Grandfathered Products definition

Grandfathered Products has the meaning set forth in Section 2.3.2 (Acquisitions by Third Parties).
Grandfathered Products has the meaning set forth in Section 3.7 (Effect of Acquisition of C4).
Grandfathered Products means those PRODUCTS [**] that are manufactured by BIRI for XANODYNE and are identified in Attachment A

Examples of Grandfathered Products in a sentence

  • The term “Specifications” means the specifications for each Product as set forth in the applicable ANDA, or in the case of Grandfathered Products, in the specifications applicable to the original FDA approved finished dosage form.

  • The term “Products” means those ANDA Products, Grandfathered Products and Patent Challenging Products set forth on Exhibit A, attached hereto and incorporated herein, as may be amended by mutual agreement of the Parties from time to time, to be (i) subject (with the exception for Grandfathered Products) to an ANDA on behalf of A-S; and (ii) to be manufactured by Strides pursuant to this Agreement.

  • In such case, such Acquired Party may continue to perform the ​ applicable Competitive Activities with respect to such Grandfathered Products after such Change of Control only if and for so long as no CASI Technology is used by or on behalf of such Acquired Party or its Affiliates in connection with any subsequent performance of any such Competitive Activities with respect to any such Grandfathered Products.

  • Dedicated Inbound Special Pricing Monthly Usage Rates Per Minute by Contract Term TERMS & CONDITIONS FOR INTERSTATE TELECOMMUNICATIONS SERVICES SECTION 5 – GRANDFATHERED PRODUCTS AND RATES (Continued) 5.1 Legacy Company Grandfathered Products and Rates Special Dedicated Toll Rates for AdvantEdge Customers This special toll pricing is available only to customers who subscribe to AdvantEdge services.

  • The Members intend the Company to outsource from Strides manufacturing facility in India, the development and manufacturing of certain Grandfathered Products, Patent Challenging Products and ANDA Products under the terms of the OEM Agreement (defined below).

  • Conclusion or verifying is the result of analyzing that answer the research problem based on the data analyzing.

  • Good Manufacturing Practice (GMP) Audits Grandfathered Products The Surveillance Unit Problem Reporting and Recall Adverse Drug Reaction (ADR) Reports Listing and Compliance Section Medicines supplied on the Australian market are subject to a number of levels of surveillance by the Therapeutic Goods Administration (TGA).


More Definitions of Grandfathered Products

Grandfathered Products has the meaning set forth in Section 2.9.
Grandfathered Products means any insurance, reinsurance or risk transfer product listed as underwritten on the relevant underwriting systems of record by any of the Insurance Companies or any related ISPV from their establishment until the Commencement Date inclusive;

Related to Grandfathered Products

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • Nondesignated country end product means any end product that is not a U.S.-made end product or a designated country end product.

  • Covered Products means Your Applications, Libraries, Passes, Safari Extensions, Safari Push Notifications, and/or FPS implementations developed under this Agreement.

  • Designated country end product means a WTO GPA country end product, a Free Trade Agreement country end product, a least developed country end product, or a Caribbean Basin country end product.

  • Diagnostic Product means an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

  • Combination Products means COBI Combination Products, EVG Combination Products, TDF Combination Products, TAF Combination Products and Quad Product.

  • Exempt compound means the same as defined in Rule 2.

  • Combination Product means a product (a) containing a Licensed Product together with one or more other active ingredients, or (b) with one or more products, devices, pieces of equipment or components, but sold for an integrated price (e.g., with the purchase of one product the customer gets a coupon for the other) or for a single price.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Back Ordered Products If product is not expected to ship within the time provided to the TIPS member by the Vendor, customer is to be notified within 3 business days and appropriate action taken based on customer request. Xxxxxxxx Xxxxxx Vice-President of Operations 1/29/19 The Interlocal Purchasing System (TIPS Cooperative) Supplier Response Bid Information Contact Information Ship to Information Bid Creator Email Xxxx Xxxxxx General Counsel/Procurement Compliance Officer xxxx.xxxxxx@xxxx-xxx.xxx Address Region VIII Education Service Center 0000 XX Xxxxxxx 000 Xxxxx Address Contact Phone (000) 000-0000 x Xxxxxxxxx, XX 00000 Fax Contact Xxxxxxx Xxxxxxx, Department Contracts Compliance Building Bid Number 181102 Specialist Title Internet & Network Security Floor/Room Bid Type RFP Department Telephone Issue Date 11/1/2018 08:00 AM (CT) Building Fax Close Date 12/14/2018 03:00:00 PM (CT) Email Floor/Room Supplier Information Company Sectigo Limited Address 0 Xxxxxx Xxxx Road Suite 300 Roseland, NJ 07068 Contact Department Building Floor/Room Telephone (000) 000-0000 Fax Email Submitted 12/12/2018 04:32:07 PM (CT) Total $0.00 By submitting your response, you certify that you are authorized to represent and bind your company. Signature Xxxxxxxx Xxxxxx Email xxxxxxxx.xxxxxx@xxxxxxx.xxx Supplier Notes Bid Notes Bid Activities Bid Messages Date Subject Message 11/08/18 Typographical date error on RFP in the section of the specifications, TIPS listed dates under section entitled "ANTICIPATED SCHEDULE OF Specifications PDF AWARD OR RELATED EVENT:" as 2019. This is an error and should be 2018 on the dates on this page and section. Bid Attributes Please review the following and respond where necessary # Name Note Response 1 Yes - No Disadvantaged/Minority/Women Business Enterprise - D/M/WBE (Required by some participating governmental entities) Vendor certifies that their firm is a D/M/WBE?Vendor must upload proof of certification to the ”Response Attachments” D/M/WBE CERTIFICATES section. NO 2 Yes - No Historically Underutilized Business - HUB (Required by someparticipating governmental entities) Vendor certifies that their firm is a HUB as defined by the State of Texas at xxxxx://xxxxxxxxxxx.xxxxx.xxx/purchasing/vendor/hub/ No or in a HUBZone as defined by the US Small Business Administration at xxxxx://xxx.xxx.xxx/offices/headquarters/ohp Proof of one or both may be submitted. Vendor must upload proof of certification to the “Response Attachments” HUB CERTIFICATES section.

  • Least developed country end product means an article that—

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

  • Licensed Compound means a TAK-385 Licensed Compound or a TAK-448 Licensed Compound.

  • Qualified high-technology business means a business or facility whose primary business activity is high-technology activity or a qualified high-wage activity.

  • Covered Program means an education program or activity over which the College exercised substantial control over both the Respondent and the context in which the sexual harassment occurred.

  • Qualifying country component means a component mined, produced, or manufactured in a qualifying country.

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Cancer drug means a prescription drug used to treat:

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • X-ray field means that area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the exposure rate is one-fourth of the maximum in the intersection.

  • Innovative control technology means any system of air pollution control that has not been adequately demonstrated in practice, but would have a substantial likelihood of achieving greater continuous emissions reduction than any control system in current practice or of achieving at least comparable reductions at lower cost in terms of energy, economics, or non-air quality environmental impacts.