relevant acquiror or (ii) cause the relevant
acquiror to enter into a pharmacovigilance-related agreement with Nabriva Parent (or such other member of the Seller Group designated
by Nabriva Parent), in each case as necessary for Sellers that have not been liquidated to fulfill their pharmacovigilance-related responsibilities
under applicable Law.
3.14 [Intentionally
Omitted]
3.15 Sellers’
Obligations during Bridge Period; Expense Reimbursement.
3.15.1 During
the Bridge Period, Sellers shall, and shall cause each of the other members of the Seller Group to, to the extent permissible under applicable
Law:
(a) cause
Nabriva Parent and Nabriva DAC (i) to remain in existence, (ii) to remain solvent at all times, and (iii) not to liquidate,
dissolve, or wind down, or implement or effect a plan or agreement of complete or partial liquidation, dissolution, or wind-down (or publicly
announce any other steps to liquidate, dissolve, or wind down); provided, however, that if any indemnification claims are
brought by Purchaser within the Bridge Period pursuant to Section 4.1.1
and Section 4.3, the obligations of
Sellers pursuant to this Section 3.15.1(a) will
automatically extend (beyond the Bridge Period, if necessary), without any action on the part of the Parties, until the final resolution
of such indemnification claims in accordance with Article 4;
(b) cause
Nabriva DAC to remain the holder of, and maintain in active status and not withdraw or otherwise discontinue, (i) the existing Marketing
Approvals for Lefamulin in the U.S. and to continue Sellers’ existing U.S. program relating to Lefamulin in accordance with such
Marketing Approvals, (ii) subject to Purchaser’s right pursuant to Section 3.7.2,
the Marketing Approval Application filed by Nabriva DAC for Lefamulin with the NMPA and (iii) subject to Purchaser’s right
pursuant to Section 3.7.2, the import
drug license filed by Nabriva DAC with NMPA for Lefamulin;
(c) cause
Nabriva DAC to comply in all material respects with all of the obligations and responsibilities arising under or in respect of the Marketing
Approvals for Lefamulin in the U.S., the Marketing Approval Application filed by Nabriva DAC for Lefamulin with the NMPA and the import
drug license filed by Nabriva DAC with NMPA for Lefamulin, including with respect to (i) all Clinical Trials, pediatric studies,
pre-clinical studies, non-clinical studies, post-marketing studies and any other post-marketing requirements and (ii) any obligations
under the existing INDs for Lefamulin;
(d) continue
to keep the existing agreements with the CMOs and other suppliers listed on Schedule 3.15.1(d) in
place and in full force and effect to the extent necessary for the maintenance of the Marketing Approvals for Lefamulin in the U.S.;
(e) promptly
respond to any inquiries from the relevant Governmental Entities and promptly execute and provide certifications and other declarations
as required under applicable Law or requested by any Governmental Entities in connection with the Pending NMPA Applications; and
(f) notwithstanding
the termination of the Existing Nabriva License Agreements (as defined in the Termination Agreement regarding the Existing Nabriva Agreements)
pursuant to the Termination Agreement regarding the Existing Nabriva Agreements, maintain the appointment of SMPC as the exclusive drug
registration agent in the People’s Republic of China to, at Purchaser’s cost, prepare, obtain and maintain such Drug Approval
Applications, Regulatory Approvals and submissions relating to IDL (with each of such terms having the meanings ascribed to them in the
Existing Nabriva License Agreement, but without such terms being limited to “Lefamulin” as such term is defined in the Existing
Nabriva License Agreement) in the People’s Republic of China on behalf of Nabriva DAC.
3.15.2 During
the Bridge Period, Sellers shall provide to Purchaser, within [**] after the end of each [**], a [**] written report describing in reasonable
detail Sellers’ activities pursuant to Section 3.15.1(c) and
any other material regulatory or commercial matters relating to a Product or the Product Business in the Relevant Regulatory Territory
(including in relation to any Clinical Trials, pediatric studies, pre-clinical studies, non-clinical studies, post-marketing studies and
any other post-marketing requirements and any obligations under the existing INDs for a Product). In addition, during the Bridge Period,
Sellers shall (i) offer Purchaser the opportunity to consult with Sellers (and each other member of the Seller Group) prior to any
proposed meeting or other communication with the FDA, NMPA, or any other Governmental Entity relating to the Product Business, any Product
or any Marketing Approval or Marketing Approval Application for a Product (including with respect to any Clinical Trials, pediatric studies,
pre-clinical studies, non-clinical studies, post-marketing studies and any other post-marketing requirements), (ii) promptly inform
Purchaser of, and provide Purchaser with a reasonable opportunity to review, in advance, any correspondence or other communication proposed
to be submitted or otherwise transmitted to the FDA, NMPA, or any other Governmental Entity by or on behalf of a Seller (or any other
member of the Seller Group) relating to any Product or the Product Business, or any Marketing Approval or Marketing Approval Application
for a Product (including with respect to any Clinical Trials, pediatric studies, pre-clinical studies, non-clinical studies, post-marketing
studies and any other post-marketing requirements), (iii) keep Purchaser reasonably informed of any material communication (written
or oral) with or from the FDA, NMPA, or any other Governmental Entity relating to any Product, the Product Business or any Marketing Approval
or Marketing Approval Application for a Product (including with respect to any Clinical Trials, pediatric studies, pre-clinical studies,
non-clinical studies, post-marketing studies and any other post-marketing requirements), and (iv) promptly inform Purchaser and provide
Purchaser with a reasonable opportunity to comment, in each case, prior to making any change to any Clinical Trials, pediatric studies,
pre-clinical studies, non-clinical studies, post-marketing studies and any other post-marketing requirements relating to any Product,
the Product Business or any Marketing Approval or Marketing Approval Application for a Product. Sellers shall promptly notify Purchaser
of any data relating to any Product, including information related to any Adverse Events with respect to any Product or the Product Business,
which they (or any of them) discover after the Execution Date. The delivery of any notice pursuant to this Section 3.15.2
shall not in any way cure, diminish or otherwise affect any of the representations or warranties of Sellers hereunder or Purchaser’s
right to indemnification pursuant to Article 4
in respect of any breach thereof.
3.15.3 During
the Bridge Period, Sellers shall not, and shall cause each of the other applicable members of the Seller Group not to (except as expressly
consented to in writing by Purchaser or for actions that are required by applicable Law), (a) take any actions, or refrain from taking
any actions, or (b) enter into any agreements, in each case of clauses (a) and (b), that would, or would
reasonably be expected to, cause or result in (i) a material increase of any of the anticipated Operating Expenses set forth in the
Budget Plan or (ii) any Seller to be unable to satisfy its obligations as they become due.
3.15.4 In
exchange for Sellers’ obligations pursuant to Section 3.15.1
through Section 3.15.3, during the Bridge
Period, Purchaser will reimburse Nabriva Parent and/or Nabriva DAC, as applicable, on a [**] basis and up to the Aggregate Cap, for any
reasonable and documented operating expenses incurred by them in accordance with the Budget Plan (the “Operating Expenses”),
subject to the following provisions:
(a) [**].
(b) [**].
(c) Notwithstanding
anything else herein, Nabriva US and Nabriva Austria may be liquidated, dissolved or wound-down, and Nabriva US and/or Nabriva Austria
may implement or effect a plan or agreement of complete or partial liquidation, dissolution, or wind-down; provided, however,
that, prior to and as a condition to such steps, Nabriva US shall have provided evidence to Purchaser of the transfer to Nabriva DAC of
all commercial and regulatory functions in effect as of the Execution Date reasonably necessary to effect the matters contemplated by
this Section 3.15 (including with respect
to regulatory correspondence and as addressee for any such regulatory correspondence), in form and substance reasonably acceptable to
Purchaser.
(d) If
Purchaser delivers to Nabriva Parent a termination notice pursuant to clause (b) of the definition of Bridge Period,
Purchaser’s obligation to reimburse Operating Expenses hereunder shall [**].
(e) During
the Bridge Period, Nabriva Parent shall provide to Purchaser, within [**] after the end of each [**], (i) [**], and (ii) [**].
Purchaser shall reimburse such Operating Expenses, up to the Aggregate Cap and subject to the other limitations set forth in this Section 3.15.4,
within [**].
(f) For
purposes of clarity, (i) in no event shall Purchaser be obligated hereunder to reimburse Operating Expenses (or any other amounts)
pursuant to this Section 3.15.4 or otherwise
under this Agreement that in the aggregate exceed the Aggregate Cap, [**].
3.15.5 Sellers
will deliver, or cause to be delivered, to Purchaser (or its applicable designee(s)), on the Closing Date through Electronic Delivery
pursuant to Section 3.6.1, all Lab Notebooks
that are in electronic form as of the Closing Date and, to the extent the original Lab Notebooks are in physical form, any electronic
copies thereof that Sellers or any other member of the Seller Group has as of immediately prior to the Closing. During the Bridge Period
and prior to the completion of the Lab Notebook Delivery, upon Purchaser’s request, Sellers will promptly [**] (a) prepare
physical copies of those items included in the Lab Notebooks that Purchaser reasonably selects as being required, desirable or useful
in connection with (i) any pending Regulatory Approval Applications in the Territory, or (ii) the prosecution, maintenance or
enforcement of any Purchased Intellectual Property, (b) have those copies notarized and legalized as requested by Purchaser, and
(c) deliver to Purchaser the originals of such notarized and legalized documents. As soon as reasonably practicable (but in no event
later than [**]) after the Closing, Sellers will deliver, or cause to be delivered, to Purchaser (or its designee), [**], at the location
designated by Purchaser, all original Lab Notebooks that are in physical form (the “Lab Notebook Delivery”). During
the Bridge Period, Sellers shall retain all electronic copies of the Lab Notebooks that are under their Control as of immediately prior
to the Closing and, upon request of any of the Extraterritorial Licensees, Sellers shall promptly make available to such Extraterritorial
Licensee (at Sellers’ or such Extraterritorial Licensee’s cost) the relevant items included in those electronic copies of
the Lab Notebooks as requested by such Extraterritorial Licensee. Following the completion of the Lab Notebook Delivery and only to the
extent a request by an Extraterritorial Licensee goes beyond receiving electronic copies of any of the Lab Notebooks and cannot be satisfied
by Sellers (e.g., because a Governmental Entity requires notarized or legalized copies of the original Lab Notebooks), then Purchaser
shall use commercially reasonable efforts to cooperate with such Extraterritorial Licensee, at the Extraterritorial Licensee’s expense,
to make available such items included in the Lab Notebooks that are reasonably requested by any Extraterritorial Licensee as being required,
desirable or useful in connection with (x) any Regulatory Approval Applications for a Product outside of the Territory or (y) the
prosecution, maintenance or enforcement of any Patent licensed to such Extraterritorial Licensee with respect to a Product outside of
the Territory.
3.15.6 Notwithstanding
anything to the contrary set forth in this Agreement, Purchaser acknowledges and agrees that upon expiration of the Bridge Period there
shall be no restrictions on Seller Group from liquidating, dissolving, or winding down, or implementing or effecting a plan or agreement
of complete or partial liquidation, dissolution, or wind-down, or take any actions or steps, or enter into any agreements with respect
to any of the foregoing.
3.16 Transition
Trademark License. As promptly as practicable, but in no event later than [**], following the
Closing Date, Purchaser shall remove, strike over or otherwise obliterate all Seller Retained Marks from all Purchased Assets; provided,
however, that Purchaser may subsequent to such [**] period continue to use any Purchased Assets containing a Seller Retained Mark
to the extent that it is not practicable to remove or cover up such Seller Retained Mark. Any use of the Seller Retained Marks by Purchaser
pursuant to this Section 3.16
shall be in conformity with the practices of Sellers as of the Closing Date. Notwithstanding the foregoing, nothing in this Section 3.16
shall be construed to require, or to permit, Purchaser to take, or fail to take, any action which is in violation of applicable Law, including
the rules and regulations of any applicable Governmental Entity.
3.17 M&A
Qualified Beneficiaries. To the extent and while COBRA applies to an Employee Plan, the Seller
Group will offer and provide continuation coverage under one of the Seller Group’s group health plans for all “M&A Qualified
Beneficiaries” as that term is defined in Treasury Regulations Section 54.4980B-9, including coverage for employees of the
Seller Group who are not hired by Purchaser (or an Affiliate of Purchaser) and their respective spouses and dependents, and for former
employees of the Seller Group or their dependents whose COBRA qualifying events occurred prior to the Closing Date and whose COBRA coverage
is in effect as of the Closing Date, or whose election period for choosing such COBRA coverage has not ended as of the Closing Date.
