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Title: |
Distribution Agreement |
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Date: |
2005 |
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Preview shows 11KB of 109KB total |
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Price: |
$47 |
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ID: |
#1265844 |
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DISTRIBUTION AGREEMENT
THIS DISTRIBUTION AGREEMENT, effective as of March 12, 2004, (the Effective Date) between Arius Pharmaceuticals, Inc., a corporation organized and existing under the laws of Delaware, with its principal address of P.O. Box 14601, Research Triangle Park, NC 27709 (Arius), and TEAMM Pharmaceuticals, Inc., a Delaware corporation and subsidiary of Accentia, Inc., a Florida corporation, having its principal place of business at 3000 Aerial Center Parkway, Suite 110, Morrisville, North Carolina 27560 (TEAMM).
WITNESSETH
WHEREAS, Arius, among other things, is engaged in the development of Prochlorperazine maleate Buccal, a pharmaceutical for the treatment of nausea and vomiting (anti-emetic); and
WHEREAS, TEAMM has experience and capability in the marketing and distribution of such products and desires to distribute such products.
NOW, THEREFORE, for and in consideration of the covenants, conditions, and undertakings hereinafter set forth, it is agreed by and between the parties as follows:
1. Definitions. In addition to various terms defined throughout the Agreement, the following capitalized terms shall have the meanings set forth below:
| 1.1 | Act means the Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), as amended, and the regulations promulgated thereunder. |
| 1.2 | Approval Date means the date upon which the FDA (as defined below) permits the initial sale of Product (as defined below) for use as a human therapeutic pursuant to FDAs approval of an NDA filed by Arius with respect to the Product. |
| 1.3 | BEMA Technology means Atrix Laboratories proprietary bioerodible, mucoadhesive multi-layer polymer film technology for transmucosal drug delivery. |
| 1.4 | Calendar Year means the period from the date of the first commercial sale of Products in the United States until December 31st of such year, and thereafter each period of twelve (12) months from January Ist to December 31st in each and every year and the period from January lst to the date of termination of this Agreement. |
| 1.5 | Competing Product means any product whose primary indication is treatment of nausea and/or vomiting. |
| 1.6 | Contract Manufacturer means any third party with whom Arius contracts for the manufacture of Product on its behalf. |
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| 1.7 | FDA means the United States Food and Drag Administration or any successor agency. |
| 1.8 | Generic Competitor means a pharmaceutical product for human use approved by FDA, that contains a buccal form of prochlorperazine maleate, and that is bioequivalent to the Product. |
| 1.9 | Good Manufacturing Practices or GMP means the applicable current good manufacturing practices promulgated from time to time by the FDA in accordance with the Act. |
| 1.10 | NDA means a New Drug Application, as defined by the Act and FDA, including but not limited to any such application filed under section 505(b)(2) of the Act. |
| 1.11 | Net Sales means the aggregate amounts invoiced on sales of Products to any third party, net of normal and customary trade and quantity discounts (excluding free samples) actually given at the time of sale including any normal and customary discounts provided to managed healthcare organizations, and net of any returns or allowances given to such third parties for defective Product. For the avoidance of doubt, Net Sales shall not include any amounts invoiced by TEAMM to a customer for sales, use, or value added taxes,. Product will be considered sold when firm written orders are received, invoiced, billed out, or when delivered and paid for, or paid for before delivery, whichever first occurs. In the event that TEAMM sells Product as part of a bundled sale of separate products, the Net Sales attributable to such Product shall be the higher of (i) the separately stated prices stated for such Product sold in such bundled sale or (ii) the average price at which such Product is sold in a non-bundled sale during the Quarter. |
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