BENZYDAMINE DEVELOPMENT AGREEMENT
EXHIBIT 10.12
CONFIDENTIAL TREATMENT REQUESTED
Pursuant to 17 C.F.R. §§200.80(b) and 230.406
EXECUTION COPY
BENZYDAMINE DEVELOPMENT AGREEMENT
This Development Agreement is entered into as of 1 April 2006 by and between MonoSolRx, a Delaware limited liability company with offices at ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇, ▇▇▇ (“MSRX”) and Aziende Chimiche Riunite ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ A.C.R.A.F. S.p.A., a company with only one shareholder under direction and coordination of Finaf S.p.A., with offices at ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇, ▇ - ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ (“▇▇▇▇▇▇▇▇”).
Whereas, MSRX specializes in the development and manufacture of fast dissolving oral film drug delivery dosage forms (the “MSRX Delivery System”), and
Whereas, ▇▇▇▇▇▇▇▇ wishes to explore the potential development and commercialization of a film containing benzydamine using the MSRX Delivery System.
The parties, for due and sufficient consideration the receipt of which is hereby acknowledged, agree as follows.
1. The Deliverables. MSRX will use its best efforts to develop a mint flavored version of its current Benzydamine film according to the specifications described in Annex 1 (the “Specifications”). Parties agree that ▇▇▇▇▇▇▇▇ will review if the excipients contained in the formulation comply with the excipients regulations described in Annex 1. Following acceptance of the formulation by ▇▇▇▇▇▇▇▇, MSRX - on its production equipments - will make at least 3 (three) batches. Each batch will contain 300,000 film strips (the “Deliverables”). The Deliverables will be delivered to ▇▇▇▇▇▇▇▇ within 10 (ten) labour day, from packaging of strips, by and at the cost of MSRX. For the production of the Deliverables, ▇▇▇▇▇▇▇▇ agrees to supply to MSRX not more than 25 kg of Benzydamine, free of charge, therefore all the quantities of Benzydamine - ordered by MSRX - exceeding 25 kg shall be supplied at the price of USD[*]/kg Ex Works ▇▇▇▇▇▇▇▇ Manufacturing Site.
2. Experimental Stability. ▇▇▇▇▇▇▇▇ shall conduct experimental stability on the Deliverables according to the Analytical development and pre-stability program set out in Annex 2 and agrees to share those results with MSRX under confidentiality. MSRX shall make personnel available for consultation regarding analytical testing methods as requested by ▇▇▇▇▇▇▇▇, it being understood that ▇▇▇▇▇▇▇▇ shall be ultimately responsible for all analytical testing. ▇▇▇▇▇▇▇▇ shall make such information and methods available to MSRX as MSRX may reasonably request for use in cleaning validation of its production equipment in connection with the Benzydamine production.
CONFIDENTIAL TREATMENT REQUESTED
Pursuant to 17 C.F.R. §§200.80(b) and 230.406
3. Further Commercialization. ▇▇▇▇▇▇▇▇ may continue with further development and/or commercialization efforts, at its sole option, in the territories listed in the Annex 3. In the event that ▇▇▇▇▇▇▇▇ wishes to continue such efforts, including the negotiation of commercial supply of product, MSRX will negotiate a commercial supply agreement on the basis of foil-foil pouched cassettes [*] for less than $[*] per item (subject to certain batch size minimums etc, exclusive of the cost of the drug to be supplied by ▇▇▇▇▇▇▇▇ and ex works Portage)
4. Development Cost for Deliverables. MSRX shall invoice ▇▇▇▇▇▇▇▇ forty thousand ($40,000) US dollars, half upon commencement and half upon delivery to ▇▇▇▇▇▇▇▇ of the materials for experimental stability.
5. Terms. This agreement shall be governed in accordance with the laws of the Republic of Italy.
In witness whereof, this agreement was duly executed.
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A.C.R.A.F. S.p.A |
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MONOSOLRX, LLC |
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By: |
/s/ Gianloigi Mariafrozza |
By: |
/s/ ▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ |
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Name: GIANLOIGI MARIAFROZZA |
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Name: ▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ |
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Title: MANAGING DIRECTOR |
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Title: Pres. & CEO |
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DATE, 25TH MAY 2006 |
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2
CONFIDENTIAL TREATMENT REQUESTED
Pursuant to 17 C.F.R. §§200.80(b) and 230.406
ANNEX I
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CONFIDENTIAL TREATMENT REQUESTED
Pursuant to 17 C.F.R. §§200.80(b) and 230.406
ANNEX II
Analytical Development and Pre-Stability Program
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CONFIDENTIAL TREATMENT REQUESTED
Pursuant to 17 C.F.R. §§200.80(b) and 230.406
ANNEX III
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