Article 4
INDEMNIFICATION
4.1 Indemnification.
4.1.1 Indemnification
by Sellers. From and after the Closing, but subject to the provisions of this Article 4,
Sellers shall jointly and severally indemnify, defend and hold harmless Purchaser, its Affiliates and its and their Representatives, successors
and permitted assigns (collectively, “Purchaser Indemnitees”) from and against any and all Losses asserted against
or incurred by any Purchaser Indemnitee arising out of or related to:
(a) any
breach of, or inaccuracy in, any of the representations and warranties made by Sellers in this Agreement (other than the Fundamental Reps);
provided, that the determination of whether any such representation or warranty that is qualified by “material,” “in
all material respects” or “Material Adverse Effect” or any similar qualifier is so true and correct will be made as
if “material,” “in all material respects,” “Material Adverse Effect” or any similar qualifier were
not included therein;
(b) any
breach of, or inaccuracy in, any of the Fundamental Reps made by Sellers in this Agreement; provided, that the determination of
whether any such representation or warranty that is qualified by “material,” “in all material respects” or “Material
Adverse Effect” or any similar qualifier is so true and correct will be made as if “material,” “in all material
respects,” “Material Adverse Effect” or any similar qualifier were not included therein;
(c) any
failure of Sellers to perform or any breach or noncompliance by Sellers of any of their covenants, agreements or obligations contained
in this Agreement;
(d) any
failure of Sellers to pay Covered Transfer Taxes, Apportioned Obligations or other Taxes allocated to Sellers under Section 3.8.3;
(e) any
Liability arising out of Purchaser’s waiver contained in Section 5.11;
(f) any
Excluded Asset or any Excluded Liability; and
(g) any
reimbursement by Purchaser or any of its Affiliates of Nabriva Parent’s or Nabriva DAC’s operating expenses during the Bridge
Period pursuant to Section 3.15.4 in
excess of the Aggregate Cap (as such Aggregate Cap may be adjusted pursuant to the terms of the definition thereof).
4.1.2 Indemnification
by Purchaser. From and after the Closing, but subject to the provisions of this Article 4,
Purchaser shall indemnify and hold harmless Sellers, their Affiliates and their Representatives (collectively, “Seller Indemnitees”)
from and against any and all Losses asserted against or incurred by any Seller Indemnitee arising out of or related to:
(a) any
breach of, or inaccuracy in, any of the representations and warranties made by Purchaser in this Agreement (other than the Fundamental
Reps); provided, that the determination of whether any such representation or warranty that is qualified by “material,”
“in all material respects” or “Purchaser Material Adverse Effect” or any similar qualifier is so true and correct
will be made as if “material,” “in all material respects,” “Purchaser Material Adverse Effect” or
any similar qualifier were not included therein;
(b) any
breach of, or inaccuracy in, any of the Fundamental Reps made by Purchaser in this Agreement; provided, that the determination
of whether any such representation or warranty that is qualified by “material,” “in all material respects” or
“Purchaser Material Adverse Effect” or any similar qualifier is so true and correct will be made as if “material,”
“in all material respects,” “Purchaser Material Adverse Effect” or any similar qualifier were not included therein;
(c) any
failure of Purchaser to perform or any breach or noncompliance by Purchaser of any of its covenants, agreements or obligations contained
in this Agreement;
(d) any
failure of Purchaser to pay its share of Apportioned Obligations allocated to Purchaser under Section 3.8.3;
(e) any
Transfer Taxes other than Covered Transfer Taxes; or
(f) any
Purchased Asset or Assumed Liability.
4.2 Limitations
on Indemnification.
4.2.1 Notwithstanding
anything to the contrary contained in this Agreement, other than in the event of Fraud:
(a) The
Purchaser Indemnitees may not recover Losses from Sellers (including by reduction of the Indemnification Holdback) in respect of any claim
for indemnification pursuant to Section 4.1.1(a) until
the aggregate amount of all Losses suffered by the Purchaser Indemnitees equals or exceeds $[**];
(b) The
Seller Indemnitees may not recover Losses from Purchaser in respect of any claim for indemnification pursuant to Section 4.1.2(a) until
the aggregate amount of all Losses suffered by the Seller Indemnitees equals or exceeds [**], in which case Purchaser shall be liable
for all of the Seller Indemnitees’ Losses to the extent in excess of the Basket Amount;
(c) with
respect to Losses claimed pursuant to Section 4.1.1(a) or
Section 4.1.1(g), the Purchaser Indemnitees
shall recover such Losses solely by reduction of the then-remaining amount of the Indemnification Holdback;
(d) with
respect to Losses claimed pursuant to Section 4.1.1(b) through
Section 4.1.1(f) the Purchaser
Indemnitees shall recover such Losses (i) during the period commencing on the Closing Date and ending 11:59 p.m. Pacific Time
on the [**] (the “Initial Indemnification Period”), by reduction of the then-remaining
amount of the Indemnification Holdback [**]; and
(e) the
maximum Losses that (i) Purchaser Indemnitees may recover from Sellers pursuant to Section 4.1.1(b) through
Section 4.1.1(d) shall be equal
to an amount that equals (A) the Purchase Price actually received by Sellers, plus (B) the Aggregate CMO Settlement Amount,
plus (C) the Bridge Period Pre-Funded Expenses Amount (such amount, the “Liability Cap”), and (ii) Seller
Indemnitees may recover from Purchaser pursuant to Section 4.1.2(a) through
Section 4.1.2(e) shall be equal
to the Liability Cap. For purposes of clarity (but subject to Section 4.2.1(d)),
the Losses that Purchaser Indemnitees may recover from Sellers pursuant to Section 4.1.1(e) or
Section 4.1.1(f) and the Losses
that Seller Indemnitees may recover from Purchaser pursuant to Section 4.1.2(f) shall
not be subject to the Liability Cap.
4.2.2 Subject
to Section 4.2.3, each Party shall,
with respect to any claim for Losses for which indemnification is sought hereunder, use, or cause the applicable Indemnified Party to
use, commercially reasonable efforts to mitigate any such claim consistent with applicable Law; provided, however, that
the reasonably incurred out-of-pocket costs of such mitigation efforts shall constitute Losses for purposes of this Agreement. Nothing
in the foregoing shall require an Indemnified Party to waive the attorney-client privilege, work product protection or similar privilege
or protection.
4.2.3 Payments
by an indemnifying party pursuant to Section 4.1
in respect of any Losses shall be limited to the amount of any Losses that remains after deducting therefrom any insurance proceeds actually
received by the Indemnified Party in respect of any such claim; provided that (a) the amount to be deducted shall be net of
(i) costs and expenses reasonably incurred by such Indemnified Party in recovering such proceeds, (ii) any retro-premium obligations,
increases in premiums or premium adjustments to the extent directly attributable to such proceeds actually recovered and (iii) deductibles
and other amounts borne by such Indemnified Party in connection with such proceeds actually recovered, and (b) none of the Indemnified
Parties shall be obligated to pursue recovery, whether extrajudicial, through litigation or arbitration, or otherwise, under insurance
policies for any Losses. For purposes of clarity, the provisions of Section 4.2.2
shall not apply to this Section 4.2.3.
4.2.4 Notwithstanding
anything to the contrary herein or provided under applicable Law, Losses shall exclude punitive, special, exemplary or incidental damages,
or unforeseeable consequential damages (except, in each case, to the extent any such Losses are paid by an Indemnified Party with respect
to a Third-Party Claim).
4.2.5 The representations and warranties of Sellers and Purchaser contained in this Agreement shall survive the Closing and continue in full
force and effect thereafter through 11:59 p.m. Pacific Time on the 18-month anniversary of the Closing Date. All covenants and agreements
of the Parties contained herein shall survive the Closing and continue in full force and effect for the period explicitly specified therein
or for the period of time until such covenants or agreements are fully performed in accordance with their respective terms. In the event
notice of any claim for indemnification pursuant to Section 4.1.1
or Section 4.1.2 shall have been given
within the applicable survival period and such claim has not been finally resolved by the expiration of such survival period, the representations
and warranties and covenants, as applicable, that are the subject of such claim shall survive the end of the survival period of such representations,
warranties or covenants until such claim is finally resolved, but such representations, warranties and covenants shall survive only with
respect to any such asserted claim. It is the express intent of the Parties that, if the applicable survival period for an item as contemplated
by this Section 4.2.5 is longer or shorter
than the statute of limitations that would otherwise have been applicable to such item, then, by contract, the applicable statute of limitations
with respect to such item shall be shortened or increased to the shortened or lengthened survival period contemplated hereby.
4.3 Claim
Procedure.
4.3.1 Indemnification
Claim Procedure. Except with respect to Third-Party Claims as provided in Section 4.3.2:
(a) If
any Purchaser Indemnitee or Seller Indemnitee (the “Indemnified Party”) believes that it has a bona fide claim
for indemnification pursuant to this Article 4,
Nabriva Parent (and only Nabriva Parent) may deliver to Purchaser, if the Indemnified Party is a Seller Indemnitee, and Purchaser (and
only Purchaser) may deliver to Nabriva Parent, if the Indemnified Party is a Purchaser Indemnitee, a certificate (any certificate delivered
in accordance with the provisions of this Section 4.3.1(a),
a “Claim Certificate”): (i) stating that the Indemnified Party has a claim for indemnification pursuant to this
Article 4, (ii) to the extent known, containing
a good faith, non-binding, preliminary estimate of the amount such Indemnified Party claims to be entitled to receive, which shall be
the amount of Losses such Indemnified Party claims to have so suffered or could reasonably be expected to incur or suffer, and (iii) specifying
in reasonable detail (based upon the information then possessed by such Indemnified Party) the material facts known to such Indemnified
Party giving rise to such claim.
(b) No
delay in providing such Claim Certificate will affect the indemnification provided hereunder except and then only to the extent that the
recipient of such Claim Certificate (the “Indemnifying Party”) is materially prejudiced thereby.
(c) The
Indemnifying Party will have [**] from receipt of such Claim Certificate to dispute the claim. If the Indemnifying Party expressly accepts
the claim set forth in such Claim Certificate within such [**] period or does not give notice to the Indemnified Party that it disputes
such claim within such [**] period, then the Losses asserted in such Claim Certificate will be conclusively deemed Losses subject to indemnification
hereunder. If an Indemnifying Party in good faith objects to any claim made in any Claim Certificate, then such Indemnifying Party shall
deliver a written notice (a “Claim Dispute Notice”) to the Indemnified Party within such [**] period. The Claim Dispute
Notice shall set forth in reasonable detail the principal basis for the objections against any claim made in the applicable Claim Certificate.
(d) If
a Claim Dispute Notice is properly delivered hereunder in accordance with Section 4.3.1(c),
then Purchaser and Nabriva Parent will attempt in good faith to resolve any such objections raised in such Claim Dispute Notice. If Purchaser
and Nabriva Parent agree to a resolution of such objections, then a written memorandum setting forth the matters conclusively determined
by Purchaser and Nabriva Parent will be prepared and signed by all Parties.
(e) If
no such resolution can be reached during the [**] period following receipt of a valid Claim Dispute Notice hereunder, then, upon the expiration
of such [**] period, either Purchaser or Nabriva Parent (on behalf of Sellers) may bring an action to resolve the objections in accordance
with Section 5.1.
4.3.2 Third-Party
Claim Procedure.
(a) If
an Indemnified Party receives notice of any claim that has been or may be brought or asserted by a Third Party against such Indemnified
Party (a “Third-Party Claim”), then Purchaser (and only Purchaser) will notify Nabriva Parent (in the event such Indemnified
Party is a Purchaser Indemnitee) and Nabriva Parent (and only Nabriva Parent) will notify Purchaser (in the event such Indemnified Party
is a Seller Indemnitee), in each case by the delivery of a Claim Certificate that also identifies such Third Party, promptly after receipt
of the notice of any such Third-Party Claim. The failure of such Indemnified Party to so notify the Indemnifying Party of the commencement
of any such Third-Party Claim will not relieve the Indemnifying Party from Liability in connection therewith, except and only to the extent
that the Indemnifying Party is materially prejudiced as a result of such failure to give notice.
