Market Authorization definition
Examples of Market Authorization in a sentence
Supplier shall have the right to modify the Product packaging and labeling at any time, including, without limitation, to address modifications required or suggested by the relevant Government Authority issuing the Market Authorization.
Subject to the supervision of the Operations Committee, consistent with the license grants of Article 9 and except as otherwise provided herein, Crucell shall fund and be responsible for the preparation and submission of Regulatory Filings, including Market Authorization Application and Clinical Trial Applications, relating to Licensed Products in its own name with Regulatory Authorities in the Territory.
Labeling and packaging printing shall include any information required by local authorities under the Registration and Market Authorization.
It shall automatically expire when the Nominee transfer the Market Authorization to Cytovia or any of its Affiliate pursuant to clause 2.3.
In the event an Approved Local Distributor fails to comply with any terms of this Agreement, the Licensor shall have the right to withdraw its approval of such Approved Local Distributor with immediate effect by providing written notice to the Licensee, who will ensure that the Approved Local Distributor withdraws or otherwise doesn’t make use of the Market Authorization obtained in the name of the Approved Local Distributor.
JULPHAR agrees to provide to DANCE, as requested, with all information and data in JULPHAR’s possession or control for DANCE to obtain and maintain Market Authorization Approvals for the Product in any country, including information relating to the Production Site, or the methodology, raw materials used in the manufacture, processing or packaging of API, or any other matters, if proven by DANCE, that are required or requested to be provided to the EMA, FDA or any other Governmental Authority.
BNI shall use its best efforts to have the Amended FDA Market Authorization License (as defined herein) approved by the U.S. FD&A as soon as practicable.
The Lead Regulators will use their best efforts to complete this examination by July 1, 2007.
In all events such Amended FDA Market Authorization License approved by the U.S. FDA shall be approved prior to [date] (the “Amended Market Authorization Deadline”).
DISTRIBUTOR shall provide SUPPLIER with prior written notice of its contacts, liaisons, discussions, meetings, and correspondence with, and submissions to, any Government Authority to the extent relating to, or otherwise affecting, the Market Authorization of each Product (“Regulatory Correspondence”) and shall provide details of what will be, and what was, covered in such Regulatory Correspondence.