Common use of Study Conduct Clause in Contracts

Study Conduct. 3.1 Antigen Express’s willingness to provide the Study funding and supply the Antigen Express Study Drug pursuant to this Agreement is predicated upon (a) its review of, and the mutual agreement of the Parties with respect to, the Protocol; (b) Subject enrollment and Study progress in accordance with Appendix B, and (c) the terms and conditions of this Agreement. 3.2 The Study will be performed in accordance with the terms and conditions contained herein, the terms and conditions of the Protocol, and all applicable laws, rules, regulations, and guidelines including but not limited to those regulations promulgated by the FDA including ▇▇ ▇▇▇ ▇▇▇, as applicable, federal and state privacy and patient confidentiality laws, and ICH Good Clinical Practices (collectively, “Applicable Law”). 3.3 Antigen Express acknowledges that NSABP does not consider itself a HIPAA-covered entity; however, NSABP shall collect, use, store, access, and disclose personal health information (as that term is defined in HIPAA) (“PHI”) collected from Subjects only as permitted by the IRB approved Informed Consent Form or HIPAA authorization form obtained from a Subject. Antigen Express agrees that, to the extent Antigen Express and any Antigen Express designee has access to PHI, Antigen Express and such Antigen Express designee shall collect, use, store, access, and disclose PHI collected from Subjects only as permitted by the IRB approved Informed Consent Form or HIPAA authorization form obtained from a Subject. Any IRB approved Informed Consent Form or any HIPAA authorization form shall expressly permit Antigen Express to share Data with Merck. In order for Antigen Express to share or provide any Data that includes PHI with Merck, Antigen Express shall first obligate Merck to store, use, process, and handle any such Data with PHI only as permitted by the IRB approved Informed Consent Form or HIPAA authorization form. 3.4 NSABP or Antigen Express may at any time suggest amendments to the Protocol as may appear desirable; such amendments shall be discussed between Antigen Express and NSABP and (except as set forth below) such amendments may be made binding only upon mutual, signed written amendment to the Protocol. If such amendments are requested by Antigen Express and have been agreed to by NSABP, and such amendments increase or decrease the costs of the Study, NSABP will submit to Antigen Express a written estimate of the difference in costs arising from the amendments requested by Antigen Express and Antigen Express, at its discretion, shall decide whether NSABP shall implement such amendments. If such amendments are requested by NSABP, NSABP will submit to Antigen Express a written estimate of the difference in costs arising from the amendments requested by NSABP and Antigen Express, at its sole discretion, shall decide whether it will pay any increased costs. Notwithstanding anything to the contrary, if NSABP reasonably believes that generally accepted standards of clinical research and/or medical practice, or other appropriate concerns, justify an amendment to the Protocol such amendment shall become effective thirty (30) days after Antigen Express’s receipt of notice thereof from NSABP. Amendments to the Protocol shall result in a description of the impact the amendment will have on the schedule of financial support, if any. NSABP shall require that the Protocol and Informed Consent Form, and amendments thereto, be submitted to the appropriate EC/IRBs. NSABP will make all required submissions to the IND in connection with any amendment to the Protocol made pursuant to this Section 3.4. 3.5 Antigen Express shall sponsor an IND application with the FDA and will cross-reference appropriate INDs held by Merck and Antigen Express. The Parties acknowledge and agree that this is a combo-IND as the Antigen Express Study Drug is an immunotherapeutic vaccine, which falls under the Center for Biologics Evaluation and Research ("CBER"), while the Merck Study Drug is a drug that falls under the Center for Drug Evaluation and Research ("CDER"). NSABP shall perform the regulatory required filings on behalf of Antigen Express. NSABP shall copy Antigen Express on all regulatory filings and communications in respect of the IND. Antigen Express shall provide to, and shall require Merck to provide to, NSABP all necessary documentation and information required in support of such IND filings and reporting. Antigen Express shall approve any IND filings and reporting prior to NSABP submitting such documents, with the exception of SAEs due to the required timing of filings. NSABP will provide Antigen Express any SAEs filings promptly after submission to the FDA. NSABP shall provide Antigen Express with a copy of the IND application and the letter issued by the FDA, which references the IND application number, and other communications regarding the IND. Without limitation, Article XI shall apply to any Confidential Information Antigen Express supplies directly to NSABP in support of the IND.