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Title: |
Distribution Agreement |
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Entities: |
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Date: |
2005 |
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Size: |
29KB total |
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Price: |
$41 |
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ID: |
#1265915 |
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DISTRIBUTION AGREEMENT
THIS DISTRIBUTION AGREEMENT (Agreement), is dated May 28, 2003, by and among Acheron Development Group, LLC, a California limited liability company with corporate address of P.O. Box 4531, Mountain View, CA 94040 (Acheron), TEAMM Pharmaceuticals, Inc., a Delaware corporation (TEAMM), and Accentia, Inc., a Florida corporation (Accentia). TEAMM is a wholly owned subsidiary of Accentia.
WITNESSETH
WHEREAS, Acheron, among other things, is engaged in the research and development of a pharmaceutical product comprised primarily of [*] (the [*] Product); and
WHEREAS, Acheron and TEAMM have entered into a Summary of Material Terms of Proposed License Agreements, dated March 7, 2003, whereby the commercial terms for this Agreement were outlined; and
WHEREAS, Acheron 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 FDA approval, and commercialize the [*] Product; 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 there under. |
| 1.2 | Approval means FDA approval of the Product (as defined below) 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 the date upon which the FDA (as defined below) permits the initial sale of the 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 the Product. |
| 1.4 | Contract Manufacturer means Mikart or any other third party that may be engaged by Acheron or TEAMM to produce the [*] Product, 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 | Net Sales Price means, for Product sold hereunder by TEAMM to unrelated third parties (Customer), the invoiced sales price. |
| 1.7 | Net Sales means the total Net Sales Price of Product sold hereunder by TEAMM to Customer, 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 Product 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. |
Product will be considered sold when the shipment is received by Customer. The distribution of reasonable quantities of free promotional samples of Product shall not be considered a sale of a Product for royalty purposes.
| 1.8 | Product means the [*] Product. |
| 1.9 |
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 |
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