OTC Equivalent Product definition

OTC Equivalent Product means any diclofenac topical dispersible product approved by the FDA for sale in the Territory as an OTC Product, whether or not the Launch of such product results in the declassification of the Licensed Product as an Rx Product.
Sample 1Sample 2Sample 3
OTC Equivalent Product means any *** product approved by the FDA for sale in the Territory as an OTC Product, ***.
Sample 1

Examples of OTC Equivalent Product in a sentence

  • NOVARTIS shall notify ENDO when it submits a filing to the FDA in respect of an OTC Equivalent Product.

  • The JCC shall be entitled to reject any proposed clinical study if, among other reasons, such study may have an adverse impact on the Development or Commercialization of the Licensed Product, any Line Extension, any OTC Equivalent Product or any other new indication study.

  • Notwithstanding the foregoing, NOVARTIS shall not Launch an OTC Equivalent Product prior to April 1, 2014, and NOVARTIS shall not take any action that results in the loss of Rx Product status for the Licensed Product prior to such time.

  • Notwithstanding the foregoing, if a Third Party obtains *** on an OTC Equivalent Product prior to any Launch by NOVARTIS or its Affiliates, no royalties shall be payable pursuant to this Section 9.2. 1 *** % 2 *** % 3 *** % 4 *** % 5 *** % Notwithstanding any other provision hereof, ENDO shall not be entitled to any compensation with respect to the OTC Switch or OTC Equivalent Product except for the foregoing royalties, if applicable.

  • This Agreement shall automatically terminate upon the Launch in the Territory of any OTC Equivalent Product by NOVARTIS, its Affiliates or a Third Party that results in the declassification of the Licensed Product as an Rx Product.

  • Notwithstanding the foregoing, if a Third Party obtains regulatory exclusivity for at least three years on an OTC Equivalent Product prior to any Launch by NOVARTIS or its Affiliates, no royalties shall be payable pursuant to this Section 9.2.

  • This Agreement shall automatically terminate upon the Launch in the Territory of any OTC Equivalent Product by SANDOZ, its respective Affiliates or a Third Party that results in the declassification of the Licensed Products as Rx Products.

  • ENDO shall use commercially reasonable efforts to ensure that the Licensed Products are not sold to known diverters and SANDOZ shall use commercially reasonable efforts to ensure that any topical gel product containing one percent (1%) diclofenac that references the Licensed Product NDA or uses the Product Trademark (other than a Line Extension or any OTC Equivalent Product, subject to Section 8.1) is not sold to known diverters.

  • The Vendor would also be required to pay the applicable required fees for any of its subcontractors for which Vendor Name Check reviews are required.

  • In furtherance of the foregoing, ENDO agrees to use procedures to prevent diversion of the Licensed Products, and SANDOZ agrees to use procedures to prevent diversion of any topical gel product containing one percent (1%) diclofenac that references the Licensed Product NDA or uses the Product Trademark (other than a Line Extension or any OTC Equivalent Product, subject to Section 8.1), in each case which are no less stringent than procedures generally used on their respective other products.

Related to OTC Equivalent Product

  • Generic Equivalent or "generically equivalent" means a drug that has an identical amount of the same active chemical ingredients in the same dosage form, that meets applicable standards of strength, quality and purity according to the United States pharmacopeia or other nationally recognized compendium and that, if administered in the same amounts, will provide comparable therapeutic effects. Generic equivalent or generically equivalent does not include a drug that is listed by the federal food and drug administration as having unresolved bioequivalence concerns according to the administration's most recent publication of approved drug products with therapeutic equivalence evaluations.

  • 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."

  • Therapeutic equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity.

  • Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.

  • Aluminum equivalent means the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question.

  • Dose equivalent (HT means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

  • Combination Products means COBI Combination Products, EVG Combination Products, TDF Combination Products, TAF Combination Products and Quad Product.

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

  • Therapeutically equivalent means a drug product with the same efficacy and toxicity when administered to an individual as the originally prescribed drug as provided for in Section 39‑24‑40.

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

  • Equivalent Load means the sum of a Market Participant’s net system requirements to serve its customer load in the PJM Region, if any, plus its net bilateral transactions.

  • Equivalent method means any method of sampling and analyzing for an air pollutant that has been demonstrated to the satisfaction of the commissioner and the U.S. EPA to have a consistent and quantitatively known relationship to the reference method under specific conditions.

  • Bundled Product means Product sold together with any other product(s) or service(s) at a single unit price, whether packaged together or separately, and which other product(s) or service(s) have material independent value from Product itself.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

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

  • Alternative nicotine product means any noncombustible product containing nicotine that is intended for human consumption, whether chewed, absorbed, dissolved, or ingested by any other means. "Alternative nicotine product" does not include any nicotine vapor product, tobacco product, or product regulated as a drug or device by the U.S. Food and Drug Administration (FDA) under Chapter V (21

  • Replacement Product means electric generating capacity, capacity-related benefits, environmental attributes, Energy or other electric products from a generation resource other than the Facility that are provided or delivered to replace or substitute for Contract Capacity or Storage Capacity (or any Capacity-Related Benefit, Environmental Attribute, Other Electric Product, Contract Energy, or Storage Energy associated therewith), in each case, in whole or in part, pursuant to Section 4.6.

  • Dose equivalent (HT) means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

  • Other Product means Product which an End User acquired from sources other than Integrator.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Lead equivalent means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.

  • Domestic end product as used in this clause, means, (1) an unmanufactured end product mined or produced in the United States, or (2) an end product manufactured in the United States, if the cost of its components mined, produced, or manufactured in the United States, exceeds 50 percent of the cost of all its components. Components of foreign origin of the same class or kind as the products referred to in paragraphs (b)(2) or (3) of this clause shall be treated as domestic. Scrap generated, collected, and prepared for processing in the United States is considered domestic.

  • Licensed Compound means [***].

  • 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.

  • 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: