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.
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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

  • 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:

  • Regulatory Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

  • 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;

  • Third Party Licenses means licenses from third parties governing third party software embedded or used in the trading platform.

  • Intellectual Property Licenses means (i) any grant by the Company to another Person of any right, permission, consent or non-assertion relating to or under any of the Purchased Intellectual Property and (ii) any grant by another Person to the Company of any right, permission, consent or non-assertion relating to or under any third Person’s Intellectual Property.

  • 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 set out in Schedule C hereto;

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

  • 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 any approvals, authorizations, consents, licenses, registrations, permits or certificates of a Governmental Authority.

  • Patent License means all agreements, whether written or oral, providing for the grant by the Company of any right to manufacture, use or sell any invention covered by a Patent, including, without limitation, any thereof referred to in Schedule B hereto.

  • 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, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

  • 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.

  • Licensed Intellectual Property Rights means all Intellectual Property Rights owned by a third party and licensed or sublicensed to either the Company or any of its Subsidiaries.

  • 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.