12. Insurance. CRO maintains, at its own expense and expense, the following insurance coverages: (a) general liability insurance, with limits of at least $5,000,000 per event and $10,000,000 per year, which must include personal injury, bodily injury and general property damage; (b) auto/liability insurance with limits of at least $300,000 per event, which must include bodily injury, bodily injury and property damage; and (c) workers` compensation insurance, which is in accordance with existing national compensation legislation. In addition, if the services provided by CRO under this Agreement include professional services, CRO has, at its own expense and expense, professional liability or error and omission insurance, with limits of at least $5,000,000 by right and $5,000,000 per year; (ii) When cro receives, manages or stores study medicines or study equipment at its sites, CRO has non-life insurance with limits of at least $500,000 per event. CRO will list the sponsor as an “additional insured” in its general liability insurance and will make available to the sponsor, upon request, insurance certificates and other documents to prove these policies. All certificates referred to in this section contain a provision that the Sponsor must be announced in advance thirty (30) days in advance prior to termination of coverage by CRO or the relevant insurer. (g) exclusion. Each clinical reviewer and site shall not confirm that neither they, nor their collaborators assigned to the project, nor their affiliated companies or contractors are excluded pursuant to subsections 306 (a) or b) of the U.S. Federal Food Drug And Cosmetic Act (US Generic Drug Enforcement Act of 1992; 21 USC 335a (a) or b)) and that each of them is the service of a person, under this Act for the implementation of the process. The clinical auditor and website must also confirm that neither they nor their affiliates in the United States are excluded from any federal health program, including, but not limited to, Medicare and Medicaid. The clinical investigator and the site will immediately inform the sponsor if any of these certifications need to be amended on the basis of new information. 3. Clinical Site Agreements.
CRO will enter into an agreement with each study site, essentially in the form to be agreed upon by the sponsor, which in the circumstances can be agreed upon as soon as possible (this is a “clinical location agreement” after the execution of which such a proposed site is considered a “site”). If a proposed site requires substantial changes to a form of clinical location agreement approved by the Sponsor, CRO will notify the Sponsor. These proposed amendments will only be accepted once they have been approved by the proponent as it sees fit. For clarification, any agreement on clinical location expressly requires, during the period during which it is effective, that the site and the clinical examiner comply in particular with: 13.5 Cases of force majeure. . . .