NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT Sample Clauses

NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT. 18.1 Notices Relating to the Act. Bukwang shall use its best efforts to cause the Primary Licensors to notify Triangle of (a) the issuance of each U.S. patent included among the Bukwang Patents, giving the date of issue and patent number for each such patent; and (b) each notice pertaining to any patent included among the Bukwang Patents which the Primary Licensors receive as patent owners pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (hereinafter the “Act”), including but not necessarily limited to notices pursuant to §§101 and 103 of the Act from persons who have filed an abbreviated NDA (“ANDA”) or a “paper” NDA. Such notices shall be given promptly, but in any event within ten (10) days of notice of each such patent’s date of issue or receipt of each such notice pursuant to the Act, whichever is applicable.
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NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT. Notices Relating to the Act. ADDEX shall notify OMP of (a) the issuance of each patent included among the ADDEX Patents, giving the date of issue and patent number for each such patent; and (b) communications pertaining to any patent included among the ADDEX Patents which ADDEX receives as patent owner pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (hereinafter the “Act”), including but not necessarily limited to notices pursuant to §§101 and 103 of the Act from persons who have filed an abbreviated MAA (“AMAA”) or a “paper” MAA.
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NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT. 17.1 ARROW shall use its best efforts to notify TRIANGLE of (a) the issuance of each U.S. patent included among the ARROW PATENTS, giving the date of issue and patent number for each such patent; and (b) each notice pertaining to any patent included among the ARROW PATENTS which ARROW receives as patent owner pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (hereinafter the "Act"), including but not necessarily limited to notices pursuant to ss.ss.101 and 103 of the Act from persons who have filed an abbreviated NDA ("ANDA") or a 'paper' NDA. Such notices shall be given promptly, but in any event within ten (10) days of ARROW'S notice of each ---------- *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. such patent's date of issuance or receipt of each such notice pursuant to the Act, whichever is applicable. 17.2 ARROW hereby authorises TRIANGLE (a) to include in any NDA for a PRODUCT, as TRIANGLE may deem appropriate under the Act, a list of patents included among the ARROW PATENTS that relate to such PRODUCT and such other information as TRIANGLE in its reasonable discretion believes is appropriate to be filed pursuant to the Act; (b) to commence suit for any infringement of the ARROW PATENTS under ss. 271(e)(2) of Title 35 of the United States code occasioned by the submission of a third party of an IND or a paper NDA for a PRODUCT pursuant to xx.xx. 101 or 103 of the Act; and (c) subject to ARROW'S consent (which consent shall not be unreasonably withheld or delayed), to exercise any rights that may be exercisable by ARROW as patent owner under the Act to apply for an extension of the term of any patent included among the ARROW PATENTS. In the event that applicable law in any other country of the TERRITORY hereafter provides for the extension of the term of any patent included among the ARROW PATENTS in such country, upon request by either party (the requesting party), the other party shall use its best efforts to obtain such extension or in lieu thereof, shall authorise the requesting party, or if requested by the requesting party, the requesting party's sub-licensees to apply for such extension. Each party and its sub-licensees agree to cooperate with the other party and its sub-licensees, as applicable, in the exercise of the authorisation granted herein or which may be granted pursuant to this Section 17.2 and will execute such documen...
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NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT. 14.1 Notices Relating to the Act. Cellegy shall notify GW of (a) the issuance of each U.S. patent and of each patent issued in a country of the European Union included within the Patent Rights, giving the date of issue and patent number for each such patent and (b) each notice pertaining to any patent included within the Patent Rights which Cellegy receives as patent owner pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (hereinafter called the "Act"), including but not necessarily limited to, notices pursuant to xx.xx. 101 and 103 of the Act from persons who have filed an abbreviated NDA ("ANDA") under ss. 505(j) of the FD&C Act or a "Paper NDA" filed under ss. 505(b)(2) of the FD&C Act. Such notices shall be given promptly, but in any event within ten (10) days of each such patent's date of issue or receipt of each such notice pursuant to the Act, whichever is applicable.
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NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT. 25.1 SALK shall promptly notify LIGAND of (a) the issuance of each U.S. patent included within the Patent Rights, giving the date of issue and patent number for each such patent, and (b) each notice pertaining to any patent included within the Patent Rights which it receives as patent owner pursuant to the DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT, (the "Act"), including but not necessarily limited to notices pursuant to Section 101 and 103 of the Act from persons who have filed an abbreviated NDA or a "paper" NDA. 25.2 SALK hereby authorizes LIGAND to include in any NDA for a Licensed Product, as LIGAND may deem appropriate under the Act, a list identifying SALK as patent owner of those patents included within the Patent Rights which relate to such Licensed Product and such other information as may be required by federal law or regulation. SALK agrees as patent owner under the Act to apply for an extension of the term of any patent included within the Patent Rights, as permitted by the Act, upon request by LIGAND.
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NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT. 18.1 The Regents shall notify Licensee of (a) the issuance of each U.S. patent included within Regents' Patent Rights, giving the date of issue and patent number for each such patent, and (b) each notice pertaining to any patent included within Regents' Patent Rights which it receives as patent owner pursuant to the Drug Price Competition and Patent Term Restoration Act, (the Act), including but not necessarily limited to notices pursuant to Sections 101 and 103 of the Act from persons who have filed an Abbreviated New Drug Application ("ANDA") or a "paper" New Drug Application (NDA). Such notices shall be given promptly, but in any event within ten (10) calendar days of each such patent's date of issue or receipt of each such notice pursuant to the Act, whichever is applicable.
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NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT 
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  • APPLICATION AND PARTIES BOUND 5.1 The parties bound by this Agency Specific Agreement are the Civil Service Association of WA Inc and the Director General of the Department of Racing, Gaming and Liquor. 5.2 This Agency Specific Agreement does not replace the General Agreement. 5.3 This Agency Specific Agreement shall apply to all employees who are members or eligible to be members of the Union and who are covered by the General Agreement and the Award. 5.4 This Agency Specific Agreement shall be read in conjunction with the Award and the General Agreement. 5.5 Except where the General Agreement identifies conditions as core, the Agency Specific Agreement will prevail over the General Agreement and the Award to the extent of any inconsistencies. 5.6 At the date of registration the approximate number of employees covered by this Agency Specific Agreement is 16.

