Subsequent Indications Clause Samples

The "Subsequent Indications" clause defines how additional instructions, requests, or directions provided after the initial agreement are to be handled between the parties. Typically, this clause outlines the process for submitting and acknowledging such subsequent indications, specifying whether they must be in writing, who is authorized to issue them, and how they become binding. Its core practical function is to ensure that any changes or additions to the original agreement are managed in an orderly and documented manner, thereby reducing misunderstandings and disputes over later communications.
Subsequent Indications. Orchard may, at any time, request that an additional indication ([***]) be included in this Agreement and the following provisions shall apply: (a) Orchard may by written notice to BioMedica received on or before [***], nominate [***] and upon [***], such indication shall become a Subsequent Indication; and/or (b) Orchard may, at any time after [***], request [***] and, if [***], such additional indication shall become a Subsequent Indication.
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Subsequent Indications. Astellas shall not be obligated to make any milestone payments with respect to Marketing Approval for the fourth and subsequent indications of the Compound and/or Product. It is understood that, for purposes of this Section 6.2.7, a single MAA or Marketing Approval may include more than one indication, e.g. both the first and second indications, or the second and third indications, as the case may be.
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Subsequent Indications. Milestone payments shall be paid as set forth in Section 7.02(a) upon the first achievement of each milestone event for each of the First Indication, Second Indication, Third Indication and Fourth Indication. No amounts shall be due for subsequent or repeated achievement of such milestone by the same Licensed Product for additional Indications beyond the Fourth Indication. The total milestone payments payable under Section 7.02(a) shall not exceed forty million five hundred thousand U.S. dollars ($40,500,000.00). **CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
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Subsequent Indications. Milestone payments shall be paid as set forth in Section 7.02(a) upon the first achievement of each milestone event for each of [***]. No amounts shall be due for subsequent or repeated achievement of such milestone by the same Licensed Product for additional Indications beyond the Fourth Indication. The total milestone payments payable under Section 7.02(a) shall not exceed [***] per Licensed Product to Merck and [***] per Licensed Product to Cerecor.
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Related to Subsequent Indications

  • Combination Product 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.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • 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.

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.