CRO`s services are not necessarily limited to clinical trial management, regulatory advice, database management, and statistical analysis of clinical research and pharmaceutical and diagnostic development. 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. If the compensated party seeks compensation under this section 10 with respect to a right, the obligations of the compensated party are subordinated to the compensated party: (a) written notification to the compensated party of a possible compensation within thirty (30) days of the knowledge of the party withdrawing that right (except for the fact that the non-claim of such notification exempts the party compensated from its obligations only to the extent, that the sending party by such an immediate delay; (b) entrust the compensation party with exclusive control over its defence and any related transaction negotiations; and (c) cooperate and, at the request and at the expense of the compensating party, assist in that defence. Notwithstanding the above, the compensated party may participate, at its own expense, in defence and conciliation talks and has the right to approve any transaction contract involving the admission of fault on the part of the impoverished party or imposing non-monetary obligations on the compensated party; however, unless such an authorization is improperly upheld. b) In addition, some countries require the local representative to compensate the sites for the damage caused by the study drug or, on the other hand, to bear primary responsibility for the damage caused by the study drug. These countries are currently Singapore, Australia, Indonesia, Korea, Taiwan, China, India, New Zealand and Mexico (if IMSS sites are used). When the sponsor requests that CRO act as a local representative in these countries, the contracting parties are obliged to negotiate and reach an agreement on a local representative, either under the relevant PPI or as an autonomous agreement.
In addition, if the sponsor is not based in the European Union (“EU”) and services are provided in the EU, the sponsor may require CRO to be its legal representative in the EU and, if believe agrees, the contracting parties will negotiate and conclude a separate agreement setting out the terms of such representation. 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: CRO recognizes the persistent desire to provide services to the sponsor. and g) Debarment. Each clinical reviewer and website must certify that neither they, their employees close to the staff, nor their related companies or contractors are excluded from the 306 (a) or b) subsections of the United States.