Guidance for Industry Sample Clauses

Guidance for Industry. Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at xxxx://xxx.xxxxxxxxxxx.xxx or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
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Guidance for Industry. As of the Effective Date, the Company has submitted to the FDA all the clinical, nonclinical and related Module 1 documents of a New Drug Application for an Included Product with a prospective indication in Alagille Syndrome. The FDA has not required that such New Drug Application include any clinical trial data from currently ongoing or not yet initiated studies in order to accept for review or approve such New Drug Application. Neither the Company nor its Affiliates has received any notice indicating that the New Drug Application’s rolling review must terminate or cannot continue.
Guidance for Industry. Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment. U.S. Department of Health and Human Services, Food and Drug Administration. Rockville, MD : s.n., June 2006.
Guidance for Industry. Draft Guidance issued by the FDA in July 2019, that in either case (i) or (ii) has been enacted, adopted, approved or imposed between the Effective Date and the Closing Date and adversely impacts the manner in which Buyer may use, receive, hold or otherwise exploit the Priority Review Voucher.
Guidance for Industry. Draft Guidance issued by the FDA in July 2019. To the knowledge of Seller, there are no facts or circumstances that could reasonably be expected to preclude or interfere with (a) the transfer of the Purchased Assets to Buyer or (b) Buyer’s ability to use the Purchased Assets to obtain Priority Review or any other benefit associated with the Purchased Assets following the Closing. Seller has provided to Buyer true and complete copies of the Approval Letter and any other material communications between Seller or any of its Affiliates and the FDA regarding the Priority Review Voucher.
Guidance for Industry. Draft Guidance issued in July 2019. To the Knowledge of Seller, there are no facts or circumstances that could reasonably be expected to preclude or interfere with (a) the transfer of the Purchased Assets to Buyer, or (b) Buyer’s ability to use the Purchased Assets to obtain Priority Review. Seller has provided to Buyer true and complete copies of the NDA Approval Letter and any other material communications between Seller, Albireo Pharma or any of their respective Affiliates and the FDA regarding the Priority Review Voucher.

Related to Guidance for Industry

  • Procedure for Indemnification (a) If either party shall receive notice of any claim or Action brought, asserted, commenced or pursued by any person or entity not a party to this Agreement (hereinafter a "Third Party Claim"), with respect to which the other party is or may be obligated to make an Indemnity Payment, it shall give such other party prompt notice thereof (including any pleadings relating thereto), specifying in such reasonable detail as is known to it the nature of such Third Party Claim and the amount or estimated amount thereof; provided, however, that the failure of a party to give notice as provided in this Section 4.4 shall not relieve the other party of its indemnification obligations under this Article 4, except to the extent that such other party is actually prejudiced by such failure to give notice. (b) For any Third Party Claim concerning which notice is required to be given, and, in fact, is given under subparagraph (a) of this Section 4.4, the Indemnifying Party shall defend in a timely manner, to the extent permitted by law, such Third Party Claim through counsel appointed by the Indemnifying Party and reasonably acceptable to the Indemnitee. Once an Indemnifying Party has commenced its defense of an Indemnitee, it cannot withdraw from such defense until conclusion of the matter, unless the Indemnified Party agrees to the withdrawal or the Indemnitee is also defending the claim. The Indemnitee shall have the right to participate in the defense of the Third Party Claim by employing separate counsel at its own expense. (c) If a party responds to a notice of a Third Party Claim by denying its obligation to indemnify the other party, or if the Indemnifying Party fails to defend in a timely or reasonably satisfactory manner, the Indemnitee shall be entitled to defend such Third Party Claim through counsel appointed by it. In addition, if it is later determined that such party wrongfully denied such claim, or the Indemnifying Party failed to defend timely or in a reasonably satisfactory manner, then the Indemnifying Party shall (i) reimburse the Indemnitee for all reasonable costs and expenses (including attorney fees before and at trial and in connection with any appeal or petition for review, but excluding salaries of officers and employees) incurred by the Indemnitee in connection with its defense of such Third Party Claim; and (ii) be estopped from challenging a judgment, order, settlement, compromise, or consent judgment resolving the Third Party Claim entered into in good faith by the Indemnitee (if such claim has been resolved prior to the conclusion of the proceeding between the Indemnitee and Indemnifying Party). An Indemnifying Party, after initially rejecting a claim for defense or indemnification, may defend and indemnify the Indemnitee, at any time prior to the resolution of said Third Party Claim, for such claim, provided that (x) the Indemnifying Party reimburses the Indemnitee for all reasonable costs and expenses (including attorney fees before and at trial and in connection with any appeal or petition for review, but excluding salaries of officers and employees) incurred by the Indemnitee in connection with its defense of such Third Party Claim up to the time the Indemnifying Party assumes control of the defense of such claim (including costs incurred in the transition of the defense from the Indemnitee to the Indemnifying Party); and (y) the assumption of the defense of the Third Party Claim is not expected to prejudice or cause harm to the Indemnitee. (d) With respect to any Third Party Claim for which indemnification has been claimed hereunder, no party shall enter into any compromise or settlement, or consent to the entry of any judgment which (i) does not include as a term thereof the giving by the third party of a release to the Indemnitee from all further liability concerning such Third Party Claim on terms no less favorable than those obtained by the party entering into such compromise, settlement or consent; or (ii) imposes any obligation on the Indemnitee without such Indemnitee's written consent (such consent not to be withheld unreasonably), except an obligation to pay money which the Indemnifying Party has agreed to pay and has the ability to pay on behalf of the Indemnitee. In the event that an Indemnitee enters into any such compromise, settlement or consent without the written consent of the Indemnifying Party (other than as contemplated by Section 4.4(c) hereof), the entry of such compromise, settlement or consent shall relieve the Indemnifying Party of its indemnification obligation related to the claims underlying such compromise, settlement or consent. (e) Upon final judgment, determination, settlement or compromise of any Third Party Claim, and unless otherwise agreed by the parties in writing, the Indemnifying Party shall pay promptly on behalf of the Indemnitee, or to the Indemnitee in reimbursement of any amount theretofore required to be paid by the Indemnitee, the amount so determined by final judgment, determination, settlement or compromise. Upon the payment in full by the Indemnifying Party of such amount, the Indemnifying Party shall succeed to the rights of such Indemnitee to the extent not waived in settlement, against the third party who made such Third Party Claim and any other person who may have been liable to the Indemnitee with respect to the indemnified matter. (f) In connection with defending against Third Party Claims, the parties shall cooperate with and assist each other by making available all employees, books, records, communications, documents, items and matters within their knowledge, possession or control that are necessary, appropriate or reasonably deemed relevant with respect to defense of such claims; provided, however, that nothing in this subparagraph (f) shall be deemed to require the waiver of any privilege, including the attorney-client privilege, or protection afforded by the attorney work product doctrine. In addition, regardless of the party actually defending a Third Party Claim for which there is an indemnity obligation under Section 4.1 or 4.2 hereof, the parties shall give each other regular status reports relating to such action with detail sufficient to permit the other party to assert and protect its rights and obligations under this Agreement.

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