Communications with FDA Sample Clauses

Communications with FDA. All communications with FDA concerning any Detailed Product shall be the sole responsibility of Wyeth. Impax shall provide reasonable assistance to Wyeth to the extent deemed necessary by Wyeth to fully respond to such communications.
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Communications with FDA. All communications with the FDA concerning the Product shall be the sole responsibility of Relypsa and, unless required by Applicable Law, shall be initiated solely by Relypsa. Sanofi shall provide to Relypsa prompt notice if the FDA or other governmental authority in the Territory contacts Sanofi regarding the Product. Commencing upon the date that the label for the Product has been established by the FDA, Relypsa shall provide to Sanofi [***] notice of [***] with the FDA or other governmental authority in the Territory with respect to the Product which would [***] or is [***]. Sanofi shall provide reasonable assistance, at [***], to Relypsa with respect to any such communications or interactions with the FDA described in this Section 0 to the extent deemed necessary by Relypsa.
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Communications with FDA. Notwithstanding anything to the contrary in this Agreement, BIND will be solely responsible for communicating with the FDA or comparable regulatory authority regarding the Study, the Study Results or services hereunder, and USOR shall not contact the FDA or such other regulatory authority regarding the Study, the Study Results or services hereunder unless required by Applicable Law or requested by BIND in writing.
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Communications with FDA. Neauvia shall have the sole right and responsibility to make any communications to or respond to any inquiries from the FDA or any other regulatory agency related to the Products.
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Communications with FDA. All communications with the FDA concerning the Product will be the sole responsibility of GSK and will be initiated solely by GSK. GSK will keep Allergan informed of any material interactions with FDA with respect to the Product. Allergan, at its own expense, will provide reasonable assistance to GSK to the extent deemed necessary by GSK.
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Communications with FDA. All communications with the FDA concerning the Product shall be the sole responsibility of Solvay and shall be initiated solely by Solvay. Solvay shall keep CV Therapeutics promptly informed (including as provided in Sections 2.3(b) and 7.1 above), and shall provide CV Therapeutics promptly with all Solvay minutes and correspondence relating to teleconferences, meetings or other interactions with FDA with respect to the Product, and with copies of all FDA minutes and correspondence relating to the same. Solvay shall notify CV Therapeutics in advance of any planned communication with the FDA, and shall cooperate with CV Therapeutics regarding regulatory strategy for the Product as provided in Sections 2.3(b) and 7.1 above. CV Therapeutics, at its own expense, shall provide reasonable assistance to Solvay to the extent deemed necessary by Solvay to fully respond to such communications and shall have the right to participate in such communications with FDA, at CV Therapeutics’ discretion, as provided in Section 7.1.
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Communications with FDA. After the Effective Date, Nycomed shall provide BioSante with copies of all correspondence and documents to and from the FDA with respect to the Product in its possession, and all notices received from the FDA related thereto, within three (3) business days following transmission or receipt from the FDA. However, after the Effective Date, Nycomed shall not communicate with the FDA with respect to the Product. BioSante shall be responsible for all communications with the FDA with respect to the Product after the Effective Date.
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Communications with FDA 
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Related to Communications with FDA

  • Communications with Accountants Each of the Borrowers authorizes the Administrative Agent and, if accompanied by the Administrative Agent, the Lenders to communicate directly with the Accountants and authorizes the Accountants to disclose to the Administrative Agent and the Lenders any and all financial statements and other supporting financial documents and schedules including copies of any management letter with respect to the business, financial condition and other affairs of such Borrower or any of its Subsidiaries. At the request of the Administrative Agent, such Borrower shall deliver a letter addressed to the Accountants instructing them to comply with the provisions of this §8.9.2.

  • 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.

  • Negotiations with Others From and after the date hereof unless and until this Agreement shall have terminated in accordance with its terms, the Stockholder will not, and will not permit Seller or any officer, director, employee or other Representative of Seller to, directly or indirectly (a) solicit, engage in discussions or engage in negotiations with any person (other than Buyer or any of its Affiliates) with respect to an Acquisition Proposal; (b) provide information to any person (other than Buyer or any of its Affiliates) in connection with an Acquisition Proposal; or (c) enter into any transaction with any person (other than Buyer or any of its Affiliates) with respect to an Acquisition Proposal. If the Stockholder, Seller or Representative receives any offer or proposal to enter into discussions or negotiations relating to any of the above, Seller or the Stockholder will immediately notify Buyer in writing as to the identity of the offeror or the party making any such proposal and the specific terms of such offer or proposal.

  • Communications with Rating Agencies The parties hereto (other than the Seller and its Affiliates but excluding the Issuing Entity) agree that any notices or requests to, or any other written communications with, any of the Rating Agencies, or any of their respective officers, directors or employees, to be given or provided to such Rating Agencies pursuant to, in connection with or related, directly or indirectly, to the Basic Documents, the Collateral or the Notes, shall be in each case either (i) furnished to the Seller who shall forward such communication to the Rating Agencies pursuant to Section 10.18 of the Sale and Servicing Agreement; or (ii) furnished directly to the Rating Agencies with a prior copy to the Seller. In either case, the parties hereto (other than the Seller and its Affiliates but excluding the Issuing Entity) further agree to provide such notices, requests and communications or copies thereof, as applicable, to the Seller at least one Business Day prior to the date when such notices, requests and communications are required to be delivered (or are in fact delivered, whichever is earlier) to the Rating Agencies pursuant to the Basic Documents. So long as any Notes are Outstanding, each party hereto (other than the Seller and its Affiliates but excluding the Issuing Entity) agrees that neither it nor any party on its behalf shall engage in any oral communications with respect to the transactions contemplated hereby, under the Basic Documents or in any way relating to the Notes with any Rating Agency or any of their respective officers, directors or employees, without the participation of the Seller.

  • Transactions with Management In the table on the following page, describe any transaction (or series of similar transactions), during the Company’s last three Fiscal Years, or any currently proposed transaction (or series of similar transactions), to which the Company or any of its subsidiaries was or is to be a party, and in which you had or anyone in your immediate family has, a material direct or indirect financial interest. Identify the person(s) involved and state the nature of your or their interest in the transaction, the amount of the transaction and the amount of your or their interest in the transaction. (Attach a supplemental page if necessary.) Description of Transaction Persons Involved Nature of Interest Amount of Transaction Amount of Interest Question 10:

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