Regulatory Contacts. Company shall be responsible for any regulatory contacts and filings related to Company owned product(s). Supplier agrees to consult with Company prior to any [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. material meetings or filing with the EMA / FDA with respect to the Product(s) after the Regulatory Filing approval (e.g. - Compliance inspection related items such as Warning Letter). Supplier shall provide Company in a timely fashion with copies of all material correspondence with the EMA / FDA that relates to the Product(s).
Regulatory Contacts. Expect as otherwise specified in a Project Description, Ymabs will be solely responsible for all contacts and communications with any Authorities with respect to matters relating to the Services rendered under such Project Description.
Regulatory Contacts. [***] CAPSUGEL shall notify CARDAX immediately, and in no event, no later than three (3) business day(s), after it receives any contact or communication from any governmental or regulatory authority, including without limitation the FDA, that in any way relates to or may have an impact on a Product or the CAPSUGEL Development Activities.
Regulatory Contacts. Tectonic will be solely responsible for all contacts and communications (including submissions of information) with any regulatory authorities with respect to matters relating to Services. Unless required by applicable law. Service Provider will have no contact or communication with any regulatory authority regarding Services without the prior written consent of Tectonic, [***]. Service Provider will notify Tectonic promptly, and in no event later than [***], after Service Provider receives any contact or communication from any regulatory authority relating in any way to Services and will provide Tectonic with a summary of such contact and copies of any such communication within [***] after Service Provider’s receipt of such contact or communication. Unless prohibited by applicable law, Service Provider will consult with Tectonic regarding the response to any inquiry or observation from any regulatory authority relating in any way to Services and will allow Tectonic at its discretion to control and/or participate in any further contacts or communications relating to Services. Service Provider will comply with all reasonable requests and comments by Tectonic with respect to all contacts and communications with any regulatory authority relating in any way to Services.
Regulatory Contacts. Unless otherwise required by applicable law, Ophthotech will be solely responsible for all contacts and communications with any regulatory authorities with respect to matters relating to the API or any of the Manufacturing and Laboratory Services under a Statement of Work. Agilent will notify Ophthotech immediately, and in no event later than [**] days, after Agilent receives any contact or communication from any regulatory authority relating in any way to the API or Product testing or the Manufacturing and Laboratory Services under a Statement of Work and will provide Ophthotech with copies of any such communication within [**] of receipt of such communication by Agilent. Agilent will consult with Ophthotech regarding the response to any inquiry or observation from any regulatory authority relating in any way to the API or Product testing or the Manufacturing and Laboratory Services under a Statement of Work and will allow Ophthotech at Opthotech’s discretion to participate in any further contacts or communications relating to such Services. Agilent will comply with all reasonable requests and take into consideration all comments by Ophthotech with respect to all contacts and communications with any regulatory authority relating in any way to the API the Manufacturing and Laboratory Services under a Statement of Work.
Regulatory Contacts. Gland will be responsible for all regulatory contacts and filings with the FDA. If Gland is required to submit documentation to the FDA or otherwise communicates with the FDA, which documents or communications relate directly to the Product or that could reasonably be anticipated to affect the Product, Sagent or its representatives may review and comment at its discretion on all such documents and other communications prior to their submission. Gland shall consider in good faith any comments proposed by Sagent on the proposed responses. Gland shall notify Sagent promptly (within 1 business day) of any adverse finding related to the submission of such documentation by the FDA that relates directly to the Product or that could affect the Product.
Regulatory Contacts. CORONADO will be solely responsible for all contacts and communications with any regulatory authorities with respect to matters relating to any of the Services. Unless required by applicable law, Service Provider will have no contact or communication with any regulatory authority regarding any Services without the prior written consent of CORONADO, which consent will not be unreasonably withheld. Each party will notify the other promptly after such party receives any contact or communication from any regulatory authority relating in to the Services and will provide the notified party with copies of any such communication. Each party will consult with the other party regarding the response to any inquiry or observation from any regulatory authority relating to the Services.
Regulatory Contacts. PATHEON shall notify RELYPSA in a timely manner of any meetings or substantive discussions with the FDA, EMA or any other Regulatory Authority that directly relate to the Services performed by PATHEON, and RELYPSA shall have the right but not the obligation to have at least one representative participate in such meetings or discussions referred to above. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Regulatory Contacts. Unless specified otherwise in an SOW by which COMPANY delegates such responsibilities to Service Provider, COMPANY will be solely responsible for all contacts and communications with any regulatory authorities with respect to matters relating to any of the Services. Unless required by applicable law or written agreement with COMPANY, Service Provider will have no contact or communication with any regulatory authority regarding any Services without the prior written consent of COMPANY, which consent will not be unreasonably withheld. Except when duly authorized to engage in such communications, Service Provider will notify COMPANY immediately, and in no event later than one (1) day, after Service Provider receives any contact or communication from any regulatory authority relating in any way to the Services and will provide COMPANY with copies of any such communication within one (1) day of receipt of such communication by Service Provider. Service Provider will consult with COMPANY regarding the response to any inquiry or observation from any regulatory authority relating in any way to the Services and will allow COMPANY at its discretion to control and/or participate in any further contacts or communications relating to the Services. Service Provider will comply with all reasonable requests and comments by COMPANY with respect to all contacts and communications with any regulatory authority relating in any way to the Services. Notwithstanding the forgoing in this Section 2.6, nothing in this Agreement shall be construed as prohibiting Service Provider from fulfilling its obligations under the LSA or Quality Assurance Agreements. Biofrontera, Inc. – Biofrontra AGMaster Contract Services Agreement
Regulatory Contacts. (1) Warner shall be solely responsible for all contacts and communications with any and all Governmental or Regulatory Authorities in respect of the Products.
