BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Files An 8-K Termination of a Material Definitive AgreementItem 1.02
On December8, 2017, BioDelivery Sciences International, Inc. (the “Company”) received the required 90-day notice from Collegium Pharmaceutical, Inc. (“Collegium”) regarding termination of the previously announced license and development agreement between the Company and Collegium for the Company’s ONSOLIS® (fentanyl buccal soluble film) product (the “License Agreement”).
The License Agreement was originally executed between the Company and Collegium on May11, 2016. Under terms of the License Agreement, Collegium was to be responsible for the manufacturing, distribution, marketing and sales of ONSOLIS® in the United States. In return, and also in consideration of the Company’s obligations under the License Agreement, the Company was to receive certain milestone and royalty payments.
Collegium’s decision to terminate the license involved their recent execution of a license agreement to commercialize Nucynta® (tapentadol) Immediate Release and Nucynta® ER (tapentadol).
Termination of the License Agreement will be effective on March8, 2018 (the “Effective Date”). There are no early termination penalties incurred by the Company to the License Agreement.
The Company will be assessing its commercial options for ONSOLIS®, but the Company does not currently believe that the return of ONSOLIS® will have a material impact on the Company’s business.
| Item 1.02 | Other Information |
On December14, 2017, the Company issued a press release announcing the termination of the License Agreement, which press release is attached as Exhibit 99.1 hereto.
| Item 1.02. | Financial Statements and Exhibits. |
(d)Exhibits
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K, the press release included herein, and any statements of representatives and partners of the “Company related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, the results of the Company’s reacquistion of ONSOLIS and any related corporate plans or initiatives as described herein or in the attached press release) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
BIODELIVERY SCIENCES INTERNATIONAL INC ExhibitEX-99.1 2 d487444dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 BioDelivery Sciences Reacquires ONSOLIS® from Collegium Pharmaceutical RALEIGH,…To view the full exhibit click here
About BioDelivery Sciences International, Inc. (NASDAQ:BDSI)
BioDelivery Sciences International, Inc. is a specialty pharmaceutical company. The Company develops and commercializes, either on its own or in partnerships with third parties, applications of approved therapeutics to address unmet medical needs using drug delivery technologies. The Company develops pharmaceutical products aimed principally in the areas of pain management and addiction. The Company’s products utilize the BioErodible MucoAdhesive (BEMA) drug delivery technology, a small, erodible polymer film for application to the buccal mucosa (the lining inside the cheek). The Company’s United Sates Food and Drug Administration (FDA) approved product, ONSOLIS (fentanyl buccal soluble film), as well as its approved products BUNAVAIL (buprenorphine and naloxone buccal film) buccal film and BELBUCA (buprenorphine) buccal film, utilize BEMA technology.