Responsibility for Regulatory Matters Sample Clauses

Responsibility for Regulatory Matters. Following the Regulatory Transition Date, Gilead will be solely responsible for all regulatory matters relating to any Licensed Product or Gilead Combination Product in the Territory, and shall use Commercially Reasonable Efforts with respect to such regulatory matters for the first Licensed Product in each Major Market in each Target Indication, and Galapagos shall use Commercially Reasonable Efforts as requested by Gilead to assist Gilead with such regulatory matters. Notwithstanding anything to the contrary in this Agreement, the immediately foregoing obligation with respect to Commercially Reasonable Efforts in the Major Markets and the Target Indications shall be Gilead’s sole diligence obligation with respect to regulatory matters for Licensed Products and Gilead Combination Products, and Gilead shall have the sole right, but not any obligation, with respect to regulatory matters for other Licensed Products and Gilead Combination Products in other countries or for other indications and no diligence obligation of Gilead shall arise under this Agreement with respect to seeking or obtaining Regulatory Approvals for Gilead Combination Products. Gilead’s sole responsibility shall include (i) overseeing, monitoring and coordinating regulatory actions, communications and filings with, and submissions to, Regulatory Authority in the Territory with respect to Licensed Products and Gilead Combination Products; (ii) interfacing, corresponding and meeting with Regulatory Authorities in the Territory with respect to Licensed Products and Gilead Combination Products; (iii) seeking and maintaining regulatory filings in the Territory with respect to Licensed Products and Gilead Combination Products; and (iv) maintaining and submitting records required to be maintained or required to be submitted to any Regulatory Authority in the Territory with respect to Licensed Products and Gilead Combination Products.
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Responsibility for Regulatory Matters. Unless otherwise agreed by the Parties in writing, Galapagos shall be solely responsible for all regulatory matters relating to any Pre-Program Activities or Galapagos Product.
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Responsibility for Regulatory Matters. All regulatory matters regarding obtaining and maintaining any necessary clearance or other permit, permission, consent or approval, or promotion or labeling, or otherwise complying or assuring compliance with applicable law for or relating to the importation, sale and use of Celera Products, if any such requirements exist, from the FDA, or under the European IVD Directive or any other body or agency, will remain under the exclusive control of Celera and will be solely Celera’s responsibility. AB will provide Celera access to documentation under AB’s control reasonably required for Celera Product regulatory registration (subject to AB’s reasonable confidentiality requirements), provided that any such registration will not impose any duties or requirements on AB or require AB to take any action except to permit regulatory inspections as and to the extent expressly set forth in Section 11.3 of this Agreement. 12 Defects and Returns
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Responsibility for Regulatory Matters. 9 3.5 Abandonment by BMS................................. 11 3.6 Development and Marketing Obligations of BMS....... 12 3.7
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Responsibility for Regulatory Matters. Subject to the terms and conditions of this Agreement, including oversight by the JCC, Otsuka shall be responsible, [***], for the conduct of all regulatory activities relating to Products in the Otsuka Territory (and in the Perception Territory solely with respect to any Ex-Otsuka Territory Study), including (a) overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, the applicable Regulatory Authorities in the Otsuka Territory with respect to Products; (b) interfacing, corresponding and meeting with the applicable Regulatory Authorities in the Otsuka Territory with respect to Products; (c) seeking and maintaining all Regulatory Approvals with respect to Products in the Otsuka Territory, including any amendments, supplements or modifications to such Regulatory Approvals; and (d) maintaining and submitting all records required to be maintained or required to be submitted to the applicable Regulatory Authority with respect to Products in the Otsuka Territory. Otsuka shall be the holder of all Regulatory Approvals for the Products in the Otsuka Territory and will own all Regulatory Documentation in the Otsuka Territory. Notwithstanding the foregoing, if Perception (x) conducts any (i) Clinical Studies for any Product in the Otsuka Territory or (ii) Perception New Indication Studies or (y) Manufactures or has Manufactured any (i) Product in the Otsuka Territory to support Development and Commercialization of such Product in the Perception Territory or to fulfill any of its obligations under this Agreement or (ii) Perception New Indication Product in the Otsuka Territory, then in each case ((x) and (y)) Perception shall have the right to conduct all regulatory activities in the Otsuka Territory with respect to such activities.
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Responsibility for Regulatory Matters. Atrix shall be solely responsible for making all necessary or desirable declarations, filings (including, without limitation, the NDA and all supplements thereto and reports thereunder) and registrations with, and obtaining all necessary or desirable Governmental Approvals (including, without limitation, the FDA) relating to the Product and the Units; provided, however, that Block shall have the right to attend all meetings with the FDA or other similar Governmental Authority as a silent observer and Atrix shall immediately provide to Block copies of all correspondence and other documentation reflecting communications between Atrix and the FDA or other similar Governmental Authority.
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Responsibility for Regulatory Matters. In accordance with the Development Plan and any Development Amendment, at its sole expense, under the oversight of the JDC, Licensor shall retain control and responsibility for all regulatory submissions for the Existing Licensed Product in the Field in the Territory with respect to obtaining the Initial Approval. As promptly as practicable after the grant of the Initial Approval, Licensor shall transfer the NDA for the Existing Licensed Product in the Field in the Territory as set forth Section 9.1.2 (such transfer, the "REGULATORY APPROVAL TRANSFER"), and such NDA and related submissions in the Territory related to such Existing Licensed Product in the Field shall be, subject to the terms of this Agreement, the property of Licensee and held in the name of Licensee. Thereafter, at Licensee's sole expense, Licensee shall, subject to Section 5.3, 5.4, 5.5, 5.6 and ARTICLE 14, assume control of and responsibility for all regulatory submissions with respect to all Regulatory Approvals for Licensed Products in the Field in the Territory; PROVIDED, HOWEVER, that, notwithstanding anything in this ARTICLE 5, as between Licensee and Licensor, Licensor shall retain responsibility for any IND owned or Controlled by Licensor or any of its Affiliates and any Drug Master Files of Licensor, its Affiliates or any of their respective contract manufacturers.
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Responsibility for Regulatory Matters 
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Related to Responsibility for Regulatory Matters

