Orange Book Listings. To the extent required or permitted by Applicable Law, Licensee will use Diligent Efforts to promptly list and maintain with the applicable ***Confidential Treatment Requested Regulatory Authorities in the Territory during the Term correct and complete listings of applicable Licensed Patents for such POZEN Product, including all so called “Orange Book” listings required under the Xxxxx-Xxxxxx Act. [...***...].
Orange Book Listings. When applicable, Solvay shall promptly notify Depomed of Solvay’s intent to list any issued patents included in the Depomed Patents in the FDA’s “Orange Book” (i.e., the FDA’s list of Approved Drug Product with therapeutic equivalence evaluations) for the Product in the Field and in the Territory, in accordance with all Applicable Confidential Information, indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission Laws. The Parties shall mutually agree upon the Depomed Patents to be listed in the Orange Book for Product in the Field and in the Territory, provided, however, that while NDA holder, Solvay shall have the final decision with regard to any Patent related to the Product in the Field in the Territory.
Orange Book Listings. Santarus shall have the sole right, but not the obligation, to submit to all applicable Regulatory Authorities in the Territory Patent information pertaining to each Licensed Product pursuant to 21 U.S.C. §355(b)(1)(G) (or any amendment or successor statute thereto). ***Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Orange Book Listings. OPIANT shall have the sole right (but not the obligation) to list any appropriate patents within the AEGIS Patent Rights, Joint Patent Rights, and OPIANT Patent Rights in the FDA Orange Book with respect to any Product.
Orange Book Listings. With respect to filings in the FDA Orange Book (and foreign equivalents) for issued patents for a Recro Product in the Recro Territory, Licensee shall be solely responsible at its expense for fulfilling its obligations under applicable law to list any applicable Recro Patent Rights and/or Orion Patent Rights in a timely manner and make all applicable filings regarding the Recro Patent Rights and/or Orion Patent Rights required to be filed by it under applicable law. Licensee will be solely responsible for any such filings and listings, and for any and all decisions with respect to such filings and listings.
Orange Book Listings. At least fifteen (15) business days prior to the expiration of the time period under 21 C.F.R. § 314.53, or any successor regulation, for submitting patent information pertaining to Product-Specific Patents, Licensed Product Patents, Isis Core Technology Patents or Isis Manufacturing and Analytical Patents with respect to the Product, Genzyme will submit to Isis any such draft submission, including any forms such as Form FDA 3542, Form FDA 3542a or any equivalent thereof, for Isis’ review and comment. Genzyme will consider in good faith any comments made by Isis pursuant to this Section. In the event that the Parties, after good faith discussions, cannot agree with respect to any decision to be made concerning such submission of patent information, Genzyme will make such decision.
Orange Book Listings. To the extent required by or permitted by Applicable Law, LICENSEE will have the right to decide whether to list with the applicable Regulatory Authorities during the term of this Agreement any applicable Patent Rights for a Compound or Product that has become the subject of an application for Regulatory Approval submitted to FDA. Such listings may include without limitation all so-called “Orange Book” listings required under the Xxxxx-Xxxxxx Act and all so-called “Patent Register” listings as required in Canada. PFIZER will reasonably cooperate, at LICENSEE’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. LICENSEE may request in writing that [***], in order for it to be listed with the applicable Regulatory Authorities under this paragraph. In such case, PFIZER shall not unreasonably withhold its consent to such [***]; provided that if PFIZER reasonably believes it might want to list such [***] with the Regulatory Authorities for products other than Products, then it may withhold its consent without further explanation.
Orange Book Listings. Gilead shall have lead responsibility for making any filing with respect to any Galapagos Patent or any Gilead Combination Patent in connection with the FDA’s Orange Book, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents. Gilead shall consult with Galapagos regarding the strategy therefor. If the Parties disagree on the appropriate strategy with respect to such a filing, the disagreement shall be resolved by the JSC. If the JSC is unable to reach consensus on the strategy, […***…]. Each Party shall provide reasonable assistance to the other Party in connection with any such filing.
Orange Book Listings. [**] will have lead responsibility for making any filing with respect to any [**] Collaboration Patent, Joint Collaboration Patent or [**] Licensed Patent in connection with the Orange Book maintained by the FDA or similar or equivalent patent listing or linking requirement, if any, in other countries in the Territory for the Licensed Products. [**] will consult with [**] through the IP Committee regarding the strategy for such filings. If the Parties disagree on the appropriate strategy with respect to any such filings, the disagreement will be resolved by the IP Committee, subject to Section 13.4.1.4 (Decision Making). [**] will provide reasonable assistance to [**] in connection with any such filing.
Orange Book Listings. To the extent required or permitted by Applicable Law, the Party Controlling the Regulatory Filings (including the NDA and the IND) for the Licensed Products will timely list and maintain with the FDA during the Term correct and complete listings of all applicable Licensed Patents and Joint Patents for such Licensed Product in the Orange Book. [* * *] shall be responsible for the listing of Licensed Patents in the Orange Book for the Initial Products upon NDA Approval prior to the Regulatory Filing Transfer. For all subsequent filings , [* * *] shall (a) provide to [* * *] all information reasonably requested by [* * *] related to listing Licensed Patents and Joint Patents in the Orange Book, including a correct and complete list of Licensed Patents and Joint Patents covering any Licensed Product, that is necessary or reasonably useful to enable [* * *] to make such filings with the FDA with respect to the Licensed Product, and (b) cooperate with [* * *]’s reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to the extent required or permitted by Applicable Law. Each Party will promptly comply with reasonable requests (but in any case within five (5) days after such requests) by the other Party to review the listability of the Licensed Patents and Joint Patents in the Orange Book. [* * *] shall (x) reasonably consult with [* * *] prior to making any filing with the FDA contemplated by this Section 8.10 and shall consider in good faith [* * *]’s advice and suggestions with respect thereto and (y) notify [* * *] of any such filing promptly after it is made following the Regulatory Filing Transfer. In no event will [* * *] list or de-list any Licensed Patents or Joint Patents without giving notice to [* * *] at least thirty (30) days prior to taking such action, and meeting in person to discuss such action if so requested by the other Party.
