Regulatory Authority Interactions Sample Clauses

Regulatory Authority Interactions. Subject to Section 6.3 below, the Parties understand and agree that PTI, itself or through its agents, shall have the sole right to correspond with and submit INDs, NDAs, regulatory applications and other filings to the FDA or other Regulatory Authorities to obtain Product Registration approvals to import, export, sell or otherwise commercialize the Licensed Products as PTI deems useful or necessary to fulfill its obligations hereunder. Accordingly, except as otherwise required by law, DURECT shall not correspond directly with the FDA or any other Regulatory Authority relating to the process of obtaining Product Registrations or any obtained Product Registration for the Licensed Products, without PTI’s prior permission. Notwithstanding the foregoing, DURECT agrees to provide such reasonable assistance, as requested by PTI and at PTI’s expense, in preparing, submitting and maintaining NDAs and other applications for such Product Registrations.
Sample 1Sample 2Sample 3See All (5)
AutoNDA by SimpleDocs
Regulatory Authority Interactions. ​ 14.1 On and after the Transfer Date, the Distributor is responsible for completing and reporting of AE reports for Product and for submission to regulatory/competent authorities. This includes ​ ​ individual case [****] -Day Alert Reports and Periodic Safety Reports or Periodic Safety Update Reports, if applicable. ​ 14.2 On and after the Transfer Date, communications with NMPA relating to PV issues for the Product will be the responsibility of the Distributor or CASI. For clarity, prior to the Transfer Date, CASI shall continue to be responsible for all the obligations of the Distributor under this Section. ​
Sample 1Sample 2
Regulatory Authority Interactions. (a) All Regulatory Applications or Regulatory Approvals or permits that are owned, filed or applied for by Seller and which are necessary and material for Seller’s activities to date relating to the research, development, manufacture, commercialization and/or other use of Tissue Factor Antagonists are set forth on Schedule 7.5. There are no audit reports, warning letters, or notices of adverse findings, from Regulatory Authorities or other Third Parties relating to any Regulatory Application or Regulatory Approval with respect to any Tissue Factor Antagonist. Seller has made available to Purchaser true and correct copies of all written communications by or on behalf of or at the request of Seller with the FDA and all other Regulatory Authorities with respect to any Tissue Factor Antagonist, as well as copies of any notes relative to oral discussions. To Seller’s knowledge, no Third Party that conducted preclinical or clinical studies on Seller’s behalf has made, without Seller’s permission or request, any filings with the FDA or any other Regulatory Authority with respect to any Tissue Factor Antagonist. (b) To Seller’s knowledge, neither Seller nor any Third Party manufacturer of clinical supplies of Tissue Factor Antagonist has received notice of, or is subject to, any adverse inspection, finding of deficiency or non-compliance, compelled or voluntary recall, investigation, penalty for corrective or remedial action or other compliance or enforcement action by a Regulatory Authority or other Governmental Authority, in each case relating to any Tissue Factor Antagonist. (c) To Seller’s knowledge, no clinical investigator acting for Seller with respect to the Program has been or is now, or is threatened to become, the subject of any disbarment or disqualification proceedings by any Regulatory Authority.
Sample 1Sample 2
Regulatory Authority Interactions. ​ CASI is responsible for completing and reporting of AE reports for Products and for submission to regulatory/competent authorities. This includes individual case 15-Day Alert Reports and Periodic Safety Reports or Periodic Safety Update Reports, if applicable. ​ Communications with FDA relating to PV issues for the Products will be the responsibility of CASI. ​
Sample 1