  • Authorization and Application of Overtime An employee who is required to work overtime shall be entitled to overtime compensation when the overtime worked is authorized in advance.

  • Required Confidentiality Claim Form This is a requirement of the TIPS Contract and is non-negotiable. TIPS provides the required TIPS Confidentiality Claim Form in the "Attachments" section of this solicitation. Vendor must execute this form by either signing and waiving any confidentiality claim, or designating portions of Vendor's proposal confidential. If Vendor considers any portion of Vendor's proposal to be confidential and not subject to public disclosure pursuant to Chapter 552 Texas Gov’t Code or other law(s) and orders, Vendor must have identified the claimed confidential materials through proper execution of the Confidentiality Claim Form. If TIPS receives a public information act or similar request, any responsive documentation not deemed confidential by you in this manner will be automatically released. For Vendor documents deemed confidential by you in this manner, TIPS will follow procedures of controlling statute(s) regarding any claim of confidentiality and shall not be liable for any release of information required by law, including Attorney General determination and opinion. Notwithstanding any other Vendor designation of Vendor's proposal as confidential or proprietary, Vendor’s submission of this proposal constitutes Vendor’s agreement that proper execution of the required TIPS Confidentiality Claim Form is the only way to assert any portion of Vendor's proposal as confidential.

  • Compliance with Federal and State Work Authorization and Immigration Laws The Contractor and all subcontractors, suppliers and consultants must comply with all federal and state work authorization and immigration laws, and must certify compliance using the form set forth in Section 7 (“Georgia Security and Immigration Compliance Act Affidavits”). The required certificates must be filed with the Owner and copied maintained by the Contractor as of the beginning date of this contract and each subcontract, supplier contract, or consultant contract, and upon final payment to the subcontractor or consultant. State officials, including officials of the Georgia Department of Audits and Accounts, officials of the Owner, retain the right to inspect and audit the Project Site and employment records of the Contractor, subcontractors and consultants without notice during normal working hours until Final Completion, and as otherwise specified by law and by Rules and Regulations of the Georgia Department of Audits and Accounts.

  • Authorization and Validity of Agreement The execution, delivery and performance by Seller of this Agreement and by each of Seller and each Subsidiary of any other agreements contemplated hereby (to the extent such entity is a party thereto) and the consummation by each of the transactions contemplated hereby and thereby have been duly authorized by the Board of Directors of Seller. No other corporate or stockholder action is necessary for the authorization, execution, delivery and performance by Seller of this Agreement and by each of Seller and each Subsidiary of any other agreements contemplated hereby (to the extent such entity is a party thereto) and the consummation by Seller and the Subsidiaries of the transactions contemplated hereby or thereby, other than certain corporate approvals of the foreign Subsidiaries, which corporate approvals shall have been obtained by the Closing Date. This Agreement has been duly executed and delivered by Seller and constitutes a valid and legally binding obligation of Seller, enforceable against it in accordance with its terms, subject to (i) the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting the enforcement of creditors' rights generally, (ii) general equitable principles (whether considered in a proceeding in equity or at law) and (iii) an implied covenant of good faith and fair dealing. When executed and delivered as provided in this Agreement, each other agreement contemplated hereby to be executed and delivered by Seller or any Subsidiary will be a valid and legally binding obligation of Seller or such Subsidiary (to the extent a party thereto), enforceable against Seller or such Subsidiary in accordance with its terms, subject to (i) the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and other similar laws relating to or affecting the enforcement of creditors' rights generally, (ii) general equitable principles (whether considered in a proceeding in equity or at law) and (iii) an implied covenant of good faith and fair dealing.

