Development Responsibility. Licensee shall have sole responsibility for all Development (both Clinical Development and Manufacturing Development) and shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for Products in the Field and in the Territory. Licensee shall be solely responsible for all costs associated with such Development activities.
Development Responsibility. Coya, directly or through any Affiliates or Sublicensees, shall have sole responsibility for the conduct of Development activities under this Agreement and shall bear all costs and expenses incurred in connection with such Development activities. Notwithstanding the foregoing, Coya shall use Commercially Reasonable Efforts, either directly or through any Affiliates or Sublicensees, to Develop and obtain Regulatory Approval for at least one Product, in the United States, the Major EU Markets or Japan.
Development Responsibility. As of the Sublicense Effective Date, Audentes shall assume responsibility for the development and reporting obligations set out in paragraphs 9.1 through 9.3 and article 10 of the HHS Patent License Agreement, as such apply to the development and commercialization of Licensed Product. Audentes shall provide to Genethon a copy of all documents provided to PHS pursuant to its obligations under paragraphs 9.1 through 9.3 of the HHS Patent License Agreement, and the same shall be Confidential Information to be protected as provided in article 9 of the Collaborative Development Agreement and as described in paragraph 9.9 of the HHS Patent License Agreement. Genethon’s rights of termination under Section 5.3 hereof shall be the sole remedy for any breach by Audentes of the obligations set out in article 10 of the HHS Patent License Agreement.
Development Responsibility. IXI shall submit to ICQ the first Candidate Application within 14 days of Effective Date. IXI shall be solely responsible for such development, including, without limitation, all associated costs and expenses.
Development Responsibility. After exercise of the License Option on a Pharmacological Profile-by-Pharmacological Profile basis, JBI shall be solely responsible for all Development of Collaboration Molecules, Lead Molecules and/or Licensed Products with such Pharmacological Profile.
Development Responsibility. Subject to the terms and conditions of this Agreement, Seagen will have the sole and exclusive right to Develop (and will solely and exclusively control, at its discretion, the Development of), itself or with or through its Affiliates, Sublicensees or other Third Parties, the respective Licensed Degrader and Licensed Degrader-Antibody Conjugate, including all Licensed Products, in the Field in the Territory. Subject to an applicable Profit-Share Product Agreement (if executed), all such Development will be at Seagen’s sole cost and expense.
Development Responsibility. Cultural Management Plans for the Conservation Estate will be developed and authored by Yawuru RNTBC and will address both Yawuru customs and practices as well as Yawuru customary law.
Development Responsibility. Following the expiration of the Research Term, as may be extended, AbbVie (itself or through its Affiliates or Sublicensees) shall have the sole right to Develop Licensed Compounds and Licensed Products in the Field in the Territory at its own cost and expense (except with respect to costs and expenses, as otherwise expressly set forth in the Research Plan).
Development Responsibility. Unless specifically set forth in the Research and Development Plan, SIIL shall be solely responsible for the conduct of all Development activities set forth in the Research and Development Plan. Visterra shall provide assistance to SIIL in an advisory role through the JSC and shall conduct those activities for which it is specifically designated as the responsible Party in the Research and Development Plan. At each meeting of the JSC, each Party shall reasonably update the other Party on the status, progress and results of its Development activities under the Research and Development Plan.
Development Responsibility. During the twenty-four (24)-month period following the Effective Date, the JSC will evaluate, on a Country-by-Country or market-by-market basis, the potential Development of the Licensed Product in the Field for Country(ies) in the ROW. Should the JSC determine to proceed with Development of the Licensed Product in the Field for any Countries in the ROW, then the Parties will use good faith efforts to determine each Party's respective responsibilities to conduct Development under a ROW Development Plan and ROW Development Budget for such Country(ies) to be agreed by the JSC. Once the Parties reach agreement on a ROW Development Plan and ROW Development Budget for a Country in the ROW, then such Country shall become a "ROW Country" for purposes of this Agreement, and each Party will use Diligent Efforts to Develop the Licensed Product in the Field in such ROW ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. Country(ies) in accordance with such Development Plan and Development Budget. The Parties acknowledge and agree that, if MYLAN proposes to proceed with respect to the Development and Commercialization of Licensed Products in the Field in a particular Country in the ROW and demonstrates to the JSC that proceeding in such Country is commercially reasonable, the JSC shall not withhold its consent to proceed with the Development and Commercialization of the Licensed Products in the Field in such Country.
