Hatch-Waxman Sample Clauses

Hatch-Waxman. Following Roche’s exercise of its Option Right with respect to a Licensed Program, with respect to any identification of Patents to Regulatory Authorities for a Product within such Licensed Program as required or allowed for listing in the FDA’s Orange Book in the United States or foreign equivalents outside of the United States: (i) Roche will have the sole right to make any such decision to list any Product Specific Patent or any Vividion CC Patent for such Product and (ii) Vividion will have the sole right to make any such decision with respect to any Vividion Patents other than Product Specific Patents and Vividion CC Patents for any product, provided that Roche shall have the right to list any Vividion CC Patents for such Product with Vividion’s prior written consent. Notwithstanding anything herein to the contrary, should a Party receive a certification for a Product or Shared Product within a Licensed Program pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417, known as the Hatch-Waxman Act), as amended, or its equivalent in a country other than the US, then such Party shall immediately provide the other Party with a copy of such certification. Roche shall have [***] days from date on which it receives or provides a copy of such certification to provide written notice to Vividion (“H-W Suit Notice”) whether Roche will bring suit, at [***] expense, within a [***] day period from the date of such certification, and in any case at least [***] Business Days prior to which any further delay in bringing such suit would limit or compromise the remedies available in connection with such certification. Should such [***] day period expire without Roche bringing suit or providing such H-W Suit Notice, then Vividion shall be free to immediately bring suit in its name.
Sample 1
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Hatch-Waxman. Notwithstanding anything herein to the contrary, should a Party receive a certification for a Licensed Product pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98‑417, known as the Hatch‑Waxman Act), as amended, or its equivalent in a country other than the US, with respect to any activities under this Agreement in the Field, then such Party will immediately provide the other Party with a copy of such certification. For each Licensed Product, Takeda will have thirty (30) days from date on which it receives or provides a copy of such certification to provide written notice to the other Party (“H‑W Suit Notice”) whether such first Party will bring suit, at its expense, within a forty‑five (45) day period from the date of such certification. Should such thirty (30) day period expire without such first Party bringing suit or providing such H‑W Suit Notice, then such other Party will be free to immediately bring suit in its name.
Sample 1
Hatch-Waxman. Notwithstanding anything to the contrary, should a Parxx xxxeive a certification for a Product pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417), as amended, or its equivalent in a country other than the US, then such Party shall immediately provide the other Party with a copy of such certification. Prior to Roche exercising its right to obtain a License which respect to a Product, then Memory shall have the sole right to enforce Memory Patent Rights Covering such Product. After Roche has exercised its right to obtain a License with respect to a Product, then Roche shall have the right to enforce Memory Patent Rights Covering such Product; and Roche shall have [*] days from the date on which it receives or provides a copy of such certification to provide written notice to Memory ("H-W Suit Notice") whether Roche will bring suit, at its expense, within a [*] day period from the date of such certification. Should such [*] day period expire without Roche bringing suit or providing such H-W Suit Notice, then Memory shall be free to immediately bring suit in its name. If Roche brings suit, at Roche's written request, Memory agrees to be named as a party to such suit.
Sample 1
Hatch-Waxman. Notwithstanding anything to the contrary, should a Partx xxxxive a certification for a Product pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417), as amended, or its equivalent in a country other than the United States of America, then such Party shall immediately provide the other Party with a copy of such certification. Roche shall have [*] days from the date on which it receives or provides a copy of such certification to provide written notice to Memory ("H-W Suit Notice") whether Roche will bring suit, at its expense, within a [*] day period from the date of such certification. Should such [*] day period expire without Roche bringing suit or providing such H-W Suit Notice, then Memory shall be free to immediately bring suit in its name. If Roche brings suit, at Roche's written request, Memory agrees to be named as a party to such suit. [*] CONFIDENTIAL TREATMENT IS REQUESTED
Sample 1

