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EXHIBIT 10.13
CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. SECTIONS 200.80(b)(4), 200.83
AND 230.406 * INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST THAT IS FILED SEPARATELY WITH THE COMMISSION.
COLLABORATION AGREEMENT
This Collaboration Agreement (the "Agreement") is made between ALANEX
Corporation ("ALANEX"), and ASTRA AB ("ASTRA").
RECITALS
A. WHEREAS, ALANEX has developed proprietary molecular design
technology, ALANET(TM), which enables ALANEX to analyze structure affinity
relationships of agonists and antagonists of opioid receptors and to
characterize a 3-D pharmacophore hypothesis;
B. WHEREAS, ALANEX has developed proprietary methods for the rapid
development of banks of diversity organic compounds, Pharmacophore Directed
Parallel Synthesis(TM);
C. WHEREAS, ASTRA intends to supply Chemical Entity Data to ALANEX
to enable ALANEX to apply ALANET(TM)-I to assemble a database which is adequate
for the application of ALANET(TM)-II; and
D. WHEREAS, both parties desire that, in consideration of the
funding provided by ASTRA, ALANEX apply the ALANET(TM) technology to the
Chemical Entity Data supplied by ASTRA and use Pharmacophore Directed Parallel
Synthesis(TM) methods to synthesize, isolate, purify, characterize, and supply
novel, non-peptide ligands with desired opioid receptor ligand binding and
efficacy characteristics (the "Collaboration").
NOW THEREFORE, in consideration of the mutual covenants and promises
herein contained, ALANEX and ASTRA agree as follows:
1. EFFECTIVE DATE
The agreement shall be effective as of December 19th, 1994 (the
"Effective Date").
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2. DEFINITIONS
2.1 "ALANET(TM)" shall mean ALANEX's proprietary molecular design
technology, including ALANET(TM)-I and ALANET(TM)-II, which can be applied to
develop peptide-like or non-peptide molecules that mimic the actions of
peptides.
2.2 "ALANET(TM)-0" is the system applied to predict the folding of
peptides and proteins and can be used to design new compounds of interest.
2.3 "ALANET(TM)-I" is the process used in the development of a series
of active analogs of the compound of interest.
2.4 "ALANET(TM)-II" is a system that is used once a series of active
analogs is created through the use of ALANET(TM)-I for rational drug design
that allows the formulation of a 3-dimensional (3-D) pharmacophore hypothesis
based on a set of compounds with known biological affinity.
2.5 "PHARMACOPHORE DIRECTED PARALLEL SYNTHESIS(TM) (PDPS(TM))" is an
ALANEX proprietary technology that is used to rapidly generate banks of
relevant organic compounds of interest.
2.6 "CHEMICAL ENTITY DATA" shall mean data supplied by ASTRA regarding
the chemical structures and opioid receptor binding and intrinsic affinity of
compounds discovered by ASTRA prior to the Effective Date, as well as compounds
discovered independent of the Research Program after the Effective Date.
2.7 "FTE" shall mean the equivalent of one full-time researcher.
2.8 "ASTRA PATENT RIGHTS" shall mean any and all patents, patent
applications and patent rights and divisions, continuations,
continuations-in-part, divisional applications, renewals, substitutions,
extensions or additions to such patents or applications, directly or indirectly
owned or controlled by ASTRA, and any corresponding foreign patent
applications or patents which rights existed prior to the Effective Date
hereof or as later created independent of the Research Program and the
Collaboration.
2.9 "ALANEX PATENT RIGHTS" shall mean any and all patents, patent
applications and patent rights and divisions, continuations,
continuations-in-part, divisional applications, renewals, substitutions,
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extensions or additions to such patents or applications, directly or indirectly
owned or controlled by ALANEX, and any corresponding foreign patent
applications or patents based on such applications or patents which rights
existed prior to the Effective Date hereof or as later created independent of
the Research Program and the Collaboration.
2.10 "NON COLLABORATION PRODUCTS" shall mean any products
incorporating: (a) compounds that have been synthesized and are in the
possession of ASTRA prior to the Effective Date; (b) compounds discovered and
developed by ASTRA and/or third parties independent of the Research Program
that are not compounds discovered or developed as a result of the Research
Program; and (c) those compounds or products covered under any ASTRA Patent
Rights.
