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EXHIBIT 10.35
CUSTOM SYNTHESIS
DEVELOPMENT AND SUPPLY AGREEMENT
By and Between
MERCK & CO., INC.
and
ARRAY BIOPHARMA INC.
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This Agreement (the "Agreement") confirms the mutual understanding by and
between Merck & Co., Inc., a corporation organized and existing under the laws
of the State of New Jersey with its principal place of business at Xxx Xxxxx
Xxxxx, Xxxxxxxxxx Xxxxxxx, XX 00000 ("MERCK"), and Array BioPharma Inc., a
corporation organized and existing under the laws of the State of Delaware with
a place of business at 0000 00xx Xxxxxx, Xxxxxxx, Xxxxxxxx 00000 ("ARRAY").
WHEREAS, ARRAY has the ability and expertise to prepare collections of drug-like
small molecule compounds which are amenable to high-speed synthesis ("Custom
Libraries"); and
WHEREAS, MERCK desires for ARRAY to annually synthesize a certain number of
Custom Libraries solely for MERCK on an exclusive basis.
NOW THEREFORE, MERCK AND ARRAY agree as follows:
1. Purpose: Following execution of this Agreement, MERCK shall identify
Custom Libraries it would like ARRAY to synthesize. ARRAY agrees to
diligently perform services for the purpose of synthetically preparing
such Custom Libraries for MERCK (the "Services").
2. Library Design Committee: Within thirty days of the Effective Date of
this Agreement, the parties shall form a Library Design Committee
("LDC") comprised of two representatives from each party.
(a) MERCK shall submit all requests for the development of Custom
Libraries to the LDC. The LDC shall review all MERCK requests,
advise regarding the feasibility of such requests, and approve
and/or modify such requests where reasonable.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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(b) The LDC shall meet every other month, at ARRAY's offices in
Boulder, Colorado, to review the ongoing status and any
scientific issues raised by the Services performed hereunder.
(c) The parties agree that they will cooperate to reasonably
resolve any scientific disputes related to the development of
Custom Libraries. In the event that the parties cannot
reasonable resolve any such disputes, the LDC shall meet to
try to reach a final resolution.
3. Materials: MERCK shall provide to ARRAY such non-commercially available
materials in MERCK's internal collection necessary for Array to perform
the Services. Additionally, Merck shall be responsible for providing or
reimbursing (if approved by MERCK prior to purchase) Array for all
other reagents which are necessary for the synthesis of any requested
Custom Libraries (the aforementioned "non-commercially available
materials and the reagents provided or paid for by MERCK shall
hereinafter be "Materials"). These Materials are not to be used in
humans. It is understood that such materials are provided solely for
the Services being performed hereunder and shall not be used for any
other purpose nor shall such samples or any derivatives, analogs,
modifications or components thereof be transferred, delivered or
disclosed to any third party without the advance written consent of
MERCK. Any unused Materials shall be returned to MERCK promptly upon
completion of such Services or otherwise disposed of in accordance with
instructions from MERCK.
4. Custom Library Supply:
(a) ARRAY shall develop and provide approximately [ * ] Custom
Libraries for MERCK each year. Each compound provided within a
Custom Library shall be provided in [ * ] mg amounts and in
two sets of vials provided by MERCK. The number of compounds
per Custom Library will vary; but ARRAY hereby agrees to
synthesize approximately [ * ] compounds per year with
approximately [ * ] compounds per Custom Library.
(b) The Custom Libraries generated hereunder and all compounds
included therein shall be the sole and exclusive property of
MERCK. ARRAY shall deliver to MERCK, each Custom Library [ * ]
of the requested amount for each compound within a Custom
Library, accompanied by a writing, in English, describing the
step-wise synthetic procedure to prepare each compound within
the Custom Libraries ("Product Report"), HPLC analysis
(detection technique to be determined by the LDC on a Custom
Library by Custom Library basis) and mass spectral (MS)
analyses to prove chemical identity and confirm minimum purity
of [ * ] and an average purity of at least [ * ]. MERCK shall
have no obligation to accept or pay for any Custom Libraries
for which any of this data is not provided.
(c) [ * ]
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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5. Term: The Term of this Agreement shall be three years with the Services
commencing on January 1, 2001 (the "Effective Date") and ending on
December 31, 2003, unless sooner terminated pursuant to Article 15
herein.
