Common use of Data Exclusivity and Orange Book Listings Clause in Contracts

Data Exclusivity and Orange Book Listings. With respect to data exclusivity periods (including any available pediatric extensions) or periods under national implementations of Article 10.1 of Directive 2001/EC/83 (and all international equivalents), Eiger shall use Commercially Reasonable Efforts consistent with its obligations under applicable Law to seek, maintain and enforce all such data exclusivity periods available for the Licensed Products. With respect to patent listing filings in the FDA Orange Book (and foreign equivalents thereof) for issued patents for a Licensed Product, Eiger shall, consistent with its obligations under applicable Law, have the right to list in a timely manner and maintain all applicable BMS Patent Rights. At least [ * ] prior to an anticipated deadline for the filing of patent listing information for BMS Patent Rights, Eiger shall consult with BMS regarding the content of such filing, and shall consider BMS’s comments in good faith, provided that Eiger shall have the final decision right with respect to such filing, including the Patent Rights to be listed in any FDA Orange Book or any equivalent. BMS shall provide, consistent with its obligations under applicable Law, reasonable cooperation to Eiger in filing and maintaining such Orange Book (and foreign equivalent) listings.

Appears in 3 contracts

Samples: License Agreement (Eiger BioPharmaceuticals, Inc.), License Agreement (Eiger BioPharmaceuticals, Inc.), License Agreement (Eiger BioPharmaceuticals, Inc.)

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Data Exclusivity and Orange Book Listings. With respect to data exclusivity periods (including any available pediatric extensions) or periods under national implementations of Article 10.1 of Directive 2001/EC/83 (and all international equivalents), Eiger Company shall use Commercially Reasonable Efforts consistent with its obligations under applicable Law to seek, maintain and enforce all such data exclusivity periods available for the Licensed Products. With respect to patent listing filings in the any FDA Orange Book (and foreign equivalents thereofequivalents) for issued patents for a Licensed Product, Eiger Company shall, consistent with its obligations under applicable Law, have the right to list in a timely manner and maintain all applicable BMS Patent Rights. At least [ * [***] days prior to an anticipated deadline for the filing of patent listing information for BMS Patent Rights, Eiger Company shall consult with BMS regarding the content of such filing, and shall consider BMS’s comments in good faith, provided that Eiger Company shall have the final decision right with respect to such filing, including the Patent Rights to be listed in any FDA Orange Book or any equivalent. BMS shall provide, consistent with its obligations under applicable Law, reasonable cooperation to Eiger Company in filing and maintaining such Orange Book (and foreign equivalent) listings.

Appears in 3 contracts

Samples: License Agreement (Immunome Inc.), License Agreement (Ayala Pharmaceuticals, Inc.), License Agreement (Ayala Pharmaceuticals, Inc.)

Data Exclusivity and Orange Book Listings. With respect to data exclusivity periods (including any available pediatric extensions) or periods under national implementations of Article 10.1 of Directive 2001/EC/83 (and all international equivalents), Eiger Company shall use Commercially Reasonable Efforts consistent with its obligations under applicable Law to seek, maintain and enforce all such data exclusivity periods available for the Licensed Products. With respect to patent listing filings in the any FDA Orange Book (and foreign equivalents thereofequivalents) for issued patents for a Licensed Product, Eiger Company shall, consistent with its obligations under applicable Law, have the right to list in a timely manner and maintain all applicable BMS Patent Rights. At least [ * ] thirty (30) days prior to an anticipated deadline for the filing of patent listing information for BMS Patent Rights, Eiger Company shall consult with BMS regarding the content of such filing, and shall consider BMS’s comments in good faith, provided that Eiger Company shall have the final decision right with respect to such filing, including the Patent Rights to be listed in any FDA Orange Book or any equivalent. BMS shall provide, consistent with its obligations under applicable Law, reasonable cooperation to Eiger Company in filing and maintaining such Orange Book (and foreign equivalent) listings.

Appears in 2 contracts

Samples: License Agreement (Biohaven Pharmaceutical Holding Co Ltd.), License Agreement (Biohaven Pharmaceutical Holding Co Ltd.)

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Data Exclusivity and Orange Book Listings. With respect to data exclusivity periods (including any available pediatric extensions) or periods under national implementations of Article 10.1 of Directive 2001/EC/83 (and all international equivalents), Eiger Company shall use Commercially Reasonable Efforts consistent with its obligations under applicable Law to seek, maintain and enforce all such data exclusivity periods available for the Licensed Products. With respect to patent listing filings in the any FDA Orange Book (and foreign equivalents thereofequivalents) for issued patents for a Licensed Product, Eiger Company shall, consistent with its obligations under applicable Law, have the right to list in a timely manner and maintain all applicable BMS Patent Rights. At least [ * [***] prior to an anticipated deadline for the filing of patent listing information for BMS Patent Rights, Eiger Company shall consult with BMS regarding the content of such filing, and shall consider BMS’s comments in good faith, provided that Eiger Company shall have the final decision right with respect to such filing, including the Patent Rights to be listed in any FDA Orange Book or any equivalent. BMS shall provide, consistent with its obligations under applicable Law, reasonable cooperation to Eiger Company in filing and maintaining such Orange Book (and foreign equivalent) listings.

Appears in 1 contract

Samples: License Agreement (Homology Medicines, Inc.)

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