  • Responsibility for Content Vendor is solely responsible for administration, content, intellectual property rights, and all materials at Vendor’s website. DIR reserves the right to require a change of listed content if, in the opinion of DIR, it does not adequately represent the Contract.

  • Responsibility For Use (a) The Company alone will be responsible for furnishing, or arranging for a third party to furnish, all data and information required by the Documentation and the specifications therein for the Licensed System to function and perform in accordance with the Documentation, other than the data and information residing in the Licensed System in connection with BNYM’s performance of the Core Services. BNYM shall have no liability or responsibility for any Loss caused in whole or in part by the Company’s or a Permitted User’s exercise of the Licensed Rights or use of the Licensed System or by data or information of any nature inputted into the Licensed System by or under the direction or authorization of Company or a Permitted User; provided, however, this Section 2.5 shall not relieve BNYM of its obligation to act in accordance with its obligations under the Main Agreement. Company shall be responsible and solely liable for the cost or expense of regenerating any output or other remedial action if the Company, a Permitted User or an agent of either shall have failed to transmit properly and in the correct format any data or information, shall have transmitted erroneous or incorrect information or data, or shall have failed to timely verify or reconcile any such data or information when it is generated by the Licensed System (“Data Faults”).

  • Responsibility for Filing Tax Returns (a) Sellers shall prepare, or cause to be prepared, in a timely manner, all income Tax Returns of each Acquired Company that are due after the Closing with respect to any taxable period ending prior to or ending on and including the Closing Date; provided, however, that any such Tax Return shall be prepared by treating items on that Tax Return in a manner consistent with the prior Tax Returns of each Acquired Company. Sellers shall deliver to Buyer draft copies of each such Tax Return prior to the date for filing that Tax Return. Sellers shall make all changes in each such Tax Return reasonably requested by Buyer. Buyer shall cause each such Tax Return to be appropriately signed and filed, and Sellers shall pay to each Acquired Company any Taxes due from such Acquired Company on that Tax Return. (b) Buyer shall after the Closing prepare and file, or cause to be prepared and filed, Tax Returns of each Acquired Company for any period beginning prior to the Closing Date and ending after the Closing Date (a “Straddle Period”). Any such Tax Return shall be prepared by treating items on that Tax Return in a manner consistent with the prior Tax Returns of each Acquired Company. Buyer shall deliver to Sellers draft copies of each such Tax Return at least thirty (30) days prior to the date for filing that Tax Return. Buyer shall make all changes in each such Tax Return reasonably requested by Sellers. Sellers shall pay to each Acquired Company the Taxes due for the period prior to and including the Closing Date from such Acquired Company on that Tax Return.

  • Responsibility for Recitals, Etc The recitals herein and in the Notes (except in the Trustee's certificate of authentication) shall be taken as the statements of the Company, and the Trustee assumes no responsibility for the correctness thereof. The Trustee makes no representations as to the validity or sufficiency of this Second Supplemental Indenture or of the Notes. The Trustee shall not be accountable for the use or application by the Company of the Notes or of the proceeds thereof.

