Xxxxx-Xxxxxx Act Litigation Sample Clauses

Xxxxx-Xxxxxx Act Litigation. Notwithstanding anything herein to the contrary, should a Party receive (a) a certification for a Product pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417), as amended (the “Xxxxx-Xxxxxx Act”), including any notice under 21 U.S.C. § 355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) or a similar notice with respect to, in either case, any Product, or (b) any reasonable equivalent in a country in the Territory other than the U.S., then such Party shall immediately (and in any event no later than within five (5) Business Days after such receipt) provide the other Party with a copy of such certification or notice. The Party with the right to bring suit under the Xxxxx-Xxxxxx Act or reasonable equivalent in any country outside the United States, as applicable, on account of such certification or notice shall have fifteen (15) Calendar Days from the date on which it receives a copy of the application for which Regulatory Approval is sought, but in no event later than thirty-five (35) Calendar Days from the date of receipt of the certification or notice, to provide written notice to the other Party (“H-W Suit Notice”) stating whether it will bring suit, at its expense, within a forty-five (45) Calendar Day period from the date of such certification or notice, including any patent infringement suit (or other applicable time limit for bringing such suit). Should the period referred to in the prior sentence for delivering an H-W Suit Notice expire without the applicable Party providing such H-W Suit Notice, then the other Party shall be free immediately to bring suit in the name of the Party that did not give the H-W Suit Notice. Notwithstanding the foregoing, (I) no Party shall take any action in the course of exercising its rights under this Section 6.2 that (x) admits fault or wrongdoing, or incurs liability, on the part of the other Party or (y) materially limits the scope, validity, or enforceability of any of the Licensor Patents in the Territory without, in either case, the prior written consent of the other Party and (II) if Licensor is the party bringing the suit hereunder, Licensor shall not take any action in the course of exercising its rights under this Section 6.2 that would reasonably be expected to materially adversely affect the ability of Licensee to manufacture, Develop or Commercialize Products without Licensee’s prior written consent.
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Xxxxx-Xxxxxx Act Litigation. 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), as amended (the “Xxxxx-Xxxxxx Act”), including any notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) or a similar notice with respect to, in either case, any Licensed Product or any Competing Product in the Territory, then such Party shall immediately (and in any event no later than within *** after such receipt) provide the other Party with a copy of such certification.
Xxxxx-Xxxxxx Act Litigation. Notwithstanding anything herein to the contrary, should a Party receive a certification pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417), as amended (the “Xxxxx-Xxxxxx Act”), including any notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) or a similar notice (the “Certification”) relating to any Orange Book Patent in the Field in the Territory, then such Party shall immediately (and in any event no later than within [***] after such receipt) provide the other Party with a copy of such Certification. Shionogi shall have [***] from the date on which it receives a Certification to provide written notice to BDSI (“H-W Suit Notice”) stating whether it will bring suit within a [***] period from the date of such Certification, including any patent infringement suit (or other applicable time limit for bringing such suit) and, if Shionogi or any Affiliate thereof does bring such suit within such period, BDSI shall have the right to join such action using its own counsel and at its own expense. Should such [***] expire without Shionogi providing such H-W Suit Notice, then BDSI shall be free to bring suit at BDSI’s expense. Each Party shall reasonably assist the other Party in such enforcement, including joining such action as a party plaintiff if required by applicable law to pursue such action, making its personnel available, providing any necessary Information, and executing documents.
Xxxxx-Xxxxxx Act Litigation. Notwithstanding anything herein to the contrary, should a Party receive a certification as to a Licensed Product pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417), as amended (the “Xxxxx-Xxxxxx Act”), or its equivalent with respect to biologics in the United States or in a country other than the United States, then such Party shall immediately provide the other Party with a copy of such certification. The Party with the right to take an Enforcement Action pursuant to Section 8.4 with respect to the applicable Patent(s) shall, within thirty (30) days from the date on which it receives or provides a copy of such certification provide written notice to the other Party (“H-W Suit Notice”) stating whether it will bring suit, at its expense, within a forty-five (45) day period from the date of such certification, and if not, whether the applicable step-in right of the other Party pursuant to Section 8.4(b) or 8.4(c) will apply (i.e., whether such Party is exercising its right pursuant to such Section not to permit the other Party to exercise such step-in right).

Related to Xxxxx-Xxxxxx Act Litigation

  • Sxxxxxxx-Xxxxx Act There is and has been no failure on the part of the Company or any of the Company’s directors or officers, in their capacities as such, to comply with any provision of the Sxxxxxxx-Xxxxx Act of 2002 and the rules and regulations promulgated in connection therewith (the “Sxxxxxxx-Xxxxx Act”), including Section 402 related to loans and Sections 302 and 906 related to certifications.

  • Xxxxxxxx-Xxxxx Act There is and has been no failure on the part of the Company or any of the Company’s directors or officers, in their capacities as such, to comply with any provision of the Xxxxxxxx-Xxxxx Act of 2002 and the rules and regulations promulgated in connection therewith (the “Xxxxxxxx-Xxxxx Act”), including Section 402 related to loans and Sections 302 and 906 related to certifications.

