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Clinical Trial
Clinical Trial contract clause examples

Upon reasonable notification by Lyra and ​ based on an audit scope agreed upon by the Parties, ​ may conduct an audit, to the extent permitted under Lian’s applicable agreements, of Lian’s Sublicensees, subcontractors and all Clinical Trial sites engaged by Lian or its Affiliates or Sublicensees to perform Lian’s obligations under any Development Plans to ensure that the applicable Clinical Trials are conducted in compliance with such Development Plans, GCP, and applicable Law and meet Lyra’s Clinical Trial standards provided by Lyra from time to time during the Term. Lian will use Commercially Reasonable Efforts to obtain such audit rights from its Sublicensees, subcontractors and Clinical Trial sites engaged by Lian or its Affiliates and Sublicensees to enable ​ to audit such Persons in accordance with this [Section 3.4] (Clinical Trial Audits), provided that if Lian is unable to obtain such audit rights, Lian will obtain the right to conduct substantially equivalent audits itself and, ​. No later than ​ days after preparing or receiving the audit report, Lyra will provide Lian with a written summary of Lyra’s findings of any deficiencies or other areas of remediation that Lyra identifies during any such audit. Lian will ​ remediate any deficiencies identified in an audit report ​ within ​ days (or a reasonably longer, mutually agreed period (not to exceed ​ days) depending upon the deficiencies) following Lian’s receipt of such report, ​. ​.

Clinical Trial Registries. Apellis will be responsible for registering, maintaining and updating any registries pertaining to the Trial to the extent required by any Applicable Laws, including www.clinicaltrials.gov, www.clinicalstudyresults.org, and the PhRMA Website Synopsis (collectively, the “Clinical Trial Registries”).

Clinical Trial Transparency. Both Parties agree to collaborate to maintain compliance with all Applicable Law related to Clinical Trial transparency, as well as any industry guidelines/codes of conduct, or other obligations that may apply to either the sponsor of any Clinical Trial or the owner of any Regulatory Approval, as related to any Product. The Parties will cooperate to maintain Clinical Trial transparency consistent with each sponsor’s Clinical Trial registration, summary result, and data sharing transparency policies and will support disclosure of Confidential Information as needed based on the needs of the sponsors of the study or the Regulatory Approval holder with respect to any Product.

Clinical Trial Audits. TPTX or its representatives may conduct an audit of Zai, its Affiliates, or any Sublicensees or subcontractors, and all Clinical Trial sites engaged by Zai or its Affiliates or Sublicensees or subcontractors to perform Zai’s obligations under any Clinical Development Plan, in each case, to ensure that the applicable Clinical Trials are conducted in compliance with the Clinical Development Plan, GCP, and Applicable Laws; provided that in the event any such audit of Zai’s subcontractors or Clinical Trial sites engaged by Zai or its Affiliates or Sublicensees or subcontractor requires Zai’s assistance, Zai shall provide TPTX or its representatives with such assistance, to the extent reasonable, including providing personnel of Zai to be present for such audit and producing any documents or authorizations allowing TPTX or its representatives to conduct such audit, to the extent reasonable. TPTX may conduct such audit no more than ​ (unless an additional audit is warranted for cause) upon ​ days’ prior written notice to Zai. No later than ​ days after the completion of such audit, TPTX shall provide Zai with a written summary of TPTX’s findings of any deficiencies or other areas of remediation that TPTX identifies during any such audit. Zai shall use Commercially Reasonable Efforts to respond or remediate any such deficiencies within ​ days following TPTX’s receipt of such report. Without limiting the foregoing, Zai shall have the right to be present at any such audit conducted by TPTX pursuant to this Section 5.7 of any Sublicensees, subcontractors or Clinical Trial sites. With respect to any Clinical Trial in a Joint Global Study in the Territory or Local Study, if the Parties acting reasonably and in good faith agree that any deficiencies with respect to a Clinical Trial site identified pursuant to an audit (each, a “Deficient Site”) may cause a Regulatory Authority to reject or otherwise deem deficient the Clinical Trial data from the conduct of any such Clinical Trial at such Deficient Site, then TPTX shall notify Zai of such Deficient Site and the Parties shall discuss and attempt to agree upon a remediation plan for such Deficient Site. If the Parties cannot agree to such a remediation plan for a Deficient Site, then Zai shall promptly remove such Deficient Site from such Clinical Trial and replace such Deficient Site with a new Clinical Trial site (a “Replacement Site”) in the Territory, and Zai shall be solely responsible for the costs of such replacement (unless not permitted by Applicable Law or for ethical reasons). Any such Replacement Site shall be compliant in all respects with Applicable Law.

