ATXI Avenue Therapeutics Inc

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1	NAME OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	CIPLA (EU) LIMITED
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (SEE INSTRUCTIONS)			(a)	☐
				(b)	☑
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	Not Applicable (see Item 3 below)
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	United Kingdom
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			N/A
		8	SHARED VOTING POWER
			4,227,179 (See Note 1)
		9	SOLE DISPOSITIVE POWER
			N/A
		10	SHARED DISPOSITIVE POWER
			N/A
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,227,179 (See Item 5 below)
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	38.55% (See Note 2)
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	CO

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1	NAME OF REPORTING PERSONS
	I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (ENTITIES ONLY)
	CIPLA LIMITED
2	CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (SEE INSTRUCTIONS)			(a)	☐
				(b)	☑
3	SEC USE ONLY
4	SOURCE OF FUNDS (SEE INSTRUCTIONS)
	Not Applicable (see Item 3 below)
5	CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEM 2(D) OR 2(E)				☐
6	CITIZENSHIP OR PLACE OF ORGANIZATION
	India
NUMBER OF SHARES BENEFICIALLY OWNED BY EACH REPORTING PERSON WITH		7	SOLE VOTING POWER
			N/A
		8	SHARED VOTING POWER
			4,227,179 (See Note 1)
		9	SOLE DISPOSITIVE POWER
			N/A
		10	SHARED DISPOSITIVE POWER
			N/A
11	AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
	4,227,179 (See Item 5 below)
12	CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (SEE INSTRUCTIONS)				☐
13	PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
	38.55% (See Note 2)
14	TYPE OF REPORTING PERSON (SEE INSTRUCTIONS)
	CO

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This statement relates to shares of common stock (“Shares”) of Avenue Therapeutics, Inc., a Delaware corporation (the “Issuer”).  The Issuer’s principal executive offices are located at 2 Gansevoort Street, New York, New York 10014.

The descriptions of the SPMA (as defined below) and the Support Agreement (as defined below) in Item 4 of this Schedule 13D are hereby incorporated by reference.  The Stockholders (as defined below) entered into the Support Agreement in connection with the SPMA.  The Shares covered by the Support Agreement have not been purchased by any Reporting Person and no payments were made by or on behalf of any Reporting Person in connection with the execution of the Support Agreement.  InvaGen expects to pay the consideration payable in connection with the Stock Purchase Transaction out of its generally available funds or through the issuance of equity to Cipla EU.  InvaGen expects to pay the consideration payable in connection with the Merger Transaction out of its generally available funds, through the issuance of equity to Cipla EU, or by borrowing from a financial institution (except for amounts payable under the Contingent Value Rights Agreement (as defined in the SPMA), if any, which are expected to be paid from generally available funds of the Issuer).

Stock Purchase and Merger Agreement

On November 12, 2018, the Issuer, InvaGen and Madison Pharmaceuticals Inc., a newly formed wholly-owned subsidiary of InvaGen, entered into a Stock Purchase and Merger Agreement (the “SPMA”) pursuant to which InvaGen will purchase, for $35 million, Shares representing 33.3% of the fully diluted capitalization of the Issuer (the “Stock Purchase Transaction”) and subsequently acquire the remaining issued and outstanding capital stock of the Issuer for $180 million, subject to certain reductions, in a reverse subsidiary merger transaction (the “Merger Transaction”). Pursuant to the terms and subject to the conditions set forth in the SPMA, InvaGen will, at second closing, hold 100% of the issued and outstanding equity interests of the Issuer. The aggregate consideration to be paid by InvaGen under the SPMA is $215 million in cash, subject to certain potential reductions. In addition, the Issuer is subject to certain lock-up restrictions and agreed not to (subject to customary exceptions), during the period commencing at the signing of the SPMA until the Merger Transaction, issue, buy, sell, or otherwise subject to a security interest, pledge, hypothecation, mortgage or lien, any securities of the Issuer.

Under the SPMA, at the closing of the Stock Purchase Transaction, the Issuer and InvaGen will enter into an agreed upon form  registration rights agreement with respect to the Shares purchased by InvaGen (the “Registration Rights Agreement”).  In addition, at the closing of the Stock Purchase Transaction, the Issuer will cause the form of amended and restated bylaws of the Issuer agreed to among the parties to the SPMA, providing for, among other things, the nomination of three individuals selected by InvaGen to be directors of the Issuer, to be adopted as the amended and restated bylaws of the Issuer (the “Revised Bylaws”).

Consummation of the Merger Transaction is conditioned, among other things, upon U.S. Food and Drug Administration approval of IV Tramadol, its labeling and scheduling and the absence of any Risk Evaluation and Mitigation Strategy restrictions in effect with respect to IV Tramadol, as well as the expiration of any waiting period applicable to the acquisition under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

The SPMA contains certain customary closing conditions, including the approval of the Issuer’s stockholders of the Stock Purchase Transaction and the Merger Transaction.

