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MANUFACTURING AND DISTRIBUTION AGREEMENT

Manufacturing Agreement

MANUFACTURING AND DISTRIBUTION AGREEMENT | Document Parties: Neuro-Hitech, Inc | TG United Labs, LLC | TG United Liquid, Inc | TG United Pharmaceuticals, Inc | TG United, Inc You are currently viewing:
This Manufacturing Agreement involves

Neuro-Hitech, Inc | TG United Labs, LLC | TG United Liquid, Inc | TG United Pharmaceuticals, Inc | TG United, Inc

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Title: MANUFACTURING AND DISTRIBUTION AGREEMENT
Governing Law: New York     Date: 8/12/2008
Industry: Biotechnology and Drugs     Law Firm: Arent Fox;Waller Lansden     Sector: Healthcare

MANUFACTURING AND DISTRIBUTION AGREEMENT, Parties: neuro-hitech  inc , tg united labs  llc , tg united liquid  inc , tg united pharmaceuticals  inc , tg united  inc
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CONFIDENTIAL TREATMENT REQUESTED

 

MANUFACTURING AND DISTRIBUTION AGREEMENT

 

This Manufacturing and Distribution Agreement (the “ Agreement ”), effective June 6, 2008 (the “ Effective Date ”), is between TG United Pharmaceuticals, Inc., a Florida corporation with offices at 16255 Aviation Loop, Brooksville, Florida 34604 (“ Manufacturer ”) and Neuro-Hitech, Inc., a Delaware corporation with offices at One Penn Plaza, Suite 1503, New York, NY 10019 (“ Distributor ”). TG United Labs, LLC, a Florida limited liability company, TG United, Inc., a Florida corporation, and TG United Liquid, Inc., a Florida corporation (collectively, the “ Other TG United Companies ”) join in this Agreement solely for the purposes set forth in Section 19.9 of this Agreement.

 

Manufacturer and Distributor agree as follows:

 

1.   Definitions .

 

Affiliate ” of a party hereto shall mean any person, corporation or other entity, which controls, is controlling or is under common control with such party.

 

Batch ” means, with respect to solid doses, 500 bottles of 100 tablets per bottle and, with respect to liquid doses, 800 bottles of 16 ounces per bottle, in either case with such minor deviations as may occur from time to time.

 

FDA ” means the United State Food and Drug Administration or any successor.

 

NDC ” means national drug code number.

 

Products ” shall mean the branded products set forth on Attachment A hereto, all corresponding generics of the Products, and at the specific request of Distributor, any line extension or reformulations of the Products, each of which shall be deemed a separate “Product” for purposes hereof.

 

Territory ” shall mean the geographical area set forth in Attachment A-2 hereto.

 

Contract Year ” means each of the successive 12-month periods commencing on the Effective Date and ending on the next anniversary of the Effective Date.

 

2.   Grant of Distributorship .

 

2.1   Manufacturer’s Exclusivity .

 

(a)   Manufacturer hereby grants to Distributor for the Term (as defined in Section 3.1 of this Agreement) the exclusive right to purchase the Products from Manufacturer, and Distributor accepts such grant, subject to the limitations, terms and conditions stated in this Agreement. Subject to any increases permitted hereunder, the initial prices for the Products shall be as set forth on Attachment A-1 hereto.

 

(b)   Notwithstanding the foregoing, in the event that Distributor fails to purchase in any Contract Year at least ten (10) Batches of each Product, then Manufacturer may, at its sole election, deliver to Distributor written notice thereof (a “ Manufacturer Non-Exclusivity Notice ”) within 60 days of the end of such Contract Year. Upon the delivery of a Manufacturer Non-Exclusivity Notice, Distributor shall have ten (10) business days during which to purchase such amount of such Product as to which a Manufacturer Non-Exclusivity Notice was delivered as would have resulted in Distributor purchasing ten (10) Batches of such Product for the Contract Year just-ended. If Distributor fails to make such purchase, then Manufacturer shall be permitted thereafter to manufacture such Product for, or sell such Product to, any other person, irrespective of whether such other person competes with Distributor. Notwithstanding the foregoing, but without limiting Manufacturer’s rights hereunder, it shall not be construed as a breach of this Agreement for which damages or injunctive relief shall obtain, for Distributor to fail to purchase at least ten (10) Batches of each Product.

 


 

(c)   If Distributor shall purchase a Product in quantities other than Batches (as defined herein), the minimum purchase commitment set forth in Section 2.1(b) hereof required to maintain Manufacturer’s exclusivity shall be equitably adjusted to reflect the actual amounts purchased, it being the intent of the parties that the economic return to Manufacturer be not less than that as would have resulted from the purchase of such minimum quantity set forth in Section 2.1(b) hereof.

