Regulatory Authority Communications Received by a Party Sample Clauses

Regulatory Authority Communications Received by a Party. Each Party shall inform the other Party in a timely manner, not to exceed [***], of the notification of any action by, or notification or other information which it receives (directly or indirectly) from any Regulatory Authority which: (i) raises any material concerns regarding the safety or efficacy of a Product; (ii) indicates or suggests a potential material liability of either Party to Third Parties in connection with a Product; (iii) is reasonably likely to lead to a recall or market withdrawal of a Product; or (iv) relates to expedited reports of adverse events with respect to a Product, or Product Complaints, and which may have a material impact on obtaining or maintaining Regulatory Approval or the continued Commercialization of a Product, as then conducted. The other Party will fully cooperate with and assist such Party in complying with regulatory obligations and communications, including by providing to such Party, in a timely manner after a request, such information and documentation in the other Party’s possession as may be necessary or helpful for the Party to prepare a response to an inquiry from a Regulatory Authority. Each Party will provide the other Party in a timely manner with a copy of all correspondence received from a Regulatory Authority specifically regarding the matters referred to above.
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Regulatory Authority Communications Received by a Party. Prior to Regulatory Approval of an NDA, each Party shall keep the other Party informed in a timely manner, compliant with the reporting requirements of Regulatory Authorities in the Territory, of the notification of any action by, or notification or other information which it receives (directly or indirectly) from any regulatory authority which, in relation to such NDA: (a) relates to the potential approvability of the Product; or (b) raises any material concerns regarding the safety or efficacy of a Product; or (c) which may have a material impact on obtaining Regulatory Approvals. Following Regulatory Approval of an NDA, each Party shall keep the other Party informed in a timely manner, compliant with the reporting requirements of Regulatory Authorities in the Territory, of the notification of any action by, or notification or other information which it receives (directly or indirectly) from any regulatory authority which, in relation to such NDA: (a) indicates or suggests a potential material liability of Harrow to Third Parties in connection with a Product; (b) is reasonably likely to lead to a recall or market withdrawal of a Product; or (c) relates to expedited and periodic reports of adverse events with respect to a Product, or Product Complaints, and which may have a material impact on maintaining Regulatory Approvals or the continued Commercialization of a Product, as then conducted. Once an NDA has been transferred to Harrow, Harrow shall provide to Sintetica copies of all correspondence to or from the FDA or Health Canada, as appropriate, relating to the Product, including without limitation to any post-approval changes (Annual Reports, CXX-0, XXX-00, PAS or similar filings) submitted to the FDA or Health Canada. In particular, all the documentation generated after the approval of the NDA should be shared with Sintetica (e.g., any eCTD sequences filed to FDA), to ensure Sintetica has availability of the complete dossier. Harrow shall fully cooperate with and assist Sintetica in complying with regulatory obligations and communications, including by providing to Sintetica, in a timely manner after a request, such Information and documentation in Harrow’s possession as may be necessary or helpful for Sintetica to prepare a response to an inquiry from a Regulatory Authority.
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Regulatory Authority Communications Received by a Party. Each Party shall keep the other Party informed, in a timely manner and in any event in compliance with the reporting requirements of Regulatory Authorities in the Licensed Territory, of notification of any action by, or notification or other information which the first Party receives (directly or indirectly) from any such Regulatory Authority which: (a) raises any [*] of the Product; (b) indicates or suggests [*] in connection with the Product; (c) is reasonably likely to lead to [*] of the Product; or (d) relates to [*] with respect to the Product, or [*], and which may have [*] the Product, the Peptide, [*] or Hematide. The Party identified in 4.2(a) as being responsible for preparing and authoring the content of documents and components of regulatory submissions shall be responsible for preparing the response to the communication, and the Party identified as being responsible for building, submitting and maintaining submission components will submit the response. However, before submitting such response to a Regulatory Authority regarding the communication, the submitting Party shall have an opportunity to comment on the response. In the event the Parties disagree concerning the form or content of a response to a Regulatory Authority in a particular country of the Licensed Territory, the Party who has responsibility for content preparation shall decide the appropriate form and content of such response, without recourse to arbitration under Section 2.4(c). The other Party shall fully cooperate with and assist such Party in complying with such regulatory obligations and communications, including by providing to such Party, within two (2) Business Days after a request or as quickly as practicable thereafter, such information and documentation in the other Party's possession as may be necessary or helpful for the Party to prepare a response to an inquiry from a Regulatory Authority. For clarity, each Party's obligations under this Section 4.8 shall apply to any such communications regarding the matters referred to above received by such Party's Affiliate(s), contractors, partners, or other collaborators as if such communications had been received by such Party directly.