2.11 "PROGRAM COMPOUND" shall mean any novel compound discovered and
developed as set forth under Section 3.2 and any compound included or derived
from PDPS-generated banks of organic structures that have been shown to exhibit
opioid receptor binding affinity with a Ki<10uM, for which ALANEX
has developed and provided ASTRA with analytical information including detailed
synthetic procedures, spectroscopic data and physiochemical properties enabling
ASTRA to establish authenticity of the chemical structure, or such compound
developed by ASTRA using pharmacophore information provided by ALANEX pursuant
to Section 3.3.2, that exhibit opioid receptor binding affinity. The term
"Program Compound" includes salts, esters, complexes, chelates, hydrates,
isomers, stereoisomers, crystalline and amorphous forms, prodrugs, metabolites
and metabolic precursors thereof.
2.12 "RESEARCH PROGRAM" shall mean the research program described in
Section 3 below.
2.13 "RESEARCH TERM" shall mean the three year period commencing on the
Effective Date, subject to extension under Section 3.4.
2.14 "CANDIDATE DRUG" shall mean a Program Compound elected by ASTRA
based on dose finding studies for short term GLP toxicological studies and
further development.
2.15 "RESULTS" shall mean all Program Compounds and any and all ideas,
inventions and knowledge related thereto and all intellectual property rights
connected therewith.
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3. RESEARCH PROGRAM
3.1 PURPOSE AND SCOPE. The purpose of the Collaboration is to
characterize novel, non-peptide ligands with desired opioid receptor ligand
binding affinity. During the Research Term and subject to the terms and
conditions of this Agreement, ALANEX will use its good faith, scientific and
business judgement to conduct the Research Program and to furnish the facilities
and personnel necessary to carry out its responsibilities under the Research
Program pursuant to the funding provided in Section 4 hereof.
3.2 ALANEX RESPONSIBILITIES.
3.2.1 ALANEX shall (i) apply ALANET(TM)-I to the Chemical
Entity Data supplied by ASTRA to assemble a database of analogs of the
compounds for which the Chemical Entity Data was supplied and, (ii) apply
ALANET(TM)-II to that database to identify new compounds with desired affinity
at opioid receptors and to characterize a 3-D pharmacophore based on those
compounds. ALANEX acknowledges that ASTRA will determine the Research Program
direction within the target of development of compounds with opioid receptor
binding activity. The target may be changed subject to mutual agreement by the
parties.
3.2.2 ALANEX will use its peptide, organic and medicinal
chemistry, PDPS(TM) technology, and current and future databases to synthesize,
isolate, purify and characterize novel non-peptide ligands with desired
affinity to opioid receptors.
3.2.3 ALANEX, with the assistance of ASTRA, will set up
specific opioid receptor binding assays for the routine testing of compounds
synthesized at ALANEX.
3.2.4 ALANEX will provide to ASTRA adequate quantities of pure
and characterized compounds identified by ALANEX that exhibit desired binding
affinity to opioid receptors. Adequate Quantities shall mean amounts required
for verification of in vitro affinity, physiochemical properties and early
pharmacology studies.
3.2.5 ALANEX shall provide ASTRA with 3-D pharmacophore
information about peptide-like and/or non-peptide candidates that fulfill the
requirements of the hypothesis. This will be an iterative process that will
require refinement of the pharmacophore hypothesis after the synthesis and
testing of new compounds.
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3.3 ASTRA RESPONSIBILITIES.
3.3.1 ASTRA shall be responsible for providing, at its own
discretion, the Chemical Entity Data to enable ALANEX to assemble a database
for ALANET(TM)-I that is adequate for the application of ALANET(TM)-II.
3.3.2 ASTRA may carry on an effort independent of ALANEX,
utilizing pharmocophore information supplied by ALANEX, to synthesize organic
compounds with the required characteristics for binding to the opioid receptors
of interest.
3.4 RESEARCH DURATION. The Research Program shall be performed during
the Research Term hereof, subject to extension upon mutual agreement of the
parties.
3.5 RECORD KEEPING. ALANEX will keep accurate scientific records
relating to the Research Program and will make such records available to ASTRA
or its authorized representative throughout the Term of the Agreement during
normal business hours upon reasonable notice.
3.6 ALANEX AGREEMENT REGARDING RESEARCH. ALANEX agrees that during
the Research Term, as may be extended or terminated in accordance with the terms
of this Agreement, and for twelve (12) months thereafter, it will not, alone or
together with any third party, engage in research regarding opioid receptor
ligands. Nothing herein shall limit ALANEX's ability to conduct research
regarding any subject other than opioid receptor ligands during the period
described in the immediately preceding sentence or ALANEX's ability to conduct
research regarding any subject following the expiration of such period.
4. FUNDING
4.1 PROJECT INITIATION FEE. To fund the performance by ALANEX of its
obligations under this Agreement, ASTRA will pay to ALANEX $250,000.00 after
the signing of this Agreement and prior to the initiation of the project. This
fee should be used to purchase equipment needed for the initiation of the
research program and is independent of FTE and milestone payments.
