Wyeth-Ayerst Laboratories
September 30, 1997
Page 5
September 30, 1997
Wyeth-Ayerst Laboratories
P.O. Box 8299
Philadelphia, PA 19101-1245
Dear Sirs:
This letter sets forth the proposed terms and conditions for an
extension of the Agreement between Ostex International, Inc. ("OSTEX") and
Wyeth-Ayerst Laboratories ("W-A") dated September 20, 1995, regarding detailing
of diagnostic testing, prevention and treatment of osteoporosis to health care
professionals.
1. OSTEX grants W-A a world-wide, non-exclusive right to detail
osteoporosis diagnostic tests developed by OSTEX together with
technology, data, test results, clinical and other studies related
thereto and sales materials, medical education programs, disease
management programs and sample tests so as to promote the sale and
utilization of OSTEX's osteoporosis tests.
2. W-A grants OSTEX the non-exclusive right to detail W-A products
marketed by W-A together with promotional, educational and sales
materials so as to encourage the use of W-A's Premarin(R) family of
products in the prevention and treatment of osteoporosis.
3. It is understood and agreed that each party shall determine, in its
sole discretion, the detailing activities it shall undertake, including
frequency, detail position, physician targets, field force commitment,
call plan and whether or not to detail.
4. The parties shall appoint coordinators who shall meet regularly to
develop advertising, marketing and sales programs, including sales
training programs, for the OSTEX and W-A products to be detailed
hereunder. Such programs may include medical education for health care
professionals, disease management programs for managed care audiences
and convention exhibits for key target audiences. Each party shall
provide appropriate training materials and trainers to educate the
trainers and/or sales representatives of the other party.
5. OSTEX agrees to conduct or arrange for the conduct of assays to
generate data derived from osteoporosis diagnostic tests developed by
OSTEX and utilized in patients receiving W-A products. OSTEX grants W-A
the non-exclusive right to utilize OSTEX test data in detailing W-A
products.
6. Neither party shall be obligated to make payments to the other for any
rights granted or services to be performed hereunder. Each party shall
be responsible for its own expenses in connection with negotiations,
documents, or transactions, services or performance contemplated hereby
and additionally neither party shall have any liability whatsoever for
any fees or expenses of the other party owed to third parties.
7. Neither party shall have any responsibility for the hiring,
firing, compensation or employee benefits of the other party's employees.
Except as specifically set forth herein, no employee or representative of a
party shall have any authority to bind or obligate the other party for any sum
or in any manner whatsoever, or to create or impose any contractual or other
liability on the other party without such other party's written approval. OSTEX
and W-A's legal relationship under this Agreement shall be that the parties are
independent of each other and not that of partners or joint venturers. Neither
party's representatives shall have any authority regarding sales of the other
party's products or to bind or obligate the other party for any orders, prices,
discounts, rebates, allowances, etc., or any other commercial terms and
conditions of sale.
8. Each party hereby represents and warrants to the other that its
products shall be approved by FDA for marketing; that neither the
products' applications for market approval nor any other filing with
FDA or other reports or records shall contain any misrepresentations of
material fact. Each party further represents and warrants that in the
performance of its obligations hereunder each party and its
representatives shall at all times comply with all applicable laws,
rules, and regulations issued or promulgated by any governmental
authority having jurisdiction over the activities contemplated
hereunder.
9. Each party shall give the other party notice of all complaints or
adverse experiences associated with the products of the other party. If
the information obtained indicates a serious or unusual experience or
complaint, it shall be reported to the other party by telephone or in
writing within twenty-four hours after initial receipt. Other
information shall be reported within five working days. Reports shall
contain the name, address and telephone number of the source, and an
indication of the adverse drug experience or other complaint.
10. All advertising, marketing and sales promotion materials utilized
hereunder shall be created by or on behalf of or approved by the party
whose products are being described. Such materials shall be reviewed
and approved by the other party prior to use by the other party which
approval shall not be unreasonably withheld. All advertising, marketing
and sales promotion materials, detailing and other activities by either
party shall be in accordance with approved product labeling and all
applicable laws and regulations.
11. No advertising, promotional, sales or publicity concerning this
Agreement or the business relationship between OSTEX and W-A created
hereby or wherein the name of the other party or its products are
mentioned shall be released or made use of by anyone acting on behalf
of a party without the prior approval of the other party. Nothing
contained in this Section 11 shall be deemed to prohibit either party
(a) from detailing with respect to the products of the other as
provided herein or (b) from notifying appropriate governmental agencies
in accordance with, or otherwise complying with the requirements of any
applicable law or regulation.
12. The term of this Agreement shall be for one (1) year from the
date hereof in accordance with the provisions of Section 12 of the
Agreement dated September 20, 1995. This Agreement may be extended for
additional terms of one (1) year each upon the mutual agreement of the parties.
