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EXHIBIT 10.28
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REDACTED VERSION
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[LETTER HEAD OF CR STRATEGIES]
MASTER SERVICE AGREEMENT
BETWEEN
CR STRATEGIES, L.L.C. AND NEORX CORPORATION
FEBRUARY 28, 2001
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1. OVERVIEW. This agreement states the terms and conditions by which CR
Strategies, L.L.C. will deliver and NeoRx Corporation will receive any or
all of the services provided by CR Strategies, L.L.C. The specific
services to be provided hereunder are identified and described in detail
in the applicable SERVICE LEVEL AGREEMENT attached to this Agreement. Each
SERVICE LEVEL AGREEMENT accepted and executed by both parties is hereby
incorporated by reference into this agreement. This agreement is intended
to cover any and all services ordered by NeoRx Corporation and provided by
CR Strategies, L.L.C.
2. DEFINITIONS. When used in this Agreement, the "BOLDED" terms listed below
shall have the following meanings:
(a) "NEORX CORPORATION TECHNOLOGY" shall mean any proprietary technology owned
by NeoRx Corporation, or licensed to NeoRx Corporation by third parties,
and all similar proprietary information provided to CR Strategies, L.L.C.
by NeoRx Corporation in connection with CR Strategies, L.L.C.'s provision
of services to NeoRx Corporation.
(b) "CONFIDENTIAL INFORMATION" shall mean any information disclosed by either
party to the other party, directly or indirectly, in writing, orally or by
inspection of tangible objects that is designated as "Confidential",
"Proprietary" or some other similar designation, including information
disclosed to a disclosing party by third parties. Confidential Information
shall not include any information that: is or becomes publicly known and
generally available without violation of this Agreement; is in the
possession of the receiving party prior to the disclosure without the
obligation to maintain its confidentiality; is independently developed by
the receiving party without use of or reference to the disclosing party's
Confidential Information; is obtained from third parties without
restrictions on disclosure; or is required by law or legal process to be
disclosed by the receiving party, provided that, if permitted, the
receiving party gives the disclosing party prompt written notice prior to
such disclosure.
(c) "CR STRATEGIES, L.L.C. TECHNOLOGY" shall mean any designs, concepts,
reports, documentation, written materials, and any techniques, methods,
patterns, formulas and any and all intellectual property rights used,
invented, developed or delivered by CR Strategies, L.L.C. in the course of
providing services.
(d) "EFFECTIVE DATE" shall mean the date on which authorized representatives
of NeoRx Corporation and CR Strategies, L.L.C have executed this Master
Service Agreement.
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3. SERVICE LEVEL AGREEMENT. A SERVICE LEVEL AGREEMENT is attached to this
Master Service Agreement. Extensions or modifications to such SERVICE
LEVEL AGREEMENT may be requested by NeoRx Corporation subject to any
procedures set forth in such SERVICE LEVEL AGREEMENT or herein, and shall
be subject to CR Strategies, L.L.C.'s approval and execution of an
amendment to the SERVICE LEVEL AGREEMENT or, if appropriate, a new SERVICE
LEVEL AGREEMENT.
4. PAYMENTS. NeoRx Corporation agrees to pay to CR Strategies, L.L.C.
according to the schedule provided in the attached SERVICE LEVEL
AGREEMENT.
NeoRx Corporation shall remit payment to CR Strategies, L.L.C.,
referencing the CR Strategies, L.L.C. invoice number, to:
CR Strategies, L.L.C.
00 Xxxxxxxx Xxxxx
Xxxxxxxxxxxx, XX 00000
Attn: Accounts Receivable
or to such other address as CR Strategies, L.L.C. shall designate in
writing to NeoRx Corporation.
5. OWNERSHIP AND LICENSE. The documentation, enhancements, revisions,
updates, upgrades, modifications, and derivative works thereto, and all
other items delivered by CR Strategies, L.L.C. under this Agreement are
owned by NeoRx Corporation.
