Common use of Development Responsibilities Clause in Contracts

Development Responsibilities. The JSC shall select the lead development party (“Lead Development Party”) for each Clinical Trial of a Collaboration Product, provided that Trubion shall be the initial Lead Development Party for all Clinical Trials and Non-Clinical Studies of TRU-016 that are on-going as of the Signing Date. The JSC shall, in allocating Lead Development Party responsibilities between the Parties: (a) endeavor to take advantage of the respective resources, capabilities and expertise of Facet and Trubion; (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 Development Plan and Development Budget; and (c) act in the best interests of the Collaboration. The Lead Development Party shall be responsible for implementing the Development Plan with respect to the applicable Clinical Trial, provided that [ * ] = 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. the other Party shall perform all tasks with respect to such Clinical Trial that are allocated to it pursuant to the Development Plan and may direct and conduct certain additional Development activities not specifically allocated to either Party pursuant to the Development Plan, if the JDC agrees upon such allocation. The Lead Development Party shall not have the right to change the Development Plan or to make changes to the Clinical Trial protocol or the statistical analysis plan or make changes that affect study design or Clinical Trial strategy (any of the foregoing actions falling under the authority of the JDC or JSC, as applicable).

Appears in 2 contracts

Samples: Collaboration and License Agreement (Facet Biotech Corp), Collaboration and License Agreement (Trubion Pharmaceuticals, Inc)

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Development Responsibilities. The JSC shall select the lead development party (“Lead Development Party”) for each Clinical Trial of a Collaboration Product, provided that Trubion shall be the initial Lead Development Party for all Clinical Trials and Non-Clinical Studies of TRU-016 that are on-going as of the Signing Date. The JSC shall, in allocating Lead Development Party responsibilities between the Parties: (a) endeavor to take advantage of the respective resources, capabilities and expertise of Facet and Trubion; (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 Development Plan and Development Budget; and (c) act in the best interests of the Collaboration. The Lead Development Party shall be responsible for implementing the Development Plan with respect to the applicable Clinical Trial, provided that [ * ] = 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. the other Party shall perform all tasks with respect to such Clinical Trial that are allocated to it pursuant to the Development Plan and may direct and conduct certain additional Development activities not specifically allocated to either Party pursuant to the Development Plan, if the JDC agrees upon such allocation. The Lead Development Party shall not have the right to change the Development Plan or to make changes to the Clinical Trial protocol or the statistical analysis plan or make changes that affect study design or Clinical Trial strategy (any of the foregoing actions falling under the authority of the JDC or JSC, as applicable).

Appears in 2 contracts

Samples: Collaboration and License Agreement (Trubion Pharmaceuticals, Inc), Collaboration and License Agreement (Facet Biotech Corp)

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Development Responsibilities. The JSC shall select the lead development party (“Lead Development Party”) for i. With regards to each Clinical Trial of a Collaboration Product, provided that Trubion this Section 3.1.1 shall be the initial Lead Development Party for all Clinical Trials and Non-Clinical Studies of TRU-016 that are on-going as apply prior to Alnylam’s exercise of the Signing DateAlnylam Commercialization Option for such Product pursuant to Section 4.3 and shall continue to apply if Alnylam does not exercise the Alnylam Commercialization Option for such Product. The JSC shallParties have agreed on a preliminary Development Plan for the Products contemporaneously with the execution of this Agreement, in allocating Lead including the anticipated timeline for the Development Party responsibilities between activities to be conducted under this Agreement. Dicerna shall have the Parties: (a) endeavor right to take advantage modify the preliminary Development Plan, at its sole discretion, as it sees fit as it proceeds with Development of the respective resourcesProducts, capabilities and expertise of Facet and Trubion; (b) endeavor to as long as such modification is consistent with (i) maintain[* * *] under Section 3.2 and (ii) the final decision rights as specified in Section 3.6. Notwithstanding anything to the contrary herein, the Parties acknowledge and agree that Dicerna intends to, and shall, to the extent reasonably practical practicable, promptly initiate the Chronic Tox Study promptly following the Effective Date and appropriateto complete it in a timely manner. Subject to Section 3.6 and the terms of this Agreement, continuity in functions and commitments of personnel and physical resources of as between the Parties, (ii) avoid duplication of efforts by the Parties Dicerna shall have sole discretion and (iii) xxxxxx efficient use by the Parties of resources and personnel, consistent with this Agreement and the Development Plan and Development Budget; and (c) act in the best interests of the Collaboration. The Lead Development Party shall be responsible for implementing the Development Plan authority with respect to all decisions concerning the applicable Clinical TrialDevelopment of Products in the Field, provided that [ * ] = Certain confidential information contained in including the clinical and regulatory strategy of Products covered under 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 amendedAgreement. the other Party Alnylam shall perform all tasks not conduct any Research or Development activities with respect to any Product or Combination Product in the Field without Dicerna’s prior written consent and approval, and any such Clinical Trial Research or Development work shall be done solely at Dicerna’s direction. If Dicerna requests that are allocated to it Alnylam perform Development activities pursuant to this Section 3.1, the Development Plan Parties will discuss and may direct agree upon reasonable procedures to govern the invoicing by Alnylam and conduct certain additional Development activities not specifically allocated to either Party pursuant to the Development Plan, if the JDC agrees upon such allocationpayment by Dicerna therefor. The Lead Development Party shall not have the right to change the Development Plan or to make changes to the Clinical Trial protocol or the statistical analysis plan or make changes that affect study design or Clinical Trial strategy (any of the foregoing actions falling under the authority of the JDC or JSC, as applicable).||

Appears in 1 contract

Samples: Collaboration and License Agreement (Dicerna Pharmaceuticals Inc)

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