(b) Within
the earlier of (i) [**] after delivery of such Claim Certificate or (ii) [**] prior to the due date for the answer or response
to the Third-Party Claim, but subject to Section 4.3.2(d) regarding
Special Claims, the Indemnifying Party may, upon written notice thereof to the Indemnified Party, assume control of the defense of such
Third-Party Claim if such notice includes an acknowledgement of the Indemnifying Party that any Losses that may be assessed in connection
with the Third-Party Claim shall constitute Losses for which the Indemnified Party will be indemnified pursuant to this Article 4
without contest or objection and an acknowledgement that the Indemnifying Party will advance all reasonable, documented, out-of-pocket
expenses and costs of defense (a “Third-Party Claim Assumption Notice”). If it is not the party controlling the defense
of a Third-Party Claim, the Indemnified Party shall be entitled to employ separate counsel and to participate in the defense thereof,
but the fees and expenses of such counsel shall be at the expense of the Indemnified Party, except that the reasonable fees and expenses
of such separate counsel shall be borne by the Indemnifying Party if the Indemnified Party has been advised by outside counsel that (A) a
reasonable likelihood exists of a conflict of interest between the Indemnifying Party and the Indemnified Party, or (B) the Third-Party
Claim is one in which the Indemnifying Party is also a party and joint representation would be inappropriate or there are legal defenses
which are reasonably available to the Indemnified Party which are different from or additional to those available to the Indemnifying
Party.
(c) If
an Indemnifying Party delivers a Third-Party Claim Assumption Notice, such Indemnifying Party shall not agree to any compromise, discharge
or settlement of such Third-Party Claim or consent to any judgment in respect thereof, in each case without the prior written consent
of the Indemnified Party (which consent may be withheld, conditioned or delayed in its sole discretion), unless (i) such compromise,
discharge, or settlement provides for a complete and unconditional release of the Indemnified Party from all Liability with respect thereto
and does not contain any admission or statement suggesting any wrongdoing or Liability on behalf of the Indemnified Party or any of its
Representatives, (ii) the settlement obligates such Indemnifying Party to pay the full amount of the Losses of the Indemnified Party
related to such Third-Party Claim, and (iii) the settlement agreement does not contain any sanction or restriction upon the conduct
of any business by the Indemnified Party or its Affiliates or other non-monetary relief to be satisfied by the Indemnified Party or its
Affiliates.
(d) The
Indemnifying Party will lose its right to contest, defend, litigate and, subject to the terms of Section 4.3.2(c),
settle any Third-Party Claim pursuant to Section 4.3.2(b) if
it fails to accept a tender of the defense of the Third-Party Claim or ceases to actively and diligently conduct the defense in the reasonable
determination of the Indemnified Party. In such event, the Indemnified Party will, subject to the terms of Section 4.3.2(f),
have the sole right to conduct and control the defense of any such Third-Party Claim.
(e) Notwithstanding
the foregoing provisions of Section 4.3.2(b),
in no event may the Indemnifying Party, without the Indemnified Party’s written consent (which may be withheld in its sole discretion),
assume, or maintain control of, the defense of any Third-Party Claim (i) involving any criminal proceeding, action, indictment, allegation
or investigation, (ii) in which any relief other than monetary damages is sought against any Indemnified Party (other than such other
relief that is incidental and de minimis to monetary damages as the primary relief sought), (iii) if, in the event the Third-Party
Claim were to be unfavorably decided or resolved, and after aggregating with all other potential claims for indemnification, the Indemnifying
Party would be reasonably likely to be liable for Losses in excess of the amounts required to be paid under this Article 4,
(iv) if such Third-Party Claim is asserted by or on behalf of a Person that is a material supplier to, material customer of, or otherwise
has a material relationship with, the Product Business or the Purchased Assets and the Third-Party Claim involves a matter that could
be reasonably expected to materially and adversely affect the Product Business or the operation of the Purchased Assets, (v) if such
Third-Party Claim could reasonably be expected to materially harm the reputation of Purchaser or any of its Affiliates or otherwise have
a material adverse impact on Purchaser’s or its Affiliates’ businesses or their relationship with any Governmental Entity,
(vi) if the Indemnifying Party’s participation would reasonably be expected to result in the loss of any attorney-client privilege
or right under the work-product doctrine of any Indemnified Party in respect of such claim, or (vii) if a defense available to the
Indemnified Party cannot be asserted by or on behalf of the Indemnifying Party (the foregoing clauses (i) – (vii) collectively,
the “Special Claims”). In connection with any Special Claim, the Indemnified Party will have the right, subject to
the terms and conditions of Section 4.3.2(f), to conduct and control, through counsel of its choosing, the defense, compromise
and settlement of any such Third-Party Claim.
(f) If
the Indemnifying Party is not entitled to control the defense of a Third-Party Claim pursuant to the foregoing provisions of this Section 4.3.2,
then the Indemnified Party will have the right to conduct, control and defend the Third-Party Claim, through counsel of its choosing,
to a final conclusion or settlement at the discretion of the Indemnified Party. In such event, the Indemnifying Party may participate
in, but not control, any defense or settlement controlled by the Indemnified Party pursuant to this Section 4.3.2(f),
and the Indemnifying Party will bear its own costs and expenses with respect to such participation; provided that the Indemnifying
Party will not be permitted to participate in such defense to the extent such participation would affect any privilege of the Indemnified
Party in respect of such Third-Party Claim, and the Indemnifying Party will not admit any Liability, file any papers or consent to the
entry of any judgment or propose to the Third Party, or enter into, any settlement agreement, compromise or discharge with respect to
the Third-Party Claim without the prior written consent of the Indemnified Party. Further, in such circumstances, the Indemnified Party
shall not agree to any settlement of, or the entry of any judgment arising from, any such Third-Party Claim without the prior written
consent of the Indemnifying Party, which shall not be unreasonably withheld, conditioned or delayed.
(g) With
respect to any Third-Party Claim, the controlling Party shall (i) keep the non-controlling Party reasonably advised of the status
of such Third-Party Claim and the defense thereof and shall consider recommendations made by the non-controlling Party with respect thereto
and (ii) deliver to the non-controlling Party, promptly after the controlling Party’s receipt thereof, copies of all notices
and documents (including court papers) received by the controlling Party relating to the Third-Party Claim.
(h) With
respect to any Third-Party Claim, the non-controlling Party shall (i) reasonably cooperate with the controlling Party in the defense
or prosecution thereof, including the retention and (upon the controlling Party’s reasonable request) the provision to the controlling
Party of records and information that are reasonably relevant to such Third-Party Claim, and (ii) use their reasonable efforts to
make their employees available on a mutually convenient basis to provide additional information and explanation of any material related
to such Third-Party Claim.
(i) If
reasonably requested by the Party controlling the defense of the Third-Party Claim, the non-controlling Party will enter into a separate
confidentiality or joint defense agreement prior to participating in the defense of any Third-Party Claim.
4.3.3 Sole
Authority for Bringing Indemnification Claims. Purchaser shall have sole authority to bring, resolve, compromise or waive claims for
indemnification that may be brought by or on behalf of any Purchaser Indemnitee. Nabriva Parent shall have sole authority to bring, resolve,
compromise or waive claims for indemnification that may be brought by or on behalf of any Seller Indemnitee.
4.4 Tax
Treatment of Indemnification Payments. The Parties agree to treat any indemnity payment made
pursuant to this Article 4, to the extent
permitted by applicable Law, for federal income Tax and other applicable Tax purposes, as an adjustment to the cash proceeds received
by Sellers in the Transactions.
4.5 Indemnification
Holdback.
4.5.1 From
and after the Closing Date, for the period set forth in Section 4.5.2 and
subject to the terms thereof, the Purchaser Indemnitees will have the right to recover Losses from the Indemnification Holdback in accordance
with this Article 4.
4.5.2 The
period during which claims for indemnification from the Indemnification Holdback may be initiated will commence on the Closing Date and
end at the Holdback Period Expiration Time. The positive amount, if any, that equals (a) the Indemnification Holdback minus
(b) the amounts, if any, that prior to the Holdback Period Expiration Time have been paid out from the Indemnification Holdback to
any Purchaser Indemnitee on the account of indemnification claims hereunder in accordance with the terms of this Article 4
minus (c) such amount as may be reasonably necessary in the good faith judgment of, and estimated in good faith by, Purchaser
to satisfy any unresolved or unsatisfied indemnification claims to the extent specified and claimed in one or more Claim Certificates
which were delivered to Nabriva Parent before the Holdback Period Expiration Time (the amount resulting from clauses (a) through
(c), the “Remaining Holdback Amount”), will be released to Nabriva Parent on the [**] immediately following
the Holdback Period Expiration Time. The Remaining Holdback Amount will remain in the Indemnification Holdback until the underlying indemnification
claim has been fully resolved or satisfied and thereafter released to Purchaser to the extent the Purchaser Indemnitee(s) prevail(s) in
such claim and released to Nabriva Parent to the extent the Indemnifying Party prevails in such claim.
4.6 Other
Provisions Relating to Indemnification.
4.6.1 No
Subrogation. Each Party waives, and acknowledges and agrees that no Indemnifying Party will have or permit its Affiliates or Representatives
to have, and no Indemnifying Party will exercise or assert (or attempt to exercise or assert), or permit its Affiliates or Representatives
to exercise or assert any right of contribution or subrogation against an Indemnified Party, or any of such Indemnified Party’s
respective Representatives, Affiliates, successors or assigns, for any indemnification claims asserted by an Indemnified Party against
such Indemnifying Party with respect to any indemnification obligation or any other Liability to which such party may become subject under
or in connection with this Agreement.
4.6.2 Right
to Maximum Recovery. In any situation in which a claim for indemnification pursuant to this Article 4
may be brought by an Indemnified Party under multiple sections of this Article 4,
such Indemnified Party may bring such claim under the section or sections of this Article 4
that would provide the highest amount of recovery (but may not make duplicate claims or recover duplicate amounts with respect to the
same underlying facts giving rise to such claim).
4.7 Exclusive
Remedy. Subject to Section 5.9,
each Party acknowledges and agrees that, following the Closing, the remedies provided for in this Article 4
shall be the sole and exclusive remedies for claims and damages available to the Parties and
their respective Affiliates arising out of or relating to this Agreement and the Transactions, except that nothing herein shall limit
the Liability of any Party for Fraud to the extent committed by such Party or affect any Party’s ability to exercise any rights
or remedies available to such Party under any Ancillary Agreement with respect to claims arising under such Ancillary Agreement. Notwithstanding
anything to the contrary contained in this Agreement, no breach of any representation, warranty, covenant or agreement contained herein
shall, after the consummation of the Transactions, give rise to any right on the part of Purchaser, on the one hand, or Sellers, on the
other hand, to rescind this Agreement or any of the Transactions.
Article 5
MISCELLANEOUS
5.1 Governing
Law, Jurisdiction, Venue and Service.
5.1.1 Governing
Law. This Agreement (and any claim or controversy arising out of or relating to this Agreement) shall be governed by the Law of the
State of Delaware, without giving effect to any choice of law or conflict of law provision or rule (whether of the State of Delaware
or any other jurisdictions) that would cause the application of the Laws of any jurisdiction other than the State of Delaware.
5.1.2 Dispute
Resolution and Venue.
(a) Any
dispute, claim or controversy arising out or relating to this Agreement or the breach, termination, enforcement, interpretation or validity
of this Agreement or the Ancillary Agreements, including any claim based on contract, tort, statute, or constitution, or the determination
of the scope or applicability of this Agreement to arbitrate, will be determined by binding arbitration seated in New York, New York.
The arbitration will be conducted in English in accordance with the Rules of Arbitration of the International Chamber of Commerce
(“ICC”), as modified in this Section 5.1.2.
The arbitration shall be administered by the ICC in accordance with those rules.
(i) The
arbitration shall be conducted before three arbitrators (each, an “Arbitrator” and collectively, the “Tribunal”).
One Arbitrator shall be selected by each of Purchaser and Nabriva Parent. The third Arbitrator (the “Chair”) shall
be selected by the other two Arbitrators or by the ICC if the two Party-appointed arbitrators cannot agree on the Chair within [**] after
the date on which the Chair was nominated in writing by one of the previously nominated Arbitrators and noticed to the other of the Arbitrators.
(ii) The
Tribunal or the Chair will have the power to order hearings and meetings to be held in such place or places as he or she or they deem
in the interests of reducing the total cost to the parties of the arbitration. The arbitration proceedings will be conducted in English.
(iii) The
Tribunal will have the power to order any remedy, including monetary damages, specific performance and all other forms of legal and equitable
relief, in each case to the extent expressly contemplated by this Agreement (including by Section 5.9),
except that the Tribunal will not have the power to order punitive damages.
(iv) The
Tribunal shall apply in the arbitration, in addition to the ICC Rules of Arbitration, the IBA Rules on the Taking of Evidence
in International Arbitration.
(v) The
Tribunal may appoint expert witnesses only with the consent of all of the parties to the arbitration.
(vi) The
award rendered by the Tribunal will be final and binding on the parties to the arbitration. Judgment on the award rendered by the Arbitrator
or the Tribunal may be entered by any court having jurisdiction, or application may be made to such court for judicial recognition and
enforcement of the award or for vacatur thereof, as the case may be. In conducting such proceedings, the Parties will exercise reasonable
best efforts to disclose publicly only the minimum amount of information concerning the arbitration as is required to obtain such acceptance
or order.
