2025年度生物制药研发合同履行与临床试验监管协议

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2025年度生物制药研发合同履行与临床试验监管协议本合同共三部分组成，仅供学习使用，第一部分如下：第一条合同目的本合同旨在明确双方在2025年度生物制药研发过程中的合作内容、权利义务、履行期限及监管事项，确保生物制药研发项目的顺利进行。第二条合作内容第三条权利义务1.研发方权利义务（1）研发方负责提供2025年度生物制药研发项目的详细资料，包括但不限于研发目标、研究方案、实验设计等。（2）研发方应保证提供的数据真实、准确、完整，不得伪造、篡改、隐瞒。（3）研发方应按照监管方的监管要求，及时提供临床试验相关资料，配合监管方的监督检查。2.监管方权利义务（1）监管方负责对研发方的生物制药研发项目进行临床试验监管，确保临床试验符合相关法规、标准和伦理要求。（2）监管方有权对研发方的研发过程、实验结果、临床试验数据等进行监督检查。（3）监管方应保证监督检查的公正、公平、公开，不得滥用职权。第四条履行期限本合同履行期限为2025年度，自双方签字之日起至2025年12月31日止。第五条违约责任1.如研发方未按时提供研发资料或提供虚假资料，监管方有权暂停或终止本合同，并要求研发方承担相应的违约责任。2.如监管方未按合同约定进行监督检查，研发方有权要求监管方进行整改，如监管方未在合理期限内整改，研发方有权解除本合同。3.双方如因不可抗力因素导致合同无法履行，应立即通知对方，并采取一切必要措施减轻损失。第六条争议解决1.双方在履行本合同过程中发生争议，应友好协商解决。2.如协商不成，任何一方均有权向合同履行地人民法院提起诉讼。第七条合同生效与解除1.本合同自双方签字盖章之日起生效。2.双方协商一致，可解除本合同。第八条合同未尽事宜本合同未尽事宜，双方可另行协商解决。附件：1.研发方资料2.研发项目研究方案3.临床试验监管要求甲方（研发方）：___________________乙方（监管方）：___________________代表人（签字）：___________________日期：______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________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