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EXHIBIT 10.55
MASOPRACOL LICENSE AGREEMENT
Masopracol License Agreement (hereinafter "Agreement"), effective March 19, 1997
("Effective Date") is by and between Access Pharmaceuticals, Inc a Delaware
corporation having its principal place of business at 0000 Xxxxx Xxxxxxxx
Xxxxxxx, Xxxxx 000, Xxxxxx, XX 00000-0000 (hereinafter "Access") and Shaman
Pharmaceuticals, Inc. a Delaware Corporation having its principal place of
business at 000 Xxxx Xxxxx Xxxxxx, Xxxxx Xxx Xxxxxxxxx, XX 00000-0000
(hereinafter "Shaman").
PREAMBLE
WHEREAS Access has rights to certain pre-clinical data, the rights to reference
the ActinexTM New Drug Application ("NDA") on file at the US Food and Drug
Administration ("FDA") and Patents for the synthesis of Masopracol;
WHEREAS Shaman wishes to utilize the pre-clinical data and reference the NDA on
file at the FDA and to obtain exclusive rights for the use of Masopracol and
synthetic analogues in diabetes and related disease, including hyperlipidemia,
("The Field") and Access is willing to grant such rights;
NOW, THEREFORE, in consideration of the foregoing premises and of the mutual
covenants of the parties hereinafter contained, the parties hereto agree as
follows:
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ARTICLE 1. DEFINITIONS.
1.01 The term "Affiliate" shall mean:
a) any corporation, firm, partnership or other entity which directly or
indirectly owns, is owned by or is under common ownership with a party, to the
extent of at least fifty percent (50%) of the equity (or such lesser percentage
which is the maximum allowed to be owned of a foreign corporation in a
particular jurisdiction) having the power to vote on or direct the affairs of
the entity, and
b) any person, firm, partnership, corporation or other entity actually
controlled by, controlling or under common control with a party.
1.02 The term "Products" shall mean:
any product developed in The Field pursuant to the terms of an
Agreement which will be negotiated between the Parties within 60 days of the
Effective Date incorporating the terms of the memorandum of understanding dated
November 21, 1996 with the initialed changes by Xxxxx X. Xxxx, attached hereto
as Schedule A.
1.03 The term "Licensed Territory shall mean:
Worldwide
1.04 The term "Requested Data" shall mean:
The pre-clinical data listed on Schedule B attached hereto.
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ARTICLE 2. GRANT OF LICENSE.
2.01 Grant of License:
a) Subject to the terms and conditions of this agreement, Access hereby
grants to Shaman an exclusive license, with the right to sublicense, to
utilize the Masopracol pre-clinical data and to reference the
Actinex(TM) NDA on file with the FDA in its regulatory filings, solely
for the purpose of developing therapeutic or diagnostic products in The
Field.
b) Sub-licensing Rights: Shaman is granted rights to provide the Requested
Data to sub-licensees with Access approval, which shall not be
unreasonably withheld.
ARTICLE 3. TERM OF THE AGREEMENT
3.01 This Agreement shall commence upon the Effective Date and shall expire
December 31, 2006.
ARTICLE 4. OBLIGATION OF ACCESS
4.01 Upon effectiveness of this agreement Access will promptly provide Shaman
with all the requested pre-clinical data listed on Schedule B attached hereto.
4.02 Access or its licensee will provide a letter to the FDA permitting Shaman
to reference the ActinexTM NDA, and take any additional steps necessary so that
Shaman is allowed to reference the Actinex(TM) NDA.
4.03 Access or its licensee will provide a letter assuring Shaman the right to
purchase Masopracol from Western Engineering and Research Company.
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ARTICLE 5. EXCHANGE OF INFORMATION AND CONFIDENTIALITY.
5.01 Exchange of Information
Access shall promptly disclose to Shaman all pre-clinical data
requested by Shaman that is in Access' possession and any other information
related to the synthesis of Masopracol and its analogues which is requested by
Shaman. Shaman and any development partners or sub- licensee will limit
disclosure of all exchanged information to only those of its officers, employees
and consultants who are bound by appropriate obligations to maintain the
confidentiality of such data and information.