6. CONFIDENTIAL INFORMATION. Each party agrees not to use any Confidential
Information of the other party for any purpose except in the performance
of the services. Each party agrees not to disclose any Confidential
Information of the other party to such party's employees or to third
parties, except those who need to know such information for the purposes
hereof. Each party agrees that it shall take reasonable efforts to protect
the secrecy of and avoid disclosure and unauthorized use of any
Confidential Information of the other party. Without limiting the
foregoing, each party shall take at least those measures that it takes to
protect its most highly confidential information. All documents and other
tangible objects containing or representing Confidential Information which
have been disclosed by either party to the other party, and all copies
thereof which are in the possession of the receiving party, shall be and
remain the property of the disclosing party and shall promptly be returned
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to the disclosing party upon the request of the disclosing party. Except
as expressly provided herein, nothing contained in this Agreement is
intended to grant any rights to either party under any patent, mask work
right, copyright, trademark, service xxxx or other intellectual property
right of the other party.
7. LIMITED WARRANTY; LIMITATION OF LIABILITY.
(a) CR Strategies, L.L.C. warrants that the services shall materially
comply with the specifications for such services set forth in the
attached SERVICE LEVEL AGREEMENT. To the extent that any failure of
the services to comply with the specifications results in a failure
or inability of CR Strategies, L.L.C. to provide services to NeoRx
Corporation, CR Strategies, L.L.C.'s obligations and liability with
respect to such failure, and NeoRx Corporation's sole remedy with
respect to such failure, will be limited to a refund of that portion
of the SERVICE LEVEL AGREEMENT total cost that is attributable to
the specific services giving rise to the claim for damages.
Subject to the limitations set forth herein, NeoRx Corporation
agrees to defend, indemnify and hold CR Strategies, L.L.C., and its
officers, employees and agents harmless against and for all losses,
causes of action, liability, costs, expenses, claims and damages,
including all expenses of litigation, reasonable attorney's fees and
court costs, that either party may at any time suffer or sustain or
become liable for, due to injury or death of a person, or for damage
to any property arising out of, in connection with, or incidental to
the service(s) provided by CR Strategies, L.L.C. under the terms of
this agreement.
(b) Except for NeoRx Corporation's payment obligations in section 4
neither party shall be liable for any special, indirect, incidental
or consequential damages (even if advised of the possibility of such
damage), including without limitation, lost profits or lost savings,
loss of use of services (except as specifically provided in the
attached SERVICE LEVEL AGREEMENT), cost of capital, cost of
substitute services or re-procurement, downtime costs, or damages
resulting from loss of use of data or from third party claims. CR
Strategies, L.L.C. shall have no liability from damages resulting
from NeoRx Corporation's failure to perform their responsibilities
hereunder, including, but not limited to, NeoRx Corporation's
failure to provide accurate and complete information to CR
Strategies, L.L.C. In no event, shall CR Strategies, L.L.C.'s
liability for damages hereunder exceed the amounts paid to CR
Strategies, L.L.C. by NeoRx Corporation for the services giving
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rise to the claim for damages. NeoRx Corporation recognizes that the
fees specified in the attached SERVICE LEVEL
(c) AGREEMENT are based in part on the limited warranty and limitation
of liability set forth above. The remedies specified in this
agreement are exclusive.
8. WORKMANSHIP. CR Strategies, L.L.C. represents and warrants that all of the
services specified in the attached SERVICE LEVEL AGREEMENT will be
performed in a good, workmanlike and professional manner in accordance
with industry standards by qualified persons fully familiar with the
requirements for such services.
9. FORCE MAJEURE. Except with respect to payment obligations, neither party
shall be liable, nor shall any credit allowance or other remedy be
extended, for any failure to fulfill its obligations under this Agreement
due to causes beyond such party's reasonable control, including, but not
limited to: acts of God, flood, extreme weather, fire or other natural
calamity; any law, order, regulation, direction, action, or request of any
governmental entity or any civil or military authority; unavailability of
rights-of-way or materials; national emergencies, insurrections, riots, or
wars; or strikes, lock-outs, work stoppages, or other labor difficulties.
