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EXHIBIT 10.14
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 NOVO NORDISK ("NOVO NORDISK").
RECITALS
A. WHEREAS, ALANEX has developed proprietary molecular design
technology, ALANET(TM), which enables ALANEX to analyze structure affinity
relationships of **************** receptors and to characterize 3-dimensional
"3-D" pharmacophore hypotheses;
B. WHEREAS, ALANEX has developed proprietary methods for the rapid
development of libraries of diverse organic compounds, Pharmacophore Directed
Parallel Synthesis(TM) "PDPS(TM)"; and
C. WHEREAS, both parties desire that, in consideration of the
funding to be provided by NOVO NORDISK, ALANEX apply the ALANET(TM) technology
to the Chemical Entity Data (as defined below) supplied by NOVO NORDISK and use
PDPS(TM) methods to synthesize, isolate, purify, characterize and supply novel,
non-peptide ligands with desired **************** receptor ligand binding and
efficacy characteristics (the "Collaboration").
NOW THEREFORE, in consideration of the mutual covenants and promises
herein contained, ALANEX and NOVO NORDISK agree as follows:
1. EFFECTIVE DATE
This agreement shall be effective as of October 31, 1995 (the
"Effective Date").
2. DEFINITIONS
2.1 "AFFILIATE" used in connection with any of the parties to this
Agreement shall, unless otherwise specifically indicated, mean any corporation
or other entity controlled by or controlling the party mentioned, or being
under the common control with the party mentioned, directly or indirectly,
through stock ownership, or otherwise. "Control" shall mean the ownership of
more than fifty percent (50%) of the outstanding equity or voting interests in
such entity.
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2.2 "ALANET(TM)" shall mean ALANEX's proprietary molecular design
technology, including ALANET(TM)-0, ALANET(TM)-I and ALANET(TM)-II, which can
be applied to develop peptide-like molecules that mimic the actions of peptides.
2.3 "ALANET(TM)-0" is a system that can be used to predict the
folding of peptides and proteins and can be used to design new compounds of
interest.
2.4 "ALANET(TM)-1" is the process used in the development of a
series of active analogs of the compound of interest.
2.5 "ALANET(TM)-II" is a system that is used once a series of
active analogs is created through the use of ALANET(TM)-I that allows the
formulation of a 3-D pharmacophore hypothesis based on a set of compounds of
interest.
2.6 "Chemical Entity Data" shall mean data supplied by NOVO NORDISK
regarding the chemical structures and **************** receptor binding and
intrinsic affinity of compounds discovered by NOVO NORDISK 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 or one full-time researcher.
2.8 "Non collaboration Products" shall mean any products
incorporating: (i) compounds that have been synthesized and are in the
possession of NOVO NORDISK prior to the EFFECTIVE DATE; (ii) compounds
discovered and developed by NOVO NORDISK and/or third parties independent of
the Research Program and the Collaboration and that are not compounds discovered
or developed as a result of the Research Program or the Collaboration; and
(iii) those compounds or products covered under any NOVO NORDISK Patent Rights.
2.9 "NOVO NORDISK 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 NOVO NORDISK, 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 "Pharmacophore Directed Parallel Synthesis(TM) "PDPS(TM)" " is
an ALANEX proprietary technology that is used to rapidly generate libraries of
relevant organic compounds of interest.
2.11 "Preclinical Lead Profile (PLP) Candidate" shall mean a Program
Compound selected by NOVO NORDISK based on dose finding studies for short term
**************** toxicological studies and further development in
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accordance with the current NOVO NORDISK guidelines for selection of lead
candidates (Appendix 1).
2.12 "Program Compound" shall mean (i) any compound discovered and
developed as set forth under Section 3.2; (ii) any compound included or derived
from PDPS-generated banks or organic structures that have been shown to
exhibit **************** receptor binding affinity with a ******************
or structures necessary to obtain broad patent coverage independent of binding
affinity, for which ALANEX has developed and provided NOVO NORDISK with
analytical information including detailed synthetic procedures, spectroscopic
date and physiochemical properties enabling NOVO NORDISK to establish
authenticity of the chemical structure; or (iii) any compound developed by NOVO
NORDISK using pharmacophore information provided by ALANEX pursuant to Section
3.3, that exhibit *************** 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.
2.13 "Program Compound Option" shall mean Program Compounds that
exhibit activities in addition to or other than *************** binding
activity.
2.14 "Research Program" shall mean the research program described in
Section 3 below.
2.15 "Research Term" shall mean the three-year period commencing on
the Effective Date, subject to extension under Section 3.4.
2.17 "Results" shall mean all Program Compounds and any and all
ideas, inventions and knowledge thereto and all intellectual property rights
connected therewith.
