Obtain Regulatory Approval definition

Obtain Regulatory Approval means those actions required or advisable to prepare and submit commercially viable Products for Regulatory Approval as soon as reasonably practicable, including without limitation formulation, modification and refinement activities, determination of dosage, conducting clinical trials, and labeling the Products.
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Examples of Obtain Regulatory Approval in a sentence

  • Approval Date; Termination Related to Failure to Timely Obtain Regulatory Approval.

  • CUBIST desires to obtain a license under the XTL Patent Rights and XTL Know-How upon the terms and conditions set forth herein in order to Obtain Regulatory Approval and commercialize such monoclonal antibodies, and XTL desires to grant such a license.

  • Notwithstanding anything in this Section 5 or elsewhere in this Agreement to the contrary, XTL shall cease any activities to Obtain Regulatory Approval, including any pre-clinical and clinical activity for Products, upon receipt of written notice from CUBIST to cease such activity, or as soon as practicable thereafter.

  • Upon CUBIST’s reasonable request, XTL shall cooperate with and assist CUBIST in the communication with any Regulatory Authority or in the preparation and submission of any regulatory filing regarding Product, and will provide such information and data in XTL’s possession or control that is necessary to Obtain Regulatory Approval.

  • Notwithstanding anything in this Section 6 or elsewhere in this Agreement to the contrary, XTL shall cease any regulatory activity and all attempts to Obtain Regulatory Approval with respect to any Product upon receipt of written notice from CUBIST to cease such activity, or as soon as practicable thereafter.

  • In connection with any activities undertaken by XTL to Obtain Regulatory Approval in connection with any Product, XTL shall comply with all applicable laws, rules and regulations regarding such activities, as such laws, rules and regulations are in effect where such activities are undertaken.

  • Each Party will notify the other Party of any material health hazards with respect to Products that may impact employees involved in the activities to Obtain Regulatory Approval, manufacture, production or supply of Products as soon as practicable, and in any event within forty-eight (48) hours, after such Party becomes aware of such hazards.

  • If a Product becomes the subject of a claim by a Third Party that the activities undertaken to Obtain Regulatory Approval, manufacture, use, sell, Commercialize or export or import Product constitutes, causes or results in infringement of any patent rights of such Third Party or other related intellectual property rights (any such claim, a “Third Party Infringement Claim”), the Party first having notice of such Third Party Infringement Claim shall promptly notify the other Party.

  • For the purposes of calculating Designated Costs, XTL’s activities under this Section 4.1(a) (with the exception of XTL’s obligation to transfer information or technology to an Israeli subsidiary of CUBIST) in connection with HepeX-B shall be considered to be activities necessary or advisable to Obtain Regulatory Approval for a commercially viable formulation of HepeX-B for the prevention of recurrent Hepatitis B infections in liver transplant patients in the Territory.

  • The Guidelines outline the scientific, clinical, regulatory and manufacturing activities that are currently contemplated to be required to Obtain Regulatory Approval for a commercially viable formulation of HepeX-B for the prevention of recurrent Hepatitis B infections in liver transplant patients in the US and the EU.

Related to Obtain Regulatory Approval

  • Regulatory Approval means, with respect to the Licensed Product in any country or jurisdiction, all approvals (including, where required, pricing and reimbursement approvals), registrations, licenses or authorizations from the relevant regulatory authority in a country or jurisdiction that is specific to the Licensed Product and necessary to market and sell such Licensed Product in such country or jurisdiction.

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

  • 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.

  • 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;

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

  • 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.

  • 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.

  • 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.

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

  • 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.

  • FDA Approval means the approval of the United States Food and Drug Administration necessary for the marketing, distribution in interstate commerce and sale of the Initial Product (as defined in the Collaboration and License Agreement) in the United States.

  • 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.

  • 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.

  • 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).

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Licensed Product as a drug 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.

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • 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 Authority means any applicable supranational, national, regional, state or local regulatory agency, department, bureau, commission, counsel, or other government entity involved in granting of Regulatory Approval for a Licensed Product in a regulatory jurisdiction within the Territory, including the FDA and the EMEA.

  • Regulatory Authorizations means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies, including all Product Authorizations.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

  • 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:

  • Conditional approval means a time-limited status that results when an approved nursing education program has failed to maintain requirements as set forth in this chapter.