AGREEMENT
Effective Date: February 12, 1998
Between: CLL Pharma, a Corporation having offices at 455 Xxxxxxxxx xxx
Xxxxxxx, 00000 Nice, XXXXX 0, XXXXXX (CLL Pharma);
And: Flemington Pharmaceutical Corp., a New Jersey Corporation,
having offices at 00 Xxxxx Xxxxxx, Xxxxxxxxxx, Xxx Xxxxxx
00000 (Flemington)
Whereas, Flemington is a pharmaceutical company engaged in the development
of various products, including a lingual spray having progesterone as its active
ingredient; and,
Whereas, CLL Pharma is a pharmaceutical company which develops and intends
to market products having progesterone as the principal active ingredient, and
CLL Pharma desires to enter into a Joint Venture for the development,
manufacture and marketing of Flemington's progesterone lingual spray in the
Territory described below; and,
Whereas, Flemington desires enter into such a Joint Venture with CLL
Pharma;
Now, Therefore, in consideration of the foregoing, and of the mutual
undertakings contained herein, the parties agree as follows:
1. Definitions.
(a) Product means a lingual spray preparation having progesterone as
its active ingredient, for treatment or prevention of pre- and/or
post-menopausal complications due to progesterone deficiency.
(b) NDA means a New Drug Application for the Product, to be prepared
and filed with the United States Food and Drug Administration (FDA) in the
United States, and comparable applications for regulatory approval elsewhere in
the Territory.
(c) FDA Approval means approval by FDA of the NDA for the Product,
authorizing manufacturing, marketing and sale of the Product within the United
States and shall apply as well to final regulatory approval elsewhere in the
Territory by other regulatory agencies having jurisdiction in their respective
areas.
(d) Territory means the World.
(e) Gross Sales means the gross sales price for Product sold by CLL
Pharma, Flemington, the Joint Venture or any subsidiaries, affiliates and
sub-licensees, reduced by returns, allowances and rebates. Sales shall be deemed
to have occurred upon invoicing.
(f) IND means an Investigational New Drug Application to be filed with
FDA or comparable filings to be made with other regulatory entities elsewhere in
the Territory.
(g) Pilot Biostudy means a study of approximately eight (8) human
volunteers, to be carried out by Flemington, in accordance with a protocol to be
agreed upon by Flemington and CLL Pharma, for the purpose of making a
preliminary evaluation of the pharmacokinetic profile of the Product.
(h) Trials means studies in human volunteers of the Product for use in
supporting an NDA seeking FDA Approval for the Product.
(i) Joint Venture means a corporation, presently to be equally owned
and controlled by CLL Pharma and Flemington, for the purpose of developing and
marketing the Product.
2. Pilot Biostudy.
Promptly following execution of this Agreement, Flemington, in consultation
with, and with the assistance of, CLL Pharma, shall undertake to arrange for the
manufacture of a clinical dosage formulation, and an associated accelerated
stability study, to carry out, monitor and analyze the Pilot Biostudy, and
submit a Final Report to CLL Pharma setting forth the results thereof. A general
outline of the design of the Pilot Biostudy, and the division between Flemington
and CLL Pharma of tasks and responsibilities in connection with it is set forth
in a letter of Flemington to
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CLL Pharma dated contemporaneously with this Agreement, a copy of which is
annexed to this Agreement as an Exhibit.
3. Grant.
(a) Flemington presently owns one hundred percent of the shares of a
legally existing, but inactive, New Jersey corporation named Enteralpharma.
Within sixty days of the execution of this Agreement, Flemington shall cause
such corporation to be reactivated, its name shall be changed to one mutually
agreed upon by Flemington and CLL Pharma and shares of stock shall be issued to
Flemington and CLL Pharma in such numbers that Flemington and CLL Pharma shall
each own fifty percent (50%) of the total issued and outstanding stock of the
corporation. This corporation shall constitute the Joint Venture. As part of
such organization of the Joint Venture, the parties shall agree upon the
identity of the corporation's officers and directors, its by-laws and other
organic organizational documents, including a "Buy-Sell" agreement. Any future
sale to any third party of an equity interest in the Joint Venture may only be
done with the agreement of Flemington and CLL Pharma.