3. RESEARCH PROGRAM
3.1 Purpose and Scope. The purpose of the Collaboration is to
characterize novel, non-peptide ligands with desired ******************
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 judgment 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 NOVO NORDISK to assemble a database of analogs of the
compounds for which the Chemical Entity Data was supplied, and (ii) apply
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ALANET(TM)-II to that database to identify new compounds with desired affinity
at ***************** receptors and to characterize a 3-D pharmacophore based on
those compounds. ALANEX acknowledges that NOVO NORDISK will determine the
Research Program direction within the target of development of compounds with
***************** 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
***************** receptors.
3.2.3 ALANEX, with the assistance of NOVO NORDISK, will set up specific
***************** receptor binding assays for the routine testing of compounds
synthesized at ALANEX.
3.2.4 ALANEX will provide to NOVO NORDISK adequate quantities of pure
and characterized compounds identified by ALANEX that exhibit desired binding
affinity to ***************** receptors. Adequate quantities shall mean amounts
reasonably required for verification of in vitro affinity, physiochemical
properties and early pharmacology studies.
3.2.5 ALANEX shall provide NOVO NORDISK with 3-D pharmacophore
information about peptide-like and/or non-peptide candidates that fulfill the
requirements of the hypothesis. This will be an interactive process that will
require refinement of the pharmacophore hypothesis after the synthesis and
testing of new compounds.
3.3 NOVO NORDISK RESPONSIBILITIES.
3.3.1 NOVO NORDISK may carry on an effort independent of ALANEX,
utilizing pharmacophore information supplied by ALANEX, to synthesize organic
compounds with the required characteristics for binding to the *********
******* receptors of interest.
3.3.2 NOVO NORDISK will provide ALANEX with cells transfected with
cloned ***************** receptors to be used in in vitro receptor binding and
functional assays.
3.3.3 NOVO NORDISK will perform in vitro profiling including **********
************ receptor binding affinities, and all in vivo pharmacological
characterization studies of Program Compounds.
3.4 RESEARCH DURATION. The Research Program shall be performed during
the Research Term hereof, subject to extension upon mutual agreement of the
parties.
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3.5 RECORD KEEPING. ALANEX will keep accurate scientific records
relating to the Research Program and will make such records available to NOVO
NORDISK 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 ************ thereafter, it will not, alone or
together with any third party, engage in research regarding *****************
receptor ligands. Nothing herein shall limit ALANEX's ability to conduct
research regarding any subject other than ***************** 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 ALANEX of its
obligations under this Agreement, NOVO NORDISK will pay to ALANEX ********
upon the signing of this Agreement and prior to the initiation of the Research
Program. This fee will be used by ALANEX to purchase equipment needed for the
initiation of the Research Program and is independent of FTE and milestone
payments. All such equipment shall be and shall remain the property of ALANEX,
irrespective of any termination of this Agreement.
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 prepaid quarterly basis commencing not later than one (1) month
after the Effective Date. The initial number of FTE's will be ********. These
will include ********* for a computational chemist, ************* for synthetic
organic-medicinal chemistry, ********* for a peptide chemist, and ***********
for pharmacologists to perform receptor ligand binding assays. The FTE payments
and the milestone payments (if any) contemplated by Section 7 constitute the
entire compensation for the services performed under this Agreement.
4.3 FUNDING COMMITMENT MODIFICATION. At any time during the term of
the 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 the Research Program. Upon reasonable demonstration
by ALANEX that ALANEX's research department cost structure exceeds the FTE rate
set forth in Section 4.2 and, with the consent of NOVO NORDISK which shall not
be unreasonably withheld, the FTE rate will be increased accordingly.
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5. CONSULTATION AND REPORTS
5.1 Consultation. During the Term of the Agreement, NOVO NORDISK's
representatives may consult informally with ALANEX's representatives regarding
the Research Program, both personally and by telephone. Access to NOVO NORDISK
work carried on in ALANEX laboratories in the course of the Research Program
shall be made available to NOVO NORDISK 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 locations will alternate
between Copenhagen and San Diego. The chairman of each Research Committee
Meeting will be a member from the host company. The Research Committee will,
within the framework 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.
5.4 Report Usage. All reports and information submitted to NOVO
NORDISK as a result of the Research Program may be freely utilized by NOVO
NORDISK for whatever purpose.
6. OWNERSHIP; PATENTS
6.1 Ownership.
6.1.1 ********************************************************
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6.2 Patents. ***************************************************
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6.2.1 ALANEX undertakes at the request of NOVO NORDISK to sign
any and all documents necessary or useful in connection with applications for
patent or application for any other intellectual property right to the Program
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Compounds and further to confirm NOVO NORDISK's proprietary right (ownership)
to the Results and Program Compounds.
6.2.2 ALANEX undertakes to see to it that employees and other
persons working with ALANEX in such ways that they can be considered as
inventors to any patentable Results or Program Compound generated pursuant to
the Research Program or the Collaboration, are obligated as ALANEX to this
Agreement.
6.2.3 IF NOVO NORDISK determines not to file a patent
application on a particular compound, ALANEX shall have the right to do so and
such compound shall be the property of ALANEX and deemed not to be a Program
Compound.
6.3 Program Compound Patents. NOVO NORDISK will, on a continuous
basis, maintain a list of all patents and patent applications concerning
Program Compounds.