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*CONFIDENTIAL TREATMENT REQUESTED
4.2 FTE PAYMENTS. ALANEX will be paid *********** per year per FTE,
adjusted annually by the Consumer Price Index of San Diego, California, USA,
over the preceding calendar year starting 1995 (the "FTE Rate"). Payments will
be made on a quarterly basis commencing not later than December 20, 1994. The
initial number of FTE's will be *******. These will include one (1) FTE for a
computational chemist, ************* for synthetic organic-medicinal
chemistry, and one (1) FTE for a pharmacologist to perform receptor ligand
binding assays. The FTE constitutes the entire compensation for the services
performed under this Agreement.
4.3 FUNDING COMMITMENT MODIFICATION. At any time during the term of a
Research Program, either Party may propose in writing an increase or decrease
of the number of FTE's. ALANEX may request a change in the FTE Rate for the
remaining term of such Research Program; after providing competent proof and
explanation that ALANEX's research department cost structure exceeds the FTE
rate set forth in Section 4.2 and upon approval of ASTRA, which approval shall
not be unreasonably withheld, the FTE rate will change accordingly.
Notwithstanding the above, ASTRA is entitled upon three (3) months'
prior written notice to ALANEX to terminate the Research Program for any
reason. Upon such premature termination of the Research Program, the remainder
of this Agreement will continue to be in full force and effect until terminated
in accordance with Article 10 below, and ASTRA will, as entire compensation for
the premature termination of the Research Program, compensate ALANEX for
reasonable and unavoidable wind-up costs not exceeding the FTE rate for six (6)
months.
5. CONSULTATION AND REPORTS
5.1 CONSULTATION. During the Term of the Agreement, ASTRA's
representatives may consult informally with ALANEX's representatives regarding
the Research Program, both personally and by telephone. Access to ASTRA work
carried on in ALANEX laboratories in the course of the Research Program shall
be made available to ASTRA during normal business hours upon reasonable notice.
5.2 RESEARCH COMMITTEE. A Research Committee will be created to manage
the Research Program. Each Party will designate three (3) representatives to
act as members of the Research Committee. Meetings will be held no less than
every three (3) months and their location will
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alternate between Montreal and San Diego. The chairman of each Research
Committee Meeting will be a member from the host company. The Research
Committee will, within the frames of this Agreement, be responsible for the
formulation and ongoing revision of the Research Plan and for the monitoring
and assessment of the resultant research.
5.3 REPORTS. Routines of reporting will be established by the Research
Committee.
5.3 REPORT USAGE. All reports and information submitted to ASTRA as a
result of the Research Program may be freely utilized by ASTRA.
6. OWNERSHIP: PATENTS
6.1 OWNERSHIP.
6.1.1 ALANEX acknowledges that ALANEX has no ownership rights in or to
any peptide or non-peptide materials furnished by ASTRA or to any ASTRA Patent
Rights or any other ASTRA proprietary rights. ASTRA acknowledges that ASTRA has
no rights in or to any ALANEX Patent Rights or any other ALANEX proprietary
rights referable to ALANET(TM) and PDPS(TM).
6.1.2 The entire right, title and interest in and to the Results shall
be the exclusive proprietary rights of ASTRA, including the right to apply for
patents in its own name and to exploit any part of the Results regardless if
such part originates from ASTRA or ALANEX.
6.2 PATENTS. ASTRA shall be free to determine whether or not it chooses
to file one or more patent applications to obtain patent rights with respect to
any ASTRA Compound or Program Compound. ASTRA shall pay any and all expenses in
connection with filing and maintaining such patents.
6.2.1 ALANEX undertakes at the request of ASTRA to sign any and all
documents necessary or useful in connection with applications for patent or
application for any other industrial property right and further to confirm
ASTRA's proprietary right (ownership) to the Results.
6.2.2 ALANEX undertakes to see to it that employees and other persons
working with ALANEX in such ways, that they can be
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*CONFIDENTIAL TREATMENT REQUESTED
considered as inventors to any patentable invention generated as a Result, are
obligated as ALANEX to this Agreement.
7. MILESTONE PAYMENTS
7.1 MILESTONE PAYMENTS. ASTRA shall pay to ALANEX the milestone
payments described below within thirty (30) days after attainment by ASTRA of
each described milestone:
(a) For the first Program Compound selected by ASTRA as
Candidate Drug the milestone events and payments are the
following:
- upon selection as a Candidate Drug $ *******
- upon the first filing of an IND $ *******
- upon the first filing of an NDA $*********
- upon the first NDA approval in the U.S. $*********
(b) For each subsequent Program Compound(s) selected by ASTRA as
Candidate Drug(s), the milestone events will be the same as
above under (a), but the payments will be ************
***** the amounts indicated for each milestone
above under (a).
