Sanofi Option on Combination Products Sample Clauses

Sanofi Option on Combination Products. If Biontech alone or in collaboration with an Affiliate or a Third Party develops a combination product which (i) is administered by [***] (ii) comprises both a [***] of a Licensed Product for the treatment of [***] and (iii) is formulated as [***] (such product, a Sanofi Option Combination Product), Sanofi has the exclusive option to co-Develop and co- Commercialize such Sanofi Option Combination Product on a worldwide basis, subject to the terms and conditions of this Section 4.2.3. The option shall be exercisable by written notice to Biontech at the following opt-in points: (a) prior to initiation of the first research program for such Sanofi Option Combination Product (which shall be notified by Biontech to Sanofi in writing no less than [***] prior to the intended date of initiation, with the Early Opt-in Package joined to such notification) and subject to payment of [***] of the option exercise fee pursuant to Section 6.4.4; and (b) if Sanofi has rejected or failed to exercise the option at the opt-in point indicated under (a) above, prior to the [***] for the considered Sanofi Option Combination Product (which shall be notified by Biontech to Sanofi in writing no less than [***] before [***], and subject to the payment of [***] of the option exercise fee pursuant to Section 6.4.4, provided that an IND filing has occurred within [***] from the date on which Sanofi selected the corresponding Licensed Product. Any such option shall be exercised by Sanofi in writing within [***] upon Sanofi’s receipt of Biontech’s respective notice as indicated in (a) and (b) above. For the purposes of this Section 4.2.3, “exclusive option” shall mean that Biontech or any of its Affiliates may not Commercialize a Sanofi Option Combination Product or enter into any arrangement with any Third Party to Commercialize a Sanofi Option Combination Product without having first complied with the provisions of this Section 4.2.3. Subject to the provisions of Section 4.6 below, Biontech shall be free to conduct Development or Commercialization of any Sanofi Option Combination Product without any further option rights of Sanofi after Sanofi has finally declined or failed to exercise its two-step option according to the foregoing terms and conditions. [***].
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Related to Sanofi Option on Combination 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.

  • Combination Product The term “

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

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

  • Preference for domestically manufactured goods The provisions of paragraphs 2.54 and 2.55 of the Guidelines and Appendix 2 thereto shall apply to goods manufactured in the territory of the Borrower.

  • 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.

  • Licensing Schemes and Geographic Scope The following provisions do not apply to the Quintiq Last Mile Edition (5MB-LEQ) nor to Quintiq Last Mile Shipments (for Retail) (5MP-LMQ) nor to Quintiq Last Mile Shipments (for Express) (5MP-LMQ-X) 3DS Offerings. For the Quintiq Last Mile Edition (5MB-LEQ), Quintiq Last Mile Shipments (for Retail) (5MP-LMQ) and Quintiq Last Mile Shipments (for Express) (5MP-LMQ-X) 3DS Offerings, please refer to section 5 hereinafter.

  • 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 [***].

  • 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.

  • 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.

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