Examples of Manufacturing Approvals in a sentence
Each Party will have the right, during normal business hours and upon reasonable prior notice, to inspect and copy those records of the other Party referred to herein that are necessary or useful to the inspecting Party for the purposes of making any required filings with Regulatory Authorities in order to obtain Manufacturing Approvals and/or Marketing Approvals.
The Approved Facilities (i) comply in all material respects with all relevant and applicable Law and standards and have all relevant regulatory permits and approvals including valid Manufacturing Licenses and Manufacturing Approvals; and (ii) currently have, and Pacira shall use commercially reasonable efforts to maintain, the necessary Equipment and personnel required for the manufacture of the Licensed Product in compliance with the NADA.
The Project Manager shall be the first point of contact between the Parties in relation to the placement of Bulk Product orders, confirmation of Delivery Dates, issues relating to manufacturing and Manufacturing Approvals.
Santarus will use its Commercially Reasonable Efforts to promote, sell and distribute a Licensed Product in the Field and in the Territory after it obtains Regulatory Approval therefore to market and sell, consistent with accepted business practices, provided that all Manufacturing Approvals are in place and continuously effective.
Pacira shall maintain and shall require any Third Party Manufacturer to maintain in good order all Manufacturing Approvals and permits relating to the Approved Facilities, the Backup Facility, if applicable and the Manufacturing Services, as granted by any Relevant Authority, for so long and insofar as is necessary to permit Pacira to provide the Manufacturing Services as contemplated hereunder.
The SIMM is a model that has evolved over time since its first release to regulators in September 2014.
Pacira shall be responsible for ensuring that each Third Party Manufacturer has all necessary Manufacturing Approvals, is a cGMP-approved facility and is otherwise in compliance with the terms and conditions of this Agreement and all Applicable Laws.
Santarus further agrees to commercially launch a Licensed Product for the Initial Indication in the U.S. within one hundred twenty (120) days following receipt of all necessary Regulatory Approvals to market and sell such Licensed Product in the U.S. for the Initial Indication (subject to prior timely receipt of adequate Launch Supplies from Pharming and provided that all Manufacturing Approvals are in place and effective).
Pacira shall, and will require any Third Party Manufacturer to, make copies of such Manufacturing Approvals and all related documents available to Company and its designees for inspection, upon reasonable request from Company.
The Project Manager shall be the first point of contact between the parties in relation to the placement of Product orders, the status of import and export licenses, confirmation of Delivery Dates, issues relating to Manufacturing and Manufacturing Approvals.