AGREEMENT
Effective Date: December 29, 1997
Between: Xxxx Resources Inc., having offices at 0000 Xxxxxxxx Xxxx,
Xxxxxxxx Xxxx, XX 00000 (Xxxx Resources);
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 ganaxolone as its active
ingredient; and,
Whereas, Xxxx Resources is a Delaware corporation engaged in the development of
businesses, and Xxxx Resources desires to enter into a Joint Venture to develop,
manufacture and market Flemington's ganaxolone lingual spray formulation in the
Territory described below; and,
Whereas, Flemington desires to enter into such a Joint Venture with Xxxx
Resources;
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 ganaxolone as its
active ingredient, for treatment of or the prevention of migraine.
b. Joint Venture means a corporation to be formed to develop and market
the product wherein Flemington and Xxxx Resources are equal owners.
c. NDA means a New Drug Application for the Product in the USA or other
file suitable for registration in the intended country targeted for
registration to be prepared jointly by Flemington and by Xxxx Resources,
and filed with the United States Food and Drug Administration (FDA) or
other regulatory body as appropriate.
d. Regulatory approval means approval by the governing regulatory
authority in countries designated for registration of the file for the
Product, authorizing marketing and sale of the Product within the Territory
by the Joint Venture or their subsidiaries, affiliates or sub-licensees.
e. Territory means the world.
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x. Xxxxx sales means the gross sales price for Product sold by
Flemington, Xxxx Resources, the Joint Venture or their subsidiaries,
affiliates or sub-licensees. Sales shall be deemed to have occurred upon
invoicing.
g. IND means an Investigational New Drug Application to be filed with FDA
or other file required for carrying out clinical studies in the country of
interest.
h. 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 Xxxx Resources, for the purpose of
preliminarily evaluating the pharmacokinetic profile of the Product.
i. Trials means studies in human volunteers of the Product for use in
supporting an NDA seeking regulatory approval for the Product.
2. Pilot Biostudy.
Promptly following execution of this Agreement, Flemington, in consultation
with and with the assistance of Xxxx Resources, shall undertake to arrange
for the manufacture of a clinical dosage formulation, accelerated stability
study on same and to carry out, monitor and analyze the Biostudy, and
prepare a Final Report setting forth the results thereof. A general outline
of the design of the Biostudy, and the tasks and responsibilities in
connection with it is annexed to this Agreement as Exhibit A. The parties
agree that they will share between them the cost of carrying out the
biostudy including all ancillary costs. A party incurring shall be
reimbursed by the other within 10 days of the presentation of an
appropriately documented invoice.
3. Grant.
a. During the Term of this Agreement, subject to the terms and conditions
set forth herein, the Joint Venture shall have the right to 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 both parties consent, which shall not
be withheld unreasonably by either party.
b. The IND and NDA shall be prepared and filed by the Joint Venture or
sub-licensee. The trials and other studies such as stability studies to be
performed pursuant to the IND, for the purpose of supporting the NDA shall
be carried out by the Joint Venture or sub-licensee.
The anticipated costs for the studies and other work required for
registration will be jointly set forth in Exhibit B. The costs are at best
an estimate and detailed budgets for each phase of the work will be
presented prior to starting that phase for approval. These detailed budgets
presented and approved by the Joint Venture will be binding on both
parties.
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To the extent the Joint Venture desires, either itself or through a
subsidiary, affiliate or sub-licensee, to seek any necessary regulatory
approval for the manufacture, marketing and sale of Product in the
Territory, it shall be the responsibility of the Joint Venture, its
subsidiaries, affiliates or sub-licensees to do so. 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 or sub-licensee.
c. To the extent the marketing of the Product by the Joint Venture or
sub-licensee pursuant hereto requires the Joint Venture or sub-licensee to
use or employ any inventions, secret formula(e), secret process(es) or
other confidential or secret information of Flemington or Xxxx Resources,
whether or not patented, Flemington and Xxxx Resources hereby grant the
Joint Venture or sub-licensee the right and license to do so, but solely
for the purposes, and during the Term, of this Agreement,
d. The Joint Venture or sub-licensee shall acquire all of its
requirements for the Product from a manufacturing operation to be
established by the Joint Venture.