6. Amount: Each time MERCK requests the development of a Custom Library,
MERCK shall pay a non-refundable except as provided under Article
15(b)(2), process development fee, of [ * ] per compound, for such
Custom Library. ARRAY shall have no obligation to develop or provide
Custom Libraries which are not approved by the LDC pursuant to Article
2(a). MERCK shall have no obligation to make any payment hereunder
until its Custom Library Request is approved by the LDC pursuant to
Article 2(a). Within thirty days after receipt of any Custom Library
compound(s), MERCK shall pay ARRAY an additional and final amount of
[ * ] per compound meeting the specifications set forth herein. If
MERCK fails to notify ARRAY within thirty days of its receipt of
compound(s) that such compounds do not meet the applicable
specifications, then such compound(s) shall be deemed accepted. Within
thirty days after receiving the remaining compound(s) for each Custom
Library and the Product Report, MERCK shall pay ARRAY an additional and
final amount of [ * ] per compound meeting the specifications set forth
herein in such final Custom Library delivery. If MERCK fails to notify
ARRAY within thirty days of its receipt of a final Custom Library
delivery and Product Report , that such Custom Library compound(s) do
not meet the applicable specifications or that the Product Report is
incomplete, then such Custom Library compounds and Product Report shall
be deemed accepted. MERCK shall have no obligation to make any payments
whatsoever or bear any costs or expenses for any Custom Libraries other
than those set forth hereunder. Additionally, MERCK shall pay ARRAY for
[ * ], quarterly in advance, starting on the Effective Date at an
annual rate per FTE of [ * ]. All fees and schedule payments to Array
shall be adjusted on an annual basis to reflect the aggregate increase
in the Producer Price Index for Pharmaceutical Manufacturers (Table 3 -
Producer Price Indexes for Selected Commodity Groupings Unadjusted
Index Commodity Code 06-3) during the preceding year.
7. Confidentiality: ARRAY agrees to keep confidential and not to use,
except for the purpose described in Article 1 above, all information
supplied by MERCK and all information, reports and Custom Libraries
generated by ARRAY as a result of the Services performed hereunder.
These obligations of confidentiality and non-use shall continue at all
times beyond the term of this Agreement. This Agreement shall not
restrict ARRAY's use or disclosure of information which (i) is in the
public domain by use and/or publication before its receipt from MERCK;
(ii) was already in ARRAY's possession prior to receipt from MERCK,
except if such information was received or developed under a prior
agreement with MERCK; (iii) is properly obtained by ARRAY from a third
party which has a valid legal right to disclose such information to
ARRAY and is not under a confidentiality obligation to MERCK; or (iv)
is required to be disclosed by a Court of competent jurisdiction
provided ARRAY gives MERCK prompt notice of such disclosure
requirement.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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8. Reports/ Use of Information: ARRAY shall provide MERCK with written
reports on a monthly basis for each of the Custom Libraries, and the
Product Report upon delivery of each Custom Library as outlined in
Articles 4 and 6 of this Agreement. MERCK and its Affiliates (entities
at least 50% owned by, under common ownership with or which own at
least 50% of MERCK) shall have the right to use [ * ]. It is further
understood that MERCK and its Affiliates shall have an unrestricted
right to use [ * ] Agreement or [ * ] hereunder, provided the [ * ]
Services performed hereunder.
9. Inventions: ARRAY shall promptly inform MERCK of any and all inventions
or discoveries. Inventions and discoveries, whether patentable or not,
resulting from the Services and related to the Custom Libraries, and
all Custom Libraries and compounds therein, (with the specific
exception of synthetic chemical procedures and protocols which would be
considered general chemical knowledge, applicable to a broad range of
synthetic procedures and in no way specific to MERCK's Custom Libraries
and compound(s)) [ * ]. For the avoidance of doubt, [ * ] shall
include, but not be limited to, [ * ]. Prior to the initiation of
Custom Library synthesis by Array, the LDC shall establish which
templates shall define analogs for each Custom Library. ARRAY will,
upon request by MERCK and at MERCK's expense, promptly execute any and
all [ * ], which shall be [ * ] MERCK at MERCK's cost and expense.
MERCK hereby grants to ARRAY a non-exclusive, worldwide, fully-paid,
royalty-free, non-sublicensable license to [ * ] to the extent that
they are necessary or useful in [ * ]. However, it is expressly
understood and agreed to by the parties that (1) ARRAY shall not
disclose to any third party the existence of, or its right to use,
[ * ]; and (2) ARRAY may only use such [ * ] a product which can be
manufactured using such [ * ]"
ARRAY represents and warrants that no governmental entity nor any third
party has or shall have any claim or right to any inventions or
discoveries resulting from the Services hereunder.
10. Compliance with Law: ARRAY shall conduct the Services in accordance
with all applicable laws, rules and regulations, including without
limitation, all current governmental regulatory requirements concerning
Good Laboratory Practices. ARRAY hereby certifies that it will not or
has not employed or otherwise used, in performing the Services, any
person debarred under Section 306 (a) or (b) of the Federal Food, Drug
and Cosmetic Act.
11. Limitation of Liability: MERCK assumes no responsibility and shall have
no liability for the conduct of the Services, testing or other work
performed by ARRAY under this Agreement. Notwithstanding the foregoing,
ARRAY assumes no responsibility and shall have no liability for any use
or other disposition of the compound(s) by MERCK or its Affiliates.
