OUS Territory Sample Clauses

OUS Territory. Subject to the terms and conditions of this Agreement, Alector hereby grants to GSK an exclusive license (subject to Alector’s reserved rights under Section 3.9.1) under the Alector Intellectual Property to Commercialize the Licensed Products in the Field in the OUS Territory; provided that Alector shall retain the right to perform such activities (if any) to the extent allocated to Alector under the Global Strategic Launch Plan or requested by GSK or its Affiliate.
Sample 1
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OUS Territory. During the Term, GSK, either itself or by and through its Affiliates, Sublicensees or subcontractors, will be solely responsible for all Medical Affairs activities with respect to the Licensed Products throughout the OUS Territory and Opt Out Products in the U.S., at GSK’s sole cost and expense, in accordance with the Global Strategic Launch Plan and Exhibit *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Sample 1
OUS Territory. The provisions of this Section 5.1.3 shall apply with respect to regulatory activities for the Licensed Compounds and Licensed Products in the OUS Territory: (a) With respect to each country in the OUS Territory, the MA Holder for such country shall have the sole right to prepare, obtain and maintain all Regulatory Documentation (including all INDs, Drug Approval Applications and Regulatory Approvals) and to prepare other submissions to, and conduct communications with, all Regulatory Authorities, in each case, for the Licensed Compounds and Licensed Products in such country. The Non-MA Holder Party shall support the MA Holder, as may be [****] requested by the MA Holder, in obtaining and maintaining Regulatory Approvals for the Licensed Products in such country and supporting activities, including providing all documents or other materials as may be necessary or reasonably useful for the MA Holder to obtain and maintain Regulatory Approvals for the Licensed Products in such country and attending meetings with Regulatory Authorities with respect thereto in such country. (b) With respect to each Designated Country, (i) the MA Holder for such Designated Country shall provide the Non-MA Holder Party for such Designated Country with an opportunity to review and comment on all [****] regulatory filings (including INDs and any amendments and supplements thereto) to, and [****] communications with, Regulatory Authorities in such Designated Country and (ii) the MA Holder for such country shall provide access to interim drafts of such filings and communications to the Non-MA Holder Party for such country via the access methods (such as secure databases) mutually agreed by the Parties, and the Non-MA Holder Party for such Designated Country shall provide its comments on the final drafts of such filings or communications [****] (or [****] for Drug Approval Applications), or such other longer period of time mutually agreed to by the Parties. If any Regulatory Authority establishes a response deadline for any such filings or material communications shorter than such [****] period, the Parties shall work cooperatively to ensure that the Non-MA Holder Party for the applicable Designated Country has a [****] opportunity for review and comment within such deadlines. With respect to each Designated Country, the MA Holder shall, and shall cause its Affiliates and Sublicensees to, consider [****] any timely comments of the Non-MA Holder Party for such country. (c) With respec...
Sample 1
OUS Territory. As between the Parties, AbbVie shall have the sole right, at its sole cost and expense, to perform all Development activities with respect to the Licensed Compounds and Licensed Products that are solely and specifically intended to support or maintain Regulatory Approval in [****] countries in the OUS Territory and, for clarity, such Development shall not be included in the Development Plan.
Sample 1
OUS Territory. As between the Parties, AbbVie shall have the sole right, at its sole cost and expense, to perform all Commercialization activities that are solely and specifically performed with respect to [****] countries in the OUS Territory and, for clarity, such Commercialization shall not be included in the Commercialization Plan.
Sample 1
OUS Territory. Until the [****] of the First Commercial Sale of a Licensed Product in the OUS Territory, within [****] following [****] of each [****], AbbVie shall provide to Licensor a high-level report on the status of the Commercialization with respect to the Licensed Compounds and Licensed Products in the [****] period ending [****] or [****], as applicable.
Sample 1
OUS Territory. Subject to the terms and conditions of this Agreement, argenx hereby grants, and shall cause its Affiliates to grant, to Xxxxxxx, during the Term, an exclusive (except for the rights retained by argenx as set out in Section 3.1.3(c)) license under the argenx Intellectual Property and argenx’s interest in Joint Intellectual Property to sell, offer to sell, have sold, import and otherwise Commercialize the Licensed Compounds and Licensed Products in the Field in the OUS Territory.
Sample 1
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Related to OUS 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.

  • 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.

  • 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.

  • Competing Products The provisions of Section 21 are set forth on attached Exhibit H and are incorporated in this Section 21 by this reference.

  • Combination Product The term “

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • Combination Products If a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

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