Premarket Approval definition

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.

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Premarket Approval means a premarket approval as defined in the FFDCA necessary to market Reducer in the United States.

Premarket Approval or “PMA” means a premarket approval application filed with the FDA, for approval by such agency for the marketing and sale of Products in the US pursuant to 21 CFR 814, as such regulations may be amended from time to time. 1.32 “Product” means the monthly, non-absorbable silicone-based, non-hormonal (which releases ferrous gluconate and ascorbic acid), ring-based vaginal contraceptive device, wherein the ringed- mesh comprises a composite ring comprising a flexible matrix containing one or more bioactive agent or agents and needed excipients or modulators, which encircles a fluid-permeable mesh material, currently known as Ovaprene. Product shall include any improvement or modification to the Product that is made or introduced by or on behalf of either Party during the Term; provided that Bayer shall acquire no rights to any improvement or modification to the Product that is not Controlled by Daré. 1.33 “Promotional Materials” means all sales representative training materials and all written, printed, graphic, digital, electronic, audio or video matter, intended for use or used by or on behalf of Bayer, any of its Affiliates or sublicensees, and any of their respective sales forces, sales managers and other sales personnel, in connection with promotion of the Product, which may include without limitation journal advertisements, sales visual aids, leave-behind items, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings and sites and broadcast advertisements. 1.34 “Regulatory Authority” means the FDA or any national or local agency, authority, department, inspectorate, official, or public or statutory person having jurisdiction over any of the activities contemplated by this Agreement or the Parties, or any successor bodies thereto. 1.35 “Regulatory Documentation” means all applications, registrations, licenses, authorizations and approvals, all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents and all clinical studies and tests, in each case specifically addressing the Product, and all data included in the foregoing, including all IDEs, PMAs, Marketing Approvals, adverse events files and complaints files. 1.36 “Results Package” has the meaning stated in Section 2.1. 1.37 “Side Letter” means that letter sent by PMI to Daré dated March 18, 2017 in which PMI agrees wi...

Examples of Premarket Approval in a sentence

• Iomed agrees that Abbott shall have the right to review Iomed's proposed Pre-market Approval submissions.

• The Awardee will serve as the Sponsor of the Regulatory Application (an Investigational New Drug Application (IND), Investigational Device Exemption (IDE), New Drug Application (NDA), Biologics License Application (BLA), Premarket Approval Application (PMA), or 510(k) Pre-Market Notification Filing (510(k)) or another regulatory filing submitted to FDA) that controls research under this agreement.

• Neither Eyegate nor any of its Affiliates has applied for or obtained a Premarket Approval (PMA) or a Premarket Notification 510(k) for the EyeGate® II Delivery System.

• MANUFACTURER is desiring to designate MAH as its Designated Marketing Authorization Holder (Sen-nin Seizou Hanbai Gyosha) (hereinafter referred to as “DMAH”) under PAL, a Pre-market Approval Holder under article 19-2 of PAL MAH, which stands for “MARKETING AUTHORIZATION HOLDER” (Seizou Hanbai Gyosha), is a Marketing Authorization Holder (Seizou Hanbai Gyosha) and is authorized to act as a DMAH under PAL.

• Provide authorization to reference Abbo▇▇'▇ ▇▇▇reviated New Drug Application, as appropriate for Pre-market Approval submissions by Iomed.

• In addition, Buyer assumes no responsibility or obligation with respect to requests or governmental regulatory inquiries, investigations, or demands that would require the filing of a Premarket Approval Supplement with the FDA for any substantial redesign work associated with the Product Lines or its components.

• Since January 1, 2021, the Company Products, where required, are being marketed under and consistent with valid 510(k) clearances or approved Premarket Approval Applications (“PMAs”) exclusively owned by a member of the Company Group.

• Orthovita shall also be responsible for conducting human clinical trials of the Product under protocols agreed to by Howmedica; for filing and pursuing to issuance an application for Premarket Approval ("PMA") in the United States; for filing and pursuing to approval the CE ▇▇▇▇ in the European Community; and for pursuing regulatory approvals in all other countries (except Japan) deemed necessary and appropriate by Howmedica and Orthovita.

• Since January 1, 2022, the Company Products, where required, are being marketed under and consistent with valid 510(k) clearances or approved Premarket Approval Applications (“PMAs”) exclusively owned by an Acquired Company.

• Without limiting the generality of the foregoing, except as set forth in Section 4.6 of the Ophthalmic Disclosure Schedule, all of the products presently marketed by Ophthalmic have been approved or cleared to market pursuant to valid and subsisting Premarket Approval or Section 501(k) Clearances issued by the United States Food and Drug Administration ("FDA").

More Definitions of Premarket Approval

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.

Premarket Approval is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, or those that present a potentially high risk for a patient, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Heart valves, cochleary implants, and defibrillators are examples of Class III medical devices. 1.65. “Project Manager” has the meaning set forth in Section 3.10.1. 1.66. “Protocol” means the written documentation that describes the Study and sets forth specific activities to be performed as part of the conduct of the Study. 1.67. “Receiving Party” has the meaning set forth in the definition of Confidential Information. 1.68. “Regulatory Agreement” means that certain regulatory agreement regarding the Combination to be entered into by the Parties pursuant to Section 3.9, as the same may be amended from time to time. 1.69. “Regulatory Approvals” means, with respect to the MSD Compound, the Novocure Device, or the Combination (in each instance as the context may require), any and all

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-

Premarket Approval means the authority to sell a medical device in the United States granted by the FDA pursuant to 21 Code of Federal Regulations Section 814.20, as amended.

Premarket Approval or “PMA” means a class III medical device that has received premarket approval under 21 U.S.C. § 360e, or any foreign equivalent. “Prepayment Premium” means the Tranche A Prepayment Premium, the Tranche B Prepayment Premium, Tranche C Prepayment Premium or the Tranche D Prepayment Premium (as applicable) or any combination thereof, as the context dictates.