Common use of Company Development Activities Clause in Contracts

Company Development Activities. Company shall be responsible for completing the Existing Study, subject to the Parties entering into a mutually agreeable clinical management agreement with customary terms (“Clinical Agreement”), including compensation to Company on an FTE basis at the FTE Rate, plus Company’s cost of materials, requirements that all Development activities are conducted in accordance with GCP, GMP and other applicable standards in the industry and Applicable Law, and other customary terms for agreements of this sort. Notwithstanding the foregoing, Company will not amend the protocol or enroll in any expansion or phase 2 cohorts other than ***or transition to *** for any *** for any Existing Study, without a decision of the JSC. To ensure timely submission of data to regulatory authorities, JSC may elect to have Licensee assume some or all of the operational aspects of the Existing Study, including but not limited to ***. Company may elect, subject to JSC approval and the Parties entering into a Clinical Agreement, to assume responsibility to perform up to two (2) additional *** on *** in ***. The Licensee shall not unreasonably withhold the approval of its JSC members for such additional ***. Notwithstanding the foregoing, the JSC shall not be required to consider, and may in its sole decision decline, any proposed election relating to a Terminated Indication. Following JSC approval of any additional *** to be conducted by Company, the Parties will work together, via the JSC, to incorporate such *** into the then-current Development Plan. Company’s conduct of the Existing Study and any such additional activities approved by the JSC are referred to herein, collectively, as the “Company Development Activities.” Company shall use Commercially Reasonable Efforts to perform the Company Development Activities. For clarity, JSC may not assign a Company Development Activity to Company in the Development Plan without the prior written consent of Company. The activities of Company’s Affiliates and its permitted Sublicensees shall be attributed to Company for the purposes of evaluating Company’s fulfillment of the obligations set forth in this Section 5.4. Except for Company Development Activities, neither Company nor its Affiliates shall perform any Development of IMMU-132.

Appears in 3 contracts

Samples: Development and License Agreement (Immunomedics Inc), Development and License Agreement (Immunomedics Inc), Development and License Agreement (Immunomedics Inc)

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Company Development Activities. Company shall be responsible for completing the Existing Study, subject to the Parties entering into a mutually agreeable clinical management agreement with customary terms (“Clinical Agreement”), including compensation to Company on an FTE basis at the FTE Rate, plus Company’s cost of materials, requirements that all Development activities are conducted in accordance with GCP, GMP and other applicable standards in the industry and Applicable Law, and other customary terms for agreements of this sort. Notwithstanding the foregoing, Company will not amend the protocol or enroll in any expansion or phase 2 cohorts other than ***[ * ] or transition to **[ * ] for any [ * ] for [*** for ] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the SEC. any Existing Study, without a decision of the JSC. To ensure timely submission of data to regulatory authorities, JSC may elect to have Licensee assume some or all of the operational aspects of the Existing Study, including but not limited to ***[ * ]. Company may elect, subject to JSC approval and the Parties entering into a Clinical Agreement, to assume responsibility to perform up to two (2) additional **[ * ] on **[ * ] in ***[ * ]. The Licensee shall not unreasonably withhold the approval of its JSC members for such additional ***[ * ]. Notwithstanding the foregoing, the JSC shall not be required to consider, and may in its sole decision decline, any proposed election relating to a Terminated Indication. Following JSC approval of any additional **[ * ] to be conducted by Company, the Parties will work together, via the JSC, to incorporate such **[ * ] into the then-current Development Plan. Company’s conduct of the Existing Study and any such additional activities approved by the JSC are referred to herein, collectively, as the “Company Development Activities.” Company shall use Commercially Reasonable Efforts to perform the Company Development Activities. For clarity, JSC may not assign a Company Development Activity to Company in the Development Plan without the prior written consent of Company. The activities of Company’s Affiliates and its permitted Sublicensees shall be attributed to Company for the purposes of evaluating Company’s fulfillment of the obligations set forth in this Section 5.4. Except for Company Development Activities, neither Company nor its Affiliates shall perform any Development of IMMU-132.

Appears in 1 contract

Samples: Development and License Agreement (Seattle Genetics Inc /Wa)

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Company Development Activities. Company shall be responsible for completing the Existing Study, subject to the Parties entering into a mutually agreeable clinical management agreement with customary terms (“Clinical Agreement”), including compensation to Company on an FTE basis at the FTE Rate, plus Company’s cost of materials, requirements that all Development activities are conducted in accordance with GCP, GMP and other applicable standards in the industry and Applicable Law, and other customary terms for agreements of this sort. Notwithstanding the foregoing, Company will not amend the protocol or enroll in any expansion or phase 2 cohorts other than [***] or transition to [*** ] for any [*** ] for any Existing Study, without a decision of the JSC. To ensure timely submission of data to regulatory authorities, JSC may elect to have Licensee assume some or all of the operational aspects of the Existing Study, including but not limited to [***]. Company may elect, subject to JSC approval and the Parties entering into a Clinical Agreement, to assume responsibility to perform up to two (2) additional [*] on [** on ] in [*** in ***]. The Licensee shall not unreasonably withhold the approval of its JSC members for such additional [***]. Notwithstanding the foregoing, the JSC shall not be required to consider, and may in its sole decision decline, any proposed election relating to a Terminated Indication. Following JSC approval of any additional [*** ] to be conducted by Company, the Parties will work together, via the JSC, to incorporate such [*** ] into the then-current Development Plan. Company’s conduct of the Existing Study and any such additional activities approved by the JSC are referred to herein, collectively, as the “Company [*] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the SEC. Development Activities.” Company shall use Commercially Reasonable Efforts to perform the Company Development Activities. For clarity, JSC may not assign a Company Development Activity to Company in the Development Plan without the prior written consent of Company. The activities of Company’s Affiliates and its permitted Sublicensees shall be attributed to Company for the purposes of evaluating Company’s fulfillment of the obligations set forth in this Section 5.4. Except for Company Development Activities, neither Company nor its Affiliates shall perform any Development of IMMU-132.

Appears in 1 contract

Samples: Development and License Agreement (Seattle Genetics Inc /Wa)

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