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 on behalf of LFB/GTC LLC. 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.
Sample 1
AutoNDA by SimpleDocs
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 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. Section 1.12.1 of the Agreement shall be amended and restated in its entirety to read as follows:
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
AutoNDA by SimpleDocs

Related to European Territory

  • Territory 33.1 This Agreement applies to the territory in which CenturyLink operates as an ILEC in the State. CenturyLink shall be obligated to provide services under this Agreement only within this territory. 33.2 Notwithstanding any other provision of this Agreement, CenturyLink may terminate this Agreement as to a specific operating territory or portion thereof pursuant to Section 6.7 of this Agreement.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • 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.

  • 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 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • Regulatory Applications (a) Western and PNB and their respective Subsidiaries shall cooperate and use their respective reasonable best efforts to prepare all documentation, to effect all filings and to obtain all permits, consents, approvals and authorizations of all third parties and Governmental Authorities necessary to consummate the transactions contemplated by this Agreement. Western and PNB shall use their reasonable best efforts to make all required bank regulatory filings, including the appropriate filing with the Regulatory Authorities. Each of Western and PNB 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 all material written information submitted to any third party or any Governmental 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 necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the other party appraised of the status of material matters relating to completion of the transactions contemplated hereby. (b) Each party agrees, upon request, to furnish the other party with all information concerning itself, its Subsidiaries, directors, officers and shareholders and such other matters as may be reasonably necessary or advisable in connection with any filing, notice or application made by or on behalf of such other party or any of its Subsidiaries to any third party or Governmental Authority.

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • Country [insert country where ITT is issued]

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!