XXXXXXXXXX.XXXXX DA.4.20.98
ENZO DIAGNOSTICS, INC. - AFFYMETRIX, INC.
DISTRIBUTORSHIP AGREEMENT
THIS AGREEMENT, effective upon acceptance by both parties below, is by and
between ENZO DIAGNOSTICS, INC. ("ENZO"), a New York corporation having its
principal place of business at 00 Xxxxxxxxx Xxxxxxxxx, Xxxxxxxxxxx, Xxx Xxxx
00000-0000, and AFFYMETRIX, INC. and its affiliates ("AFFYMETRIX"), a California
corporation having its principal place of business at 0000 Xxxxxxx Xxxxxxxxxx,
Xxxxx Xxxxx, Xxxxxxxxxx 00000.
WHEREAS, ENZO holds rights to certain patents listed in EXHIBIT A ("PATENTS"),
and it warrants that it can grant the distributorship rights under this
AGREEMENT;
WHEREAS, ENZO manufactures and/or sells certain products listed in EXHIBIT B
("PRODUCTS") and/or certain components of the PRODUCTS ("LABELING AND DETECTION
COMPONENTS") defined below, the manufacture, sale or use of which is covered by
claims of one or more PATENTS (EXHIBIT A);
WHEREAS, ENZO owns or holds the rights to patent applications, proprietary
technology and know-how, trade secrets, and other technical and/or confidential
information, that was developed by ENZO or developed on its behalf; and
WHEREAS, AFFYMETRIX wishes to market and distribute directly or through its
designated affiliates and distributors, and to use said PRODUCTS as provided
hereunder in connection with arrays including GeneChip-Registered Trademark-
products and GeneChip-Registered Trademark- assays;
NOW, THEREFORE, in consideration of the good and valuable mutual agreements
hereinafter set forth, the parties hereto agree to the provisions below.
DEFINITIONS:
AFFYMETRIX AFFILIATE shall mean any corporation, company, partnership, joint
venture and/or firm which is controlled by AFFYMETRIX. For purposes of this
Section, "control" shall mean, in the case of corporations (or foreign
equivalents of corporations), direct ownership of 50% or more of the stock
having the right to vote for directors of such corporation or, in the case of
partnerships, 50% or more of the ownership interest in such partnership.
AFFYMETRIX Affiliates covered by this AGREEMENT, if any, will be listed in
EXHIBIT C. Other AFFYMETRIX Affiliates may be added to EXHIBIT C upon written
notice from AFFYMETRIX to ENZO, for the latter's written acceptance, which will
not be unreasonably withheld.
------------------------
THE SYMBOL "**" IS USED THROUGHOUT THIS EXHIBIT TO INDICATE THAT A
PORTION OF THE EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION.
AFFYMETRIX DISTRIBUTOR shall mean a bona fide distributor of Affymetrix probe
array products, which distributor is required to engage in substantive
marketing, distribution, and/or market development activities on behalf of
AFFYMETRIX. AFFYMETRIX Distributors covered by this AGREEMENT if any, will be
listed in EXHIBIT D. Other AFFYMETRIX Distributors may be added to EXHIBIT D
upon written notice from AFFYMETRIX to ENZO, for the latter's written
acceptance, which will not be unreasonably withheld. For purposes of this
AGREEMENT and this definition, all manufacturer's representatives of AFFYMETRIX
are considered to be AFFYMETRIX Distributors, and are also listed in EXHIBIT D.
AFFYMETRIX means Affymetrix, Inc., including AFFYMETRIX Affiliates and
AFFYMETRIX Distributors.
ENZO means Enzo Diagnostics, Inc.
PRODUCT means an individual reagent, component or combination thereof including
kits for use in nucleic acid labeling and detection, the manufacture, use or
sale of which is covered by one or more claims of ENZO PATENTS (EXHIBIT A), the
PRODUCTS being listed in EXHIBIT B.
LABELING AND DETECTION COMPONENT means a PRODUCT which comprises a labeling and
detection system manufactured by ENZO for labeling and detecting nucleic acids,
such labeling and detection methods being also covered by one or more claims of
ENZO's PATENTS.