(vii) Except
as required by Law (including the rules of any stock exchange on which a Party is traded), as reasonably necessary to provide to
a Party’s own independent auditors or insurers, or in proceedings seeking the enforcement or vacatur of an arbitral award, no Party
may disclose the existence, contents or results of an arbitration brought in accordance with this Agreement, or the documents presented
and evidence produced by its opposing Parties, or any analyses or summaries derived from such evidence. To the extent permitted by Law,
the arbitration shall be considered and treated by the Parties as a confidential proceeding.
(b) Each
Party hereby agrees that this Agreement does not preclude any Party from seeking provisional remedies in aid of arbitration from any Chosen
Court or from the Tribunal once the Tribunal is constituted. Each of the Parties will submit itself and its property to the personal jurisdiction
of any Chosen Court; provided that (i) the proceedings have been initiated to seek provisional remedies in aid of arbitration,
(ii) such Party will not attempt to deny or defeat such personal jurisdiction by motion or other application, (iii) such Party
will not bring any Legal Proceeding relating to this Agreement, the Ancillary Agreements or any of the Transactions in any other court
and (iv) such Party will not assert as a defense that such Legal Proceeding may not be brought or is not maintainable in said courts
or that the venue thereof may not be appropriate or that this Agreement or the Ancillary Agreements may not be enforced in or by such
courts.
(c) Delivery
of process or other papers in the manner provided in Section 5.2
(Notices) in connection with any Legal Proceeding under this Agreement or in such other manner as may be permitted by Law will be valid
and sufficient service thereof, and each Party irrevocably waives any defenses it may have to service in such manner.
(d) The
Parties acknowledge that, for the avoidance of doubt, in no event is anything in this Section 5.1.2
intended to limit, or shall be construed to limit, in any manner, the Parties’ rights to seek specific performance in a Legal Proceeding
instituted in any Chosen Court as set forth in Section 5.9.
5.2 Notices.
All notices, requests, demands, claims and other communications which are required or may be given under this Agreement will be in writing,
in English, and shall be deemed to have been duly given: (a) on the date of delivery, if delivered in person or by email (upon confirmation
of receipt) prior to 5:00 p.m. in the time zone of the receiving Party or on the next Business Day, if delivered after 5:00 p.m. in
the time zone of the receiving Party, (b) on the third Business Day following the date of dispatch, if delivered by an internationally
recognized courier service (upon proof of delivery) or (c) upon receipt if delivered by certified or registered mail, return receipt
requested. In each case, notice will be addressed to a Party as specified in this Section 5.2:
If to Nabriva Parent or Sellers, to:
Alexandra House, Office 225/227,
The Sweepstakes, Ballsbridge,
Dublin 4, Ireland
Attn.: [**]
E-mail: [**]
with a copy (which shall not constitute notice) to:
Wilmer Cutler Pickering Hale and Dorr LLP
7 World Trade Center
250 Greenwich Street
New York, NY 10007
Attn.: Christopher Barnstable-Brown, Esq.; Jenna Ventorino, Esq.
E-mail: chris.barnstable-brown@wilmerhale.com; jenna.ventorino@wilmerhale.com
If to Purchaser, to:
Tokyo Nihombashi Tower, 2-7-1
Nihonbashi, Chuo-ku, Tokyo 103-6012, Japan
Attn.: [**]
E-mail: [**]
with a copy (which shall not constitute notice) to:
Jones Day
3161 Michelson Drive
Irvine, CA 92612-4412
Attention: Jonn
R. Beeson, Esq.
Email: jbeeson@jonesday.com
or to such other place and with such other copies
as each of the Parties may designate as to itself by written notice to the other Parties (in accordance with this Section 5.2)
at least 10 days prior to such address taking effect.
5.3 No
Benefit to Third Parties. The covenants and agreements set forth in this Agreement are for the
sole benefit of the Parties and their successors and permitted assigns, and, they shall not be construed as conferring any rights on any
other Persons. Nothing in this Agreement is intended to provide any rights or remedies to any employee of the Seller Group.
5.4 Waiver
and Non-Exclusion of Remedies. Nabriva Parent, on the one hand and Purchaser, on the other hand,
may (a) extend the time for performance of any of the obligations or other acts of Purchaser or Sellers, respectively, contained
herein, (b) waive any inaccuracies in the representations and warranties of Purchaser or Sellers, respectively contained herein or
in any document, certificate or writing delivered by such Party pursuant hereto, or (c) waive compliance by the Purchaser or Sellers,
respectively, with any of the agreements or conditions contained herein. Any agreement on the part of either Nabriva Parent or Purchaser
to any such extension or waiver shall be valid only if set forth in a written instrument executed and delivered by a duly authorized officer
on behalf of such Party. No failure or delay of either Party in exercising any right or remedy hereunder shall operate as a waiver thereof,
nor shall any single or partial exercise of any such right or power, or any abandonment or discontinuance of steps to enforce such right
or power, or any course of conduct, preclude any other or further exercise thereof or the exercise of any other right or power.
5.5 Fees
and Expenses. Except as otherwise specified herein, and whether or not the Closing takes place,
each Party shall bear any costs and expenses incurred by it with respect to the Transactions.
5.6 Assignment.
Neither this Agreement nor either Purchaser’s or Sellers’ rights or obligations hereunder may be assigned or delegated by
such Party without the prior written consent of Purchaser in the case of an assignment or delegation by a Seller or Nabriva Parent in
the case of an assignment or delegation by Purchaser, and any attempted assignment or delegation of this Agreement or any of such rights
or obligations by a Party without such prior written consent shall be void and of no effect; provided, however, that each
of Sellers and Purchaser may assign or delegate any or all of its rights or obligations hereunder to an Affiliate without prior written
consent so long as the assigning or delegating Party also remains primarily obligated for the performance of its obligations under this
Agreement and such Affiliate agrees to be bound by the provisions of this Agreement and, without limiting the foregoing, to assume all
obligations of the assigning or delegating Party hereunder. Subject to the preceding sentence, this Agreement will be binding upon, inure
to the benefit of, and be enforceable by, the Parties and their respective successors and permitted assigns.
5.7 Amendment.
This Agreement may not be modified, amended, altered or supplemented except upon the execution and delivery of a written agreement executed
by Purchaser and Nabriva Parent.
5.8 Severability.
If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future Law, and if the rights
or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall
be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had
never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not
be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (d) in lieu of such illegal, invalid
or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision as
similar in terms or scope to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties.
5.9 Specific
Performance. Each of the Parties hereto acknowledges and agrees that the other Parties would
be damaged irreparably, and in a manner for which monetary damages would not be an adequate remedy, in the event any of the provisions
of this Agreement are not performed in accordance with its specific terms or otherwise are breached. Accordingly, each of the Parties
hereto agrees that the other Parties will be entitled to an injunction or injunctions to prevent breaches of the provisions of this Agreement
and to enforce specifically this Agreement and the terms and provisions hereof, in addition to any other remedy to which they may be entitled,
at law or in equity. Each Party hereto irrevocably and unconditionally agrees (a) to waive any requirement for the security or posting
of any bond in connection with any equitable remedy and (b) not to assert that a remedy of specific performance is unenforceable,
invalid, contrary to applicable Law or inequitable for any reason, or to assert that a remedy of monetary damages would provide an adequate
remedy. Each Party hereto also irrevocably and unconditionally (i) submits to the jurisdiction of the Court of Chancery of the State
of Delaware in connection with any Legal Proceeding brought in accordance with this Section 5.9,
and agrees that it will not bring any such Legal Proceeding in any other court other than the Court of Chancery of the State of Delaware,
or if (and only if) such court finds it lacks subject matter jurisdiction, any state or federal court sitting in the State of Delaware,
and appellate courts thereof (the “Chosen Court”), (ii) agrees that it will not attempt to deny or defeat such
jurisdiction by motion or other request for leave from any such court, (iii) agrees to waive, and not to assert by way of motion,
defense or otherwise, in any such Legal Proceeding, that the Legal Proceeding is brought in an inconvenient forum, that the venue of the
Legal Proceeding is improper or that this Agreement may not be enforced in or by the above-named court and (iv) agrees to waive any
right to trial of any issue by jury. With respect to any claims brought in accordance with this Section 5.9,
each Party acknowledges and agrees that service of any process, summons, notice or document by delivery to and, to the Party’s respective
address set forth in, Section 5.2 shall
be effective service of process for any such Legal Proceeding. The Parties hereto agree that a final judgment in any such Legal Proceeding
shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by applicable Law.
5.10 English
Language. This Agreement shall be written and executed in, and all other communications under
or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official
version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version
shall control.
5.11 Bulk
Sales Statutes. The Parties hereby waive compliance with the provisions of any bulk sales, bulk
transfer or similar Laws of any jurisdiction that may otherwise be applicable with respect to the sale of any or all of the Purchased
Assets to Purchaser; it being understood that any Liabilities arising out of the failure of Sellers to comply with the requirements and
provisions of any bulk sales, bulk transfer or similar Laws of any jurisdiction which would not otherwise constitute Assumed Liabilities
shall be treated as Excluded Liabilities.
5.12 Counterparts;
Electronic Signature. This Agreement may be executed in several counterparts, each of which will
constitute an original and all of which, when taken together, will constitute one agreement. This Agreement may be executed by facsimile
or electronic mail of a document in Adobe Portable Document Format (or scanned signature pages) or other electronic file based on common
standards, including any electronic signature complying with the U.S. federal ESIGN Act of 2000 (e.g., www.docusign.com) and any
counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.
5.13 Disclosure
Schedule. The Disclosure Schedule has been arranged, for purposes of convenience only, as separate
parts corresponding to the subsections of Section 2.1.
The representations and warranties contained in Section 2.1
are subject to (a) the exceptions and disclosures set forth in the subsection of the Disclosure Schedule corresponding to the particular
subsection of Section 2.1 in which such
representation and warranty appears and the subsections of the Disclosure Schedule expressly referenced herein are a part of this Agreement
as if fully set forth herein; (b) any exceptions or disclosures explicitly cross-referenced in such subsection of the Disclosure
Schedule by reference to another subsection of the Disclosure Schedule; and (c) any exception or disclosure set forth in any other
subsection of the Disclosure Schedule to the extent it is reasonably apparent on the face of such disclosure that such exception or disclosure
is intended to qualify another subsection of the Disclosure Schedule. No reference to or disclosure of any item or other matter in the
Disclosure Schedule shall be construed as an admission or indication that such item or other matter is material (nor shall it establish
a standard of materiality for any purpose whatsoever) or that such item or other matter is required to be referred to or disclosed in
the Disclosure Schedule. The information set forth in the Disclosure Schedule is disclosed solely for the purposes of this Agreement,
and no information set forth therein shall be deemed to be an admission by Sellers or Purchaser to any Third Party of any matter whatsoever,
including of any violation of Law or breach of any agreement. The Disclosure Schedule and the information and disclosures contained therein
are intended only to qualify and limit the representations and warranties of Sellers contained in Section 2.1.
5.14 Interpretation
of Agreement. Except where the context otherwise requires, wherever used, the singular includes
the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word “or” is used in
the inclusive sense (and/or). The captions and headings of this Agreement are for convenience of reference only and in no way define,
describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term “including”
as used herein does not limit the generality of any description preceding such term. Each Party acknowledges that it has participated
in the drafting of this Agreement, and any applicable rule of construction to the effect that ambiguities are to be resolved against
the drafting Party will not be applied in connection with the construction or interpretation of this Agreement. Although the same or similar
subject matters may be addressed in different provisions of this Agreement, the Parties intend that, except as reasonably apparent on
the face of the Agreement or as expressly provided in this Agreement, each such provision will be read separately, be given independent
significance and not be construed as limiting any other provision of this Agreement (whether or not more general or more specific in scope,
substance or content). Unless otherwise specified or where the context otherwise requires, (a) references in this Agreement (or in
Exhibit A) to any Article, Section, Schedule or Exhibit are references to such Article, Section, Schedule or Exhibit of
this Agreement; (b) references in any Section to any clause are references to such clause of such Section; (c) “hereof,”
“hereto,” “hereby,” “herein” and “hereunder” and words of similar import when used in
this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement; (d) references to a Person
are also to its permitted successors and assigns; (e) references to a Law include any amendment or modification to such Law and any
rules or regulations issued thereunder, in each case, as in effect at the relevant time of reference thereto; (f) references
to any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally executed
or, if subsequently amended, replaced or supplemented from time to time, as so amended, replaced or supplemented and in effect at the
relevant time of reference thereto; (g) “extent” in the phrase “to the extent” means the degree to which
a subject or other thing extends, and such phrase does not mean simply “if,” and (h) references to monetary amounts are
denominated in United States Dollars. The phrase “made available,” when used in reference to any documents or information
made available to Purchaser or any of its Representatives prior to the execution of this Agreement, shall be deemed to mean uploaded to,
and accessible to Purchaser and its Representatives in, the online data rooms entitled “Sumitomo Royalty Buyout” hosted on
behalf of Sellers by Citrix ShareFile in complete and unredacted form at least [**] prior to the execution and delivery of this Agreement.