e. Nothing in this agreement shall be construed to grant to the Joint
Venture or sub-licensee any right or license to manufacture the Product
under any inventions, secret formula(e), secret process(es) or other secret
or confidential information owned or controlled by Flemington and/or Xxxx
Resources or its contract manufacturers. The Joint Venture agrees, however,
that if a sub-licensee should, in the future, wish to manufacture the
Product, the Joint Venture will transfer any necessary technology to the
sub-licensee and grant the sub-licensee a license to manufacture the
Product, upon mutually satisfactory terms and conditions, including the
applicable royalty rate and minimum annual royalties, to be agreed upon by
the parties at that time.
4. Term.
a. If the results of the Biostudy to be carried out by Flemington and
Xxxx Resources, pursuant to Paragraph 2 above, demonstrate a formulation
advantage over existing formulations sufficient to warrant development,
Flemington and Xxxx Resources shall undertake to arrange funding for the
further development of this project. Failure of Flemington and Xxxx
Resources to do so within one hundred and eighty (180) days after the
presentation by Flemington to Xxxx Resources of the biostudy report shall
cause this Agreement to terminate. Time is of the essence hereof. 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 termination, including each party's
continuing obligation of confidentiality regarding the other's confidential
information. Upon such termination, all information developed in the
performance of the Biostudy shall be the sole and exclusive property of
Flemington.
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b. If, within said one hundred and eighty (180) days following the date
of delivery by Flemington to Xxxx Resources of the Final Report of the
results of the Biostudy, funding for the project has been arranged by
Flemington and Xxxx Resources all of the provisions of this Agreement shall
come into force and the parties shall cause the Joint Venture to be created
and organized. The Term of this Agreement thereafter shall continue for
fifteen (15) years from the date of this agreement, and Xxxx Resources
shall have the right to renew the Term for one or more successive five (5)
year extensions by the giving to Flemington Notice to that effect at least
one (1) year before the expiration of the initial Term or any subsequent
extension thereof. If Xxxx Resources fails to give Flemington Notice
provided for herein, this Agreement shall terminate and neither party shall
have any further rights against or duties to the other, except for any
rights or obligations which may have vested before or upon such
termination, including each party's continuing obligation of
confidentiality regarding the other's confidential information. The time
limitations for the giving of Notice by Xxxx Resources to Flemington
hereunder are of the essence.
5. Payments.
If this Agreement comes into full effect, Flemington and Xxxx Resources
will share all revenues from the project including but not limited to
lump-sum milestone payments, moneys in excess of cost for each phase of
development, profit from sale of product, royalty payments, etc. on an
equal basis (50/50).
6. Trademarks.
The parties agree that any trademarks used on the Product are the exclusive
property of the Joint Venture or sub-licensee and no other party shall have
any rights thereto.
7. Termination.
This Agreement, and the rights and obligations of the parties under it
(other than those which may have vested before termination), may be
terminated:
a. 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 shall become effective sixty (60) days
after the date of giving Notice, unless the breach has been cured within
that period.
b. If this Agreement was terminated by Flemington pursuant to
sub-paragraphs 4a, above, Xxxx Resources shall, upon the request of
Flemington, transfer all registration files to Flemington, and execute any
documents necessary to effect such transfer with the applicable regulatory
authority, at no cost to Flemington.
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c. If this Agreement is terminated pursuant to subparagraph a, above,
after the formation of the Joint Venture the party terminating the
agreement shall have the right to purchase the interest of the defaulting
party at its liquidation value.
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.
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.