7. MILESTONE PAYMENTS
7.1 Conditions for Milestone Payments. Milestone payments will be
made by NOVO NORDISK to ALANEX subject to the following conditions:
7.1.1 The selection of a PLP Candidate to enter into clinical
trials is to be determined in accordance with current
NOVO NORDISK guidelines for PLP Candidate selection
(Appendix 1) and will be established at the sole
discretion of NOVO NORDISK.
7.1.2 Payment of IND and NDA milestones will depend on FDA
approval of the first clinical trial and approval of
marketing authorization including all necessary
documentation, respectively.
7.1.3 Milestone events shall be applicable only to second
generation and new indication compounds and not to
back-ups. If a PLP Candidate proceeds into phase II
clinical trials (as defined by FDA NDA guidelines,
Appendix 2), this compound cannot be considered a
back-up.
7.2 Milestone Payments. NOVO NORDISK shall pay to ALANEX the
milestone payments described below within thirty (30) days after attainment of
each described milestone:
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7.2.1 For the first Program Compound selected by NOVO NORDISK
as PLP Candidate, the milestone events and payments are
the following:
- upon *********************** ********
- upon *********************** ********
- upon *********************** ********
- upon **************************** ********
7.2.2 For each subsequent Program Compound(s) selected by NOVO
NORDISK as Preclinical Lead Profile Candidate(s), the
milestone events will be the same as above under Section
7.2.1.
7.2.3 Other than as set forth in Section 4 above, this Section
7 and Section 8 below, NOVO NORDISK shall not be obliged
to pay any compensation to ALANEX for services provided
or the rights granted to NOVO NORDISK hereunder.
8. LICENSING AGREEMENT
It is anticipated that NOVO NORDISK, after completion of the relevant
research and development activities, may produce one or more drug candidates
based, inter alia, on the Results, the Research Program and/or the
Collaboration, the NOVO NORDISK Patent Rights and other intellectual property
rights, know-how and technology belonging to NOVO NORDISK. In addition hereto,
it may be necessary for NOVO NORDISK to carry out such production to have
access, and ALANEX is willing to grant such access, to know-how, trade secrets
and technology belonging to ALANEX necessary to make, have made, use, promote,
and sell one or more candidate drugs. In the event that NOVO NORDISK exercises
the option described in the immediately preceding sentence, the license
acquired shall be sublicenseable and royalty bearing. Unless otherwise agreed,
said license shall be governed by a license agreement which, in all material
respects, shall be identical to the License Agreement attached hereto as
Appendix 3.
In the event that NOVO NORDISK has included in the Research Program a
Non collaboration Product and, in such event, comes under an obligation to pay
royalties or other remuneration to a third party for having obtained the full
rights to commercialize such Non collaboration Product, *** of such royalty or
other remuneration shall be deductible from any royalty payments due to ALANEX;
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provided, however, in no event shall the royalty payable to ALANEX be reduced
by more than ***.
In the event that the Chemical Entity Data supplied by NOVO NORDISK
includes hits with a *************************** the milestone payments
provided for in Section 7 hereof and the royalty payments contemplated in this
Section 8, and the standard License Agreement attached hereto as Exhibit 3,
shall be subject to renegotiation in good faith, it being recognized by ALANEX
that NOVO NORDISK shall be granted more favorable terms in such situation based
on the additional input and know-how, thus provided by NOVO NORDISK towards the
collaboration.
9. PUBLICITY
9.1 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 (which consent shall not be unreasonably withheld).
9.2 Publications. With respect to publication of information other
than a press release, NOVO NORDISK shall have the right to submit for
publication any information concerning a NOVO NORDISK Compound. NOVO NORDISK
will include appropriate ALANEX personnel in the preparation and authorship of
all resultant publications.
9.2.1 ALANEX undertakes not to make any publications
whatsoever regarding the Results without the prior written consent of NOVO
NORDISK.
10. CONFIDENTIAL INFORMATION
10.1 Definition. 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
nature, is confidential and proprietary information of Discloser is below
referred to as Confidential Information.
10.2 Protection. 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 every reasonable
precaution to prevent and restrain the unauthorized disclosure of such
Confidential Information by any employees or other persons working with
Receiver.
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10.3 EXCLUSIONS. The provisions of this Section 10 shall not apply to
any information disclosed hereunder which:
10.3.1 at the time of disclosure is in the public domain;
10.3.2 after disclosure becomes part of the public domain by publication
or otherwise, except by breach of Receiver's undertakings under
this Agreement;
10.3.3 Receiver can establish by competent proof was in its possession
at the time of disclosure and was not acquired, directly or
indirectly, from Discloser;
10.3.4 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
10.3.5 NOVO NORDISK is required to disclose to relevant authorities in
connection with its development and exploitation of a Program
Compound.
10.4 The confidentiality obligations above will be valid during the
term of this Agreement and ************* thereafter.
11. USE OF PROGRAM COMPOUNDS OPTIONS OUTSIDE THE
SCOPE OF THE COLLABORATION
The terms and conditions for the use of Program Compounds Options by
NOVO NORDISK for activities other than **************** binding affinities
will be negotiated on a case by case good faith basis.
