OMS103 definition

OMS103 means a fixed-dose combination drug product containing, as active pharmaceutical ingredients, amitriptyline HCl ([†] mg/mL), oxymetazoline HCl ([†] mg/mL), and † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION ketoprofen ([†] mg/mL), in lyophilized or liquid solution form, as well as [†]. For clarity, the term OMS103 shall be understood to include formulations of such a fixed-dose combination drug product previously referred to by Omeros as OMS103, OMS103HP and OMS103HP-S.
OMS103 means a fixed-dose combination drug product containing, as active pharmaceutical ingredients, amitriptyline HCl ([†] mg/mL), oxymetazoline HCl ([†] mg/mL), and

Examples of OMS103 in a sentence

  • Item 1.02 Termination of a Material Definitive Agreement‌In anticipation of its discontinuance of its development of OMS103 and subsequent entry of the Agreement with Fagron, on June 9, 2015, Omeros delivered to Hospira Worldwide Inc., or Hospira, a notice terminating the parties’ Commercial Supply Agreement, effective October 9, 2007, or the Supply Agreement, for the commercial supply of OMS103HP-S.

  • OMS103 has been developed for use during arthroscopic procedures, including partial meniscectomy surgery.

  • Omeros will incur no further development costs, other than maintaining the licensed intellectual property, in connection with OMS103.

  • You agree to promptly notify GTJAF of any (actual or envisaged) breach by any of the Authorized Users of any of the obligations described here above.

  • For a period of twelve (12) months after the Effective Date in the case of the OMS103 Product and upon the launch of any other Licensed Product added to this Agreement, or such longer time as Omeros may agree in its sole discretion, Omeros shall cooperate with JCB by using reasonable efforts to make appropriate personnel available, at no charge for time but with out-of-pocket costs reimbursable by JCB, to respond to questions that JCB may raise with respect to the Licensed Know-How.

  • Under the terms of the Agreement, upon commercialization, Omeros will receive payments representing a substantial majority share of gross revenue from future OMS103 product sales within the United States, which revenue share will not be less than a minimum per unit amount.

  • OMS103 is covered by three issued U.S. patents and four pending U.S. patent applications, together with 32 issued patents and 13 pending patent applications in foreign markets.

  • Baptised Catholic children resident in the parish of Our Lady of the Annunciation & St Bernadette (the part of the parish formerly referred to as St Marie's, Standish).

  • Pursuant to the Agreement, Omeros granted Fagron an exclusive, royalty-free license to the OMS103 intellectual property, manufacturing information and clinical data to produce on a large scale registered basis and commercialize OMS103 in the United States.

  • We note that, in addition to the above, Omeros holds IP on its OMS103 candidate via issued patents slated to expire as late as September 24, 2022 and pending claims that may, if granted, expire as late as August 3, 2032.

Related to OMS103

  • NI 31-103 means National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations;

  • 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.

  • 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.

  • O. Reg. 419/05 means the Ontario Regulation 419/05, Air Pollution – Local Air Quality.

  • PMDA means Japan’s Pharmaceuticals and Medical Devices Agency or any successor entity thereto.

  • NI 62-104 means National Instrument 62-104 Take-Over Bids and Issuer Bids adopted by the Canadian securities regulatory authorities, as now in effect or as the same may from time to time be amended, re-enacted or replaced;

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Civil Aeronautical Product means any civil aircraft, aircraft engine, or propeller or subassembly, appliance, material, part, or component to be installed thereon.

  • NI 45-106 means National Instrument 45-106 – Prospectus Exemptions;

  • NI 45-102 means National Instrument 45-102 – Resale of Securities.

  • PHSA means the Public Health Service Act (or any successor thereto), as amended from time to time, and the rules, regulations, guidelines, guidance documents and compliance policy guides issued or promulgated thereunder.

  • MI 62-104 means Multilateral Instrument 62-104 Take-Over Bids and Issuer Bids;

  • MHLW means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • NI 51-102 means National Instrument 51-102 – Continuous Disclosure Obligations;

  • NI 44-102 means National Instrument 44-102 – Shelf Distributions;

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • international application means an application filed under this Treaty;

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • 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.

  • Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

  • Rural health clinic means a rural health clinic as defined under section 1861 of part C of title XVIII of the social security act, chapter 531, 49 Stat. 620, 42 U.S.C. 1395x, and certified to participate in medicaid and medicare.

  • Xxxxx–Xxxxx Act For any federally assisted construction contract, in excess of two thousand dollars ($2,000), the contractor, subcontractor, subrecipient shall comply with all of the requirements of the Xxxxx-Xxxxx Act (40 U.S.C. 3141 – 3148) as supplemented by Department of Labor Regulations (29 CFR Part 5, “Labor Standards Provisions Applicable to Contracts Covering Federally Financed and assisted Construction”); and 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”). For a definition of “Construction” see 48 CFR 2.101.

  • Sxxxxxxx-Xxxxx Act means the Sxxxxxxx-Xxxxx Act of 2002, as amended.