Sample Testing. As between the Parties, GCAR has the sole right to test all Samples collected in the course of the Study (“Sample Testing”) and, subject to Section 3.11.1 will own all Samples and results of the Sample Testing performed by or on behalf of GCAR (the “Sample Testing Results”). GCAR will own all Sample Testing Results (including all COMPANY Arm Sample Testing Results). 3.11.1. The COMPANY Arm Routine Results will form part of the COMPANY Arm Data and will be jointly owned by the Parties. 3.11.2. GCAR will provide COMPANY with Sample Testing Results in accordance with the scope set forth in the COMPANY Protocol and Sample Testing Schedule, and timing set forth in the Data Sharing Schedule; COMPANY will pay for such Sample Testing in accordance with Exhibit D. 3.11.3. During the conduct of the Study, GCAR shall collect sufficient Samples to perform the Sample Testing as the Parties have agreed to pursuant to the Sample Testing Schedule and COMPANY Arm Protocol, either during the COMPANY Arm or following COMPANY Arm Completion subject to Section 3.11.3; 3.11.4. Any obligations on either Party related to additional Sample Testing not agreed to in the Sample Testing Schedule or COMPANY Arm Protocol upon execution of this Agreement (“Additional Sample Testing”) shall be agreed to in advance under the Sample Testing Schedule, and provided further that any Additional Sample Testing shall be subject to (a) GCAR’s right to refuse to perform Sample Testing if it determines such collection or testing would be infeasible or disruptive to the other Arms, and (b) additional costs and expenses related to such Additional Sample Testing to be paid by COMPANY to GCAR, which shall be updated in Exhibit D as necessary. Any Additional Sample Testing agreed and included in Exhibit D will be considered COMPANY Arm Sample Testing Results for the purpose of this Agreement, if so agreed by the Parties in Exhibit D. For clarity, nothing in this Section 3.11 shall limit GCAR’s right to conduct Sample Testing outside of Exhibit D at its sole discretion.
Appears in 1 contract
Sources: Clinical Trial Collaboration and Supply Agreement (Kazia Therapeutics LTD)
Sample Testing. As 9.1 GSK shall perform or have performed all Sample Testing and shall own all Samples and Sample Testing Results.
9.2 GSK shall perform Sample Testing (a) of Biomarkers to the Sub-Study as set out in the applicable protocol and, (b) in relation to other Clinical Studies conducted under the Development Plan, as may be agreed between the Parties, GCAR has acting through the sole right JDC and
9.3 SpringWorks shall identify to test all GSK at the JDC its preferred vendor(s) for the conduct of bioanalytical testing relating to pharmacokinetic Samples collected from subjects in any Clinical Study conducted under the Development Plan, as provided in the course of the relevant protocol for such Clinical Study (the “Sample Bioanalytical Testing”). GSK shall use reasonable efforts to use such preferred vendor(s) andfor the Bioanalytical Testing, subject provided that such vendor(s) are approved in accordance with GSK’s internal due diligence processes and acceptable to Section 3.11.1 will own all Samples GSK’s procurement and/or third party resourcing functions, as applicable (“Approved Vendor(s)”). [***]. Unless otherwise agreed and results set out in the Development Plan, the Bioanalytical Testing shall be conducted [***] and GSK shall be responsible for overseeing the conduct of such testing by the Sample Approved Vendor(s). SpringWorks shall:
(a) provide the necessary authorization for the Approved Vendor(s) to conduct the Bioanalytical Testing performed by or on behalf of GCAR (GSK and for the “Sample Testing Results”). GCAR will own all Sample Testing Results (including all COMPANY Arm Sample Testing Results).
3.11.1. The COMPANY Arm Routine Results will form part delivery of the COMPANY Arm Data and will results of such testing to GSK so that the results may be jointly owned by the Parties.
3.11.2. GCAR will provide COMPANY with Sample Testing Results in accordance with the scope set forth included in the COMPANY Protocol and Sample Testing Schedule, and timing set forth in the Data Sharing Schedule; COMPANY will pay for such Sample Testing in accordance with Exhibit D.
3.11.3. During the conduct of the Study, GCAR shall collect sufficient Samples to perform the Sample Testing as the Parties have agreed to pursuant to the Sample Testing Schedule and COMPANY Arm Protocol, either during the COMPANY Arm or following COMPANY Arm Completion subject to Section 3.11.3;
3.11.4. Any obligations on either Party related to additional Sample Testing not agreed to in the Sample Testing Schedule or COMPANY Arm Protocol upon execution of this Agreement (“Additional Sample Testing”) shall be agreed to in advance under the Sample Testing Schedule, and provided further that any Additional Sample Testing shall be subject to (a) GCAR’s right to refuse to perform Sample Testing if it determines such collection or testing would be infeasible or disruptive to the other ArmsCSR, and (b) additional costs authorize the Approved Vendor(s) to provide GSK with access to the validation report and expenses related method for the analysis of the SpringWorks Compound, in the case of both (a) and (b), no later than [***] days following the engagement of such Approved Vendor. 10. PHARMACOVIGILANCE AGREEMENT. Within [***] days of the Effective Date, the Parties shall review the Pharmacovigilance Agreement and, to the extent necessary, shall update and amend such Additional Sample Testing Pharmacovigilance Agreement to ensure the exchange of relevant safety data within appropriate timeframes and in appropriate format to enable the Parties to fulfil local and international regulatory reporting obligations and to facilitate appropriate safety reviews in relation to the activities to be paid by COMPANY to GCAR, which shall be updated in Exhibit D as necessary. Any Additional Sample Testing agreed and included in Exhibit D will be considered COMPANY Arm Sample Testing Results for the purpose of conducted under this Agreement. In the event of a conflict between this Agreement and the Pharmacovigilance Agreement, if so agreed by the terms of the Pharmacovigilance Agreement shall control in relation to pharmacovigilance issues (including exchange of safety data) only. The Parties in Exhibit D. For clarity, nothing in this Section 3.11 shall limit GCAR’s right to conduct Sample Testing outside of Exhibit D at its sole discretionmay enter into new pharmacovigilance agreements as necessary or desirable for each GSK BCMA Product.
