Clinical Trial Audit Rights Sample Clauses

Clinical Trial Audit Rights. (a) Upon reasonable notification by Five Prime and at Five Prime’s cost and expense, Five Prime or its representatives shall be entitled to conduct an audit of any Clinical Trial sites engaged by Zai or its Affiliates or sublicensees to conduct Zai’s obligations under (i) the Global Development Plan, to ensure that such Clinical Trials are conducted in compliance with the Global Development Plan and all Applicable Laws and (ii) the Territory Development Plan, to ensure such Clinical Trials are conducted in compliance with GCP and meet Five Prime’s global Clinical Trial standards. No later than [***] following the completion of any such audit, Five Prime will provide Zai with a written summary of Five Prime’s findings, including any deficiencies or other areas of remediation that Five Prime identifies during such audit. Zai will use Commercially Reasonable Efforts to remediate any such deficiencies within [***] following Zai’s receipt of such report, at Zai’s cost and expense. (b) With respect to the FPA144-004 Study, to the extent Five Prime reasonably determines, in its sole discretion, that any deficiencies with respect to a Clinical Trial site identified pursuant to Section 5.6(a) (each, a “Deficient Site”) may cause a Regulatory Authority to reject or otherwise deem deficient the Clinical Trial data from Zai’s conduct of the FPA144-004 Study at such Deficient Site, then Zai will use its best efforts to promptly remove such Deficient Site from the FPA144-004 Study and replace such Deficient Site with a new Clinical Trial site (a “Replacement Site”) within the Territory, which Replacement Site shall be compliant in all respects with Applicable Laws and Five Prime’s global Clinical Trial standards, at Zai’s cost and expense; provided that if Zai is unable to replace any Deficient Site with a Replacement Site or, in Five Prime’s discretion, is unable to do so in a timely manner so as not to jeopardize the Parties’ ability to meet the timelines for Regulatory Submissions set forth in the CFDA Submission Timeline, then Five Prime may replace such Deficient Site with one or more Replacement Sites outside the Territory. (c) Zai will provide Five Prime with copies of all quality oversight or audit reports, including English translations thereof, prepared in connection with any audit that Zai, its Affiliates or sublicensees conduct of a Clinical Trial site that Zai, its Affiliates or sublicensees have engaged or are evaluating to potentially engage to fulfill Za...
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Clinical Trial Audit Rights. (a) Upon reasonable notification by Zymeworks and at Zymeworks’ cost and expense, Zymeworks or its representatives shall be entitled to conduct an audit of any Clinical Trial sites engaged, or other facilities used, by BeiGene or its Affiliates or sublicensees to conduct BeiGene’s obligations under (i) […***…] and (ii) […***…]. No later than […***…] following the completion of any such audit, Zymeworks will provide BeiGene with a written summary of Zymeworks’ findings in English, including any deficiencies or other areas of remediation that Zymeworks reasonably identifies during such audit and the Parties shall promptly meet to discuss any such deficiencies or other areas of remediation identified by Zymeworks. BeiGene will use Commercially Reasonable Efforts to remediate such deficiencies 44 Competitive Information – Discovery Information and Commercially Sensitive Terms. 45 Competitive Information – Discovery Information and Commercially Sensitive Terms. 46 Competitive Information – Commercially Sensitive Terms. 47 Competitive Information – Commercially Sensitive Terms. promptly following BeiGene’s receipt of such report […***…]. […***…] and Zymeworks reasonably determines, […***…]. Without limiting the foregoing, […***….].48 (b) BeiGene will provide Zymeworks with copies of all quality oversight or audit reports, including certified translations into English thereof, prepared in connection with any audit that BeiGene, its Affiliates or sublicensees conduct of a Clinical Trial site that BeiGene, its Affiliates or sublicensees have engaged or are evaluating to potentially engage to fulfill BeiGene’s obligations under the Global Development Plan or the Territory Development Plan no later than […***…] after receiving or preparing, as applicable, any such report.49
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Clinical Trial Audit Rights. Upon reasonable notification by Verastem and at Verastem’s cost and expense, Verastem or its representatives shall be entitled to conduct an audit of any Clinical Trial sites engaged by Licensee or its Affiliates or Sublicensees to conduct Development activities under the Development Plan, subject to any applicable restrictions contained in Licensee’s contracts with such Clinical Trial sites, to ensure that such Clinical Trials; (i) are conducted in compliance with applicable GCP, and (ii) meet Verastem’s standards for the Global Clinical Trial as well in case of such Clinical Trial sites are engaged in the Global Clinical Trials. No later than [* * *] days following the completion of any such audit, Verastem shall provide Licensee with a written summary of Verastem’s findings, including any potential deficiencies or other areas of remediation that Verastem identifies during such audit, and the Parties shall discuss in good faith such potential deficiencies and other areas of remediation. Licensee will remediate any such deficiencies and any other areas of remediation confirmed by both Parties within [* * *] days following such confirmation, at Licensee’s cost and expense.
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Clinical Trial Audit Rights. Upon reasonable notification by Verastem and at Verastem’s cost and expense, Verastem or its representatives shall be entitled to conduct an audit of any Clinical Trial sites engaged by Licensee or its Affiliates or Sublicensees to conduct Development activities under the Development Plan, subject to any applicable restrictions contained in Licensee’s contracts with such Clinical Trial sites, to ensure that such Clinical Trials; (i) are conducted in compliance with applicable GCP, and (ii) meet Verastem’s standards for the Global Clinical Trial as well in case of such Clinical Trial sites are engaged in the Global Clinical Trials. No later than [* * *] days following the completion of any such audit, Verastem shall provide Licensee with a written summary of Verastem’s findings, including any potential deficiencies or other areas of remediation that Verastem identifies during such audit, and the Parties shall discuss in good faith such potential deficiencies and other areas of remediation. Licensee will remediate any such deficiencies and any other areas of remediation confirmed by both Parties within [* * *] days following such confirmation, at Licensee’s cost and expense. Notwithstanding the foregoing, if such deficiencies or other areas of remediation are not, by their nature, reasonably capable of remediation within such [* * *] day period (e.g., due to delays of the Clinical Trial site), then such period shall be reasonably extended.
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Clinical Trial Audit Rights. (a) Upon reasonable notification by AssemblyBio and at AssemblyBio’s cost and expense, AssemblyBio or its representatives shall be entitled to conduct an audit of any Clinical Trial sites or vendors engaged, or other facilities used, by BeiGene or its Affiliates or sublicensees to conduct BeiGene’s obligations under the Global Development Plan and Territory Development Plan, to ensure that such Clinical Trials are conducted in compliance with the Global Development Plan, Territory Development Plan and all Applicable Laws, including GCP. No later than [* * *] following the completion of any such audit, AssemblyBio will provide BeiGene with a written summary of AssemblyBio’s findings in English, including any deficiencies or other areas of remediation that AssemblyBio reasonably identifies during such audit and the Parties shall promptly meet to discuss any such deficiencies or other areas of remediation identified by AssemblyBio. BeiGene will use Commercially Reasonable Efforts to remediate such deficiencies promptly following BeiGene’s receipt of such report, at BeiGene’s cost and expense. (b) BeiGene will provide AssemblyBio with copies of all quality oversight or audit reports, including certified translations into English thereof, prepared in connection with any audit that BeiGene, its Affiliates or sublicensees conduct of a Clinical Trial site or vendor that BeiGene, its Affiliates or sublicensees have engaged or are evaluating to potentially engage to fulfill BeiGene’s obligations under the Global Development Plan or the Territory Development Plan no later than [* * *] after receiving or preparing, as applicable, any such report.
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Clinical Trial Audit Rights 
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Related to Clinical Trial Audit Rights

