CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Exhibit 10.13
MANUFACTURING AND SUPPLY AGREEMENT
THIS MANUFACTURING AND SUPPLY AGREEMENT (the " Agreement" ) is made and entered into this 6 day of June, 2003 (the " Effective Date" ), by and between TEAMM PHARMACEUTICALS, INC. (" TEAMM" ) and MIKART, INC. (" Mikart" ). Mikart is a Georgia corporation with its principal place of business at 1750 Chattahoochee Avenue, Atlanta, Georgia 30318. TEAMM is a Florida corporation with its principal place of business at 3000 Aerial Center Parkway, Suite 110, Morrisville,
North Carolina 27560.
BACKGROUND:
Subject to the terms and conditions contained in this Agreement, TEAMM desires to engage Mikart to manufacture the " Products" (as hereinafter defined) for commercial distribution by TEAMM, and Mikart desires to accept such appointment.
NOW, THEREFORE, FOR AND IN CONSIDERATION of the premise, Ten Dollars ($10.00) in hand paid, the mutual promises, covenants and agreements contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:
ARTICLE 1 DEFINITIONS
The following words, terms and phrases, when used herein, shall have the following respective meanings:
1.1 " Batch" shall mean the quantity of 1,100,000 tablets of the Products.
1.2 " Contract Year" shall mean a twelve (12) consecutive month period after the Qualification Date and during the Term of this Agreement. The first Contract Year shall commence as of the Qualification Date, and subsequent Contract Years shall commence on each anniversary of the Qualification Date.
1.3 " FDA" shall mean the United States Food and Drug Administration or any successor agency thereof.
1.4 " Health Registrations" shall mean the Abbreviated New Drug Application issued by the FDA with respect to the Products and any other governmental or regulatory consents, registrations, approvals or permits necessary to sell or manufacture the Products in the Territory or elsewhere as may become necessary in accordance with Section 2.4 hereof.
1.5 " Products" shall mean [*]
1.6 " Qualification Date" shall mean the date on which Mikart satisfactorily completes its validation and testing pursuant to Article 2 of this Agreement such that it becomes authorized to begin manufacturing the Products under the Health Registrations in accordance with the terms of this Agreement.
1.7 " Specifications" shall mean the specifications for the manufacturing, packaging and labeling of the Products described on Exhibit A attached hereto and incorporated herein by reference.
1.8 " Territory" shall mean the United States of America and its territories and such other locations as may be designated by the parties hereto pursuant to Section 2.4.
ARTICLE 2 VALIDATION, TESTING AND HEALTH REGISTRATIONS
2.1 Validation . TEAMM and Mikart acknowledge and agree that Mikart must validate three (3) Batches of the Products prior to selling any of the Products to TEAMM. Mikart shall conduct such validation on three (3) Batches of the Products and, thereafter, TEAMM shall be obligated to purchase such Batches in accordance with the terms of this Agreement. Such Batches shall be a part of, and shall be applied to, TEAMM' s minimum purchase requirements within the first Contract Year.
2.2 Testing. Upon its successful completion of the validations described in Section 2.1, Mikart shall conduct stability testing on the Products as required by federal law. All of Mikart' s costs incurred in connection therewith shall be periodically billed to and paid by TEAMM on a quarterly basis.
2.3 Health Registrations. Mikart shall own the Health Registrations in its own name and shall maintain the same in full force and effect at all times during the Term of this Agreement.
2.4 Additional Locations . In the event TEAMM desires to market, distribute or sell the Products in any location not set forth in Section 1.8 (or previously designated pursuant to this Section 2.4), then Mikart shall, at TEAMM' s request, cooperate in good faith with TEAMM to obtain any Health Registrations necessary or appropriate therefore (and TEAMM shall pay all of Mikart' s reasonable out-of-pocket expenses therefore); provided, however, TEAMM shall not market, distribute or sell any Products in such locations unless and until such Health Registrations are obtained.