Regulatory Authority Interactions. 7.1 KANGZHE will coordinate communication with authorities in the Territory with regard to 2016 Product IMPs but will provide XXXX, as soon as possible, with copies of 2016 Product IMPs-related submissions, correspondence, reports and discussions with authorities on quality issues. 7.2 Each Party shall notify the other Party immediately orally and in writing of any unannounced authority inspection relating to the Manufacturing and/or distribution of 2016 Product IMPs in the distribution network. Further, each Party shall notify the other Party as soon as possible, and in any event within five (5) business days following receipt of notice, of any announced authority inspection of its facility or Subcontractor’s facility relating to the2016 Product IMPs. Each Party shall permit a representative of the other Party to be present at the respective facilities to be inspected. 7.3 Each Party shall provide the other Party with copies of reports prepared by authorities related to the 2016 Product IMPs within fifteen (15) business days of receipt of such reports. Should a Party receive any document of regulatory action related to 2016 Product IMPs, such Party will inform the other Party of the document and shall provide the other Party the opportunity to comment and shall duly consider such comments when responding to such document of action.
Sample 1
Regulatory Authority Interactions. When Molecular Partners is Regulatory Lead, Molecular Partners is responsible for interfacing, corresponding and meeting with the applicable Regulatory Authorities for the Licensed Bispecific. Following Amgen’s assumption of Regulatory Lead, Amgen is responsible for interfacing, corresponding and meeting with the applicable Regulatory Authorities for the Products. The applicable Regulatory Lead shall notify the other Party of any scheduled meeting or conference with any Regulatory Authority that relates to the Licensed Bispecific reasonably in advance of such meeting and shall provide the other Party with any material documentation (provided that Amgen may redact proprietary CMC or manufacturing process development information which it reasonably determines to be competitively sensitive) prepared for such meeting or conference prior to such meeting or conference. [***] The Regulatory Lead shall promptly furnish the other Party with copies of all material correspondence to or from, and minutes of material meetings (including telephonic meetings) with, any Regulatory Authority relating to Development of the Licensed Bispecific (provided that Amgen may redact proprietary CMC or manufacturing process development information which it reasonably determines to be competitively sensitive).
Sample 1
Regulatory Authority Interactions. The Regulatory Lead shall provide the Non-Regulatory Lead with prior written notice, to the extent the Regulatory Lead has advance knowledge, of any action taken by a Regulatory Authority pertaining to a Licensed Compound or Licensed Product or of any scheduled substantive meeting or discussion (including any advisory committee meeting) with a Regulatory Authority in the Major Markets relating to a Licensed Compound or Licensed Product, which notice shall be provided within [***] after the Regulatory Lead first receives notice of the scheduling of such substantive meeting or discussion (or within such shorter period as may be necessary in order to give the Non-Regulatory Lead a reasonable opportunity to attend such meeting or discussion). In addition to any other involvement of the Non-Regulatory Lead in regulatory interactions agreed to by the Parties, the Non-Regulatory Lead shall (i) have the right to have at least [***] of its employees participate in, all such substantive meetings and discussions for the [***], and (ii) with the Regulatory Lead’s consent (not to be unreasonably withheld, delayed or conditioned), have at least [***] of its employees attend, as an observer, all such substantive meetings and discussions [***]. The Regulatory Lead will, at the request of the other Party, provide the other Party with a copy of any substantive correspondence from or to the Regulatory Authority, including any substantive reports, such as meeting minutes, or findings issued by the Regulatory Authority in connection with an audit by such Regulatory Authority or otherwise.
Sample 1
AutoNDA by SimpleDocs
Regulatory Authority Interactions. Section 7 of the QA shall be amended by replacing “2016 Product IMPs” with “Product IMPs” in each instance.
Sample 1
Regulatory Authority Interactions. KYE shall: (a) promptly provide Catalyst with reasonable advance written notice of any material Regulatory Filings, and any material meetings, telephone conferences or other discussions or correspondence made by KYE with any Regulatory Authority in the Territory, that pertain to the Product or Compound (b) afford representatives of Catalyst a reasonable opportunity to comment on such Regulatory Filings and proposed reply correspondence or other communications with Regulatory Authorities, and (c) incorporate in good faith Catalyst’s reasonable comments on the same. KYE shall provide Catalyst with copies of all such Regulatory Filings and shall promptly notify Catalyst with respect to any material changes or material matters that may arise in connection with any Regulatory Approval of the Product in the Territory.
Sample 1

