Health Registrations definition

Health Registrations means the Abbreviated New Drug Application approval issued by the FDA with respect to the Products and any other governmental or regulatory consents, registrations, approvals or permits necessary to sell or manufacture the Products or applications for the same.

Health Registrations means the technical, medical and scientific licenses, registrations, authorizations and/or approvals of a Patented Product or Other Product (including any prerequisite manufacturing approvals or authorizations related thereto) that are required or deemed necessary by any national, supra-national (e.g., the European Commission or the Council of the European Union), regional, state or local regulatory agency, department, bureau or other governmental entity, and any pricing, third party reimbursement approvals and labeling approvals required or deemed necessary for the manufacture, distribution, use or sale of such Product.

Health Registrations means the technical, medical and scientific licenses, registrations, authorizations and/or approvals of the Product (including the prerequisite manufacturing approvals or authorizations, marketing authorization based upon such approvals and pricing, Third Party reimbursement and labeling approvals related thereto) that are required by any national, regional, state or local regulatory agency, department, bureau or other governmental entity in the Territory, for the Manufacture, distribution, use or sale of Product in the Territory, as amended or supplemented from time to time, including, without limitation, an ANDA or NDA, for the Product, as amended or supplemented from time to time.

Examples of Health Registrations in a sentence

• The parties will cooperate to develop strategies to extend or modify existing Health Registrations for the Product and to obtain Health Registrations for any Joint Product Improvement.

• BioVectra hereby grants Keryx an irrevocable, perpetual, worldwide, fully paid-up license, with the right to grant sublicenses (through multiple tiers) to use such information, data and other BioVectra Technology reflected in such documentation for the purpose of obtaining and maintaining the Health Registrations for Product as well as a right of reference to any regulatory approvals of BioVectra for use in connection with Product.

• Notwithstanding the foregoing, Keryx shall have the right to use BioVectra’s trademarks, trade names, designs or logos, as may be required by Applicable Law (or as may otherwise be reasonably necessary) in connection with obtaining and maintaining Health Registrations for the Products or in connection with marketing and sale of Product (e.g., listing BioVectra as the manufacturer of product on the packaging, if applicable).

• Impax shall provide Schering on a periodic basis, and at least annually, such information concerning Product, production batches, yields and quality status as is specified in the Health Registrations (commonly referred to as Annual Product Reviews) and as may be reasonably requested by Schering from time to time.

• Keryx, in its discretion, may provide BioVectra with CMC information applicable to BioVectra for BioVectra to Manufacture Product in accordance with this Agreement and the Health Registrations (hereinafter, “CMC Information”), and BioVectra shall comply with all such CMC Information in performing its activities hereunder.

More Definitions of Health Registrations

Health Registrations means the technical, medical and scientific licenses, registrations, authorizations and/or approvals of Drug Product(s) (including the prerequisite manufacturing approvals or authorizations related thereto) that are required or deemed necessary by any Regulatory Authority (including any national, supra-national (e.g., the European Commission or the Council or the European Union), regional, state or local regulatory agency, department, bureau or other governmental entity in the Territory), necessary for the manufacture, distribution, use or sale of such Drug Product(s) in the Territory, as they may be amended or supplemented from time to time. With respect to the United States, Health Registration shall include, without limitation, any New Drug Application or Abbreviated New Drug Application for the Drug Product(s), as amended or supplemented from time to time.

Health Registrations means the NDA issued by the FDA with respect to the Products and any other governmental or regulatory consents, registrations, approvals or permits necessary to sell or manufacture the Products in the Territory.

Health Registrations means the technical, medical and scientific licenses, registrations, authorizations and/or approvals of a pharmaceutical product (including the prerequisite manufacturing approvals or authorizations, and marketing authorization based upon such approvals and labeling approvals related thereto) that are required by any national, supra-national (e.g., the European Commission or the Council of the European Union), regional, state, provincial or local Regulatory Authority in the Territory, for the manufacture, distribution, use or sale of a pharmaceutical product in the Territory, as amended or supplemented from time to time. For the avoidance of doubt, Health Registrations includes Pricing Approvals.

Health Registrations means the technical, medical and scientific licenses, registrations, authorizations and/or approvals of the Product (including the prerequisite manufacturing approvals or authorizations related thereto) that are required or deemed necessary by any national, supra-national (e.g., the European Commission or the Council or the European Union), regional, state or local regulatory agency, department, bureau or other governmental entity in the Territory, as necessary for the manufacture, distribution, use or sale of Product in the Territory, as they may be amended or supplemented from time to time. With respect to the United States, the Health Registration shall mean the NDA for the Product, as amended or supplemented from time to time.

Health Registrations means the technical, medical and scientific licenses; registration, authorizations and/or approvals of a Product (including any prerequisite manufacturing approvals or authorizations related thereto) that are required or deemed necessary by any national, supra-national (e.g., the European Commission or the Council of the European Union), regional, state or local regulatory agency, department, bureau or other governmental entity, and any pricing, third party reimbursement approvals and labeling approvals required or deemed necessary by such agencies, departments, bureaus or entities for the manufacture, distribution, use or sale of such Product.

Health Registrations means the health registrations listed in Exhibit 3 of this Agreement.

Health Registrations means the technical, medical and scientific licenses, registrations, authorizations and/or approvals of a pharmaceutical producer (including the prerequisite manufacturing approvals or authorizations, and marketing authorization based upon those approvals and labeling approvals related to them) that are required by any national, supra-national, regional, state, provincial or local Regulatory Authority for the manufacture, distribution, use or sale of a pharmaceutical product, as amended or supplemented from time to time, including (in the United States of America) FDA Approval. Holdco is defined in the Preamble.