Responsibility for the Product Sample Clauses

Responsibility for the Product. From and after the Closing Date, and in no event later than the effective date of the transfer to Duramed of the applicable NDA, Duramed shall assume all regulatory responsibilities under applicable laws in connection with the Product and the Product NDA, including (a) responding to all medical inquiries, (b) responsibility for reporting any adverse drug events in connection with the Product, (c) responsibility for compliance with the Prescription Drug Marketing Act of 1987, as the same may be amended from time to time, and (d) responsibility for any and all fee obligations for holders or owners of approved NDAs and Regulatory Approvals relating to the Product, including those defined under the Prescription Drug User Fee Act of 1992, as the same may be amended from time to time. In connection therewith, Shire shall promptly after Closing deliver to Duramed all records, documentation and other information that Shire has prepared or has had prepared regarding the development, efficacy, safety and legal compliance of the Product, including all correspondence with Regulatory Authorities or other government/health agencies related to the Product. Shire acknowledges that pursuant to the terms of the Pharmacovigilance Agreement, Shire shall be responsible for compliance with certain of the foregoing obligations following the Closing. Without limiting Shire’s obligations under the Pharmacovigilance Agreement, Shire shall cooperate with Duramed following the Closing to provide reasonable assistance in connection with Duramed’s regulatory obligations related to the Product for a period of [*].
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Responsibility for the Product. Pursuant to the terms of the Pharmacovigilance Agreement, promptly after the Closing Date, and in no event later than the effective date of the transfer to Purchaser of the applicable Product Registrations, Purchaser shall assume all regulatory responsibilities permitted or required by applicable laws, in connection with the Product and the Product Registrations in the Territory, including (i) responding to all medical inquiries, (ii) responsibility for reporting any adverse drug events in connection with the Product, and (iii) responsibility for compliance with the Prescription Drug Marketing Act of 1987, as the same may be amended from time to time. After the Closing Date, Purchaser shall assume all responsibility for any and all fee obligations for holders or owners of approved NDA's and Regulatory Approvals relating to the Product, including those defined under the Prescription Drug User Fee Act of 1992, as the same may be amended from time to time.
Sample 1
Responsibility for the Product. (a) Subject to the Supply Agreement, from and after the Closing Date, Buyer shall assume all regulatory responsibilities permitted by applicable Laws to be assumed by Buyer, reporting and otherwise, in connection with the Product, the Product Registrations, to the extent related to the period from and after the Closing Date, including responsibility for reporting any adverse drug experiences in connection with the Product in or with respect to the Territory, and responsibility for compliance with the Prescription Drug Marketing Act of 1987, as the same may be amended from time to time. (b) Seller and its Affiliates shall promptly submit to Buyer all written medical inquiries, adverse drug experience information or customer complaints received in writing by Seller or its Affiliates in respect of the Product, as well as any material written notifications received by Seller or its Affiliates concerning the safety or efficacy of the Product. (c) From and after the Closing Date, Seller shall direct all complaints or inquiries concerning the Product in the Territory to Buyer to the attention of l , l , AXA Assistance USA, 100 Xxxxx Xxxxxxxx Xxxxxx, Xxxxx 0000, Xxxxxxx, Xxxxxxxx 00000 at the phone number l and facsimile number l . (d) Seller shall, and shall cause its Affiliates to, submit promptly to Buyer and its Affiliates copies of all correspondence, documents, data, reports, information, files, including third-party consulting reports, and records related thereto in its possession submitted to, reported by, or provided to with respect to such Product complaints, inquiries or reports of adverse drug reactions to any Governmental Authority pursuant to applicable Law.
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Responsibility for the Product. Subject to compliance by the Parties with the applicable provisions of the Transition Plan, from and after the Transition Date (or such earlier date as the NDA transfers to Orexo in accordance with Section 8.6(b) below), Orexo shall have all regulatory responsibilities under applicable Laws and regulations, reporting and otherwise, in connection with the Product in the Orexo Territory.
Sample 1
Responsibility for the Product. (a) Promptly after the Closing Date Purchaser shall (i) obtain new NDC numbers for the Product, (ii) have its labeling for Product approved by the FDA, and (iii) use such new NDC numbers on all invoices, orders and other communications with customers and Regulatory Authorities. Seller shall report the termination date of its NDC numbers for the Product to the Centers for Medicare and Medicaid Services (“CMS”) in accordance with CMS guidelines, which termination date shall be the expiration date for the last lot of Product with its NDC numbers. (b) Promptly after the Closing Date, and in no event later than the effective date of the transfer to Purchaser of the applicable Product Registration, subject to the terms of the Transitional Services Agreement, Purchaser shall assume all regulatory responsibilities permitted or required by applicable laws, in connection with the Product and the Product Registrations in the Territory, including (i) responding to all medical inquiries, (ii) responsibility for reporting any and all adverse drug events in connection with the Product, and (iii) responsibility for compliance with the Prescription Drug Marketing Act of 1987, as the same may be amended from time to time. After the Closing Date, Purchaser shall assume all responsibility for any and all fee obligations for holders or owners of approved NDAs and Regulatory Approvals relating to the Product, including those defined under the Prescription Drug User Fee Act of 1992, as the same may be amended from time to time.
Sample 1
Responsibility for the Product. From and after the Closing Date, Caraco shall have all post-Closing regulatory responsibilities under applicable laws and regulations, reporting and otherwise, in connection with the Products, except that Forest shall have the authority and responsibility with respect to regulatory matters and compliance with Applicable Law relating to Forest’s manufacture and supply obligations pursuant to Section 5.04(a) and the Supply Agreement referenced therein, including, securing necessary FDA approvals and site transfer approvals.
Sample 1
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Related to Responsibility for the Product

  • 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 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 Damage Resident is solely responsible for any damage, defacement or loss arising within the assigned bedroom space. All assigned residents of an apartment are jointly and severally responsible for any damage, defacement or loss to common areas, other parts of the Property, fixtures or appliances, except for the portion of damages over $100,000 where it is finally established that Resident or one or more other residents of the apartment were solely at fault for the entire loss, in which case such person(s) will be solely responsible. Resident is fully responsible for the conduct of Resident’s guests, visitors, licensees and invitees (“Guests”), including without limitation harm to individuals or damage or defacement of any part of the Property or its fixtures or property of third parties (including other residents) by such Guests.

  • 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.

  • 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 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 Damages Contractor is responsible for all damage that occurs as a result of Contractor’s fault or negligence or that of its’ employees, agents, or representatives in connection with the performance of this Contract. Contractor shall immediately report any such damage to people and/or property to the Contract Administrator.

  • Responsibility for Costs The Servicer is responsible for collection from such Borrower of any recording or similar costs or expenses incidental to the granting of relief with respect to a delinquent Mortgage Loan.

  • 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 for Equipment City shall not be responsible for any damage to persons or property as a result of the use, misuse or failure of any equipment used by Contractor, or by any of its employees, even though such equipment be furnished, rented or loaned to Contractor by City.

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