SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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|Item 1.01||Entry into a Material Definitive Agreement.|
On September 30, 2020, Collegium Pharmaceutical, Inc. (the “Company”) announced that it reached a settlement with Teva Pharmaceuticals USA, Inc. (“Teva”) resolving the patent litigation in the U.S. District Court for the District of Delaware. The Company brought this litigation in response to Teva’s filing of an Abbreviated New Drug Application, which sought approval to market a generic version of Xtampza ER prior to the expiration of the Company’s applicable patents.
Pursuant to the terms of the settlement, which is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice, the Company will grant Teva a license to market its generic version of Xtampza ER in the United States beginning on or after September 2, 2033 (subject to U.S. Food and Drug Administration approval, and acceleration under certain circumstances). As a result of the settlement, Teva has agreed to a consent judgment confirming that its proposed generic products infringe upon the Company’s asserted patents and that those patents are valid and enforceable with respect to Teva’s proposed generic products. Additional details regarding the settlement are confidential.
The foregoing description of the settlement agreement and the license Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the agreements, which, with confidential terms redacted, are filed as Exhibit 10.1 to this current report on Form 8-K.
|Item 8.01||Other Information.|
On September 30, 2020, the Company issued a press release announcing the settlement. A copy of the press release is filed as Exhibit 99.1 to this Form 8-K.
|Item 9.01||Financial Statements and Exhibits.|
|10.1*||Settlement Agreement, dated September 29, 2020, by and among Collegium Pharmaceutical, Inc. and Teva Pharmaceuticals USA, Inc.|
|99.1||Press Release dated September 30, 2020|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
* Certain portions of the exhibits that are not material and would be competitively harmful if publicly disclosed have been redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K. Copies of the unredacted exhibits will be furnished to the Commission upon request.
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.
|Dated: September 30, 2020||Collegium Pharmaceutical, Inc.|
|By:||/s/ Paul Brannelly|
|Name: Paul Brannelly|
|Title: Executive Vice President and Chief Financial Officer|