Standard Distribution Agreements For Pharmaceutical Products

5.6.2 Recordings. In the event of a recall or action produced, each party shall prepare a complete and accurate statement of all expenses imposed on it in connection with the recall or action produced, a copy of which shall be provided to the other party upon request as soon as the recall or action of the product is completed, as is possible. DRL and Mikah each have the right to serve, at their discretion and expense, a third party to support its obligations related to a recall or product action. All costs and expenses related to such a recall or product transaction (including cost of goods sold, selling fees and third party recall fees) are the “recall fees”. 2.3 Exclusive co-nomination of Decitabine. SuperGen appoints and grants EuroGen the co-exclusive right to promote, market, market and sell decitabine in the Territory, and EuroGen accepts such a nomination. EuroGen`s sole power is to obtain administrative authorisations for decitabine in the territory and to promote, market, market and sell decitabine exclusively in the territory. Notwithstanding the rights granted to EuroGen with respect to decitabine, if SuperGen wishes to sell and transfer rights to Decitabine to a third party and SuperGen wishes to freely transfer such rights by EuroGen, SuperGen may, at its discretion, terminate this Agreement, which shall take effect on the day of superGen`s transfer of such rights. If SuperGen is able to withdraw decitabine from this agreement, SuperGen euroGen shall reimburse all reasonable direct costs incurred by EuroGen in connection with the development of decitabine and measures to establish a marketing and distribution channel in the region. Within thirty (30) days of such an event, EuroGen shall provide SuperGen with a statement of such expenses and transfer to SuperGen all authorizations and/or other rights of the decitabine. `cGMP` means the current standards for good manufacturing practices and generic biologics, as adopted in accordance with the United States Federal Food Drug and Cosmetic Act at 21 CFR (Chapters 210, 211, 600 and 610) and the Guide to Good Manufacturing Practice for Medicinal Products adopted in accordance with European Directive 2003/94/EC (91/356/EEC); as well as current good manufacturing practices and general standards for organic products, as published in Chinese Decree No. .


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