  • Responsibility of the Parties The Parties undertake to indemnify each other for any damage (loss) caused by their partial or complete non-performance or improper performance of the Agreement, and the indemnification of damage (loss) does not relieve the Parties from the performance/payment of their obligations under the Agreement. In addition, the Customer shall be liable for any damage (loss) caused to the Bank by its partial or complete non-performance or improper performance of the Agreement. Inter alia, in the event of a breach of the term specified in the subsection 3.3.6. of Annex N1 to the Bank Guarantee Agreement, Bank is entitled to charge the Customer with additional amount of the respective Interest (as the damage (loss) inflicted) for the period of breach of the term or the Bank shall be entitled to repay the above obligations not later than 14 (fourteen) calendar days after the written application. Indemnification of the damage (loss) does not release the Customer from the performance/payment of the obligations under the Agreement. Notwithstanding the guarantees specified in Sections 5.1 and 5.2. of Annex N1 to the Bank Guarantee Agreement, in order to ensure full and proper performance of the Customer’s obligations under the Agreement, and, respectively, to secure the Bank’s rights and claims, the Customer hereby expressly gives its prior consent that the Bank is fully authorized to: In the case of several debt arrears, determine the sequence and order of payments of Bank Guarantee and the payments under it; Block any Account of the Customer without acceptance in the amount of the payment due and in accordance with its applicable rules until any payment is under the Agreement is fully and duly covered; Write off without acceptance all payments due from the any Account of the Customer, and if the payment due and the amount available on the Account are in different currencies, the Bank itself can perform conversion at the commercial rate of exchange applicable at the Bank on the date of payment or the rate of exchange agreed with the Customer (if any), and write off also the conversion cost without acceptance from the Account, and channel the converted amount to cover the appropriate payments. During the period of Force Majeure, the Bank shall not be liable for complete or partial nonfulfillment or improper fulfillment of its obligations under the Agreement. In the event of Force Majeure, the Parties shall be guided by ICC Uniform Rules. Any official communication between the Parties shall be in writing. The written notice intended to the Party may be delivered in person or sent by a courier (including an international courier) or through a post delivery (including by a registered letter). For urgency and subject to the following provisions, except by submitting to the Customer a claim for full performance of its obligations under the Agreement or notifying about the complete or partial termination of the Agreement, it is permissible to notify the other Party by email or other electronic means (including via mobile banking, internet banking) provided that upon request of the other Party, such notice shall also be provided in writing within a reasonable time. The notice shall be deemed to have been accepted by the addressee on the day of its receipt if the receipt of the notice is confirmed by the addressee (including by electronic document, receipt, other appropriate means of notification, etc.). If the receipt of the notice is not confirmed by the addressee, any such notice shall be deemed to have been sent and received accordingly: In case of sending a written message by a courier or registered mail - on the day of confirmation of delivery; In case of sending by email and/or other electronic means - on the second Banking Day after the date of sending; Notice shall be deemed to have been received even if the notice is returned to the notifying Party due to the absence of the addressee of the notification on the sent address/contact data, the addressee refuses to receive the notice or avoids receiving it. The Parties will communicate according to the addresses/contact details specified in the Agreement (or any other address/contact information that one Party will provide in writing to the other). The Party is obliged to notify the other Party on the change of the above address or any of their data in a timely manner, otherwise the communication (notification etc.) carried out to the address indicated by the Party shall be deemed to have been duly performed.

  • Responsibility of PFPC (a) PFPC shall be under no duty to take any action on behalf of the Fund except as specifically set forth herein or as may be specifically agreed to by PFPC in writing. PFPC shall be obligated to exercise care and diligence in the performance of its duties hereunder, to act in good faith and to use its best efforts in performing services provided for under this Agreement. PFPC shall be liable for any damages arising out of PFPC's failure to perform its duties under this Agreement to the extent such damages arise out of PFPC's willful misfeasance, bad faith, negligence or reckless disregard of such duties. (b) Without limiting the generality of the foregoing or of any other provision of this Agreement, PFPC shall not be under any duty or obligation to inquire into and shall not be liable for (A) the validity or invalidity or authority or lack thereof of any Oral Instruction or Written Instruction, notice or other instrument which conforms to the applicable requirements of this Agreement, and which PFPC reasonably believes to be genuine; or (B) subject to Section 10, delays or errors or loss of data occurring by reason of circumstances beyond PFPC's control, including acts of civil or military authority, national emergencies, labor difficulties, fire, flood, catastrophe, acts of God, insurrection, war, riots or failure of the mails, transportation, communication or power supply. (c) Notwithstanding anything in this Agreement to the contrary, neither PFPC nor its affiliates shall be liable to the Fund for any consequential, special or indirect losses or damages which the Fund may incur or suffer by or as a consequence of PFPC's or its affiliates' performance of the services provided hereunder, whether or not the likelihood of such losses or damages was known by PFPC or its affiliates. (d) Notwithstanding anything in this Agreement to the contrary, the Fund shall not be liable to PFPC nor its affiliates for any consequential, special or indirect losses or damages which PFPC or its affiliates may incur or suffer by or as a consequence of PFPC's performance of the services provided hereunder, whether or not the likelihood of such losses or damages was known by the Fund.

