Notice of Investigation or Inquiry Sample Clauses

Notice of Investigation or Inquiry. If any Regulatory Authority (i) contacts a Party with respect to the alleged improper Development, Manufacture, Medical Affairs Activities or Commercialization of Licensed Product (anywhere in the world), (ii) conducts, or gives notice of its intent to conduct, an inspection at such Party’s facilities to the extent related to any Licensed Compound or the Licensed Product (anywhere in the world), or (iii) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of such Party that could reasonably be expected to materially adversely affect any Development, Manufacturing, Medical Affairs Activities or Commercialization activities with respect to the Licensed Product for use or sale anywhere in the world, then such Party shall promptly notify the other Party of such contact, inspection or notice. The inspected Party shall provide such other Party with copies of all pertinent information and documentation issued by any such Regulatory Authority as soon as reasonably practicable after receipt, and the JSC (or such employees of a Party or its Affiliates as a Party’s JSC Co-Chair may designate) shall have the right to review and provide comment in advance, where feasible, of any responses that pertain thereto.
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Notice of Investigation or Inquiry. Each Party shall notify the other Party within two (2) Business Days after it receives information about the initiation of any investigation or inquiry by any Regulatory Authority concerning any improper use, distribution, promotion or sale of the Licensed Product, not otherwise described above.
Sample 1Sample 2
Notice of Investigation or Inquiry. If any Regulatory Authority (a) contacts a Party or its Affiliate with respect to the alleged improper Development, Manufacture or Commercialization of any Licensed Compound or Product in the Territory, (b) conducts, or gives notice of its intent to conduct, an inspection at a Party’s or its Affiliate’s facilities used in the Development or Manufacturing of Licensed Compound or Products, or (c) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of a Party or its Affiliate that could reasonably be expected to adversely affect any Development, Manufacture or Commercialization activities with respect to a Licensed Compound or Product in the Territory, then such Party shall promptly notify the other Party of such contact, inspection or notice.
Sample 1
Notice of Investigation or Inquiry. If any Regulatory Authority (a) contacts a Party or its Affiliate with respect to the alleged improper Development, Manufacture or Commercialization of any Product, (b) conducts, or gives notice of its intent to conduct, an inspection at a Party’s or its Affiliate’s facilities used in the Development or Manufacturing of Product, or (c) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of a Party or its Affiliate that could reasonably be expected to adversely affect any Development, Manufacture or Commercialization activities with respect to a Product in the other Party’s Territory, then such Party will promptly notify the other Party of such contact, inspection or notice. In addition, each Party will provide the other Party with at least [**] days’ advance notice of any meeting with any Regulatory Authority regarding any Regulatory Approval Application for any Product or any such audit or inspection conducted by any Regulatory Authority at any site at which such Product is being Manufactured or Clinical Studies with respect to such Product are being conducted. To the extent any such meeting is between CANbridge and any Regulatory Authority in Europe, then, to the extent that CANbridge reasonably determines that there is space sufficient for AVEO representatives to attend such meeting and such attendance by AVEO will not delay the proposed timing for the meeting, AVEO may elect to send representatives reasonably acceptable to CANbridge to participate in any such meeting at AVEO’s sole cost and expense.
Sample 1
Notice of Investigation or Inquiry. If any Regulatory Authority (1) contacts a Party with respect to the alleged improper Development, manufacture, or Commercialization of any Product in the Territory, (2) conducts, or gives notice of its intent to conduct, an inspection at such Party’s facilities to the extent related to a Collaboration Compound or Product, or (3) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of such Party that could reasonably be expected to adversely affect any Development or Commercialization activities with respect to a Product in the Territory, then such Party shall promptly notify the other Party of such contact, inspection or notice. The inspected Party shall provide such other Party with copies of all pertinent information and documentation issued by any such Regulatory Authority within two (2) Business Days of receipt, and the JDC shall have the right to review and approve in advance any responses that pertain to the Product.
Sample 1
Notice of Investigation or Inquiry. If any Regulatory Authority (a) with respect to Medarex, in the United States and (b) with respect to BMS, in a Major Market Country or any other country in Europe, (1) contacts such Party with respect to the improper Development, use, distribution, manufacture or Commercialization of any Product, MDX-1379 or any other Agent’s use in connection with a Product, (2) conducts, or gives notice of its intent to conduct, an inspection at such Party’s facilities or (3) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of such Party that could reasonably be expected to adversely affect any Development or Commercialization activities with respect to any Product, MDX-1379 or any other Agent’s use in connection with a Product under this Agreement, then such Party shall promptly notify the other Party of such contact or notice. Such other Party shall have the right to be present at and to participate in any such inspection or regulatory action with respect to the Products or MDX-1379. The inspected Party shall provide such other Party with copies of all pertinent information and documentation issued by any such Regulatory Authority within two (2) Business Days of receipt (or sooner if necessary to permit such other Party to be present at such visit) and the JDC shall have the right to review and approve in advance any responses that pertain to the Products, MDX-1379 or any other Agent’s use in connection with a Product.
Sample 1

Related to Notice of Investigation or Inquiry

  • Effect of Investigation The representations, warranties and covenants of the Indemnifying Party, and the Indemnified Party’s right to indemnification with respect thereto, shall not be affected or deemed waived by reason of any investigation made by or on behalf of the Indemnified Party (including by any of its Representatives) or by reason of the fact that the Indemnified Party or any of its Representatives knew or should have known that any such representation or warranty is, was or might be inaccurate or by reason of the Indemnified Party’s waiver of any condition set forth in Section 7.02 or Section 7.03, as the case may be.

