Paragraph IV Notice Sample Clauses

Paragraph IV Notice. If either Party receives a notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) concerning any MannKind Patent, Joint Patent or United Therapeutics Patent, then it shall provide a copy of such notice to the other Party within two Business Days after its receipt thereof. Patent infringement litigation based on such a notice concerning a MannKind Patent, Joint Patent or United Therapeutics Patent shall be brought and controlled as provided in Section 9.3(b) or 9.3(c) as applicable.
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Paragraph IV Notice. In the event that Idenix or its Affiliates receives a patent certification notice in accordance with 21 U.S.C. §§ 355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV), as amended (a “Paragraph IV Notice”), relating to the LdT Product Patent Rights, Idenix, its Affiliates and co-owners of LdT Product Patent Rights shall provide a copy of such Paragraph IV Notice to Novartis promptly and in any event within [**] Business Days after receipt.
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Paragraph IV Notice. If either Party receives a notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) (or any foreign equivalent) concerning any MannKind Patent, Joint Patent or Sanofi Patent, then it shall provide a copy of such notice to the other Party within two Business Days after its receipt thereof. Patent infringement litigation based on such a notice concerning a MannKind Patent, Joint Patent or Sanofi Patent shall be brought and controlled as provided in Section 9.3(b), 9.3(c) or 9.3(d), as applicable.
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Paragraph IV Notice. If either Party receives a notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) concerning a Licensed Patent (a “Paragraph IV Notice”), then it shall provide a copy of such notice to the other Party within two (2) Business Days after its receipt thereof. Adolor shall have the only right, but no obligation, to initiate patent infringement litigation based on a Paragraph IV Notice concerning a Licensed Product, at its own expense. Upon request of Adolor, Lilly agrees to timely join as party-plaintiff in any such litigation, and in any event to cooperate with Adolor in connection with such infringement action, including timely filing such action in Lilly’s name if required.
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Paragraph IV Notice. As soon as permissible and practicable, XOMA shall list all Servier Patents that are permitted by applicable Regulatory Authorities in the “Orange Book” as pertaining to the Initial Licensed Product or Additional Combination Product(s), as the case may be. In the event that either Party receives a patent certification notice in accordance with 21 U.S.C. §§ 355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV), as amended (a “Paragraph IV Notice”), relating to the Servier Intellectual Property, that Party shall promptly provide a copy of such Paragraph IV Notice to the other Party, in any event within [*] Business Days after receipt by the first Party.
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Paragraph IV Notice. If either Party receives a notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) from a Third Party filing an Abbreviated New Drug Application in which a Licensed Product is the subject listed product (a “Paragraph IV Notice”), then it shall provide a copy of such notice to the other Party within [**] after its receipt thereof. The Parties’ rights to initiate patent infringement litigation based on such Paragraph IV Notice shall be as set forth in Section 8.2.
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Related to Paragraph IV Notice

  • Notice of Third Party Claims Pursuant to Public Contract Code Section 9201, District shall provide Contractor timely notification of the receipt of any third-party claim relating to this Contract. District shall be entitled to recover its reasonable costs incurred in providing such notification.

  • Termination Notice for Force Majeure Event If a Force Majeure Event subsists for a period of 180 (one hundred and eighty) days or more within a continuous period of 365 (three hundred and sixty five) days, either Party may in its discretion terminate this Agreement by issuing a Termination Notice to the other Party without being liable in any manner whatsoever, save as provided in this Article 34, and upon issue of such Termination Notice, this Agreement shall, notwithstanding anything to the contrary contained herein, stand terminated forthwith; provided that before issuing such Termination Notice, the Party intending to issue the Termination Notice shall inform the other Party of such intention and grant 15 (fifteen) days time to make a representation, and may after the expiry of such 15 (fifteen) days period, whether or not it is in receipt of such representation, in its sole discretion issue the Termination Notice.

  • Notice of Material Breach and Intent to Exclude The parties agree that a material breach of this CIA by Indivior constitutes an independent basis for Indivior’s exclusion from participation in the Federal health care programs. The length of the exclusion shall be in OIG’s discretion, but not more than five years per material breach. Upon a determination by OIG that Indivior has materially breached this CIA and that exclusion is the appropriate remedy, OIG shall notify Indivior of: (a) Indivior’s material breach; and (b) OIG’s intent to exercise its contractual right to impose exclusion (this notification is hereinafter referred to as the “Notice of Material Breach and Intent to Exclude”).

  • Statutory Notice Pursuant to section 119.0701(2)(a), F.S., for contracts for services with a contractor acting on behalf of a public agency, as defined in section 119.011(2), F.S., the following applies: Pursuant to section 119.0701(2)(b), F.S., for contracts for services with a contractor acting on behalf of a public agency as defined in section 119.011(2), F.S., the Contractor shall: (a) Keep and maintain public records required by the public agency to perform the service. (b) Upon request from the public agency’s custodian of public records, provide the public agency with a copy of the requested records or allow the records to be inspected or copied within a reasonable time at a cost that does not exceed the cost provided in Chapter 119, F.S., or as otherwise provided by law. (c) Ensure that public records that are exempt or confidential and exempt from public records disclosure are not disclosed except as authorized by law for the duration of the Contract term and following the completion of the Contract if the Contractor does not transfer the records to the public agency. (d) Upon completion of the Contract, transfer, at no cost, to the public agency all public records in possession of the Contractor or keep and maintain public records required by the public agency to perform the service. If the Contractor transfers all public records to the public agency upon completion of the Contract, the Contractor shall destroy any duplicate public records that are exempt or confidential and exempt from public records disclosure requirements. If the Contractor keeps and maintains public records upon completion of the Contract, the Contractor shall meet all applicable requirements for retaining public records. All records stored electronically must be provided to the public agency, upon request from the public agency’s custodian of public records, in a format that is compatible with the information technology systems of the public agency.

