Obtaining Regulatory Approval Sample Clauses

Obtaining Regulatory Approval. BioMarin will continue to act as regulatory agent for and be responsible for all ongoing communications with the FDA regarding obtaining Regulatory Approvals for Orapred ODT and Orapred RT in the United States and will bear all costs associated with obtaining such Regulatory Approvals. After FDA grants Regulatory Approvals for Orapred ODT and Orapred RT, Alliant will act as regulatory agent for and be responsible for maintaining Regulatory Approvals for Orapred ODT and Orapred RT, including all costs associated with such maintenance. For Orapred in all of North America, for Orapred ODT and Orapred RT in all of North America other than the United States, and for all other Licensed Products in all of North America, BioMarin shall use commercially reasonable efforts to cause Alliant to be named as regulatory agent for and be responsible for obtaining and maintaining Regulatory Approvals, including all costs associated with those activities, provided that if Alliant is not permitted to act as a regulatory agent under the terms and conditions of the Ascent License, then BioMarin will continue to act as a regulatory agent for the Licensed Products on behalf of Alliant and pursuant to the instructions provided by Alliant; provided that Alliant shall be responsible for preparing, at its expense, all regulatory filings that are required by Law or deemed desirable by Alliant. While acting as a regulatory agent with respect to Licensed Products, each Party will comply with all requirements under 21 CFR Part 203 (Prescription Drug Marketing Act), 21 CFR Part 314.70 (Supplements and Other Changes to an Approved Application), 21 CFR Part 314.80 (Post-Marketing Reporting of Adverse Drug Experiences) and 21 CFR Part 314.81 (Other Post-Marketing Reports). After the Acquisition Date, during the License Term, BioMarin will transfer to Alliant all FDA Licenses for the Orapred Products that the FDA grants to BioMarin or its Affiliate.
Sample 1
AutoNDA by SimpleDocs
Obtaining Regulatory Approval. Sanofi shall be responsible for filing Regulatory Materials that are necessary for obtaining the Regulatory Approvals of the Product in the Sanofi Territory in the Field (“Sanofi Territory Approvals”), including performing any and all Development activities in the Sanofi Territory in connection therewith. Sanofi shall file for the Sanofi Territory Approvals in such countries in the Sanofi Territory at its cost and expense and on such schedule, in each case, that are consistent with Commercially Reasonable Efforts and Sanofi’s diligence obligations as set forth in Section 4.5. For clarity, the Regulatory Materials for which Sanofi is responsible hereunder include INDs and XXXx that are specific for countries or regions in the Sanofi Territory, but expressly exclude any Regulatory Materials filed with the FDA or EMA.
Sample 1
Obtaining Regulatory Approval. Without limitation, this subscription and the transactions contemplated by this Subscription Agreement are conditional upon and subject to the Company having obtained such regulatory approval of this subscription and the transactions contemplated by this Subscription Agreement as the Company considers necessary.
Sample 1
Obtaining Regulatory Approval 
Sample 1

Related to Obtaining Regulatory Approval

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • Other Regulatory Approvals Each party hereto shall cooperate and use its reasonable best efforts to promptly prepare and file all necessary documentation to effect all necessary applications, notices, petitions, filings and other documents, and use all reasonable efforts to obtain (and will cooperate with each other in obtaining) any consent, acquiescence, authorization, order or approval of, or any exemption or nonopposition by, any Governmental Entity required to be obtained or made by Parent or the Company or any of their respective Subsidiaries in connection with the Offer and the Merger or the taking of any other action contemplated by this Agreement.

  • Regulatory Authorities Except as described in the Registration Statement, the General Disclosure Package or the Prospectus, each of the Company and its subsidiaries: (a) is and at all times has been in material compliance with all statutes, rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”); (b) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (c) possesses all Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (d) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (e) has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that any such Governmental Authority is considering such action; and (f) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission). The studies, tests and preclinical and clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each of its subsidiaries, were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its subsidiaries has received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are material to the Company and its subsidiaries taken as a whole.

Time is Money Join Law Insider Premium to draft better contracts faster.