Additional Combination Products Sample Clauses

Additional Combination Products. Without limiting the rights granted to FOREST pursuant to Sections 2.2.1 and 2.2.2 above, ALMIRALL hereby also grants to FOREST a first right to extend the license granted by ALMIRALL to FOREST hereby to include Additional Combination Products subject to the following specific conditions:
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Additional Combination Products. During the Option Term, XOMA shall have the exclusive option (the “Option”) to include in the license granted in Section 2.1 one or more Additional Combination Products, and Servier shall not (a) engage in any sales, distribution or transfer in the Territory of a particular Additional Combination Product or (b) solicit any offers, respond substantively to any inquiries except as required by Law or order after notice thereof to XOMA, conduct any negotiations or enter into any agreement with any Third Party regarding rights to a particular Additional Combination Product in the Territory without first receiving a written waiver from XOMA of the Option regarding such Additional Combination Product. In the event XOMA exercises the Option with respect to a particular Additional Combination Product during the Option Term, it shall provide Servier with a written notice, whereupon, for no additional consideration, (i) all references herein to API shall be deemed to include the Indapamide API and/or the other additional active pharmaceutical ingredient(s) to be included in such Additional Combination Product, (ii) all references herein to Licensed Products shall be deemed to include such Additional Combination Product, (iii) the definition of “Servier Intellectual Property” shall be amended to specifically include any and all Patents owned or controlled by Servier related to such Additional Combination Product, the Indapamide API and/or the other additional active pharmaceutical ingredient(s) to be included in such Additional Combination Product or any method of use of any of the foregoing, and (iv) XOMA shall have the right to terminate its rights and obligations under this Agreement with respect to such Additional Combination Product (but only such Additional Combination Product) as provided in Section 15.3 for any of the reasons set forth in clauses (c), (d) or (f) thereof (as if such provisions referred to such Additional Combination Product rather than the Initial Licensed Product). In the event XOMA exercises the Option, the Parties will, in good faith, discuss and agree on the representations and warranties substantially similar to those set forth in this Agreement that Servier will make in relation to those Additional Combination Products. Pending exercise by XOMA of the Option, Servier agrees not to intentionally take any action, or omit to take any action, that would prevent it or its Affiliates from being able to give representations and warranties in rel...
Additional Combination Products. XOMA shall notify Servier in writing within [*] Business Days of the first achievement of each of the milestone events in the table below with respect to each Additional Combination Product, and the corresponding milestone payment shall be due within [*] Business Days of XOMA’s receipt of an invoice therefor from Servier. Event Payment Upon confirmation by the FDA that an NDA submission for such Additional Combination Product will be accepted without requiring one or more additional clinical trials [*] U.S. Dollars (US$[*]) Upon Marketing Approval for such Additional Combination Product. [*] U.S. Dollars (US$[*]) However, should the FDA require with the Marketing Approval additional clinical studies or Phase IV studies (hereinafter referred to as “Additional Studies”), then the external expenses incurred by XOMA and duly documented for the performance of the Additional Studies above [*] U.S. Dollars (US$[*]), if any, shall be deducted from the amount of [*]U.S. Dollars (US$[*]) due to Servier, without Servier being obliged to pay any sum to XOMA.

Related to Additional 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 “

  • 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.