(c) Other than as set forth in section 4 above, and this section
7, ASTRA shall not be obliged to pay any compensation to
ALANEX for services provided or the rights granted to ASTRA
hereunder.
8. PUBLICITY
8.1 PRESS RELEASE AND REQUIRED REPORTING. Neither party shall make
reference to the other in a press release or any other written statement in
connection with this Agreement if it is intended for use in the public media,
except as required by the applicable law or regulation, or with the consent of
the other party.
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8.2 PUBLICATIONS. With respect to publication of information other
than a press release, ASTRA shall have the right to submit for publication any
information concerning an ASTRA Compound. ASTRA will include appropriate ALANEX
personnel in the preparation and authorship of all resultant publications.
8.2.1 ALANEX undertakes not to make any publications
whatsoever regarding the Results without the prior written consent of ASTRA.
9. CONFIDENTIAL INFORMATION
9.1 The Secrecy Agreement between the parties dated February 28, 1994,
is hereby terminated and replaced by the confidentiality provisions hereinafter
set forth.
9.2 In the collaboration hereunder, it is acknowledged that each party
will disclose to the other ("Receiver") information, which is confidential and
proprietary information of the disclosing party ("Discloser"). Any information
provided hereunder from one party to the other which, by its nature, is
confidential and proprietary information of Discloser is below referred to as
Confidential Information.
9.3 Receiver shall maintain the Confidential Information of Discloser
in confidence, and shall not disclose, divulge or otherwise communicate such
Confidential Information to others, or use it for any purpose, except pursuant
to, and in order to carry out, the terms and objectives of this Agreement, and
hereby agrees to exercise ever reasonable precaution to prevent and restrain
the unauthorized disclosure of such Confidential Information by any of its
employees or other persons working with Receiver.
9.4 The provisions of Article 9 shall not apply to any Confidential
Information disclosed hereunder which:
(a) at the time of disclosure is in the public domain;
(b) after disclosure becomes part of the public domain by
publication or otherwise, except by breach Receiver's
undertakings under this Agreement;
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(c) Receiver can establish by competent proof was in its
possession at the time of disclosure and was not acquired,
directly or indirectly, from Discloser;
(d) Receiver can establish by competent proof was either
developed by Receiver independently of the Confidential
Information received from Discloser or received from a
third party provided, however, that such information was
not obtained by said third party directly or indirectly
from Discloser; or
(e) ASTRA is required to disclose to relevant authorities in
connection with its development and exploitation of a
Program Compound.
9.5 The confidentiality obligations above will be valid during the
term of this Agreement and seven (7) years thereafter.
10. TERMINATION
10.1 TERM. This Agreement shall remain in full force and effect from
the Effective Date until terminated by operation of law or by acts of the
parties in accordance with the terms of this Agreement.
10.2 EARLY TERMINATION. This Agreement may be terminated:
(a) by the written agreement of both parties;
(b) in the event that either party shall be in default of its
material obligations under this Agreement and upon written
notice thereof, this Agreement shall Terminate upon
expiration of the sixty (60) day period; or
(c) by either party upon the insolvency of, or filing either a
voluntary petition by or an involuntary petition against
(if not dismissed within sixty (60) days after the filing)
the other party.
10.3 EFFECT OF TERMINATION. Upon termination of this Agreement prior
to the expiration of the Research Term, the Research Program set forth in
Section 3 shall cease. Notwithstanding any
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termination, the provisions of Sections 4, 6, 7, 8 and 9 shall survive to the
extent obligations have accrued thereunder prior to termination and including,
without limitation, the obligation of ASTRA to make milestone payments provided
for herein.
11. DISPUTE RESOLUTION; VENUE AND CHOICE OF LAW
11.1 DISPUTE RESOLUTION. In the event that at any time during the term
of this Agreement a disagreement, dispute, controversy or claim should arise
out of or relating to the interpretation of or performance under, this
Agreement, or the breach or invalidity thereof, the parties will attempt in
good faith to resolve their differences before restoring to the termination
procedures provided in Section 10 of this Agreement by submitting such dispute
to the Chief Executive Officers of the parties (or their designees) for thirty
(30) days, following which either party shall be free to take any action and
seek any remedy it may have at law or in equity including specific performance
and injunctive relief.
11.2 GOVERNING LAW. This Agreement is made in accordance with and
shall be governed and construed under the laws of the State of New York.
