Lead Development Party. Jazz and its Affiliates will have operational responsibility for leading the conduct of and executing all studies under each JDP as then in effect, subject to the right of Codiak and its Affiliates to participate in any such activities as are allocated to it or them under such JDP, and to provide input, which Jazz and its Affiliates will consider in good faith. In the event the Parties through the JSC disagree with respect to any operational aspects of any Non-Clinical Studies or Clinical Trials in the JDP, Jazz will have the final say with respect to such aspect.
Lead Development Party. PDL shall be the lead development Party for all studies of the HuLuc63 Product that are ongoing as of the Effective Date. In the event BMS exercises the BMS Option pursuant to Section 3.7, PDL shall be the lead development Party for all studies of the PDL-241 Product until the completion of all Phase I Clinical Trials of the PDL-241 Product. For clarity, if BMS does not exercise the BMS Option, PDL shall have the right to develop PDL-241 Products, * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portions. without BMS’ consent and consistent with PDL’s rights as provided in Section 3.8. [****]*. The JDC shall, in allocating responsibilities between the Parties with respect to Development activities under this Agreement: (a) endeavor to take advantage of the respective resources, capabilities and expertise of PDL and BMS, and (b) endeavor to (i) maintain, to the extent reasonably practical and appropriate, continuity in functions and commitments of personnel and physical resources of the Parties, (ii) avoid duplication of efforts by the Parties and (iii) xxxxxx efficient use by the Parties of resources and personnel, consistent with this Agreement and the applicable Global Development Plan and budget and the applicable Annual Development Plan and budget; provided, in any case, that the JDC shall allocate to BMS responsibilities for the Development of Products solely with respect to the Royalty Territory. Any agreements relating to clinical studies or other testing, research services, or Development that were entered into between PDL and a clinical site or a Third Party service provider before the Effective Date shall become part of the initial Global Development Plan and initial Annual Development Plan.
Lead Development Party. CTI will be the lead Development Party with respect to obtaining Regulatory Approval for all Collaboration Products in the Co-Promotion Territory and, as a result, shall be obligated and responsible for carrying out Development pursuant to each Development Plan. CTI will assemble its development team and commence reporting to the JDC within thirty (30) days following the Effective Date. ORTHO agrees to carry out such Development tasks as are reasonably requested by CTI and accepted by ORTHO. ORTHO agrees to apply its expertise to assist CTI in all aspects of each Development Plan. ORTHO will be the lead Development Party with respect to obtaining Regulatory Approval for all Royalty Bearing Products in the Royalty Bearing Territory, and, acting in this capacity, shall have the right to act independently of the JDC; provided, -------- however, that ORTHO shall not take any action in connection with obtaining ------- Regulatory Approval for a Royalty Bearing Product in the Royalty Bearing Territory that would materially and adversely affect CTI's ability to conduct Development pursuant to the Development Plan.
Lead Development Party. The JSC shall agree on a strategy to allocate operational responsibility for regulatory activities relating to each Candidate or Product to a Lead Development Party by reference to the country or region within the Territory for which that Party is to act as the Lead Development Party in respect of a Clinical Trial for one or more Candidates or Products. The JSC’s initial allocation shall be that Lead Development Party for regulatory activities relating to each Candidate or Product in the EU shall be BioNTech, and the Lead Development Party for regulatory activities relating to each Candidate or Product in the USAshall be Pfizer. Subject to the JSC’s mutual consent to seek Regulatory Approval in one or more countries or regions in the ROW, Pfizer shall be the Lead Development Party for regulatory activities relating to each Candidate or Product in such country or region in the ROW. If the JSC cannot agree on whether Regulatory Approval shall be sought for any country or region in the ROW, the Party that wishes to seek Regulatory Approval in such country or region shall be entitled to be the Lead Development Party for regulatory activities relating to each Candidate or Product in such country or region and seek such Regulatory Approval at its own cost. The JSC may vary from the foregoing allocations by mutual consent. The other Party shall cooperate with the Lead Development Party, at its reasonable request, with respect to any regulatory matters for which the Regulatory Approval holder is responsible or to whom regulatory matters have been delegated.
