Required Development of Initial Product in the Additional Territory Sample Clauses

Required Development of Initial Product in the Additional Territory. If (i) the Regulatory Authorities in a particular country in the Additional Territory require that additional clinical trials or other development work be conducted on the Initial Product as a condition of and prior to granting Regulatory Approval for the Initial Product in such country (such required clinical trials or other development work, “Pre-Approval Required Additional Territory Development” in the applicable country), or (ii) the Regulatory Authorities in a particular country in the Additional Territory require additional clinical trials or other development work on the Initial Product after granting Regulatory Approval of the Initial Product in such country to obtain or maintain such Regulatory Approval in such country in the Additional Territory (such required post-approval clinical trials or other development work, “Post-Approval Required Additional Territory Development”, and, collectively with the Pre-Approval Required Additional Territory Development, the “Required Additional Territory Development”), Eisai shall notify Arena of such Required Additional Territory Development, and the Parties shall, through the JDC, promptly meet to discuss in good faith and seek to agree on the Development Plan (consistent with Section 3.4) and the Regulatory Strategy for such Required Additional Territory Development; provided, that if the JDC (and thereafter the JSC and the Senior Executives pursuant to Section 4.1(f)) are unable to agree on such Development Plan or Regulatory Strategy (or any amendments thereto) within a reasonable time period (not to exceed 90 days after notice from the applicable Party), neither Party shall have final decision-making authority with respect to such Development Plan or Regulatory Strategy (or any amendments thereto) until [...***...], after which time Eisai shall have final decision-making authority subject to and in accordance with Section 4.1(f) with respect to such Development Plan and Regulatory Strategy for such Required Additional Territory Development (and any amendments thereto). The Development Expenses with respect to any such Required Additional Territory Development shall be allocated between the Parties as follows: Eisai shall bear 90% and Arena shall bear 10% of the Development Expenses with respect to any Required Additional Territory Development (including any required Phase 4 clinical trial or outcomes studies) conducted by either Party. Unless otherwise agreed by the Parties in writing, Eisai shall have t...
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Related to Required Development of Initial Product in the Additional Territory

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

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

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

  • 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.

  • 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 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.

  • Additional Products Throughout the Term, Rockwell shall provide to DaVita and the DaVita Facilities the right to purchase and/or lease all current or new products manufactured, utilized, licensed, sold or distributed by Rockwell or any of its Affiliates (including products and product lines acquired by Rockwell or any of its Affiliates as a result of an acquisition, merger or other transaction involving Rockwell or any of its Affiliates) that are or that become Commercially Available and which are not already covered by this Agreement or by any other agreement, whether written or oral, between the parties hereto (such products are collectively referred to as “Additional Products” and individually as an “Additional Product”). Rockwell agrees to include DaVita in all of its and its Affiliates distributions of customer announcements regarding Rockwell’s or its Affiliates’ Additional Products. The purchase price for any such Additional Products shall be negotiated by the parties hereto in good faith and the agreed upon purchase price shall be memorialized in writing as a supplement or amendment to this Agreement. Rockwell covenants and agrees that it shall only make an offer for the sale of any Additional Product(s) to DaVita’s Vice-President of Clinical Operations, Chief Medical Officer, or Vice-President of Purchasing, and not to any DaVita Facility directly; provided that the purchase of any Additional Product by DaVita or any DaVita Facility through a Rockwell product catalog made generally available to the dialysis community shall not be a breach by Rockwell of this Section 8.1. If Rockwell or any of its Affiliates acquires any Additional Product(s) as a result of an acquisition, merger or other transaction involving Rockwell or any of its Affiliates with a Person with which DaVita or a DaVita Facility, as applicable, already has a purchase or rebate arrangement whether written or oral (a “Prior Agreement”), Rockwell or such Affiliate covenants and agrees that it shall continue to abide by all of the terms and conditions of such Prior Agreement or if DaVita requests, such Additional Product(s) shall be included in this Agreement on terms to be negotiated and determined by the parties hereto as provided in this Section 8.1.

  • Development of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.

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

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