EXHIBIT 10.9
Confidential Treatment has been
requested for portions of this agreement. Those portions have been
marked [Redacted].
SUPPLY AGREEMENT for
DORZOLAMIDE HYDROCHLORIDE
This AGREEMENT, effective as of
18 th
July 2008, is made by and
between:
HI-TECH PHARMACAL CO. INC, a company
organized and existing under the laws of Delaware, USA, having its
legal seat at 369 Bayview Avenue, Amityville, New York 11701, USA
(hereinafter referred to as “CLIENT”),
and
RAGACTIVES S.L.U., a company
organized and existing under the laws of Spain, having its legal
seat at Parque Tecnológico, Parcelas 2 y 3, 47151.Boecillo
(Valladolid), Spain (hereinafter referred to as
“RAGACTIVES”).
RECITALS
WHEREAS, RAGACTIVES manufactures
Dorzolamide Hydrochloride (hereinafter referred to as
“Product”).
WHEREAS, RAGACTIVES is the holder of
the granted Patent US 2003/0220509.
WHEREAS, RAGACTIVES submitted on
May 31 st 2005 a Drug Master File (“DMF”)
Number 18385 with US Food and Drug Administration
(“FDA”).
WHEREAS, RAGACTIVES can supply the
Product to the CLIENT. The Product may be invoiced to the CLIENT by
RAGACTIVES or any other company designated by
RAGACTIVES.
WHEREAS, CLIENT has already
established facilities for manufacturing finished dosage forms,
distribution and marketing of pharmaceutical products in the
Territory, as hereinafter defined.
NOW, THEREFORE, in consideration of
the premises and the covenants contained herein, the parties hereto
have agreed as follows:
ARTICLE
I-DEFINITIONS
Whenever used in this Agreement, the
following terms shall have the following meanings:
1.1. “Product” as used
in this Agreement shall mean the active ingredient Dorzolamide
Hydrochloride.
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1.2. “Scientific and Technical
Information” shall mean all scientific and technical data
possessed by RAGACTIVES relating to the Product.
1.3. “Territory” shall
mean Canada and the United States of America.
ARTICLE II-DISCLOSURE OF
SCIENTIFIC AND TECHNICAL INFORMATION /
CONFIDENTIALITY
2.1. RAGACTIVES will deliver to the
CLIENT free of charge all the technical documentation in the
possession of RAGACTIVES which CLIENT needs for registration
purposes.
2.2. During the term of this
Agreement and at any time subsequent thereto, CLIENT shall keep
confidential and secret all Scientific and Technical Information
which is disclosed to it by RAGACTIVES under this
Agreement.
2.3. CLIENT shall not reveal or
disclose to third parties any of said Scientific and Technical
Information and other information it may develop without the prior
written consent of RAGACTIVES. Scientific and Technical information
shall include, but not be limited to, all technical information and
other pertinent information, except any portion thereof
which:
a ) is in the public domain at the
time of disclosure;
b ) is published or otherwise
becomes part of the public domain through no fault of the
parties;
c ) is known by CLIENT before
receipt for under this Agreement, as shown by prior written
records; or
d ) becomes available from a third
party who has the right to disclose it.
Nothing contained in the above
paragraphs shall be construed to restrict CLIENT from disclosing
the Scientific and the Technical Information as may be required for
purposes of compliance with governmental, administrative or
regulatory laws, regulations, orders or requests. In such event
CLIENT shall take such reasonable measures as may be available to
ensure that no unauthorized use or disclosure is made by others to
whom access to confidential information is granted.
ARTICLE III-SUPPLY OF THE
PRODUCT
3.1. During the term of this
Agreement, CLIENT shall purchase the Product in bulk from
RAGACTIVES, and RAGACTIVES shall sell such requirements of the
Product to CLIENT upon and subject to the terms of this Art 3.
Nothing herein shall restrict CLIENT from purchasing the Product
from another source of supply. However, during the term of this
Agreement, CLIENT will consider RAGACTIVES as its preferential
supplier for the Product and therefore will communicate to
RAGACTIVES any offer for the Product which may have received from
other equivalent manufacturer with approved DMF in USA,
enabling
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RAGACTIVES to align its price to such of other
equivalent manufacturer (“equivalent manufacturer”
means in this contract any third party with a Drug Master File
approved by the FDA selling the Product). In this respect CLIENT
shall buy from RAGACTIVES at least 75% of its annual consumption of
the Product as long as RAGACTIVES price is not over 10% of other
equivalent manufacturer’s price.
