AGREEMENT
EFFECTIVE DATE: June 2nd ,1992
BETWEEN: FLEMINGTON PHARMACEUTICAL CORPORATION,
00 Xxxxx Xxxxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000
(Flemington);
AND: RAPID SPRAY, XxxX. & XX. XX, 0000 Xxxxxxxx,
Xxxxxxx (Rapid Spray).
WHEREAS, Rapid Spray has developed aerosol dosage formulations containing
nitroglycerine as its effective ingredient, as set forth in detail in Exhibit A,
which is attached to and made a part of this Agreement (the Product); and;
WHEREAS, Flemington intends to obtain regulatory approval permitting Flemington
to market the Product within the Territory (deemed below); and,
WHEREAS, Flemington is willing to undertake the project of procuring
bioavailability studies, in order to obtain approval by regulatory authorities
within the Territory for the marketing of the Product within the Territory; and,
WHEREAS, following approval by the various regulatory authorities, Flemington
wishes to obtain the right to purchase Product from Rapid Spray, together with
the exclusive right to sell and distribute Product within the Territory;
NOW, THEREFORE, in consideration of the foregoing, and of the mutual
undertakings contained in this Agreement, the parties agree as follows.
1. Promptly following execution of this Agreetnent, Rapid Spray shall provide
Flemington with a sample of Product as"described in Exhibit A, which sample
shall have been synthesized by a process approved by the United States Food and
Drug Administration (FDA), and which sample (together with the process by which
it was synthesized) shall not infringe on any rights or patents held by others,
the Product shall have been manufactured by Rapid Spray in accordance with
then current Good Manufacturing Practices (GMP), as established by FDA or other
regulatory authorities from time to time.
2. Within a reasonable time after Flemington has been provided by Rapid Spray
with necessary ancillary documentation, Flemington shall initiate or cause to be
initiated, and thereafter shall pursue diligently, all necessary clinical
studies required to prepare and file an application(s) with FDA and other
regulatory authorities, and, following completion thereof to Flemington's
satisfaction, Flemington shall prepare, file and diligently pursue the
application(s). Rapid Spray agrees to supply Flemington with manufacturing and
quality control procedures and data, including stability testing using approved
stability assay procedures of a chemical and pharmaceutical nature necessary to
support an Abbreviated New Drug Application (ANDA) or New Drug Application
(NDA). Upon approval of the application(s), all right, title and interest in
and to them shall be and remain the sole and exclusive property of Flemington.
Flemington shall use its best efforts to maintain the approved application(s) in
force, including, without limitation, the filing of all necessary
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reports, and the maintenance of all necessary records, required by any or all
regulatory authorities having jurisdiction, and Rapid Spray shall cooperate with
Flemington in all ways necessary to discharge this obligation.
3. Rapid Spray hereby appoints Flemington as its sole and exclusive distributor
of the Product within the Western Hemisphere, Europe and Japan (the Territory).
Except as provided in paragraph 14(a), below, Flemington agrees to purchase from
Rapid Spray all of Flemington's requirements of Product for sale in the
Territory. Flemington agrees, from time to time, to provide Rapid Spray with
forecasts of Flemington's requirements for Product, as described below.
4. Nothing contained in this Agreement is intended by the parties to grant to
Flemington any right or license to manufacture Product under any inventions,
secret formulae, secret processes or other secret technical information owned or
controlled by Rapid Spray, whether or not patented, relating to the Product or
its manufacture.
5. Flemington shall use its best efforts to keep Rapid Spray as reasonably
informed as possible of the progress of the application(s) and the date upon
which Flemington expects to receive approval. On approval by FDA, or other
regulatory authorities having jurisdiction, of the application, or as long
before that date as is reasonably possible, Flemington shall provide Rapid Spray
with an estimate of Flemington's anticipated monthly requirements for Product
for the then current and following calendar year. The estimate given by
Flemington shall not be construed to require Flemington to purchase
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any particular amount of Product during the period covered by it. Thereafter, on
or before October 1 of any given year, Flemington shall provide Rapid Spray with
a similar non-binding estimate of Flemington's requirements for Product during
the next calendar year.
6. From time to time after FDA approval (or, as to registration(s) outside the
United States, of the appropriate regulatory authorities), Flemington shall
place with Rapid Spray firm purchase orders for Product. Any order given shall
not call for delivery more than three months after the date of order placement,
unless otherwise agreed to by Rapid Spray. So long as the total of orders placed
with Rapid Spray by Flemington calling for delivery within a given month do not
exceed Flemington's estimated forecast of its requirements of Product for such
month by more than 150 percent, such orders shall be deemed to have been
accepted by Rapid Spray upon order placement by Flemington. If Flemington's
orders for any given month exceeds Flemington's estimated forecast for such
month by more than 150 percent, Rapid Spray shall use its best efforts to fill
such portion of the order(s) which exceeds the 150 percent level.