  • Limitation of Vendor Indemnification and Similar Clauses This is a requirement of the TIPS Contract and is non-negotiable TIPS, a department of Region 8 Education Service Center, a political subdivision, and local government entity of the State of Texas, is prohibited from indemnifying third-parties (pursuant to the Article 3, Section 52 of the Texas Constitution) except as otherwise specifically provided for by law or as ordered by a court of competent jurisdiction. Article 3, Section 52 of the Texas Constitution states that "no debt shall be created by or on behalf of the State … " and the Texas Attorney General has opined that a contractually imposed obligation of indemnity creates a "debt" in the constitutional sense. Tex. Att'y Gen. Op. No. MW-475 (1982). Thus, contract clauses which require TIPS to indemnify Vendor, pay liquidated damages, pay attorney's fees, waive Vendor's liability, or waive any applicable statute of limitations must be deleted or qualified with ''to the extent permitted by the Constitution and Laws of the State of Texas." Does Vendor agree? Yes, I Agree TIPS, a department of Region 8 Education Service Center, a political subdivision, and local government entity of the State of Texas, does not agree to binding arbitration as a remedy to dispute and no such provision shall be permitted in this Agreement with TIPS. Vendor agrees that any claim arising out of or related to this Agreement, except those specifically and expressly waived or negotiated within this Agreement, may be subject to non-binding mediation at the request of either party to be conducted by a mutually agreed upon mediator as prerequisite to the filing of any lawsuit arising out of or related to this Agreement. Mediation shall be held in either Camp or Titus County, Texas. Agreements reached in mediation will be subject to the approval by the Region 8 ESC's Board of Directors, authorized signature of the Parties if approved by the Board of Directors, and, once approved by the Board of Directors and properly signed, shall thereafter be enforceable as provided by the laws of the State of Texas. Does Vendor agree? Yes, Vendor agrees Does Vendor agree? Yes, Vendor agrees Vendor agrees that nothing in this Agreement shall be construed as a waiver of sovereign or government immunity; nor constitute or be construed as a waiver of any of the privileges, rights, defenses, remedies, or immunities available to Region 8 Education Service Center or its TIPS Department. The failure to enforce, or any delay in the enforcement, of any privileges, rights, defenses, remedies, or immunities available to Region 8 Education Service Center or its TIPS Department under this Agreement or under applicable law shall not constitute a waiver of such privileges, rights, defenses, remedies, or immunities or be considered as a basis for estoppel. Does Vendor agree? Yes, Vendor agrees Vendor agrees that TIPS and TIPS Members shall not be liable for interest or late-payment fees on past-due balances at a rate higher than permitted by the laws or regulations of the jurisdiction of the TIPS Member. Funding-Out Clause: Vendor agrees to abide by the applicable laws and regulations, including but not limited to Texas Local Government Code § 271.903, or any other statutory or regulatory limitation of the jurisdiction of any TIPS Member, which requires that contracts approved by TIPS or a TIPS Member are subject to the budgeting and appropriation of currently available funds by the entity or its governing body.