Lead Development Party. Except with respect to the Exelixis Clinical Trials, BMS shall act as the lead development Party for each Co-Developed Product, although the Annual Development Plan may specify that outside contractors (and/or Exelixis, subject to Exelixis’ consent) will have responsibility to direct and conduct any additional pre-clinical activities and applicable clinical trials in any country. The Parties shall make such determinations in the best interests of the Collaboration. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Lead Development Party. It is expected that BMS would act as the lead development Party for each Product, although the Annual Development Plan may specify that outside contractors (and/or, in the case of Co-Promotion Products, EXEL) will have responsibility to direct and conduct any additional pre-clinical activities and applicable clinical trials in any country. The JDC shall make such determinations in the best interests of the Collaboration. In the event EXEL files an IND on a Provisional Collaboration Program’s Lead Compound, and BMS exercises its Co-Development Option for such Provisional Collaboration Program pursuant to Section 3.4(b)(iii), then any Phase I Clinical Study agreements that were entered into between EXEL and a clinical site before the effective date of BMS’ exercise of its Co-Development Option and that specifically relate to such Lead Compound, shall become part of the initial Global Development Plan and initial Annual Development Plan.
Lead Development Party. The JRDC shall recommend to Sanofi-Aventis the Party that it believes should serve as the lead Party for the conduct of the first Phase I Clinical Trial for each Product. The JRDC’s recommendation shall be made in the best interest of the Collaboration. After careful review of the recommendation of the JRDC, Sanofi-Aventis shall determine which Party shall serve as the lead Party for the conduct of the first Phase I Clinical Trial (the “Lead Development Party”). If Sanofi-Aventis determines that Exelixis serve as the Lead Development Party for a Product, then Exelixis’ responsibility to Develop such Product shall cease after the Transfer Date for the first Phase I Clinical Trial for such Product, and Sanofi-Aventis shall be responsible (as of the Transfer Date) for all further Development of such Product pursuant in Section 3.1. If Sanofi-Aventis is the Lead Development Party for a Product, then Sanofi-Aventis shall be responsible for all Development of such Product pursuant to Sections 3.1, 5.2 and 5.3.
Lead Development Party. Notwithstanding anything in the Agreement ---------------------- to the contrary, effective as of the ORTHO Suspension Date, CTI shall be the Lead Development Party in all geographic territories. As Lead Development Party, CTI shall have sole control over all aspects of Development under the Agreement. ORTHO shall have no obligations for Development after the ORTHO Suspension Date until the ORTHO Resumption Date.
Lead Development Party. The lead development Party shall, on a study-by-study basis, have primary operational responsibility for leading the conduct of and executing such study under the Joint Development Plan as then in effect, subject to the right of the other Party to participate in such activities as are allocated to it under such plan, and to provide input, which the lead development Party will consider in good faith. The other Party shall be entitled to have its representatives (including those in Clinical, Biostatistics, Study/Project Management and Pharmaceutical Sciences) participate in any decision regarding the planning of such studies and strategy for the trial design of such studies, as desired by such other Party. In the event the Parties disagree with aspects of the planning and strategy on Non-Clinical Studies or Clinical Trials, then the Parties shall refer such disagreement to the JDC. In addition, such other Party shall have the right to attend and participate in all key study meetings, including advisory boards, consultants’ meetings, investigator meetings, data safety monitoring board meetings, and meetings where data analysis and interpretation or changes to the Initial Joint Development Plan will be discussed and discussions on any significant issue that arises regarding the conduct or execution of the Initial Development Plan. [*] shall as soon as reasonably practicable inform [*] of any changes in the conduct or execution of Non-Clinical Studies or Clinical Trials included in the Initial Joint Development Plan, including changes to the Clinical Trial protocol, the statistical analysis plan and study sites and any developments that could affect the ability of a site to properly conduct a Clinical Trial.
Lead Development Party. One Party shall have primary responsibility for the day-to-day operational activities and decision-making with respect to each Non-Clinical Study and Pre-Approval Trial in connection with Development of Products hereunder, as further described in this Section 3.6 (such Party, the “Lead Development Party”).
