Health Registration definition
Health Registration means the technical, medical and scientific licences, registration, authorisations or approvals required or deemed necessary by any Regulatory Authority for the advertising, distribution, import, export, marketing or sale of the Products in the Territory or any part thereof.
Health Registration means a New Drug Application or [***] prepared in conformance with applicable Agency regulations for filing with the Agency for marketing authorization of Product.
Health Registration means any and all consents, licenses, authorizations, reimbursement pricing or approvals required by the U.S. Food and Drug Administration or any Ministry of Health for the distribution, sale, manufacture, or testing of a pharmaceutical product, including, without limitation, an IND, NDA or supplemental NDA or other application or supplemental application for a Health Registration.
Examples of Health Registration in a sentence
P&G will work with API to develop Health Registration packages and filing strategies for Paget’s disease, PMO, corticosteroid induced osteoporosis and other indications intended to maximize the commercial success of the Product.
If and when a Health Registration Approval is obtained in any country of the Territory, Flexion shall inform AstraZeneca of such Health Registration Approval within thirty (30) days.
In the event Impax subsequently modifies any relevant Health Registration (or the CMC) for which it is responsible, it shall promptly notify Schering and provide it with copies of such Health Registration (or CMC) supplements or amendments.
Distributor shall also be entitled to disclose the Confidential Information to the Health Authority to the extent required to apply for and obtain clinical trial authorisations, Health Registration and the maintenance thereof.
Nanomerics shall not assign, transfer, convey or otherwise encumber its rights to the Licensed Patents, Licensed Know-How, Licensed Improvements or Health Registration Approvals in any way that is detrimentally inconsistent with the exclusive licenses or other rights granted to Virpax under this Agreement.
More Definitions of Health Registration
Health Registration herein shall mean governmental authorizations and/or approvals required by the competent authorities in the TERRITORY for manufacturing, marketing and selling of the PRODUCT, and for importing of the COMPOUND in the TERRITORY, if necessary, including but not limited to, product registration(s) and price and marketing approvals, as applicable.
Health Registration means, with respect to a Product, approval for marketing and sale of that Product by the requisite governmental or regulatory authority ***.
Health Registration shall include, as applicable, an “Investigational New Drug Application” or a “New Drug Application,” as defined in 21 C.F.R. Part 312 and 21 C.F.R. Part 314 respectively, for such End Product, as amended or supplemented from time to time.
Health Registration means, with respect to a pharmaceutical product containing Product, all registrations with and approvals from the relevant Governmental Authority necessary to market and sell such pharmaceutical product in a given country or group of countries, including the technical, medical and scientific licenses, registrations, authorizations and/or approvals of such medicinal product (including any marketing authorizations, pricing approvals, reimbursement approvals, and labeling approvals, as applicable). For the United States, the term Health Registration shall include a New Drug Application (NDA), for such pharmaceutical product and any amendments thereto.. For a Product in this Agreement, “Health Registration” shall also refer to the Health Registration for the Product’s final finished form, as applicable. For clarity, Health Registrations shall exclude any permits specific to the Facility.
Health Registration means all registrations with and approvals from the relevant Governmental Authority necessary to market, sell and otherwise distribute the End Product in the Territory, including the technical, medical and scientific licenses, registrations, authorizations and/or approvals of such End Product (including any marketing authorizations, pricing approvals, reimbursement approvals, and labeling approvals, as applicable). With respect to the United States, the term “Health Registration” shall include, as applicable, an “Investigational New Drug Application” or a “New Drug Application,” as defined in 21 C.F.R. Part 312 and 21 C.F.R. Part 314 respectively, for such End Product, as amended or supplemented from time to time.
Health Registration means any and all consents, licenses, authorizations, reimbursement pricing or approvals required by the U.S. Food and Drug Administration or any Ministry of Health for the distribution, sale, manufacture, or testing of a pharmaceutical product, including, without limitation, an IND, NDA or supplemental NDA or other application or supplemental application for a Health Registration. 7 <PAGE> 1.23. "IND" means an Investigational New Drug application, as described by the U.S. Food, Drug and Cosmetics Act of 1938, 21 U.S.C. 301 et seq., as amended, and associated regulations. 1.24. "Inventions" or "Technology" mean all inventions, trade secrets and other information, whether tangible or intangible, whether or not patentable, resulting from work by the parties (either individually or jointly) in the Field during the Research Term. 1.25 "Joint Projects" mean the research projects undertaken by the parties pursuant to the Multi-Project Collaboration Agreement and identified in Attachment 2.2 as "Joint Projects". 1.26. "J-V" means such collaborative relationship as may be established pursuant to Section 3.7 of this Agreement. J-V may or may not be structured as a separate legal entity, such as a corporation, partnership, LLC, or such other form as the Parties may agree. In agreeing on the form of the collaborative relationship, the Parties shall take appropriate account of, among other factors, ease of administration and tax liabilities. 1.27. "Know-how" means the entire right, title and interest in trade secret technology. "P&G Know-how" shall mean the entire right, title and interest in Know-how owned solely or jointly by Procter & ▇▇▇▇▇▇ with a Third Party. "Regeneron Know-how" shall mean the entire right, title and interest in Know-how owned solely or jointly by Regeneron with a Third Party. "Joint Know-how" shall mean the entire right, title and interest in Know-how jointly owned by the Parties pursuant to Section 5.1(b). 1.28. "Lead Compound" means a Research Compound that has been demonstrated to meet Success Criteria as ready to begin regulated safety studies and development of clinical supplies pursuant to Section 3.3 during the Research Term or Tail Period. The terms Development Compound and Lead Compound may be used interchangeably. 1.29. "Major Country" means the United States, United Kingdom, Belgium, Germany, France, Italy, Netherlands and Canada. 1.30. "Major Decision" means the following decisions to be made by the Operations Committee: 8 <PAGE> (a...
Health Registration shall have the meaning defined in the License Agreement. References to Sections, Clauses, and Appendices, are to Sections, Clauses, and Appendices of this Agreement, except where noted otherwise. Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions.