Impax Product definition

Impax Product means all formulations and dosages of VADOVA® (carbidopa/levadopa), subject to approval by the FDA.

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Impax Product means the Generic Equivalent that is the subject of the Impax ANDA.

Impax Product means any product that (i) is the subject of the Impax ANDA as of the Effective Date, or (ii) is the subject of the Impax ANDA and which is substantially equivalent to those products that are the subject of the Impax ANDA as of the Effective Date, including any future dosage strengths of the product that is the subject of the Impax ANDA as of the Effective Date. For clarity, a product will be considered “substantially equivalent” to those products that are the subject of the Impax ANDA as of the Effective Date if regulatory approval of such product by the FDA would not require the performance of any additional bioequivalence studies (other than bioequivalence studies required by the FDA for new dosage strengths of or new reference listed drug descriptions for the product that is the subject of the Impax ANDA as of the Effective Date or any other changes that do not substantially change the formulation of the products subject to the Impax ANDA), and if its formulation is substantially the same formulation as the products that are the subject of the Impax ANDA as of the Effective Date.

Examples of Impax Product in a sentence

Impax may elect to include the Impax Product (but not any other product) as the primary or secondary product in any Call it performs as part of the Services, subject to the Call Plan set forth on Schedule 3 and the terms and conditions of this Agreement.
Except for any Intellectual Property Rights that relate exclusively to the Impax Product, all right, title and interest in any Intellectual Property Rights created, generated or arising in connection with the provision of the Services shall vest in Shire.
Except for the warranties, obligations and undertakings of each of the Parties set forth in this Agreement, no warranty, condition, term, undertaking or representation (express or implied, statutory or otherwise) is given by one Party to the other in respect of the Trademark, the Shire Product or the Impax Product; such warranties, conditions, terms, undertakings and representations are to the extent permitted by law expressly excluded.
Impax desires to convert the exclusive license granted under the Agreement with respect to the D-24 Product in the United States, its territories and possessions, to a semi-exclusive license allowing Impax to authorize one other Impax Entity to offer to sell, sell, import, package, and/or distribute Impax Product and WCH is willing to agree to such amendment on the terms and subject to the conditions set forth herein.
For all other Impax Product sales, any payments received by Endo from Impax with respect to such sales shall be deemed to be “Applicable Sublicense Consideration” and Penwest shall be entitled to payment thereon pursuant to the Agreement.
Endo and/or Penwest shall provide reasonable cooperation to Impax in connection with such waiver, including by (i) submitting a mutually agreeable notice to FDA of the existence of such waiver and (ii) not opposing the approval of Impax Product effective as of the Commencement Date based on any applicable regulatory exclusivity in force at the time.
The foregoing notwithstanding, the obligations of Shire regarding supply of AG Product under this Agreement shall extend from the date hereof only until the earlier of: (i) September 30, 2014, or (ii) Impax’s Launch of an Impax Product (the “Supply Term”), subject to Section 15.
For clarity, notwithstanding any other provision of this Agreement, an Impax Product Launch shall not release Shire from its obligation to [***] to Impax under Section 5.
During the Supply Term, upon Launch of the Impax Product, Impax shall give Shire written notice of the Launch within [***] thereafter (“Impax’s Launch Notice”).
Impax will provide notice to Endo and Penwest as soon as practicable, and in any event prior to launch of the Impax Product, if it believes that the Commencement Date will be earlier than January 1, 2013.

More Definitions of Impax Product

Impax Product means all formulations and dosages of VADOVA® (carbidopa/levadopa), subject to approval by the FDA. “IMS” means the International Marketing Services Prescription Reporting Service, or such other prescription reporting service to which Impax and Shire may mutually agree to in writing. “Incentive Compensation Plan” means a plan for providing incentive compensation to the Sales Force members for sales of the Shire Product, such plan to contain terms and conditions as are customary for sales representatives in the pharmaceutical industry. “Intellectual Property Rights” means patents, trade marks, service marks, logos, get-up, trade names, internet domain names, rights in designs, copyright (including rights in computer software) and moral rights, database rights, semi-conductor topography rights, utility models, rights in know-how and other intellectual property rights, in each case whether registered or unregistered and including applications for registration, and all rights or forms of protection having equivalent or similar effect anywhere in the world. “IRS” means the Internal Revenue Service of the United States of America and any successor thereto. “Law” means any laws, rules, and regulations, including any statutes, rules, regulations, guidelines, or other requirements that may be in effect from time to time and apply to the development, manufacture, registration, or marketing of the Shire Product in the Territory. “NDA” means a New Drug Application and all supplements filed with the FDA, including all documents, data and other information concerning the Shire Product which are necessary for, or included in, a product approval to market the Shire Product in the United States of America, as more fully defined in the Federal Food Drug and Cosmetic Act of 1934, and the rules and regulations promulgated thereunder, as in effect from time to time. “New Hires” has the meaning given to it in Section 4.3. “Oversight Committee” has the meaning given to it in Section 6.1. “Party” means either Impax or Shire (as applicable) and “Parties” means both Impax and Shire. “PDMA” means the Prescription Drug Marketing ▇▇▇ ▇▇▇▇.