5.02 Confidentiality
Except where specifically requested in writing by Shaman and approved
by Access, Shaman agrees to keep in strict confidence and not to disclose to any
person other than those described in Section 5.01 above without the prior
written consent of Access any data and information obtained from Access under
this Agreement, provided, however, that the provisions of this section shall not
apply to the data and information which;
a) becomes known to Shaman through a third party who has the right to disclose
the data and information to Shaman, or
b) is or becomes known to the public other than as a result of any disclosure or
other act by Shaman, or
c) are required to be furnish to regulatory authorities. The obligation of
Shaman under this Section shall survive termination of this Agreement for a
period of five (5) years.
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ARTICLE 6. REPRESENTATIONS AND WARRANTIES.
6.01 Due Authorities.
ACCESS and Shaman each represent to the other that they have full power
and authority to enter into this Agreement and to carry out the transactions
contemplated hereby.
ARTICLE 7. EXCHANGE OF DATA
7.01 Promptly after the execution of this Agreement and from time to time
thereafter during the term of this Agreement, Access shall disclose to Shaman
all relevant additional data possessed by Access generated on Masopracol or its
analogues which is necessary or helpful for Shaman or its sublicensees:
a) to obtain the NDA approvals or other governmental approvals to
market the Products in the Licensed Territory,
b) to manufacture Products in The Field, and
c) to generally fulfill the purpose of this Agreement.
7.02 During the term of this Agreement, Shaman may use any data disclosed by
Access to Shaman hereunder for the purpose of developing products for use in the
field without any additional payment.
ARTICLE 8. TRADEMARKS AND TRADE NAMES.
8.01 Trademarks.
Shaman and its sublicensees shall choose and own all trademarks and trade names
which are specific to the individual Products in the Territory.
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8.02 Application and Maintenance.
Product specific trademarks will be applied for and maintained by Shaman in the
Territory and all the cost associated therewith shall be borne by Shaman.
ARTICLE 9. TERMINATION
9.01 Term
This Agreement shall be in effect for the period of duration set forth
in Section 3.01 hereof.
9.02 Termination.
a) Either party may terminate this Agreement by giving written notice of
termination to the other party at any time during the term of this Agreement;
i) in the event that the other comments any material breach of
its obligations hereunder and fails to remedy such breach
within ninety (90) days after receipt of written notice
requesting the correction of the breach; or
ii) upon the filing or institution of bankruptcy, reorganization
or receivership proceedings by the other party or upon the
failure by the other party for more than ninety (90) days to
take steps to oppose the initiation of such actions against
it.
b) Exercise by either party hereto of a termination right provided for under
this Agreement shall not give rise to the payment of damages or any other form
of compensation or relief to the other party with respect hereto.
c) Subject to Section 9.02(b), termination of this Agreement shall not preclude
either party from claiming any other damages, compensation or relief that it may
be entitled to under this Agreement or by law or in equity upon such
termination.
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9.03 Effects of Termination.
If this Agreement is terminated as set forth in Section 9.02, Shaman
will:
a) Renounce all rights to utilize the Requested Data, reference the
ActinexTM NDA and utilize the Patents provided by and under this
Agreement.
b) Shaman will return all Confidential Information to Access.
ARTICLE 10. ARBITRATION.
10.01 Agreement to Arbitrate.
The Parties will endeavor to settle amicably any dispute which may
arise out of this Agreement. Failing of such settlement, any dispute shall be
finally settled by arbitration, in accordance with the rules then in effect of
the American Arbitration Association. The arbitration will be held in Denver,
Colorado. The dispute or difference shall be referred to a single arbitrator, if
the Parties agree upon one, or otherwise three (3) arbitrators, one to be
appointed by each party and the third to be appointed by the first two (2)
arbitrators selected by the Parties. If a Party shall refuse or neglect to
appoint an arbitrator within thirty (30) days after the other Party shall have
served a written notice of such other Party's choice and requesting that the
first-mentioned Party make its choice, then the arbitrator first appointed
shall, at the request of the Party appointing him, proceed to hear and determine
the matters in difference as if he were a single arbitrator appointed by both
parties.
10.02 Arbitration Decision.
The arbitrators shall base their decision in accordance with and based
upon all the provisions of this Agreement and any other agreements referenced
herein, to the extent such other agreements are not superseded by this Agreement
or subsequent agreements between the Parties. In making their decision, the
arbitrators shall apply the substantive law of the State of
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Delaware and the United States of America, excluding the United Nations
Convention on the international Sale of Goods. The decision of a majority of the
arbitrators shall be final and binding upon each Party, and judgment upon the
award may be entered in any court of competent jurisdiction.
