Early Access Program means any program that provides patients with a Product prior to Regulatory Approval in any country or region in the Territory and in which the use of such Product is not primarily intended to obtain information about the safety or effectiveness of a drug. “Early Access Programs” shall include treatment INDs / protocols, and named patient programs.
Early Access Program or “EAP” means any program to provide patients in the United States with a Product prior to Marketing Approval and First Commercial Sale in the United States. Early Access Programs include treatment INDs / protocols, named patient programs and compassionate use programs, as applicable. For clarity, an EAP with respect to a Product may continue to be performed following Marketing Approval of the Product and costs may continue to be incurred in accordance with the performance of such EAP after Marketing Approval.
Early Access Program or “EAP” means the activities directed to (a) the education of physicians and patients regarding the possibility of early access to innovative medical treatments not yet the subject of a Marketing Authorisation through named-patient use, hospital exemption or compassionate use, (b) patient recruitment, (c) the securing of Early Access Approvals, for the use of such treatments, (d) the distribution and sale of Product for such treatments pursuant to such Early Access Approvals, (e) inventory management, accountability and control, (f) pharmacovigilance activities as set forth in the Pharmacovigilance Agreement set forth in Exhibit 6 and/or (g) the collection of data, including but not limited to patient-reported outcomes, doctor-reported experiences and registry data
Examples of Early Access Program in a sentence
YourKit Early Access Program (EAP) is the easiest way to get in touch with the latest technologies from YourKit.
Unless otherwise agreed to by the Parties in writing, the term of the Early Access Program will end upon the New Product Release of the relevant Instrument.
Claims Services will also be offered during the Early Access Program.
All available domain names will be open to such registration.A Registrar sponsoring an Applicant can submit an Application for Registration or may modify a Registration on behalf of the Domain Name Holder.The first ten (10) days of General Availability will consist of an Early Access Program (EAP) where domain registrations will be subject to additional fees.
No more than [*] Beta Prototype Instruments will be provided for use in the Early Access Program.
More Definitions of Early Access Program
Early Access Program or “EAP” means any program to provide patients in a country with a Licensed Product before receipt of Marketing Approval and before First Commercial Sale in such country in which the use of the Licensed Product is not primarily intended to obtain information about the safety or effectiveness of such Licensed Product, including Treatment INDs / Protocols, Named Patient Programs and Compassionate Use programs. For clarity, an EAP with respect to a Licensed Product may continue to be performed after receipt of Marketing Approval of such Licensed Product and costs may continue to be incurred in accordance with the performance of such EAP after Marketing Approval.
Early Access Program or “EAP” means the activities directed to (a) the education of physicians and patients regarding the possibility of early access to innovative medical treatments not yet the subject of a Marketing Authorization through named-patient use, compassionate use, expanded access and hospital exemption (b) patient and physician outreach related to the platform, (c) the securing of Early Access Approvals, for the use of such treatments, (d) the distribution and sale of such treatments pursuant to such Early Access Approvals, (e) pharmacovigilance activities in accordance with the Pharmacovigilance agreement, attached as Exhibit 6 and/or (f) to the extent permitted by Applicable Law, the collection of data, including but not limited to patient-reported outcomes, doctor-reported experiences and registry data as set out in more detail in Exhibit 9.
Early Access Program. OR "PROGRAM" means the arrangement between the Parties pursuant to this Agreement whereby DuPont has access to the Resolver-TM- System prior to its commercial release for internal use only, and provides feedback to Rosetta regarding the Resolver-TM- System together with the Resolver-TM- Software so that Rosetta can continue its development efforts in respect thereof.
Early Access Program means a program in which one or more third parties or Affiliates are given access to Beta Prototype Collaboration Product prior to New Product Release in return for a fee, including the providing of service or information to a third party by Illumina.
Early Access Program means a program through which customers gain access to the Celera Database and Analysis Products for no less than the amount of the Subscription Fee specified in Section 5.1 and have the ability to provide input for consideration in the development of the Subscriber Information System and the Celera Database and Analysis Products.
Early Access Program or “EAP” means, with respect to any country, any program to provide patients with a drug or biological product before receipt of Marketing Approval and before First Commercial Sale in such country, in which program the use of the drug or biological product is not primarily intended to obtain information about the safety or effectiveness of such drug or biological product, including Treatment INDs / Protocols, Named Patient Programs and Compassionate Use programs. For clarity, an EAP with respect to a drug or biological product may continue to be performed following receipt of Marketing Approval of such drug or biological product and costs may continue to be incurred in accordance with the performance of such EAP after Marketing Approval.
Early Access Program or “EAP” has the meaning set forth in the Financial Exhibit.