Future Indications Clause Samples

The "Future Indications" clause defines how parties will address matters or requirements that may arise after the agreement is executed but are not currently specified. Typically, this clause allows for the addition or modification of terms in response to future developments, such as regulatory changes or new business needs, often requiring mutual agreement or a specified process for amendments. Its core practical function is to provide flexibility and adaptability within the contract, ensuring that unforeseen circumstances can be managed without renegotiating the entire agreement.
Future Indications. Notwithstanding anything herein to the contrary, (i) neither Party shall have the rights or responsibilities set forth in Sections 3.1, 3.2, 3.3, 3.4, 3.5 and 3.6 with respect to any Product in a particular Future Indication as to which such Party has Opted Out and not Opted Back In, and (ii) in the case of any Product in a particular Future Indication as to which Alexion has Opted Out and not Opted Back In, XOMA shall have the rights and responsibilities ascribed to Alexion in this Section 3.5; provided, that, with respect to both clause (i) and clause (ii), both Parties shall in any event retain their obligations pursuant to the first two sentences of Section 3.5(c), Section 4.14 and the first sentence of Section 4.16, regardless of any such Opt Out.
View SourceView Similar (5)
Future Indications. If the Parties agree to develop a Drug Product for Future Indications, each Party shall and hereby does grant to the other a worldwide, fully paid up, non-exclusive and royalty-free license to use its respective Background Technology and Collaboration Technology for development for Future Indications.
View SourceView Similar (3)
Future Indications. ▇▇▇▇▇▇ shall bear sole financial responsibility, including Regulatory Filing fees, for obtaining Regulatory Approval for all future indications for each CoSeal Unit, except as set forth in subsection 6.1(f)(i) above, and shall be responsible for all development, clinical and regulatory activities relevant to these future indications, and for the preparation of regulatory documents and any supplemental studies necessary to achieve Regulatory Approvals for such future indications in the Territory.
View SourceView Similar (2)
Future Indications. Subject to Section 4.2(k), neither Party shall Develop (including seek or obtain Regulatory Approval for), or Commercialize any indication (other than the Initial Indications and any previously agreed Future Indications) for any Composition or Product in the Company Territory other than in accordance with this Section 2.8(a). Upon a Party’s request, the Parties shall discuss in good faith whether to seek Regulatory Approval for, or otherwise Develop, any such indications for a Product in the Company Territory under this Agreement. If either Party then requests to pursue any such additional indication and: (i) the other Party agrees [***] to pursue any such additional indication hereunder, (A) such additional indication shall be deemed a “Future Indication”, and (B) the Parties will [***] agree on (1) a written plan for the conduct of any Development activities with respect to each such Future Indication in the Company Territory, including specifying any Development activities to be conducted by or on behalf of each Party and (2) a written budget for such Development activities. The costs and expenses of such Development activities shall be allocated [***]; or (ii) the other Party does not agree to pursue such additional indication pursuant to Section 2.8(a)(i), then (A) if Company is the requesting Party, such additional indication shall be deemed a “Future Indication” [***]. The requesting Party shall notify the other Party prior to [***] and provide the other Party with top-line results of any preclinical and clinical data generated in connection therewith, and the other Party shall have the right to opt in to such Future Indication upon written notice to the requesting Party delivered within [***] of receipt of such data, as follows: (x) if Company is the requesting Party and ARS elects to opt in, then [***] ARS shall have the right, outside the Company Territory, to use and reference any Regulatory Data, Regulatory Filings and Regulatory Approvals arising therefrom, provided, however, that Company shall be responsible for Regulatory Filing or equivalent fees for any submission made by Company or any of its Affiliates to Regulatory Authorities with respect to such Future Indication, (y) if ARS is the requesting Party and Company elects to opt in, then [***] and such additional indication shall be deemed a “Future Indication” and (z) the costs and expenses of such Development activities thereafter shall be allocated [***].
View Source
Future Indications. Immtech shall use Commercially Reasonable Efforts to ensure that any new indications for pafuramidine shall be in materially different presentation from the Product (e.g., tradename, dosage form or reference listed drug). If the presentation is not materially different, the Parties will negotiate in good faith a payment to Par to cover revenues that Par lost in commercial sales of the Product due to the new and immaterially different presentations. Neither Immtech nor Par shall directly encourage use of the Product, nor use of the future indications of pafuramidine for treatment of conditions other than PCP, for any indication for which it does not have commercialization rights. For purposes of clarification, the Parties agree that FDA may require that there be more than one indication on the same product label and such additional indication(s) shall not be deemed to affect the scope of the license granted herein in respect of the Product.
View Source
Future Indications. At the reasonable request of Baxter, AAC shall cooperate in ▇▇▇▇▇▇’▇ efforts to obtain Regulatory Approval for any future indications for the Ingredients, Devices, Accessories and/or Products in the Field in the Territory. Baxter shall prepare and approve all clinical plans and clinical protocols and shall conduct all clinical trials. Baxter shall be responsible for preparing and filing all regulatory documents.
View Source
Future Indications. In order to preserve efficacy and responsible use of the Drug Product, each Party agrees that neither the API nor the Drug Product shall be developed by or on behalf of either Party for the Future Indications without the prior consent of the other Party, not to be unreasonably withheld.
View Source

Related to Future Indications

  • 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.

  • 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.

  • 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 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.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement or the Prospectus, or the results of which are referred to in the Registration Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMA, Health Canada and other comparable regulatory agencies outside of the U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Registration Statement or the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.