Japanese Approval definition

Japanese Approval means the approval of a Product for marketing in Japan by the Japanese Ministry of Health and Welfare (or any future equivalent process), together with any other approval necessary to make and sell Product commercially in Japan without the requirement for price having been approved. If a Product can be sold in Japan without Ministry of Health and Welfare approval, Japanese Approval will be deemed to have been obtained on the first sale of a Product in Japan.
Sample 1Sample 2Sample 3
Japanese Approval means the approval of an ATL1103 Product for marketing in Japan by the Japanese Ministry of Health and Welfare (or any future equivalent process), together with any other approval necessary to make and sell an ATL1103 Product commercially in Japan (including Pricing Approval, but excluding Pricing Approval with respect to the achievement of Milestones). If an ATL1103 Product can be sold in Japan without Ministry of Health and Welfare approval, Japanese Approval will be deemed to have been obtained on the First Commercial Sale of an ATL1103 Product in Japan.
Sample 1Sample 2Sample 3
Japanese Approval means the approval of a Product for marketing in Japan by the Japanese Ministry of Health and Welfare (or any future
Sample 1

Examples of Japanese Approval in a sentence

  • Where vehicles have been imported from Japan, evidence that the vehicle was type approved in that country will be taken to confirm that the vehicle meets the requirements in respect of those items where Japanese Approval is considered comparable (see Section 3.2 on page 10 titled ‘Comparable standards’).

  • This document describes the conformity assessment procedures of the Japanese Approval Scheme that may be followed.

  • Japanese Approval means the approval of an ATL1103 Product for marketing in Japan by the Japanese Ministry of Health and Welfare (or any future equivalent process), together with any other approval necessary to make and sell an ATL1103 Product commercially in Japan (including Pricing Approval, but excluding Pricing Approval with respect to the achievement of Milestones).

  • Where vehicles have been imported from Japan, evidence that the vehicle was type approved in that country will be taken to confirm that the vehicle meets the requirements in respect of those items where Japanese Approval is considered comparable (see section 5.2 page 15) ‘Comparable Standards’).

  • In addition, each occasion where the Merger Agreement contemplates the Parent Company obtaining the Japanese Approvals and delivering evidence thereof to Buyer, including, without limitation, Section 6.09, shall be deemed to refer to the Parent Company's receipt and delivery of the Japanese Approval of this Third Amendment in accordance with this Section 13.

  • I want to thank my parents, Teresa and Jeffery McCaw, Sr. It is through their guidance and support of my inquisition into all things I do not understand, that I arrived at this particular place, asking uncomfortable questions with the hope that someone who reads this will be inspired to work with me toward finding the answers.

  • Conformity Assessment Procedures of the Japanese Approval Scheme3.1 OverviewTo prove your product complies with the Japanese requirements you can use different conformity assessment procedures.

  • If an ATL1103 Product can be sold in Japan without Ministry of Health and Welfare approval, Japanese Approval will be deemed to have been obtained on the First Commercial Sale of an ATL1103 Product in Japan.

  • The Parties hereby acknowledge and agree that the Merger Agreement (other than Sections 6.06 and 9.20 thereof) shall not be deemed an effective or binding obligation of any Party until the Parent Company obtains the Japanese Approval of this Third Amendment and provides documentation to Buyer evidencing the receipt of such Japanese Approval.

  • Notwithstanding anything to the contrary contained in the Merger Agreement, the Parent Company, at its sole cost and expense, shall obtain the Japanese Approval of this Third Amendment and deliver evidence thereof to Buyer within twenty-one (21) days of the execution of this Third Amendment.

Related to Japanese Approval

  • Price Approval means, in any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).

  • 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;

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • 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.

  • 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.

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

  • 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.

  • Requisite Approval means the affirmative vote of the holders of (a) at least a majority of the outstanding shares of Company Capital Stock, voting together as a single class and (b) at least a majority of the outstanding shares of Series A-1 Preferred Stock, Series B Preferred Stock and Series C Preferred Stock, voting together as a single class on an as-converted basis.

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

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

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • 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.

  • 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).

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

  • Government Approval means an approval, permit, license, authorization, certificate, or consent of any Governmental Authority.

  • Approval Authority means the authority of a Member State with competence for all aspects of the approval of a type of vehicle, system, component or separate technical unit or of the individual approval of a vehicle; for the authorisation process, for issuing and, if appropriate, withdrawing approval certificates; for acting as the contact point for the approval authorities of other Member States; for designating the technical services and for ensuring that the manufacturer meets his obligations regarding the conformity of production;

  • 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.

  • Pricing Approval means any approval, agreement, determination, or decision establishing prices that can be charged to consumers for a pharmaceutical or biological product or that will be reimbursed by Governmental Authorities for a pharmaceutical or biological product, in each case, in a country where Governmental Authorities approve or determine pricing for pharmaceutical or biological products for reimbursement or otherwise.

  • 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.

  • FCC Approval means the FCC’s grant of the FCC Applications; provided that the possibility that an appeal, request for stay, or petition for rehearing or review by a court or administrative agency may be filed with respect to such grant, or that the FCC may reconsider or review such grant on its own authority, shall not prevent such grant from constituting FCC Approval for purposes of the Plan.

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • 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).

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

  • 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.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.