Patent Rights Listings. To the extent required or permitted by applicable Law, the Party filing an NDA with respect to the Licensed Product in any country(ies) may list with the applicable Regulatory Authorities information regarding any Licensed Patent Right or Licensee Patent Right. In connection with such listings, the Parties shall meet to evaluate and identify all potentially applicable Licensed Patent Rights or Licensee Patent Rights; provided, however, that # Licensee will not unreasonably refuse to list, and maintain the listing for, any Licensed Patent Rights that Acorda requests that Licensee list pursuant to a notice given by Acorda at least ten (10) days prior to the listing deadline and the listing of which is consistent with applicable Law; and # subject to the [foregoing clause (i)], the Party filing the NDA shall retain final decision making authority over the decision to list (or de-list) any Patent Rights covering the Licensed Product.

Patent Listings. In connection with a Licensed Product, PARTNER shall have the sole right to determine and make all listings or filings with Regulatory Authorities or patent agencies in the Territory with respect to REGENX Patents, PARTNER Patents, and Joint Patents, including as required or allowed in the [[Address A:Address]], in the FDA’s Orange Book or Purple Book, or under other international equivalents. REGENX shall # provide to PARTNER all Information, including a correct and complete list of REGENX Patents covering the Licensed Product or otherwise necessary or reasonably useful to enable PARTNER to make such listing or filings with Regulatory Authorities or patent agencies in the Territory with respect to such Patents, and # cooperate with PARTNER in connection therewith, including using commercially reasonable efforts to make any submission deadlines, in each case ((a) and (b)), to the extent required or permitted by Applicable Law.

Patent Listings. As between the Parties, and subject to [Section 4.1], the Regulatory Party shall have the sole right to make decisions regarding and shall have the right to make all patent listing filings with Regulatory Authorities in the Territory with respect to its Background Patents and Program Patents, including as required or allowed # in the United States, in the FDA’s Orange Book, # the European Union, under the national implementations of [Article 10.1(a)(iii)] of Directive 2001/EC/83, and # under other international equivalents.

Patent Listings. As between the Parties, Licensee shall have the sole right to make decisions regarding and make all filings with Regulatory Authorities in the Territory with respect to the [[AstraZeneca:Organization]] Patents, including as required or allowed # in the United States, in the FDA’s Orange Book and # in the European Union, under the national implementations of [Article 10.1(a)(iii)] of Directive 2001/EC/83 or other international equivalents. To the extent reasonably practicable, Licensee shall reasonably consult with [[AstraZeneca:Organization]] to determine the course of action with respect to such filings.

Patent Exclusivity Listings. If either Party receives a copy of an application submitted to the FDA under subsection # of [Section 351] of the PHSA (a “Biosimilar Application”) naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in [Section 351(l)(9)(C)] of the PHSA), either Party shall, within ​, notify the other Party so that the other Party may seek permission to view the application and related confidential information from the filer of the Biosimilar Application under [Section 351(l)(1)(B)(iii)] of the PHSA. If either Party receives any equivalent or similar certification or notice in any other jurisdiction in the Territory, either Party shall, within ​, notify and provide the other Party with copies of such communication. Regardless of the Party that is the “reference product sponsor” for purposes of such Biosimilar Application, # [[Organization A:Organization]] shall have the sole right to designate pursuant to [Section 351(l)(1)(B)(ii)] of the PHSA the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application; # [[Organization A:Organization]] shall have the sole right to list any [[Organization A:Organization]] Background Patent, [[Organization A:Organization]] Program Patent and Joint Program Patents (and, with the agreement of Licensor, any Licensor Background Patents or Licensor Program Patents), insofar as they claim or cover the applicable Licensed Product as required pursuant to [Section 351(l)(3)(A)], [Section 351(l)(5)(b)(i)(II)], or [Section 351(l)(7)] of the PHSA, to respond to any communications with respect to such lists from the filer of the Biosimilar Application, and to negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange than that specified in [Section 351(l)] of the PHSA; and # [[Organization A:Organization]] shall have the sole right to identify Patents or respond to communications under any equivalent or similar listing in any other jurisdiction in the Territory. If required pursuant to Applicable Law, Licensor shall prepare such lists and make such responses at [[Organization A:Organization]]’s direction. Licensor shall # provide to [[Organization A:Organization]], within ​ of [[Organization A:Organization]]’s request, all Information, including a correct and complete list of Licensor Background Patents or Licensor Program Patents covering any Licensed Product, that is necessary or reasonably useful to enable [[Organization A:Organization]] to make such lists and communications with respect to the Licensor Background Patents or Licensor Program Patents, and # cooperate with [[Organization A:Organization]]’s reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to the extent required or permitted by Applicable Law. [[Organization A:Organization]] shall # reasonably consult with Licensor prior to identifying any Licensor Background Patents or Licensor Program Patents to a Third Party as contemplated by this [Section 8.3.3] and shall consider in good faith Licensor’s advice and suggestions with respect thereto, and # notify Licensor of any such lists or communications promptly after they are made.

Actual or Threatened Infringement, Disclosure or Misappropriation; Defense Actions; Orange Book Listings; And Patent Term Extension

Patent Listings. With respect to any filings made to Regulatory Authorities with respect to any Kyorin Controlled Patents for any Licensed Product or any Patents within the New aTyr IP or the aTyr Licensed Technology (including any Joint Patent) for any Licensed Product, 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 12.6.2.4, # the Parties will list any such Patents as may be required by applicable Laws, and # otherwise # Kyorin will have the sole right to make any such decision whether to list for any Kyorin Controlled Patents with respect to any Licensed Product, and # aTyr will have the sole right to make any such decision whether to list for any Patents within the New aTyr IP or the aTyr Licensed Technology (including any Joint Patent) with respect to any Licensed Product. Upon the request by a Party, the other Party will reasonably cooperate in the implementation of such requesting Party’s decisions made in a manner consistent with this Section 12.8.

Listings. All interests in and to telephone and fax numbers, post office boxes and all listings in all telephone books and directories, stationery, forms, labels, shipping materials, catalogs, brochures, art work, photographs, digital marketing materials and advertising and promotional materials, whether in written or electronic form;

Orange Book Listings. To the extent required by or permitted by Applicable Law, Pint will have the right to decide whether to list with the applicable Regulatory Authorities in the Territory during the term of this Agreement any applicable Patents for a Compound or Product that has become the subject of an application for Regulatory Approval submitted to such Regulatory Authorities. Such listings may include without limitation any equivalents in the Territory of the so-called “Orange Book” listings required under the Hatch-Waxman Act and all so-called “Patent Register” listings as required in Canada. Puma will reasonably cooperate, at Pint's request and expense, in preparing and/or filing such listings within the time frames available or required for such listings to be submitted in connection with such Compound and/or Product.

With respect to Regeneron Co-Funding Products, Regeneron will have sole decision-making authority with respect to the determination of which Intellia Patent Rights or Patent Rights Controlled by Regeneron or its Affiliates to submit to a Third Party that files a Biosimilar Application, or any other act of patent information exchange or listing as required by the BPCIA or other similar measure in any other country worldwide (provided that with respect 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 [[Unknown Identifier]] PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.