Product License Approvals definition

Product License Approvals means those regulatory approvals required for the importation, promotion, marketing and sale of the Agreement Product and any Improved Agreement Product(s) in the Territory (including any reimbursement or pricing approvals).
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Product License Approvals means with respect to each country in the Territory, those regulatory approvals required for the promotion, marketing and sale of the Agreement Product in such country; provided, however, that, except as specifically provided to the contrary herein, Product License Approval shall not include any approvals with regard to pricing.
Sample 1

Examples of Product License Approvals in a sentence

  • All such labelling, packaging and promotional material shall be consistent with the relevant Product License Approvals and all labelling and packaging materials shall be reviewed by Biomatrix and shall be subject to its written approval prior to use, such approval not to be unreasonably withheld.

  • The Distributor shall use its best efforts to obtain and maintain at its cost any Product License Approvals and to conduct at its cost any clinical trials required for the marketing and sale of the Agreement Product and any Improved Agreement Product(s) in each country in the Territory, except for the European Territory, throughout the term of this Agreement.

  • Biomatrix agrees that the regulatory authorities of the countries where the Agreement Product is marketed by Syntex or its designated Affiliates, or where applications have been made for Product License Approvals (hereinafter the "Regulatory Authorities") shall be able to inspect, during regular business hours, the facilities, documentation systems, operations and equipment as set forth in Section 9.3 above, as the same relate to the Agreement Product that is to be shipped to such countries.

  • Subject to Biomatrix's approval rights as set forth in Section 15.2(g), Syntex shall use its best efforts (as defined below) to obtain and maintain at its expense all regulatory approvals required for the marketing and sale by Syntex of the Agreement Product in each country in the Territory, including all Product License Approvals and pricing and reimbursement approvals where applicable.

  • Tenant’s indemnity of Landlord as set forth, qualified and conditioned in this Lease shall also apply with respect to any and all costs, losses, damages, injuries and liabilities to the extent related in any way to any act or omission of Tenant or Tenant’s Agents, or anyone directly or indirectly employed by any of them, or in connection with Tenant’s non-payment of any amount arising out of the Tenant Improvements and/or Tenant’s disapproval of all or any portion of any request for payment.

  • All such labelling, packaging and promotional material shall be consistent with the relevant Product License Approvals and shall also be reviewed by Biomatrix prior to its use and the substance thereof shall be reasonably acceptable to it, Biomatrix's acceptance of or objection to such material to be communicated to Syntex within * of Biomatrix's receipt thereof; provided that no such communication by Biomatrix within such * period shall be deemed to be Biomatrix's acceptance of such material.

Related to Product License Approvals

  • Product Approval(s) means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

  • Development Approvals means all permits and other entitlements for use subject to approval or issuance by CITY in connection with development of the Property including, but not limited to:

  • Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Sub-License means the sub-licensing of any space in the Station Development Assets and Project Utilities in the Station Development Project, by the Station Facility Manager to any licensee, in accordance with the Station Facility Management Agreement;

  • Intellectual Property License Agreement means the license agreement with respect to certain Excluded Intellectual Property, substantially in the form of Exhibit B attached hereto.

  • Third Party Licenses has the meaning set forth in Section 3.

  • Patent Licenses means all licenses, contracts or other agreements, whether written or oral, naming any Grantor as licensee or licensor and providing for the grant of any right to manufacture, use or sell any invention covered by any Patent (including, without limitation, all Patent Licenses set forth in Schedule II hereto).

  • Intellectual Property Licenses means all licenses, sublicenses and other agreements by or through which other Persons, including Seller’s Affiliates, grant Seller exclusive or non-exclusive rights or interests in or to any Intellectual Property that is used in or necessary for the conduct of the Business as currently conducted.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Company Licensed Intellectual Property means all Intellectual Property that is licensed to the Company by any third party.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Company License Agreements means any license agreements granting any right to use or practice any rights under any Intellectual Property (except for such agreements for off-the-shelf products that are generally available for less than $25,000), and any written settlements relating to any Intellectual Property, to which the Company is a party or otherwise bound; and the term “Software” means any and all computer programs, including any and all software implementations of algorithms, models and methodologies, whether in source code or object code.

  • Intellectual Property License means any license, sublicense, right, covenant, non-assertion, permission, immunity, consent, release or waiver under or with respect to any Intellectual Property Rights or Technology.

  • Licenses means all licenses, permits, certificates of authority, authorizations, approvals, registrations, franchises, and similar consents granted or issued by any Person and are associated with or necessary to operate the Company and/or used in connection with the Business.

  • Patent License means any written agreement granting any right with respect to any invention on which a Patent is in existence or a Patent application is pending, in which agreement Borrower now holds or hereafter acquires any interest.

  • Patent License Agreement means the Patent License Agreement substantially in the form of Exhibit C.

  • Government Approvals means all permits, licenses, authorisations, consents, clearances, decrees, waivers, privileges, approvals from and filing with government instrumentalities necessary for the development, construction and operation of the Work.

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • CREFC® Intellectual Property Royalty License Fee With respect to each Mortgage Loan (including any REO Mortgage Loan) and for any Distribution Date, the amount accrued during the related Interest Accrual Period at the CREFC® Intellectual Property Royalty License Fee Rate on, in the case of the initial Distribution Date, the Cut-Off Date Balance of such Mortgage Loan and, in the case of any subsequent Distribution Date, the Stated Principal Balance of such Mortgage Loan as of the close of business on the Distribution Date in the related Interest Accrual Period; provided that such amounts shall be computed for the same period and on the same interest accrual basis respecting which any related interest payment due or deemed due on the related Mortgage Loan is computed and shall be prorated for partial periods. For the avoidance of doubt, the CREFC® Intellectual Property Royalty License Fee shall be payable from the Lower-Tier REMIC.

  • Regulatory Authorizations means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies, including all Product Authorizations.

  • Licensed Intellectual Property Rights means any Intellectual Property Rights owned by a third party that a Person has a right to use, exploit or practice by virtue of a license grant, immunity from Legal Action or otherwise.

  • Project Approvals means all approvals, consents, waivers, orders, agreements, authorizations, permits and licenses required under Applicable Laws or under the terms of any restriction, covenant, easement or agreement affecting all or any applicable Phase of the Project, or otherwise necessary or desirable for the ownership, acquisition, construction, development, equipping, use or operation of the Project.

  • Sub-Licensee means all person/ agency with whom Licensee has executed sub license agreement as per terms and conditions of license agreement executed between DMRC and the Licensee, for commercial utilization of the Bare Spaces.

  • Third Party License means licenses from third parties governing third party software embedded or used in the Trading Platform.