10.03 Pre-Decision Settlement.
Before rendering their final decision, the arbitrators will first act
as friendly, disinterested parties for the purpose of helping the Parties
attempt to reach a compromise settlement on the points in dispute.
10.04 Payment of Costs.
The cost of arbitration will be in the discretion of the arbitrators.
Each Party shall pay its own costs associated with the arbitrators, plus
one-half of the costs of the arbitration itself (including but not limited to
arbitrators fees).
10.05 Injunctive Relief
Each of the parties hereto acknowledges and agrees that damages will
not be an adequate remedy for any material breach or violation of this Agreement
if such material breach or violation would cause immediate and irreparable harm
(an "Irreparable Breach"). Accordingly, in the event of a threatened or ongoing
Irreparable Breach, each Party hereto shall be entitled to seek, in any state or
federal court in the State of Delaware, equitable relief of a kind appropriate
in light of the nature of the ongoing threatened Irreparable Breach, which
relief may include, without limitation, specific performance or injunctive
relief, provided however, that if the Party bringing such action is unsuccessful
in obtaining the relief sought, the moving Party shall pay the non-moving
Party's reasonable costs, including attorney's fees, incurred in connection with
the defending such action. Such remedies shall not be the Parties' exclusive
remedies, but shall be in addition to all other remedies provided in this
agreement.
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ARTICLE 11. PAYMENTS
11.01 Payments
Access will receive the following payments:
i) $137,500 upon signing of this Agreement
ii) $25,000 on July 1, 1997
iii) $25,000 on October 1, 1997
iv) $87,500 on submission of an investigational new drug
application ("IND") for a therapeutic use of Masopracol
or a synthetic analogue in The Field with the FDA.
11.02 Development
Shaman will undertake at its own cost, the performance of all
formulation/clinical development work, regulatory actions and filings necessary
for government approval of the Products in the Territory.
ARTICLE 12. PUBLIC ANNOUNCEMENTS
12.01 Press Releases
Neither Party shall issue any press release in whatever form, or
make public, in whatever form, information regarding the Agreement without prior
written approval of the other party, except as required by applicable law and
regulations.
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ARTICLE 13. WARRANTIES, LIMITATIONS & INDEMNIFICATION
13.01 Access Limitation
Except as expressly set forth in this Agreement, Access makes no
representations or warranties of any kind, either express or implied, including
without limitation, warranties of merchantability or fitness for a particular
purpose or with respect to (1) the scope of validity of any of the patent
rights; (2) whether the patent rights or technology may be exploited by licensee
or any sublicensee without infringing the rights (including patent rights) of
others; or (3) the results to be obtained by use of the patent rights, the
technology, or the licensed processes. The Patent rights and Requested Data are
delivered "As Is" in every respect.
13.02 Indemnification
Shaman shall at all times during the term of this Agreement and
thereafter, defend and hold Access, its officers, directors, employees, agents
and affiliates (together, Indemnities) harmless from and against all claims,
suits, demands, liability and expenses, including legal expenses and reasonable
attorneys' fees, arising out of (a) the death of or injury to any person or
persons, (b) damage to property, or (c) any other claim, proceeding, demand,
expense and liability of any kind whatsoever resulting from (i) the design,
production, manufacture, shipping, handling, use (in commerce or otherwise),
sale, lease, consumption, promotion or advertisement of the Products, services
or process relating to or developed by Shaman or a sub-licensee under this
Agreement (ii) any obligation or activity of Shaman under this Agreement or of
any sublicensee under any sublicense. Shaman's obligation under this 13.2 shall
apply without regard to whether any liability is attributable to Shaman's or
sublicensee's negligence.
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ARTICLE 14. MISCELLANEOUS
14.01 Governing Law.
This Agreement shall be construed and enforced in accordance with
the laws of the State of Delaware, United States of America.
