Early Access Programs definition

Early Access Programs shall include treatment INDs / protocols, and named patient programs.
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Early Access Programs or similar uses shall not constitute a First Commercial Sale. In addition, sales of a Product by and between ASLAN and its Affiliates and Sublicensees shall not constitute a First Commercial Sale.
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Examples of Early Access Programs in a sentence

  • The Parties shall discuss at the Steering Committee the appropriate mechanism for considering, approving, providing for supply of Licensed Product in respect of, and otherwise administering, any Early Access Programs [***].

  • Additional Feature(s): means additional features or functionality (including, but not limited to, Built by Zendesk Marketplace Applications, Zendesk Labs apps, Early Access Programs, or Beta Services) that are available or enabled through the Service, but do not form part of the Service.

  • Compassionate use and “named patient sales” (Early Access Programs) will be excluded from Net Sales calculations.

  • This relationship has enormous near-term potential for MGC with Sciensus Rare’s existing distribution network into Early Access Programs, licensed distribution programs throughout the United Kingdom and EU.Post year-end, the Company acquired a 40% stake in ZAM Software Limited, the owner of an AI data gathering and learning algorithm which has the potential for use in real-time data collection applications across the pharmaceutical and healthcare industries.

  • For example, the ability to extract oxygen from the lunar soil might provide not only breathable air for the crew’s life support system but also perhaps fuel for spacecraft.Another priority will be to build on our experience with the International Space Station to develop efficient recycling techniques that will reduce the use of consumables such as air, power and water.

  • Included in inventory are products which could, besides commercial activities, be used in preclinical and clinical programs as well as in non-reimbursed Early Access Programs.

  • Outlook for second half of 2022 GENinCode continues to advance its US ‘soft launch’ preparations for Cardio inCode® and Lipid inCode® via the roll- out of Early Access Programs (s) supported by the Company’s new US CLIA lab facility in California.

  • Subject to Section 8.3 (Manufacturing Technology Transfer), Everest shall exclusively purchase from Xxxxx, and Xxxxx shall (itself or through its Affiliate or a CMO) Manufacture and supply the Product for Development and Commercialization by Everest and its Affiliates and Sublicensees in the Territory, including the Manufacture and supply of the Product for any Early Access Programs, in accordance with the terms of this Agreement and the Supply Agreements.

  • In addition to enabling patient access, Early Access Programs can provide manufacturers with several advantages.

  • Real-world data capture from global Early Access Programs are increasingly accepted by regulators as supportive evidence for safety and effectiveness – especially with small patient populations.

Related to Early Access Programs

  • Wellness program means a program offered by an employer that is designed to promote health or

  • Access Provider in this RAO means the Access Provider stated in the cover of this RAO who owns or provides the Access Service listed in the Access List and who is a Licensee as defined in the Act.

  • User Interface(s means any technologies thatiii. Customer owns and/or for which Customer has secured an appropriate license/subscription and is/areiv. used to develop/manage user interaction features and characteristics for ERP. Solely for clarity regarding ERP licensing requirements under a contract, User Interfaces for ERP shall be deemed part of ERP and therefore require human users Using ERP via such User Interfaces to have a “Named User” and/or “User” license for ERP, as applicable.

  • User Guide means such user guide or document issued or prescribed by us, through any medium, setting out instructions on the use of the EB Services;

  • Multiple Exchange Carrier Access Billing or “MECAB” means the document prepared by the Billing Committee of the OBF, which functions under the auspices of the Carrier Liaison Committee (CLC) of the Alliance for Telecommunications Industry Solutions (ATIS). The MECAB document, published by ATIS as ATIS/OBF-MECAB- Issue 6, February 1998, contains the recommended guidelines for the billing of access services provided to an IXC by two (2) or more LECs, or by one LEC in two (2) or more states within a single LATA.

  • Conditional Access System means any technical measure and/or arrangement whereby access to a protected radio or television broadcasting service in intelligible form is made conditional upon subscription or other form of prior individual authorisation;

  • Access Tandem Switch is a Switch used to connect End Office Switches to interexchange Carrier Switches. Qwest's Access Tandem Switches are also used to connect and switch traffic between and among Central Office Switches within the same LATA and may be used for the exchange of local traffic.

  • User Interface means the interface for the Hosted Services designed to allow individual human users to access and use the Hosted Services.

  • Unmanned aircraft system means an unmanned aircraft and associated elements, including communication links and components that control the unmanned aircraft that are required for the pilot in command to operate safely and efficiently in the national airspace system.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Directory Assistance Database shall have the meaning set forth in Section 10.5.2.2. "Directory Assistance Lists" shall have the meaning set forth in Section 10.6.1.1.

  • Open type traction battery means a type of battery requiring liquid and generating hydrogen gas released to the atmosphere.

  • Switched Access Service means the offering of transmission and switching services to Interexchange Carriers for the purpose of the origination or termination of telephone toll service. Switched Access Services include: Feature Group A, Feature Group B, Feature Group D, 8XX access, and 900 access and their successors or similar Switched Access Services.

  • Network Data Mover (NDM) or “Connect Direct” means the industry standard protocol for transferring information electrically.

  • Terms of Use means any privacy policy, terms of use or other terms and conditions made applicable by BNYM in connection with the Company’s or a Permitted User’s access to and use of a Component System or a BNYM Web Application or other access site or access method.

  • Primary enclosure means any structure used to immediately restrict an animal or animals to a limited amount of space, such as a room, pen, cage, compartment, or hutch.

  • Application Review Start Date means the later date of either the date on which the District issues its written notice that the Applicant has submitted a completed Application or the date on which the Comptroller issues its written notice that the Applicant has submitted a completed Application and as further identified in Section 2.3.A of this Agreement.

  • Master subcontracting plan means a subcontracting plan that contains all the required elements of an individual subcontracting plan, except goals, and may be incorporated into individual subcontracting plans, provided the master subcontracting plan has been approved.

  • User Guides means Sprinklr materials made available to Customer through the support portal to assist users of the Platform, as such materials may be updated during the Term.

  • Municipal Separate Storm Sewer System Management Program means a management program covering the duration of a state permit for a municipal separate storm sewer system that includes a comprehensive planning process that involves public participation and intergovernmental coordination, to reduce the discharge of pollutants to the maximum extent practicable, to protect water quality, and to satisfy the appropriate water quality requirements of the CWA and regulations, and this article and its attendant regulations, using management practices, control techniques, and system, design, and engineering methods, and such other provisions that are appropriate.

  • Local Access Transport Area (LATA) is As Defined in the Act.

  • Residential child care facility means a twenty-four-hour residential facility where children live together with or are supervised by adults who are not their parents or relatives;

  • payment system means a funds transfer system with formal and standardised arrangements and common rules for the processing, clearing and/or settlement of payment transactions;

  • Access Card means an ATM card, debit card or credit card and includes our Visa Card

  • Local Access and Transport Area (LATA) Shall have the meaning set forth in 47 U.S.C.

  • Non-Administrator Substance Use Disorder Treatment Facility means a Substance Use Disorder Treatment Facility that does not meet the definition of an Administrator Substance Use Disorder Treatment Facility.