Voting and Support Agreement

On November 12, 2018, concurrently with the entry into the SPMA, Fortress Biotech, Inc. (“Fortress”), and Dr. Lucy Lu, the Issuer’s chief executive officer (“Dr. Lu”, and together with Fortress, the “Stockholders”), entered into a Voting and Support Agreement (the “Support Agreement”) with InvaGen and the Issuer.

Under the Support Agreement, the Stockholders agreed, among other things, to (i) be present at any meeting of the Issuer’s stockholders, in person or represented by proxy, or otherwise cause all of their voting securities to be counted as present for purposes of calculating a quorum, and (ii) vote or cause to be voted (including by proxy or written consent, if applicable) all of their securities in favor of the Proposals (as defined in the SPMA), adjourning or postponing the stockholders meeting to a later date if there are not sufficient votes for the requisite stockholder approval, electing the Buyer Directors as members of the board of directors of the Issuer or any other matter necessary for the consummation of the Stock Purchase Transaction, Merger Transaction and any other transactions contemplated by the SPMA or the ancillary agreements. Further, pursuant to the Voting Agreement, the Stockholders will vote against any Takeover Proposal (as defined in the SPMA), any other action made in opposition to adoption of the SPMA or the ancillary agreements, any action reasonably expected to materially impede any of the transactions contemplated by the SPMA or the ancillary agreements, any action reasonably expected to result in a breach in any respect of any covenant, representation or warranty or any other obligation or agreement of the Issuer contained in the SPMA, or of the Stockholders contained in the Voting Agreement, any sale, lease or transfer of any material asset of the Issuer, any reorganization, recapitalization or liquidation of the Issuer, any change in the present capitalization, dividend policy, certificate of incorporation or bylaws of the Issuer, and any other change in the Issuer’s corporate structure or business. In addition, the Stockholders agreed not to transfer any Issuer securities held by them until the earlier of the Merger Transaction and the termination of the SPMA.

The foregoing descriptions of the SPMA, the Support Agreement, the Registration Rights Agreement and the Revised Bylaws set forth in this Item 4 do not purport to be complete and are qualified in their entirety by reference to their full texts, which are incorporated by reference as Exhibit B , Exhibit C , Exhibit D , and Exhibit E hereto, respectively.

Stockholders Agreement

The description of the Stockholders Agreement entered into by the Issuer, InvaGen and the Stockholders on November 12, 2018, including InvaGen’s right to nominate the Buyer Directors (as defined in the Stockholders Agreement), that is set forth under Item 1.01 of the Issuer’s Current Report on Form 8-K filed with the Securities Exchange Commission on November 14, 2018 (“Form 8-K”) and the full text of the Stockholders Agreement provided as Exhibit 10.2 to Form 8-K are hereby incorporated by reference.

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The descriptions of the SPMA and the Support Agreement in Item 4 of this Schedule 13D are hereby incorporated by reference.

The description of the Waiver Agreement entered into by InvaGen and Fortress on November 12, 2018 that is set forth under Item 1.01 of Form 8-K and the full text of the Waiver Agreement provided as Exhibit 10.6 to Form 8-K are hereby incorporated by reference.

The description of the restrictive covenant agreement entered into by InvaGen and Fortress on November 12, 2018 that is set forth under Item 1.01 of Form 8-K and the full text of the restrictive covenant agreement provided as Exhibit 10.7 to Form 8-K are hereby incorporated by reference.

The description of the Indemnification Agreement entered into by InvaGen and Fortress on November 12, 2018 that is set forth under Item 1.01 of Form 8-K and the full text of the Indemnification Agreement provided as Exhibit 10.8 to Form 8-K are hereby incorporated by reference.

The description of the restrictive covenant agreement entered into by InvaGen and Dr. Lu on November 12, 2018 that is set forth under Item 1.01 of Form 8-K and the full text of the restrictive covenant agreement provided as Exhibit 10.9 to Form 8-K are hereby incorporated by reference.

The description of the Contingent Value Rights Agreement that is set forth under Item 1.01 of Form 8-K is hereby incorporated by reference.

Exhibit	Description
Exhibit A	Joint Filing Agreement by and among InvaGen Pharmaceuticals Inc., Cipla (EU) Limited and Cipla Limited dated as of November 23, 2018.
Exhibit B	Stock Purchase and Merger Agreement by and among Avenue Therapeutics, Inc., InvaGen Pharmaceuticals Inc. and Madison Pharmaceuticals Inc. dated as of November 12, 2018. Incorporated by reference to Exhibit 10.1 to Form 8-K.
Exhibit C	Voting and Support Agreement by and among Avenue Therapeutics, Inc., InvaGen Pharmaceuticals Inc. and certain Stockholders of Avenue Therapeutics, Inc. dated as of November 12, 2018.   Incorporated by reference to Exhibit 10.5 to Form 8-K.
Exhibit D	Form of Registration Rights Agreement.
Exhibit E	Form of Revised Bylaws.

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SIGNATURE

After reasonable inquiry and to the best of his or her knowledge and belief, the undersigned certifies that the information set forth in this statement is true, complete and correct.

Dated: November 23, 2018