 

2.2   Distributor’s Exclusivity . Unless Distributor gives written notice to Manufacturer not later than 60 days prior to Distributor’s commencement thereof (a “ Distributor Non-Exclusivity Notice ”), Distributor shall not itself manufacture or have manufactured for it, or directly or indirectly sell, any products from third parties that are substantially similar to the Products. Distributor shall itself purchase products from third parties that are substantially similar to the Products only if Manufacturer (a) breaches its obligations to manufacture and deliver Products to Distributor in a timely and complete manner, (b) is unable to produce Products to required specifications or (c) is unable to produce Products at or below the per unit price offered by another manufacturer for the same or similar batch size (provided, when comparing per unit prices, consideration shall be given to any up-front, start up or development or other fees and expenses charged by such other manufacturer, which fees and expenses shall be pro rated among units purchased) and, in any such case, such breach or inability to produce Products continues for a period of 60 days following written notice thereof from Distributor. Upon delivery of a Distributor Non-Exclusivity Notice, Manufacturer shall be permitted thereafter to manufacture Products for, or sell Products to, any other person, irrespective of whether such other person competes with Distributor, and Distributor shall be permitted thereafter to have manufactured for it, or directly or indirectly sell, any products from third parties that are substantially similar to the Products.

 

2.3   Discounts .

 

(a)   Until the aggregate amount of discounts given to Distributor by Manufacturer under this Section 2.3 equals four hundred thousand dollars ($400,000), Distributor shall receive a discount equal to twenty-five percent (25%) of the gross amount of each invoice delivered by Manufacturer to Distributor.

 

(b)   Pursuant to that certain Consulting Agreement, dated the Effective Date, David Ambrose has agreed to use commercially reasonable efforts to propose to Distributor a certain number of pharmaceutical products for distribution by Distributor. For any such products which Distributor determines to launch and for which Manufacturer is engaged to manufacture on behalf of Distributor, Distributor shall receive a discount equal to ten percent (10%) of the gross amount of each invoice delivered by Manufacturer to Distributor with respect to such products until the aggregate amount of discounts given to Distributor in any Contract Year equals one hundred thousand dollars ($100,000).

 

2.4   Pricing . Distributor will have sole control over market pricing and strategy relating to Products purchased by Distributor. Distributor market and pricing decisions with respect to sales by Distributor will be independent of the price of Products as listed in Attachment A-1 , which Product prices are subject to change as set forth in Section 6.2.

 

3.

Term and Renewal .

 

3.1   Term . This Agreement shall remain in effect for an initial term beginning on the Effective Date and ending on the fifth (5 th ) anniversary of the Effective Date (the “ Initial Term ”). This Agreement is subject to renewal for additional periods as set forth in Section 3.2 hereof (each a “ Renewal Term ” and together with the Initial Term, the “ Term ”).

 


 

3.2   Renewal . After the expiration of the Initial Term, Manufacturer and Distributor may, upon mutual written agreement, extend the term of this Agreement for additional, successive one (1) Contract Year terms. In the event Distributor desires to renew this Agreement, Distributor shall provide Manufacturer with written notice (“ Notice of Renewal ”) sixty (60) calendar days in advance of the expiration of the Initial Term or any Renewal Term. A Notice of Renewal shall contain a proposed revision to the minimum purchase commitment set forth in Section 2.1(b) hereof required to maintain Manufacturer’s exclusivity. Within 15 calendar days of receipt of the Notice of Renewal, Manufacturer and Distributor shall meet to negotiate such minimum quantity and the amount shall be agreed to in writing. If the parties fail to reach an agreement on such amounts by the commencement of the Renewal Term, the amounts for the preceding quarter shall remain in place and the parties shall seek to resolve such amounts for such Renewal Term in accordance with Section 19.8 of this Agreement.

 

3.3   New Products .

 

(a)   In addition to the exclusivity provisions of Section 2.1 above, during the Term and as long as Distributor is not in material breach of this Agreement, Manufacturer will offer Distributor the right to become the exclusive distributor for any new pharmaceutical products constituting a branded product that Manufacturer has internally developed and can legally offer (a “ New Product ”). New Products shall be deemed to specifically exclude OTC Monograph products, ANDA’s and other generic products. Manufacturer’s offer will be on terms and conditions not less favorable to Distributor in any material respect than those terms which Manufacturer offers or is willing to offer to any other third party. Distributor will have 60 days from the date Manufacturer provides written notice of such New Product and such terms and conditions to exercise such right on the terms and conditions set forth in such notice. If Distributor acquires the exclusive right to distribute any such New Product, then such New Product shall be added to Attachment A-1 hereto and the parties shall agree on the minimum quantity of product to be purchased from Manufacturer during the first four full quarters of Distributor’s purchase thereof, which shall be set forth with such New Product on Attachment A-1 . If the parties shall be unable to agree on such minimum quantity by the conclusion of such 60 day period, then Manufacturer shall be free to sell on a non-exclusive basis unless until such time as Manufacturer and Distributor agrees to a minimum quantity with respect to such New Product.

