Selection of Sites and Investigators Sample Clauses

Selection of Sites and Investigators. (a) The JDC will approve the study sites to conduct each Trial as proposed by OPKO. (b) OPKO will enter, and each Approved CRO will enter, into an agreement with each study site; such an agreement will be substantially in the form to be agreed upon by the Parties within *** days following approval by the JDC of the Development Plan (the “Clinical Trial Agreement”) (upon execution of the Clinical Trial Agreement, such study site will be deemed a “Site”), and will provide that any Trial may be freely transferred or assigned to Pfizer or a designee of Pfizer without any negotiation of the CTA necessary. If a study site requires any material changes to such form Clinical Trial Agreement, OPKO will inform the JDC and seek JDC approval of such change, and the JDC will not unreasonably withhold such *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. approval. For clarity, each Clinical Trial Agreement will specify reasonable terms, consistent with industry standards for similar agreements, and will expressly require during the period which it is effective the applicable Site and Clinical Investigator to comply with the terms hereof as if such Site and Clinical Investigator were a Party hereto, including the terms pertaining to ownership of Intellectual Property and publications, treatment of Confidential Information and that the Site, the Clinical Investigators and other personnel working on any Trial at each Site have (i) GCP and other appropriate training and experience to conduct such Trial(s), including training with respect to the Development Plan; (ii) access to an adequate number of subjects that satisfy the criteria in the Development Plan to meet subject enrollment requirements for such Trial(s); (iii) any licenses, certifications and/or accreditations required by Applicable Laws; and (iv) understand the Development Plan and their obligation to comply therewith and all Applicable Laws in conducting such Trial(s). Any such representations and warranties will be made for the benefit of OPKO and Pfizer as third party beneficiaries. (c) The Clinical Trials Agreements will also provide that the Clinical Investigators, any sub-investigators (e.g., research fellows, residents and associates) and any others required by Applicable Law at each Site complete the financial disclosure document with respect to Pfizer and OPKO, and such f...
Sample 1
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Selection of Sites and Investigators. (a) The JDC will approve the study sites to conduct each Trial *** as proposed by OPKO. (b) OPKO will enter, and each Approved CRO will enter, into an agreement with each study site; such an agreement will be substantially in the form to be agreed upon by the Parties within *** days following approval by the JDC of the Development Plan (the “Clinical Trial Agreement”) (upon execution of the Clinical Trial Agreement, such study site will be deemed a “Site”), and will provide that any Trial *** may be freely transferred or assigned to Pfizer or a designee of Pfizer without any negotiation of the CTA necessary. If a study site requires any material changes to such form Clinical Trial Agreement, OPKO will inform the JDC and seek JDC approval of such change, and the JDC will not unreasonably withhold such approval. For clarity, each Clinical Trial Agreement will specify reasonable terms, consistent with industry standards for similar agreements, and will expressly require during the period which it is effective the applicable Site and Clinical Investigator to comply with the terms hereof as if such Site and Clinical Investigator were a Party hereto, including the terms
Sample 1
Selection of Sites and Investigators. (a) The JDC will approve the study sites to conduct each Trial as proposed by OPKO. (b) OPKO will enter, and each Approved CRO will enter, into an agreement with each study site; such an agreement will be substantially in the form to be agreed upon by the Parties within *** days following approval by the JDC of the Development Plan (the “Clinical Trial Agreement”) (upon execution of the Clinical Trial Agreement, such study site will be deemed a “Site”), and will provide that any Trial may be freely transferred or assigned to Pfizer or a designee of Pfizer without any negotiation of the CTA necessary. If a study site requires any material changes to such form Clinical Trial Agreement, OPKO will inform the JDC and seek JDC approval of such change, and the JDC will not unreasonably withhold such *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission.
Sample 1
Selection of Sites and Investigators. 3.2.1.1 SFJ will select the study sites to conduct the HNC Clinical Trials and will inform the JOC in advance of SFJ’s choice of each study site; the JOC will have the right to reject any such site(s) which the JOC will determine in its reasonable judgment are not appropriate. The study sites for the HNC Clinical Trials will be located in one or more of the countries listed on Exhibit J. 3.2.1.2 SFJ will enter, and will ensure that its Affiliates enter, and each Approved CRO will enter, into an agreement with each study site; such an agreement will ACTIVE/105681617.22 be substantially in the form agreed upon by the Parties [***] following approval by the JOC of the final Protocol (the “Clinical Trial Agreement”) (upon execution of such Clinical Trial Agreement, such study site will be deemed a “Site”). If a study site requires any material changes to such form Clinical Trial Agreement, SFJ will inform the JOC and seek JOC approval of such change, and the JOC will not unreasonably withhold such approval. For clarity, each Clinical Trial Agreement will be on commercially reasonable and customary terms, consistent with industry standards for similar agreements and sufficient to enable SFJ to comply with its obligations hereunder with respect to such HNC Clinical Trial, including, but not limited to, Section 2.2.2, the terms pertaining to ownership of Intellectual Property and publications, and treatment of Confidential Information.
Sample 1

Related to Selection of Sites and Investigators

  • Institution and Investigator acknowledge and agree that its, his or her judgment with respect to its, his or her advice to and care of each Subject is not and shall not be affected by the compensation Institution and/or Investigator receive in accordance with the Study.

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