Either party may terminate this Agreement by thirty (30) days' notice in writing
to the other. Upon the effective date of termination, the detailing activities
specified herein shall cease and promotional materials utilized shall be
guarantied until disposition is agreed upon by the parties. Termination of this
Agreement shall not relieve the parties hereto of any liability which accrued
hereunder prior to the effective date of such termination nor preclude either
party from pursuing all rights and remedies it may have hereunder or at law or
in equity with respect to any breach of this Agreement nor prejudice either
party's right to obtain performance of any obligation provided for in this
Agreement which expressly survives termination.
13. Nothing contained herein shall be deemed to grant to OSTEX, either
expressly or impliedly, a license or other right or interest in any
patent, trademark, trade name or logo or other similar property of W-A,
except as may be necessary for OSTEX to detail W-A products hereunder.
Nothing contained herein shall be deemed to grant to W-A, either
expressly or impliedly, a license or other right or interest in any
patent, trademark, trade name or logo or other similar property of
OSTEX, except as may be necessary for W-A to perform its obligations
hereunder.
14. Each party shall indemnify, defend and hold harmless the other
and its officers, directors, agents, servants and employees against any and
all claims, losses, damages and liabilities, including reasonable attorneys'
fees, but excluding loss of profits and consequential damages, to the extent
that any such claim, loss, damage or liability is based on or determined by a
court of competent jurisdiction to result from or arise out of utilization of
such party's products. Provided, however, that a party shall have no obligation
to indemnify the other party for any act or omission of the other party or any
employee, representative or agent thereof or any product of the other party or
unapproved advertising, marketing, promotion or selling activity or warranties
or representations of the other party or any violation of any applicable statute
or regulation, or breach of this Agreement by the other party.
15. Except as otherwise expressly provided under this Agreement, each party
shall hold in confidence all confidential information provided by the
other party in furtherance of this Agreement. The foregoing
confidentiality obligations shall not apply to:
a) any information which at the time of disclosure or
acquisition is part of the public knowledge or
literature, or thereafter becomes part of the public
knowledge or literature otherwise than by
unauthorized disclosure by the recipient;
b) any information which at the time of disclosure or
acquisition was in the recipient's possession
as evidenced by its written records; or
c) any information which becomes available to the
recipient from any other source not bound to
secrecy to the disclosing party with respect to such
information.
16. If the performance by either party is prevented, restricted or
interfered with by reason of any event or cause whatsoever beyond the
reasonable control of the party so affected, such party shall be
excused from performance to the extent of such prevention, restriction
or interference; provided that such cause is not the result of a breach
of this Agreement. In any such case, prompt written notice shall be
given by the affected party to the other of the existence of such cause
and of readiness to resume performance. Labor disputes shall be deemed
to be events beyond the reasonable control of the party affected, and
neither party shall be required to settle a labor dispute against its
will.
17. Neither party may assign this Agreement or rights granted
hereunder in whole or in part without the written consent of the other
party except to their affiliates or subsidiaries or to a successor to or
assignee of all or substantially all of the pharmaceutical interests, assets and
good will of the assigning party; provided, however, that W-A shall have the
right to terminate this Agreement at any time on not less than fifteen (15)
days' notice in writing to OSTEX upon the occurrence of any transaction or
series of transactions which results in the transfer of ownership or control,
directly or indirectly, of a majority of the capital stock, with right to vote,
or of substantially all of the assets of OSTEX or of any parent company of
OSTEX.
18. These terms and conditions constitute the complete and exclusive
understanding of OSTEX and W-A with respect to the subject matter
hereof, and no statements or agreements, oral or written, made prior to
or at the signing hereof shall modify the written terms hereof. Neither
party shall claim any modification or revision of any provision hereof
unless such modification or revision is in writing, signed by the other
party and states it is an amendment to this Agreement.
19. The failure on the part of OSTEX or W-A to exercise or enforce any
rights conferred hereunder shall not be deemed to be a waiver of any
such rights nor operate to bar the exercise or enforcement thereof at
any time or times thereafter.
20. The construction, validity and performance of this Agreement shall be
governed in all respects by the laws of Pennsylvania, excluding,
however, its laws respecting choice of law.
If the foregoing terms and conditions meet with your approval, please
signify your acceptance by signing, dating and returning the enclosed copy of
this letter.
Very truly yours,
OSTEX INTERNATIONAL, INC.
By: /S/ Thomas A. Bologna
Thomas A. Bologna
President and Chief Executive
Officer
Accepted:
WYETH-AYERST LABORATORIES
By: /S/ Susan Jasper
Title: Group Product Director
Date: October 20, 1997