Research and Development Activities. 10 3.2 Product Registrations ..................................... 13 3.3 Pricing and Reimbursement Approvals ....................... 17 3.4 Failure to Obtain Approvals; Restrictions ................. 17 3.5
Research and Development Activities. 5.1.1 In consideration for the research and development of the Product by Elan under this Agreement, Acorda shall pay to Elan the amounts set out in Article 5.1.2.
Research and Development Activities. (a) Following the Effective Date, Schering or its Affiliates shall assume and incur all costs and expenses in connection with the research and development activities which in its sole judgment are necessary to obtain any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory. ICN shall supply Schering with all of its requirements of Product for such research and development activities in finished bulk capsules, and bulk substance as necessary for preclinical studies, [ REDACTED ]. During the Exclusive Period, Schering shall also be responsible, at its cost and expense, for all preclinical studies, pre-marketing and compassionate use programs, clinical trials, chemistry/pharmacy data, any post approval studies required as a condition of obtaining any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory, and any other information and data required as a condition of obtaining any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory. The studies which Schering intends to undertake, together with preliminary timetables and preliminary budgets, are set forth in Exhibit D attached hereto and incorporated herein by reference. Schering shall commence, within 45 days after the Effective Date, the activities necessary to obtain Regulatory Approval in the EU, and shall diligently pursue and conduct such activities as may be necessary in order to obtain regulatory Approval for the Product for the chronic hepatitis C indication in each country in the Territory, in accordance with Section 3.2.
Research and Development Activities. Applera and Celera agree that (i) the human in vitro diagnostics business of Celera includes research and development activities toward commercialization of products and services in the HIVD Field and (ii) the restrictions imposed on Applera pursuant to this Agreement shall not prevent Applera from conducting its own research and development activities in the HIVD Field at any time during the term of this Agreement.
Research and Development Activities. As of the Effective Date, SPL shall be responsible, at its cost and expense, and in its sole judgment, for all research and development activities which are necessary to obtain Regulatory Approval for a Licensed Product in the Territory for the Primary Indication and any post-approval studies required as a condition of obtaining any Regulatory Approval for a Licensed Product for the Primary Indication. The parties acknowledge and agree that SPL's obligations under this Section 2.6(c) shall include all of the costs of conducting the CART Study (whether incurred before or after the Effective Date) which are estimated at [ * ]. In addition, SPL shall be responsible for any other studies (or portions of studies) necessary or desirable, in its sole judgment, for maintaining any Regulatory Approval (for the Primary Indication or any other indication for which SPL, in its sole discretion, may decide to seek Regulatory Approval) in the Territory, as well as any pre-marketing studies prior to such Regulatory Approval and post-marketing studies conducted following a Regulatory Approval.
Research and Development Activities. As of the Effective Date, Schering shall be responsible, at its cost and expense, and in its sole judgment, for all research and development activities which are necessary to obtain Regulatory Approval for a Licensed Product in the Territory for the Primary Indication and any post-approval studies required as a condition of obtaining any Regulatory Approval for a Licensed Product for the Primary Indication. The parties acknowledge and agree that Schering's obligations under this Section 2.6(c) shall include all of the costs of conducting the CART Study (whether incurred before or after the Effective Date) which are estimated at [ * ]. In addition, Schering shall be responsible for any other studies (or portions of studies) necessary or desirable, in its sole judgment, for maintaining any Regulatory Approval (for the Primary Indication or any other indication for which Schering, in its sole discretion, may decide to seek Regulatory Approval) in the Territory, as well as any pre-marketing studies prior to such Regulatory Approval and post-marketing studies conducted following a Regulatory Approval.
Research and Development Activities. TCR2 may at its sole discretion and expense, and without restriction, carry out research and development activities on Base MSLN Binders and Improved MSLN Binders during the Term and thereafter. HARPOON may at its sole discretion and expense, and without restriction, carry out research and development activities on the Base BCMA Binder and Improved BCMA Binders during the Term and thereafter. For the avoidance of doubt, any and all Intellectual Property (and all associated Patent Rights) arising from, made or developed solely by or on behalf of the Party carrying out such research and development activities (“Developed IP” ) shall also be solely owned by such Party.
Research and Development Activities. (i) All product research and development activities, including quality assurance, quality control, testing, and research and analysis activities, conducted by the Company in connection with their business is being conducted, in all material respects, in accordance with best industry practices and in compliance, in all material respects, with all industry, laboratory safety, management and training standards applicable to the Company’s current and proposed business, and all such processes, procedures and practices, required in connection with such activities are in place as necessary and are being complied with, in all material respects.
Research and Development Activities. Subject to and in accordance with its diligence obligations set forth in Section 2.4(a), following the Effective Date, Lilly shall be responsible, at its cost and expense, and in its sole judgment, for all research and development activities which are necessary to submit Regulatory Applications for and obtain marketing authorization for, Product, and any post-approval studies required as a condition of obtaining any marketing authorization for Product. In addition, Lilly shall be responsible for any other studies (or portions of studies) necessary or desirable, in its sole judgment, for maintaining any NDA, as well as any pre-marketing studies prior to marketing authorization, and post-marketing studies conducted following marketing authorization.
Research and Development Activities. (a) In accordance with existing research and development policy, the Commonwealth will, under Part 3 Australian Meat and Live-stock Industry Xxx 0000, maintain the matching funding of industry research and development to be undertaken by or arranged through MLA.