12. TERMINATION
12.1 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.
12.2 EARLY TERMINATION. This Agreement may be terminated:
12.2.1 by the written agreement of both parties;
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12.2.2 if ALANEX or NOVO NORDISK at any time materially defaults in
fulfilling any of their obligations required hereunder, or in the
payment of any money due hereunder, or in fulfilling any of the
other obligations or conditions hereunder, either party may waive
the default, or if electing to not waive the default, such party
shall notify the other in writing of said default and allow sixty
(60) days for the other to correct the default. If at the end of
said time period the default remains uncorrected, the aggrieved
party may terminate this Agreement by giving written notice of
termination to the other party.
12.2.3 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.
12.3 NOVO NORDISK ELECTION TO TERMINATE. Notwithstanding Sections 3,
10.1 and 10.2, NOVO NORDISK shall be entitled, at any time during the term of
this Agreement, at its option, to terminate the Research Program upon three
(3)months' prior written notice to ALANEX. Upon such termination of the
Research Program, the remainder of this Agreement will continue in full force
and effect until terminated in accordance with Sections 12.1 or 12.2 above. In
the event that NOVO NORDISK serves notice to ALANEX of such termination of the
Research Program during the first two and one-half years of the term to this
Agreement, ***********************************************************
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**************************************************************** No other
payments shall be due by NOVO NORDISK to ALANEX, except for any FTE payments
due up to and including the termination date and any milestone or royalty
payments which become due as a result of NOVO NORDISK exercising the option to
obtain a license in accordance with Section-8 hereof.
12.4 EFFECT OF TERMINATION. Upon termination of this Agreement for
whatever reason, the provisions of Sections 6, 8, 9 and 10 shall remain in
force. Furthermore, any payments by NOVO NORDISK having become due as of the
effective date of the termination, shall be effected.
12.5 EXTENSION AGREEMENT. Agreement on extension is to be made no
later than nine (9) months prior to the expiration date.
13. DISPUTE RESOLUTION; VENUE AND CHOICE OF LAW
13.1 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
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breach or invalidity thereof, the parties will attempt in good faith to resolve
their differences before restoring to the termination procedures provided in
Section 12 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 invoke the arbitration contemplated by
section 13.3 and seek any remedy it may have at law or in equity including
specific performance and injunctive relief.
13.2 GOVERNING LAW. This Agreement is made in accordance with and
shall be governed and construed under the laws of the State of New York.
13.3 ARBITRATION. The English wording of this Agreement shall prevail.
The parties agree to submit to arbitration under the International Chamber of
Commerce any dispute arising from this Agreement which cannot be solved in an
amicable manner. The arbitration shall take place in New York City, New York,
and shall not include the conciliation procedure. Judgment upon the award
rendered may be entered in any court in any country for execution.
13.4 INDEMNIFICATION.
For the purpose of this Collaboration Agreement and any subsequent
License Agreement entered into according to Section 8 hereof, ALANEX hereby
represents and warrants to NOVO NORDISK that the rights granted to NOVO NORDISK
do not conflict with the rights of any third party the NOVO NORDISK's legal
position shall not be adversely affected by the rights of any third party with
whom ALANEX has entered into an agreement, including the rights of New England
Medical Center Hospitals, Inc., from whom ALANEX has licensed the *************
used by ALANEX in the course of the Research Program. ALANEX agrees to fully
indemnify and hold harmless NOVO NORDISK in the event of any such breach of
the foregoing representation, third party rights adversely affecting NOVO
NORDISK's legal position.
14. MISCELLANEOUS
14.1 WAIVER. No delay in enforcing a party's rights hereunder or any
waiver as to 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.
14.2 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 more of the voting power of
the assigned
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party. The parties may assign their rights and/or obligations to any of the
respective Affiliates.
14.3 ADDITIONAL DOCUMENTS. Each party agrees to execute such further
papers or agreements as may be necessary to effect the purposes of this
Agreement.
14.4 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 NOVO NORDISK:
NOVO NORDISK A/S
Novo Alle
2880 Bagsvaerd
Denmark
Executive VP Health Care Discovery &
Development
In the case of ALANEX:
ALANEX Corporation
3550 General Atomics Court
San Diego, CA 92121
Attn: Marvin Brown, M.D.
President & Chief Executive Officer
Phone: 619/455-3200
Fax: 619/455-3201
Either party may change its address for communication by a notice to the other
party in accordance with this section.
14.5 AMENDMENT. No amendment or modification hereof shall be valid or
binding upon the parties unless made in writing and signed by both parties.
14.6 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 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, explosions, 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.
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14.7 INDEPENDENT CONTRACTORS. In making and performing this
Agreement, ALANEX and NOVO NORDISK shall at all times act 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 NOVO NORDISK 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.
14.8 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 the Agreement shall be rendered valid and
enforceable to the full extent.
14.9 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.
14.10 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.