11.3 ARBITRATION. Any controversy or claim arising out of or related
to this Agreement shall be determined by arbitration in accordance with the
International Arbitration Rules of the American Arbitration Association.
12. MISCELLANEOUS
12.1 WAIVER. No delay in enforcing a party's rights hereunder or any
waiver as to a particular breach or default of any of the covenants or
agreements herein set forth shall be deemed a waiver as to any subsequent or
similar breach or default.
12.2 ASSIGNMENT. This Agreement shall be binding upon and inure to the
benefit of the parties hereto and their permitted successors and assigns;
provided, however, other than as contemplated by the Agreement, neither party
shall assign any of its rights and obligations hereunder except as incident to
the merger, consolidation, reorganization, or acquisition of stock or assets
affecting substantially all of the assets or 50% or
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more of the voting power of the assigned party. The parties may assign their
rights and/or obligations to any of their respective Affiliates.
12.3 ADDITIONAL DOCUMENTS. Each party agrees to execute such further
papers or agreements as may be necessary to effect the purposes of this
Agreement.
12.4 NOTICES. Any notice or other communication required or permitted
to be given and to be effective on the date of delivery if delivered in person
or by facsimile or five (5) days after mailing by registered or certified mail,
postage paid, to the other party at the following address:
In the case of ASTRA:
ASTRA Pain Control
000 xxx, xxxx. Xxxxxxx Xxxxxxxx
Edifice 3000
Laval, Quebec, Canada
H7V 4A7
Attn: Claes Wahlestedt, M.D., Ph.D.
Director of Montreal Research Unit
Phone: 514/000-0000
Fax: 514/000-0000
In the case of ALANEX:
ALANEX Corporation
0000 Xxxxxxx Xxxxxxx Xxxxx
Xxx Xxxxx, XX 00000
Attn: Xxxxxx X. Xxxxx, M.D.
President & Chief Executive Officer
Phone: 619/000-0000
Fax: 619/000-0000
Either party may change its address for communications by a notice to the other
party in accordance with this section.
12.5 AMENDMENT. No amendment or modification hereof shall be valid or
binding upon the parties unless made in writing and signed by both parties.
12.6 FORCE MAJEURE. Any delays in performance by any party under this
Agreement (other than a party's failure to pay money to the other party) shall
not be considered a breach of this Agreement if and
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to the extent caused by occurrences beyond the reasonable control of the party
affected, including but not limited to acts of God, embargoes, governmental
restrictions, strikes or other concerted acts of workers, fire, flood,
explosion, riots, wars, civil disorder, rebellion or sabotage. The party
suffering such occurrences shall immediately notify the other party and at any
time for performance hereunder shall be extended by the actual time of delay
caused by the occurrence.
12.7 INDEPENDENT CONTRACTORS. In making and performing this Agreement,
ALANEX and ASTRA act and shall act at all times as independent contractors, and
nothing contained in this Agreement shall be construed or implied to create an
agency, partnership or employer and employee relationship between ASTRA and
ALANEX. At no time shall one party make commitments or incur any charges or
expenses for or in the name of the other party.
12.8 SEVERABILITY. If any term, condition or provision of this
Agreement is held to be unenforceable for any reason, it shall, if possible, be
interpreted rather than voided, in order to achieve the intent of the parties
to this Agreement to the extent possible. In any event, all other terms,
conditions and provisions of this Agreement shall be rendered valid and
enforceable to the full extent.
12.9 CUMULATIVE RIGHTS. The rights, powers and remedies hereunder
shall be in addition to, and not in limitation of, all rights, powers and
remedies provided at law or in equity, or under any other agreement between the
parties. All of such rights, powers and remedies shall be cumulative, and may be
exercised successively or cumulatively.
12.10 ENTIRE AGREEMENT. This Agreement and any and all Exhibits
referred to herein embody the entire understanding of the parties with respect
to the subject matter hereof and supersedes all previous communications,
representations or understandings, either oral or written, between the parties
relating to the subject matter hereof.
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IN WITNESS WHEREOF, both ALANEX and ASTRA have executed this Agreement,
in duplicate originals, by their respective officer hereunto duly authorized,
as of the day and year hereinabove written.
ASTRA AB
By: /s/ Xxxxx Xxxxxxxxxxx By: /s/ Goran Lerenius
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Xxxxx Xxxxxxxxxxx, M.D., Ph.D. Goran Lerenius
Executive Vice President Vice President
Head, Research & Development Head of Legal Affairs
ALANEX CORPORATION
By: /s/ Xxxxxx X. Xxxxx
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Xxxxxx X. Xxxxx, M.D.
President & Chief Executive Officer
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