Related to Regulatory Authority Interactions

  • 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.

  • Regulatory Authority If any regulatory authority having jurisdiction (or any successor boards or agencies), a court of competent jurisdiction or other Governmental Authority with the appropriate jurisdiction (collectively, the ''Regulatory Body'') issues a rule, regulation, law or order that has the effect of cancelling, changing or superseding any term or provision of this Agreement (the ''Regulatory Requirement''), then this Agreement will be deemed modified to the extent necessary to comply with the Regulatory Requirement. Notwithstanding the foregoing, if a Regulatory Body materially modifies the terms and conditions of this Agreement and such modification(s) materially affect the benefits flowing to one or both of the Parties, as determined by either of the Parties within twenty (20) business days of the receipt of the Agreement as materially modified, the Parties agree to attempt in good faith to negotiate an amendment or amendments to this Agreement or take other appropriate action(s) so as to put each Party in effectively the same position in which the Parties would have been had such modification not been made. In the event that, within sixty (60) days or some other time period mutually agreed upon by the Parties after such modification has been made, the Parties are unable to reach agreement as to what, if any, amendments are necessary and fail to take other appropriate action to put each Party in effectively the same position in which the Parties would have been had such modification not been made, then either Party shall have the right to unilaterally terminate this Agreement forthwith.

  • Regulatory Authorizations Each Party represents and warrants that it has, or applied for, all regulatory authorizations necessary for it to perform its obligations under this Agreement.

  • Communications with Regulatory Authorities During the Collaboration Term, Xencor shall provide MorphoSys with reasonable advance notice of any meeting or substantive telephone conference with any Regulatory Authority relating to any Licensed Antibody and/or Licensed Product. MorphoSys shall have the right to attend and observe (but not participate actively in) any material meeting or material conference call with any Regulatory Authority regarding any of MorphoSys (or its Affiliate’s or Sublicensee’s) Licensed Antibody and/or Licensed Products. In addition, Xencor shall promptly furnish to MorphoSys copies of all correspondence that Xencor (or its Affiliate) receives from, or submits to, any Regulatory Authority (including contact reports concerning conversations or substantive meetings) relating to any Licensed Antibody and/or Licensed Product. Xencor shall also provide to MorphoSys any meeting minutes that reflect material communications with any Regulatory Authority regarding a Licensed Antibody and/or Licensed Product. Subject to the provisions of Section 2.2(c)(ii), MorphoSys shall provide in its MorphoSys Annual Development Reports to Xencor, and through JDC discussion, information regarding its (or its Affiliate’s or, to the extent permitted by the Sublicense, Sublicensee’s) interactions with Regulatory Authorities with respect to all Licensed Antibodies and/or Licensed Products in its respective Territory. In addition, to the extent permitted by law and subject to Section 3.6, Xencor may participate in communications and meetings with any Regulatory Authority to the extent the name and/or then-current Xencor logo is used on the drug product label and such labeling is being discussed in such communication or meeting. Notwithstanding MorphoSys’ obligations under this Article 3, MorphoSys shall not be required to share with Xencor any information which MorphoSys is not permitted to share with Xencor under the applicable laws or regulations of the Securities & Exchange Commission or other regulatory body of the US or elsewhere.

  • Other Regulatory Approvals All necessary approvals, authorizations and consents of any governmental or regulatory entity required to consummate the Merger shall have been obtained and remain in full force and effect, and all waiting periods relating to such approvals, authorizations and consents shall have expired or been terminated.

  • Statutory Authority Connecticut General Statute §§ 10a-104, 10a-108, 4a-52a, and 10a-151b provide the University with authority to enter into contracts in the pursuit of its mission.

  • Regulatory Applications (a) Western and PNB and their respective Subsidiaries shall cooperate and use their respective reasonable best efforts to prepare all documentation, to effect all filings and to obtain all permits, consents, approvals and authorizations of all third parties and Governmental Authorities necessary to consummate the transactions contemplated by this Agreement. Western and PNB shall use their reasonable best efforts to make all required bank regulatory filings, including the appropriate filing with the Regulatory Authorities. Each of Western and PNB shall have the right to review in advance, and to the extent practicable each will consult with the other, in each case subject to applicable laws relating to the exchange of information, with respect to all material written information submitted to any third party or any Governmental Authority in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto agrees to act reasonably and as promptly as practicable. Each party hereto agrees that it will consult with the other party hereto with respect to the obtaining of all material permits, consents, approvals and authorizations of all third parties and Governmental Authorities necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the other party appraised of the status of material matters relating to completion of the transactions contemplated hereby. (b) Each party agrees, upon request, to furnish the other party with all information concerning itself, its Subsidiaries, directors, officers and shareholders and such other matters as may be reasonably necessary or advisable in connection with any filing, notice or application made by or on behalf of such other party or any of its Subsidiaries to any third party or Governmental Authority.

