OFF-LABEL SALES Sample Clauses

OFF-LABEL SALES. If Connetics exercises the option set forth in Section 4.1 then:
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OFF-LABEL SALES. Each Party (and its Affiliates) shall not knowingly promote or sell (or encourage or facilitate the sale of) any Licensed Product for use outside the approved indications for such Licensed Product, and in all cases, outside any Licensed Indication. Each Party and its Affiliates (and their respective Sublicensees) shall not provide funding to or otherwise support continuing education programs for sales representatives and/or medical professionals in which information is provided about the use of any Licensed Product for use outside the approved indications for such Licensed Product, and in all cases, outside any Licensed Indication, except in accordance with Applicable Law.
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OFF-LABEL SALES. If a Product of the Collaboration receives Regulatory Approval in the Royalty Territory prior to the receipt by Chiron (or its licensee or joint development partner) of Regulatory Approval in the Royalty Territory of a product containing the same Compound as the Product for an indication outside the Field, then all sales of such Product used for any indication (whether inside or outside the Field) in the Royalty Territory shall be included in the Net Sales used to calculate the royalty payable by Chiron pursuant to Section 8.1. Notwithstanding the foregoing, [CONFIDENTIAL TREATMENT REQUESTED] All sales of the Product used in any indication outside the Field (according to market reports accepted in the industry) in a country in the Royalty Territory shall be excluded for purposes of calculating the royalty payable by Chiron pursuant to Section 8.1 in such country when Chiron (or its licensee or joint development partner) receives Regulatory Approval for an indication outside the Field for such Product either in such country itself or in any country in the Major Markets, whichever occurs first.
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OFF-LABEL SALES. If Cara or its Affiliates Commercialize, or grant a license to Third Party to Commercialize, either (a) a Licensed Product for an Additional I.V. Indication and/or (b) a commercial product that is an oral formulation of the Compound in the United States, then the Parties shall agree in good faith on an effective mechanism to (i) seek to prevent off-label sales in each other’s respective field (for Vifor, in the Field, and for Cara (and its Affiliates and Third Party licensees), outside the Field) in the Licensed Territory of such Licensed Product and (ii) provide adequate compensation to the other Party for off-label sales in its respective field in the Licensed Territory of such Licensed Product. If such an agreement is not reached, the matter will be resolved as provided under Section 11.4. As used herein, an “Additional I.V. Indication” means a therapeutic use of an I.V. Licensed Product relating to the prevention or treatment of acute pain in hospital settings. ​ CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CARA THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED. ​ ARTICLE III ​ GOVERNANCE – JCC
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Related to OFF-LABEL SALES

  • Gross Sales Notwithstanding anything in the Lease to the contrary the definition of Gross Sales shall be as follows:

  • Net Sales The term “

  • 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 “

  • 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.

  • Royalty Stacking If COMPANY or an AFFILIATE or SUBLICENSEE is legally required to pay royalties to one or more third parties, in order to obtain a license or similar right necessary to practice the PATENT RIGHTS, and COMPANY, AFFILIATE or SUBLICENSEE actually pays said third party royalties, COMPANY may offset a total of **** of such third-party payments against any royalty payments that are due to THE PARTIES in the same REPORTING PERIOD; provided, however, that in no event shall the royalty payments under this section, when aggregated with any other offsets and credits allowed under the AGREEMENT, be reduced below **** of the running royalty for such a LICENSED PRODUCT, DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT in any REPORTING PERIOD; provided, further, that COMPANY also make best efforts to require such third parties to offset its royalties as a result of royalties payable to THE PARTIES for the Patent RIGHTS by at least the same amount as THE PARTIES has offset its royalties under this Section. For purposes of clarity, third parties may include THE PARTIES.

  • 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.

  • Product The term “

  • Other Products After clinical or other evidence, provided in writing [***] to Company, demonstrating the practicality of a particular market or use within the LICENSED FIELD which is not being developed or commercialized by Company, Company shall either provide JHU with a reasonable development plan and start development or attempt to reasonably sublicense the particular market or use to a third party. If within six (6) months of such notification [***] Company has not initiated such development efforts or sublicensed that particular market or use, JHU may terminate this license for such particular market or use. This Paragraph shall not be applicable if Company reasonably demonstrates to JHU that commercializing such LICENSED PRODUCT(S) or LICENSED SERVICE(S) or granting such a sublicense in said market or use would have a potentially adverse commercial effect upon marketing or sales of the LICENSED PRODUCT(S) developed and being sold by Company.

  • Manufacture of Product Prior to commercialization of the Product, the Parties may, if appropriate for both parties, negotiate in good faith a manufacturing and supply agreement to provide for Licensor to fulfill the manufacturing requirements of Licensee for Product for sale in the European market. The cost of such manufacturing shall not be greater than * percent (*%) of the cost of any competitor cGMP contract manufacturing facility that proposes to manufacturer the Product for Licensee. * Confidential information has been omitted and filed confidentially with the Securities and Exchange Commission.

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