IN WITNESS WHEREOF, both ALANEX and NOVO NORDISK have executed this
Agreement, in duplicate originals, by their respective officer hereunto duly
authorized, as of the day and year hereinabove written.
NOVO NORDISK
By: /s/ Bruce Carter By: /s/ Mads Krogsgaard Thomsen
----------------------------------- ---------------------------------
Bruce Carter Mads Krogsgaard Thomsen
Executive Vice President Corporate Vice President
ALANEX CORPORATION
By: /s/ Marvin R. Brown, M.D.
-----------------------------------
Marvin R. Brown, M.D.
President & Chief Executive Officer
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APPENDIX 1
PRECLINICAL LEAD PROFILE CANDIDATE (PLPc) PROPOSAL
Project title and originator:
Project aim:
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APPENDIX 2
Phase II clinical studies shall mean open (i.e., non-blinded) and blinded
controlled clinical studies conducted in accordance with applicable FDA
standards, in which patients with diabetes are administered a development
compound for the purpose of evaluating initial safety and efficacy and which
involve a cumulative total of approximately 300 patients.
16
17
APPENDIX 3
to Collaboration Agreement dated October 31, 1995, between ALANEX Corporation
and NOVO NORDISK A/S.
LICENSE AGREEMENT
This License Agreement (hereinafter referred to as the Agreement) is entered
into between
NOVO NORDISK A/S
Novo Alle
DK-2880 Bagsvaerd
Denmark
(hereinafter referred to as the Licensee)
and
ALANEX Corporation
3550 General Atomics Court
San Diego, CA 92121
USA
(hereinafter referred to as the Licensor)
WITNESSETH:
WHEREAS Licensor is the owner of certain patent rights (hereinafter referred to
as the ALANEX Patent Rights);
WHEREAS Licensee has exercised its option under Section 8 of the Collaboration
Agreement dated October 31, 1995, between the parties hereto (hereinafter
referred to as the Collaboration Agreement) and Licensee desires to obtain a
license under the ALANEX Patent Rights and certain know-how related to the
research performed under the Collaboration Agreement;
NOW, THEREFORE the parties agree as follows:
1. DEFINITIONS
1.1 ALANEX PATENT RIGHTS" shall mean the patents described in
Exhibit 1 attached hereto. (Exhibit 1 to be completed upon exercise of the
option set forth in Section 8 of the Collaboration Agreement. Patents to be
listed shall be patents
1
18
covering Program Compounds and any other Results discovered through research
funded under the Collaboration Agreement.)
1.2 "PATENTS" shall mean patents and patent applications of all
countries including, but not limited to, additions, divisions, continuations,
continuations-in-part, amendments, amalgamations and reissues of such
applications or patents thereof or therefor, and extensions and renewals of all
such patents or patent applications in whatsoever legal form or by whatsoever
legal title they are granted.
1.3 "AFFILIATE" used in connection with any of the parties to this
Agreement shall, unless otherwise specifically indicated, mean any corporation
or other entity controlled by or controlling the party mentioned, or being under
the common control with the party mentioned, directly or indirectly, through
stock-ownership, or otherwise. "Control" shall mean the ownership of more than
fifty percent (50%) of the outstanding equity or voting interests in such
entity.
1.4 "LICENSED PRODUCT" shall mean any product which is comprised of
a Compound.
1.5 "COMPOUND" shall mean any Program Compound (as defined in the
Collaboration Agreement) or Candidate Drug (as defined in the Collaboration
Agreement).
1.6 "SALE" shall mean a transfer of title in Licensed Product for
money or other consideration from Licensor to a third party not being an
Affiliate of Licensor or from a sub-licensee of Licensor to others than
Licensor or Affiliates thereof.
1.7 "NET PROCEEDS OF SALE" shall mean Licensor's, its Affiliates'
and sub-licensees' gross receipts from the Sale of Licensed Product, less the
sum of trade and quantity rebates, allowances for return of goods, value added
taxes, transport cost and insurance, all to the extent stated on the invoice
and actually paid or allowed. It is understood that, in the case of sale or
combined products or bundling, only the part of the selling price which can
reasonably be allocated towards the Licensed Product itself shall be included
in the Net Proceeds of Sale.
1.8 "TERRITORY" shall mean the entire world.
2. LICENSING OF PATENT RIGHTS AND TECHNOLOGY
2.1 Licensor grants to Licensee the exclusive right and license
under the ALANEX Patent Rights and any related know-how to make, have made, use
or sell Licensed Product within the Territory.
2
19
* CONFIDENTIAL TREATMENT REQUESTED
The license granted herein shall, subject to third party rights,
include all improvements made by Licensor during the term hereof in the method
of manufacture or administration of Licensed Product.
2.2 Licensor grants to licensee and its Affiliates the unrestricted
right to sub-license any portion or all of the ALANEX Patent Rights and the
related know-how to make, have made, use or sell Licensed Product within the
Territory; provided that prior notice shall be given to Licensor. Licensee
shall remain primarily liable for the performance of such sub-licensees. Each
sub-licensee shall enter into a written sub-license agreement having the same
obligations towards Licensor as those provided for herein.
