Early Access Program means any program that provides patients with a Licensed Product prior to Regulatory Approval in the Territory and in which the use of the Licensed Product is not primarily intended to obtain information about the safety or effectiveness of a drug. “Early Access Programs” shall include treatment INDs / protocols, named patient programs and compassionate use 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 any program to provide patients with a Product prior to receipt of Marketing Approval and prior to First Commercial Sale in the country in which the use of the Product is not primarily intended to obtain information about the safety or effectiveness of such Product, including Treatment INDs / Protocols, Named Patient Programs and Compassionate Use programs in other countries. For clarity, an EAP with respect to a Product may continue to be performed following receipt of Marketing Approval of such Product and costs may continue to be incurred in accordance with the performance of such EAP after Marketing Approval.
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.
I understand that as a Volunteer in the Early Access Program for the Digital Edition I will receive access to intellectual property of the Foundation.
This Agreement governs the use of Symphony Classroom AI Hubs and the Xxxxxx Solution procured by the Institution in connection with the Xxxxxx Mind Early Access Program.
As a Volunteer in this Early Access Program, I understand that the Foundation will grant me early access to the current version of a combined text and audio production of A Course in Miracles, which is a work copyrighted by the Foundation, also known as the Digital Edition of A Course in Miracles (the “Work”).
In the event you request to opt out from communications related to Early Access, your participation in the Early Access Program may be terminated, and your use of the applicable Early Access Services will likewise be terminated regardless of their state of use or completion.
More Definitions of Early Access Program
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
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 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) the collection of data, including but not limited to patient-reported outcomes, doctor-reported experiences and registry data.
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. 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 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” has the meaning set forth in the Financial Exhibit.