Data Exclusivity. As applicable, BMS (by itself or through its Affiliates) will, after the License Effective Date, have the sole right and authority for securing, maintaining and enforcing exclusivity rights with respect to a Product in the Field that may be available under Applicable Law in a country, such as any data, market, pediatric, orphan drug or other regulatory exclusivity periods. BMS shall not consent, during the Initial TC Term, to the use of or any cross reference to PROSTVAC-related data generated by BN or BMS or held by any Regulatory Authority for the purpose of a Third Party gaining Regulatory Approval for a product (other than PROSTVAC or a Companion Diagnostic) that encodes PSA in any country in the Territory without BN’s prior written consent, not to be unreasonably withheld or conditioned; except that BMS may, without BN’s prior written consent, consent to a Third Party’s use of or cross reference to such data solely for the development, Regulatory Approval and Commercialization of such Third Party’s product in combination use with PROSTVAC (but not as a fixed dose combination product). BN will cooperate fully with and provide all reasonable assistance to BMS and use all commercially reasonable efforts consistent with its obligations under Applicable Law (including any applicable consent order or decree) to seek, maintain and enforce all data exclusivity periods available for the Products.
Appears in 3 contracts
Sources: Option and License Agreement (Bavarian Nordic a/S / ADR), Option and License Agreement (Bavarian Nordic a/S / ADR), Option and License Agreement (Bavarian Nordic a/S / ADR)