Appears in 1 contract
Sources: Collaboration and License Agreement (SpringWorks Therapeutics, Inc.)
Sample Testing. As between the Parties, GCAR has the sole right to test 9.1 GSK shall perform or have performed all Samples collected in the course of the Study (“Sample Testing”) and, subject to Section 3.11.1 will Testing and shall own all Samples and results of the Sample Testing performed by or on behalf of GCAR (the “Sample Testing Results”). GCAR will own all Sample Testing Results (including all COMPANY Arm Sample Testing Results).
3.11.1. The COMPANY Arm Routine Results will form part of Solely to the COMPANY Arm extent specified on the Data and will be jointly owned by Sharing Schedule as being shared, GSK shall provide to SpringWorks the Parties.
3.11.2. GCAR will provide COMPANY with Sample Testing Results in accordance with electronic form or other mutually agreeable alternate form, on the scope set forth in the COMPANY Protocol and Sample Testing Schedule, and timing set forth timelines specified in the Data Sharing Schedule; COMPANY will pay for such Schedule or as otherwise mutually agreed.
9.2 GSK shall perform Sample Testing of Biomarkers to the Sub-Study as set out in accordance with Exhibit D.
3.11.3. During the conduct Protocol as of the Study, GCAR shall collect sufficient Samples to perform the Sample Testing Effective Date and as may be agreed between the Parties have agreed to pursuant to the Sample Testing Schedule and COMPANY Arm Protocol, either during the COMPANY Arm or following COMPANY Arm Completion subject to Section 3.11.3;
3.11.4. Any obligations on either Party related to additional Sample Testing not agreed to in the Sample Testing Schedule or COMPANY Arm Protocol upon execution Term of this Agreement (“Additional Sample Biomarker Testing”). The Parties shall discuss in good faith and may agree that GSK should [***]. GSK shall be responsible for directing and overseeing the conduct of any Biomarker Testing (including as may be mutually agreed after Effective Date). In the event that a Biomarker discovered or developed by SpringWorks may be relevant to the Sub-Study, then the Parties shall discuss and agree [***] and [***] to GSK. Any agreed Biomarker Testing (including as set out in the Protocol as of the Effective Date) shall be performed at GSK’s expense.
9.3 SpringWorks shall identify to GSK in writing its preferred vendor(s) for the conduct of bioanalytical testing relating to pharmacokinetic Samples from Sub-Study subjects as provided in the Sub-Study Protocol (the “Bioanalytical Testing”) on or by the Effective Date. GSK shall be agreed use commercially reasonable efforts to use such preferred vendor(s) for the Bioanalytical Testing, provided that such vendor(s) are approved in advance under the Sample Testing Scheduleaccordance with GSK’s internal due diligence processes and acceptable to GSK’s procurement and/or third party resourcing functions, and provided further that any Additional Sample as applicable (“Approved Vendor(s)”). [***]. The Bioanalytical Testing shall be subject to conducted [***] and GSK shall be responsible for overseeing the conduct of such testing by the Approved Vendor(s). SpringWorks shall: (a) GCAR’s right provide the necessary authorization for the Approved Vendor(s) to refuse conduct the Bioanalytical Testing on behalf of GSK and for the delivery of the results of such testing to perform Sample Testing if it determines such collection or testing would GSK so that the results may be infeasible or disruptive to included in the other ArmsFinal Sub-Study Report, and (b) additional costs authorize the Approved Vendor(s) to provide GSK with access to the validation report and expenses related to such Additional Sample Testing to be paid by COMPANY to GCAR, which shall be updated in Exhibit D as necessary. Any Additional Sample Testing agreed and included in Exhibit D will be considered COMPANY Arm Sample Testing Results method for the purpose analysis of this Agreementthe SpringWorks Compound, if so agreed by in the Parties in Exhibit D. For claritycase of both (a) and (b), nothing in this Section 3.11 shall limit GCAR’s right to conduct Sample Testing outside of Exhibit D at its sole discretionno later than [***] days following the Effective Date.
Appears in 1 contract
Sources: Clinical Trial Collaboration and Supply Agreement (SpringWorks Therapeutics, Inc.)