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. 13.1 Full agreement; changes. This agreement, the exhibits, the annexes and any amendments to this agreement constitute the full understanding and replace all previous written and oral agreements between and between the parties with respect to the purpose of this agreement. Neither party is liable or bound to the other party in any way by assurances, guarantees or alliances with respect to that purpose, unless expressly stated. No clause in this agreement may be amended unless otherwise stated in this agreement. 1.1 CASI and the distributor are parties to the exclusive distribution contract for the distribution of the product which will come into effect on February 15, 2019 (since this agreement may be amended from time to time, the “exclusive distribution agreement”), executed on a date just with this pharmacovigilance agreement (this “APV”). 14.9 Full agreement. This agreement and the exhibits constitute the whole agreement between the parties with respect to the purpose of this agreement and carry out all previous negotiations, agreements and agreements, orally or in writing, relating to the issues covered by this agreement. 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. CONSIDERING that SuperGen is active in the development, manufacture, distribution and sale of pharmaceuticals; current standards for good manufacturing practices and general biologics, in accordance with the U.S.
Federal Drug and Cosmetics Act of 21 CFR (Chapters 210, 211, 600 and 610) and the ERC Guide to Good Drug Manufacturing Practices, in accordance with the 2003/94/EC European Directive (replaced by 91/356/EEC) and current good manufacturing practices and current general standards for organic products, as set out in China`s Decree No. 79 on Good Manufacturing Practices of the Ministry of Health and all relevant laws and regulations adopted by the National Medical Products Administration of China (NMPA) , of the former Chinese Food and Drug Service), including any changes to these provisions, as these provisions refer to directives on biopharmaceuticals, pharmaceutical drugs and active substances. 4.3 When existing regulatory requirements change and there is disagreement over the interpretation of one aspect of the VPA and/or one of the contracting parties requests a review of these VPAs due to problems or conflicts related to legal or regulatory requirements, the contracting parties agree to review and, if necessary, amend and/or revise the terms of these VPAs.