Related to Hatch-Waxman

  • Sxxxxxxx-Xxxxx Certification Each Form 10-K with respect to the Trust shall include a Sxxxxxxx-Xxxxx Certification in the form attached to this Agreement as Exhibit X required to be included therewith pursuant to the Sxxxxxxx-Xxxxx Act. The Certificate Administrator, the Master Servicer, the Special Servicer, the Operating Advisor, the Asset Representations Reviewer (in the case of the Asset Representations Reviewer, solely with respect to reporting periods in which the Asset Representations Reviewer is required to deliver an Asset Review Report Summary), the Custodian and the Trustee shall provide (and (i) with respect to any Servicing Function Participant of such party that is a Mortgage Loan Seller Sub-Servicer, shall use commercially reasonable efforts to cause such Servicing Function Participant to provide, and (ii) with respect to any other Servicing Function Participant of such party (other than any party to this Agreement), shall cause such Servicing Function Participant to provide) to the Person who signs the Sxxxxxxx-Xxxxx Certification for the Trust or any Other Securitization Trust (the “Certifying Person”) no later than March 1 in the year immediately following the year as to which such Form 10-K relates or, if March 1 is not a Business Day, on the immediately following Business Day, a certification in the form attached to this Agreement as Exhibit Y-1, Exhibit Y-2, Exhibit Y-3, Exhibit Y-4, Exhibit Y-5, Exhibit Y-6, Exhibit Y-7 and Exhibit Y-8, as applicable, on which the Certifying Person, the entity for which the Certifying Person acts as an officer, and such entity’s officers, directors and Affiliates (collectively with the Certifying Person, “Certification Parties”) can reasonably rely. With respect to each Outside Serviced Mortgage Loan serviced under an Outside Servicing Agreement, the Certificate Administrator shall use commercially reasonable efforts to procure, and upon receipt deliver to the Certifying Person, a Sxxxxxxx-Xxxxx back-up certification similar in form and substance to the certifications referenced in the preceding sentence, from the related Outside Servicer, the related Outside Special Servicer, the related Outside Paying Agent and the related Outside Trustee. In the event any Reporting Servicer is terminated or resigns pursuant to the terms of this Agreement, or any applicable Sub-Servicing Agreement or primary servicing agreement, as the case may be, such Reporting Servicer shall provide a certification to the Certifying Person pursuant to this Section 10.06 with respect to the period of time it was subject to this Agreement or the applicable sub-servicing or primary servicing agreement, as the case may be.

  • Xxxxxxxx-Xxxxx Certification Each Form 10-K with respect to the Trust shall include a Xxxxxxxx-Xxxxx Certification in the form attached to this Agreement as Exhibit X required to be included therewith pursuant to the Xxxxxxxx-Xxxxx Act. The Certificate Administrator, the Master Servicer, the Special Servicer, the Operating Advisor, the Asset Representations Reviewer (in the case of the Asset Representations Reviewer, solely with respect to reporting periods in which the Asset Representations Reviewer is required to deliver an Asset Review Report Summary), the Custodian and the Trustee shall provide (and (i) with respect to any Servicing Function Participant of such party that is a Mortgage Loan Seller Sub-Servicer, shall use commercially reasonable efforts to cause such Servicing Function Participant to provide, and (ii) with respect to any other Servicing Function Participant of such party (other than any party to this Agreement), shall cause such Servicing Function Participant to provide) to the Person who signs the Xxxxxxxx-Xxxxx Certification for the Trust or any Other Securitization Trust (the “Certifying Person”) no later than March 1 in the year immediately following the year as to which such Form 10-K relates or, if March 1 is not a Business Day, on the immediately following Business Day, a certification in the form attached to this Agreement as Exhibit Y-1, Exhibit Y-2, Exhibit Y-3, Exhibit Y-4, Exhibit Y-5, Exhibit Y-6, Exhibit Y-7 and Exhibit Y-8, as applicable, on which the Certifying Person, the entity for which the Certifying Person acts as an officer, and such entity’s officers, directors and Affiliates (collectively with the Certifying Person, “Certification Parties”) can reasonably rely. With respect to each Outside Serviced Mortgage Loan serviced under an Outside Servicing Agreement, the Certificate Administrator shall use commercially reasonable efforts to procure, and upon receipt deliver to the Certifying Person, a Xxxxxxxx-Xxxxx back-up certification similar in form and substance to the certifications referenced in the preceding sentence, from the related Outside Servicer, the related Outside Special Servicer, the related Outside Paying Agent and the related Outside Trustee. In the event any Reporting Servicer is terminated or resigns pursuant to the terms of this Agreement, or any applicable Sub-Servicing Agreement or primary servicing agreement, as the case may be, such Reporting Servicer shall provide a certification to the Certifying Person pursuant to this Section 10.06 with respect to the period of time it was subject to this Agreement or the applicable sub-servicing or primary servicing agreement, as the case may be.