14.02 Severability.
In the event any portion of this Agreement shall be held illegal,
void or ineffective, or in conflict with any applicable statute or rule of law,
such portion shall be deemed modified to the extent necessary to avoid such
result and the remaining portions shall remain in full force and effect. If
compliance with the foregoing sentence results in a material alteration of this
Agreement, the Parties agree to renegotiate in good faith the terms and
conditions of the altered portion in order to approximate as nearly as possible
the intent of the Parties with respect to any relevant portion
14.03 Waiver
The failure of Access and Shaman at any time to exercise or enforce
any right granted in this Agreement or obligation arising hereunder shall not be
deemed to be a waiver of such right or obligation or operate to bar the exercise
or enforcement thereof at any time thereafter.
14.04 Force Majeure
If either Party shall be delayed, hindered, interrupted in or
prevented from the performance of any obligation hereunder by reason of force
majeure (hereinafter referred to as "Force Majeure"), including earthquake,
flood or other act of God, fire, war (declared or undeclared), public disaster,
riots, strike or labor differences, governmental enactment, rule or regulation
or any other cause beyond such Party's reasonable control, such Party shall not
be liable to the other therefor; and the time for performance of such obligation
shall be extended for a period equal to the duration of the contingency which
occasioned the delay, interruption or prevention. The Party invoking such Force
Majeure rights under this Section must notify the other Party by registered
letter within a period of fifteen (15) days,
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from the first and last day of the Force Majeure unless the Force Majeure
renders such notification impossible in which case notification will be made as
soon as possible. If the delay resulting from the Force Majeure exceeds six (6)
months, the parties commit to consult together in good faith to find an
appropriate solution.
14.05 Successors and Assigns.
This Agreement shall be binding upon and shall inure to the benefit
of, successors and assigns of each of the Parties, but neither this Agreement
nor any of the rights, interests or obligations hereunder may be assigned by
either of the Parties hereto without the prior written consent of the other
Party, which consent shall not be unreasonably withheld; provided that the
Agreement may be assigned in the event of a transfer to an Affiliate, or in
connection with a merger, consolidation, or sale of substantially all of the
assets of the transferring Party. Notwithstanding anything to the contrary
herein, ACCESS may delegate to its Affiliates its duties and obligations
hereunder without the consent of Shaman.
14.06 Relationship of Parties
This Agreement shall not create an agency, partnership, joint
venture or employer/employee relationship between the Parties. Access and Shaman
each hereby agrees not to represent itself in any of such capabilities in any
manner whatsoever.
14.07 Captions.
The captions provided in this Agreement are for convenience of
reference only and shall not effect its interpretation.
14.08 The Agreement
This Agreement represents the entire agreement between the parties
relating to the subject matter hereof and supersedes all other writings and
discussions related to such subject matter.
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14.09 Notice
Any notice expressly provided for under this Agreement shall be in
writing, sent by registered or certified first class airmail, overnight express
mail or courier service, facsimile transmission or other similar electronic
means of written communication, addressed as set forth below:
If to Access: Access Pharmaceuticals, Inc
0000 Xxxxx Xxxxxxxx Xxxxxxx, Xxxxx 000
Xxxxxx, Xxxxx 00000
Attention: President and CEO
Copy to: Xxxxxxx, Xxxx and Xxxxx LLP
000 Xxxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx, 00000-0000
If to Shaman: Shaman Pharmaceuticals, Inc.
000 Xxxx Xxxxx Xxxxxx,
Xxxxx Xxx Xxxxxxxxx, XX 00000-0000
Attention: President and CEO
Copy to:
-----------------------------------
-----------------------------------
-----------------------------------
Facsimile transmission numbers for the Parties are as follows:
If to Access USA 000-000-0000
If to Shaman USA 000-000-0000
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ACCESS PHARMACEUTICALS, INC. SHAMAN PHARMACEUTICALS, INC.
by: /s/ XXXXX X. XXXX by: /s/ A.S. Xxxxxxxxx
----------------------- ---------------------------
Title: President & CEO Title: Sr. V.P. Development
----------------------- ---------------------------
Date: 03/19/97 Date: 03/24/97
----------------------- ---------------------------
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[SHAMAN PHARMACEUTICALS, INC. LETTERHEAD]
SCHEDULE A
November 21, 1996
Xxxxx Xxxx
President & CEO.
Access Pharmaceuticals, Inc.