QUALIFICATION means the demonstrated performance of a PRODUCT in an assay for
which such PRODUCT is intended as set forth in a PRODUCT specification.
1. DISTRIBUTOR APPOINTMENT
During the term of this AGREEMENT, ENZO hereby appoints AFFYMETRIX to act as its
nonexclusive worldwide distributor for the distribution and sale of only the
PRODUCTS listed in EXHIBIT B, and AFFYMETRIX accepts such appointment and agrees
to act as such distributor under the terms and conditions set forth herein.
During the term of this AGREEMENT, ENZO agrees to manufacture and/or supply the
PRODUCTS to AFFYMETRIX under the terms set forth herein.
2
AFFYMETRIX hereby agrees:
a. not to purchase any PRODUCTS from other suppliers or manufacturers;
b. not to manufacture PRODUCTS except as otherwise stated in this AGREEMENT;
c. to rely on ENZO as its sole source of PRODUCTS, including PRODUCTS for the
arrays including the GeneChip-Registered Trademark- arrays and
GeneChip-Registered Trademark- assays;
d. not to use any PRODUCT(s) to manufacture other PRODUCTS or other products,
except for quality control purposes or for developing new gene chip products
under specific authorization from ENZO as provided in Section 5 below;
e. that all PRODUCTS distributed by AFFYMETRIX are for distribution in the
research market for research use only; and that it is expressly understood that
the PRODUCTS are not intended for nor will they be used for diagnostic purposes
or as therapeutic agents; and
f. that except for distribution under the terms and conditions of this
AGREEMENT and authorized use as provided in Section 5 below, purchase of
PRODUCTS does not include any right or license to exploit the PRODUCTS
commercially, including any right or license to sell the PRODUCTS to other
distributors (except as listed in EXHIBIT D), and that any other commercial use
or development of these PRODUCTS or development using these PRODUCTS without the
express prior written authorization of ENZO is strictly prohibited.
ENZO hereby agrees:
a. to use reasonable efforts in QUALIFICATION of the PRODUCTS as set forth in
the PRODUCT specifications;
b. to manufacture and/or supply the PRODUCTS (EXHIBIT B) in accordance with
commercially reasonable practices and as set forth in Sections 5, 8, and 9; and
c. to manufacture and/or supply such PRODUCTS to meet the relevant
specifications accepted by both ENZO and AFFYMETRIX.
3
2. RELATIONSHIP BETWEEN ENZO AND AFFYMETRIX
Nothing herein creates or constitutes a partnership, joint venture, or an
agreement of agency between the parties with respect to any activities
whatsoever. The relationship between ENZO and AFFYMETRIX shall be that of
seller and buyer, and neither party shall conclude any contract or agreement or
make any commitment, representation or warranty which binds or purports to bind
the other party or otherwise act in the name of or on behalf of the other party.
ENZO and AFFYMETRIX agree that the distribution relationship between them does
not constitute, nor does it imply, a license of any of ENZO's technology or
patents, nor does it abrogate any of ENZO's rights under its patents. ENZO
maintains full rights under its PATENTS. The foregoing statements are paramount
to this AGREEMENT.
3. ASSIGNMENT
This AGREEMENT may not be assigned or otherwise transferred by AFFYMETRIX
without the prior written consent of ENZO, except in the case of a
reorganization or reincorporation of AFFYMETRIX, in which case this AGREEMENT
may be assigned. Any attempted assignment or transfer without such consent
shall be void AB INITIO. In the case of an outright bona fide purchase by a
third party of all of AFFYMETRIX's relevant significant probe array assets, ENZO
will not unreasonably withhold its consent to the assignment or transfer of this
AGREEMENT by AFFYMETRIX to such third party. Any such third party will be
subject to all of the provisions and obligations of this AGREEMENT. In the
event that ENZO consents to the assignment or transfer of this AGREEMENT, then
the provisions of Section 16 below with respect to termination will be shortened
from six (6) months to four (4) months.
Notwithstanding any of the provisions of the preceding paragraph, the authorized
use rights from ENZO to AFFYMETRIX described in further detail in Section 5
below cannot be assigned or otherwise transferred by AFFYMETRIX under any
circumstances, unless prior written approval from ENZO is first obtained.
