Common use of Study Conduct Clause in Contracts

Study Conduct. (a) Institution agrees to conduct any Study in strict compliance with: (i) the Study Protocol, as approved by Introgen, Investigator, Institution and its responsible Institutional Review Board (along with any subsequently approved (by all parties) written amendments to the Study Protocol); (ii) all applicable local, state and federal laws, rules and regulations; (iii) all applicable medical privacy laws or regulations; and (iv) the terms of this Master Agreement and the applicable Study Specific Agreement. (b) Institution and Investigator will use any Materials only to conduct the Study in accordance with the Protocol; will not chemically, physically or otherwise modify Materials, unless specifically required to do so by the Protocol; and will handle, store, and ship or dispose of Materials in compliance with all applicable local, state and federal laws, rules and regulations including, but not limited to, those governing hazardous substances. Institution and Investigator will not charge any Study subject or third-party payor for any Materials, or for Study procedures for which payment by Introgen has or will be made under the applicable Study Specific Agreement. (c) In accordance with mutually agreed time periods, Institution will resolve all written data queries from Introgen and will deliver to Introgen any Study-related deliverables identified in writing by Introgen and agreed to by Investigator/Institution. (d) Institution represents and certifies that no individual or entity will provide services on behalf of Institution in connection with a Study if that individual or entity has been debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. § 335a(a) and (b) (or regulations promulgated thereunder); disqualified as a testing facility under the provisions of 21 C.F.R. Part 58, Subpart K; or disqualified as a clinical investigator under the provisions of 21 C.F.R. § 312.70. Institution will notify Introgen of any action with respect to debarment or disqualification against Institution or any individual or entity providing services on behalf of Institution in connection with a Study. (e) Institution represents and certifies that it practices good animal care and use practices and is accredited by the American Association for Accreditation of Laboratory Animal Care (AAALAC). Any animals that receive any of the Materials in the course of investigations or products derived from such animals will not be used for food purposes at any time. The Materials will be used only for testing in vitro or in laboratory research animals, and not for human clinical testing. (f) Subject to compliance with confidentiality obligations under Section 7, and Introgen’s patent and other intellectual-property rights, including Introgen’s rights in Inventions under Section 9, nothing in this Master Agreement will limit or prohibit Institution or any Study Staff, or any Investigator, from conducting any research or for performing research for or with any entity or person, including any other outside sponsors. Introgen acknowledges that this provision is intended to preserve the academic freedom and integrity of Institution and its faculty.