Reserved Indications definition

Reserved Indications means the following Indications:
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Reserved Indications has the meaning assigned in Section 4.2.1.
Sample 1

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.

  • Site 2 is located to the east of Lloyd Way and on land upon which Probyn House presently stands,together with its grounds.

  • 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.

  • 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.

  • 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.

  • 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.

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 a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

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

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

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

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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.

  • Original Product means the product from which You are upgrading. You are authorized to use the Software only if You are the authorized user of the Original Product and You may use the Software to replace Your licensed unit count of the Original Product on a one-for-one basis, not exceeding the authorized licensed unit count for the Original Software. This Agreement shall replace and govern any license agreement for the surviving units of Original Product. This Agreement is specific to the Software (by product and version) that it accompanies, and You may not re-allocate Your Software licensed unit count to another product or version except under express written permission from Licensor. Maintenance and Support. Licensor has no obligation to provide support unless You purchase an offering that expressly includes support services. If You make such a purchase and no separate agreement specifically applies to the support services, then the terms of this Agreement will govern the provision of such support services (“Services”). For more information on Licensor's current support offerings, see xxxxx://xxx.XxxXX.xxx/support.

  • 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 any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • 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 III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Additional Products means products, services and applications that are not part of the Services but that may be accessible, via the Admin Console or otherwise, for use with the Services.