7. Any order for Product placed by Flemington with Rapid Spray shall be in a
minimum quantity of ______________ canisters per order.
8. The price to be charged by Rapid Spray to Flemington for Product is set forth
on Exhibit B, which is attached to and made a part of this Agreement. Prices are
F.O.B. Laupheim, insurance and freight prepaid for Flemington's account for each
order a letter of credit payable 60 days after shipment from Rapid Spray at
_____ Bank in the amount of the invoice including insurance and freight is to be
given, see German version from March 30, 1992, paragraph 8. If market conditions
or other circumstances either in the Territory or the place of manufacture
should
change so that either party to this Agreement is unable to make a reasonable
profit (which shall be evaluated according to gross margins historically
achieved by such party on Product hereunder), the parties shall meet
and negotiate a good faith adjustment of the price of the Product.
9. Any duties or other import taxes or exactions imposed by any jurisdiction
within the Territory into which Flemington is importing Product from Rapid Spray
shall be paid for by Flemington for its own account.
10. Invoices from Rapid Spray to Flemington for deliveries of Product shall be
due and payable by Flemington to Rapid Spray 60 days after shipment of Product
by Rapid Spray.
11. Product supplied by Rapid Spray to Flemington shall comply strictly with the
specffications set forth in Exhibit A, or such other specifications as the
parties mutually shall agree upon from time to time. Any claim by Flemington for
defect(s) in Product shall be made by it, in writing, with full particulars,
within 60 days after actual receipt by Flemington of the allegedly defective
Product. All quality assurance testing for acceptance shall be based upon the
criteria set forth in Exhibit A. After acceptance of Product by Flemington, or
the expiration of 60 days after receipt of Product by Flemington without any
objection by it, no claim shall be made by Flemington for failure to comply
with the specifications set forth in Exhibit A, with the exception of
subsequently discovered failure to meet stability requirements, which may be
raised at any time. If a timely objection to Product is
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made by Flemington and the Product is found not to meet specifications, Rapid
Spray shall replace the defective Product with complying Product, and Rapid
Spray shall hold Flemington harmless from any cost or expense incurred by
Flemington as a result of such non-compliance. Any dispute about whether or not
Product complies with specifications shall be referred to an independent
laboratory mutually acceptable to the parties. The cost of the assay, and any
other related services of the independent laboratory, shall be borne by the
party whose analysis was found to be in error.
12. Rapid Spray makes no representations, extends no warranties of any kind,
express or implied, nor assumes any responsibility whatsoever, including
responsibility for any claim of toxicity, side effects, adverse drug reactions
or lack of efficacy, to any third party or to Flemington with respect to the
manufacture or use of the Product, except that the Product shall comply with the
specifications set forth in Exhibit A at the time of shipping, and that the
Product shall be supplied to Flemington from manufacturing facilities operated
in compliance with GMP of FDA or other applicable regulatory authorities. Rapid
Spray agrees to permit representatives of Flemington to examine Rapid Spray's
facilities at any reasonable time during regular business hours, and to adopt
such recommendations as reasonably may be made to assure compliance with all GMP
regulations and requirements. Notwithstanding the foregoing, Flemington agrees
to indemnify Rapid Spray, and hold it harmless, from an and all liability to
third parties beyond what liability would, or could, be imposed upon Rapid Spray
under the laws and regulations of the European Community, except with respect
to any failure of Rapid Spray to comply
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with GMP regulations, or any more stringent regulations which may apply within
any jurisdiction other than the United States of America in which the Product is
known by the parties to be marketed.
13. Flemington shall use its best efforts to begin marketing Product in the
Territory approximately three months after approval by the appropriate
regulatory authority(ies) having jurisdiction over the application(s) covering
the Product in a given jurisdiction and shall devote such efforts to marketing
the Product as it would to products developed by it having similar sales and
profit potential.
