Patent Listings. Licensee shall have the right and responsibility to make all filings with Regulatory Authorities in the Territory with respect to the AstraZeneca Patents, including as required or allowed (i) in the United States, in the FDA’s Orange Book and (ii) in the European Union, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents; provided that Licensee shall consult with AstraZeneca to determine the course of action with respect to such filings.
Patent Listings. With respect to any filings made to Regulatory Authorities with respect to the Moderna Patents for any Elected Candidate or Product, including as required or allowed in connection with in the United States, the FDA’s Orange Book, if applicable, or outside the United States, other international equivalents, Merck will have the sole right to make all decisions regarding such filings as Merck deems appropriate. Upon the request by Merck, Moderna will reasonably cooperate in the implementation of Merck’s decisions regarding the filing and listing pursuant to this Section 13.3.
Patent Listings. With respect to any filings made to Regulatory Authorities with respect to any Patents within the Novartis Technology or the Surface Technology for any Licensed Product within such Party’s Territory, including as required or allowed in connection with in the United States, the FDA’s Orange or Purple Book, if applicable, or outside the United States, other international equivalents, but subject to Section 14.4.2.3, (a) the Parties will list any such Patents as may be required by applicable Laws, and (b) otherwise (i) Novartis will have the sole right to make any such decision whether to list for Patents within the Collaboration IP or CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Joint Collaboration IP for the Novartis Territory and for any Licensed Product (other than any Regional Licensed Product in the Surface Territory); (ii) Surface will have the sole right to make any such decision whether to list for Patents within the Collaboration IP or Joint Collaboration IP for the Surface Territory for any Regional Licensed Product; and (iii) each Party will have the sole right to make any such decision whether to list for Patents otherwise within the Novartis Technology for Novartis or the Surface Technology for Surface with respect to any Licensed Product. Upon the request by a Party, such other Party will reasonably cooperate in the implementation of such requesting Party’s decisions made in a manner with this Section 14.6.
Patent Listings. Adapt shall have the sole right to make all filings with Regulatory Authorities with respect to Product Specific Patents, Adapt Applied Patents and Lightlake Patents (subject to Section 6.6) and Joint Patents in relation to the Product, including as required or allowed (i) in the United States, in the FDA’s Orange Book, and (ii) outside the United States, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents; provided that Adapt shall consult with Lightlake prior to making any such filing and consider Lightlake’s comments on such filing in good faith.
Patent Listings. As between the Parties, Licensee shall have the sole right to make decisions regarding and Licensee shall have the right to make all filings with Regulatory Authorities in the Territory with respect to the Exclusive Licensed Patents including as required or allowed (i) in the United States, in the FDA’s Purple Book and (ii) in the European Union, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents.
Patent Listings. With respect to patent listings in any patent listing system established by any applicable Regulatory Authority in Japan or under Applicable Law, for Licensor Patent Rights, the Parties will discuss and agree which Licensor Patent Rights to list in such patent listing in Japan (the “Listing Patent Rights”)
(i) prior to the submission of the first and any subsequent MAA for such Licensed Product in Japan to such applicable Regulatory Authority, (ii) within [***] days, but in any event reasonably in advance of the deadline for listing under Applicable Laws, after the receipt of the first and any subsequent Regulatory Approval in Japan for such Licensed Product from such Regulatory Authority, including any additional indication for such Licensed Product, and (iii) within [***] days, but in any event reasonably in advance of the deadline for listing under Applicable Laws, after the issuance in Japan of a patent included in the Listing Patent Rights; provided that, except as otherwise permitted under Applicable Laws, Licensee will not list, and will not be obligated to list, as of the date of listing, (A) any unissued patent, (B) any Patent Right that does not Cover the Licensed Product, (C) any patent that is of a type or that contains patent claims that are of a type not permitted to be listed under Applicable Law, or (D) any patent that such Party knows or has a reasonable basis to know is reasonably likely to be declared invalid by a competent Governmental Authority in such jurisdiction. In furtherance of the foregoing clause (D), if either Party has such knowledge or reasonable basis, then such Party will promptly notify and inform the Party of all facts and circumstances it is aware of underlying such knowledge or reasonable basis. If the Parties are unable to agree on which Patent Rights to list by the time required as provided under clause (i) to (iv) above, subject to the above proviso, then, as between the Parties, Licensee will have the final decision-making right over such listing. Licensee will promptly, and in any event at least [***] days prior to the applicable deadline for listing under Applicable Laws, list the Listing Patent Rights in the applicable patent listing system in Japan. Licensee will provide copies of all documentation to be filed in connection with any such listing of Listing Patent Rights to Licensor prior to filing thereof and will consider Licensor’s comments with respect to such documentation. Licensor will cooperate with Lice...
