Exhibit 10.1


 


AMENDMENT NO. 2


 


TO


 


DEVELOPMENT AND
SUPPLY AGREEMENT


 


This
Second Amendment (“2nd Amendment”) is made as of this 2nd day of December 2019
(the “Amendment Effective Date”) is between Trevena,
Inc. (“Trevena”) and the Pfizer
Centreone Group of Pfizer
Inc. (“Pfizer”).


 


Whereas,
Pfizer and Trevena are parties to that certain Development and Supply Agreement (the “Agreement”) dated
as of December 15, 2016 relating to the development, manufacture and supply by Pfizer for Trevena of Trevena’s proprietary
pharmaceutical compound, Oliceridine (“Product”);


 


Whereas,
in order to mitigate supply risks for the Product in accordance with Trevena’s business plan, the parties have determined
that it is in their mutual interests to proceed with a formal technical transfer plan fully to qualify the Pfizer Rocky Mount
facility as the site for the manufacture of the Product;


 


Whereas,
Pfizer is in agreement fully to support the technical transfer plan and to implement the plan as soon as possible;


 


Whereas,
in order to undertake and complete the mitigation plan, that Parties have agreed to modify the Agreement to regarding mutual rights
of termination as provided herein; and


 


Whereas,
Pfizer and Trevena wish to amend the Agreement to reflect their mutual agreement, as provided in this 2nd
Amendment.


 


Now,
Therefore, in consideration of the mutual covenants, conditions
and agreements set forth herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, Pfizer and Trevena agree as follows:


 


		1.	Capitalized terms used but not defined herein shall have
the meanings set forth in the Agreement.



 


		2.	Definitions.



 


		a.	Section 1.10 is hereby amended by replacing the existing definition in its entirety with
the following new definition:



 


“Commercial
Year” means each period of twelve (12) consecutive calendar months during this Agreement beginning on January 1st
and ending December 31st, except for the first Commercial Year, which
shall commence on the first day of the month after the month in which Trevena makes its first bona fide commercial sale
of a Product manufactured by Pfizer in accordance with this Agreement to a non- Affiliate customer and ends on December 31st
of the following year.


 


CERTAIN IDENTIFIED INFORMATION
HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
OMISSIONS ARE DESIGNATED [***]




 






     


     


    

 


		b.	Section 1.21 is hereby amended by replacing the existing definition in its entirety with
the following new definition:



 


“Facility”
means Pfizer's pharmaceutical manufacturing plant at Rocky Mount, North Carolina or such other manufacturing facility agreed by
the parties in writing.”


 


 3.     
 Section 10.3 (General Termination Rights). The Parties hereby agree to delete Section 10.3(a) of the Agreement in its entirety and to replace it with the following amended provisions:




 


Either Party may terminate
this Agreement:


 


“(a) Failure
to Obtain Regulatory Approval. Upon [***] days written notice if the FDA or other relevant Regulatory Authority does not
grant Regulatory Approval for the Product by December 31, 2021; or”


 


4.     
Supplemental Statement of Work. A new Statement of Work, No. [***] is hereby added to this Agreement in the form
as attached hereto as Annex A, attached hereto. The goal of the project is to wind-down, cease and transfer all development
and manufacturing work on the Trevena Products from the McPherson Facility to the Rocky Mount Facility. Pfizer will ensure that
technical transfer work to be carried out under Statement of Work No. [***] shall be done in a professional and business-like manner,
including the manufacturing of stability, validation and registration batches of Products thereunder and that such manufacturing
will be in accordance with the Manufacturing Process and the Specifications as transferred from Trevena to Pfizer under the Agreement.


 


5.     
All other terms and conditions of the Agreement shall remain in full force and effect and are hereby ratified and confirmed.


 


6.     
In the event that there are any conflicts between the terms of this 2nd
Amendment and the terms of the Agreement, the terms of this 2nd Amendment shall
control. The terms of this 2nd Amendment shall be controlling over any terms of
any purchase order, sales acknowledgement, invoice or other such documents issued by either party.


 


7.     
This 2nd Amendment may be executed in two or more counterparts, each of
which shall be deemed to be an original, and all of which shall together constitute one and the same agreement.


 


8.     
Delivery of a signed 2nd Amendment by reliable electronic means, including
facsimile or email, shall be an effective method of delivering the executed 2nd
Amendment. This 2nd Amendment may be stored by electronic means and either an
original or an electronically stored copy of this 2nd Amendment can be used for
all purposes, including in any proceeding to enforce the rights and/or obligations of the parties to this 2nd
Amendment.


 


SIGNATURE PAGE FOLLOWS


 


CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS
EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. OMISSIONS ARE DESIGNATED
[***]




 






     


     


    

 


In
Witness Whereof,
the parties hereto have caused their authorized representatives to execute this 2nd
Amendment as of the Amendment Effective Date.


 


	PFIZER CENTREONE PFIZER, INC.	 	TREVENA, INC.
	 	 	 
	By:	/s/ Thomas P Wilson 	 	By:	/s/ Mark A Demitrack MD 
	 	(Signature)	 	 	(Signature)
	 	 	 
	Name:	Thomas P Wilson	 	Name:	Mark A Demitrack MD
	 	 	 	 	 
	Title:	Pfizer CenterOne Contract Manufacturing Business Leader	 	Title:	Chief Medical Officer



 


CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS
EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. OMISSIONS ARE DESIGNATED
[***]


 






     


     


    

 


 


 


Statement of Work NO. [***]


 


[***] (7 pages omitted)


 


CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS
EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. OMISSIONS ARE DESIGNATED
[***]