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 Lilly. (it being understood that Lilly will review such proposed NDA and provide such comments as expeditiously as practicable) All INDs (and equivalent regulatory filings), Marketing Approvals and Regulatory Materials for Products outside the U.S. shall be held in Lilly's name and be owned solely by Lilly, subject to Amylin's rights under this Agreement and the Related Agreements. Amylin shall consult and cooperate with Lilly in Lilly's preparation of such NDAs and in obtaining Marketing Approvals outside the U.S. Lilly agrees to consult with Amylin regarding, and keep Amylin regularly and fully informed of, the preparation, Regulatory Authority review and approval of NDA filings for which Lilly is responsible. Additionally, Lilly shall provide Amylin 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 Amylin shall have the right to review such proposed NDA and provide its comments to Lilly within sixty (60) days of the delivery of such proposed NDA to Amylin (it being understood that Amylin will review such proposed NDA and provide such comments as expeditiously as practicable). Each Party agrees to consider in good faith any comments or suggested made by the other. In order for each Party to meet the foregoing responsibilities, the Regulatory Lead will have the right to: (i) integrate data into such Regulatory Material in its Regulatory Jurisdiction; (ii) have full access to Manufacturing data within the Party's possession or Control and have the right to require the Party responsible for Manufacturing to generate additional Manufacturing data to the extent necessary to obtain and maintain Marketing Approvals in its Regulatory Jurisdiction; (iii) seek and/or obtain any necessary approvals of Regulatory Authorities for any label, labeling, package inserts and packaging, samples and Promotional Materials to be used in its Regulatory Jurisdiction in connection with the Product; (iv) make all final decisions regarding the appropriate label language in connection with such Regulatory Material and the content of such label, labeling, package inserts and packaging, samples, Promotional Materials and Regulatory Material in its Regulatory Jurisdiction; and (v) review and approve all Regulatory Material utilized to apply for Marketing Approval in its Regulatory Jurisdiction in advance of submission to a Regulatory Authority and determine, with the input and advice of the other Party, whether the Regulatory Material meets the regulatory standards, and is consistent with the regulatory strategy of the Parties. No Product label, labeling, and packaging, samples or Promotional Materials shall be used or distributed by either Party without prior written approval of the Joint Commercialization Committee or Steering Committee, or its designee(s), unless in accordance with the Commercialization Plan.
