(a) If CRO is required to enter into contracts with investigators or investigative sites (all “investigators”), CRO will use its form for the local clinical trial, subject to verification, modification and approval of the proponent (“local CTAs”) designed to be used in certain countries on the basis of local requirements. In countries where this is necessary, local STC is prepared in language or English, as long as this is permissible and appropriate, unless a form compliant with industry standards is required in the country concerned or a location-specific form is required for a selected site. CRO makes available to the promoter all applicable local CSAs, the usual industry forms, location-specific forms for review and approval by the sponsor prior to their use, and CRO will immediately forward copies of all executed documents to the promoter. If an examiner insists on substantial changes to the provisions that directly affect the proponent (confidentiality, intellectual property, liability, compensation, publication, protocol compliance and inspections), CRO will submit the proposed amendment to the proponent and the proponent will review, comment on and/or approve these proposed changes within 10 (10) working days. If the above forms or amendments approved by the proponent deviate from the terms of this Agreement (including, but are not limited to provisions allowing an examiner to publish results or data prohibiting the CRO), CRO disclaims any liability for these provisions or amendments. 6. Payment. For the service, the SPONSOR CRO pays a maximum amount of $amount (“maximum amount”). Any amount above the maximum amount is subject to prior written authorization from the promoter. Payments are made in Appendix B in accordance with the financial plan attached to this schedule and are incorporated as a reference. [If the currency is different from the USD, it will be based on the average monthly rate of the currency, as published on www.oanda.com.] All invoices are sent electronically to – and all invoices must include the following information: 16. Pharmacovigilance.
CRO undertakes not to conduct clinical activities involving pharmacovigilance obligations for the product prior to the implementation of a pharmacovigilance agreement submitted by the sponsor. (h) cro is not a party to an agreement that would prevent it from meeting its obligations under this agreement or imposing conflicting obligations on CRO, and CRO agrees that it will not, for the duration of this agreement, enter into a service provision agreement that would in some way prevent it from providing the services provided by this agreement or imposing conflicting obligations on CRO; 28. Compliance with applicable law. CRO will comply with all applicable laws in the performance of its obligations or the exercise of its rights under this Agreement. This agreement does not require CRO or Sponsor to take or refrain from taking or refraining from taking action contrary to existing legislation, including applicable national and international codes of conduct for the pharmaceutical industry. Regardless of the above and notwithstanding other provisions of this Agreement, neither CRO nor Sponsor are required to incur any costs associated with an activity under this Agreement that they may reasonably in breach in good faith the laws in force (including any applicable national and international pharmaceutical code of practice) or “Corporate Integrity” or similar agreement with a government authority of which it is a member.