3. MILESTONE PAYMENTS
3.1 NOVO NORDISK's obligation to make milestone payments in accordance
with Section 7 of the Collaboration Agreement shall not be waived or otherwise
affected by entering into this Agreement.
4. ROYALTIES AND PAYMENT TERMS
4.1 Licensee will pay Licensor a royalty for the Sale of Licensed
Product at a royalty rate based on the amount of Net Proceeds of Sale, according
to the following schedule:
Annual Net Proceeds of Sale Royalty rate applicable to Sales
in described interval
***************** ***
******************** ***
******************** ***
******************** ***
4.2 Only one royalty shall be paid under this Agreement for each
Licensed Product, regardless of the number of claims of patents or patent
applications applicable thereto or the number of Sales of the same Licensed
Product by Licensee or any sublicensee of Licensee.
4.3 While Licensee will have the right to conduct Sales through
Affiliates and sub-licensees, Licensee shall be responsible for the payment of
all royalties and the performance of all other obligations hereunder for such
Sales.
4.4 In the event of the grant of one or more compulsory licenses in a
country in the Territory to a third party under any Patent included in the
ALANEX Patent Rights for a specific Licensed Product, the applicable royalty
rate as provided in Section 4.1 will be reduced by the same royalty payable by
that
3
20
*CONFIDENTIAL TREATMENT REQUESTED
third party in respect of the sale and manufacture of the specific Licensed
Product in that country of the Territory.
4.5 All royalties and other payments due hereunder shall be paid in
U.S. Dollars. All royalties and other payments due hereunder shall be originated
from a bank located in the U.S.A. and shall be made by bank wire transfer in
immediately available funds to such account as Licensor shall designate before
such payment is due. If at any time legal restrictions in any country in the
Territory prevent the prompt remittance in the manner set forth in this Section
4.5 of part or all royalties owning with respect to Sales of Licensed Product in
such country, then the parties shall meet and mutually determine a lawful manner
of remitting the restricted part of such royalty payment so long as such legal
restrictions exit.
4.6 With respect to Sales of Licensed Product invoiced in a currency
other than U.S. Dollars the Net Proceeds of Sales of licensed Product and the
royalties payable shall be calculated using the average closing buying rate for
such currency quoted in the continental terms method of quoting exchange rates
by the European version of the Wall Street Journal, or, in the absence of quoted
exchange rates from the European version of the Wall Street Journal, a
comparable bank or financial institution, on each of the last business days of
each month in the quarter prior to the date of payment.
4.7 If required to do so by law, Licensee may withhold from royalty
payments due to Licensor any withholding or similar taxes required to be
withheld or collected on behalf of Licensor, provided that any such deductions
for the payment of such taxes are supported by duly executed receipts.
4.8 NOVO NORDISK shall be entitled to deduct any milestone payments
made in respect of the relevant Program Compound from any royalties due
hereunder for the sale of the corresponding Licensed Products, it being
understood, however, that NOVO NORDISK shall in the event be allowed to
withhold more than **************** of the royalty amount otherwise due.
5. RECORD KEEPING PAYMENT AND REPORTS
5.1 Licensee shall keep a complete and correct account of the
amounts sold and Net Proceeds of Sale of Licensed Product, and shall be
obliged to keep such account for three (3) years after the year of making of a
royalty payment as provided in Article 5.2.
5.2 Licensee shall within sixty (60) days after the end of each
calendar quarter send to Licensor a written statement, certified by an
authorized officer of Licensee showing Net Proceeds of Sales of Licensed
Product, the deductions used to calculate such amount, withholding taxes, if
any, required by law to be deducted in respect of such sales, and the applicable
currency exchange
4
21
* CONFIDENTIAL TREATMENT REQUESTED
calculations. Such statements shall be accompanied by a payment of the total
amount of royalty then due. If no royalty is due, licensee shall nevertheless
render a statement to reflect such fact. Licensee shall also furnish such
additional information as Licensor may reasonably request from time to time to
assure that the proper royalty amount was paid.
5.3 Not more than once in a calendar year, at Licensor's request
and cost, Licensee agrees to allow Licensor's independent auditors to audit the
relevant books and records of Licensee relating to the Net Proceeds of Sale and
the determination of the royalty; provided, however, if any such audit reflects
a discrepancy of greater than 5% in the amount of royalties payable, Licensee
shall bear the cost of such audit.
6. WARRANTIES
6.1 Licensor represents and warrants that, to the best of its
knowledge, upon due investigation, as of the effective date of this Agreement:
6.1.1 it is the sole owner of the entire right, title and
interest in the ALANEX patent Rights and related know-how
and has the right to enter into this Agreement;
6.1.2 there are no administrative or judicial proceedings
contesting the inventorship, ownership, validity of
enforceability of any element of ALANEX patent Rights;
and
6.1.3 except as provided under or in connection with the
Collaboration Agreement, it has granted no prior license
or assignment of the ALANEX Patent Rights and the related
know-how within the Territory.
