Non-Required Development of Initial Product in the Additional Territory Sample Clauses

Non-Required Development of Initial Product in the Additional Territory. (i) If either Party desires to conduct additional clinical trials or other development work on the Initial Product to enhance or expand the Regulatory Approval for the Initial Product in a country in the Additional Territory beyond the scope of the initial Regulatory Approval for the Initial Product in such country (but not for a new Indication), or for the purpose of enhancing scientific knowledge and understanding of the clinical utility of the Initial Product in such country, or for any other appropriate purposes that are not Required Additional Territory Development (“Non-Required Additional Territory Development”), the Party desiring to conduct such Non-Required Additional Territory Development shall promptly notify the other Party, and the Parties, through the JDC, shall promptly meet to discuss in good faith and seek to agree on the terms under which the Parties would conduct such Non-Required Additional Territory Development, including (A) the Parties’ responsibilities for conducting such Non-Required Additional Territory Development, (B) the sharing of Development Expenses with respect to such Non-Required Additional Territory Development, (C) a Development Plan for such Non-Required Additional Territory Development in such country in the Additional Territory consistent with Section 3.4, and (D) the Regulatory Strategy for such Non-Required Additional Territory Development. For clarity, development of the Initial Formulation for Indications other than the Indications that, as of the 2nd Amendment Effective Date, are the subject of the Initial Product NDA shall not be considered Non-Required Additional Territory Development and shall instead be considered development of an Additional Product under Section 3.3. (ii) If the Parties fail to agree on the matters in subclause (i) above, including the JDC (and thereafter the JSC and the Senior Executives pursuant to Section 4.1(f)) not agreeing on a Development Plan and Regulatory Strategy covering any Non-Required Additional Territory Development within a reasonable time period (not to exceed 90 days after notice from the applicable Party), then (x) Arena shall have the right, but not the obligation, to conduct such Non-Required Additional Territory Development, and (y) Eisai shall have the right to, but not the obligation, to conduct such Non-Required Additional Territory Development solely to the extent it is Non-Required Eisai Development, in each case at such Party’s own expense and in its sole disc...
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Related to Non-Required Development of Initial Product in the Additional Territory

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK

  • Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

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

  • Additional Products Upon satisfying the minimum order requirements above, Enrolled Affiliate may order Additional Products.

  • 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.

  • 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.

  • 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.

  • Drug Free Work Place Grantee shall establish and maintain a drug-free work place policy.

  • Country and Territory Names The country and territory names (including their IDN variants, where applicable) contained in the following internationally recognized lists shall be withheld from registration or allocated to Registry Operator at All Levels: the short form (in English) of all country and territory names contained on the ISO 3166-1 list, as updated from time to time, including the European Union, which is exceptionally reserved on the ISO 3166-1 list, and its scope extended in August 1999 to any application needing to represent the name European Union <xxxx://xxx.xxx.xxx/iso/support/country_codes/iso_3166_code_lists/iso-3166-1_decoding_table.htm>; the United Nations Group of Experts on Geographical Names, Technical Reference Manual for the Standardization of Geographical Names, Part III Names of Countries of the World; and the list of United Nations member states in 6 official United Nations languages prepared by the Working Group on Country Names of the United Nations Conference on the Standardization of Geographical Names; provided, that the reservation of specific country and territory names (including their IDN variants according to the registry operator IDN registration policy, where applicable) may be released to the extent that Registry Operator reaches agreement with the applicable government(s). Registry Operator must not activate such names in the DNS; provided, that Registry Operator may propose the release of these reservations, subject to review by ICANN’s Governmental Advisory Committee and approval by ICANN. Upon conclusion of Registry Operator’s designation as operator of the registry for the TLD, all such names that remain withheld from registration or allocated to Registry Operator shall be transferred as specified by ICANN. Registry Operator may self-allocate and renew such names without use of an ICANN accredited registrar, which will not be considered Transactions for purposes of Section 6.1 of the Agreement.

  • Placement of DNS probes Probes for measuring DNS parameters shall be placed as near as possible to the DNS resolvers on the networks with the most users across the different geographic regions; care shall be taken not to deploy probes behind high propagation-­‐delay links, such as satellite links.

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