Regulatory Data Protection. To the extent required by or permitted by Law, each Party will use Commercially Reasonable Efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities during the Term, all applicable GlobeImmune Licensed Patents for any Licensed Product Celgene intends to, or has begun to Commercialize, and that have become the subject of a marketing application submitted to FDA, including all so called “Orange Book” listings required under the Xxxxx-Xxxxxx Act and all so called “Patent Register” listings as required in Canada. Prior to such listings, the Parties will meet to evaluate and identify all applicable Patents. Notwithstanding the preceding sentence, Celgene will retain final decision-making authority as to the listing of all applicable Patents for such compound.
Appears in 6 contracts
Samples: Collaboration and Option Agreement (Globeimmune Inc), Collaboration and Option Agreement (Globeimmune Inc), Collaboration and Option Agreement (Globeimmune Inc)
Regulatory Data Protection. To the extent required by or permitted by Law, each Party Celgene will use Commercially Reasonable Efforts to promptly, accurately and completely list, list with the applicable Regulatory Authorities during the Term, Term all applicable GlobeImmune Licensed Forma Patents and Joint Patents for any Licensed Product that Celgene intends to, or has begun to, commercialize, such listings to Commercialize, and that have become the subject of a marketing application submitted to FDA, including include all so called “Orange Book” listings required under the U.S. Xxxxx-Xxxxxx Act and Act, all so called “Patent Register” listings as required in CanadaCanada and all similar listings in any other relevant countries. Prior to such listings, the Parties will meet to evaluate and identify all applicable Patents. Notwithstanding To the preceding sentenceextent required or permitted by Law, Celgene will retain final decisionmay, at its sole discretion, request or apply for any other available Regulatory-making authority as to the listing of all applicable Patents Based Exclusivity for such compoundany Licensed Product that Celgene intends to, or has begun to, commercialize.
Appears in 2 contracts
Samples: License Agreement (Forma Therapeutics Holdings, Inc.,), License Agreement (Forma Therapeutics Holdings, Inc.,)
Regulatory Data Protection. To the extent required by or permitted by Law, each Party will EPIZYME shall use Commercially Reasonable Efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities during the Term, all applicable GlobeImmune Licensed Patents for any Licensed Product Celgene that EPIZYME intends to, or has begun to Commercializeto, Commercialize and that have become the subject of a marketing an application for Regulatory Approval submitted to FDA, including such listings to include all so called “Orange Book” listings required under the Xxxxx-Xxxxxx Act and all so called “Patent Register” listings as required in Canada. Prior to such listings, the Parties will shall meet to evaluate and identify all applicable Patents. Notwithstanding the preceding sentence, Celgene will EPIZYME shall retain final decision-making authority as to the listing of all applicable Patents for such compoundLicensed Product, regardless of which Party owns such Patent.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Epizyme, Inc.), Collaboration and License Agreement (Epizyme, Inc.)
Regulatory Data Protection. To the extent required by or permitted by applicable Law, each Party [***] will use Commercially Reasonable Efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities in the Territory during the License Term, all applicable GlobeImmune Licensed Patents for any Licensed Product that Celgene intends to, or has begun to to, Commercialize, and that have become the subject of a marketing application submitted such listings to FDA, including include all so called “Orange Book” listings required under the U.S. Xxxxx-Xxxxxx Act and Act, all so called “Patent Register” listings as required in CanadaCanada and all similar listings in any other relevant countries. Prior to such listings, the Parties will meet to evaluate and identify all applicable Patents. Notwithstanding the preceding sentence, Celgene will retain final decision-making authority [***] as to the listing of all applicable Patents for such compoundLicensed Product, regardless of which Party owns such Patent.
Appears in 1 contract
Samples: Master Research and Collaboration Agreement (OncoMed Pharmaceuticals Inc)