Neither this Agreement nor a party's interest in the Join Venture may be
assigned by Flemington or Xxxx Resources, except to a parent, subsidiary or
affiliate of Flemington or Xxxx Resources or to an entity acquiring all or
substantially all of Flemington or Xxxx Resource'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 sent by the giver to the
receiver in writing via fax, with confirming copies via both ordinary and
certified mail.
12. Force Majeure.
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 majeure.
13. Amendments.
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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 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 including any dispute as to valuation under
Section 7c above, 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 will be controlled by and interpreted in accordance with the
law of the State of New Jersey.
17. Benefit.
This Agreement shall bind and inure 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, earlier or
inconsistent statements or expressions, written or oral, as to the subject
matter are expressly superseded.
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19. 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. Xxxx Resources Inc.
By: /s/ XXXXX X. XXXXXX By: /s/ XXXXXX XXXXX
------------------------------ ------------------------------
Xxxxx X. Xxxxxx Xxxxxx Xxxxx
Title: President & CEO Title: President
Date: December 23, 1997 Date: December 29, 1997
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Amendment Number 1
Effective Date: February 9, 1998
Between: Xxxx Resources, Inc., 0000 Xxxxxxxx Xxxx, Xxxxxxxx Xxxx,
Xxxxxxxx 6035 (Xxxx);
And: Flemington Pharmaceutical Corp., 00 Xxxxx Xxxxxx, Xxxxxxxxxx,
Xxx Xxxxxx 00000 (Flemington).
Whereas, the parties are parties to an Agreement dated December 29, 1997, (the
Agreement) the subject of which is the development of a product having
ganaxolone as its active ingredient formation and the possible formation of a
joint venture for that purpose; and,
Whereas, the parties wish to explore possible development of additional products
within the structure created by the Agreement, and to amend the Agreement
accordingly,
Now, Therefore, in consideration of the foregoing and of the mutual undertakings
contained herein, the parties agree as follows:
1. Pursuant to Paragraph 13 of the Agreement, the parties agree that the
within Amendment Number 1 (the Amendment) is hereby incorporated into and made a
part of the Agreement. All of the terms and conditions contained in the
Agreement shall apply to the subject matter of this Amendment as if set forth in
full herein.
2. Annexed to this Amendment as an Exhibit (the Candidate List) is a list of
pharmaceutical compounds which the parties have an interest in considering for
development. It is the parties' expectation that, from time to time, they
mutually shall agree upon candidates from such list to investigate for further
development through the conduct of a Pilot Biostudy. The selection of each such
candidate, from time to time, shall be evidenced by a writing signed by both
parties. Upon such selection, as to each candidate, all of the terms and
conditions set forth in the Agreement shall come into effect for each such
candidate.
(a) As to each such candidate, if the parties elect to pursue development
beyond the Pilot Biostudy stage, the parties shall as part of that
decision determine whether the further development and marketing of
the candidate shall be accomplished through a then-existing Joint
Venture entity of the parties or through a new Joint Venture entity to
be created.
3. So long as the Agreement remains in effect, the parties agree that each of
them shall only engage in any development activity as to any pharmaceutical
compound on the Candidate List through the mechanism, and subject to the terms
of, the Agreement, unless they mutually agree, in writing, hereafter to remove a
given compound from the Candidate List.
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4. Except as modified herein, all of the terms and conditions contained in the
Agreement shall continue in effect.
In Witness Whereof, this Amendment Number 1 has been signed by the duly
authorized representatives of the parties, effective the date set forth above.
Xxxx Resources, Inc. Flemington Pharmaceutical Corp.