5.15 Entire
Agreement. This Agreement, together with the Schedules and Exhibits expressly contemplated hereby
and attached hereto, the Disclosure Schedule, the Ancillary Agreements and the other agreements, certificates and documents delivered
in connection herewith or therewith or otherwise in connection with the Transactions, contain the entire agreement between the Parties
with respect to the Transactions and supersede all prior agreements, understandings, promises and representations, whether written or
oral, between the Parties with respect to the subject matter hereof and thereof. In the event of any inconsistency between any such Schedules
and Exhibits and this Agreement, the terms of this Agreement shall govern.
5.16 Austrian
Stamp Duty.
5.16.1 Each
Party agrees that (a) any communication between the Parties relating to this Agreement or the Transactions will be made in accordance
with the provisions of this Section 5.16
and (b) it will not produce in, bring into, send to, or cause to be sent to, or otherwise import to, or cause to be imported to,
Austria any signed original or certified copy of this Agreement or any other document that contains any written confirmation or written
reference to this Agreement or send to any Party any written confirmation or reference (including via e-mail or fax message) to this Agreement
or to any of the Transactions (individually and collectively the “Stamp Duty Sensitive Documents”), in each case other
than to the extent that (i) no Austrian stamp duty (Rechtsgeschäftsgebühr) is triggered thereby, (ii) such
Party is required to do so by applicable Law or (iii) such Party is required to present a Stamp Duty Sensitive Document in Austria
in order to preserve or enforce a right of, or remedy available to, any Party from time to time arising under or in respect of such Stamp
Duty Sensitive Document.
5.16.2 With
respect to any court, arbitral or governmental proceeding in Austria, each Party further agrees not to (a) object to the introduction
into evidence of any uncertified copy of any Stamp Duty Sensitive Document, (b) raise as a defense to any action or exercise of a
remedy a failure to introduce an original of any Stamp Duty Sensitive Document into evidence, (c) object to the submission of any
uncertified copy of any Stamp Duty Sensitive Document in any proceeding; or (d) contest the authenticity, and conformity to the original,
of an uncertified copy of any Stamp Duty Sensitive Document, in each case only if and to the extent that any such uncertified copy actually
introduced into evidence accurately reflects the content of such Stamp Duty Sensitive Document.
5.16.3 Each
Party shall take all reasonable steps to mitigate any circumstances which arise and which would result in any amount becoming payable
under, in respect of, or pursuant to, Stamp Duty Sensitive Documents.
5.16.4 For
purposes of clarity, Sellers shall bear all Covered Transfer Taxes, including any Covered Transfer Taxes resulting from a breach of any
obligation under this Section 5.16.
5.17 Place
of Performance. All obligations under this Agreement must be performed at a place outside Austria
on which the Parties explicitly agree on. No Party is entitled to perform any such obligation in Austria. In particular, no payments (if
any) under this Agreement may be made to or from an Austrian bank account. It is expressly agreed that any such performance within Austria
or via an Austrian bank account will not establish Austria as the place of performance and shall be deemed not effective with respect
to any Party. Further, it is agreed that the fulfilment of any obligation under this Agreement within Austria does not result in a discharge
of such obligation (keine schuldbefreiende Wirkung).
[Signature
pages follow]
IN
WITNESS WHEREOF, each of Sellers and Purchaser has caused this Agreement to be executed as of the date first written above
through their duly authorized representatives or respective officers.
SELLERS:
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SIGNED and DELIVERED
as a DEED for and on behalf of NABRIVA THERAPEUTICS IRELAND DESIGNATED ACTIVITY COMPANY by its lawfully appointed attorney
Steven Gelone in the presence of |
| /s/ Emma Gelone |
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/s/ Steven Gelone |
| (Witness' Signature) |
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Attorney |
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| Emma Gelone |
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| (Witness' Address) |
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SIGNED and
DELIVERED as a DEED for and on behalf of NABRIVA THERAPEUTICS PUBLIC LIMITED COMPANY by its lawfully appointed attorney
Steven Gelone in the presence of |
| /s/ Emma Gelone |
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/s/ Steven Gelone |
| (Witness' Signature) |
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Attorney |
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| Emma Gelone |
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[Signature
Page to Asset Purchase Agreement]
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Nabriva Therapeutics US, Inc. |
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By: |
/s/ Michael Hogan |
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Name: Michael Hogan |
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Title: President |
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Nabriva Therapeutics GmbH |
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By: |
/s/ Steven Gelone |
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Name: Steven Gelone |
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Title: Attorney |
[Signature
Page to Asset Purchase Agreement]
IN
WITNESS WHEREOF, each of Sellers and Purchaser has caused this Agreement to be executed as of the date first written above
through their duly authorized representatives or respective officers.
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PURCHASER: |
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Sumitomo Pharma Co., Ltd. |
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By: |
/s/ Hiroshi Nomura |
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Name: Hiroshi Nomura |
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Title: Representative Director, President and Chief Executive
Officer |
[Signature
Page to Asset Purchase Agreement]
Exhibit A
Certain Definitions
“Adverse Event”
means, with respect to a Product, any undesirable, untoward or noxious event or experience associated with the use, or occurring during
or following administration, of such product in humans, occurring at any dose, whether expected and whether considered related to or caused
by such Product, including such an event or experience as occurs in the course of the use of such Product in professional practice, in
a Clinical Trial, from overdose, whether accidental or intentional, from abuse, from withdrawal or from a failure of expected pharmacological
or biological therapeutic action of such Product, and including those events or experiences that are required to be reported to the FDA
under 21 C.F.R. sections 312.32 and 314.80, as applicable, or to foreign Governmental Entities under corresponding applicable Law outside
the United States (including the DAL).
“Affiliate”
means, with respect to a Person, any other Person that, directly or indirectly, through one or more intermediaries, controls, is controlled
by or is under common control with such first Person. For purposes of this definition, “control” and, with correlative meanings,
the terms “controlled by” and “under common control with” mean (a) the possession, directly or indirectly,
of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by Contract
relating to voting rights or corporate governance, or otherwise or (b) the ownership, directly or indirectly, of more than 50% of
the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity,
its general partner or controlling entity).
“Aggregate Cap”
means an amount of $3,000,000; provided that if the Bridge Period is extended beyond March 31, 2024 pursuant to the requirements
set forth in the definition of Bridge Period, then the Aggregate Cap shall automatically be increased by [**].
“Aggregate CMO Settlement
Amount” means the aggregate U.S. dollar amount set forth in Schedule 1.3.1(c) payable by Sellers or the
relevant other members of the Seller Group, as applicable, to the CMOs pursuant to the terms of the Settlement Agreements in order for
the settlement, discharge of all outstanding obligations, release of claims and other provisions set forth in the Settlement Agreements
to become effective.
“Agreement”
means the Asset Purchase Agreement to which this Exhibit A is attached, including the Disclosure Schedule.
“Ancillary Agreements”
means (i) the Austrian Local Transfer Agreement, (ii) the Termination Agreement regarding Existing Nabriva Agreements, (iii) the
Intellectual Property Assignment Agreement, and (iv) the Intellectual Property License Agreement.
“Austrian Local Transfer
Agreement” means a Local Transfer Agreement substantially in the form attached to the Agreement as Exhibit B.
“Bridge Period”
means the period commencing on the Closing Date and ending at the earlier of (a) [**] (b) [**] and (c) 11:59 p.m. Pacific
Time on March 31, 2024; provided, further, that Purchaser may, by notice sent in writing not later than [**], unilaterally
extend the Bridge Period for such number of months specified in the notice (but in no event beyond September 30, 2024), in which
case the term “Bridge Period” hereunder shall refer to the Bridge Period as so extended. For purposes of clarity, if the
Bridge Period is extended pursuant to the terms of this definition, Purchaser shall be obligated to continue reimbursing Operating Expenses
in accordance with, and subject to the limitations set forth in, Section 3.15.4.
“Bridge Period Pre-Funded
Expenses Amount” means $2,000,000 paid by Purchaser to Nabriva DAC at the Closing to fund certain expenses to be incurred by
Nabriva DAC during the Bridge Period.
“Budget Plan”
means a [**], attached to the Agreement as Exhibit C.
“Business Day”
means any day that is not a Saturday, a Sunday or other day on which banks are required or authorized by Law to be closed in the City
of New York, United States of America, in Dublin, Ireland, or in Tokyo, Japan.
“cGCP”
means, then current ethical, scientific and quality standards and procedures comprising current good clinical practices, as set forth
under Law, including, as applicable, the following: (a) the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50,
54, 56 and 312, (b) the People’s Republic of China Pharmaceutical Clinical Trial Quality Management Standard, issued in April 2020
by the NMPA and the NHC, and (c) other foreign equivalents of the foregoing, in each case, as same may be amended from time to time.
“cGMP”
means, then current standards of good manufacturing practices for the manufacture, processing, packaging, testing or holding of a medicinal
product for human use set forth under Law, including, as applicable, the following: (a) the FDCA and its implementing regulations
at 21 C.F.R. Parts 210-211, and (b) other foreign equivalents of the foregoing, in each case, as same may be amended from time to
time.
“Clinical Trial”
means any clinical investigation, study or trial conducted on one or more human subjects with respect to a therapeutic product, including:
(a) a clinical trial or investigation of a product or compound or other intervention in humans, the principal purpose of which is
to make a preliminary determination of metabolism, pharmacokinetics, dose findings or safety in healthy individuals or patients, including
those meeting the definition of 21 C.F.R. § 312.21(a), or other comparable applicable foreign Law (and including any trial or investigation
labeled as a “Phase 1a” or “Phase 1b” trial), (b) a clinical trial or investigation conducted mainly to test
the effectiveness of a product or compound or other intervention in humans for purposes of identifying the appropriate dose for a subsequent
clinical trial or investigation for a particular indication or indications, including those meeting the definition of 21 C.F.R. 312.21(b),
or other comparable applicable foreign Law, or, if no further trials are required by the applicable Governmental Entity, a clinical trial
or investigation otherwise in support of the issuance of a Marketing Approval (and including any trial or investigation labeled as a “Phase
2a” or “Phase 2b” trial), (c) a clinical trial or investigation designed to (i) prove that a product or compound
or other intervention in humans is safe and efficacious for its intended use, (ii) define warnings, precautions and adverse reactions
associated with the compound, product or intervention, and (iii) otherwise support the issuance of a Marketing Approval, including
those meeting the definition of 21 C.F.R. 312.21(c) or other comparable applicable foreign Law, (d) any post-marketing trial,
investigation or study conducted or required to be conducted to obtain additional information about a product, compound or intervention
in humans, including regarding patient subsets such as the pediatric population, the product, compound or intervention’s risks,
benefits, and best use, in the indication for which Marketing Approval was issued or to explore potential Label expansion or otherwise
support marketing claims, or (e) a “sponsor-investigator” trial, as defined in 21 CFR 312.3(b) and any other clinical
trial or investigation regarding which an Investigator, hospital, academic medical center, CRO or entity other than a pharmaceutical,
biotech or medical device company serves as the sponsor.
“Clinical Trial Agreement”
means a Contract between a sponsor, CRO or other sponsor designee, on the one hand, and a Clinical Trial site and/or Investigator, on
the other hand, providing for the conduct of a Clinical Trial.
“Clinical Trial Authorization”
means any issued Permit required to be obtained from a Governmental Entity or an IRB, in order to conduct a Clinical Trial in an applicable
jurisdiction (including the DAL) under applicable Law (including the People’s Republic of China Provisions for Drug Registration
or equivalents thereof), and including acceptance of an IND.
“Clinical Trial Authorization
Application” means an application for a Clinical Trial Authorization, including an IND.
“Closing Date”
means the date on which the Closing occurs.
“CMO” means
contract manufacturing organization.
“COBRA”
means the continuation coverage requirements of Section 4980B of the Code and Part 6 of Subtitle B of Title I of ERISA and any
similar state Law.
“Code”
means the Internal Revenue Code of 1986, as amended, and the rules and regulations promulgated thereunder.
