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Title: |
Distribution Agreement |
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Date: |
2005 |
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Preview shows 16KB of 63KB total |
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Price: |
$50 |
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ID: |
#1265825 |
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DISTRIBUTION AGREEMENT
THlS DISTRIBUTION AGREEMENT (Agreement) is dated June 15, 2004, by and among Argent Development Group, LLC, a California limited liability company (Argent), TEAMM Pharmaceuticals, Inc., a Florida corporation (TEAMM), and Accentia, Inc., a Florida corporation (Accentia). TEAMM is a wholly-owned subsidiary of Accentia.
WITNESSETH
WHEREAS, Argent, among other things, is engaged in the research and development of various pharmaceutical products comprised primarily of the following: [*] (the [*] Product); [*] (the [*] Product); [*] (the [*] Product); [*] (the [*] Product); [*] (the [*] Product); [*] (the [*] Product); and [*] (the [*] Product).
WHEREAS, Argent and Accentia have entered into a TEAMM Proposal dated March 16,2004, whereby the commercial terms for this Agreement were outlined; and
WHEREAS, Argent and Mikart, Inc., a contract manufacturer and developer of pharmaceutical products, with corporate offices at 1750 Chattahoochee Ave., Atlanta, GA 30318 (Mikart), have entered into a development project to formulate, develop, obtain regulatory approval, and commercialize the Products; and
WHEREAS, TEAMM has experience and capability in the marketing and distribution of such products and desires to distribute such products.
NOW, THEREFORE, for good and valuable consideration, and the covenants, conditions, and undertakings hereinafter set forth, the receipt, adequacy and sufficiency of which are hereby acknowledged, it is agreed by and among 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 means FDA (as defined below) approval of the Product by the FDA for use as a pharmaceutical product for the treatment of pain pursuant to the FDAs abbreviated new drug application (ANDA) process to be filed by Mikart for the Product. |
| 1.3 | Approval Date means, with respect to each of the Products, the date which the FDA permits the initial sale of such Product for use as a pharmaceutical product for the treatment of pain pursuant to the Approval of the ANDA to be filed by Mikart for such Product. |
| 1.4 | Contract Manufacturer means Mikart or any other third party that may be engaged by Argent or TEAMM to produce the Products, as provided for in Section 4 of this Agreement. |
| 1.5 | FDA means the United States Food and Drug Administration or any successor agency. |
| 1.6 | Launch means the first date that TEAMM sales representatives begin delivering personal sales presentations to target physicians in the Territory for a Product. |
| 1.7 | Net Sales Price means, for Product sold hereunder by TEAMM to unrelated third parties (individually, a Customer and collectively, the Customers), the invoiced sales price. |
| 1.8 | Net Sales means the total Net Sales Price of Product sold hereunder by TEAMM to Customers, after deduction of the following items: |
| (a) | packing, transportation and insurance charges; |
| (b) | discounts or rebates actually allowed and taken to the extent customary in the trade; |
| (c) | credits or allowances given or made for rejection or return; |
| (d) | any tax or other governmental charge levied directly on the sale, transportation or delivery of Products and borne by the seller; and |
| (e) | chargebacks and rebates granted to managed care health organizations, federal and state government agencies, and/or other purchasers and/or reimbursers, including, for example, group purchasing organization administration fees. |
A Product will be considered sold when the shipment is received by a Customer. The distribution of reasonable quantities of free promotional samples of the Products shall not be considered a sale of a Product for royalty purposes.
| 1.9 |
Product means individually any of the, and Products mean collectively all of the, [*] Product, the [*] Product, the [*] |
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Product, the [*] Product, the [*] Product, the [*] Product and/or the [*] Product. |
| 1.10 | Proprietary Information means all financial information, marketing information, sales information, customer information, raw materials, know-how, drawings, compositions, manufacturing and other specifications, analytical procedures, flow sheets, reports, market studies, preclinical and clinical test results, FDA and other regulatory submissions, software and other medical, research, technical, and marketing information disclosed, directly or indirectly, by either party to the other party designated Confidential, Proprietary or the like, or which by its nature is information normally intended to be held in confidence, unless the receiving party demonstrates that such information: (a) is or becomes public knowledge through no fault of the receiving party; (b) is legally in the possession of the receiving party prior to receipt from the disclosing party, as shown by receiving partys written records; or (c) is subsequently and lawfully received without obligation of confidentiality from a third party under no nondisclosure obligation with respect to such information. |
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