Regulatory Materials. Subject to the Development Plan, and the terms of this Agreement, Amylin shall assume sole right and principal responsibility for the preparation, submission, and maintenance of Regulatory Materials (including, without limitation, NDAs) and for seeking Marketing Approval in connection with Products in the U.S., and Lilly shall assume sole right and principal responsibility for the preparation, submission and maintenance of Regulatory Materials (including, without limitation, NDAs) and for seeking Marketing Approval in connection with Products (i) in each Major Market outside the U.S. and (ii) in each country in the Territory outside of the Major Markets that is determined by the JCC to be feasible and commercially attractive for marketing of the Product. Such responsibilities shall be pursued using Commercially Reasonable Efforts and in compliance with other regulatory obligations related to the conduct of Development of the Product in the applicable jurisdiction(s) and shall include responsibility for seeking any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in the applicable jurisdiction(s) in connection with the Product. The Party with the lead regulatory responsibility in a country in the Territory shall be referred to as the "Regulatory Lead" and the country(ies) in which such Party is the Regulatory Lead shall be referred to as such Party's "REGULATORY JURISDICTION." All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials for Products in the U.S. shall be held in Amylin's name and shall be owned solely by Amylin, subject to Lilly's rights under this Agreement and the Related Agreements. Lilly shall consult and cooperate with Amylin in Amylin's preparation of such NDAs and in obtaining Marketing Approvals in the U.S. Amylin agrees to consult with Lilly regarding, and keep Lilly regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Amylin is responsible. Additionally, Amylin shall provide Lilly with the then most current copy of any proposed NDA filing for such jurisdiction reasonably (and in any event at least ninety (90) days) prior to its anticipated submission to the applicable Regulatory Authority, and Lilly shall have the right to review such proposed NDA and provide its comments to Amylin within sixty (60) days of the delivery of such proposed NDA to ...
Regulatory Materials. Takeda or its Affiliates own all Regulatory Materials to be assigned to Licensee hereunder, and to Takeda’s Knowledge, Takeda and its Affiliates have maintained and retained all material Regulatory Materials that are required to be maintained or retained pursuant to and in accordance with Applicable Law, and all such information is true, complete, and correct in all material respects.
Regulatory Materials. AstraZeneca shall transfer and assign to FibroGen all Regulatory Materials and Regulatory Approvals for Products in the terminated regions, if any, that are Controlled by AstraZeneca or its Affiliates or Sublicensees.
Regulatory Materials. Promptly following the Inventory Sell Down Period:
Regulatory Materials. To the extent permitted by applicable Laws, [***].
Regulatory Materials. Facet shall transfer and assign to Trubion in the form and format in which such materials are maintained by Facet in the ordinary course of business, all Regulatory Materials for Products in the Territory that are Controlled by Facet or its Affiliates or permitted sublicensees.
Regulatory Materials. Unless terminated for Safety Reasons in accordance with section 13.2(b), upon CytomX’s written request, BMS shall use commercially reasonable efforts to provide CytomX with copies of preclinical and clinical data for Compounds or Products directed to the terminated Collaboration Target and Regulatory Materials for any Compounds or Product(s) targeting the terminated Collaboration Target in all country(ies) or territories that are held or controlled by or under authority of BMS, its Affiliates or Sublicensees, that are necessary for the Development and/or Commercialization of Probodies (other than any specific terminated Compound(s) or Product(s)) with respect to the terminated Collaboration Target in such country(ies) or territories.
Regulatory Materials. Gilead shall grant to Galapagos a right of reference under all Regulatory Materials and Regulatory Approvals Controlled by Gilead, in each case, that relate to any applicable Reversion Product(s) in or for the benefit of the applicable Terminated Region(s), unless and until such Regulatory Materials or Regulatory Approvals are assigned to Galapagos pursuant to any Transition Agreement.
Regulatory Materials. The Transition Agreement shall require Gilead to transfer and assign to Galapagos […***…], that relate to any applicable Reversion Product(s) in or for the benefit of the applicable Terminated Region(s). The Transition Agreement shall contain terms governing the coordination of any ongoing regulatory responsibilities with respect to such Reversion Product(s) that are required under Applicable Law to be conducted by Gilead with respect to the applicable Terminated Region(s).
Regulatory Materials. Each Fiscal Year, the Administrative Agent shall have the right, through counsel of the Administrative Agent’s choice, to conduct a review (in scope reasonably satisfactory to the Administrative Agent in a manner that does not materially interfere with the business operations of the Credit Parties) of (i) the forms of customer contracts in use by the Credit Parties, (ii) the Credit Parties’ compliance management systems and any policies and procedures related thereto (iii) the Credit Parties’ servicing guidelines, documents and materials, and (iv) privacy notices, any information relating to consumer complaints, or any other materials provided to or presented to consumers. All reasonable costs and expenses incurred by the Administrative Agent in connection with such reviews and reports shall be promptly reimbursed by the Credit Parties after receipt of supporting documentation; provided that the Administrative Agent shall endeavor, so long as no Event of Default shall have DB1/ 85911004.13 occurred or be continuing and absent the deployment of new business lines, to limit such costs and expenses in connection with such reviews and reports to not more than $25,000 per Fiscal Year. Each Credit Party shall at all times enforce and fully implement its compliance management systems to ensure compliance with the requirements of all Laws and all other orders, writs, injunctions and decrees applicable to it, except where the failure to do so would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