“Consent”
means any consent, approval or waiver.
“Commercialization”
means all activities related to the commercial exploitation of a Product, including the importation, exportation, regulatory reporting
or post-market requirements, marketing, promotion, co-promotion, distribution, launch, supply, sale or offering for sale of a Product
or to license or otherwise permit any Person to conduct any of the foregoing. When used as a verb “Commercialize” means to
engage in “Commercialization.”
“Contract”
means any contract, agreement, lease, sublease, license, sublicense or other legally binding commitment or arrangement.
“Control”
or “Controlled” means, (a) with respect to any Intellectual Property, possession of the right to assign or grant
a license, sublicense or other right to or under such item of Intellectual Property and (b) with respect to any Product Records,
Regulatory Approvals, Regulatory Approval Applications, Regulatory Documentation, and Product Promotional Material, the right to assign,
grant the right to use, or grant a right of access or reference thereto, in each case of (a) and (b) pursuant to the terms of
this Agreement, including the Ancillary Agreements, and without violating the terms of any Contract or other arrangement with any Third
Party.
“Copyrights”
means all copyrights (whether in published or unpublished works) and copyrightable works (including databases and other compilations of
information, mask works and semiconductor chip rights), including all rights of authorship, use, publication, reproduction, distribution,
performance, transformation, moral rights and rights of ownership of copyrightable works, and all registrations and rights to register
and obtain renewals and extensions of registrations, together with all other interests accruing by reason of international copyright.
“CRO” means
a Person (including a commercial, academic, or other organization) contracted by a sponsor to perform one or more of a sponsor’s
Clinical Trial-related duties and functions, including those defined in (a) 21 C.F.R. 312.3(b), (b) GCP-2020, and (c) foreign
equivalents of the foregoing.
“CTA” means
a Clinical Trial application that is required to initiate a Clinical Trial for registering a drug product under applicable Law of an applicable
jurisdiction, including the DAL and the People’s Republic of China Provisions for Drug Registration or equivalents thereof, as the
same may be amended from time to time.
“DAL” means
the Drug Administration Law of the People’s Republic of China, as such may be amended from time to time.
“Development”
means all activities related to the development of a compound or potential medicinal product including the pursuit of a Marketing Approval
for such compound or potential medicinal product and any activities related to the research, development, pre-clinical testing, toxicology
and stability testing, formulation, Clinical Trials, regulatory affairs, medical writing, qualification and validation, quality control
and assurance and regulatory submissions related thereto. When used as a verb, “Develop” means to engage in Development.
“Disclosure Schedule”
means the disclosure schedule delivered by Sellers to Purchaser contemporaneously with the execution and delivery of the Agreement.
“Domain Names”
means internet domain names registered with or assigned by any domain name registrar, domain name registry or other domain name registration
authority as part of an electronic address on the Internet and all applications for any of the foregoing.
“Drug Substance”
means each substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in the
production of such product, becomes an active pharmaceutical ingredient of such product.
“Electronic Delivery”
means the delivery by electronic means of the Purchased Intellectual Property and other Purchased Assets, in each case, to the extent
in electronic format via remote transfer or through an electronic data room as mutually agreed between the Parties; provided that,
unless otherwise selected by Purchaser pursuant to Section 3.6.1, Purchaser will in no event obtain possession or ownership
of any tangible personal property (such as computers, servers, hard drives, storage media, cloud storage accounts, or other devices) on
which any of the Purchased Intellectual Property or copies thereof are located or stored unless they are otherwise included in the Purchased
Assets.
“EMA” means
the European Medicines Agency and any successor agency thereto.
“Employee Plans”
means all: (i) “employee benefit plans” (as defined in Section 3(3) of ERISA, whether or not subject to ERISA),
(ii) employment, consulting, severance pay, salary continuation, bonus, commission, incentive, stock option, restricted stock, equity-based,
phantom stock, health, welfare, retirement, pension, profit sharing, change-of-control compensation, retention, fringe benefit, or deferred
compensation plans, Contracts, programs, funds or arrangements of any kind; and (iii) other employment, compensation and employee
benefit plans, Contracts, programs, funds or arrangements (whether written or oral, qualified or nonqualified, funded or unfunded, foreign
or domestic) and any trust, escrow or similar agreement related thereto, in each case, in respect of any current or former employee, director,
manager, officer, equity holder, consultant or individual independent contractor of the Seller Group and (A) that are sponsored or
maintained by the Seller Group, (B) with respect to which any member of the Seller Group has made or is required to make payments
or contributions, or (C) with respect to which any member of the Seller Group has any current or contingent Liability.
“Encumbrance”
means any mortgage, lien, license, charge, pledge, security interest, restriction, right of first refusal or negotiation, or other encumbrance.
“Enforceability Exceptions”
means to the extent enforceability is limited by bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium or similar Laws
of general application affecting or relating to the enforcement of creditors’ rights generally, and subject to equitable principles
of general applicability, whether considered in a proceeding at law or in equity.
“Environmental Laws”
means all federal, state or local laws (including any statute, rule, regulation, ordinance, code or rule of common law), and all
judicial or administrative interpretations thereof, and all decrees, judgments, policies, written guidance or judicial or administrative
orders relating to the environment, health, safety or Hazardous Substances, including the Comprehensive Environmental Response, Compensation
and Liability Act, 42 U.S.C. § 9901 et seq., the Resource Conservation and Recovery Act of 1976, 42 U.S.C. § 6901 et seq., the
Emergency Planning and Community Right-to-Know Act, 42 U.S.C. § 11001 et seq., the Clean Air Act, 42 U.S.C. § 7401 et seq.,
the Federal Water Pollution Control Act, 33 U.S.C. § 1251 et seq., the Toxic Substance Control Act, 15 U.S.C. § 2601 et seq.,
the Safe Drinking Water Act, U.S.C. § 300f et seq., the Occupational Safety and Health Act, 42 U.S.C. § 1801 et seq., the Federal
Insecticide, Fungicide and Rodenticide Act, 7 U.S.C. § 136 et seq., the Hazardous Materials Transportation Act, 49 U.S.C. §
1801 et seq., and their state counterparts or equivalents, all as amended, and any regulations or rules adopted or promulgated pursuant
thereto.
“ERISA”
means the Employee Retirement Income Security Act of 1974, as amended, and the rules and regulations promulgated thereunder.
“Exploit”
and “Exploitation” means to Develop, have Developed, Manufacture, have Manufactured, Commercialize, hold or keep (whether
for disposal or otherwise), transport or otherwise dispose of, or to license or otherwise permit any Person to conduct any of the foregoing.
“Extraterritorial
Agreements” means (a) the Distribution Agreement by and between Er-Kim Pharmaceuticals Bulgaria EOOD and Nabriva DAC, effective
as of July 7, 2022 and (b) the License Agreement by and between Nabriva DAC and Sunovian Pharmaceuticals Canada Inc., effective
as of March 28, 2019.
“Extraterritorial
Licensee” means the Third Party counterparty to any Extraterritorial Agreement.
“FDA” means
the United States Food and Drug Administration and any successor agency thereto.
“FDCA”
means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and its applicable implementing regulations and related
guidance.
“Fraud”
means, with respect to a Party, intentional fraud under Delaware common law (including as an element the intent that the other party relied
thereon to its detriment) by such Party with respect to an express representation and warranty made in this Agreement.
“Fundamental Reps”
means the representations and warranties set forth in Section 2.1.1(a) (Organization and Qualification),
Section 2.1.2 (Authority), Section 2.1.4 (No Broker), Section 2.1.6 (Purchased
Assets), Section 2.1.8(b) (Settlement Agreements), Section 2.1.12 (Taxes), Section 2.1.15
(Solvency; Fair Value; No Fraudulent Conveyance) Section 2.2.1(a) (Organization and Qualification),
Section 2.2.2 (Authority) and Section 2.2.4 (No Broker).
“GAAP”
means generally accepted accounting principles in the United States.
“Good Manufacturing
Practice for Drugs” means the People’s Republic of China Pharmaceutical Manufacturing Quality Management Standard, amended
in 2010 by People’s Republic of China Ministry of Health.
“Governmental Entity”
means any federal, state, provincial, local, foreign, or supranational or international (a) government; (b) court of competent
jurisdiction; (c) governmental official agency, arbitrator, authority or instrumentality; (d) department, commission, board
or bureau; (e) instrumentality of any jurisdiction, domestic or foreign, or (f) other regulatory body, including the FDA, the
EMA, the NMPA, and the United States Drug Enforcement Administration, the People’s Republic of China Human Genetic Resource Administration
Office and any corresponding foreign agency, and including the United States Patent and Trademark Office, China National Intellectual
Property Administration and any corresponding foreign agency.
“GxP” means,
collectively, cGCP, cGMP and other applicable, generally accepted industry best practice standards for the pharmaceutical or biotech industry.
“HCP” means
any Person (i) qualified to prescribe, administer, use or supply any medicinal or medical products or (ii) perform any professional
medical, laboratory, research, nursing, phlebotomy, behavioral health, or other clinical services; the foregoing to include any Investigator,
physician, pharmacist, registered nurse, licensed practical nurse, advanced practice nurse, nurse practitioner, certified registered nurse
practitioner, physician assistant, therapist, mental health coach or other health care provider or practitioner.
“Hazardous Substance”
means any: contaminant or pollutant; toxic, radioactive or hazardous waste, chemical, substance, material or constituent; asbestos; polychlorinated
biphenyls (PCBs); paint containing lead or mercury; fixtures containing mercury or urea formaldehyde; natural or liquefied gas; flammable,
explosive, corrosive, radioactive, medical and infectious waste; and oil or other petroleum product, all as defined in Environmental Laws.
“Health Care Laws”
means all Laws that regulate the Exploitation of pharmaceutical, biotech, or other medical products or that regulate interactions between
pharmaceutical manufacturers or Persons acting on their behalf with HCPs, including, without limitation: (a) the FDCA, (b) the
PHSA, (c) the Clinical Laboratory Improvement Amendments (42 U.S.C. § 263a), (d) the federal Medicare and Medicaid statutes
(Title XVIII and Title XIX of the federal Social Security Act), (e) the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)),
(f) the Stark Anti-Self-Referral Law (42 U.S.C. §§ 1395nn), (g) the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)),
(h) the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), (i) the administrative False Claims Law (42 U.S.C. §
1320a-7b(a)), (j) Section 6002 of the Patient Protection and Affordable Care Act (Public Law No. 111-148), as amended by
the Health Care and Education Reconciliation Act of 2010 (Public Law No. 111-152), (k) the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical
Health Act (42 U.S.C. § 17921(2) et seq.) Directive 95/46/EC, Regulation (EU) 2016/679 (when applicable) and any other Applicable
Laws protecting or regulating protected health information, personal data, sensitive information, privacy and security matters, (l) the
exclusion laws (42 U.S.C. 1320a-7), (m) the federal Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), (n) GxP, (o) the
applicable version (under applicable Law) of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research
Involving Human Subjects and other Applicable Laws regulating the conduct of Clinical Trials, (p) the DAL, (q) the GCP-2020,
(r) Good Manufacturing Practice for Drugs, (s) People’s Republic of China Provisions for Drug Registration, (t) the
Federal Trade Commission Act (15 U.S.C. § 41 et seq.), (u) state or foreign equivalents of the foregoing, and (v) all regulations
or rules promulgated pursuant to the foregoing.
“Holdback Period
Expiration Time” means the 18-month anniversary of the Closing Date.
“Import License”
means sufficient approval or a Permit from each Governmental Entity as is necessary to import a therapeutic product or compound or other
intervention in humans into a country or jurisdiction in the Territory.
“IND” means
any investigational new drug application filed with the FDA pursuant to 21 C.F.R. 312, or any substantially equivalent Law of a foreign
jurisdiction.
“Indemnification
Holdback” means $1,800,000.
“Intellectual Property”
means Copyrights, Domain Names, Patents, Trademarks, rights in Trade Secrets, industrial property rights or other intangible property
rights in Know-How, other intellectual property, industrial property or other rights in intangibles recognized by a Governmental Entity,
all rights to enforce rights in and to collect damages for past, present and future violations of the foregoing, and all goodwill associated
with any of the foregoing.
Intellectual
Property Assignment Agreement” means an Intellectual Property Assignment Agreement substantially in the form attached
to the Agreement as Exhibit F.
“Intellectual Property
License Agreement” means an Intellectual Property License Agreement substantially in the form attached to the Agreement as Exhibit E.
“Investigator”
means a Person (i) as defined in 21 C.F.R. 312.3(b), or (ii) as defined under equivalent Laws of other applicable jurisdictions,
and, in each case, including all Persons identified as “Investigator”, “Principal Investigator”, “Sub-Investigator”
or, a “Sponsor-Investigator” as defined in 21 C.F.R. 312.3(b).