  • Notification of Threatened Action Each Party will immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, which may affect the safety or efficacy claims of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

  • No Duty of Investigation Notice in Trust Instruments, etc. No purchaser, lender, transfer agent or other person dealing with the Trustees or with any officer, employee or agent of the Trust shall be bound to make any inquiry concerning the validity of any transaction purporting to be made by the Trustees or by said officer, employee or agent or be liable for the application of money or property paid, loaned, or delivered to or on the order of the Trustees or of said officer, employee or agent. Every obligation, contract, undertaking, instrument, certificate, Share, other security of the Trust, and every other act or thing whatsoever executed in connection with the Trust shall be conclusively taken to have been executed or done by the executors thereof only in their capacity as Trustees under this Declaration or in their capacity as officers, employees or agents of the Trust. The Trustees may maintain insurance for the protection of the Trust Property, its Shareholders, Trustees, officers, employees and agents in such amount as the Trustees shall deem adequate to cover possible tort liability, and such other insurance as the Trustees in their sole judgment shall deem advisable or is required by the 1940 Act.

  • Legal Action Notice A prompt report of any legal actions pending or threatened in writing against Borrower or any of its Subsidiaries that could result in damages or costs to Borrower or any of its Subsidiaries of, individually or in the aggregate, One Hundred Thousand Dollars ($100,000) or more; and

  • No Notice of Infringement To the Knowledge of the Company, neither the Company nor any of its Subsidiaries has received notice from any third party that the operation of the business of the Company or any of its Subsidiaries or any act, product or service of the Company or any of its Subsidiaries, infringes or misappropriates the Intellectual Property of any third party or constitutes unfair competition or unfair trade practices under the laws of any jurisdiction.

  • Notice of Infringement If, during the Term, either Party learns of any actual, alleged or threatened infringement by a Third Party of any Licensed Patents, such Party shall promptly notify the other Party and shall provide the other Party with available evidence of such infringement.

  • No Duty of Investigation; Notice in Trust Instruments, Etc No purchaser, lender, transfer agent or other Person dealing with the Trustees or any officer, employee or agent of the Trust or a Series thereof shall be bound to make any inquiry concerning the validity of any transaction purporting to be made by the Trustees or by said officer, employee or agent or be liable for the application of money or property paid, loaned, or delivered to or on the order of the Trustees or of said officer, employee or agent. Every obligation, contract, instrument, certificate, Share, other security of the Trust or a Series thereof or undertaking, and every other act or thing whatsoever executed in connection with the Trust shall be conclusively presumed to have been executed or done by the executors thereof only in their capacity as Trustees under this Declaration or in their capacity as officers, employees or agents of the Trust or a Series thereof. Every written obligation, contract, instrument, certificate, Share, other security of the Trust or a Series thereof or undertaking made or issued by the Trustees may recite that the same is executed or made by them not individually, but as Trustees under the Declaration, and that the obligations of the Trust or a Series thereof under any such instrument are not binding upon any of the Trustees or Shareholders individually, but bind only the Trust Property or the Trust Property of the applicable Series, and may contain any further recital which they may deem appropriate, but the omission of such recital shall not operate to bind the Trustees individually. The Trustees shall at all times maintain insurance for the protection of the Trust Property or the Trust Property of the applicable Series, its Shareholders, Trustees, officers, employees and agents in such amount as the Trustees shall deem adequate to cover possible tort liability, and such other insurance as the Trustees in their sole judgment shall deem advisable.

  • Survival Regardless of Investigation The indemnification and contribution provided for herein will remain in full force and effect regardless of any investigation made by or on behalf of Indemnitee or any officer, director, employee, agent or controlling person of Indemnitee.

  • Investigation Period The first sentence of Section 4.1 of the Purchase Agreement is hereby deleted in its entirety and the following is hereby substituted in lieu thereof: “During the time period commencing upon the Effective Date of this Agreement, and terminating at 11:59 p.m. on October 18, 2012 (the “Investigation Period”), Buyer shall have the right to conduct and complete an investigation of all matters pertaining to the Property and Buyer’s purchase thereof including, without limitation, the matters described in this Section 4.1.”

  • Investigation of Breach If the Seller (i) has knowledge of a breach of a representation or warranty made in Section 3.4, (ii) receives notice from the Depositor, the Trust, the Owner Trustee or the Indenture Trustee of a breach of a representation or warranty made in Section 3.4, (iii) receives a written request to repurchase a Receivable due to an alleged breach of a representation and warranty in Section 3.4 from the Owner Trustee, the Indenture Trustee, any Verified Note Owner or any Noteholder (which repurchase request shall provide sufficient detail so as to allow the Seller to reasonably investigate the alleged breach of the representations and warranties in Section 3.4; provided, that with respect to a repurchase request from a Noteholder or a Verified Note Owner, such repurchase request shall initially be provided to the Indenture Trustee) for a Receivable (each, a “Repurchase Request”) or (iv) receives a final report from the Asset Representations Reviewer that indicates that the Asset Representations Reviewer has determined that a test procedure under the Asset Representations Review Agreement has not been satisfied with respect to a representation or warranty set forth in Section 3.4 for a Receivable, then, in each case, the Seller will investigate the Receivable to confirm the breach and determine if the breach materially and adversely affects the interests of the Purchaser, the Issuer or the Noteholders in any Receivable. None of the Servicer, the Issuer, the Owner Trustee, the Indenture Trustee, the Asset Representations Reviewer or the Administrator will have an obligation to investigate whether a breach of any representation or warranty has occurred or whether any Receivable is required to be repurchased under this Section 3.5.

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