Product Approval. Notwithstanding the terms set forth above, Client shall use its best efforts to expedite and obtain all regulatory approvals necessary for Catalent to commence production at the Facility (“Regulatory Approvals”).
Product Approval. “Product Approval” shall mean final FDA approval of Barrier’s New Drug Application (“NDA”) or other Regulatory Documentation.
Product Approval. Notwithstanding the terms set forth above, Indivior shall use its best efforts to expedite and obtain all regulatory approvals necessary for Curia to commence production at a Facility, as applicable ("Regulatory Approvals").
Product Approval. .1 Bidders are required to provide submittals indicating compliance with this specification. Submit test reports from approved independent testing laboratories, certifying compliance with reference standards.
Product Approval. “Product Approval” shall mean final FDA approval of Zavante’s New Drug Application (“NDA” or “ANDA”).
Product Approval. University shall have the right to review any and all products of the associated with the Permitted Uses and reserves the right to reject and disallow Facility User’s use or distribution of any and all content that denigrates the quality or reputation of the university, faculty, staff, students or degrees in anyway.
Product Approval. If any Regulatory Approvals in the United States necessary for Catalent to commence Processing at the Facility have not been obtained by Client by the Regulatory Approval Target Date, then Client shall pay to Catalent the monthly fee as provided in Attachment D (“Delayed Approval Fee”) until the earlier of (A) the date this Agreement is terminated by a party pursuant to this Section 7.3 or (B) the date such Regulatory Approval has been obtained. If such Regulatory Approval has not been obtained within [**] following the Regulatory Approval Target Date, then Client and Catalent shall each have the right to terminate this Agreement pursuant to Section 16.2(C).
Product Approval. 3.1 Supplier will reasonably assist Cempra in compilation of information for the chemistry, manufacturing and control documentation which Cempra determines in good faith is needed for completion of Product Approvals or filings or submissions with respect thereto, regulatory or otherwise. Supplier shall (i) provide Cempra with the publicly available portion of any drug master file established, maintained, or referenced by Supplier with respect to Supplied API supplied hereunder or otherwise related to its performance under this Agreement, (ii) maintain and update all such drug master files in compliance with all Applicable Laws (including but not limited to GMP and all FDA regulations and guidelines and those requirements included in the Product Approvals), and (iii) grant Cempra a right of reference (including rights of sublicense and assignment of such right of reference) to any such drug master file or related supporting information. Supplier Agent may perform certain of the Supplier’s foregoing obligations at the request of Supplier.
3.2 Supplier or Supplier Agent shall notify Cempra in writing as soon as possible of any notification received by either Supplier or Supplier Agent from FDA or any other applicable Regulatory Authority to conduct an inspection of Supplier’s manufacturing, development or other facilities directly related to the manufacture or supply of Supplied API under this Agreement. Within five (5) business days of receipt thereof, Supplier or Supplier Agent shall provide to Cempra a copy of any report and other written communications (including a detailed summary, in English, of any oral comments made by an agent of the FDA or applicable Regulatory Authority) received by them from the FDA or applicable Regulatory Authority to the extent that such report or communication relates to Supplier’s performance under this Agreement or the manufacture of Supplied API. Supplier or Supplier Agent shall provide Cempra with frequent, prompt status updates with regard to any audit or inspection conducted by FDA (or other applicable Regulatory Authority) of Supplier which relates directly to Supplied API supplied under this Agreement or which could impact on the ability to make or to continue to make and supply Supplied API under this Agreement.
Product Approval. If any Regulatory Approval necessary for Catalent to commence Processing at the Facility has not been obtained by Client within 12 months following the Effective Date, then Client shall pay to Catalent a fee as provided in Attachment B (“Delayed Approval Fee”) until such Regulatory Approval has been obtained and Catalent is able to commence Processing.
Product Approval. (a) It is of the essence of this agreement that the Licensee obtain the Licensor's prior written approval of each and every item of the Products (including, without limitation, the form and content of all advertising and promotional material in which the Property appears for use at trade shows and in the press, magazines, television, radio, billboard, on-line and cinema advertisements or in any other way) which the Licensee desires to exploit pursuant to this agreement. Licensee acknowledges that Licensor cannot issue any approvals hereunder without the Licensor first receiving the AFL's approval. In this regard the Licensee shall submit to the Licensor at no cost or expense to the Licensor (whether recoupable or otherwise) for the Licensor's approval:
(i) a description of the concept, including full information on the nature and function of the proposed item and a general description of how the Property and other material will be used on them;
(ii) complete layouts and descriptions of the proposed Products and promotional and packaging material showing exactly how and where the Property and other artwork and wording will be used;
(iii) pre-production models or prototype samples of the proposed Products and promotional and packaging material;
(iv) proposed timetabling for the Products in the market; and
(v) not less than ten (1 0) actual non-royalty bearing production samples of the proposed products and promotional and packaging material.
(b) Unless and until the Licensee shall receive the Licensor's written approval of such samples of the Products, the Licensee shall not proceed to manufacture (other than for pre-production purposes), distribute or exhibit the same. The Products so manufactured and distributed shall be of the same quality and content as the samples approved by the Licensor as aforesaid and shall be manufactured in accordance with specifications approved by the Licensor. Promptly following the initial manufacturing run of each of the Products, the Licensee shall furnish the Licensor at no cost or expense to the Licensor (whether recoupable or otherwise) with twenty four (24) further items of the Products. The Licensor may purchase from the Licensee each Product for non-competitive reasons at Licensee's cost price plus ten percent (1 0%). At the Licensor's request and at the Licensee's sole cost and expense, the Licensee shall submit random samples of the Products to the Licensor for inspection. Additionally at the Licenser's request, the ...
