NewLink Genetics Corporation (NASDAQ:NLNK) Files An 8-K Entry into a Material Definitive AgreementItem 1.01. Entry into a Material Definitive Agreement.
Amendment to Public Health Agency of Canada License Agreement
On December 5, 2017, BioProtection Systems Corporation, or BPS, a wholly owned subsidiary of NewLink Genetics Corporation (together, “we”, “our” or the “Company”) and the Public Health Agency of Canada, or PHAC, amended and restated the License Agreement by and between BPS and PHAC dated May 4, 2010, or the PHAC License Agreement. Under the PHAC License Agreement, certain provisions of our existing agreement with PHAC were amended, among other things, to change the scope of the licenses granted to BPS. Our license from PHAC is now exclusive for the Ebola Zaire field of use and non-exclusive for the Ebola Sudan field of use. PHAC will retain all rights under the licensed intellectual property to all other VHF viruses. Under the PHAC License Agreement, we clarified that PHAC’s consent is not required for any assignment of the PHAC License Agreement in connection with a change of control of NewLink or BPS, unless such change of control is to a defined prohibited entity.
Under the terms of the PHAC License Agreement, our obligation to pay royalties to PHAC will extend on a country-by-country and product-by-product basis for the longer of the life of the licensed patents covering such product in such country and a specified period of time after the first commercial sale in such country, depending on the type of product and whether there is patent coverage at the time of such first commercial sale. Additionally, our royalty obligation is subject to customary reductions after expiration of patent coverage for such product in such country and no royalties will be owed on sales in Africa and GAVI eligible countries.
Unless terminated earlier, the PHAC License Agreement will remain in effect until the earlier of July 28, 2033 and the date upon which the Company, its affiliates and sublicensees cease all development and commercialization with respect to the licensed products.
The foregoing description of the PHAC License Agreement is not complete and is qualified in its entirety by reference to the full text of the agreement, a copy of which will be filed with the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2017, portions of which will be subject to a FOIA Confidential Treatment Request to the U.S. Securities and Exchange Commission to Rule 24-b under the Securities Exchange Act of 1934, as amended. The omitted material will be included in the request for confidential treatment.
Amendment to Merck Agreement
On December 5, 2017, BPS and Merck Sharp & Dohme Corp, or Merck, entered into an amendment, or the Merck Amendment, to the License and Collaboration Agreement between BPS and Merck dated November 21, 2014, or the Collaboration Agreement. The Merck Amendment modifies certain terms of our existing Collaboration Agreement with Merck to reflect the PHAC License Agreement. Under the terms of the Merck Amendment, the parties modified the scope of Merck’s sublicense with respect to the intellectual property rights granted under the PHAC License Agreement to be non-exclusive with respect to the Ebola Sudan field of use. Additionally, the Amendment adjusts the expiration of Merck’s obligation to pay royalties to BPS based on the royalty term of the PHAC License Agreement.
The foregoing description of the Merck Amendment is not complete and is qualified in its entirety by reference to the full text of the agreement, a copy of which will be filed with the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2017, portions of which will be subject to a FOIA Confidential Treatment Request to the U.S. Securities and Exchange Commission to Rule 24-b under the Securities Exchange Act of 1934, as amended. The omitted material will be included in the request for confidential treatment.
About NewLink Genetics Corporation (NASDAQ:NLNK)
NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing and commercializing immunotherapeutic products for cancer treatment. The Company’s portfolio includes biologic and small-molecule immunotherapy product candidates for a range of oncology indications. Its biologic product candidates are based on its HyperAcute immunotherapy technology platform, which is designed to stimulate the human immune system. Algenpantucel-L is its clinically advanced product candidate for patients with pancreatic cancer. Its additional HyperAcute cellular HyperAcute Cellular Immunotherapy product candidates in clinical development include tergenpumatucel-L and dorgenmeltucel-L for patients with advanced lung cancer and melanoma. It has two small-molecule product candidates in clinical development: GDC-0919 and indoximod. These product candidates are indoleamine-2, 3-dioxygenase (IDO) pathway inhibitors and focus on breaking the immune system’s tolerance to cancer.