Ongoing Clinical Trial. If at the time of such termination, any Clinical Trials for the Products are being conducted by or on behalf of Zai, then, at TPTX’s election on a Clinical Trial-by-Clinical Trial basis: # Zai shall, and shall cause its Affiliates and Sublicensees to, # continue to conduct such Clinical Trial during the Transition Period or another period of time as determined by TPTX after the effective date of such termination at TPTX’s cost, and # after such period, to # fully cooperate with TPTX to transfer the conduct of all such Clinical Trial to TPTX or its designee or # continue to conduct such Clinical Trials, at TPTX’s cost, for so long as necessary to enable such transfer to be completed without interruption of any such Clinical Trials and # TPTX shall assume any and all liability and costs for such Clinical Trial after the effective date of such termination, and # Zai shall, and shall cause its Affiliates and Sublicensees to, ​, orderly wind down the conduct of any such Clinical Trial which is not assumed by TPTX under clause (1).

Ongoing Clinical Trial. If, at the time of such termination, Zai or its Affiliates are conducting any Clinical Trials, then, at NVCR’s election on a Clinical Trial-by-Clinical Trial basis: # to the extent permissible under Applicable Law and commercially feasible, Zai shall, and shall cause its Affiliates to, cooperate with NVCR to transfer the conduct of such Clinical Trial to NVCR or its designees and complete such transfer promptly and, in any case, within ​ months after the termination effective date, and NVCR shall assume any and all liability for the conduct of such transferred Clinical Trial after the effective date of such transfer (except to the extent arising prior to the transfer date or from any willful misconduct or negligent act or omission by Zai, its Affiliates or their respective employees, agents and contractors); and # Zai shall, at ​ cost and expense, orderly wind-down the conduct of any such Clinical Trial that is not assumed by NVCR under [clause (i) above].

Clinical Trial Register. Each of EISAI and [[EPIZYME:Organization]] shall have the right to list and publish summaries of data and results from any human clinical trials conducted by such Party under this Agreement on its clinical trials registry or on a government-sponsored database such as www.clinicaltrials.gov or other publicly available websites such as www.clinicalstudyresults.org, without requiring the consent of the other Party. The Parties shall discuss and reasonably cooperate in order to facilitate the process to be employed in order to ensure the publication of any such summaries of human clinical trials data and results as required on the clinical trial registry of each Party and any government-sponsored database such as clinicaltrials.gov or other publicly available websites such as www.clinicalstudyresults.org, and shall provide copies of such summaries to the other Party at least thirty (30) days prior to the proposed publication date for the purposes of preparing any necessary patent filings.

Clinical Trial Protocols. Zai Lab will provide INCY with a protocol for each planned Clinical Trial for each Licensed Product(s) to be conducted in the Zai Lab Territory. INCY will promptly review such protocol and may provide comments to Zai Lab. Zai Lab will consider in good faith any comments relating to the design and conduct of such activities and will not conduct any such Clinical Trial if INCY notifies Zai Lab that ​ and provides its rationale for such belief in writing to Zai Lab.

Ongoing Clinical Trial. If, at the time of such termination, Zai or its Affiliates are conducting any Clinical Trials, then, at NVCR’s election on a Clinical Trial-by-Clinical Trial basis: # to the extent permissible under Applicable Law and commercially feasible, Zai shall, and shall cause its Affiliates to, cooperate with NVCR to transfer the conduct of such Clinical Trial to NVCR or its designees and complete such transfer promptly and, in any case, within ​ months after the termination effective date, and NVCR shall assume any and all liability for the conduct of such transferred Clinical Trial after the effective date of such transfer (except to the extent arising prior to the transfer date or from any willful misconduct or negligent act or omission by Zai, its Affiliates or their respective employees, agents and contractors); and # Zai shall, at ​ cost and expense, orderly wind-down the conduct of any such Clinical Trial that is not assumed by NVCR under [clause (i) above].

Ongoing Clinical Trial. If, at the time of such termination, Zai or its Affiliates are conducting any Clinical Trials, then, at NVCR’s election on a Clinical Trial-by-Clinical Trial basis: # to the extent permissible under Applicable Law and commercially feasible, Zai shall, and shall cause its Affiliates to, cooperate with NVCR to transfer the conduct of such Clinical Trial to NVCR or its designees and complete such transfer promptly and, in any case, within ​ months after the termination effective date, and NVCR shall assume any and all liability for the conduct of such transferred Clinical Trial after the effective date of such transfer (except to the extent arising prior to the transfer date or from any willful misconduct or negligent act or omission by Zai, its Affiliates or their respective employees, agents and contractors); and # Zai shall, at ​ cost and expense, orderly wind-down the conduct of any such Clinical Trial that is not assumed by NVCR under [clause (i) above].

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