“IRB” means
any national, central, local or regional institutional review board or ethics committee of any applicable jurisdiction designated to review,
approve or monitor the conduct of clinical research, with the aim to protect the rights, welfare and safety of human subjects, including
any such entity as described in 21 C.F.R. Part 56, or foreign equivalent of the foregoing.
“Know-How”
means unpublished inventions (whether patentable or not), industrial designs, discoveries, improvements, ideas, designs, models, formulae,
genetic sequences, recipes, compositions, molecules, cell lines, biological materials, patterns, compilations, data collections, diagrams,
drawings, blueprints, mask works, devices, methods, techniques, bioassays, processes, know-how, instructions, configurations, prototypes,
samples, procedures, specifications, technology, Trade Secrets, experiment results, test results, confidential information, proprietary
information, customer lists, source code and technical information, and moral and economic rights of authors and inventors in any of the
foregoing.
“Lab Notebooks“
means all lab notebooks (including any experiment notes), whether in physical or electronic format, under the Control of Sellers or any
other member of the Seller Group to the extent relating to a Product (whether or not in the Territory), the Product Business, or the Purchased
Assets.
“Labeling”
has the meaning under Section 201(m) of the FDCA (21 U.S.C. § 321(m)) and other comparable foreign Law relating to the
subject matter thereof, including the applicable Product’s label, packaging and package inserts accompanying such Product, and any
other written, printed, or graphic materials accompanying such Product, including patient instructions or patient indication guides.
“Law” means
any domestic or foreign, federal, state or local statute, law, treaty, judgment, ordinance, rule, administrative interpretation, regulation,
order or other requirement having the force of law of any Governmental Entity, including Health Care Laws.
“Legal Proceeding”
means any action, suit, charge, complaint, litigation, arbitration, proceeding (including any civil, criminal, administrative, investigative
or appellate proceeding), hearing, inquiry, audit, qui tam action, subpoena, examination or investigation commenced, brought, conducted
or heard by or before, or otherwise involving, any court or other Governmental Entity or any arbitrator or arbitration panel.
“Liabilities”
means any debts, liabilities or obligations, whether known or unknown, fixed or contingent, determined or determinable (including all
adverse reactions, recalls, product and packaging liabilities) and whether or not the same would be required to be reflected in financial
statements or disclosed in the notes thereto and whether called a liability, obligation, indebtedness, guaranty, claim or otherwise.
“Licensed Product
IP” means all Intellectual Property licensed to Purchaser pursuant to the Intellectual Property License Agreement.
“Lookback Date”
means January 1, 2020.
“Loss”
or “Losses” means any and all losses, Liabilities, damages, claims, suits, judgments, settlements, costs and expenses,
and Taxes, including costs of settlement, and defense, legal and consulting fees and disbursements, court costs, and any interest costs
or penalties.
“Manufacture”
and “Manufacturing” means all activities related to the production, manufacture, processing, filling, finishing, packaging,
labeling, shipping and holding of a product or any intermediate thereof, including process development, process qualification and validation,
scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality
assurance and quality control.
“Manufacturing Approval”
means sufficient approval or a Permit from the applicable Governmental Entity(ies) as necessary to perform any Manufacturing activities
relating to a therapeutic product or compound or other intervention in humans in the facility concerned.
“Manufacturing Approval
Application” means an application or submission for a Manufacturing Approval.
“Marketing Approval”
means with respect to a Marketing Approval Application and a particular country or jurisdiction, the approval by a Governmental Entity
of competent authority of such Marketing Approval Application for such country or jurisdiction as necessary for the Commercialization
of a therapeutic product or compound or other intervention in humans in such country or jurisdiction, including any pricing or reimbursement
approval.
“Marketing Approval
Application” means an application in any country or jurisdiction for the approval, license or authorization of the applicable
Governmental Entity(ies) necessary for the Commercialization of a therapeutic product or compound or other intervention in humans in such
country or jurisdiction, including an NDA.
“Material Adverse
Effect” means any change, event, circumstance, condition, effect, occurrence or development that individually or in the aggregate
with other changes, events, circumstances, conditions, effects, occurrences or developments, has or would reasonably be expected to have
a material adverse effect on the Purchased Assets or on the results of operations of the Product Business, taken as a whole; provided,
however, that in determining whether a Material Adverse Effect has occurred, none of the following, shall be deemed to constitute,
or shall be taken into account in determining whether there has been, a “Material Adverse Effect:” (i) political or economic
conditions or conditions affecting the capital or financial markets generally; (ii) conditions generally affecting the industry in
which the Product Business operates; (iii) any actual or proposed change in GAAP or applicable Law; (iv) any hostility, act
of war, terrorism or military actions, or any escalation of any of the foregoing; (v) any hurricane, flood, tornado, earthquake,
pandemic, epidemic or other natural disaster (including related governmental or similar responses thereto); and (vi) the failure
of the Product Business to achieve any financial projections, predictions or forecasts (provided, that the underlying causes of such failure
shall not be excluded); except, in each of clauses (i) through (v), for those conditions that have a disproportionate effect on the
Purchased Assets and Assumed Liabilities, taken as a whole, relative to other Persons operating businesses similar to the Product Business.
“NDA” means
a new drug application, as defined in the FDCA and applicable regulations promulgated thereunder by FDA, including all amendments and
supplements to any such application, and any equivalent application, amendment or supplement to the equivalent Governmental Entity in
any other regulatory jurisdiction.
“NHC” means
the People’s Republic of China National Health Commission.
“NMPA”
means the National Medical Products Administration of the People’s Republic of China.
“Order”
means any order, decision, ruling, writ, injunction, decree, judgment, award, settlement, consent decree, corporate integrity agreement,
deferred prosecution agreement, monitoring agreement, subpoena, civil investigative demand, legally binding agreement or stipulation issued,
promulgated, made, rendered, enforced or entered into by or with any Governmental Entity.
“Patent Files”
means, with regard to the Purchased Patents, any and all files, documents and materials (whether in electronic or tangible format) that:
(i) relate to the investigation, evaluation, preparation, prosecution, maintenance, defense, enforcement, filing, issuance or registration
of any of the Purchased Patents; or (ii) help to support or establish the dates of conception or reduction to practice of any inventions.
“Patents”
means (a) all national, regional and international applications for patent or other indicia of ownership of a design, industrial
property, invention or discovery issued by a Governmental Entity, including provisional patent and utility model applications; (b) all
applications claiming priority, directly or indirectly, from any of the foregoing, including divisionals, continuations, continuations-in-part,
converted provisionals, continued prosecution applications and other pre-issue forms of any of the foregoing described in clauses (a);
(c) any and all patents or other indicia of ownership of a design, industrial property, invention or discovery issued by a Governmental
Entity that have issued or in the future issue from any of the foregoing described in clauses (a) and (b), including utility models,
petty patents, innovation patents and design patents and certificates of invention; (d) any and all extensions or restorations by
existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any
supplementary protection certificates and the like), and other post-issue forms of any of the foregoing described in clauses (a), (b) and
(c); and (e) any similar rights, including so-called pipeline protection or any importation, revalidation, confirmation or introduction
patent or registration patent or patent of additions to any of the foregoing described in clauses (a) – (d).
“Permit”
means any license, permit, application, consent, certificate, registration, exemption, waiver, clearance, approval or authorization issued,
granted, given or otherwise made available by, or under the authority of, any Governmental Entity.
“Permitted Encumbrance”
means any (a) Encumbrance for current Taxes not yet due or delinquent, to the extent such does not constitute an Encumbrance on the
Purchased Assets after the Closing Date; (b) Encumbrance caused by Law that does not materially detract from the current value of,
or materially interfere with, the present use and enjoyment of any Purchased Asset subject thereto or affected thereby in the ordinary
course of business of the Product Business; (c) Encumbrance not securing indebtedness or guarantees of indebtedness that does not
materially detract from the current value of, or materially interfere with, the present use and enjoyment of such Purchased Asset in the
ordinary course of business of the Product Business, and (d) non-exclusive licenses or sublicenses granted in the ordinary course
of business to contractors or service providers solely to enable them to supply products to, or perform services for, the Seller Group.
“Person”
means any individual, partnership, limited partnership, limited liability company, joint venture, syndicate, sole proprietorship, corporation,
unincorporated association, trust, trustee, executor, administrator or other legal personal representative, or any other legal entity,
including a Governmental Entity.
“Personal Data”
means information that: (i) identifies or can be used to identify an individual (including names, signatures, addresses, telephone
numbers, e-mail addresses and other unique identifiers); (ii) can be used to authenticate an individual (including employee identification
numbers, government-issued identification numbers, passwords or PINs, financial account numbers, credit report information, biometric
or health data, answers to security questions and other personal identifiers); or (iii) is considered “personal data,”
“personal information,” or “personally identifiable information” or the like under applicable Law.
“PHSA”
means the United States Public Health Service Act (42 U.S.C.§ 201 et seq.) and the regulations promulgated thereunder, including
21 CFR 600-680.
“Privacy Obligations”
means applicable Laws, contractual obligations, self-regulatory standards that are applicable to the operation of the Product Business,
or policies or terms of use that are related to privacy, data protection or the processing of Personal Data, in each case as and to the
extent applicable to the operation of the Product Business or the Purchased Assets or otherwise applicable to any member of the Seller
Group.
“Product”
means the compound set forth on Schedule B to the Agreement and any and all pharmaceutical products comprising or containing
such compound, in the form such products have been studied by or on behalf of any member of the Seller Group or any of their licensees
in Clinical Trials at any time prior to the Closing.
“Product Business”
means the Exploitation of Products in the Territory.
“Product IP”
means the Purchased Intellectual Property and the Licensed Product IP.
“Product Promotional
Material” means, to the extent in the possession or Control of any member of the Seller Group, in any medium, including audio,
visual, print, magnetic or electronic, the advertising, promotional and media materials, medical education and informational materials,
sales training materials (including related quizzes and answers, if any), point of sales materials, existing customer lists, co-pay cards,
other marketing data and materials (including related to market research), trade show materials (including displays) and videos, including
materials containing clinical data, if any, to the extent primarily used in the past or present for or related to the Commercialization
of a Product that has Regulatory Approval in the Territory (including any such materials included in the Regulatory Documentation).
“Product Records”
means, with respect to any product, to the extent relating to a product, in any medium including audio, visual, print, magnetic or electronic
(if in electronic form, in its native file and .PDF format, and otherwise in the same form as existing): all books and records related
to the Product, the Purchased Assets, or the Product Business (other than the Regulatory Documentation) including (a) copies of all
applicable technical reports, including characterization reports, stability study protocols and reports and development reports and batch
documentation (including executed batch records, disposition packages applied to Clinical Trials), (b) product and raw material specifications
(including the percentages and specifications of ingredients, any related formulae or flow diagrams and bill of materials), in-process
control documentation, intermediate specifications (where applicable), and Drug Substance and drug product release specifications, (c) standard
operating procedures (such as master batch records and applicable supporting procedures) and related Manufacturing, engineering and other
manuals (as applicable) for such product, (d) copies of process validation reports, copies of analytical method validation reports,
applicable method development reports, method qualification reports, and/or method transfer reports, (e) quality control and release
testing procedures supportive of in-process, release, and stability release criteria, (f) copies of applicable documentation related
to the master and working cell banks, (g) data contained in laboratory notebooks related to such product, and (h) copies of
all books and records reasonably necessary to Exploit such product as previously Exploited, including vendor and supplier lists and correspondence,
records regarding product samples and training materials. Product Records shall not include (i) Trade Secrets of Third Parties, other
than any such Trade Secrets that are the subject of an Ancillary Agreement, (ii) any attorney work product, attorney-client communications
and other items protected by established legal privilege, unless the books and records can be transferred together with such privilege
to the transferee, (iii) human resources and any other employee books and records, (iv) any financial, Tax and accounting records
to the extent not related to a Product, and (v) any items to the extent applicable Law prohibits their transfer.
“Purchase Price”
means $13,000,000.
“Purchased Intellectual
Property” means (a) all Purchased Patents, (b) the Purchased Know-How, (c) the Purchased Trademarks, and (d) all
other Intellectual Property (other than Patents, Know-How and Trademarks), Controlled, or purported to be Controlled, solely or jointly,
by a member of the Seller Group and primarily related to or otherwise used in the Product Business.
“Purchased Know-How”
means all Know-How Controlled, or purported to be Controlled, solely or jointly, by any member of the Seller Group and that is (i) primarily
related to the Development, Manufacture or Commercialization of a Product or (ii) otherwise used by or on behalf of any member of
the Seller Group for or in connection with the Product Business.