14(a). This Agreement shall be effective as of the date specified above and
shall continue for the life of the Product or the end of Flemington's obligation
to pay royalties to Rapid Spray as elsewhere provided for below in this
Agreement. The obligation of Rapid Spray to supply Product to Flemington in
accordance with this Agreement shall continue until the expiration of the term
of any patent(s) covering the Product, or of the tenth complete calendar year
after the beginning of marketing of Product in the Territory, whichever comes
later; provided, however, either party may renew its rights for an additional
five year period by giving written notice to that effect to the other party
before the expiration of the ninth complete calendar year after the beginning of
the marketing of Product within the Territory. If, at any time during the Term
of this Agreement, it should appear to Flemington that market conditions
relevant to the Product have changed, or are changing, in such a way that
Flemington's ability to market the Product has been, or is being, adversely
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affected in a material manner, the parties agree to negotiate in good faith such
modifications to this Agreement, and the parties' relationship, as will
reasonably enable each party most closely to satisfy their mutual intentions and
expectations in entering into this Agreement.
14(b). Either party may terminate this Agreement in its entirety if the other
party shall be in default of any of its obligations hereunder, and such default
shall not have been remedied within a 60 day period after the giving of a notice
of default, which notice shall specify the particulars of the alleged default.
Notice shall be given in the manner provided below. If the party to which notice
of default was given shall not cure the default within the 60 day period, the
party giving the notice shall have the absolute right to terminate this
Agreement, by giving written notice of its exercise of such right to the other;
upon the giving of such notice this Agreement shall terminate immediately. In
addition, if either party shall begin, in the capacity of a debtor, any
proceedings under any bankruptcy, insolvency, reorganization, readjustment of
debt, receivership, assignment for the benefit of creditors, dissolution or
liquidation law, of any government having jurisdiction over the subject matter
or the parties, or if any such proceedings have been begun against either party,
and any trustee or receiver of either party shall be appointed in such
proceeding, and such party by any act or failure to act shall indicate approval,
consent or acquiescence in such proceedings or the appointment of such trustee
or receiver; or if any warrant or attachment shall be issued against all of the
assets of a party and shall not be dismissed or released within 30 days after
levy; then, in any such case, the other party not involved in any such
proceedings shall have the right to terminate this Agreement by giving written
notice of the exercise of that
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right to the party involved in such proceedings, and upon the giving of that
notice this Agreement shall terminate.
15. The parties agree that any dispute arising between them in connection with
this Agreement shall be finally settled under the Rules of Conciliation and
Arbitration of the International Chamber of Commerce, by one or more arbitrators
appointed in accordance with such Rules. The arbitration shall be held in a
mutually agreeable place, but if the parties cannot agree upon a place they
shall be held in Brussells, Belgium.
16. Except as may expressly be authorized in writing, neither party shall
possess, nor hold itself out to third parties as possessing, any power or
authority to bind or act as the agent of the other.
17. The performance by either party of any covenant or obligation on its part to
be performed hereunder (other than an obligation of either party to pay money to
the other) shall be excused because of any reason customarily recognized as
constituting force xxxxxx; provided, however, that the party affected shall
exert its best efforts to eliminate, cure or overcome any of such causes and
resume performance hereunder. Promptly following execution hereof, the parties
shall confer for the purpose of identifying one or more alternative sites of
manufacture to be used if Rapid Spray's production of Product should be
interrupted because of force xxxxxx.
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18. Neither this Agreement nor the rights or obligations of either party to it
may be assigned, either in whole or in part, by either party without the advance
written consent of the other, except that Rapid Spray is permitted to assign to
any person or entity owning more than 50% of its shares; provided, however, in
the case of an assignment in connection with the sale or transfer of all or
substantially all of a party's pharmaceutical business, or its merger or
consolidation with another company, such consent shall not be withheld
unreasonably.
19. Any notice required or permitted under this Agreement (not intended to
include ordinary day-to-day communications) shall be given in writing, by fax
transmission, to the other party's principal office, addressed to the chief
executive officer of the recipient, with confirming hard copy being sent by
international overnight letter or service. Communications are effective upon
delivery.
20. Any and all written information, data or know/how received by either party
from the other shall be maintained in confidence by the receiving party during
the term of this Agreement and for five years thereafter; provided, however,
that this obligation shall not apply to any information which the recipient can
establish was known to it before disclosure, or is in or enters the public
domaine through a third party not under obligation of confidentiality to the
receiving party.
21. This Agreement may not be amended except by a writing identifying itself as
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such, executed with the same formality as this Agreement. This requirement of
written amendment may not be waived orally.
22. This Agreement shall bind and benefit the parties and their permitted
successors and assigns.
IN WITNESS WHEREOF, this Agreement has been signed by the duly authorized
representatives of the parties, effective the date set forth above.
FLEMINGTON PHARMACEUTICAL CORP.
By: /s/ Xxxxx X. Xxxxxx
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RAPID SPRAY, GmbH. & Co. KG
By: /s/ Laupheim, der 02.06.92
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