Data Exclusivity. As applicable, BMS will have the sole right and authority for securing, maintaining and enforcing exclusivity rights that may be available under Applicable Law in a country for a Product, such as any data, market, pediatric, orphan drug or other regulatory exclusivity periods. Ambrx 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.
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 ***Text Omitted and Filed Separately with the Securities and Exchange Commission. Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(2), (4), (5) and (6) and 230.406 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.
Data Exclusivity. With respect to data exclusivity periods (such as those periods listed in the Orange Book (including any available pediatric extensions) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83, and all equivalents in any country), FBIO, in consultation with Cephalon, shall seek and maintain all such data exclusivity periods that may be available for any of the Licensed Products.
Data Exclusivity. With respect to data exclusivity periods, Lumena shall have the sole right, but not the obligation, (consistent with its obligations under applicable Laws (including any applicable consent order)), to seek, maintain and enforce all such data exclusivity periods available for Licensed Products.
Data Exclusivity. With respect to data exclusivity periods (including any available pediatric extensions) or periods under national implementations of Article 9.1(a)(iii) of Directive 2001/EC/83, any future laws or regulations covering similar subject matter, and all international equivalents), BMS shall use commercially reasonable efforts consistent with its obligations under applicable law (including any applicable consent order) to seek, maintain and enforce all such data exclusivity periods available for the Products.
Data Exclusivity. With respect to data exclusivity periods (such as those periods listed in the Biologics Price Competition and Innovation Act of 2009 and the Patient Protection and Affordable Care Act, as amended, or foreign equivalents of such laws), Servier shall use Diligent Efforts consistent with its obligations under applicable Laws (including any applicable consent order) to seek, maintain and enforce all such data exclusivity periods available for the Products in the Licensed Territory and, if XOMA does not exercise the Cardiometabolic Indications Option, in the Retained Territory.
Data Exclusivity. With respect to data exclusivity periods, Fulcrum shall have the sole right, but not the obligation, at its sole cost and expense, to seek, maintain and enforce all such data exclusivity periods available for Licensed Products.
Data Exclusivity. With respect to data exclusivity periods, Reneo shall have the sole right, but not the obligation, consistent with its obligations under applicable Laws (including any applicable consent order), to seek, maintain and enforce all such data exclusivity periods available for Licensed Products.
Data Exclusivity. With respect to data exclusivity periods provided by Regulatory Approval under the FD&C Act or its foreign equivalents or periods under national implementations of Article 9.1(a)(iii) of the Directive 2001/EC/83, any future laws or regulations covering similar subject matter, and all international equivalents, Vertex shall use Reasonable Commercial Efforts consistent with its obligations under Applicable Laws (including any applicable consent order) to seek, maintain and enforce all such data exclusivity periods available for Licensed Products or Combination Products.
Data Exclusivity. As applicable, ContraFect will have the sole right and authority for securing, maintaining and enforcing exclusivity rights that may be available under Applicable Law in a country for a Product, such as any data, market, pediatric, orphan drug or other regulatory exclusivity periods. Trellis will cooperate fully with and provide all reasonable assistance to ContraFect 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.