12. Indemnification
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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(a) ARRAY hereby agrees to indemnify, defend and hold harmless,
MERCK, its subsidiaries and Affiliates and their respective
officers, employees and directors against any and all claims
for liability, loss, damages, costs or expenses (including
attorneys' fees and expenses and costs of investigation)
brought by a third party, which any of them may incur, suffer
or be required to pay as the result of any damage suffered or
alleged to be suffered, including, without limitation, death
or personal injury and any direct, consequential, special
and/or punitive damages, which result from the gross
negligence or willful misconduct of ARRAY in the course of
performing the Services performed by ARRAY, hereunder,
provided, however, that such loss, liability or damage is not
attributable to the fraud, gross negligence, or willful
misconduct of MERCK.
(b) MERCK hereby agrees to indemnify, defend and hold harmless,
ARRAY, its subsidiaries and Affiliates and their respective
officers, employees and directors against any and all
liability, loss, damages, costs or expenses (including
attorneys' fees and expenses and costs of investigation) which
any of them may incur, suffer or be required to pay as the
result of any damage suffered or alleged to be suffered,
including, without limitation, death or personal injury and
any direct, consequential, special and/or punitive damages,
for claims that result from the commercialization (including
Product Liability) by MERCK of any compound(s) delivered by
ARRAY, hereunder, provided, however, that such loss, liability
or damage is not attributable to the fraud, gross negligence,
or willful misconduct of ARRAY.
13. Use of Name: Neither party shall use the name, trade name, trademark or
logo of the other party in any publicity, news releases or advertising
related to this Agreement or the subject matter hereof without the
prior written consent of the other party. Subject to the foregoing,
ARRAY may issue a one-time press-release, (a copy of which is attached
hereto as Exhibit A) regarding this Agreement and the Services provided
to MERCK, hereunder. Such press-release shall be subject to MERCK's
prior review and approval. Thereafter, ARRAY may discuss the specific
content of the original press-release with third parties without
advance written consent from MERCK, but ARRAY may not issue any other
press-release(s) or issue any publicity or advertising using Merck's
name, trade name, trademarks or logo, except as expressly stated
herein, without the prior written consent of MERCK.
14. Governing Law: This Agreement shall be governed by the laws of the
State of New Jersey and the United States as applicable herein.
15. Termination:
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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(a) Following the one year anniversary of this Agreement, MERCK
may terminate this Agreement at any time, upon six month's
written notice. Six months following the date that the
termination notice is sent shall be considered the
"Termination Date." MERCK will have no further financial
obligations to ARRAY following the Termination Date.
(b) Either party may terminate this Agreement, at any time, for
cause, upon thirty days written notice if such non-conforming
performance is not cured within such thirty day period. In
such event:
(1) [ * ] ; and
(2) [ * ]
(c) [ * ]. Additionally, the provisions of Articles 7, 8, 9,
10, 11, 12, 13, 14 and 15 shall survive termination or
expiration of this Agreement.
16. Assignment: [ * ]
17. Force Majeure: Neither party shall be held liable or responsible to the
other party nor be deemed to have defaulted under or breached the
Agreement for failure or delay in fulfilling or performing any term of
the Agreement when such failure or delay is caused beyond the
reasonable control of the affected party such as fire, floods,
embargoes, war, acts of war, insurrections, riots, civil commotions,
strikes, lockouts or other labor disturbances, acts of God or acts,
omissions or delays in acting by any governmental authority or the
other party. The affected party shall notify the other party of such
force majeure circumstances as soon as reasonably practical.
18. Contacts: All notices which are required or permitted hereunder shall
be in writing and sufficient if sent by e-mail, telecopier or
nationally-recognized overnight courier or sent by registered or
certified-mail, postage prepaid, and addressed as follows:
If to MERCK: Merck & Co., Inc.
Attn: Office of the Secretary
Xxx Xxxxx Xxxxx
Xxxxxxxxxx Xxxxxxx, XX 00000
With a copy to: [ * ]
If to ARRAY: Array BioPharma, Inc.
Attn: Chief Operating Officer
0000 00xx Xxxxxx
Xxxxxxx, XX 00000
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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19. Entire Agreement: This Agreement constitutes the entire agreement
between the parties with regard to the Custom Library Services provided
by ARRAY hereunder. All express or implied agreements and
understandings, either oral or written, heretofore made are expressly
merged in and made a part of the Agreement. The Agreement may be
amended, or any term hereof modified, only by a written instrument duly
executed by both parties hereto.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duly authorized representatives, effective as of the later date set forth
below.
MERCK & CO., INC. ARRAY BIOPHARMA, INC.
By: /s/ Xxxxxx X. Xxxxxxxx, M.D. /s/ Xxxxx Xxxxxxx
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Title: President Chief Operating Officer
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Date: 9/6/00 8/22/00
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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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EXHIBIT A
PRESS RELEASE
[ * ]
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