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ARTICLE 3
MANUFACTURE
3.1 Exclusivity . Subject to the terms and conditions contained herein, Mikart shall not manufacture, package or sell any product with an identical formulation to the Products for any person or entity other than TEAMM from and after the Qualification Date and throughout the remainder of the Term of this Agreement (the " Manufacturing Period" ), and TEAMM shall purchase exclusively from Mikart all of TEAMM' s requirements of the Products during the Term of this Agreement. TEAMM hereby agrees that, in the event it desires to enhance, extend or otherwise modify the Products during the Term of this Agreement, it shall offer the right of first refusal to Mikart to be the sole manufacturer thereof (on commercial terms other than price substantially similar to those contained herein). Nothing contained herein shall be deemed in any way to preclude Mikart from manufacturing, packaging or selling any products on behalf of any person or entity where the formulation for such products differs from the formulation for the Products. During the Term of this Agreement, Mikart shall not sell or transfer the Products to any third party without written consent of TEAMM.
3.2 Limited Warranties . Mikart hereby represents and warrants to TEAMM that the Products when manufactured and sold to TEAMM hereunder shall conform to the Specifications. In addition, Mikart represents and warrants to TEAMM that Mikart, in its manufacture of the Products, shall comply with all applicable federal, state and local laws, rules and regulations in the Territory, including without limitation the current Good Manufacturing Practices as published and amended from time to time by the FDA, and Mikart' s manufacturing and storage facilities shall comply with all applicable federal, state and local laws, rules and regulations in the Territory. EXCEPT AS SET FORTH IN THIS SECTION 3.2 AND SECTION 9.1, MIKART MAKES NO OTHER REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, AND MIKART HEREBY SPECIFICALLY DISCLAIMS ALL SUCH OTHER REPRESENTATIONS AND WARRANTIES, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. With respect to each Batch of the Products manufactured hereunder, this Section 3.2 shall remain effective until the expiration date noted on such Products.
3.3 Quality Control .
(a) Mikart shall perform quality control testing on the Products in accordance with normal industry standards to determine whether such Products conform to the Specifications. Contemporaneously with each shipment of Products hereunder, Mikart shall provide TEAMM with a certificate of analysis with respect to such Products. In addition, Mikart shall perform, at TEAMM' s expense, any and all other testing relating to the Products which is reasonably requested by TEAMM to confirm that such Products meet the Specifications and promptly provide TEAMM with the results thereof.
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(b) In addition, Mikart shall be responsible for conducting an ongoing stability program for the Products as required by federal law.
(c) Mikart shall, upon the reasonable request of TEAMM, assay any Products returned to TEAMM by a third party purchaser. TEAMM shall reimburse Mikart for the costs of any such assay unless the results thereof prove the cause of return is as a result of Mikart' s negligence or willful misconduct or the failure of such Products to comply with the limited warranties contained in Section 3.2 hereof.
(d) In the event that any Batch is subject to a recall, TEAMM, at its expense, shall conduct the recall, except that Mikart shall reimburse TEAMM for the costs of such recall (including reimbursing TEAMM for the Products at the invoice prices paid by TEAMM therefore) in the Territory to the extent such recall results from the failure of the Products to comply with the limited warranties contained in Section 3.2 hereof.
(e) Each party hereto shall promptly notify the other of any recall of Products which has been directed by it or by any governmental or regulatory entity or agency for any reason whatsoever. Such notice shall identify the reason for the recall and all relevant details thereof.
(f) Each party hereto shall promptly deliver to the other a copy of all notices received by it from the FDA during the Term of this Agreement relating to the manufacture, packaging, storage or sale of the Products.
(g) Upon the reasonable advance request of TEAMM, Mikart shall permit a representative of TEAMM to inspect its facilities where the Products are manufactured, packaged and stored, provided such representative first executes a copy of Mikart' s standard visitor confidentiality agreement.
3.4 Packaging and Labeling Materials. Mikart shall order from time to time, at TEAMM' s request and expense, labels, package inserts and other packaging materials (the " Labeling Materials" ) in sufficient quantities to permit the packaging of the Products ordered by TEAMM from time to time hereunder.
ARTICLE 4 ORDERS AND SALES
4.1 Forecasts . Commencing on the Qualification Date, and thereafter at least thirty (30) days prior to the commencement of each calendar quarter, TEAMM shall provide Mikart with a non-binding, rolling twelve (12) month forecast of its requirements for the Products.
4.2 Purchase Orders . TEAMM shall place its orders for the Products no later than ninety (90) days prior to the requested delivery date using separately numbered, written purchase orders. Each purchase order must be for one or more full Batches (provided TEAMM
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shall have the right to specify the size packaging requirements of each order from among 100 or 500 table ...