FDA means the United States Food and Drug Administration and any successor agency thereto.
Nonconformance as used in this clause means a condition of any hardware, software, material, or service/workmanship in which one or more characteristics do not conform to requirements.
Third Party Applications means online, Web-based applications and offline software products that are provided by third parties and are identified as third-party applications, including but not limited to those listed on the AppExchange and the Reseller Application.
Product means any deliverable under the Contract, which may include commodities, services, technology or software.
Client Application means an application developed by Licensee that a) utilizes the Runtime Product, b) is installed fully on an end user’s machine, with all report processing local to that machine, and c) adds significant and primary functionality to the Runtime Product.
Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.
Programme Party means a party to a Programme Document (other than the Issuer and ETP Securityholders).
Recall means any measure aimed at achieving the return of a device that has already been made available to the end user;
Direction-indicator lamp means the lamp used to indicate to other road-users that the driver intends to change direction to the right or to the left;
Unproven/ Experimental treatment means the treatment including drug experimental therapy which is not based on established medical practice in India.
Biosimilar Application has the meaning set forth in Section 7.3.3.
Collaborating physician means the physician who,
Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.
Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.
Marketing Authorisation means, with respect to a country, region or other jurisdiction in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations, or authorisations of any Regulatory Authority necessary to commercially distribute, sell, or market Product in such country or other jurisdiction, including, where applicable, (a) pre- and post-approval regulatory approvals (including any prerequisite manufacturing approval or authorisation related thereto), and (b) approval of Product labelling.
Renewal Application means a document used to collect pertinent data for renewal of permits
Antipsychotic medications means that class of drugs
Licensed Application means an Application that (a) meets and complies with all of the Documentation and Program Requirements, and (b) has been selected and digitally signed by Apple for distribution, and includes any additional permitted functionality, content or services provided by You from within an Application using the In-App Purchase API.
Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.
Recall campaign means the period of time beginning on the
Good Laboratory Practice or “GLP” means the applicable then-current standards for laboratory activities for pharmaceuticals (including biologicals) or vaccines, as applicable, as set forth in the Act and any regulations or guidance documents promulgated thereunder, as amended from time to time, together with any similar standards of good laboratory practice as are required by any Regulatory Authority having jurisdiction over the applicable activity.
Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.
Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.
Protocols means written directions and orders, consistent with the department’s standard of care, that are to be followed by an emergency medical care provider in emergency and nonemergency situations. Protocols must be approved by the service program’s medical director and address the care of both adult and pediatric patients.
TO Proposal - Technical means the TO Contractor’s technical response to the CATS II TORFP dateddate of TO Proposal – Technical.
Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority, including all INDs and NDAs.