7. PAID-UP LICENSE
7.1 Licensee's obligation to pay royalties under Section 4.1 shall
cease and this Agreement will remain in effect as a paid-up, non-exclusive,
royalty-free license of the ALANEX Patent Rights and related know-how to make,
have made, use and sell the Licensed Product in a country covered by the
Territory upon the date of the (i) expiration of the last of any Patent
(product patents only) belonging to NOVO NORDISK in that country, or (ii)
*************** after the first commercial sale (i.e., after all required
regulatory and pricing approvals) of the Licensed Product in such country. If
the applicable ALANEX Patent Rights expire before the end of such **********
****** the royalties payable under Section 4.1 shall be reduced by ***********
************; provided that if material generic competition should develop for
the Licensed Product, the royalty rate shall be further reduced by another
*********************** on a country-by-country basis.
5
22
* CONFIDENTIAL TREATMENT REQUESTED
8. TERMINATION
8.1 If Licensee or Licensor at any time materially defaults in
rendering any of the reports required hereunder, or in the payment of any money
due hereunder or in fulfilling any of the other obligations or conditions
hereunder, either party may waive the default, or if electing not to waive the
default, such party shall notify the other in writing of said default and allow
sixty (60) days (or thirty (30) days in the case of non-payment) for the other
to correct the default. If at the end of said time period the default remains
uncorrected, the aggrieved party may terminate this Agreement and any licenses
granted thereunder by giving written notice of termination to the other party.
Upon the giving of such notice, this Agreement and any licenses granted
hereunder shall terminate immediately.
8.2 Licensee shall have the right to terminate this Agreement at any
time upon giving Licensor sixty (60) days' written notice. Licensee shall upon
such termination becoming effective pay to Licensor all royalties accrued prior
to such termination date.
9. LITIGATION
9.1 If any judgment holds claims of the ALANEX Patent Rights covering
such licensed Product, its use or manufacture unenforceable or invalid (whether
or not such judgment is further reviewable), any royalties which are due to be
paid to Licensor after the date of judgment under Section 4.1 shall be reduced
by ***********************; provided that if material generic competition
should develop for the Licensed Product, the royalty rate shall be further
reduced by another ***********************, on a country-by-country basis. In
the event that the validity or enforceability of the claims is reinstated, the
full royalty rate or amount specified in Section 4.1 shall be restored and
Licensee will pay Licensor the difference between the full and reduced royalty,
plus *************** annual interest, for the period when the reduced royalty
rate was in effect.
9.2 Licensor agrees to notify Licensee in writing if the validity,
infringement or priority of invention of any of the ALANEX Patent Rights is put
in issue by any person.
9.3 Upon learning of any infringement of the ALANEX Patent Rights,
Licensee will promptly discuss the matter with Licensor. If such infringement
is likely to materially and adversely affect the sale of the Licensed Product,
Licensee shall have the right at any time upon written notice to Licensor to
take whatever action Licensee in its reasonable discretion deems appropriate,
including appropriate court action, to terminate the infringement or to enter
into a settlement agreement with the infringing party or parties. Such action
shall include the defense of any action in which the validity or infringement
of the
6
23
* CONFIDENTIAL TREATMENT REQUESTED
ALANEX Patent Rights is placed in issue by a third party, e.g. by way of a
declaratory judgment action. Any such action or defense shall be under the sole
control of Licensee at Licensee's expense and with counsel of Licensee's
choosing and of whom Licensor does not reasonably object. Licensor shall have
the right to participate in such proceedings and to share equally all costs.
Licensor shall also be entitled to have a counsel of its choice observe the
progress of such action. Licensor agrees to cooperate fully with licensee and
provide Licensee with any assistance that Licensee might require in said action
(at Licensee's expense, as regards out-of-pocket expenses) including joining
with Licensee as a named party in any law suit in which licensee may become
involved in its efforts to terminate the infringement or confirm the validity
of the ALANEX Patent Rights. If Licensee does not elect within sixty (60) days
after such notice to so control the defense of such suit, Licensor may
undertake such control at its own expense, and Licensee shall then have the
right to be represented by advisory counsel of its own selection and at its own
expense, and Licensee shall cooperate fully with Licensor and provide Licensor
with any assistance that Licensor might require in said action.
9.4 After deduction of all legal fees and expenses of either party, any
sums received by Licensee, if Licensee controlled the suit, as damages or
settlement for infringement shall be shared equally if Licensor participated in
such proceedings (and shared the legal costs); otherwise, Licensee shall retain
***************** of such net recovery. If licensee does not elect to
control the defense of any suit as provided in Section 9.3 above, the Licensor
undertakes such control, Licensor shall retain such net recovery.