3.2. CLIENT agrees to provide a
rolling forecast of its Product requirements on a quarterly basis
to RAGACTIVES so as to facilitate RAGACTIVES to carry out
production planning of the Product for sale and supply pursuant to
the terms of this Agreement. The rolling forecast on this basis
will be communicated to RAGACTIVES three (3) months prior to
the commencement of the relevant calendar year during the term of
this Agreement and will be updated on a quarterly basis. CLIENT
shall submit firm purchase orders setting forth specific Product
quantities and shipping instructions for each shipment at least one
hundred and twenty (120) days prior to required delivery
dates, and RAGACTIVES shall acknowledge receipt thereof and confirm
said terms. RAGACTIVES shall supply CLIENT with the quantities set
forth on such firm purchase orders and such additional amounts that
CLIENT may order in excess of CLIENT’s forecasted amounts
constituting firm purchase orders; provided that RAGACTIVES shall
have confirmed and accepted such additional orders within ten
(10) days of RAGACTIVES’ receipt of any such additional
orders. RAGACTIVES agrees to use its best efforts to meet any such
additional orders. RAGACTIVES covenants to maintain capacity to
manufacture on an annualized basis 120% of the forecasted
requirements of CLIENT set forth in any forecast submitted by
CLIENT in accordance with this Agreement.
3.3. RAGACTIVES shall supply the
Product in accordance with the Product Specifications as stated in
Annex 1. CLIENT shall be responsible for analytical controls made
by it on the Product purchased from RAGACTIVES.
3.4. CLIENT shall have thirty
(30) days from the date of delivery of the Product to reject
all or any part of the Product which is damaged or does not conform
with the Product Specifications. In the event of notice of such
non-conformity, RAGACTIVES shall, to the exclusion of any other
remedy, replace the defective Product at no cost to CLIENT. In the
event that RAGACTIVES does not agree with CLIENT’s statement
of nonconformity, RAGACTIVES shall submit a sample of the allegedly
nonconforming Product to an independent qualified laboratory for
testing as to the Product conformity with the Product
Specifications, which laboratory shall have been approved by
CLIENT. The decision of the independent qualified laboratory shall
be final and all reasonable costs associated with the analysis
shall be borne by the losing party.
ARTICLE IV-PRODUCT PRICES AND
PAYMENT TERMS
4.1. The confidential portion has
been omitted and filed separately with the Securities and Exchange
Commission.
4.2. Terms of Payment shall be
thirty (30) days after invoice date upon shipment of the
Product and receipt of Invoice. Product shall be shipped to CLIENT
CIF New York, USA. Additional orders will not be shipped until
previous one has been fully paid.
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ARTICLE V-QUALITY AND
CONTROLS
5.1. RAGACTIVES guarantees that the
quality of the Product supplied under this Agreement shall meet, at
the time of delivery to CLIENT, all Specifications as stated in
Annex 1. RAGACTIVES shall enclose a certificate of analysis for
each batch of the shipment proving that the Product meets such
quality standards.
5.2. The Product supplied to CLIENT
shall be manufactured in compliance with RAGACTIVE’s DMF
filed with the US FDA and shall be manufactured in compliance with
all applicable laws and regulations, including but not limited to
the FDA Current Good Manufacturing Practices (“cGMP”).
Upon request, RAGACTIVES will make its best efforts to provide
CLIENT with any substantive impurities from the synthesis process
whenever it is possible to isolate them by chemical conventional
means.
5.3. RAGACTIVES will supply CLIENT
with copies of all governmental inspections, approvals and Drug
Master Files in connection with the Product in the Territory.
Summaries of quality test results of the Product will be available
to CLIENT. The CLIENT or its representatives will have the right at
reasonable times during normal business hours, to inspect the
facilities where the Product is manufactured upon advance written
notice to RAGACTIVES for the purposes of quality control
