SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 4, 2019
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation)
955 Chesterbrook Boulevard, Suite 110
Chesterbrook, PA 19087
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (610) 354-8840
(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:
¨ 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|
|Common Stock, $0.001 par value||TRVN||The Nasdaq Stock Market LLC|
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 x
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. x
|Item 1.01||Entry into a Material Definitive Agreement.|
On December 4, 2019, Trevena, Inc. (the “Company”) and Pfizer CenterOne Group of Pfizer Inc. (“Pfizer”) entered into an amendment (dated December 2, 2019) (the “Amendment”) to the Development and Supply Agreement, dated as of December 15, 2016 (the “Agreement”). Pursuant to the Amendment, the Company and Pfizer agreed to, among other things, (i) clarify that the first “commercial year” shall commence after the month in which the Company makes its first bona fide commercial sale of a product manufactured by Pfizer in accordance with the Agreement, and (ii) modify the termination rights, such that either party may terminate the Agreement if the U.S. Food and Drug Administration or other regulatory authority does not grant regulatory approval for a product covered by the Agreement by December 31, 2021.
Except as modified by the Amendment, all terms and conditions of the Agreement remain in full force and effect.
The foregoing summary of the Amendment is not complete and is qualified in its entirety by reference to the Amendment, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.
|Item 9.01||Financial Statements and Exhibits.|
|10.1^||Amendment No. 2 to Development and Supply Agreement, by and between the Company and Pfizer CenterOne Group of Pfizer Inc, dated as of December 2, 2019.|
^ Pursuant to Item 601(b)(10)(iv) of Regulation S-K promulgated by the Securities and Exchange Commission (the “SEC”), certain portions of this exhibit have been redacted. The Company hereby agrees to furnish supplementally to the SEC, upon its request, an unredacted copy of this exhibit.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: December 9, 2019||By:||/s/ Barry Shin|
|Chief Financial Officer|