10. CONFIDENTIALITY
10.1 In consideration of disclosure by either of the parties to the
other party of confidential information in written or oral form or in the form
of samples, the recipient and the recipient's Affiliates undertake for a period
of ************ from the date of disclosure to treat received information as
strictly secret and therefore not to disclose it to any third party (except
reliable employees, sub-licensees and Affiliates under similar secrecy
obligations), and to make no commercial use of it except for the purposes of
this Agreement. This obligation does not apply to:
10.1.1 information which, at the time of disclosure, is already
in the public domain;
10.1.2 information which, after disclosure, becomes a part of
the public domain by publication through no violation of this Agreement;
10.1.3 information which the recipient is able to prove to have
been in possession of prior to any disclosure; or
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24
10.1.4 information which is hereafter lawfully disclosed by a
third party to the recipient, which third party did not acquire the information
under a still effective secrecy obligation.
11. NOTICES
11.1 All notices required or provided for use in this Agreement shall be
in writing and shall be given by telefax or certified mail prepaid and properly
addressed to the address of the party to be served as shown below. Notice shall
be effective upon the date on which such notice was dispatched. Reports under
Section 5.2 shall not be considered notices.
If to ALANEX: ALANEX CORPORATION
3550 General Atomics Court
San Diego, CA 92121
U.S.A.
Telefax:619/445-3201
If to NOVO NORDISK: NOVO NORDISK A/S
Novo Alle
DK-2880 Bagsvaerd
Denmark
Telefax: +45
12. FORCE MAJEURE
12.1 Each of the parties hereto shall be excused from the performance
of its obligations (other than the obligation to pay monies due) and shall not
be liable for damages to the other in the event that such performance is
prevented by circumstances beyond its effective control. Such excuse from
performance shall continue for so long as the condition responsible for such
excuse continues and for a thirty (30) day period thereafter. For the purposes
of this Agreement, circumstances beyond the control of a party which excuse
that party from performance shall include, but not limited to, acts of God,
acts, regulations or laws of any government, injunction or judgment of any
court, war, civil commotion, destruction of facility or materials by fire,
earthquake, storm or other casualty, labor disturbances, epidemic and failure
of public utilities or common carrier.
13. MISCELLANEOUS
13.1 This Agreement shall be construed and interpreted in accordance
with the laws of the State of New York. The English wording of this Agreement
shall prevail. The parties agree to submit to arbitration under the
International Chamber of Commerce any dispute arising from this Agreement which
cannot
8
25
be solved in an amicable manner. The arbitration shall take place in New York
City, New York, and shall not include the conciliation procedure. Judgment upon
the award rendered may be entered in any court in any country for execution.
13.2 Both parties hereto agree that it is not the intention to
violate any public policy, statutory or common laws. However, if any sentence,
paragraph, clause or combination of the same is in violation of any state or
federal law or is found to be otherwise unenforceable by a court from which
there is no appeal, or no appeal is taken, such sentences, paragraphs, clauses
or combinations of the same shall be deleted and the remainder of this
Agreement shall remain binding.
13.3 This Agreement and the covenants herein contained shall be
binding and inure to the benefit of the parties hereto and their heirs,
assigns, successors and legal representatives. Except as otherwise provided
herein, this Agreement shall not be assignable.
13.4 This Agreement constitutes the entire understanding between the
parties with respect to the subject matter hereof and shall, except for the
Collaboration Agreement, supersede all previous communications,
representations, understandings and agreements, either oral or written, between
the parties with respect to the subject matter of this Agreement. This
Agreement may be amended or modified only by a written instrument executed by
all of the parties hereto.
13.5 The paragraph headings contained herein are for reference only;
they are not a part of this Agreement nor shall they in any way affect the
interpretation thereof.
13.6 The express or implied waiver by either party of a breach of any
provision of this Agreement shall not constitute a continuing waiver of other
breaches of the same or other provisions of this Agreement.
IN WITNESS WHEREOF, the parties hereto have affixed their authorized signatures
as of the date given.
Bagsvaerd, 1995 San Diego, 1995
NOVO NORDISK A/S ALANEX CORPORATION
- ------------------------------------ ----------------------------------------
By: By:
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26
Addendum
- --------
HEALTH CARE CHEMISTRY [NOVO NORDISK LETTERHEAD]
Dr. Marvin Brown, President and Executive Officer
Alanex Corporation
3550 General Atomics Court
San Diego, CA 92121
U.S.A.
Addition to Section 4.3: Funding Commitment Modification
in the Collaboration Agreement between Alanex Corporation and Novo Nordisk.
As proposed by Novo Nordisk and accepted by Alanex *********************** will
be added per ********** by Alanex to the Research Program re. characterization
of novel ******************************************************************.
*************************************************************************.
The number of the Additional FTE's can be modified by the Steering Committee.
Which FTE's will be added to the Research Program is based on the decision of
the Steering Committee.
27
2.
*************************************************************************
*************************************************************************
*************************************************************************
*************************************************************************
********************************.
Bagsvaerd, 1996 San Diego, 1996
NOVO NORDISK A/S ALANEX CORPORATION
/s/ M. V. THOMSEN /s/ MARVIN R. BROWN
- -------------------------------- --------------------------------
By: M. V. Thomsen By: Marvin R. Brown
Corporate Vice President President & CEO