Additional Indication Freedom to Launch definition

Additional Indication Freedom to Launch means that neither (a) the manufacture (inside or outside the Territory) of a Product by or for ALVOTECH, nor (b) the marketing and sale (within the Territory) of a Product by or on behalf of STADA, its Affiliates or Distributors falls within the scope of protection of any or all of the Additional Indications Patents, or, if such manufacture and/or such marketing and sale falls within the scope of protection of any or all of the Additional Indications Patents, there is an irrevocable obligation from the holder(s) or owner(s) of such Additional Indications Patents (or any Third Party entitled to defend the Additional Indications Patents such as an exclusive licensee) not to assert any claim(s) based on any or all of such Additional Indications Patents (including for the lifetime of the same), with such obligation extending also to STADA, its Affiliates and/or Distributors.
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Examples of Additional Indication Freedom to Launch in a sentence

  • ALVOTECH shall keep STADA informed as to its progress in obtaining such Additional Indication Freedom to Launch.

  • The Nominated Counsel, acting reasonably, shall advise ALVOTECH if he/she approves or does not approve the draft settlement as satisfactory for the purposes of ALVOTECH confirming Freedom to Launch or Additional Indication Freedom to Launch (as applicable) under this Agreement and shall clearly advise in its response as to whether the settlement agreement provides for Freedom to Launch or Additional Indication Freedom to Launch (as applicable).

  • Without limitation of ALVOTECH’s responsibility (as stated in this Article 11.4) for Freedom to Launch and, if required pursuant to Article 11.3, Additional Indication Freedom to Launch, the Parties will discuss issues relating to Third Party Patents in order to try and reach an agreed opinion as to when it is reasonable to Launch the Products without incurring a material risk of a successful infringement challenge under any Third Party Patent.

  • The appointed Patent Counsel shall then determine if STADA has provided reasonable arguments in declaring its dissatisfaction as to whether there is Freedom to Launch or Additional Indication Freedom to Launch (as applicable) or not under the settlement agreement, along with a final determination as to whether the settlement agreement provides for Freedom to Launch or Additional Indication Freedom to Launch (as applicable).

  • STADA, acting entirely at its own discretion, shall decide that it approves or does not approve the draft settlement as satisfactory for the purposes of ALVOTECH confirming Freedom to Launch or Additional Indication Freedom to Launch (if applicable).

  • The Nominated Counsel will be retained, and paid for, by ALVOTECH as a second or alternative legal counsel and will be instructed by ALVOTECH with a copy to STADA that his/her review covers only (i) the key question whether the settlement agreement provides for Freedom to Launch or Additional Indication Freedom to Launch (as applicable) and (ii) how to redraft the draft settlement agreement in order to achieve such Freedom To Launch or Additional Indication Freedom to Launch (as applicable).

  • Provided that, within [***] of receiving a copy of such confirmation and any available details of the settlement agreement, STADA has not notified ALVOTECH that it is “not satisfied” according to Article 11.5(d)(ii), then STADA accepts that there is Freedom to Launch or Additional Indication Freedom to Launch (as applicable).

  • Provided that, within [***] days of receiving a copy of such confirmation and any available details of the settlement agreement, STADA has not notified ALVOTECH that it is “not satisfied” according to Article 11.5(d)(ii), then STADA accepts that there is Freedom to Launch or Additional Indication Freedom to Launch (as applicable).

Related to Additional Indication Freedom to Launch

  • Additional Indication means any indication other than the Initial Indication.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Clinical Trial means any human clinical trial of a Product.

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Development Milestone is defined in Section 5.3.

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.