Patent Listings. As between the Parties, [***] shall have the sole right to make all filings with Regulatory Authorities in the Territory solely with respect to the AbbVie Patents, Morphic Patents, and Joint Patents that claim any Licensed Compound or Licensed Product or the Exploitation of such Licensed Compound or Licensed Product, including as required or allowed in the United States or other jurisdictions.
Patent Listings. (a) Denali shall have the sole right to make all filings with Regulatory Authorities in the Territory regarding Licensed Products and with respect to Licensor Program Patents, Denali Program Patents, Denali Background Patents and Joint Program Patents, including as required or allowed (a) in the United States, in the FDA’s Orange Book if in the future legislation employs the Orange Book for biologics, or its alternative, and (b) outside the United States, under the national implementations of Article 10.1(a)(iii) of Directive 2001/83/EC or other international equivalents. Licensor shall (i) provide to Denali all Information, including a correct and complete list of Licensor Program Patents to enable Denali to make such filings with Regulatory Authorities in the Territory with respect to such Patents, and (ii) cooperate with Denali’s reasonable requests in connection with Licensor Program Patents, including meeting any submission deadlines, in each case ((i) and (ii)), to the extent required or permitted by Applicable Law.
(b) The Parties will negotiate in good faith regarding filings with Regulatory Authorities in the Territory regarding Licensed Products with respect to Licensor Program Patents, including as required or allowed (i) in the United States, in the FDA’s Orange Book if in the future legislation employs the Orange Book for biologics, or its alternative, and (ii) outside the United States, under the national implementations of Article 10.1(a)(iii) of Directive 2001/83/EC or other international equivalents. In the event that the Parties are unable to reach agreement, Denali will have the tie-breaking vote.
Patent Listings. AbbVie shall have the sole right to make all filings with Regulatory Authorities in the AbbVie Territory with respect to Galapagos Patents, AbbVie Patents and Joint Patents, including as required or allowed (i) in the United States, in the FDA’s Orange Book, and (ii) outside the United States, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents. Galapagos shall (a) provide to AbbVie a correct and complete list of Galapagos Patents covering any Product, or otherwise necessary or reasonably useful, to enable AbbVie to make such filings with Regulatory Authorities in the Territory with respect to such Patents, and (b) cooperate with AbbVie’s reasonable requests in connection therewith or with any Joint Patents, including meeting any submission deadlines, in each case ((a) and (b)), to the extent required or permitted by Applicable Law. All filings with Regulatory Authorities in the Galapagos Territory with respect to Galapagos Patents, AbbVie Patents and Joint Patents shall be subject to the review and approval of AbbVie.
Patent Listings. AbbVie shall have the sole right to make, and shall exercise Commercially Reasonable Efforts with respect to making, all filings with Regulatory Authorities in the Territory with respect to Receptos Patents and AbbVie Patents, including as required or allowed (i) in the United States, in the FDA’s Orange Book, and (ii) outside the United States, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents. In this regard, AbbVie shall make such decisions without regard for any compounds, technologies or other intellectual property beyond Licensed Compounds and Licensed Products if it is reasonable to expect that the potential protection of any Licensed Compound or Licensed Product could be adversely affected by taking any such other interests into account. Receptos shall (A) provide to AbbVie all Information, including a correct and complete list of Receptos Patents covering any Licensed Product or otherwise necessary or reasonably useful to enable AbbVie to make such filings with Regulatory Authorities in the Territory with respect to such Patents, and (B) cooperate with AbbVie’s reasonable requests in connection therewith, including meeting any submission deadlines, in each case ((A) and (B)), to the extent required or permitted by Applicable Law.