 

4.   Certain Representations and Warranties of Manufacturer and Distributor .

 

Each of the Manufacturer and the Distributor represents and warrants to the other that, with respect to itself:

 

4.1   Authorization of Transaction . Such party has full and corporate power and authority to execute and deliver this Agreement and to perform their respective obligations hereunder. This Agreement constitutes the valid and legally binding obligation of such party, enforceable in accordance with its terms and obligations. Such party need not give any notice to, make any filing with, or obtain authorization, consent, or approval of any government or governmental agency in order to consummate the transactions contemplated by this Agreement.

 

4.2   Noncontravention . The execution and delivery of this Agreement and the consummation of the transactions contemplated hereby, do not and will not, with or without the giving of notice or the passage of time or both, (a) violate any constitution, statute, regulation, rule, injunction judgment, order, decree, ruling, charge, or other restriction of any government, governmental agency, or court to which such party is subject or any provision of its respective charter or bylaws or (b) conflict with, result in a breach of, constitute a default under, result in the acceleration of, create in any party the right to accelerate, terminate, modify, or cancel, or require any notice under any agreement, contract, lease, license, instrument, or other arrangement to which such party is a party or by which it is bound or to which any of its assets is subject.

 


 

5.   Distributor’s Duties .

 

Distributor shall:

 

(a)   submit its non-cancelable orders for Products by written purchase order, it being agreed that the terms and conditions of Distributor’s standard purchase order form shall not apply to transactions pursuant to this Agreement;

 

(b)   pay for such orders within 30 days from date of invoice in U.S. dollars and payment shall be made by wire transfer, check or letter of credit approved by Manufacturer; all prices are quoted FOB Brooksville, Florida, USA. Past due amounts not received within 30 days incur interest thereafter at the rate of 1.5% of the invoice amount per month;

 

(c)   provide to its customers instructions in the use of the Products and field service for such Products in accordance with Product information provided by Manufacturer;

 

(d)   use its commercially reasonable efforts to purchase the quantities of each Product set forth in Section 2.1;

 

(e)   not give any warranties, above and beyond those in Section 10 hereto, to any end-use customers;

 

(f)   provide instruction and assistance on compliance with any regulatory and labeling requirements of the Territory; however, Manufacturer does not hereby delegate or attempt to delegate any of its federal and state regulatory and labeling obligations with respect to the Products;

 

(g)   cooperate to a reasonable degree with Manufacturer to obtain any regulatory approval of the Products as required by the Territory;

 

(h)   register all products with correct NDC’s and provide such information to Manufacturer.

 

6.   Manufacturer’s Duties .

 

6.1   Manufacturer shall:

 

(a)   ship promptly Distributor’s orders for Products, FOB Brooksville, Florida, USA, at the prices set forth on Attachment A-1 hereto, subject to Section 6.2 hereof;

 

(b)   adequately package and label Products to conform with any federal and state regulatory and labeling requirements of the Territory with respect to the Products; and

 

(c)   products will be co-labeled with Manufacturer and Distributor information under Distributor’s NDC’s.

 


 

6.2   Manufacturer has the right to change the prices for Products at any time during the Term only to the extent of [*]; provided, however, that no such price change shall be effective without at least sixty (60) days prior notice by Manufacturer to Distributor and that during any calendar year, Manufacturer may not raise the price of Products sold to Distributor by any [*] for the prior calendar year.

 

7.   Trademarks and Trade Names; Intellectual Property .

 

7.1   Any and all trademarks and trade names owned by Manufacturer or its Affiliates shall remain the property of Manufacturer or its Affiliates and nothing in this Agreement shall confer in Distributor any ownership in any trademarks or trade names owned by Manufacturer or its Affiliates. Trademarks and trade names owned by Manufacturer or its Affiliates in connection with the Products shall be used by Distributor only with reference to such Products and only in the manner approved by the Manufacturer. Any and all goodwill associated with Manufacturer’s trademarks and trade names used by Manufacturer or Distributor in connection with the Products shall belong to Manufacturer.

 

7.2   Any and all trademarks and trade names owned by Distributor or its Affiliates shall remain the property of Distributor or its Affiliates and nothing in this Agreement shall confer in Manufacturer any ownership in any trademarks or trade names owned by Distributor or its Affiliates. Trademarks and trade


 
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