Specified Indication definition

Specified Indication shall have the meaning set forth in Section 3.1(b).
Sample 1Sample 2Sample 3
Specified Indication means (a) Pompe Disease or (b) the indication designated pursuant to Section 2.2 (Identification of Second Specified Indication), in each case ((a) or (b)) as designated by Genzyme pursuant to Section 2.4 (Option Exercise). For the avoidance of doubt, upon designation pursuant to Section 2.2 (Identification of Second Specified Indication), there shall be two (2) potential Specified Indications, and the second such Specified Indication shall be one of DM1 or FSHD.
Sample 1
Specified Indication has the meaning set forth in Article 2.8.
Sample 1

Examples of Specified Indication in a sentence

  • If the Dermion Proposed System relates to the delivery of a Ciba Proprietary Drug for treatment of the Specified Indication, Ciba shall have the right during the term of this Agreement to elect to have Dermion develop a Product for such Ciba Proprietary Drug for treatment of the Specified Indication for it pursuant to the Program instead of the Proposed Dermion System.

  • If during the term of this Agreement Ciba makes the determination to engage a third party (other than Dermion) to develop a System for a Drug owned, licensed or manufactured by Ciba (other than a Ciba Proprietary Drug for treatment of the Specified Indication, which shall be covered by Section 3.5(a) above) (a "Ciba Proposed System"), prior to initiating discussions with such third party, Ciba shall notify Dermion in writing.

  • If the Proposed Field is not a Ciba Field and if the Drug proposed to be delivered pursuant to the Dermion Proposed System is not a Ciba Proprietary Drug for treatment of the Specified Indication, Dermion may freely develop the Dermion Proposed System for a third party (which development may be pursuant to an agreement under which Dermion grants exclusive licenses to such third party).

  • Barring any unforeseen circumstances, the Proposed Acquisition is expected to be completed by the 3rd quarter of 2020.

  • If Novartis so elects, it shall give notice thereof to the Committee within fifteen (15) Business Days of receipt by the Committee of the Notice, in which case Iomed and Dermion shall be prohibited during the term of this Agreement from developing the Proposed System for treatment of the Specified Indication, subject to the last sentence of this Section 3.3(c).

  • If Dermion so elects, it shall give notice thereof to the Committee within fifteen (15) Business Days of receipt by the Committee of such notice, in which case Novartis shall be prohibited during the term of this Agreement from developing the Novartis Proposed Proprietary System for treatment of the Specified Indication outside the scope of the Program, subject to the last sentence of this Section 3.5(a).

  • Notwithstanding the foregoing, if Licensee selects as a Specified Indication any (i) [***] or (ii) [***], then, in each case ((i)and (ii) ), it shall be obligated to pay the amounts set forth below in column (A) of Table 1 for the each of the [***] such [***] (as applicable) selected as Specified Indications (i.e., for each of the [***], and for each of the [***]), but thereafter shall not be obligated to pay any Milestones for any subsequent [***], as applicable, selected as Specified Indications.

  • If Dermion so elects, it shall give notice thereof to the Committee within fifteen (15) Business Days of receipt by the Committee of such notice, in which case Ciba shall be prohibited during the term of this Agreement from developing the Ciba Proposed Proprietary System for treatment of the Specified Indication outside the scope of the Program, subject to the last sentence of this Section 3.5(a).

  • If the Proposed System relates to the delivery of a Novartis Proprietary Drug for treatment of the Specified Indication, Novartis shall have the right during the term of this Agreement to elect to have Iomed or Dermion develop a Product for such Novartis Proprietary Drug for treatment of the Specified Indication for it pursuant to the Program instead of the Proposed System.

  • Unless terminated sooner in accordance with the terms set forth herein, the license granted pursuant to Section 2.1 (Research License) of this Agreement and this Agreement shall expire on the [***] anniversary of the Effective Date if, as of such date, no Specified Product (and related Specified Indication) has been selected by Licensee as contemplated herein.


More Definitions of Specified Indication

Specified Indication means (i) the distinct disease identified in a Specification Notice for which an initial BLA for a Specified Product is filed and (ii) the distinct disease identified in a Specification Notice for which a separate Efficacy Supplement would be required following filing of an initial BLA for a Specified Product.
Sample 1
Specified Indication means any of the following Indications: any Primary Indication, Multiple Sclerosis, Huntington’s Disease, Epilepsy, Duchenne Muscular Dystrophy, Alzheimer’s Disease, Xxxxxxxxx’x Disease and Stroke.
Sample 1

Related to Specified 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 [***].

  • Development Milestone is defined in Section 5.3.

  • 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.

  • 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).

  • 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:

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

  • 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).

  • 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.

  • 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.

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

  • 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.

  • 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 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 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.

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

  • 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.

  • Major Market Country means each of the United States, Japan, France, Germany, Italy, Spain and the United Kingdom.

  • 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.

  • 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.

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

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Project Milestone means the project milestone set forth in Schedule-J;

  • 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.