4. PAST SALES AND ACTIVITIES
AFFYMETRIX and ENZO agree that as between [**.]
4
5. PRODUCTS AND PRICE AND PAYMENT
PRODUCTS covered by this AGREEMENT are listed in EXHIBIT B. The price to
AFFYMETRIX will be [**.] For new or modified PRODUCTS not listed in EXHIBIT B,
the transfer price to AFFYMETRIX for each PRODUCT will be [**.] ENZO has the
right to adjust prices to AFFYMETRIX after providing AFFYMETRIX with [**]
written notice. Any price adjustment will affect future purchases, but will not
affect those already under existing firm purchase order commitment. ENZO will
not [**] as described further below in this section.
Notwithstanding the provisions of Section 8 below, ENZO, may, at its sole
discretion and upon written notice to AFFYMETRIX, designate another party as an
interim manufacturer to manufacture certain PRODUCTS or certain components of
PRODUCTS for ENZO. Upon written notice to AFFYMETRIX, ENZO may, at its sole
option, either resume manufacturing such PRODUCT(s) or such PRODUCT components
itself, or it may designate another alternate manufacturer.
New products may be added to this AGREEMENT and will be considered PRODUCTS and
listed in EXHIBIT B upon the consent of ENZO and AFFYMETRIX.
ENZO agrees to permit AFFYMETRIX to use PRODUCTS and ENZO's confidential
information ("C.I.") as defined in Section 14 below only for the following
purposes and AFFYMETRIX agrees that its use of same shall be limited to:
(a) performing quality control procedures for the PRODUCTS;
(b) optimizing the function of GeneChip-Registered Trademark- products and
GeneChip-Registered Trademark- Assays; and
(c) developing new gene chip products.
If any invention or product is conceived during the course of AFFYMETRIX' use of
the PRODUCTS and/or ENZO's C.I. and is directed to the PRODUCTS, or their use,
or improvements thereto, [**,] and [**.]
AFFYMETRIX agrees to reimburse ENZO for its costs and reasonable overhead
incurred in the development of any new PRODUCTS or products as reasonably
requested by AFFYMETRIX and approved in writing by both parties.
5
6. TERMS OF PAYMENT AND AUDIT
Payment shall be net thirty (30) days from delivery of PRODUCT.
At the end of each calendar year, AFFYMETRIX will additionally pay ENZO
an amount equal to [**] for PRODUCTS sold hereunder to account for the
distribution, sales and services provided by use of the GeneChip-Registered
Trademark- arrays or array sets in those instances where PRODUCTS were
purchased from ENZO in quantities less than would be used in conjunction with
the GeneChip-Registered Trademark- arrays or array sets associated with a
PRODUCT during such calendar year. If [**], then AFFYMETRIX will
additionally pay ENZO an amount equal to [**] for such PRODUCTS. AFFYMETRIX
can adjust this annual payment if [**.] Any such payments shall be
contingent upon ENZO meeting the time, quantity, and quality requirements of
AFFYMETRIX for the PRODUCTS, provided that any adjustments shall be only to
the extent of any deficiencies in supply by ENZO.
AFFYMETRIX agrees to permit its books and records related to the product
sales to be examined by ENZO on reasonable prior written notice to verify
receipts. Examination will take place on reasonable prior written notice, as
necessary, but not more often than once per year.
7. PRODUCT SHIPMENTS
All PRODUCTS shipped by ENZO to AFFYMETRIX will be shipped F. 0. B.
Farmingdale, NY.
8. FORECASTS AND PURCHASE ORDERS
AFFYMETRIX will issue a forecast schedule during the [**] covering its
estimated requirements for PRODUCTS for the succeeding [**]. Such forecast
will be considered for planning purposes only and not a purchase commitment.
Within ten (10) business days after the effective date of this AGREEMENT,
AFFYMETRIX will issue to ENZO its first forecast schedule, it being
understood by the parties that the first forecast for PRODUCTS will be based
upon an [**.]