By: /s/ XXXXXX XXXXX By: /s/ XXXXX X. XXXXXX
------------------------------ ------------------------------
Xxxxxx Xxxxx Xxxxx X. Xxxxxx
President President & CEO
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EXHIBIT TO
AMENDMENT
NUMBER 1
Candidate List
--------------
17-Beta Estradiol
(Generic Estrogen)
Seratonin uptake
inhibitors:
Prozac, Paxil, Zoloft
Vasomax
Viagra
Yohimbine
Cilostazol
L-Arginine
L-Tryptophan
Various Herbal
Products:
Ginsing
Ginko
St. John's Wort
Genestine
(Phytoestrogen)
DHEA
Melatonin
Neuropeptide Y
Cognex
Aricept
Glyburide
Flexeril
Compazine
Amendment Number 2
Effective Date: November 29, 1999
Between: Xxxx Pharma, LLC, assignee of Xxxx Resources, Inc., 0000
Xxxxxxxx Xxxx, Xxxxxxxx Xxxx, Xxxxxxxx 6035 (Xxxx);
And: Flemington Pharmaceutical Corp., 00 Xxxxx Xxxxxx, Xxxxxxxxxx,
Xxx Xxxxxx 00000 (Flemington).
Whereas, the parties are parties to an Agreement dated December 29, 1997, (the
Agreement) the subject of which is the development of a product having
ganaxolone as its active ingredient formation and the possible formation of a
joint venture for that purpose; and,
Whereas, on February 9, 1998 the parties executed Amendment Number 1 to the
Agreement, which amendment, inter alia, added a number of additional compounds
to the definition of Product in the Agreement, one of which additional compounds
was Estradiol; and
Whereas, the parties wish to modify the time periods in the Agreement as they
relate to Estradiol, and,
Whereas, Xxxx wishes to memorialize Flemington's consent to an assignment of
Xxxx'x interest in the Agreement to an affiliated company,
Now, Therefore, in consideration of the foregoing and of the mutual undertakings
contained herein, the parties agree as follows:
1. Pursuant to Paragraph 13 of the Agreement, the parties agree that the
within Amendment Number 2 (the Amendment) is hereby incorporated into and made a
part of the Agreement. All of the terms and conditions contained in the
Agreement shall apply to the subject matter of this Amendment as if set forth in
full herein.
2. With respect to the Estradiol compound on which the parties have been
working, the 180-day period provided for in paragraphs 4(a) and 4(b) are hereby
revised to be one year.
3. The assignment by Xxxx Resources, Inc. of all of its rights, interest and
obligations under the Agreement to its affiliated entity, Xxxx Pharma, LLC, is
hereby consented to and approved by Flemington.
4. Except as modified herein, all of the terms and conditions contained in the
Agreement and Amendment Number 1 to the Agreement shall continue in effect.
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In Witness Whereof, this Amendment Number 2 has been signed by the duly
authorized representatives of the parties, effective the date set forth above.
Xxxx Pharma, LLC Flemington Pharmaceutical Corp.
By: By:
------------------------------ -------------------------------
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Amendment Number 3
Effective date: May 5, 2000
Between: Xxxx Pharma, LLC 0000 Xxxxxxxx Xxxx,
Xxxxxxxx Xxxx, Xxxxxxxx 6035 (Xxxx)
And: Flemington Pharmaceutical Corp., 00 Xxxxx Xxxxxx
Xxxxxxxxxx XX 00000
Whereas on February 9, 1998 the parties executed Amendment Number 1 to the
agreement of December 29, 1997 adding estradiol to the list of products to be
jointly developed and
Whereas the parties wish to modify the time periods in the agreement as they
relate to estradiol, now therefore in consideration of the forgoing and of the
mutual undertakings herein the parties agree as follows:
With respect to the estradiol compound on which the parties have been working
the 180 day period provided for in paragraphs 4(a) and 4(b) are hereby revised
to be 18 months.
Except as modified herein, all of the terms and conditions contained in the
Agreement and Amendments Numbers 1 and 2 to the agreement shall continue in
effect.
In witness whereof, this Amendment Number 3 has been signed by the duly
authorized representative of the parties effect the date set forth above.
Xxxx Pharma LLC Flemington Pharmaceutical Corp.
By: By: /s/ XXXXX X. XXXXXX
------------------------------ ------------------------------
Xxxxx X. Xxxxxx