  • Cloud Computing State Risk and Authorization Management Program In accordance with Senate Bill 475, Acts 2021, 87th Leg., R.S., pursuant to Texas Government Code, Section 2054.0593, Contractor acknowledges and agrees that, if providing cloud computing services for System Agency, Contractor must comply with the requirements of the state risk and authorization management program and that System Agency may not enter or renew a contract with Contractor to purchase cloud computing services for the agency that are subject to the state risk and authorization management program unless Contractor demonstrates compliance with program requirements. If providing cloud computing services for System Agency that are subject to the state risk and authorization management program, Contractor certifies it will maintain program compliance and certification throughout the term of the Contract.

  • Power, Authorization and Validity (a) Company has the right, power and authority to enter into and perform its obligations under this Agreement and all Company Ancillary Agreements. The execution, delivery and performance of this Agreement and the Company Ancillary Agreements, and the Merger, have been duly and validly approved and authorized by Company, and this Agreement has been duly executed and delivered by Company. The affirmative votes of the holders of (i) a majority of the shares of Company Common Stock that are issued and outstanding (voting as a separate class), (ii) a majority of the shares of Company Common Stock and Company Preferred Stock that are issued and outstanding (voting together as a single class on an as-converted to Company Common Stock basis), (iii) a majority of the shares of Company Series D Preferred Stock that are issued and outstanding (voting as a separate class on an as-converted to Company Common Stock basis) and (iv) a majority of the shares of Company Preferred Stock that are issued and outstanding (voting together as a single class on an as-converted to Company Common Stock basis) (collectively, the “Requisite Votes”) are the only votes of the Company Stockholders necessary under all Applicable Laws and the Company Charter Documents to approve the Merger, this Agreement and, if required, each Company Ancillary Agreement and all other agreements, transactions and actions contemplated hereby and thereby. (b) No filing, authorization, consent, approval, permit, order, registration or declaration from any United States Governmental Authority is necessary to enable Company to enter into, and to perform its obligations under, this Agreement or the Company Ancillary Agreements, except for the filing of the Certificate of Merger with the State of Delaware Secretary of State. (c) This Agreement and the Company Ancillary Agreements are, or when executed by Company will be, and assuming the due authorization, execution and delivery hereof (and in the case of Acquirer Ancillary Agreements, thereof) by Acquirer and all other parties thereto will each constitute, valid and binding obligations of Company, enforceable against Company in accordance with their respective terms, subject only to the effect, if any, of (i) applicable bankruptcy and other similar laws affecting the rights of creditors generally, and (ii) rules of law governing specific performance, injunctive relief and other equitable remedies.