  • Anti-Money Laundering and Red Flag Identity Theft Prevention Programs The Trust acknowledges that it has had an opportunity to review, consider and comment upon the written procedures provided by USBFS describing various tools used by USBFS which are designed to promote the detection and reporting of potential money laundering activity by monitoring certain aspects of shareholder activity as well as written procedures for verifying a customer’s identity (collectively, the “Procedures”). Further, the Trust has determined that the Procedures, as part of the Trust’s overall anti-money laundering program and the Red Flag Identity Theft Prevention program, are reasonably designed to prevent the Fund from being used for money laundering or the financing of terrorist activities and to achieve compliance with the applicable provisions of the Fair and Accurate Credit Transactions Act of 2003 and the USA Patriot Act of 2001 and the implementing regulations thereunder. Based on this determination, the Trust hereby instructs and directs USBFS to implement the Procedures on the Trust’s behalf, as such may be amended or revised from time to time. It is contemplated that these Procedures will be amended from time to time by the parties as additional regulations are adopted and/or regulatory guidance is provided relating to the Trust’s anti-money laundering and identity theft responsibilities. USBFS agrees to provide to the Trust:

  • Environment, Health, and Safety (i) The Seller, and its predecessors and Affiliates has complied with all Environmental, Health, and Safety Laws, and no action, suit, proceeding, hearing, investigation, charge, complaint, claim, demand, or notice has been filed or commenced against any of them alleging any failure so to comply. Without limiting the generality of the preceding sentence, each of the Seller, and its predecessors and Affiliates has obtained and been in compliance with all of the terms and conditions of all permits, licenses, and other authorizations which are required under, and has complied with all other limitations, restrictions, conditions, standards, prohibitions, requirements, obligations, schedules, and timetables which are contained in, all Environmental, Health, and Safety Laws.

  • Xxxxxxx, 265 Cal App. 2d 40 (1968). By executing this Guaranty, Holdings freely, irrevocably, and unconditionally: (i) waives and relinquishes that defense and agrees that Holdings will be fully liable under this Guaranty even though the Secured Parties may foreclose, either by judicial foreclosure or by exercise of power of sale, any deed of trust securing the Obligations; (ii) agrees that Holdings will not assert that defense in any action or proceeding which the Secured Parties may commence to enforce this Guaranty; (iii) acknowledges and agrees that the rights and defenses waived by Holdings in this Guaranty include any right or defense that Holdings may have or be entitled to assert based upon or arising out of any one or more of §§ 580a, 580b, 580d, or 726 of the California Code of Civil Procedure or § 2848 of the California Civil Code; and (iv) acknowledges and agrees that the Secured Parties are relying on this waiver in creating the Obligations, and that this waiver is a material part of the consideration which the Secured Parties are receiving for creating the Obligations.

  • Conhecimento da Lingua O Contratado, pelo presente instrumento, declara expressamente que tem pleno conhecimento da língua inglesa e que leu, compreendeu e livremente aceitou e concordou com os termos e condições estabelecidas no Plano e no Acordo de Atribuição (“Agreement” xx xxxxxx).

  • SAFETY AND HEALTH All sources supplying coal purchased under this contract shall be in full compliance with the Federal Mine Safety and Health Act of 1977 and regulations issued thereunder. Failure to comply shall constitute a breach of contract, permitting TVA to exercise its remedies under this contract or as provided by law.

  • Environmental, Health and Safety The Policy Board shall review, approve and monitor environmental and workplace health and safety guidelines, the goal of which is to achieve compliance with current national, state and local laws and regulations regarding environmental and workplace health and safety.

  • Soldiers' and Sailors' Civil Relief Act The Mortgagor has not notified the Seller, and the Seller has no knowledge of any relief requested or allowed to the Mortgagor under the Relief Act or any similar state statute;

  • Health and Safety All employees and workers have a duty in law to act responsibly and to take reasonable care for the health and safety at work of both themselves and their colleagues. This duty can be carried out by:

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