Regulatory Data Protection Sample Clauses
The Regulatory Data Protection clause establishes the obligations and rights of parties regarding the handling, storage, and use of data that is subject to regulatory oversight. Typically, this clause requires parties to comply with applicable data protection laws, such as GDPR or HIPAA, and may specify measures like encryption, access controls, or notification procedures in the event of a data breach. Its core function is to ensure that sensitive or regulated data is managed in accordance with legal requirements, thereby reducing the risk of non-compliance and protecting both parties from potential legal and financial penalties.
Regulatory Data Protection. To the extent required by law 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 Patents for any Product that such Party intends to, or has begun to commercialize, and that have become the subject of a marketing application submitted to FDA, such listings to include all so called "Orange Book" listings required under the ▇▇▇▇▇-▇▇▇▇▇▇ 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, the Party holding the NDA for the applicable Product will retain final decision making authority as to the listing of all applicable Patents for such Product, regardless of which Party owns such Patent.
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 ▇▇▇▇▇-▇▇▇▇▇▇ 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.
Regulatory Data Protection. To the extent required by or permitted by Law, Amgen will, at its sole discretion, decide whether to list with the applicable Regulatory Authorities during the Term any applicable Arrowhead Product Patents claiming any Licensed Compound or Licensed Product that Amgen intends to, or has begun to, Commercialize, and that has become the subject of a Regulatory Approval Application submitted to FDA. In the event Amgen desires to include in such listing any Arrowhead Platform Patent, then the Parties shall meet and discuss such request in good faith and Arrowhead will not unreasonably withhold consent to such listing, provided that it shall not be unreasonable for Arrowhead to withhold its consent if such extension would materially adversely affect such Arrowhead Platform Patent. Such listings may include all so called “Orange Book” listings required under the ▇▇▇▇▇-▇▇▇▇▇▇ Act or listing of Patents as provided in the patent dispute resolution procedures of the Biologics Price Competition and Innovation Act of 2009 or under 42 U.S.C. § 262(l) or similar provisions in the Territory during the Term. Prior to such decision on listings, the Parties will meet to evaluate and identify all applicable Patents to be listed and Amgen shall reasonably incorporate and address suggestions provided by Arrowhead as to the listing or non-listing of any applicable Patents.
Regulatory Data Protection. Moderna shall have the sole authority to determine Patents to list, with the applicable Regulatory Authorities in the Territory during the Term, for any Product that Moderna intends to, or has begun to, Commercialize, such listings to include all so called “Orange Book” listings and “Purple Book” listings and all similar listings in any other relevant countries, regardless of which Party owns such Patent.
Regulatory Data Protection. [***] (or its designee) shall have the sole right to list, with the applicable Regulatory Authorities in the Territory, all applicable Patents (including any Prothena Licensed Collaboration Patents or Licensed Program Patents) for any Licensed Product, including all so called “Purple Book” listings required under the U.S. Public Health Service Act, and all similar listings in any other relevant countries, [***]. For the avoidance of doubt, [***] will retain final decision-making authority as to the listing of all applicable Patents for any Licensed Product, regardless of which Party owns such Patent, and [***] shall reasonably assist [***] in connection therewith.
Regulatory Data Protection. As between the Parties, VIVUS shall be solely responsible for deciding which of the VIVUS Patents to submit to FDA for listing in the Orange Book for any Product and for maintaining with FDA correct and complete listings of applicable patents for such Product; provided that VIVUS shall not unreasonably fail to include any VIVUS Patents requested by Auxilium to be submitted to FDA for listing in the Orange Book.
Regulatory Data Protection. To the extent required by Law, EPIZYME shall use Commercially Reasonable Efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities during the Term, all applicable Patents for any Licensed Product that EPIZYME intends to, or has begun to, Commercialize and that have become the subject of an application for Regulatory Approval submitted to FDA, such listings to include all so called “Orange Book” listings required under the ▇▇▇▇▇-▇▇▇▇▇▇ Act and all so called “Patent Register” listings as required in Canada. Prior to such listings, the Parties shall meet to evaluate and identify all applicable Patents. Notwithstanding the preceding sentence, EPIZYME shall retain final decision-making authority as to the listing of all applicable Patents for such Licensed Product, regardless of which Party owns such Patent.
Regulatory Data Protection. To the extent required by law 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 of this Agreement, all applicable Patents for any Product that such Party intends to, or has begun to commercialize, and that have become the subject of a marketing application submitted to FDA, such listings to include all so called “Orange Book” listings required under the ▇▇▇▇▇-▇▇▇▇▇▇ Act and all so called “Patent Register” listings as required in Canada. Prior to such listings, the Parties will meet, through the Joint Patent Subcommittee, to evaluate and identify all applicable Patents. Notwithstanding the preceding sentence, the Party responsible for marketing the applicable Product will retain final decision making authority as to the listing of all applicable Patents for such Product, regardless of which Party owns such Patent.
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 Patents for any Collaboration Compound or Product that such Party intends to, or has begun to Commercialize, and that have become the subject of a marketing application submitted to the relevant Regulatory Authority. Prior to such listings, the Parties will meet to evaluate and identify all applicable Patents. Notwithstanding the preceding sentence, the Party responsible for marketing the applicable Collaboration Compound or Product will retain final decision-making authority as to the listing of all applicable Patents for such Collaboration Compound or Product, regardless of which Party owns such Patents.
Regulatory Data Protection. To the extent required or permitted by Applicable Law, Eagle will promptly, accurately and completely list, with the applicable Regulatory Authorities during the Term, all applicable Patents for all Products throughout the world that have become the subject of an application for Regulatory Approval submitted to the FDA or other Regulatory Authority. Such listings shall include all so called “Orange Book” listings required under the ▇▇▇▇▇-▇▇▇▇▇▇ Act and all so called “Patent Register” listings as required in Canada. Prior to making any such filings or listings with any Regulatory Authority in the Territory, the Parties will meet to evaluate and identify all applicable Patents, and Eagle shall list such Patents in the Territory and take into consideration MDCO’s suggestions in respect thereof.