European Territory Sample Clauses

European Territory. Subject to the terms and conditions of this Agreement, LFB Biotech shall have exclusive rights to Commercialize Products in the European Territory. LFB Biotech shall use Commercially Reasonable Efforts to maximize profits with respect to each Product in each country of the European Territory where Regulatory Approval has been obtained, including the performance of those activities with respect to the European Territory specified in the applicable Commercialization Plan. Confidential material omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omissions.
Sample 1
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European Territory shall, at its sole cost and expense, use its best efforts to file or have its Affiliates file and correspond with the applicable Regulatory Authorities in no less than **** Critical Countries in the European Territory (and such other countries in the European Territory as **** determines is commercially reasonable) in order to obtain the required Regulatory Approvals for each Product; provided that at least **** of such Critical Countries are ****. ****, at its own cost and expense, shall use its best efforts to deliver or have its Affiliates deliver, in accordance with the Milestone Timetable, a Dossier for each Product which is sufficient and adequate to receive an MA. In addition, any additional information or documentation requested by the applicable Regulatory Authority(ies) shall be dealt with in accordance with Section 2.5.4. **** shall keep **** reasonably informed with respect to the filing and registration process. **** shall provide **** with copies of all communications from the Regulatory Authorities and a draft of all responses to the Regulatory Authorities prior to filing such responses and shall, at its cost, incorporate any changes to said responses reasonably requested by **** for the Products to the extent ****, in its full and absolute discretion, considers such inclusion reasonably necessary and practicable. The parties shall discuss such changes in accordance with the same procedure set forth in Section 2.2.1. ****, shall have the right to use and gain access to each Dossier and Marketing Authorization to file for parallel Regulatory Approvals in the name of **** or its Affiliates under the European Acts.
Sample 1
European Territory. (a) All Dossiers submitted by **** and any Marketing Authorizations granted in the European Territory therefor shall be in ****'s name and owned by ****. **** may, at its discretion and upon 20 business days written notice to ****, sell, license, or sublicense any Dossier or Marketing Authorization received in any country in the European Territory for such Product to a third party (other than to an Affiliate) for use by such third party solely within the European Territory on such terms and conditions as **** reasonably deems fair and reasonable, provided however, for all periods prior to the Product Termination Date, such terms shall include, in lieu of any payment under Section 3.5.6, the sharing with **** on a **** basis of any and all net revenues received by **** from the sale, license or other exploitation of the Dossier or Marketing Authorization, except any such payments which are intended to reimburse **** for some or all of the payments due to **** pursuant to Section 2.5 provided that, to the extent a Product is subject to such third party agreement, **** shall have no right to make the Product non-exclusive or otherwise exercise any termination rights hereunder prior to the Product Termination Date unless **** breaches its obligation to share revenues with **** as set forth above. **** shall use its best efforts to ensure that **** is the contracted supplier to the third party for products manufactured under such Marketing Authorization. **** agrees to negotiate in good faith with **** and the third party with respect to the appropriate terms relating thereto. For all periods prior to the Product Termination Date, **** shall receive from **** ****% of the net revenue received by **** or it's Affiliates from said third party in connection with the sale of Products (exclusive of the Supply Price and the **** net revenue sharing **** is to receive from **** as provided above) from such third party supply arrangement during the Term. Except as set forth in this subsection, prior to the Product Termination Date, as determined individually for each Product on an individual country basis, Alpharma's Marketing Authorization relating to the European Territory shall only be used by Alpharma and its Affiliates, in connection with Alpharma's obligations under this Agreement. After the Product Termination Date or if the Product has been made non-exclusive, Alpharma and its Affiliates shall be able to use the Marketing Authorizations and Dossier solely withi...
Sample 1
European Territory. Alpharma at its own cost and expense, shall undertake and perform the Regulatory Activities reasonably necessary or required to timely receive legally valid Regulatory Approvals under the European Acts for the Developed Products as set forth on Exhibit A in such countries within the European Territory determined by Alpharma's marketing strategy, at its sole discretion. Shasun shall have prepared, completed and delivered to Alpharma all data and information deemed necessary by Alpharma for the filing of a valid MAA for each of the Developed Products subject to this subsection in accordance with the requirements set forth on the Milestone Timetable. Shasun shall provide Alpharma a draft of the filing materials prepared in accordance with the templates agreed upon by the parties as required by the Milestone Timetable no less than sixty (60) days prior to the date required for filing to permit Alpharma to review and assess their adequacy and completeness. Alpharma shall have sole discretion to determine the adequacy and completeness of such materials and Shasun shall use commercially reasonable efforts to comply with Alpharma's determinations to change, amend or otherwise supplement the filing materials, including providing all raw data underlying any reports or data summaries at Alpharma's request. Shasun shall also cooperate with Alpharma, as needed in the preparation and finalization of the MAA, including providing any supplemental information and additional data needed by Alpharma to facilitate the acceptance and timely approval of the MAA. Alpharma shall have final control over wording, format and substance of any Regulatory Filing.
Sample 1
European Territory. Upon Cerus’ gaining Commercialization Rights for the Platelet System in the European Territory, the then-current Baxter specifications for the Platelet System applicable to the European Territory will be considered the Product Specifications applicable to such region hereunder.
Sample 1
European Territory. Upon Cerus’ gaining Commercialization Rights for the Plasma System in the European Territory, the then-current Baxter specifications for the Plasma System applicable to the European Territory will be considered the Product Specifications applicable to such country or region hereunder. For countries in the European Territory, Baxter shall, at its own expense, complete “First of Code” manufacture of the Plasma System under this Agreement (if such activity shall not have been previously completed by Baxter, at its expense, during the period of Xxxxxx’x Commercialization Rights in such country).
Sample 1
European Territory. Section 1.12.1 of the Agreement shall be amended and restated in its entirety to read as follows:
Sample 1
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Related to European Territory

  • Licensed Territory Worldwide NIH Patent License Agreement—Exclusive APPENDIX C – ROYALTIES Royalties:

  • Territory The territorial limits of this Agreement shall be identical with those of the Reinsured Contracts.

  • 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.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • 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.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • 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.

  • Regulatory Approval Any waiting period applicable to the Transactions under the HSR Act shall have been terminated or shall have expired.

  • Regulatory Applications (a) Sky and Metropolitan and their respective Subsidiaries shall cooperate and use their respective reasonable best efforts to prepare, within 45 days of the execution of this Agreement, all documentation and requests for regulatory approval, to timely effect all filings and to obtain all permits, consents, approvals and authorizations of all third parties and Governmental Authorities and Regulatory Authorities necessary to consummate the transactions contemplated by this Agreement. Each of Sky and Metropolitan shall have the right to review in advance, and to the extent practicable each will consult with the other, in each case subject to applicable laws relating to the exchange of information, with respect to, and shall be provided in advance so as to reasonably exercise its right to review in advance, all material written information submitted to any third party or any Governmental Authority or Regulatory Authority in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto agrees to act reasonably and as promptly as practicable. Each party hereto agrees that it will consult with the other party hereto with respect to the obtaining of all material permits, consents, approvals and authorizations of all third parties and Governmental Authorities or Regulatory Authorities necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the other party apprised of the status of material matters relating to completion of the transactions contemplated hereby.

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