HCV Indication definition

HCV Indication means treatment or prevention of hepatitis C virus infection in humans.
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Examples of HCV Indication in a sentence

  • As discussed below, the contrary is true in many respects.08-451 Formal Opinion 4 its lawyers.

  • Licensee shall make written notice to UGARF of the date of Licensee’s first arm’s length commercial sale for consideration of each Separate and Distinct (as defined at paragraph 1 above) Licensed Product for the HCV Indication (“HCV Indication Licensed Product”) within [ * * * ] of such sale.

  • Any prior Development Plan for a HCV Indication that is no longer being pursued by Licensee shall be deleted from Appendix A.

  • The following Annual Minimum Royalty Payments, identified in dollars in the table below, are due beginning in the [ * * * ] following the first sale of an HCV Indication Licensed Product [ * * * ] continuing through [ * * * ], and vary depending upon the total number of HCV Indication Products on the market at the end of each calendar year, as set out in the table below.

  • The following one-time development milestone payments only apply the first time each event occurs for the first Separate and Distinct HCV Indication Licensed Product.

  • Pharmasset shall not, without Roche’s prior written consent, grant a right or license to any Third Party, under any Pharmasset Patent Right, in the Roche Territory, to make, use, offer for sale, sell or import any 2’-fluoronucleoside (excluding any 4’-modified nucleoside) for an HCV Indication, except as otherwise provided in Section 2.1(h).

  • Within [ * * * ] after submitting an IND to the U.S. Food and Drug Administration (or a like application to a like agency in any other country) for a HCV Indication Licensed Product, Licensee shall provide to UGARF a Development Plan setting forth Licensee’s planned development efforts for such Licensed Product.

  • Subject to the extension provisions of paragraph 6.3 below, Licensee shall initiate a [ * * * ] within [ * * * ] of the Effective Date, [ * * * ] within [ * * * ] of the Effective Date, and [ * * * ] within [ * * * ] of the Effective Date for a HCV Indication Licensed Product.

  • The Annual Minimum Royalty Payments are only payable to the extent that the earned royalty actually paid upon the sale of such Licensed Products for a given calendar year is less than the below-stated minimum royalty payment; in which case Licensee shall pay to UGARF an amount equal to the applicable minimum royalty payment less the earned royalty actually paid for such HCV Indication Licensed Products.

Related to HCV Indication

  • 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.

  • 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.

  • 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.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

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

  • 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.

  • 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.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • 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.

  • Licensed Compound means [***].

  • 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. [***]

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Generic Product means any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

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

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • 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).

  • 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.

  • 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.

  • Hemp product means the same as that term is defined in § 3.2-4112.