A purchase order will be issued by AFFYMETRIX at least [**] in advance
of the requested delivery of PRODUCT. This purchase order will indicate
specific delivery and/or shipping requirements. Orders placed with ENZO may
not be canceled by
6
AFFYMETRIX more than [**] after issuance of the order. ENZO will meet such
delivery and/or shipping requirements unless it advises AFFYMETRIX within [**]
of the date of such purchase order that it is unable to supply PRODUCT as
ordered by AFFYMETRIX, whereupon the parties agree to discuss a revised
schedule for delivery of PRODUCT to AFFYMETRIX. After ENZO and AFFYMETRIX
agree to the provisions of a revised schedule, ENZO will make reasonable
efforts to fulfill the provisions of the revised schedule; in no instance,
however, will PRODUCT(s) be shipped [**] after issuance of the purchase order
by AFFYMETRIX, unless agreed to by both parties. If ENZO is unable to meet
the revised schedule, ENZO may designate interim or temporary manufacturers
to manufacture PRODUCTS for ENZO, until such time as ENZO is ready to
recommence supply by itself to AFFYMETRIX.
Each purchase order shall be governed by the relevant provisions of this
AGREEMENT (unless otherwise expressly provided in the individual purchase
order and confirmed in writing by ENZO and AFFYMETRIX) and no term or
condition which may appear in the printed matter in an AFFYMETRIX order form
or any ENZO form that is contrary to the provisions of this AGREEMENT shall
be binding on either party or apply to any transaction under this AGREEMENT.
9. PRODUCT DELIVERIES AND SPECIFICATIONS
Within a reasonable period of time not to exceed thirty (30) calendar
days after the effective date of this AGREEMENT, ENZO and AFFYMETRIX will
confer for the purpose of drafting and finalizing specifications,
formulations, refining the PRODUCT list, such refinements including the use
of existing ENZO PRODUCTS or ENZO PRODUCTS under development performing in an
equivalent manner, and package inserts for those PRODUCTS in Exhibit B that
AFFYMETRIX intends to distribute. The purpose of such conference will also
include any other matters or details necessary or appropriate to carry out
the provisions of this AGREEMENT.
When an order is placed by AFFYMETRIX, ENZO shall ship the PRODUCT in
accordance with Sections 7 and 8 above. Failure by AFFYMETRIX to notify ENZO
of rejection of the PRODUCT within [**] of receipt of PRODUCT will constitute
acceptance. ENZO will supply, at the time of shipment of the PRODUCT to
AFFYMETRIX, a statement that the PRODUCT conforms to the PRODUCT
specifications.[**.]
7
AFFYMETRIX shall immediately give written notice to ENZO of any notice,
claim, demand, or communication from another for which AFFYMETRIX wishes to
obtain indemnification from ENZO. As part of the notice given to ENZO,
AFFYMETRIX shall include copies of all correspondence and written materials
relating to the notice.
In its sole and absolute discretion, [**.]
[**.]
10. SALES PROMOTIONS
AFFYMETRIX shall exert on its own account its commercially reasonable
efforts in sales promotions and advertisement of the PRODUCTS in association
with the sale of others of its products. Such efforts may include individual
client contact, direct mailings, catalog listings and trade meeting
promotions. Upon request, ENZO will provide AFFYMETRIX with literature,
technical data, specifications and the like describing any of ENZO's PRODUCTS
for the purpose of assisting AFFYMETRIX in the preparation of advertisements,
catalogs and other sales and promotional material for the PRODUCTS.
AFFYMETRIX will list PRODUCTS in its next available or published product
catalog(s) in which the PRODUCTS can be listed after the effective date of
this AGREEMENT. ENZO has the right to list the PRODUCTS in its product
catalog and other advertisements and sales and promotional materials, it
being understood that as a result of such activities of ENZO certain PRODUCTS
may be purchased directly from ENZO or its distributors or licensees, and
AFFYMETRIX shall be relieved from certain of its payments under Section 6 for
any such sales.
11. PRODUCT WARRANTY
ENZO warrants that the PRODUCTS manufactured by ENZO for distribution by
AFFYMETRIX will meet the specifications described in ENZO's PRODUCT or
package inserts. [**.] ENZO further warrants that all relevant quality
control tests and quality assurance procedures will be performed for each
batch of PRODUCTS so that each batch of PRODUCT conforms with the
specifications, and that the PRODUCTS will be contained, packaged and labeled
as specified by the product specifications for such PRODUCTS.
