Clinical Research Organization Agreement

8.1 Study behaviour. CRO performs the services of each PPI in accordance with the applicable provisions of each study protocol, approved SOPs, current guidelines on good clinical practice for trials (“GCP guidelines”) and all local, state and federal laws and regulations applicable to the conduct of clinical trials by, including, but not limited to, the Federal Food Act , drugs and cosmetics and regulations of the Food and Drug Administration (“FDA”) and the Health Insurance Portability and Accountability Act of 1996 (HIPA) of the Department of Human Health and Health (“HHS”). There are different types of CROs, depending on the specific services they offer. In general, CROs are segmented into Discovery, preclinical, clinical and laboratory services. A CRO is an outsourcing company that hires a sponsorship company as an independent contractor to lead clinical studies and other research assistance services on its behalf. CROs typically enter into contracts with companies in the pharmaceutical, biotechnology or medical device industries, but their clients also include public institutions, foundations and universities. These organizations enter into contracts with CROs to acquire the specific expertise needed to safely and effectively implement trials without the recruitment of permanent staff. 1.1 The scope of the agreement. As a “master,” this agreement allows contracting parties to enter into contracting in relation to studies, through the execution and implementation of agreements in a manner comparable to the individual project agreement (as attached to Section 1.2 below) to enter into contracts without having to renegotiate the fundamental conditions set out in them. This agreement includes the provision of services by CRO and the associated CRO and CRO companies to the sponsor and sponsor associated companies (see item 1.4) and, therefore, this agreement allows the promoter and its associated companies to effectively enter into contracts with CRO and its related companies on a global basis covering a wide range of services. 5. Financial disclosure.

CRO will require that clinical researchers, all sub-explorers. all laboratories used to test samples and other samples prescribed by applicable legislation at each site, complete the financial bulletin relating to the CRO and the sponsor; financial information in the form to be provided by the promoter (the “financial opening form”). For clear reasons, if one of the previous individuals is not required to complete this form of financial disclosure, they cannot participate, or do any work related to the project.