Split Territory Licensed Product definition

Split Territory Licensed Product means any FA Licensed Product, HD Licensed Product, PD Licensed Product or Future Licensed

Examples of Split Territory Licensed Product in a sentence

  • Voyager shall provide Genzyme with reasonable advance notice of all formal meetings and teleconferences with Regulatory Authorities in the Voyager Territory pertaining to any Split Territory Licensed Product, or with as much advance notice as practicable under the circumstances.

  • In addition, each Party shall promptly share with the other Party all material developments and information that it comes to possess relating to the Development of any Split Territory Licensed Products, including Safety Concerns and study reports and data generated from Clinical Studies of such Split Territory Licensed Product.

  • Voyager shall use Commercially Reasonable Efforts to (a) Develop each Split Territory Licensed Product and obtain Regulatory Approval therefor by the FDA in the United States; and (b) perform the Development activities allocated to it under each applicable Split Territory Global Development Plan, as each such Split Territory Global Development Plan may be amended in accordance with this Agreement.

  • Voyager’s sole and exclusive remedy for any breach by Genzyme of this Section 7.1.1.4 with respect to any Split Territory Licensed Product shall be [***].

  • Each Party shall calculate and maintain records of Global Development Costs incurred by it and its Affiliates with respect to a Split Territory Licensed Product and, within [***] following the end of each Calendar Quarter, each Party shall submit to the other a report detailing the Global Development Costs incurred by it and its Affiliates during such Calendar Quarter, and, if requested, shall provide reasonable supporting documentation to the other Party (an “Global Development Costs Report”).

  • Each Party, in consultation with the other Party, shall decide whether to conduct a recall of a Split Territory Licensed Product in its own Territory and the manner in which any such recall shall be conducted (except in the case of a government mandated recall, when such Party may act without such advance notice but shall notify the other Party as soon as possible).

  • Each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order to effect a recall of a Split Territory Licensed Product in the other Party’s Territory.

  • In addition, notwithstanding anything to the contrary in this Agreement, Voyager shall not conduct any Clinical Study for a Split Territory Licensed Product in a country in the Genzyme Territory without Genzyme’s prior written consent.

  • Genzyme will submit the Global Branding Strategy for a Split Territory Licensed Product to the PSC responsible for such Split Territory Licensed Product at least annually.

  • Each Split Territory Global Development Budget shall be updated annually by the PSC responsible for the applicable Split Territory Licensed Product in accordance with Section 5.2.4 (Updates and Amendments Split Territory Global Development Plans and Split Territory Global Development Budgets).

Related to Split Territory Licensed Product

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Licensed Territory means worldwide.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Licensed Field means all fields of use.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Licensed producer means a person or entity licensed to produce medical cannabis.

  • Licensed Fields of Use means the fields of use identified in Appendix B.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Licensed Programs means, collectively, NeoSystems’ and any Third Party Vendor computer software programs to be provided to Client for use on certain hardware on Client’s premises or a third party’s premises as set forth in an Agreement. The Licensed Programs shall include any fixes, work-arounds, updates, revisions, modifications, enhancements and any derivative works that are provided to Client by NeoSystems under an Agreement.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound or the active pharmaceutical contained in a Unity Bcl-2 [***] Product, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Territory means worldwide.

  • Licensed Field of Use means all fields.

  • Licensed Services means all functions performed by the Licensed System.

  • Service Territory means the geographic area within which PG&E as a Utility Distribution Company is authorized and required to provide electric transmission and distribution service.

  • New Products means any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.

  • Hemp products means all products made from industrial hemp,

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;