  • Title VI List of Pertinent Nondiscrimination Acts and Authorities During the performance of this contract, the Consultant, for itself, its assignees, and successors in interest (hereinafter referred to as the “Consultant”) agrees to comply with the following non-discrimination statutes and authorities; including but not limited to: • Title VI of the Civil Rights Act of 1964 (42 U.S.C. § 2000d et seq., 78 stat. 252), (prohibits discrimination on the basis of race, color, national origin); • 49 CFR part 21 (Non-discrimination In Federally-Assisted Programs of The Department of Transportation—Effectuation of Title VI of The Civil Rights Act of 1964); • The Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970, (42 U.S.C. § 4601), (prohibits unfair treatment of persons displaced or whose property has been acquired because of Federal or Federal-aid programs and projects); • Section 504 of the Rehabilitation Act of 1973, (29 U.S.C. § 794 et seq.), as amended, (prohibits discrimination on the basis of disability); and 49 CFR part 27; • The Age Discrimination Act of 1975, as amended, (42 U.S.C. § 6101 et seq.), (prohibits discrimination on the basis of age); • Airport and Airway Improvement Act of 1982, (49 USC § 471, Section 47123), as amended, (prohibits discrimination based on race, creed, color, national origin, or sex); • The Civil Rights Restoration Act of 1987, (PL 100-209), (Broadened the scope, coverage and applicability of Title VI of the Civil Rights Act of 1964, The Age Discrimination Act of 1975 and Section 504 of the Rehabilitation Act of 1973, by expanding the definition of the terms “programs or activities” to include all of the programs or activities of the Federal-aid recipients, sub-recipients and contractors, whether such programs or activities are Federally funded or not); • Titles II and III of the Americans with Disabilities Act of 1990, which prohibit discrimination on the basis of disability in the operation of public entities, public and private transportation systems, places of public accommodation, and certain testing entities (42 U.S.C. §§ 12131 – 12189) as implemented by Department of Transportation regulations at 49 CFR parts 37 and 38; • The Federal Aviation Administration’s Non-discrimination statute (49 U.S.C. § 47123) (prohibits discrimination on the basis of race, color, national origin, and sex); • Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, which ensures non-discrimination against minority populations by discouraging programs, policies, and activities with disproportionately high and adverse human health or environmental effects on minority and low-income populations; • Executive Order 13166, Improving Access to Services for Persons with Limited English Proficiency, and resulting agency guidance, national origin discrimination includes discrimination because of limited English proficiency (LEP). To ensure compliance with Title VI, you must take reasonable steps to ensure that LEP persons have meaningful access to your programs (70 Fed. Reg. at 74087 to 74100); • Title IX of the Education Amendments of 1972, as amended, which prohibits you from discriminating because of sex in education programs or activities (20 U.S.C. 1681 et seq).

  • RESERVATION AND AUTHORIZATION OF COMMON STOCK From and after the Closing Date, the Company shall at all times reserve and keep available for issue upon the exercise of Warrants such number of its authorized but unissued shares of Common Stock as will be sufficient to permit the exercise in full of all outstanding Warrants. All shares of Common Stock which shall be so issuable, when issued upon exercise of any Warrant and payment therefor in accordance with the terms of such Warrant, shall be duly and validly issued and fully paid and nonassessable, and not subject to preemptive rights. Before taking any action which would cause an adjustment reducing the Current Warrant Price below the then par value, if any, of the shares of Common Stock issuable upon exercise of the Warrants, the Company shall take any corporate action which may be necessary in order that the Company may validly and legally issue fully paid and non-assessable shares of such Common Stock at such adjusted Current Warrant Price. Before taking any action which would result in an adjustment in the number of shares of Common Stock for which this Warrant is exercisable or in the Current Warrant Price, the Company shall obtain all such authorizations or exemptions thereof, or consents thereto, as may be necessary from any public regulatory body or bodies having jurisdiction thereof.

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