Health Registration Approval definition

Health Registration Approval means, with respect to a country in the Territory, any and all approvals, licences, registrations or authorisations of any Health Authority necessary to commercially distribute, sell or market a Licensed Product in such country, including, where applicable, (a) Regulatory Approval, (b) pricing or reimbursement approval in such country, (c) pre- and post-approval marketing authorisations (including any prerequisite Manufacturing approval or authorisation related thereto), (d) labelling approval and (e) technical, medical and scientific licences.
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Health Registration Approval means, with respect to a country, any and all approvals, licences, registrations or authorisations (including supplements and amendments) of any national, supra-national (e.g., European Commission or the Council of the European Union or its equivalent), regional, state or local health or regulatory authority, agency, department, bureau, commission, council or other governmental entity, necessary to commercially manufacture, distribute, sell or market the Product or a Combination Product in such country, including, where applicable, (a) pricing and reimbursement approval in such country, (b) pre- and post-approval marketing authorisations (including any prerequisite manufacturing approval or authorisation related thereto), (c) labelling approval and (d) technical, medical and scientific licences.
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Health Registration Approval means any and all approvals, licences, registrations or authorisations of any Health Authority only necessary lawfully to distribute, sell and market a Product, Including, where applicable, post-approval marketing authorisations, labelling approvals and technical, medical and scientific licences, but excluding any pre-approval marketing authorisations; ID-LELYSTAD means ID-Lelystad, Instituut voor Dierhouderij en Diergezondheld B.V. of Lelystad, the Netherlands;
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Examples of Health Registration Approval in a sentence

  • VIVUS shall use Commercially Reasonable Efforts to maintain the Health Registration Approval and/or ability to market the Product in the Territory.

  • For the avoidance of doubt, subject to VIVUS’s obligations set forth in this Agreement, VIVUS shall have the sole right and responsibility, at its sole discretion, to (i) establish and set the price of the Product in the Territory, (ii) book sales of the Product in the Territory, (iii) commercially distribute the Product in the Territory, (iv) manufacture and supply the Product for the Territory and (v) maintain the Health Registration Approval for the Product in the Territory.

  • If and when a Health Registration Approval is obtained in any country of the Territory, Neoprobe shall promptly inform AstraZeneca of such Health Registration Approval.

  • 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.

  • At the end of the Calendar Quarter in which the cumulative Net Sales of a Licensed Product under a Health Registration Approval exceeds for the first time each respective milestone set forth below, AstraZeneca shall make the corresponding payment to Palatin, as follows.

  • It is acknowledged by Neoprobe that such assistance will be utilised only to an extent absolutely required for the purpose of obtaining Health Registration Approval and in view of this the Parties have agreed that AstraZeneca will not charge Neoprobe for such assistance.

  • If and when a Health Registration Approval is obtained in any country of the ***Confidential Treatment Requested Territory, Flexion shall inform AstraZeneca of such Health Registration Approval within thirty (30) days.

  • AstraZeneca shall have no obligation to provide a translation of any such application for Health Registration Approval (if there are any applications for Health Registration Approval in languages other than English) unless AstraZeneca has made such a translation for its own internal review.

  • In any event, if and when a Health Registration Approval is obtained in any country of the Territory, Virpax shall promptly inform Nanomerics of such Health Registration Approval.

  • Prior to approval of the application for Health Registration Approval, AstraZeneca shall provide Nektar with advance draft written summaries of any communication that AstraZeneca or its Affiliates intend to convey to FDA by telephone, teleconference or video conference regarding any cardiovascular safety issues (other than communications that are purely administrative in nature).


More Definitions of Health Registration Approval

Health Registration Approval means, with respect to a country in the TERRITORY, approval by the health authorities necessary to manufacture and market the LICENSED PRODUCTS in the country, including pricing and reimbursement approval in that country.
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Health Registration Approval means, with respect to a country in the Territory, any and all approvals, licenses, registrations or authorisations of any Health Authority necessary to commercially distribute, sell or market a Licensed Product in such country, including, where applicable, (a) pricing or reimbursement approval in such country, (b) pre- and post-approval marketing authorisations (including any prerequisite manufacturing approval or authorisation related thereto), and (c) labelling approval. Certain identified information has been excluded because it is both not material and would likely cause competitive harm if publicly disclosed.
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Health Registration Approval means, with respect to a country in the Territory, the approval by the appropriate agency or governmental body required to manufacture, distribute, sell and market a Final Product in that country. For the purpose of Section 3, a Health Registration Approval shall be deemed a separate Health Registration Approval for each therapeutic area (e.g., oncology, rhinitis, asthma, inflammatory bowel disease, rheumatoid arthritis or chronic obstructive pulmonary disease (COPD)) covered by the Health Registration Approval whether given as one or several approvals.
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Health Registration Approval means, with respect to a Product in any country, approval for marketing and sale of that Product by the requisite governmental or regulatory authority in or for such country (e.g., approval of a New Drug Application with respect to a Product by the FDA).
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Health Registration Approval means, with respect to a country or region in the Territory, any and all approvals, licenses, registrations or authorizations of any Health Authority necessary to commercially distribute, sell or market a product in such country, including, where applicable, (a) pricing or reimbursement approval in such country, (b) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto), (c) labeling approval and (d) technical, medical and scientific licenses, necessary for commercial distribution, sale or marketing of such product in such country.
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Health Registration Approval shall have the meaning set forth in the License Agreement.
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Related to Health Registration Approval

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Registration Application means an application for registration of this Agreement as a planning agreement on the title of the Land pursuant to Section 7.6 of the Act in a form approved by the Registrar General;

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities set out in Schedule C hereto;

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • Application Approval Date means the date that the Application is approved by the Board of Trustees of the District and as further identified in Section 2.3.B of this Agreement.

  • MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

  • type-approval means the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements;

  • CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

  • Pricing Approval means such mandatory governmental approval, agreement, determination or decision establishing prices for the Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority.

  • New Drug Application means a New Drug Application filed with the FDA in accordance with Applicable Law.

  • Marketing Authorisation means any approval (including all applicable pricing and governmental reimbursement approvals) required from the FDA or relevant Competent Authority to market and sell a Product in a particular country.

  • Regulatory Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.