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. (a) In the development of the Licensed Products, and prior to Licensee sourcing, marketing, manufacturing or distributing any Licensed Product, Licensee shall submit to Callaway Golf for Callaway Golf’s prior written approval and consent, which approval and consent shall not be unreasonably withheld, the line art, fabric swatches, labels, hangtags, and sourcing plan for each proposed Licensed Product, including component, logo and color direction (a “Design Submission”). Each Design Submission submitted shall show how the Licensed Trademark will be applied and how it will look. Each such Design Submission shall include a written transmittal conspicuously including the statement “FAILURE TO EXPRESSLY DISAPPROVE OF THE ENCLOSED DESIGN SUBMISSION WITHIN FIFTEEN (15) DAYS SHALL RESULT IN A DEEMED APPROVAL OF THIS DESIGN SUBMISSION.” Callaway Golf shall have fifteen (15) calendar days following its receipt of a new Design Submission within which to approve or disapprove in its sole and absolute discretion such Design Submission, including without limitation the form and appearance of the Licensed Trademarks on the proposed Licensed Product. If Licensee does not receive written approval from Callaway Golf within such fifteen-day period, such Design Submission shall be deemed to be approved, provided a representative of the Callaway Golf Licensing Department has acknowledged in writing (including e-mail) the receipt of such Design Submission.
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. .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. 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.
Product Approval. “Product Approval” shall mean final FDA approval of Zavante’s New Drug Application (“NDA” or “ANDA”).
Product Approval. “Product Approval” shall mean final approval by FDA of OMEROS’ NDA or ANDA for marketing of Product or analogous approval(s) from other Regulatory Authorities, as applicable.