  • Initial Business Combination/Distribution Procedure The Company may consummate the Initial Business Combination and conduct redemptions of Common Stock for cash upon consummation of such Initial Business Combination without a stockholder vote pursuant to Rule 13e-4 and Regulation 14E of the Exchange Act, including the filing of tender offer documents with the Commission. Such tender offer documents will contain substantially the same financial and other information about the Initial Business Combination and the redemption rights as is required under the Commission’s proxy rules and will provide each stockholder of the Company with the opportunity prior to the consummation of the Initial Business Combination to redeem the Common Stock held by such stockholder for an amount of cash equal to (A) the aggregate amount then on deposit in the Trust Account as of two Business Days prior to the consummation of the Initial Business Combination representing (x) the proceeds held in the Trust Account from the Offering and the sale of the Private Placement Warrants and (y) any interest, divided by (B) the total number of Public Shares then outstanding. In the event the Company conducts redemptions pursuant to the tender offer rules, the Company’s offer to redeem will remain open for at least 20 Business Days, in accordance with Rule 14e-1(a) under the Exchange Act, and the Company will not be permitted to complete the Initial Business Combination until the expiration of the tender offer period. If, however, the Company elects not to file such tender offer documents, a stockholder vote is required by law or stock exchange listing requirement in connection with the Initial Business Combination, or the Company decides to hold a stockholder vote for business or other legal reasons, the Company will submit such Initial Business Combination to the Company’s stockholders for their approval (“Business Combination Vote”). The company will give not less than 10 days nor more than 60 days prior written notice of any such meeting, if required, at which a Business Combination Vote shall be taken. With respect to the Business Combination Vote, the Sponsor and the Company’s initial stockholders, executive officers and directors have agreed to vote all of their Founder Shares and Public Shares in favor of the Company’s initial Business Combination. If the Company seeks stockholder approval of the Initial Business Combination, the Company will offer to each Public Stockholder holding shares of Common Stock the right to have its shares redeemed in conjunction with a proxy solicitation pursuant to the proxy rules of the Commission at a per share redemption price (the “Redemption Price”) equal to (I) the aggregate amount then on deposit in the Trust Account as of two Business Days prior to the consummation of the Initial Business Combination representing (1) the proceeds held in the Trust Account from the Offering and the sale of the Private Placement Warrants and (2) any interest, divided by (II) the total number of Public Shares then outstanding. The Company may proceed with such Initial Business Combination only if a majority of the shares voted are voted to approve such Initial Business Combination. If, after seeking and receiving such stockholder approval, the Company elects to so proceed, it will redeem shares, at the Redemption Price, from those Public Stockholders who affirmatively requested such redemption. Only Public Stockholders holding Common Stock who properly exercise their redemption rights, in accordance with the applicable tender offer or proxy materials related to such Initial Business Combination, shall be entitled to receive distributions from the Trust Account in connection with an Initial Business Combination, and the Company shall pay no distributions with respect to any other holders or shares of capital stock of the Company in connection therewith. In the event that the Company does not effect an Initial Business Combination within the time period set forth in the Amended and Restated Certificate of Incorporation, the Company will (i) cease all operations except for the purpose of winding up, (ii) as promptly as reasonably possible but not more than ten (10) Business Days thereafter, redeem 100% of the Public Shares, at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the Trust Account, including any interest (which shall be net of amounts withdrawn to pay taxes and up to $100,000 of interest to pay dissolution expenses), divided by the number of then outstanding Public Shares, which redemption will completely extinguish Public Stockholders’ rights as stockholders (including the right to receive further liquidation distributions, if any), subject to applicable law, and (iii) as promptly as reasonably possible following such redemption, subject to the approval of the Company’s remaining stockholders and the Company’s board of directors, dissolve and liquidate, subject in each case to the Company’s obligations under Delaware law to provide for claims of creditors and the requirements of other applicable law. Only Public Stockholders holding Common Stock included in the Securities shall be entitled to receive such redemption amounts and the Company shall pay no such redemption amounts or any distributions in liquidation with respect to any other shares of capital stock of the Company. The Company will not propose any amendment to the Amended and Restated Certificate of Incorporation to modify the substance or timing of the Company’s obligation to provide for the redemption of the Public Shares in connection with an Initial Business Combination or to redeem 100% of its Public Shares if it does not complete its initial business combination within the time period set forth in the Amended and Restated Certificate of Incorporation, unless it provides its public stockholders with the opportunity to redeem their shares of Class A common stock upon approval of any such amendment, as described in the Statutory Prospectus and Prospectus.

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • 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.

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

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

  • Acquisition Target Not Selected Prior to the date hereof, the Company has not selected any business combination target and has not, nor has anyone on its behalf, initiated any substantive discussions, directly or indirectly, with any business combination target.

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