0000 Xxxxxxxx Xxxxxxx, Xxxxx 000.
Xxxxxx, XX 00000-0000
Dear Xxxxx:
This is a follow-up to your facsimile dated November 14, 1996 and our phone
conversation this morning. Outline below is the memorandum of understanding
which will form the basis for a legal contract between Access Pharmaceutical,
Inc. and Shaman Pharmaceuticals, Inc. for right to reference Actinex(TM) NDA and
the right to purchase masoprocol from Western Engineering and Research
Corporation.
MEMORANDUM OF UNDERSTANDING
Access will Provide the Following:
1) Copies of the following studies and sections of the Actinex(TM) NDA and
NDS will be provided:
a) NDA Pharmacology summary*
b) NDS Pharmacology summary*
c) NDS CMC Section
d) T005-89 - Xxxx Test - CHX 100 - Summary & Report*
e) T003-87 - Acute Oral Rat Tox. - CHX 100 - Summary & Report*
f) T004-87 - Acute Oral Rabbit Tox. - CHX 100 - Summary & Report*
g) T004-89 - Target Organ Oral Rat Tox. - CHX 100 - Summary &
Report*
h) T004-89 - Oral Segment II - Rat - CHX 100 - Summary & Report*
i) T009-89 - Oral Rabbit Dose Finding Segment II - CHX 100 -
Summary & Report*
j) TOO1-90 - Oral Rabbit Segment II - CHX 100 - Summary & Report*
k) KOO1-84 - Rat Biodistribution, Oral, Intravenous and Dermal -
CHX 100 - Summary & Report*
* Denotes reports already received by Shaman Pharmaceuticals
2) If available, a copy of any oral mass balance studies on CHX 100
conducted by Chemex/Access
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3) Access will provide reports of Segment I & III reproductive safety
studies on CHX 100 in the first quarter of 1997.
4) Access or its licensee will provide letter to FDA to allow Shaman
Pharmaceuticals, inc. to reference the ActinexTM NDA
5) Access or its licensee will provide assurance of rights for Shaman to
purchase masoprocol from WEC (This may require a letter from
Xxxxxx-Xxxxx to WERC)
Shaman Will Provide the Following Compensation:
1) $25,000 upon signing of a definite agreement
2) $87,500 on January 2, 1997
3) $97,500 on submission of an IND to FDA
4) Shaman Pharmaceuticals, Inc. will pay Access Pharmaceuticals, Inc.
$75,000 in three equal installments of $25,000 each on April 1, 1997,
July 1, 1997 and October 1, 1997 for Segment I & III reproductive
safety studies,
In addition, Shaman will agree to license from Access, patent(s) relating to
synthesis of NDGA and analogs at the time of filing of the IND for masoprocol.
Shaman will pay Access $50,000 upon signing of licensing agreement. If Shaman
commercializes a product containing masoprocol or an analog, Shaman will pay
Access a Royalty of 0.25%. The length of royalty payment and definition of net
sales will be delineated in the contract and will be consistent with Shaman's
agreement with Lipha for marketing of diabetes products.
Please acknowledge your agreement with terms of this memorandum of understanding
by signing and returning a copy to me by facsimile.
I am certain that both Shaman and Access will benefit from this agreement.
/s/ A.S. Xxxxxxxxx
Best Regards,
cc: Xxxx Xxxxx
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SCHEDULE B
1) Copies of the following studies and sections of the Actinex(TM) NDA and
NDS will be provided:
a) NDA Pharmacology summary
b) NDS Pharmacology summary
c) NDS CMC Section
d) T005-89 - Xxxx Test - CHX 100 - Summary & Report
e) T003-87 - Acute Oral Rat Tox. - CHX 100 - Summary & Report
f) T004-87 - Acute Oral Rabbit Tox. - CHX 100 - Summary & Report
g) T004-89 - Target Organ Oral Rat Tox. - CHX 100 - Summary &
Report
h) T004-89 - Oral Segment II - Rat - CHX 100 - Summary & Report
i) T009-89 - Oral Rabbit Dose Finding Segment II - CHX 100 -
Summary & Report
j) TOO1-90 - Oral Rabbit Segment II - CHX 100 - Summary & Report
k) KOO1-84 - Rat Biodistribution, Oral, Intravenous and Dermal -
CHX 100 - Summary & Report
2) If available, a copy of any oral mass balance studies on CHX 100
conducted by Chemex/Access
3) Segment I & III reproductive safety studies on CHX 100 (to be provided
in the 1st quarter 1997)
