Existing Trials Clause Samples
The 'Existing Trials' clause defines how ongoing clinical trials or studies that began before the agreement's effective date are to be handled under the contract. It typically clarifies whether such trials are included in the scope of the agreement, outlines the parties' rights and obligations regarding these trials, and may specify reporting or data-sharing requirements. This clause ensures that both parties have a clear understanding of how pre-existing research activities are treated, preventing disputes over ownership, responsibilities, or access to results.
Existing Trials. Except as otherwise set forth in the Development Plan, OPKO shall continue to conduct all Trials initiated prior to the Execution Date (such trials, “Existing Trials”) in accordance with the protocol, standard operating procedures and other development plans established by OPKO with respect to such Existing Trials prior to the Execution Date, subject to oversight by the JDC. OPKO shall keep Pfizer apprised of the progress of all such Existing Trials, engage with Regulatory Authorities, and otherwise perform its Development obligations as provided for in and in accordance with this Article 3. OPKO will provide access to all documents and electronic information currently held by OPKO or OPKO’s CROs and other Vendors, related to all Existing Trials and any completed Trials, and to facilitate site visits by Pfizer. OPKO will undertake specific actions requested by Pfizer to remediate incomplete documentation and make amendments to current SOPs if, in Pfizer’s opinion, these changes are required to meet regulatory requirements or will have a material impact on the success of any BLA submissions by Pfizer.
Existing Trials. The Parties acknowledge and agree on the importance of conducting the Existing Trials in accordance with the Transition Plan and Trial Completion Plan. Notwithstanding any other provision of this Agreement, no Existing Advanced Trial will be terminated or wound down (other than as set forth in the relevant Trial Completion Plan) other than in the following circumstances:
(a) if at any time LICENSEE becomes aware of safety concerns with respect to the relevant Product in a given indication, LICENSEE may terminate or wind down the Existing Advanced Trial in the same indication (or if in the reasonable judgment of LICENSEE, such safety concerns affect the Product regardless of indication, both Existing Advanced Trials) without any need for PFIZER’s consent thereto, provided that LICENSEE shall discuss such concerns with PFIZER;
(b) if, on a trial-by-trial basis, after the date which is [***], any of the following events occurs, LICENSEE may terminate or wind down such Existing Advanced Trial without any need for PFIZER’s consent thereto, provided that LICENSEE shall discuss such events with PFIZER: (i) the occurrence of material changes in the market for, or the commercial potential of, the relevant Product, (ii) material adverse changes in the intellectual property protection available for the relevant Product (other than by reason of any actions taken by LICENSEE), or (iii) LICENSEE becomes aware of any material change in data that indicates that the relevant Product will not be efficacious for the indication being studied in such Existing Advanced Trial; or
(c) except as set forth in clause (a) or (b) above, only with PFIZER’s prior written consent (not to be unreasonably withheld).
Existing Trials. If a Combined Therapy Trial is added to a pre-existing clinical trial of one of the Parties, none of the cohorts of such pre-existing clinical trial shall be deemed part of the Combined Therapy Trial and none of the results, information, data, data analyses, reports, records, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, and developments from such cohorts will be Study Data unless the Protocol expressly provides otherwise. Where a cohort of a Combined Therapy Trial is a monotherapy cohort with just the Exelixis Compound or with just the Roche Compound, then the Study Data from such cohort will be Exelixis Study Data in the case where such cohort is a monotherapy cohort with just the Exelixis Compound and Roche Study Data in the case where such cohort is a monotherapy cohort with just the Roche Compound.