(b) During the Term of this Agreement, subject to the terms and
conditions set forth herein, the Joint Venture shall have the exclusive right to
manufacture, sell and distribute the Product within the Territory, including the
right to grant sub-licenses; provided, however, that the grant by the Joint
Venture of a sub-license may not be done without the parties' mutual consent,
which shall not be withheld unreasonably.
(c) The IND and NDA shall be prepared and filed by the Joint Venture
and shall show it as the sole applicant. The Trials to be performed pursuant to
the IND, for the purpose of supporting the NDA shall be carried out by the Joint
Venture (or its sub-licensee), at its sole expense. The anticipated costs for
the studies and related work will be set forth in an Addendum to be agreed upon
by the parties and attached to this Agreement; such costs will represent only an
estimate, and detailed budgets shall be agreed upon by the parties before
beginning each discrete
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part of the project. It is the parties' intent that the approved NDA, or the
equivalent regulatory approval in other jurisdictions in the Territory, shall
continue throughout the Term of the Agreement to be in the sole name of the
Joint Venture, its subsidiary, affiliate or sub-licensee.
(d) To the extent the manufacture of the Product by the Joint Venture
pursuant hereto requires it to use or employ any inventions, secret formula(e),
secret process(es) or other confidential or secret information of Flemington or
CLL Pharma, whether or not patented, Flemington and CLL Pharma each hereby
agrees to grant the Joint Venture the right and license to do so, but solely for
the purposes, and during the Term, of this Agreement, and each also agrees to
execute any and all documents reasonably necessary to carry such grant into full
effect. If a sub-licensee of the Joint Venture should, in the future, desire to
manufacture the Product and to use or employ any inventions, secret formula(e),
secret process(es) or other confidential or secret information of Flemington or
CLL Pharma, whether or not patented, Flemington and CLL Pharma each hereby
agrees to grant the sub-licensee the right and license to do so, upon agreement
to mutually satisfactory terms and conditions, including payment to the party
granting the license of a reasonable royalty (including minimum annual
royalties) on Gross Sales.
4. Term.
(a) If the results of the Pilot Biostudy to be carried out by
Flemington and CLL Pharma pursuant to Paragraph 2, above, demonstrate to the
parties' mutual satisfaction a formulation advantage over existing formulations
sufficient to warrant further development, the parties shall undertake to
arrange funding for such further development. Such funding arrangement may
include the sale to one or more other parties of common stock or other corporate
securities of the Joint Venture. Failure to arrange such funding within 180 days
of presentation of the Final Report by Flemington to CLL Pharma shall cause this
Agreement to terminate. Time is of the essence. Following such termination,
neither party shall have any further obligation to or rights against the other,
with the exception of any rights or obligations which may have vested before
such termina-
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tion, including each party's continuing obligation of confidentiality regarding
the other's confidential information.
(b) If, within said 180 days following the date of delivery by
Flemington to CLL Pharma of the Final Report of the results of the Biostudy, the
funding contemplated by the foregoing subparagraph shall have been arranged, all
of the provisions of this Agreement shall come into force.
5. Payments.
Flemington and CLL Pharma shall share equally any and all costs, as
reflected in budgets agreed upon from time to time, for all development
activities of the Joint Venture. Each party's overhead shall be included as a
cost item as the work progresses. Any distributions from the Joint Venture shall
be made to Flemington and CLL Pharma on an equal basis.
6. Trademarks.
Any trademarks used with the sale of the Product shall be and remain the
sole and exclusive property of the Joint Venture.
7. Termination.
This Agreement, and the rights and obligations of the parties under it
(except those which may have vested before termination), may be terminated:
(a) Without action by either party, if the parties are unable to
arrange necessary funding pursuant to paragraph 4, above, or FDA, in a final
agency action, denies approval of the NDA, and the Joint Venture decides not to
appeal that denial.
(b) By both parties if the results of the Pilot Biostudy or Clinical
Studies are deemed to be unsatisfactory and the project is to be abandoned.
(c) By written Notice of one party to the other, if the party to which
the Notice is directed is in material breach of its obligations under this
Agreement, in which case termination
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shall become effective sixty (60) days after the date of giving Notice, unless
the breach has been cured within that period.
