Protiva Biotherapeutics Inc., a development stage biotechnology company, develops nucleic acid based pharmaceutical products. The company focuses on developing products to fight various human diseases, such as cancer, influenza, Ebola, inflammatory diseases, and chronic viral infections. Its products include Pro 1, a tumor cell growth inhibitor, which kills tumor cells and inhibits tumor growth; Pro-101, an siRNA product that acts to inhibit the production of a protein involved in tumor growth; Pro-B, which acts to inhibit the expression of a protein, apolipoprotein B; Pro-EBOV and Pro-MARV that act to inhibit the replication of the Ebola and Marburg viruses; and Stable Nucleic-Acid Lipid Pa...
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Dicerna Pharmaceuticals, Inc. Enters into License Agreement and Development and Supply Agreement with Protiva Biotherapeutics Inc. and Tekmira Pharmaceuticals Corporation
Nov 18 14
On November 16, 2014 Dicerna Pharmaceuticals, Inc., a Delaware corporation (Dicarna), entered into a License Agreement and a Development and Supply Agreement with Protiva Biotherapeutics Inc. (Protiva) and Tekmira Pharmaceuticals Corporation (Tekmira). Under the terms of the License Agreement, Protiva and Tekmira grant Dicerna an exclusive (except with respect to previously granted license rights), worldwide license to use Protiva and Tekmira's proprietary lipid nanoparticle (LNP) technology for delivery of certain therapeutics to treat primary hyperoxaluria type 1 (PH1). During the term of the License Agreement, Dicerna will not in-license from a third party for use with a licensed product a drug delivery system competitive with Protiva's LNP technology, provided, however, that if Dicerna in-licenses such a delivery system from a third party after the first commercial sale of a licensed product, the license grant of the LNP technology to Dicerna will thereafter be on a non-exclusive basis. Dicerna made an upfront payment of $2,500,000 in connection with the signing of the License Agreement. Dicerna will make potential total development and approval milestone payments of $22,000,000. Dicerna is also required to pay a mid-single digit percentage royalty on all net sales of licensed products during the royalty period. The royalty period in a country is the longer of the expiration of the data exclusivity granted by the country's regulatory authority, the last to expire of certain patent claims applicable to products sold in such country, and the 10 year anniversary of the commencement of commercial sales in such country. The License Agreement may be terminated if: either party commits a material, uncured breach, Dicerna does not use commercially reasonable efforts to develop or commercialize the licensed product, Dicerna commences an action challenging the validity of the licensed patents; or if either party initiates bankruptcy, liquidation or similar proceedings. Contemporaneously with the execution of the License Agreement, Dicerna, Protiva and Tekmira entered into the Development and Supply Agreement. Under the terms of the Development and Supply Agreement, Protiva will perform certain development and other services for Dicerna and manufacture and test licensed products for Dicerna, including: the manufacture of all licensed products for pre-clinical testing and development, design of the final licensed product formulation to be used as the clinical development candidate, manufacture of the final formulated licensed product for clinical trials, assistance in the preparation of regulatory submissions and interactions with the FDA and its foreign equivalents, and performing technical transfer to Dicerna's selected contract manufacturer for the licensed product. Dicerna will pay Protiva on a time and materials basis at an agreed upon FTE rate and with an administrative mark-up on the acquisition of materials. The Development and Supply Agreement provides that intellectual property developed by a single party pursuant to activities contemplated by the agreement and not based on the practice of certain confidential information or intellectual property of the other party or directed solely to the other party's materials provided pursuant to the agreement shall be owned by such party. The agreement provides for joint ownership of certain jointly developed intellectual property as well as joint or collaborative prosecution, maintenance, and defense of such intellectual property.