  • Xxxx-Xxxxx-Xxxxxx Act The waiting period (and any extension thereof) applicable to the consummation of the transactions contemplated hereby under the HSR Act shall have expired or been terminated.

  • Xxxxx-Xxxxx Act Xxxxx-Xxxxx Act, as amended (40 U.S.C. 3141-3148). When required by Federal program legislation, all prime construction contracts in excess of $2,000 awarded by non- Federal entities must include a provision for compliance with the Xxxxx-Xxxxx Act (40 U.S.C. 3141- 3144, and 3146-3148) as supplemented by Department of Labor regulations (29 CFR Part 5, “Labor Standards Provisions Applicable to Contracts Covering Federally Financed and Assisted Construction”). In accordance with the statute, contractors must be required to pay wages to laborers and mechanics at a rate not less than the prevailing wages specified in a wage determination made by the Secretary of Labor. In addition, contractors must be required to pay wages not less than once a week. The non-Federal entity must place a copy of the current prevailing wage determination issued by the Department of Labor in each solicitation. The decision to award a contract or subcontract must be conditioned upon the acceptance of the wage determination. The non-Federal entity must report all suspected or reported violations to the Federal awarding agency. The contracts must also include a provision for compliance with the Xxxxxxxx “Anti-Kickback” Act (40 U.S.C. 3145), as supplemented by Department of Labor regulations (29 CFR Part 3, “Contractors and Subcontractors on Public Building or Public Work Financed in Whole or in Part by Loans or Grants from the United States”). The Act provides that each contractor or Subrecipient must be prohibited from inducing, by any means, any person employed in the construction, completion, or repair of public work, to give up any part of the compensation to which he or she is otherwise entitled. The non-Federal entity must report all suspected or reported violations to the Federal awarding agency.

  • Xxxxxx Xxxx The right-of-way, the roadway and all improvements constructed thereon connecting the airport to a public highway.

  • XXXXXX XXX Xxxxxx Xxx, a federally chartered and privately owned corporation organized and existing under the Federal National Mortgage Association Charter Act, or any successor thereto.

  • Xxxxxxx Xxxx CareFirst BlueChoice’s Service Area is a clearly defined geographic area in which CareFirst BlueChoice has arranged for the provision of health care services to be generally available and readily accessible to Members. CareFirst BlueChoice will provide the Member with a specific description of the Service Area at the time of enrollment. The Service Area is as follows: the District of Columbia; the state of Maryland; in the Commonwealth of Virginia, the cities of Alexandria and Fairfax, Arlington County, the town of Vienna and the areas of Fairfax and Xxxxxx Xxxxxxxx Counties in Virginia lying east of Route 123. SAMPLE If a Member temporarily lives out of the Service Area (for example, if a Dependent goes to college in another state), the Member may be able to take advantage of the CareFirst BlueChoice Away From Home Program. This Program may allow a Member who resides out of the Service Area for an extended period of time to utilize the benefits of an affiliated Blue Cross and Blue Shield HMO. This Program is not coordination of benefits. A Member who takes advantage of the Away From Home Program will be subject to the rules, regulations and plan benefits of the affiliated Blue Cross and Blue Shield HMO. If the Member makes a permanent move, he/she does not have to wait until the Annual Open Enrollment Period to change plans. Please call 000-000-0000 or visit xxx.xxxx.xxx for more information on the Away from Home Program. This attachment contains certain terms that have a specific meaning as used herein. These terms are capitalized and defined in Section A below, and/or in the Individual Enrollment Agreement to which this document is attached. These procedures replace all prior procedures issued by CareFirst BlueChoice, which afford CareFirst BlueChoice Members recourse pertaining to denials and reductions of claims for benefits by CareFirst BlueChoice. These procedures only apply to claims for benefits. Notification required by these procedures will only be sent when a Member requests a benefit or files a claim in accordance with CareFirst BlueChoice procedures. An authorized representative may act on behalf of the Member in pursuing a benefit claim or appeal of an Adverse Benefit Determination. CareFirst BlueChoice may require reasonable proof to determine whether an individual has been properly authorized to act on behalf of a Member. In the case of a claim involving Urgent/Emergent Care, a Health Care Provider with knowledge of a Member's medical condition is permitted to act as the authorized representative. SAMPLE

  • Xxxxx Xxxx Purchase Order and Sales Contact Email 2 Purchase Order and Sales Contact Phone 2 3 Company Website 2 4 Entity D/B/A's and Assumed Names 5 Primary Address 2 6 Primary Address City 7 Primary Address State 2 8 Primary Address Zip 9 Search Words Identifying Vendor Certification of Vendor Residency (Required by the State of Texas)

  • Xxxxxx Xxxxxx Xxxx Xx Day, 3rd Monday in January;

  • Sxxxxxxx-Xxxxx The Company is, or on the Closing Date will be, in material compliance with the provisions of the Sxxxxxxx-Xxxxx Act of 2002, as amended, and the rules and regulations promulgated thereunder and related or similar rules or regulations promulgated by any governmental or self-regulatory entity or agency, that are applicable to it as of the date hereof.

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