POZEN and Pernix agree that Pernix will use its Commercially Reasonable Efforts to submit a supplementary N.DA to NDA #21-926 for a MT 400 containing 10 mg Sumatriptan and 60 mg Naproxen sodium by December 31, 2014.
NI 51-101 means National Instrument 51-101 Standards of Disclosure for Oil and Gas Activities;
NI 41-101 means National Instrument 41-101 – General Prospectus Requirements;
Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.
NI 31-103 means National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations;
Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.
MI 61-101 means Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions;
NI 58-101 means National Instrument 58-101 Disclosure of Corporate Governance Practices;
Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Licensed Product as a drug in a regulatory jurisdiction.
NI 45-106 means National Instrument 45-106 – Prospectus Exemptions;
Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.
15(519) means the weekly statistical release designated as such, or any successor publication, published by the Board of Governors of the Federal Reserve System. The date of determination of a Make-Whole Premium will be the third Business Day prior to the applicable prepayment date and the "most recent H.15(519)" means the H.15(519) published prior to the close of business on the third Business Day prior to the applicable prepayment date.
PTCE 95-60 As defined in Section 5.02(b). PUD: A planned unit development.
New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. § 601.2, or any equivalent or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the United States.
Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.
H.15(519) means the weekly statistical release designated as H.15(519), or any successor publication, published by the Board of Governors of the Federal Reserve System.
NI 43-101 means National Instrument 43-101 – Standards of Disclosure for Mineral Projects;
NI 54-101 means National Instrument 54-101 Communication with Beneficial Owners of Securities of a Reporting Issuer;
Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.
NI 51-102 means National Instrument 51-102 – Continuous Disclosure Obligations;
Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.
NI 44-101 means National Instrument 44-101 – Short Form Prospectus Distributions;