Reserved Indications definition

Reserved Indications means the following Indications:
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Reserved Indications has the meaning assigned in Section 4.2.1.
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Examples of Reserved Indications in a sentence

  • The Parties may, from time to time, discuss any advances in the understanding of the use of Compounds in the treatment, diagnosis and/or prevention of any disease in humans and, subject to the prior written agreement of the Parties, any indications discussed may be included in the Reserved Indications or the Shared Indications.

  • For the avoidance of doubt, an ECN Compound that is a back-up for a Lead Product and for which milestones are not to be paid under Section 10.4, shall not be counted as an ECN Compound for determining the number of Reserved Indications to which BMS is entitled.

  • After the end of the Combined Period, BMS, by written notice to AMRI, may, with respect to an ECN Compound, change an existing Reserved Indication(s) therefor to an existing Reserved Indication(s) for another ECN Compound as long as an ECN Compound does not have more than * Reserved Indications when there is only one ECN Compound and each ECN Compound does not have more than * Reserved Indications when there is more than one ECN Compound.

  • In the event that BMS is complying with BMS’ obligations under this Section 8.2 with respect to one Retained Product, then all Reserved Indications shall remain Reserved Indications.

  • Addex Therapeutics Ltd (Registrant) Date: August 15, 2022 /s/ Tim Dyer Tim DyerChief Executive Officer EXHIBIT INDEX Exhibit Number Description 99.1 Press release dated August 22, 2022EXHIBIT 99.1Addex and Indivior Extend GABAB Positive Allosteric Modulator Research Collaboration for Substance Use DisordersAddex to Receive CHF850,000 ($900,000) of Additional Funding; Addex’s Reserved Indications Expanded to include Chronic CoughAd Hoc Announcement Pursuant to Art.

  • All such Indications for which AMRI receives such written notification shall collectively be called the “Reserved Indications.” The “Unrestricted Indications” shall be all Indications other than the Reserved Indications.

Related to Reserved Indications

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

  • Second Indication means [***].

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

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Major Market Countries means the United States, Japan, England, Germany, France, Italy and Spain.

  • Development Plans has the meaning set forth in Section 3.2.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

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

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • Development Plan has the meaning set forth in Section 3.2.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Existing Products Tangible Products and intangible licensed Products which exist prior to the commencement of work under the Contract. Contractor retains the burden of proving that a particular product was existing before commencement of the Project. .

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Regulatory Approval means, with respect to the Licensed Product in any country or jurisdiction, all approvals (including, where required, pricing and reimbursement approvals), registrations, licenses or authorizations from the relevant regulatory authority in a country or jurisdiction that is specific to the Licensed Product and necessary to market and sell such Licensed Product in such country or jurisdiction.

  • 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.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Major Countries means Canada, France, Germany, Italy, Japan, Spain, United Kingdom and the United States.

  • Designated country end product means a WTO GPA country end product, a Free Trade Agreement country end product, a least developed country end product, or a Caribbean Basin country end product.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • 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.

  • Licensed Field means all fields of use.

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.