MA Approval definition

MA Approval means approval, licenses, registrations, or authorizations of Regulatory Authorities in the applicable regulatory jurisdiction for the use, storage, import, transport and/or sale of a pharmaceutical, therapeutic and medical device product in such regulatory jurisdiction.
Sample 1Sample 2
MA Approval means any MA approved, accepted or issued by a Regulatory Authority and the consequent grant of the right to sell the Licensed Formulation for use in the Licensed Field as a pharmaceutical or medicinal product, and corresponding or related approvals, licenses, registrations, or authorizations granted or issued by any Regulatory Authority. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 406 of the Securities Act of 1933, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission
Sample 1

Examples of MA Approval in a sentence

  • Exhibit 2: Plan of Land of #00 Xxxxxxx Xxxx, Barnstable, MA, Approval Not Required plan, prepared by Down Cape Engineering, Inc., dated 11/22/2021 Exhibit 3: Existing Design Review Procedure for the Hospital, as revised Exhibit 4: Xxxxxxx Road Medical Community Design Guidelines, prepared by TRO/The Xxxxxxx Organization, dated 6/14/2003 Exhibit 5: Letter, Re: Xxxxxxx Xxxx (CCC File No. DA-02014, submitted by Xxxxxxxxx X.

  • Pursuant to Article 26 of the Investment Law, a foreign investor must seek a preliminary approval ("M&A Approval") if it intends to acquire equity of an existing company.

  • In addition, there is inconsistency regarding the entities responsible for submitting the application dossier for M&A Approval as regulated under Article 26 of the Investment Law and Article 66 of Decree 31/2021/ND-CP.

  • In practice, several investment registration authorities have provided guidance that an M&A Approval will be required if the new investor(s) bears different nationality from the current investor, even if the acquisition does not change the foreign ownership ratio in the existing company (e.g., a Singapore investor has a subsidiary or a joint venture in Vietnam that does manufacturing, and then sells its equity in such company to a Thai investor).

  • We recommend (i) guidance/instruction to the local investment registration authorities that an M&A approval is not required if there is no change in the foreign ownership ratio in the first two cases; (ii) guidance on definition of Security Area; and (iii) confirmation on applicant of the M&A Approval.

  • Therefore, the competent authorities are highly cautious when dealing with this situation and likely to advise foreign investors and target companies to submit applications for M&A Approval for review and written confirmation as long as the target companies hold the appropriate land use rights.

  • This broad definition leads to the practice that various local investment registration authorities have advised the foreign investors and target companies to apply for and obtain M&A Approval as long as the target companies own the relevant land use right.

  • Just send it on to them.Jeannine BlackwellDean of the Graduate School University of Kentucky102 Gillis Building Lexington, KY 40506‐0033 blackwell@uky.edu From: Bailey, Francis MSent: Tuesday, March 26, 2013 9:20 AMTo: Blackwell, JeannineCc: Rouhier-Willoughby, Jeanmarie; Gebert, FriedaSubject: RE: TESL MA Approval Problem - Assistance Requested This looks great.

  • C Service Rendered transfers allowed during entire stay in UAE Approval of 1500 2500 3500 1 year Unlimited internal labour permit for PhD & MA Approval of 3000 3500 4000 2 Years 2 internal labour permit for BA or equivalent Approval of 5000 5500 6000 3 Years 1 internal labour permit for all other groups Sponsorship transfer fees of workers above 60 years and belonging to any of the three workers’ categories is Dhs.5000/- regardless of the category of the new sponsoring company as well.

  • However, in practice, we have seen a case where the Management Authority of an industrial zone requested the local DPI to give opinions for the application for M&A Approval.

Related to MA Approval

  • 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.

  • 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.

  • 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.

  • 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:

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

  • 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.

  • 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.

  • 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).

  • 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.

  • HSR Approval means expiration of all applicable waiting periods under the HSR Act (including any voluntary agreed extensions) or earlier termination thereof.

  • 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.

  • 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.

  • 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 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.

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

  • Special Approval means approval by a majority of the members of the Conflicts Committee.

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

  • 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;

  • 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).

  • Initial approval means authorization to admit students and enter into contractual agreements for clinical facilities. It is granted only after an application has been submitted, reviewed and a survey visit made by the Board. No students shall be admitted to the program until the institution has received written notification that initial approval has been granted. Failure to comply will delay initial approval.

  • 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).

  • Reimbursement Approval means an approval, agreement, determination, or other decision by the applicable Governmental Authority that establishes prices charged to end-users for pharmaceutical or biologic products at which a particular pharmaceutical or biologic product will be reimbursed by the Regulatory Authorities or other applicable Governmental Authorities in the Territory.

  • Development approval means any written authorization from a

  • 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.