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.

  • Diagnostic Assessment 6.3.1 Boards shall provide a list of pre-approved assessment tools consistent with their Board improvement plan for student achievement and which is compliant with Ministry of Education PPM (PPM 155: Diagnostic Assessment in Support of Student Learning, date of issue January 7, 2013). 6.3.2 Teachers shall use their professional judgment to determine which assessment and/or evaluation tool(s) from the Board list of preapproved assessment tools is applicable, for which student(s), as well as the frequency and timing of the tool. In order to inform their instruction, teachers must utilize diagnostic assessment during the school year.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Inspection/Testing In order to assess Supplier’s work quality and/or compliance with this Order, upon reasonable notice by Buyer: (a) all goods, materials and services related to the items purchased hereunder, including, raw materials, components, assemblies, work in process, tools and end products shall be subject to inspection and testing by Buyer, its customer, representative or regulatory authorities at all places, including sites where the goods are made or located or the services are performed, whether at Supplier’s premises or elsewhere; and (b) all of Supplier’s facilities, books and records relating to this Order shall be subject to inspection by Buyer or its designee. If specific Buyer and/or Buyer’s customer tests, inspection and/or witness points are included in this Order, the goods shall not be shipped without an inspector’s release or a written waiver of test/inspection/witness with respect to each such point; however, Buyer shall not be permitted to unreasonably delay shipment; and Supplier shall notify Buyer in writing at least twenty (20) days prior to each of Supplier’s scheduled final and, if applicable, intermediate test/inspection/witness points. Supplier agrees to cooperate with such/audit inspection including, completing and returning questionnaires and making available its knowledgeable representatives. Buyer’s failure to inspect or test goods, materials or services or Buyer’s failure to reject or detect defects by inspection or testing shall not relieve Supplier from its warranty obligations or any of its other obligations or responsibilities under this Order. Supplier agrees to provide small business as well as minority and/or women owned business utilization and demographic data upon request.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Project Review A. Programmatic Allowances 1. If FEMA determines that the entire scope of an Undertaking conforms to one or more allowances in Appendix B of this Agreement, with determinations for Tier II Allowances being made by SOI-qualified staff, FEMA shall complete the Section 106 review process by documenting this determination in the project file, without SHPO review or notification. 2. If the Undertaking involves a National Historic Landmark (NHL), FEMA shall notify the SHPO, participating Tribe(s), and the NPS NHL Program Manager of the NPS Midwest Regional Office that the Undertaking conforms to one or more allowances. FEMA shall provide information about the proposed scope of work for the Undertaking and the allowance(s) enabling FEMA’s determination. 3. If FEMA determines any portion of an Undertaking’s scope of work does not conform to one or more allowances listed in Appendix B, FEMA shall conduct expedited or standard Section 106 review, as appropriate, for the entire Undertaking in accordance with Stipulation II.B, Expedited Review for Emergency Undertakings, or Stipulation II.C, Standard Project Review. 4. Allowances may be revised and new allowances may be added to this Agreement in accordance with Stipulation IV.A.3, Amendments. B. Expedited Review for Emergency Undertakings

  • Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).