COLLABORATION and LICENSE AGREEMENT between CRUCELL HOLLAND B.V. and BAVARIAN NORDIC A/SCollaboration and License Agreement • November 10th, 2015 • Bavarian Nordic a/S / ADR • Biological products, (no disgnostic substances)
CRUCELL HOLLAND B.V., a Dutch company with offices located at Archimedesweg 4, 2333 CN Leiden, the Netherlands, (hereinafter “Crucell”);
OPTION AND LICENSE AGREEMENTOption and License Agreement • November 10th, 2015 • Bavarian Nordic a/S / ADR • Biological products, (no disgnostic substances) • England
THIS OPTION AND LICENSE AGREEMENT (the “Agreement”) is made and entered into effective as of 03 March, 2015 (the “Effective Date”) by and among BAVARIAN NORDIC A/S, a Danish corporation having its principal place of business at Hejreskovvej 10A, DK-3490 Kvistgaard, Denmark (“BN”) and BAVARIAN NORDIC INC., BN’s wholly owned subsidiary, which is a Delaware corporation having its principal place of business at 2425 Garcia Avenue, Mountain View, CA 94043, USA (“BNInc”), on the one hand, and BRISTOL-MYERS SQUIBB COMPANY, a Delaware corporation headquartered at 345 Park Avenue, New York, New York 10154 USA (“BMS”), on the other hand. BN and BMS are sometimes referred to herein individually as a “Party” and collectively as the “Parties”. BNInc shall be considered a “Party” and one of the “Parties”, in each case jointly with BN, only with respect to the BNInc Provisions and shall have no other rights, obligations or liabilities under this Agreement other than as set out in the BNInc Provisions
PUBLIC HEALTH SERVICE PATENT LICENSE AGREEMENT — EXCLUSIVE COVER PAGEPatent License Agreement • November 10th, 2015 • Bavarian Nordic a/S / ADR • Biological products, (no disgnostic substances) • District of Columbia
This Patent License Agreement, hereinafter referred to as the “Agreement”, consists of this Cover Page, an attached Agreement, a Signature Page, Appendix A (List of Patent(s) or Patent Application(s)), Appendix B (Fields of Use and Territory), Appendix C (Royalties), Appendix D (Benchmarks and Performance), Appendix E (Commercial Development Plan), Appendix F (Example Royalty Report), and Appendix G (Royalty Payment Options). The Parties to this Agreement are:
THE NATIONAL INSTITUTES OF HEALTH PATENT LICENSE AGREEMENT — EXCLUSIVE COVER PAGEPatent License Agreement • November 10th, 2015 • Bavarian Nordic a/S / ADR • Biological products, (no disgnostic substances)
(HHS Ref. No. E-099-1996/0-DE-40); Great Britain Patent Application No. 04011673.3 (now Great Britain Patent No. 1447414) (HHS Ref. No. E-099-1996/0-GB-43); Greece Patent Application No. 04011673.3 (now Greece Patent No. 1447414) (HHS Ref. No. E-099- 1996/0-GR-34); Ireland Patent Application No. 04011673.3 (now Ireland Patent No. 1447414) (HHS Ref. No. E-099-1996/0-IE-35); Italy Patent Application No. 04011673.3 (now Italy Patent No. 1447414) (HHS Ref. No. E-099-1996/0-IT-36); Luxembourg Patent Application No. 04011673.3 (now Luxembourg Patent No. 1447414) (HHS Ref. No. E-099- 1996/0-LU-44); Monaco Patent Application No. 04011673.3 (now Monaco Patent No. 1447414) (HHS Ref. No. E-099-1996/0-MC-45); Netherlands Patent Application No. 04011673.3 (now Netherlands Patent No. 1447414) (HHS Ref. No. E-099-1996/0-NL-46); Portugal Patent Application No. 04011673.3 (now Portugal Patent No. 1447414) (HHS Ref. No. E-099-1996/0-PT-37); Spain Patent Application No. 04011673.3 (now Spain Patent No. 2
DEVELOPMENT SUPPLY AGREEMENT BETWEEN Bavarian Nordic A/SDevelopment Supply Agreement • November 10th, 2015 • Bavarian Nordic a/S / ADR • Biological products, (no disgnostic substances)
PUBLIC HEALTH SERVICE COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT FOR EXTRAMURAL-PHS CLINICAL RESEARCHCooperative Research and Development Agreement • November 10th, 2015 • Bavarian Nordic a/S / ADR • Biological products, (no disgnostic substances) • District of Columbia
Plan and Appendix B, that is used within the scope of the Research Plan. The Test Article may also be referred to as Investigational Agent, Study Material, or Study Product. is further characterized below as “Investigational Agent”, “PROSTVAC VF”, CRADA Materials or “Research Agent”, depending on the regulatory stage of Test Article in the product development process.
PUBLIC HEALTH SERVICE COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT FOR EXTRAMURAL-PHS CLINICAL RESEARCHCooperative Research and Development Agreement • November 10th, 2015 • Bavarian Nordic a/S / ADR • Biological products, (no disgnostic substances) • District of Columbia
This Agreement is based on the model Cooperative Research and Development Agreement (“CRADA”) adopted by the U.S. Public Health Service (“PHS”) Technology Transfer Policy Board for use by components of the National Institutes of Health (“NIH”), the Centers for Disease Control and Prevention (“CDC”), and the Food and Drug Administration (“FDA”), which are agencies of the PHS within the Department of Health and Human Services (“HHS”).
PATENT LICENSE AGREEMENT — EXCLUSIVE COVER PAGEPatent License Agreement • November 10th, 2015 • Bavarian Nordic a/S / ADR • Biological products, (no disgnostic substances) • District of Columbia
Application No. 04011673.3 (now Great Britain Patent No. 1447414) (HHS Ref. No. E-099-1996/0-GB-43); Greece Patent Application No. 04011673.3 (now Greece Patent No. 1447414) (HHS Ref. No. E-099-1996/0-GR-34); Ireland Patent Application No. 04011673.3 (now Ireland Patent No. 1447414) (HHS Ref. No. E-099-1996/0-IE-35); Italy Patent Application No. 04011673.3 (now Italy Patent No. 1447414) (HHS Ref. No. E-099-1996/0-IT-36); Luxembourg Patent Application No. 04011673.3 (now Luxembourg Patent No. 1447414) (HHS Ref. No. E-099-1996/0-LU-44); Monaco Patent Application No. 04011673.3 (now Monaco Patent No. 1447414) (HHS Ref. No. E-099-1996/0-MC-45); Netherlands Patent Application No. 04011673.3 (now Netherlands Patent No. 1447414) (HHS Ref. No. E-099-1996/0-NL-46); Portugal Patent Application No. 04011673.3 (now Portugal Patent No. 1447414) (HHS Ref. No. E-099-1996/0-PT- 37); Spain Patent Application No. 04011673.3 (now Spain Patent No. 2286530) (HHS Ref. No. E-099-1996/0-ES-32); Sweden Patent