8
12. STORAGE AND STOCK ROTATION
ENZO agrees to share with AFFYMETRIX all necessary storage and stock
rotation practices which apply to the PRODUCTS.
AFFYMETRIX further agrees to take reasonable care not to ship PRODUCTS
to its customers which have expired, been damaged in shipping and/or
handling, or been improperly stored by AFFYMETRIX. AFFYMETRIX will be
responsible for damages arising from its shipment to its customers of
PRODUCTS that have expired, been damaged in shipping and/or handling, or been
improperly stored by AFFYMETRIX.
13. PRODUCT LABELS AND PACKAGING
AFFYMETRIX and ENZO agree to ship all PRODUCTS with a joint PRODUCT
label and joint PRODUCT insert, both of which prominently include the names
ENZO DIAGNOSTICS, INC.
and
AFFYMETRIX, INC.
with their respective company logos where appropriate.
AFFYMETRIX agrees to package and to ship the PRODUCTS as part of or in
association with applicable GeneChip-Registered Trademark- assays containing
the package inserts to be finalized in accordance with Section 9 of this
AGREEMENT and will use reasonable efforts to cause users of that assay to
utilize the PRODUCTS. In that product insert, AFFYMETRIX will recommend and
instruct the end-user of that assay to use only the PRODUCTS contained
therein. AFFYMETRIX will also advise the end-user of that assay that any
warranty for that assay will not be effective as a result of failure to use
the PRODUCTS associated with such assays contained therein.
14. CONFIDENTIALITY
AFFYMETRIX and ENZO agree that they will not disclose any proprietary
and confidential information (collectively "C.I.") made available to them by
the other party. Both parties further agree that all C.I. material will be
in writing and marked confidential and that they will not make more copies
than necessary of documents or materials
9
which are provided under this AGREEMENT, nor will they distribute such
documents or materials, or copies thereof, to any third party. Furthermore,
both parties agree to return any such documents or materials, or copies
thereof, which are provided under this AGREEMENT if directed or requested to
do so.
The above obligations shall not apply to those portions of ENZO's and
AFFYMETRIX's C.I. which (1) are or become generally publicly available
through no act or failure to act by the recipient party, (2) were
demonstrably known to the receiving party prior to disclosure under this
AGREEMENT, or (3) are subsequently disclosed by a third party having a legal
right to do so and not having a confidential relationship with respect
thereto.
15. FORCE MAJEURE
No liability shall result to either party from delay in performance or
from nonperformance under this AGREEMENT caused by circumstances beyond the
control of the party who has delayed performance or not performed. The
nonperforming party shall be diligent in attempting to remove any such cause
and shall promptly notify the other party of its extent and probable duration.
16. DURATION AND TERMINATION
This AGREEMENT shall become effective as of the date of the last signing
party below, and it will continue for a period of three (3) years. Unless
terminated, it will continue thereafter for successive renewal terms of one
(1) year each. Thereafter, or six (6) months prior to the end of the initial
three year period in the case where termination at the end of the initial
three year period is desired, either party may terminate this AGREEMENT
without cause at any time by giving the other party notice in writing at
least six (6) months in advance of the effective termination date stated in
such written notice. Notwithstanding the foregoing provisions of this
paragraph, all other provisions in this AGREEMENT relating to termination,
including Sections 3 (Assignment) and 17 (Indemnification) will remain in
full force and effect.
Upon termination of this AGREEMENT all distribution and use rights to
AFFYMETRIX will be deemed immediately canceled and will revert in toto to
ENZO.
10
17. INDEMNIFICATION
Except as set forth in and subject to the following paragraphs of this
section, no party shall be liable for damages related to the PRODUCTS of this
AGREEMENT arising from the fault or acts of commission or omission of the
other party.
[**.]
Notwithstanding anything herein to the contrary, [**.]
The obligations of AFFYMETRIX set forth in this section shall be binding
on its successors, assigns, or trustees, and shall survive liquidation,
insolvency, bankruptcy, sale, receivership, and general assignment of
AFFYMETRIX and its successors in interest. No assignment or delegation by
AFFYMETRIX shall relieve it of its obligations under this section. [**.]
