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, 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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Examples of Health Registration Approval in a sentence

  • 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.

  • Nektar and its licensees outside the Territory may, at no cost and without making any payments to Daiichi Sankyo, use any and all Safety-Related Information generated by Daiichi Sankyo in submissions for Health Registration Approval and in other Regulatory Documentation and in filings with Health Authorities, in each case outside the Territory in connection with the Licensed Product.

  • Daiichi Sankyo may, at no additional cost and without making any additional payments to Nektar, use any and all Safety-Related Information of Nektar in submissions for Health Registration Approval and in other Regulatory Documentation and in filings with Health Authorities, in each case in connection with the Licensed Product for the Approved Indications.

  • 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.

  • 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.

  • 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.

  • Daiichi Sankyo will use Commercially Reasonable Efforts to prepare and submit in a timely manner such MAAs with the applicable Health Authority seeking Health Registration Approval for the Licensed Product for the Primary Indication in Turkey; provided however, that neither Nektar nor Daiichi Sankyo shall be obligated to conduct any Clinical Studies or other Development activities in support of any such MAA in Turkey.

  • 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.

  • 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.


More Definitions of Health Registration Approval

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 lawfully to distribute, sell and market the Product in such country, including, where applicable, post-approval marketing authorisations, labelling approvals and technical, medical and scientific licences, but excluding any pre-approval marketing authorisations;
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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 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 shall have the meaning set forth in the License Agreement.
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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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Related to Health Registration Approval

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • 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 any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • 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 as 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, 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.

  • 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 of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • 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 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.

  • 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 governmental approval, agreement, determination or decision establishing prices for a Licensed 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, including all INDs and NDAs.

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • 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.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • 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.