  • Responsibility for Contract Administration The Servicer will have the sole obligation to manage, administer, service and make collections on the Contracts and perform or cause to be performed all contractual and customary undertakings of the holder of the Contracts to the Obligor. The Owner Trustee, at the written request of a Servicing Officer, shall furnish the Servicer with any powers of attorney or other documents necessary or appropriate in the opinion of the Owner Trustee to enable the Servicer to carry out its servicing and administrative duties hereunder. The Servicer is hereby appointed the servicer hereunder until such time as any Service Transfer may be effected under Article VIII.

  • Responsibility for documentation None of the Security Agent, any Receiver nor any Delegate is responsible or liable for: (a) the adequacy, accuracy or completeness of any information (whether oral or written) supplied by the Security Agent, an Obligor or any other person in or in connection with any Finance Document or the transactions contemplated in the Finance Documents or any other agreement, arrangement or document entered into, made or executed in anticipation of, under or in connection with any Finance Document; (b) the legality, validity, effectiveness, adequacy or enforceability of any Finance Document, the Transaction Security or any other agreement, arrangement or document entered into, made or executed in anticipation of, under or in connection with any Finance Document or the Transaction Security; or (c) any determination as to whether any information provided or to be provided to any Secured Party is non-public information the use of which may be regulated or prohibited by applicable law or regulation relating to insider dealing or otherwise.

  • Responsibility for Taxes This provision supplements Section 4(d) of the Performance- and Service-Based Restricted Stock Unit Agreement: (a) The Participant acknowledges that, regardless of any action taken by the Company or, if different, the Service Recipient, the ultimate liability for all income tax, excise tax, social insurance, payroll tax, fringe benefits tax, payment on account or other tax-related items related to the Participant’s participation in the Plan and legally applicable to the Participant (“Tax-Related Items”) is and remains the Participant’s responsibility and may exceed the amount actually withheld by the Company or the Service Recipient. The Participant further acknowledges that the Company and/or the Service Recipient (1) make no representations or undertakings regarding the treatment of any Tax-Related Items in connection with any aspect of the RSUs, including, but not limited to, the grant, vesting or settlement of the RSUs, the subsequent sale of Shares acquired pursuant to such settlement and the receipt of any dividends and/or any dividend equivalents; and (2) do not commit to and are under no obligation to structure the terms of the grant or any aspect of the RSUs to reduce or eliminate the Participant’s liability for Tax-Related Items or achieve any particular tax result. Further, if the Participant is subject to Tax-Related Items in more than one jurisdiction, the Participant acknowledges that the Company and/or the Service Recipient (or former service recipient, as applicable) may be required to withhold or account for Tax-Related Items in more than one jurisdiction. (b) If the obligation for Tax-Related Items is satisfied by withholding in Shares, for tax purposes, the Participant is deemed to have been issued the full number of Shares subject to the vested RSUs, notwithstanding that a number of the Shares are held back solely for the purpose of satisfying the Withholding Taxes. (c) Finally, the Participant agrees to pay to the Company or the Service Recipient, any amount of the Withholding Taxes that cannot be satisfied by the means previously described. The Company may refuse to issue or deliver the Shares or the proceeds of the sale of Shares, if the Participant fails to comply with the Participant’s obligations in connection with the Withholding Taxes. (d) Notwithstanding anything to the contrary in the Plan or in Section 4(d) of the Performance- and Service-Based Restricted Stock Unit Agreement, if the Company is required by applicable law to use a particular definition of fair market value for purposes of calculating the taxable income for the Participant, the Company shall have the discretion to calculate the Shares to be withheld to cover any Withholding Taxes by using either the price used to calculate the taxable income under applicable law or by using the closing price per Share on the New York Stock Exchange (or other principal exchange on which the Shares then trade) on the trading day immediately prior to the date of delivery of the Shares.

  • Responsibility for Evaluation Within each school the Principal will be responsible for the evaluation of employees assigned to that school. Evaluation will be made by the Principal or a qualified administrator. An employee assigned to more than one school will be evaluated by the Principal of the school in which the employee is assigned for the greater amount of time, with input provided by the Principal of the other school. Any Principal or person charged with the responsibility of evaluation of employees may involve other staff and students in the process if acceptable to the certificated teacher being evaluated.

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