  • Notice of Material Events The Borrower will notify the Administrative Agent, for distribution to the LC Issuer and each Lender, promptly, and not later than five (5) Business Days in the case of subsection (b) below and not later than ten (10) Business Days in the case of any other subsection below, after any Responsible Officer or general counsel of the Borrower has knowledge thereof, stating that such notice is being given pursuant to this Agreement, of: (a) the occurrence of any event or circumstance that has had, or could reasonably be expected to have, a Material Adverse Effect, (b) the occurrence of any Default, (c) the acceleration of the maturity of any Indebtedness owed by the Borrower or any of its Subsidiaries or of any default by the Borrower or any of its Subsidiaries under any Contractual Obligation of the Borrower or such Subsidiary, if such acceleration or default has had or could reasonably be expected to have a Material Adverse Effect, (d) the occurrence of any Termination Event, (e) the filing of any suit or proceeding, or the assertion in writing of a claim against the Borrower or any Material Subsidiary or with respect to the Borrower’s or any Material Subsidiary’s properties which could reasonably be expected to result in liability to Borrower or such Material Subsidiary in excess of $50,000,000; (f) the occurrence of any event of default by the Borrower or any of its Subsidiaries in the payment or performance of (i) any material obligations such Person is required to pay or perform under the terms of any indenture, mortgage, deed of trust, security agreement, lease, and franchise, or other agreement, contract or other instrument or obligation to which it is a party or by which it or any of its properties is bound, or (ii) any Indebtedness, to the extent, in the case of clauses (i) and (ii), such event of default could reasonably be expected to have a Material Adverse Effect; and (g) any announcement of any change in a Rating. Each notice pursuant to this Section shall be accompanied by a statement of a Responsible Officer of the Borrower setting forth details of the occurrence referred to herein and stating what action the Borrower, Subsidiary or Material Subsidiary, as applicable, has taken and proposes to take with respect thereto. Each notice pursuant to Section 6.03(b) shall describe with particularity any all provisions of this Agreement and if, applicable, other Loan Documents, that have been breached.

  • Notice of a License Action Grantee shall notify their contract manager of any action impacting its license to provide services under this Contract within five days of becoming aware of the action and include the following: a. Reason for such action; b. Name and contact information of the local, state or federal department or agency or entity; x. Xxxx of the license action; and d. License or case reference number.

  • Notice of Events As soon as Guarantor obtains knowledge thereof, Guarantor shall give Guarantied Party written notice of any condition or event which has resulted in (a) a material adverse change in the financial condition of Guarantor or Company or (b) any Event of Default or Potential Event of Default.

  • CAFA Notice Pursuant to 28 U.S.C. § 1715, not later than ten (10) days after the Agreement is filed with the Court, the Settlement Administrator shall cause to be served upon the Attorneys General of each U.S. State in which Settlement Class members reside, the Attorney General of the United States, and other required government officials, notice of the proposed settlement as required by law, subject to Paragraph 5.1 below.

  • Termination for Material Breach Either Party (the “Terminating Party”) may terminate this Agreement in its entirety, or on a country-by-country and Product-by-Product basis, in the event the other Party (the “Breaching Party”) has materially breached this Agreement, and such material breach has not been cured within sixty (60) days after receipt of written notice of such breach by the Breaching Party from the Terminating Party (the “Cure Period”). The written notice describing the alleged material breach shall provide sufficient detail to put the Breaching Party on notice of such material breach. Any termination of this Agreement pursuant to this Section 10.3 shall become effective at the end of the Cure Period, unless the Breaching Party has cured any such material breach prior to the expiration of such Cure Period; provided that in the event a claim of material breach is being contested diligently and in good faith by appropriate proceedings hereunder, any termination pursuant to this Section shall not become effective unless and until such material breach has been established in such proceedings and, in the event that, following such establishment, a cure may then be accomplished by the payment of money or the taking of certain actions, such payment or actions are not paid or taken within sixty (60) days of the conclusion of such proceedings. The right of either Party to terminate this Agreement as provided in this Section 10.3 shall not be affected in any way by such Party’s waiver of or failure to take action with respect to any previous breach under this Agreement.

  • Content of Notice The Plan Administrator shall provide written notice to every Claimant who is denied a claim for benefits which notice shall set forth the following: (i.) The specific reason or reasons for the denial; (ii.) Specific reference to pertinent Agreement provisions on which the denial is based; (iii.) A description of any additional material or information necessary for the Claimant to perfect the claim, and any explanation of why such material or information is necessary; and (iv.) Any other information required by applicable regulations, including with respect to disability benefits.

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