Patent Listing. [***] will have the sole right, but not the obligation, to submit to all applicable Regulatory Authorities patent information pertaining to each applicable Product pursuant to 21 U.S.C. § 355(b)(1)(G), any similar statutory or regulatory requirement enacted in the future regarding biologic products, or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction.
Patent Listing. Novartis will promptly, accurately and completely list, with the applicable Regulatory Authorities during the Agreement Term, all applicable Orange Book Patents. Prior to such listings, the Parties will meet, through the JPC, to evaluate * ***Confidential Treatment Requested and identify all applicable Patent Rights, and Novartis will have the right to review, where reasonable, original records relating to any invention for which Patent Rights are being considered by the JPC for any such listing. Notwithstanding the preceding sentence, Novartis will retain final decision-making authority as to [***] for a Product that [***], regardless of which Party owns such [***].
Patent Listing. Following Vertex’s exercise of the Option for a Collaboration Target, Vertex will have the sole right, but not the obligation, to submit to all applicable Regulatory Authorities patent information pertaining to each applicable Product pursuant to 21 U.S.C. § 355(b)(1)(G) (or any amendment or successor statute thereto), any similar statutory or regulatory requirement enacted in the future regarding biologic products, or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction; provided that Vertex shall not be permitted to provide any such information with respect to CRISPR Platform Technology Patents without CRISPR’s prior written consent.
Patent Listing. After ArriVent exercises the Option, as between Parties, ArriVent shall have full decision-making power and responsibility for performing all patent listing acts and requirements with respect to any Patents that claim either: the active drug substance of the applicable Compound, the applicable Product itself (formulation and composition), or an approved method of use for the applicable Product that have become the subject of an MAA submitted to any applicable Regulatory Authority, all so-called “Patent Register” listings as required in Canada, all acts required of the Reference Product Sponsor under the US Biologicals Price Competition and Innovation Act of 2009 (42 U.S.C. § 262) (“Biologics Act”), or any foreign equivalents thereof. Aarvik shall cooperate with ArriVent, as required, to perform any of the above-referenced listing acts.
Patent Listing. GSK shall have sole decision-making authority and shall be solely responsible for performing all patent listing acts and requirements for all GSK Products that have become the subject of a Marketing Authorization Approval (“MAA”) or New Drug Application (“NDA”) submitted to any applicable Regulatory Authority, such acts and requirements to include all so-called “Orange Book” listings required under the US Hxxxx-Xxxxxx Act, all acts required of the reference product sponsor under the US Biologicals Price Competition and Innovation Act of 2009 (42 U.S.C. § 262) (“Biologics Act”), or any foreign equivalents thereof. Specifically, GSK will control all of the actions, filings, and communications with any filer for a Follow-On Biologic, (a “Follow-on Biologic Applicant”) under the Biologics Act, including generating the following: (i) the list of Program Technology Patents that GSK believes could be reasonably asserted to be infringed by the launch of the biosimilars product; (ii) the list of Patents included within the Program Technology, if any, which GSK would be willing to license to the Follow-on Biologic Applicant; (iii) the detailed statement describing the factual and legal basis for why each of the listed Patents included within the Program Technology will be infringed by the Follow-on Biologic Applicant; and (iv) the response to the Follow-on Biologic Applicant’s statement regarding validity and enforceability of each of the listed Patents. GSK shall keep KineMed reasonably apprised of the status of such listings through the JPS, and KineMed shall cooperate with GSK at GSK’s expense to list applicable Program Technology Patents, including timely providing to GSK any documentation (such as internal documents, copies of laboratory notebooks, and related materials) and the reasonable assistance of KineMed’s employees, as required, in order to obtain any of such patent term extensions. GSK’s final listing decisions shall not be subject to any further review. EXECUTION COPY Confidential
Patent Listing. Akcea will promptly, accurately and completely list, with the applicable Regulatory Authorities during the Agreement Term, all applicable Patent Rights that Cover a Product. Prior to such listings, the Parties will meet, through the Joint Patent Committee, to evaluate and identify all applicable Patent Rights, and Akcea will have the right to review, where reasonable, original records relating to any invention for which Patent Rights are being considered by the Joint Patent Committee for any such listing. Notwithstanding the preceding sentence, Akcea will retain final decision-making authority as to the listing of all applicable Product-Specific Patents that are not Isis Core Technology Patents.
Patent Listing. Xxxxxxx will have the full and exclusive right, in its sole discretion, to determine and control the listing of any Patent (including any Morphic Patent or Joint Patent) in the then-current edition of the United States Food and Drug Administration publication “Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”) in connection with the Regulatory Approval of any Product, or in equivalent patent listings in any other country within the Territory.
Patent Listing. Following the Sanofi Participation Election Effective Date (if any) for a Collaboration Target, Sanofi will have the sole right, but not the obligation, to submit to all applicable Regulatory Authorities patent information pertaining to each applicable Licensed Product pursuant to 21 U.S.C. § 355(b)(1)(G), any similar statutory or regulatory requirement enacted in the future, or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction.
Patent Listing. As between the Parties, Context will have the sole right, but not the obligation, to submit to all applicable Regulatory Authorities patent information pertaining to each applicable Program Product pursuant to 21 U.S.C. § 355(b)(1)(G), any similar statutory or regulatory requirement enacted in the future, or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction.
Patent Listing. Bayer will promptly, accurately and completely list, with the applicable Regulatory Authorities during the Agreement Term, all applicable Orange Book Patents. Prior to such listings, the Parties will meet, through the Joint Patent Committee (or between the Parties if no Joint Patent Committee exists), to evaluate and identify all applicable Patent Rights, and Bayer will have the right to review, where reasonable, original records relating to any invention for which Patent Rights are being considered by the Joint Patent Committee (or the Parties) for any such listing. Notwithstanding the preceding sentence, Bayer will retain final decision-making authority as to the listing of all applicable Orange Book Patents for such Product (excluding Isis Core Technology Patents), regardless of which Party owns such Orange Book Patent.
