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. 3.5 Global harmonization; Redundant activities. Recognizing that products can be developed on a global basis and that regulatory and budgetary efficiency gains can be achieved through the global use of appropriate data and files, the parties may strive to organize each other`s product activity, but are not required to organize the application of the products in such a way as to maximize the overall harmonization of clinical and regulatory rules, i.e. (a) as part of an amendment to this agreement or (b) as part of a separate agreement. Without limitation of the above, with the exception of SuperGen`s obligation to provide a copy of data, applications, records, protocols and other information on EuroGen equipment received or submitted as part of SuperGen`s Fda approval applications, it is agreed that EuroGen will be responsible for all development costs of all clinical activities required in the countries within the territory described in the regulatory and marketing plan. 11.1 EuroGen compensation. EuroGen is committed to compensating SuperGen and its executives, collaborators and agents (a „SuperGen compensation“ each) against any liability, claim, injury, expenses or costs (including reasonable legal fees) arising from third party claims, to the extent that these claims are due to non-compliance with their obligations under this agreement or to EuroGen`s misbehaviour or negligence in the storage, storage, handling, transport, advertising and marketing of products. 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. Under the provisions of this section 2, SuperGen may, directly or indirectly, promote, market, market and sell products other than those covered by this agreement for all uses. „API,“ the pharmaceutical active ingredient for the product.
1.10 „RFN procedure“ refers to the procedure described in the agreement with the RFN party, in which SuperGen must offer the RFN party the right to an initial discussion before the sale or granting of rights related to a link owned by SuperGen or developed by SuperGen.
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