The obligations of AFFYMETRIX set forth in this section shall survive
the termination of this AGREEMENT for any reason, even if such termination is
based on ENZO's breach of this AGREEMENT. Any breach by AFFYMETRIX of its
obligations set forth in this section shall be deemed material and shall
entitle ENZO to terminate this AGREEMENT immediately and without affording
AFFYMETRIX an opportunity to cure.
[**.]
Any breach of this provision by AFFYMETRIX will be considered a material
breach of this AGREEMENT, affording ENZO a right to terminate immediately
without notice for cause.
18. NOTICES
All notices to be given with respect to this AGREEMENT shall be in writing
and shall be deemed effectively given:
when telecopied or faxed, receipt acknowledged; or
when addressed as set forth below, or to such other address that either
party designates by written notice to the other party by Federal Express or
similar overnight courier:
11
ENZO:
Enzo Diagnostics, Inc.
c/o Enzo Biochem, Inc.
000 Xxxxxxx Xxxxxx, 0xx Xxxxx
Xxx Xxxx, XX 00000
Attn: Xx. Xxxxxxx X. Xxxxxxxxxx
Vice President, Corporate Development
Fax No.: (000) 000-0000.
AFFYMETRIX:
Affymetrix, Inc.
0000 Xxxxxxx Xxxxxxxxxx
Xxxxx Xxxxx, XX 00000
Attn: President
Fax No.: (000) 000-0000.
19. GOVERNING LAW
This AGREEMENT is made under and shall be governed by the laws of the
State of New York.
20. WAIVER
Waiver by ENZO or AFFYMETRIX of any provision of this AGREEMENT shall
not be deemed a waiver of future compliance therewith and such provision as
well as all other provisions hereunder shall remain in full force and effect.
21. COMPLIANCE WITH LAWS
Each party will comply with all United States laws, ordinances and
regulations properly applicable to the manufacture, sale and distribution of
the PRODUCTS described herein. Where applicable, the parties will comply
with the laws of the country in which the product is being sold.
12
22. HEADINGS
All headings of the clauses of this AGREEMENT are inserted for
convenience only and shall not affect any construction or interpretation of
this AGREEMENT.
23. SEVERABILITY
In the event that any clause of this AGREEMENT shall be found to be void
or unenforceable, such finding shall not be construed to render any other
clause of this AGREEMENT either void or unenforceable, and all other clauses
shall remain in full force and effect unless the clause(s) which is/are
invalid or unenforceable shall substantially affect the rights or obligations
granted to or undertaken by either party.
24. ENTIRETY
This AGREEMENT together with the EXHIBITS attached hereto embodies the
entire understanding between AFFYMETRIX and ENZO, and there are no contracts
or prior drafts of the AGREEMENT, understandings, conditions, warranties or
representations, oral or written, express or implied, with reference to the
subject matter hereof which are not merged herein. Except as otherwise
specifically stated, no modification hereto shall be of any force or effect
unless (1) reduced to writing and signed by both parties hereto, and (2)
expressly referred to as being modifications of this AGREEMENT.
IN WITNESS WHEREOF, the parties have caused this AGREEMENT to be
executed by their duly authorized representatives on the dates indicated
below.
ENZO DIAGNOSTICS, INC. AFFYMETRIX, INC.
By: /s/ By: /s/
---------------------------------- ----------------------------------
Printed Name XXXX XXX XXXXXXXXXX Printed Name XXXXXXX P.A. XXXXX, Ph.D.
------------------------ -------------------------
Title: Senior Vice President Title: President and CEO
------------------------------- ------------------------------
Date: April 20, 1998 Date: April 24, 1998
------------------------------- ------------------------------
13
XXXXXXXXXX.XXXXX DA.4.20.98
*******
14
EXHIBIT A
[**]
EXHIBIT B
[**]
EXHIBIT C
AFFYMETRIX AFFILIATES
THIS PAGE IS INTENTIONALLY LEFT BLANK
EXHIBIT D
AFFYMETRIX DISTRIBUTORS
Amersham Pharmacia Biotech
