Pharma Distribution Agreements

December 14, 2020

6.5 The distributor has a complete and fully operational quality management system for pharmaceutical products (“QMS”) and a sufficient number of technical agents that coincide with the number of technicians prescribed by law, including qualified and authorized sales personnel for the sale and distribution of drugs. 7.4 The language of the exchange of pharmacovigilance data between the contracting parties is English. If submissions to public authorities are required in the language of the territory, the YY is responsible for the exact translation. (b) commercial, quantitative and bar rebates, which are common in the territory`s generic drug industry and are effectively licensed or ongoing for the product; Pharmaceutical manufacturers not only sell products themselves, they also use external partners to bring their products to market and patients. In order to normalize these relationships, a manufacturer and its distribution partners should establish standard contractual structures. 5.1 As MAH, XX maintains and coordinates the global pharmacovigilance system and provides all the necessary information to YY. 7.3 CASI makes available to the distributor all documents and invoices necessary during the sale and distribution of the product. CASI provides a delivery voucher containing information about product code, quantity, lot number, production date and expiry date. 5.4 Track and track. With respect to the product, each contracting party complies with the national pharmaceutical traceability system in the supply chain, as defined in the Drug Quality and Safety Act (H.R.

3204), which can be supplemented, modified or amended. refers to all requirements relating to pharmacovigilance in the territory, including, but not limited, legislation, other legislation, announcements of authorities and other directives. The “difference” used in this appendix is the difference between a) IPC prices and (b) the calculation of IPC prices that must be determined to ensure the agreed distribution margin between CASI and CRGK. 1.15 “tier 1 product”: any compound or pharmaceutical drug listed below or containing the following compounds mentioned as an active substance: []. C. The distributor maintains a well-established, capable and competitive distribution network to market and sell the product within the territory. refers to all regulatory requirements that apply in particular to products in the territory, but are not limited to marketing authorization positions/free listings, variations, extensions, maintenance of market authorizations/free list positions/other rights to be marketed, storage, delivery, distribution and sale of products, including laws, other legal provisions, public authorities` announcements and other directives.