If this Agreement was terminated for any reason other than the default of
Flemington, CLL Pharma shall, upon the request of Flemington, transfer all of
CLL Pharma's interest in the Joint Venture to Flemington, and execute any
documents necessary in Flemington's opinion to effect such transfer, at no cost
to Flemington. If this Agreement was terminated by CLL Pharma pursuant to
sub-paragraph (c), above, because of a default by Flemington, Flemington shall
upon the request of CLL Pharma, transfer all of Flemington's interest in the
Joint Venture to CLL Pharma, and execute any documents necessary in CLL Pharma's
opinion to effect such transfer, at no cost to CLL Pharma, except for CLL
Pharma's obligation to refund to Flemington all of Flemington's documented and
unrecaptured investment in the Joint Venture.
8. Confidentiality.
Any and all information, data or know-how received by one party from the
other shall be maintained in confidence by the party which receives it. Upon
expiration or earlier termination of this Agreement all such information
(together with any and all writings or copies which may contain it) shall be
returned to the disclosing party upon request. Failure to request return of any
such information shall not be construed as in any way releasing the obligation
of the recipient to maintain its confidentiality. The obligation set forth
herein shall not apply to information which: (a) the recipient can show by clear
and convincing evidence was already known to it before disclosure; (b) is or
comes into the public domain through no act or omission of the recipient; (c)
becomes known or available through a third party not under any obligation of
confidentiality to the recipient; or, (d) is required to be disclosed pursuant
to judicial process or order, or the disclosure of which is necessary for
Federal or State regulatory approval or compliance.
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9. No Agency.
Except as may otherwise be expressly authorized in writing, neither party
shall have, or hold itself out as having, any power or authority to bind the
other.
10. Assignment.
This Agreement may not be assigned by either party, except to a parent,
subsidiary or affiliate of it or to an entity acquiring all or substantially all
of the assignor's assets, without the consent of the other party, which consent
shall not be withheld unreasonably.
11. Notices.
Any formal notice or communication from one party to the other pursuant to
this Agreement (which is not intended by the parties to include ordinary
day-to-day business communications) shall be given to the receiver in writing
via fax, with confirming copies via both ordinary and certified mail.
12. Force Xxxxxx.
The performance by either party of any obligation under this Agreement,
other than an obligation to pay money, shall be excused for any reason
customarily regarded as constituting force xxxxxx.
13. Amendments.
This Agreement may only be amended, modified or supplemented by a writing
specifically identifying itself as such, which writing must be executed with the
same formality as this Agreement. Any party or person asserting that this
requirement of a writing for such a purpose was
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waived orally shall have the burden of proving the fact of such a waiver by
clear and convincing evidence.
14. Indemnification.
Each party agrees to indemnify the other and hold it harmless from any
claim, action, suit, proceeding, loss, liability, damage or expense (including,
without limitation, reasonable attorney's fees and expenses) arising out of a
claim by a third party based upon an act or omission of the indemnifying party.
15. Arbitration.
Any dispute between the parties shall be resolved by arbitration pursuant
to the rules and under the auspices of the American Arbitration Society. The
place of arbitration shall be in the Borough of Manhattan, New York City, New
York, unless otherwise mutually agreed.
16. Controlling Law.
This Agreement is be controlled by and interpreted in accordance with the
law of the State of New Jersey.
17. Benefit.
This Agreement shall bind and enure to be benefit of the parties and their
successors and permitted assigns.
18. Entire Agreement.
This Agreement is intended by the parties to be an integrated document and
to express their entire agreement regarding its subject matter. Any other,
earlier or inconsistent statements or expressions, written or oral, as to the
subject matter are expressly superseded.
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19. Counterparts.
This Agreement is to be executed in multiple counterparts. Any one of such
counterparts bearing original signatures of both parties, or any two which taken
together bear the original signatures of both parties, shall be deemed to be an
original of this document.
20. Headings.
Paragraph headings are for convenience only, and are not a part of this
Agreement.
In Witness Whereof, the undersigned authorized representatives of the
parties have signed this Agreement effective the date set forth above.
Flemington Pharmaceutical Corp. CLL Pharma
By: /s/ XXXXX X. XXXXXX By: /s/ XXXXXX LATNELLI
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Xxxxx X. Xxxxxx, President Xxxxxx Latnelli, President
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