PMA Product definition

PMA Product means a product, the sale of which requires the filing with and approval by the FDA of a PMA.
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PMA Product means a product, the sale of which requires the filing with and approval by the FDA of a PMA. “Premarket Approval” or “PMA” shall mean a premarket approval as defined in the FFDCA, and the regulations promulgated thereunder, necessary to market a Female Product in the United States. “Product” shall mean a Female Product, Gillette Joint Independent Product, Other Independent Product, or any product or system Exploited by Palomar pursuant to any license under the Gillette Licensed Patents that is granted by Gillette to Palomar in this Agreement, as the case may be. “Product Specifications” shall mean the written specifications for the design and Manufacture of a product or system. “Professional Field” shall mean products or systems intended or marketed for sale to doctors, health care providers or other commercial service providers for use on or with patients or customers (and not for resale to any Person). “Prototypes” shall mean one or more prototypes of the Female Product Manufactured or made by or on behalf of either party during the R&D Period for the purposes of evaluating, testing or improving such product pursuant to the R&D Plan and this Agreement, which in the case of any such unit delivered by Palomar to Gillette shall have been Manufactured or made pursuant to the then-current Product Specifications. “Regulatory Approval” shall mean, on a country-by-country basis, the right with respect to a -xiii-
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PMA Product means a product, the sale of which requires the filing with and approval by the FDA of a PMA. “Premarket Approval” or “PMA” shall mean a premarket approval as defined in the FFDCA, and the regulations promulgated thereunder, necessary to market a Female Product in the United States. “Product” shall mean a Female Product, Gillette Joint Independent Product, Other Independent Product, or any product or system Exploited by Palomar pursuant to any license under the Gillette Licensed Patents that is granted by Gillette to Palomar in this Agreement, as the case may be. “Product Specifications” shall mean the written specifications for the design and Manufacture of a product or system. “Professional Field” shall mean products or systems intended or marketed for sale to doctors, health care providers or other commercial service providers for use on or with patients or customers (and not for resale to any Person). “Prototypes” shall mean one or more prototypes of the Female Product Manufactured or made by or on behalf of either party during the R&D Period for the purposes of evaluating, testing or improving such product pursuant to the R&D Plan and this Agreement, which in the case of any such unit delivered by Palomar to Gillette shall have been Manufactured or made pursuant to the then-current Product Specifications. “Regulatory Approval” shall mean, on a country-by-country basis, the right with respect to a Female Product to sell or distribute such product or system for female Hair Management in the Consumer Field. In the case of the United States, sale or distribution of a Female Product may require a determination by the FDA of substantial equivalence (within the meaning of 21 C.F.R. § 807.100) following the filing with the FDA of a 510(k) Notification, or in the event that a PMA is required, the approval by the FDA of such PMA, and in the case of any other country or territory, any necessary international or foreign approvals. “Regulatory Authority” shall mean any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of the Female Product Technology in the Territory.
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Examples of PMA Product in a sentence

  • The Initial R&D Plan has been prepared and the initial R&D Payments have been determined on the assumption that the First Female Product will be a 510(k) Product and not a PMA Product.

  • In the event that the First Female Product is determined by the FDA to be a PMA Product, ▇▇▇▇▇▇▇▇ may elect to terminate this Agreement in accordance with Section 10.4(b), or elect to continue participating in such development and commercialization for such product.

  • Gillette shall have the right, in its sole discretion, to terminate this Agreement in its entirety by providing ten (10) days’ prior written notice to Palomar within thirty (30) days of the FDA determining that the First Female Product is a PMA Product.

  • G▇▇▇▇▇▇▇ shall have the right, in its sole discretion, to terminate this Agreement in its entirety by providing ten (10) days’ prior written notice to Palomar within thirty (30) days of the FDA determining that the First Female Product is a PMA Product.

  • In the event that the First Female Product is determined by the FDA to be a PMA Product, G▇▇▇▇▇▇▇ may elect to terminate this Agreement in accordance with Section 10.4(b), or elect to continue participating in such development and commercialization for such product.