Additional Clinical Trials Clause Samples
The 'Additional Clinical Trials' clause defines the conditions under which parties may initiate or participate in clinical trials beyond those originally specified in the agreement. Typically, this clause outlines the process for proposing, approving, and conducting such additional studies, including requirements for mutual consent, protocol development, and allocation of responsibilities or costs. Its core function is to provide a structured mechanism for expanding research collaboration while ensuring that both parties maintain control and clarity over any new clinical activities.
Additional Clinical Trials. (a) For a period of ** from the date of the Agreement, the Parties agree that they will cooperate in good faith to provide Recipient with the opportunity to be a primary clinical site in any Additional Clinical Trial sponsored by Corautus, subject to applicable law and reasonable qualifications. Corautus shall permit Recipient to state in its marketing and similar materials that Recipient is Corautus’ premier clinical site in such Additional Clinical Trials if Recipient is actively participating in such Additional Clinical Trial as an investigator. Notwithstanding the foregoing, because the details, timing and conditions of any Additional Clinical Trial cannot be predicted, Corautus shall not be obligated to Recipient as a clinical site for, and Recipient shall not be obligated to participate as a clinical site in any Additional Clinical Trial.
(b) Recipient will not sponsor or participate in Additional Clinical Trials other than those sponsored by Corautus for a period of ** from the date hereof.
Additional Clinical Trials. Subject to the terms of this Section 4.10, during the Option Period, OV will have the right to propose amendments to the Clinical Development Plan to include additional clinical trials using the Product and the DRP Biomarker for the treatment of patients with mBC. If OV desires to conduct any such additional clinical trial, it will notify the JDC in writing, and discuss such additional clinical trial with R-Pharm at the JDC and provide the JDC any information reasonably requested by the JDC related to such additional clinical trial. The JDC will consider in good faith any such proposal for an additional clinical trial, and if, and only if, the JDC approves to amend the Clinical Development Plan to include such additional clinical trial, OV may thereafter conduct such additional clinical trial (but subject to the terms and conditions imposed by the JDC as part of the JDC’s approval of the additional clinical trial). In all cases, OV shall keep the JDC updated with respect to all such additional clinical trials (including the results generated therefrom) at each meeting of the JDC, and shall provide to R-Pharm such other information with respect to any such additional clinical trial as reasonably requested by R-Pharm.
Additional Clinical Trials. If, following the completion of the Pre-Funded Activities for an Initial Licensed Program, the JDC or any Regulatory Authority determines that it is necessary, in order to obtain Regulatory Approval of an Initial Licensed Product under such Initial Licensed Program, to re-perform or conduct any additional Clinical Trial prior to a Pivotal Trial with respect to such Initial Licensed Product (each, an “Additional Clinical Trial”), then the Development Budget for such Initial Licensed Product shall be modified to include the Development Costs of the Additional Clinical Trial and, if AGTC has exercised the Milestone/Royalty Option with respect to such Initial Licensed Program, AGTC shall share such Development Costs equally with Biogen unless, in such event, AGTC notifies Biogen prior to any such Development Costs being incurred that it elects to not share such Development Costs equally, in which case, AGTC shall not be required to share any such Development Costs with Biogen, and such election shall have the effect described in the final paragraph of Section 6.4.1. For clarity, if AGTC has exercised the Cost Share Option with respect to such Initial Licensed Program, the Parties shall share any Development Costs under this Section 3.2.2(c) in accordance with the provisions of Section 6.3.
Additional Clinical Trials. 7.1 The Licensee may from time to time, propose to the Licensor that additional Clinical Studies be initiated in relation to the Product in the Territory whether on its own initiative or because a Phase IV Clinical Trial is required by FDA (“Additional Studies”). The Parties shall meet and discuss the same in good faith and if the Parties agree the plans and protocols for such Additional Studies the Licensee may at its sole cost and expense proceed with the additional Clinical Study which shall be included as part of the Lifecycle Management Plan. Provided that where any Phase IV Clinical Trial is required by the FDA in the Territory after the NDA Approval Date, the Parties shall promptly agree in good faith the plans and protocols for such Additional Study and the Licensee shall be entitled to conduct the same as a Clinical Study, at its sole cost and expense.
7.2 Where any Clinical Trial is required by the FDA in connection with the Initial NDA the Parties shall promptly agree in good faith the plans and protocols for such additional Clinical Trial and the budget therefor and it shall be conducted as agreed between the Parties. The Development Costs of any such additional Clinical Trial required in connection with the Initial NDA pre-NDA Approval Date shall be paid by the Licensor, provided that a sum equal to the first [*] dollars ($[*]) and [*] per cent ([*]%) of any Development Costs exceeding [*] dollars ($[*]) shall be reimbursed by the Licensee, by being paid in addition to the milestone payable under Clause 10.10, upon payment of such milestone.
7.3 Any failure of the Parties to agree under Clauses 7.1 or 7.2 shall be referred to Expert Determination.
Additional Clinical Trials. SPA, at its sole discretion, may conduct clinical trials of Unoprostone and/or Licensed Product in SPA Territory, at its sole expense.
Additional Clinical Trials. The Steering Committee shall determine whether to allow any Investigator Sponsored Trials or conduct any Phase II Clinical Trials, Phase III Clinical Trials, or Phase IV Studies of Prochymal for the GvHD Indication, Major Indications and Other Indications in addition to the Osiris Funded Trials (each an “Additional Clinical Trial”) that have not been initiated prior to the Effective Date; provided that in the event Genzyme makes a Prochymal Development Milestone Payment for the achievement of Statistical Significance for Prochymal for a particular Indication, then any Phase III Clinical Trial and Phase IV Study reasonably required to obtain Marketing Approval for Prochymal for such Indication shall be conducted by Osiris; and provided further that if the Steering Committee has determined to initiate any Additional Clinical Trial (other than an Investigator Sponsored Trial), such trial shall be conducted by Osiris and shall be subject to agreement by the Steering Committee on the clinical strategy and protocol design. Nothing in this Section 3.1.3 shall prohibit a Party from pursuing an At-Risk Indication. All Commercial Post-Marketing Studies will be one hundred percent (100%) funded by the Party conducting such Studies.
Additional Clinical Trials. On a Clinical Trial-by-Clinical Trial basis, prior to conducting a Clinical Trial for an Additional Indication, Licensor will provide Pfizer, through the JDMRC, with the clinical study protocol for such Clinical Trial reasonably in advance of the start of such Clinical Trial in order for Licensor to consult with Pfizer and for Pfizer to review and provide comments on such clinical trial protocol. Licensor will in good faith consider any reasonable suggestions by Pfizer with respect to such Clinical Trial, but, subject to Section 3.8.2(b) (Licensor Final Decision-Making Authority), will have the right to conduct such Clinical Trial in its sole discretion and at its sole cost.
Additional Clinical Trials. In the event that any European Union regulatory authority requires two (2) clinical trials for Approval in three (3) or more of the Major European Markets, then the Parties shall meet and negotiate in good faith a revised timeline for the Type II Variation filings, including a revised timeframe for the Second Milestone Payment set forth in Section 5.5.