Generic Versions of Drug Product Sample Clauses

Generic Versions of Drug Product. (a) BLP shall have the right, if available within the subject jurisdiction within the New Territories, to manufacture, use, sell, promote and distribute a generic equivalent to any such Drug Product (each a "GENERIC") in each jurisdiction within the New Territories in * Confidential information is omitted and filed separately with the SEC. which any third person (exclusive of any BLP affiliate) files, or otherwise makes known a good faith intention to file, for regulatory approval of a Generic within the subject jurisdiction. Prior to exercising the right set forth in the preceding sentence, BLP shall inform Pharmos in writing of all relevant facts known to BLP regarding the specific circumstances in the subject jurisdiction, including the identity of the third person and anticipated filing and approval dates, and shall consult with Pharmos prior to taking any action permitted in this Section 2.10(a). BLP agrees that if a third party files or otherwise makes known an intention to file for regulatory approval of a Generic within the subject jurisdiction, but does not receive marketing approval for such Generic or does not otherwise attempt to promote and sell a Generic, the rights accorded to BLP under this Section 2.10(a) shall terminate with respect to the subject jurisdiction unless and until a third party shall once again file, or otherwise makes known an intention to file, for regulatory approval of a Generic in such jurisdiction, provided, however, that in such event, BLP shall have the right to -------- sell off, and to have sold off, all existing inventories of Generics at prices and on terms which are no more favorable to the customer than the best price and terms offered by BLP for such Generic prior to the termination of rights of BLP described above. All Generics shall be deemed to be "Drug Product" for all purposes of this Agreement and any other agreement between Pharmos and BLP which may then be in full force and effect.
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Generic Versions of Drug Product. (a) Notwithstanding anything in this Agreement to the contrary, if the Patent Rights are held to be invalid or unenforceable in a final decision (which has not been appealed) by a court of competent jurisdiction as a result of any action or proceeding brought by a third party (an "Invalidity Event"), or upon the last to expire of the Patent Rights with respect to a particular Drug Product (an "Expiration Event"), BLP shall have the right in each instance to manufacture, use, sell, promote and distribute a generic equivalent to any such Drug Product (each a "Generic"). If BLP submits an Abbreviated New Drug Application for a Generic with respect to any Drug Product (an "ANDA"), it shall notify Pharmos in writing at least ninety (90) days prior to the anticipated date of submission. If at the time of the actual submission of such ANDA Pharmos has not granted to BLP any specific rights in or to the NDA describing the Drug Product which is the branded form of the Generic, or to any Patent Rights that may remain in effect at the time of such submission, then at the option of Pharmos exercised in its discretion, Pharmos may by written notice to BLP delivered within sixty (60) days of such submission either (i) in the case of an Invalidity Event or Expiration Event, cause the marketing rights granted to BLP under Section 2.3 above to become and thereafter remain non-exclusive, or (ii) in the case of an Invalidity Event, terminate BLP's rights under this Agreement with respect to the Drug Product which is the equivalent to the Generic, such exercise to be effective in the case of this subpart (ii) no earlier than the date of approval of the Generic.

Related to Generic Versions of Drug Product

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Manufacture of Product Prior to commercialization of the Product, the Parties may, if appropriate for both parties, negotiate in good faith a manufacturing and supply agreement to provide for Licensor to fulfill the manufacturing requirements of Licensee for Product for sale in the European market. The cost of such manufacturing shall not be greater than * percent (*%) of the cost of any competitor cGMP contract manufacturing facility that proposes to manufacturer the Product for Licensee. * Confidential information has been omitted and filed confidentially with the Securities and Exchange Commission.

  • Combination Products If a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.

  • Manufacture of Products All Products marketed through Grantor's Web ------------------------- Site shall be manufactured, packaged, prepared, and shipped in accordance with the specifications and requirements described on Exhibit A hereto as it may be modified from time to time. Quality control standards relating to the Product's weight, color, consistency, micro-biological content, labeling and packaging are also set forth on Exhibit A. In the event that Exhibit A is incomplete, Products shall be manufactured and shipped in accordance with industry standards.

  • Product The term “

  • Marking of Licensed Products To the extent commercially feasible and consistent with prevailing business practices, Company shall xxxx, and shall cause its Affiliates and Sublicensees to xxxx, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed Product.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Combination Product The term “

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

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