Designated Indication definition

Designated Indication has the meaning set forth in Section 3.5(a).
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Designated Indication means each and any of the following indications: (i) wet age-related macular degeneration (excluding pigment epithelial detachment) (“Wet AMD”), (ii) diabetic retinopathy, (iii) dry age-related macular degeneration, (iv) diabetic macular edema, and (v) glaucoma, as defined below:
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Designated Indication means indications for the treatment of tumors in the liver or pancreas that are applicable to the Development and Commercialization of the PEDD Combination Therapies hereunder.
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Examples of Designated Indication in a sentence

  • Once Salix designates the Salix Designated Indication Product, which it shall do by written notice to Alfa, it may, subject to the terms of this Section 4.2.2 (but it is not required to), substitute a different Salix Designated Indication Product for the first Salix Designated Indication Product, but may do so only one time.

  • Salix shall have the right, but not the obligation, except as described below, to present a Salix Designated Indication Product to Alfa for licensing pursuant to this Section 4.2.2. Salix has initially selected a product having the [*] Formulation and to be Developed for a Salix Designated Indication still to be designated to license to Alfa as the Salix Designated Indication Product.

  • Furthermore if Salix abandons the Development of the first Salix Designated Indication Product and selects an alternate Salix Designated Indication Product, [*].

  • Salix, in consultation with Alfa, shall select the trademark for the Salix Designated Indication Product (the “Salix Designated Indication Trademark”) and the trademarks for all other Salix Licensed Products having the [*] Formulation or an Other New Formulation (“Other New Formulation Products”) to be used in the Alfa Territory within the Field (the “Other New Formulation Trademarks”).

  • Notwithstanding the foregoing, the provisions of this Section 5.1.1 shall not apply to the Salix Designated Indication Product if Alfa elects not to obtain the Salix Designated Indication License.

  • Alfa shall have the option to choose to negotiate for an exclusive license under the Salix Technology Rights, Other Forms Claims of the [*] Patent Family and Salix’s rights in the Joint Technology Rights to Exploit (but not to Manufacture or have Manufactured) the Salix Designated Indication Product within the Field in the Alfa Territory, or to reject the offer.

  • The Parties shall provide the Valuation Principles and the [*] Report to the arbitrator, and a copy of the relevant provisions of this Agreement setting out the principles on which the compensation for the Salix Designated Indication License is based.

  • Once Salix designates a second Salix Designated Indication Product, it may not subsequently change the formulation of the Compound of the Salix Designated Indication Product or the indication it is directed at.

  • In determining the compensation payable by Alfa to Salix for, and other terms of, the Salix Designated Indication License, the Parties shall [*] (the “Valuation Principles”).

  • If Salix carries out Development work with respect to a Salix Licensed Product that it has initially designated as the Salix Designated Indication Product * Confidential treatment requested; certain information omitted and filed separately with the SEC.

Related to Designated Indication

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

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

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

  • Second Indication means [***].

  • Participating Product means any of the Breville products listed in the table below by model name and number that are supplied by Breville in Australia and sold directly by Breville or by a Participating Retail Store:

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • 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.

  • Indication means a generally acknowledged disease or condition, a significant manifestation of a disease or condition, or symptoms associated with a disease or condition or a risk for a disease or condition. For the avoidance of doubt, all variants of a single disease or condition (whether classified by severity or otherwise) shall be treated as the same Indication.

  • 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.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • inherited metabolic disease means a disease caused by an inherited abnormality of body chemistry for which testing is mandated by law;

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

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

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • 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:

  • geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.

  • 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.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • 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.

  • 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.

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • 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 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.