  • COOPERATION WITH REGULATORY AUTHORITIES OR OTHER ACTIONS The parties to this Agreement each agree to cooperate in a reasonable manner with each other in the event that any of them should become involved in a legal, administrative, judicial or regulatory action, claim, or suit as a result of performing its obligations under this Agreement.

  • Governing Law, Regulatory Authority, and Rules The validity, interpretation and enforcement of this Agreement and each of its provisions shall be governed by the laws of the state of New York, without regard to its conflicts of law principles. This Agreement is subject to all Applicable Laws and Regulations. Each Party expressly reserves the right to seek changes in, appeal, or otherwise contest any laws, orders, or regulations of a Governmental Authority.

  • Regulatory Approvals (a) Each Party shall, and shall cause its ultimate parent entity (as such term is defined in the HSR Act) to, use reasonable best efforts to file or otherwise submit, as soon as practicable after the date of this Agreement, all applications, notices, reports, filings and other documents reasonably required to be filed by such Party or its ultimate parent entity with or otherwise submitted by such Party or its ultimate parent entity to any Governmental Body with respect to the Contemplated Transactions, and shall file no later than ten (10) Business Days thereafter the Notification and Report Forms required by the HSR Act. Each Party shall (i) promptly supply the other with any information which may be required in order to effectuate such filings, (ii) submit promptly any additional information which may be reasonably requested by any such Governmental Body, and (iii) coordinate with the other Party in making any such filings or information submissions pursuant to and in connection with the foregoing that may be necessary, proper, or advisable in order to consummate and make effective the Contemplated Transactions. (b) Without limiting the generality of anything contained in this Section 5.4, in connection with its efforts to obtain all requisite approvals and authorizations, and the expiration or termination of all applicable waiting periods for the Contemplated Transactions under any Antitrust Law, each Party hereto shall use its reasonable best efforts to (i) cooperate with the other with respect to any investigation or other inquiry; (ii) promptly provide to the other a copy of all communications received by such Party from, or given by such Party to, any Governmental Body, in each case regarding the Contemplated Transactions; and (iii) to the extent not prohibited under applicable Antitrust Law, permit the other to review in advance any communication given by it to any Governmental Body concerning the Contemplated Transactions, consider in good faith the views of the other in connection with any proposed written communications by such Party to any Governmental Body concerning the Contemplated Transactions, and consult with each other in advance of any meeting or telephone or video conference with, any Governmental Body, and give the other or its outside counsel the opportunity to attend and participate in such meetings and conferences unless prohibited by the applicable Governmental Body; provided, that materials required to be provided pursuant to this Section 5.4(b) may be restricted to outside counsel and redacted to (A) remove references concerning the valuation of either Party, (B) comply with contractual arrangements, and (C) preserve attorney-client privilege. Neither Party shall commit to or agree with any Governmental Body to stay, toll or extend any applicable waiting period under applicable Antitrust Law, or pull and refile under the HSR Act, without the prior written consent of the other. Parent and the Company shall each pay one-half of the filing fee under the HSR Act relating to the HSR filing required for the Merger; provided, however, that each Party shall bear its own legal fees. (c) Except as required by this Agreement, prior to Closing, neither the Company nor Parent shall, and shall cause its Affiliates not to, acquire or agree to acquire by merging or consolidating with, or by purchasing a substantial portion of the assets of or equity in, or by any other manner, any Person or portion thereof, or otherwise acquire or agree to acquire any assets, if the entering into of an agreement relating to or the consummation of such acquisition, merger or consolidation would reasonably be expected to (i) impose any delay in the obtaining of, or significantly increase the risk of not obtaining, any authorizations, consents, orders, declarations or approvals of any Governmental Body necessary to consummate the Contemplated Transactions or the expiration or termination of any applicable waiting period, or (ii) increase the risk of any Governmental Body entering an order prohibiting the consummation of the Contemplated Transactions.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!