“Purchased Patents”
means (a) all Patents in the Territory, to the extent Controlled, or purported to be Controlled, solely or jointly, by a member of
the Seller Group that are primarily related to the Product Business, including the Patents that are listed on Section 2.1.11(b) of
the Disclosure Schedule, including all rights to enforce rights in and to collect damages for past, present and future violations of the
foregoing and (b) all Post-Closing Cooperation Patents.
“Purchased Product
Records” means originals of all Product Records owned or Controlled, or purported to be Controlled, by a member of the Seller
Group to the extent primarily related to a Product, whether or not in the Territory, or the Product Business, including those stored by
a member of the Seller Group in Austria, Ireland or other locations, including all Lab Notebooks.
“Purchased Regulatory
Documentation” means all Regulatory Documentation owned or Controlled, or purported to be Controlled, by a member of the Seller
Group to the extent primarily related to a Product in the Territory.
“Purchased Trademarks”
means the XENLETA and Xenleta Squares Trademarks in the Territory Controlled, or purported to be Controlled, solely or jointly, by any
member of the Seller Group, including the Trademarks set forth in Section 2.1.11(b) of the Disclosure Schedule.
“Purchaser Material
Adverse Effect” with respect to Purchaser means any change, event, circumstance, condition, effect, occurrence or development
that either alone or in combination with any other change, event, circumstance, condition, effect, occurrence or development would have,
or would reasonably expected to have, a material adverse effect on the ability of Purchaser to perform its obligations hereunder or under
the Ancillary Agreements or to consummate, or otherwise prevent the Transactions.
“Relevant Regulatory
Territory” means collectively, (a) the Territory and (b) the United States.
“Regulatory Approvals”
means, as applicable, all (a) Marketing Approvals, (b) Clinical Trial Authorizations, (c) Import Licenses, (d) Manufacturing
Approvals, (e) approvals from or recordals with the China Human Genetic Resource Office, and (f) IRB approvals.
“Regulatory Approval
Applications” means, as applicable, all (a) Marketing Approval Applications, (b) Clinical Trial Authorization Applications,
(c) applications for an Import License, (d) Manufacturing Approval Applications, (e) applications for approvals from or
record-filings with the China Human Genetic Resource Office, and (f) applications for IRB approvals.
“Regulatory Documentation”
means, with respect to a Product or the Product Business, in any medium including audio, visual, print, magnetic or electronic, all (a) documentation
comprising the Regulatory Approvals, Regulatory Approval Applications, or otherwise required by applicable Law or any Order to Exploit
a Product in the Territory, (b) dossiers, notifications, reports, supplements, records, data and other materials, submissions or
correspondence filed with or received from Governmental Entities relating to the Regulatory Approvals or application or submission for
obtaining a Regulatory Approval, (c) reports, supplements, records, data and other materials and correspondence, including minutes
and official contact reports relating to any communications with any Governmental Entity, and relevant supporting documents with respect
thereto, including all Labeling materials and the approved label components with respect to Product and draft and final advertising and
promotion documents submitted to a Governmental Entity for comment, Adverse Event files and complaint files, pharmacovigilance records
and studies and any other information relevant to the assessment of product safety, (d) clinical and preclinical data, results (including
all tables, listings and graphs) and reports, case report forms, and other materials or correspondence filed with or received from Governmental
Entities to the extent relating to any Clinical Trial or any other post-marketing studies or commitments), (e) all process validation,
analytical method validation, applicable method qualification, technical and inspection and audit reports related to a Product, (f) any
other notices, communications or other correspondence between a member of the Seller Group or any CRO, CMO, distributor or Third Party
holder of a Regulatory Approval, on the one hand, and any Governmental Entity, on the other hand, relating to a Product or the Product
Business and (g) other data (including clinical and pre-clinical data) contained or relied upon in any of the foregoing, in each
case, to the extent in the possession or control of Seller Group or maintained on its behalf.
“Representatives”
means, in respect of a Person, such Person’s directors, officers, managers, employees, agents and other representatives.
“Sellers’ Knowledge”,
or any other similar knowledge qualification in the Agreement means the actual knowledge, after reasonable inquiry or investigation related
to the subject matter in question, of the individuals set forth on Schedule A to the Agreement.
“Seller Product Business”
means the Exploitation of Products by any of the members of the Seller Group or any licensee or sublicensee of a member of the Seller
Group outside of the Territory.
“Seller Retained
Marks” means, other than the Purchased Trademarks, all Trademarks and Domain Names owned by a member of the Seller Group, including
the trademark “Nabriva” and any Trademarks or Domain Names that contain any of the foregoing, any translation, variation,
derivation, combination or equivalent of any of the foregoing, and any Trademark or Domain Name that is confusingly similar to any of
the foregoing.
“Subsidiary”
means, with respect to a Person, any entity, whether incorporated or unincorporated, of which at least a majority of the securities or
ownership interests having by their terms voting power to elect a majority of the board of directors or other Persons performing similar
functions is directly or indirectly owned or controlled by such Person or by one or more of its respective Subsidiaries.
“Tax Return”
means any return, declaration, report, claim for refund, information return or statement relating to Taxes, including any schedule or
attachment thereto, filed with a Governmental Entity, or required to be filed with a Governmental Entity, in connection with the calculation,
determination, assessment or collection of any Tax and includes any amended returns required as a result of examination adjustments made
by the Internal Revenue Service or other Tax authority.
“Tax” or
“Taxes” means (a) any and all taxes, fees, levies, duties, tariffs, imposts and other charges in the nature of
a tax, whether disputed or not, imposed by any Governmental Entity or taxing authority, including taxes or other charges on, measured
by, or with respect to income, franchise, windfall or other profits, gross receipts, property, sales, use, capital stock, payroll, employment,
social security, workers’ compensation, unemployment compensation or net worth; and taxes or other charges in the nature of excise,
withholding, ad valorem, stamp, transfer, escheat or unclaimed property, value-added or gains taxes; license, registration and documentation
fees; and customs duties, tariffs and similar charges; (b) any and all interest, penalties, additions to tax and additional amounts
imposed in connection with or with respect to the foregoing; and (iii) any Liabilities for items described in (a) or (b), whether
as a primary obligor or as a result of being a transferee (within the meaning of Section 6901 of the Code or any other applicable
Law) or successor of another Person, as a result of being a member of an affiliated, consolidated, unitary or combined group, pursuant
to any Law, by Contract or otherwise.
“Termination Agreement
regarding the Existing Nabriva Agreements” means an agreement regarding the termination of certain existing agreements between
one or more members of the Seller Group, on the one hand, and Purchaser or any of its Affiliates, on the other hand, in the form attached
to the Agreement as Exhibit D.
“Territory”
means, collectively, (i) the People’s Republic of China, (ii) the Hong Kong Special Administrative Region of the People’s
Republic of China, (iii) the Macau Special Administrative Region of the People’s Republic of China, and (iv) Taiwan.
“Third Party”
means any Person other than a member of the Seller Group, Purchaser and its Affiliates, and each of their permitted successors and assigns.
“Trade Secrets”
means any trade secrets, or any confidential inventions (whether patentable or unpatentable, whether or not reduced to practice, whether
or not in an invention disclosure and whether or not in writing), processes, formulae, developments, discoveries, technology, compounds,
probes, sequences, technical information and data, software, methods, biological materials, bioassays, clones, molecules, protocols, reagents,
experiments, lab results, tests, know-how, concepts, ideas, processes, research and development information and results, customer lists,
supplier lists, pricing and cost information, business and marketing plans, strategies or other confidential information or materials
which in the reasonable business judgment of the owner thereof have value or confer a competitive advantage to such owner due to being
not generally known or not publicly disseminated.
“Trademark”
means any word, name, symbol, color, product shape, designation or device or any combination thereof that functions as an identifier of
source or origin, including any trademark, trade dress, brand mark, service mark, trade name, brand name, product configuration, logo
or business symbol, whether or not registered, all applications for registration of any of the foregoing, all registrations of any of
the foregoing, all pre-issue and post-issue forms of the foregoing applications or registrations, and all goodwill associated with and
symbolized by any of the foregoing.
“Transactions”
means the transactions contemplated by this Agreement and the Ancillary Agreements.
“VAT” means
value added tax charged under VATCA and any other Tax charged in conformity to EU the Council Directive 2006/112/EC of 28 November 2006
and any Tax similar to or replacing same.
“VATCA”
means the Value Added Tax Consolidation Act 2010 of Ireland.
Other
Terms. The following terms are defined in the body of the Agreement and, unless otherwise indicated, shall have such meanings
ascribed to them in the Agreement.
| Defined Term |
Section Reference |
| |
|
| Agreement |
Preamble |
| Allocation |
3.8.2(a) |
| Apportioned Obligations |
3.8.3(c) |
| Arbitrator |
5.1.2(a)(i) |
| Assumed Liabilities |
1.2.1 |
| Basket Amount |
4.2.1(a) |
| Chair |
5.1.2(a)(i) |
| Chosen Court |
5.9 |
| Claim Certificate |
4.3.1(a) |
| Claim Dispute Notice |
4.3.1(c) |
| Closing |
1.4.1 |
| Closing Purchase Price |
1.3.1(b) |
| CMO Agreements |
1.4.2(a)(v) |
| Competing Product |
3.10.1 |
| Confidential Information |
3.5.2 |
| Execution Date |
Preamble |
| Defined Term |
Section Reference |
| |
|
| Expense Statement |
3.15.4(e) |
| Governmental Transfer Consent |
3.7.2 |
| ICC |
5.1.2(a) |
| Indemnified Party |
4.3.1(a) |
| Indemnifying Party |
4.3.1(b) |
| Initial Indemnification Period |
4.2.1(d) |
| Liability Cap |
4.2.1(e) |
| Lab Notebook Delivery |
3.15.5 |
| Nabriva Austria |
Preamble |
| Nabriva DAC |
Preamble |
| Nabriva Parent |
Preamble |
| Nabriva US |
Preamble |
| Operating Expenses |
3.15.3 |
| Owned Registered Purchased IP |
2.1.11(b) |
| Parties |
Preamble |
| Party |
Preamble |
| Patient Assistance Program |
2.1.10(n) |
| Payee |
3.8.1 |
| Payer |
3.8.1 |
| Payments |
3.8.1 |
| Pending NMPA Applications |
3.7.2 |
| Post-Closing Straddle Tax Period |
3.8.3(c) |
| Pre-Closing Straddle Tax Period |
3.8.3(c) |
| Prosecute and Maintain |
3.2.1 |
| Purchased Assets |
1.1.1 |
| Purchaser |
Preamble |
| Purchaser Indemnitees |
4.1.1 |
| Relevant Legal Proceeding |
3.1.2 |
| Remaining Holdback Amount |
4.5.2 |
| Seller |
Preamble |
| Seller Group |
Recitals |
| Seller Indemnitees |
4.1.2 |
| Settlement Agreements |
1.4.2(a)(v) |
| Special Claims |
4.3.2(d) |
| Stamp Duty Sensitive Documents |
5.16.1 |
| Third Party Claim |
4.3.2(a) |
| Third-Party Claim Assumption Notice |
4.3.2(b) |
| Third Party IP Action |
3.2.1 |
| Transfer Taxes |
3.8.3(a) |
| Tribunal |
5.1.2(a)(i) |
v3.23.2
Cover
|
Jul. 30, 2023 |
| Cover [Abstract] |
|
| Document Type |
8-K
|
| Amendment Flag |
false
|
| Document Period End Date |
Jul. 30, 2023
|
| Entity File Number |
001-37558
|
| Entity Registrant Name |
NABRIVA THERAPEUTICS PLC
|
| Entity Central Index Key |
0001641640
|
| Entity Tax Identification Number |
00-0000000
|
| Entity Incorporation, State or Country Code |
L2
|
| Entity Address, Address Line One |
Alexandra House Office 225/227
|
| Entity Address, Address Line Two |
The Sweepstakes
|
| Entity Address, Address Line Three |
Ballsbridge
|
| Entity Address, City or Town |
Dublin 4
|
| Entity Address, Country |
IE
|
| Entity Address, Postal Zip Code |
00000
|
| City Area Code |
610
|
| Local Phone Number |
816-6640
|
| Written Communications |
false
|
| Soliciting Material |
false
|
| Pre-commencement Tender Offer |
false
|
| Pre-commencement Issuer Tender Offer |
false
|
| Title of 12(b) Security |
Ordinary
Shares, nominal value $0.01 per share
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| Trading Symbol |
NBRV
|
| Security Exchange Name |
NASDAQ
|
| Entity Emerging Growth Company |
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