Orange Book Listing. The Party that is the NDA holder for the applicable Product shall be responsible for listing and maintaining all applicable Patents in the Orange Book, including payment of all costs and expenses related to such maintenance incurred after the Effective Date. The listing and maintaining Party shall provide the other Party with its planned listings in advance of their submission with sufficient time for the other Party to review and provide comments. The listing and maintaining Party shall consider any such comments in good faith. Upon request of the listing and maintaining Party, the other Party shall cooperate in the filing of appropriate information with the FDA listing such Patents in the Orange Book.
Orange Book Listing. The Parties hereto shall cooperate with each other and discuss in good faith, as to any particular Product, what Patent Rights should be listed in the “Orange Book” and other similar national (or supranational) equivalents thereto. Astellas shall have the sole right, after good faith reasonable discussion with Ambit, to make all filings with the Regulatory Authorities with respect to Ambit Licensed Patents and Program Patents and Astellas Patents in connection with required regulatory activities for Products, including as required or allowed in connection with: (i) in the United States, 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. Ambit shall, at Astellas’s expense, (A) provide to Astellas all Information in Ambit’s Control, including a correct and complete list of Ambit Licensed Patents and Ambit Program Patents covering any Product or otherwise necessary or reasonably useful to enable Astellas to make such filings with Regulatory Authorities with respect to the Products, and (B) cooperate with Astellas’s reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to extent required or permitted by Applicable Law. Astellas shall notify Ambit in writing of any such filings with the Regulatory Authorities with respect to the Ambit Licensed Patents or the Program Patents.
Orange Book Listing. The Parties will evaluate in good faith and identify all Legacy Patents that may meet the requirements for listing with FDA in the Orange Book, or any foreign Governmental Authority in any jurisdiction outside the United States, in connection with any new drug application or other application for marketing or regulatory approval for any Primary Royalty Product. Primary, its Affiliates, and Primary Sublicensees shall, if and as elected thereby in their reasonable discretion, be entitled to (i) submit such Legacy Patents identified thereby to the FDA for listing in the Orange Book and/or to any foreign Governmental Authority for a similar listing on a timely basis and (ii) maintain with the FDA or other applicable Governmental Authority correct and complete listings of applicable Legacy Patents for any such Primary Royalty Product.
Orange Book Listing. Nestlé will, at the Company’s expense and upon the Company’s reasonable request, (a) provide all necessary or reasonably useful information to enable the Company to make filings with Regulatory Authorities with respect to Company Patent Rights as required by Regulatory Authorities in the Territory, and (b) will cooperate with the Company in connection therewith, including providing reasonable assistance for the Company in meeting any submission deadlines.
Orange Book Listing. Xxxxxxxxx shall, at AstraZeneca’s expense and upon AstraZeneca’s reasonable request, (a) provide all necessary or reasonably useful information to enable AstraZeneca to make filings with Regulatory Authorities with respect to Xxxxxxxxx Patent Rights or Joint Patent Rights as required (i) in the United States for the FDA’s Orange Book and (ii) outside the United States under other international equivalents and (b) shall cooperate with AstraZeneca in connection therewith, including meeting any submission deadlines.
Orange Book Listing. RayzeBio and PeptiDream shall discuss in good faith the Patent Rights that will be included in the Orange Book maintained by the FDA or similar or equivalent patent listing source, if any, in other countries in the Territory for Licensed Products, provided that [***] shall have the sole right to determine which Patent Rights will be included, after considering [***]’s comments in good faith. [***] will provide such assistance as may be reasonably requested by [***] in connection with such listing.
Orange Book Listing. Upon receipt of a notice of allowance (or equivalent) of an applicable Licensed Patent, Alaunos shall inform Precigen and request information reasonably required by Alaunos to list any Licensed Patent in the Orange Book maintained by the FDA or similar or equivalent patent listing source, if any, in other countries in the Territory with respect to
Orange Book Listing. The Parties shall cooperate in good faith in determining which Adamas Patent Rights will be listed in the Orange Book for each Product (other than Namenda), and the Parties agree that [*] in the Orange Book for each Product [*]. Notwithstanding the foregoing, [*] shall have the right to [*] a particular Adamas Patent Right in the Orange Book for a particular Product [*]: (A) there is [*] listing such Adamas Patent Right; or (B) listing such Adamas Patent Right would be [*], provided that [*] shall [*] at least thirty (30) days prior to [*] and shall [*], further provided that [*] shall [*] for the purpose of [*] under this Agreement.
Orange Book Listing. After consultation with and consideration of input from MannKind, United Therapeutics shall have the sole authority and discretion to maintain with the applicable Regulatory Authorities during the Term listings of applicable MannKind Patents, Joint Patents or United Therapeutics Patents for Product then being commercialized by United Therapeutics in the Territory, including all Orange Book listings required under the Xxxxx-Xxxxxx Act.
Orange Book Listing. The Parties acknowledge that Novo Nordisk, may at its sole discretion during the Term decide to submit applicable Licensed Patents and Patent Rights in the Combined Intellectual Property for listing in the Orange Book for the applicable Licensed Product but with Xxxxxx’s prior written consent, which shall not unreasonably withheld, delayed or conditioned. Novo Nordisk shall indemnify Zosano and its Affiliates for any claim that might be made against Zosano and its Affiliates with regard to the listing of such Patent Rights in the Orange Book, including proceedings connected with an alleged wrongful listing CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. Page 24 of 52 of the applicable Patent Right in the Orange Book. If Novo Nordisk decides, at Novo Nordisk’s sole discretion but with Xxxxxx’s prior written consent, to list an applicable Patent Right in the Orange Book, then at Novo Nordisk’s request, Zosano and/or its Affiliates, as applicable, shall provide all reasonable support necessary for Novo Nordisk to list the applicable Patent Rights, such support not to be unreasonably withheld, conditioned or delayed. In the event that such Patent Rights are listed in the Orange Book, Novo Nordisk shall use Commercially Reasonable Efforts to ensure, as permitted by applicable laws and/or Regulatory Authority, that Zosano and/or its Affiliates, as applicable, shall be listed as the owner, co-owner, assignee or licensee as appropriate of such Patent Rights and both Novo Nordisk and Zosano and/or its Affiliates as applicable shall be identified as the point of contact for any Paragraph IV Certifications (as defined in C.F.R. Title 21).