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Regulatory Authority Communications Received by a Party. Each Party shall keep the other Party informed, in a timely manner and in any event in compliance with the reporting requirements of any Regulatory Authorities, of notification of any action by, or notification or other information which the first Party receives (directly or indirectly) from any such Regulatory Authority which: (a) raises any [ * ] of the Product; (b) indicates or suggests [ * ] in connection with the Product; (c) is reasonably likely to lead to a [ * ] of the Product; or (d) relates to [ * ] with respect to the Product, [ * ], and which may have [ * ] the [ * ]. Preparation and submission of the response to such communication outside the Licensed Territory shall be as set forth in the Global Agreement. Collaborator shall be responsible for preparing and submitting the response to the communication to the Regulatory Authorities in the Licensed Territory. However, before submitting such response to a Regulatory Authority regarding the communication, Affymax shall have an opportunity to comment on the [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Regulatory Authority Communications Received by a Party. Each Party shall keep the other Party informed in a timely manner, compliant with the reporting requirements of Regulatory Authorities in the Territory, of the notification of any action by, or notification or other information which it receives (directly or indirectly) from any Regulatory Authority and any regulatory authority outside of the Territory, including, but not limited to Japan’s Pharmaceuticals and Medical Devices Agency (PDMA) under the authority of Ministry of Health, Labour and Welfare (MHLW), which: (a) raises any material concerns regarding the safety or efficacy of a Product; (b) indicates or suggests a potential material liability of Harrow to Third Parties in connection with a Product; (c) is reasonably likely to lead to a recall or market withdrawal of a Product; or (d) relates to expedited and periodic reports of adverse events with respect to a Product, or Product Complaints, and which may have a material impact on obtaining or maintaining Regulatory Approvals or the continued Commercialization of a Product, as then conducted. Wakamoto shall fully cooperate with and assist Harrow in complying with regulatory obligations and communications, including by providing to Harrow, in a timely manner after a request, such Information and documentation in Wakamoto’s possession as may be necessary or helpful for Harrow to prepare a response to an inquiry from a Regulatory Authority.
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Regulatory Authority Communications Received by a Party. To the extent not prohibited by Applicable Laws and not expressly prohibited by an applicable Regulatory Authority, each Party shall keep the other Party informed in a timely manner, compliant with the reporting requirements of the applicable Regulatory Authorities, of the notification of any action by, or notification or other information which it receives (directly or indirectly) from any Regulatory Authority in the world which: (a) raises any material concerns regarding the safety or efficacy of the Vaccine; (b) indicates or suggests a potential material liability of either Party to Third Parties in connection with the Vaccine; (c) is reasonably likely to lead to a recall or market withdrawal of the Vaccine; (d) relates to expedited and periodic reports of adverse events with respect to the Vaccine and which may have a material negative impact on obtaining or maintaining Regulatory Approval or the continued Commercialization of the Vaccine, as then conducted; or
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Regulatory Authority Communications Received by a Party. Each Party shall keep the other Party informed in a timely manner compliant with the reporting requirements of Regulatory Authorities of notification of any action by, or notification or other information which it receives (directly or indirectly) from any Regulatory Authority which: (a) raises any ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information has been filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. material concerns regarding the safety or efficacy of the Product; (b) indicates or suggests a potential material liability of either Party to Third Parties in connection with the Product; (c) is reasonably likely to lead to a recall or market withdrawal of the Product; or (d) relates to expedited and periodic reports of adverse events with respect to the Product, or Product Complaints, and which may have a material impact on Development of the Product, Regulatory Approval or the continued Commercialization of the Product. The other Party will fully cooperate with and assist such Party in complying with regulatory obligations and communications, including by providing to such Party, in a timely manner after a request, such information and documentation in the other Party’s possession as may be necessary or helpful for the Party to prepare a response to an inquiry from a Regulatory Authority. Each Party will provide the other Party in a timely manner with a copy of all correspondence received from a Regulatory Authority specifically regarding the matters referred to above.
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Regulatory Authority Communications Received by a Party 
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Related to Regulatory Authority Communications Received by a Party

  • 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 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 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.

  • 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.

  • 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.

  • SIGNATORY AUTHORITY The signatories to this Agreement covenant and warrant that they have authority to execute this Agreement. By signing below, the undersigned agrees to the above terms and conditions.

  • E1 Authority Data E1.1 The Contractor shall not delete or remove any proprietary notices contained within or relating to the Authority Data.

  • Regulatory Examinations The Sub-Advisor will cooperate promptly and fully with the Advisor and/or the Trust in responding to any regulatory or compliance examinations or inspections (including information requests) relating to the Trust, the Fund or the Advisor brought by any governmental or regulatory authorities having appropriate jurisdiction (including, but not limited to, the SEC).

  • Authority Data The Contractor shall use the Authority Data only as necessary for the performance of its obligations under this Contract unless otherwise authorised in writing by the Authority.

  • 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.

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