Each party agrees to notify the other party, as soon as possible, if such
an event has occurred. The time for completion of any obligation to which
this provision applies shall be extended for a period equivalent to the
delay except for payment obligations, which shall be extended by a maximum
of 10 days.
10. INITIAL DISPUTE RESOLUTION. Except in the case of a dispute in which a
party seeks injunctive relief or must file suit in order to avoid
expiration of the applicable statute of limitations, all disputes shall be
referred to the senior executives of the parties for resolution. If the
dispute is not resolved within 60 days of receipt of the initiating
party's written notice, or if the senior executives fail to discuss the
dispute(s) within 30 days of receipt of the initiating party's notice,
either party may pursue any and all remedies available at law.
11. ASSIGNMENT. Either party may transfer its rights and duties under this
Agreement to an entity which has acquired all of such party's capital
stock or all or substantially all of such party's assets, provided that:
(i) the acquiring entity is not a competitor of the other party, (ii) the
acquiring entity agrees in writing to be bound by the terms of this
Agreement, (iii) the acquiring entity is capable of meeting all of its
obligations under this Agreement, (iv) the other party is in full
compliance with its obligations under this Agreement, and (v) the other
party consents in writing to such transfer in advance, which consent shall
not be unreasonably withheld. In all other cases, neither this Agreement
nor any rights or licenses granted
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hereunder may be assigned, or duties delegated whether by operation of law
or otherwise, by either party without the prior written consent of the
other party. Any attempted assignment or delegation in violation of this
Section shall be void and ineffective for all purposes. This Agreement
shall be binding upon and inure to the benefit of NeoRx Corporation and
any permitted assignee or successor of either party.
12. TERM AND TERMINATION. This Agreement shall become effective on the
Effective Date and shall remain in effect for the period specified in the
attached SERVICE LEVEL AGREEMENT.
(a) TERMINATION FOR MATERIAL BREACH.
(i) In the event of any other material breach of this Agreement, the
non-breaching party shall give the breaching party written notice
describing such breach. In the event that the breaching party fails to
cure such material breach within 30 days after receipt of written notice
of such breach from the non-breaching party, the non-breaching party shall
be entitled to terminate this Agreement upon written notice to the
breaching party.
(ii) Upon any termination of this Agreement for material breach by CR
Strategies, L.L.C., NeoRx Corporation shall be entitled to a pro rata
refund of amounts paid in advance for services.
(b) INSOLVENCY. In the event either party shall (i) be declared bankrupt,
become subject to any proceedings relating to its liquidation,
reorganization, or insolvency, whether voluntary or involuntary, or for
the appointment of a trustee or receiver or similar official, of or for it
or any part of its property, or (ii) fail generally, or admit in writing
its inability to pay its debts as they become due, or (iii) make a general
assignment for the benefit of creditors, or (iv) be dissolved or otherwise
cease business as an ongoing business entity, then the other party may,
upon thirty (30) days prior written notice, terminate this Agreement for
cause. In the event of the commencement of a case under the Bankruptcy
Code by or against either party, and during the period prior to the entry
of an order directing or authorizing the other party or its trustee in
bankruptcy to assume, reject or otherwise terminate this Agreement, such
party may exercise its rights under Bankruptcy Code Section 365(n), as
such section may be amended or supplemented from time to time, and the
exercise of such rights or resort to any remedies provided thereunder
shall not be deemed the exclusive rights and/or remedies available to such
party, but such party is entitled to obtain any relief to the fullest
extent provided by applicable bankruptcy or nonbankruptcy law.
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(c) RENEWAL AND EXPIRATION.
(i) Apart from the above conditions the parties shall have the right to renew
this Agreement upon mutual agreement, and it shall continue in effect for
so long as there is a SERVICE LEVEL AGREEMENT in effect. Unless
specifically provided otherwise, the term of a SERVICE LEVEL AGREEMENT,
and NeoRx Corporation's right to use the services specified in such
SERVICE LEVEL AGREEMENT, shall begin on the commencement date specified in
Section 12 and continue in effect for the term stated in the SERVICE LEVEL
AGREEMENT. Thereafter, the parties shall have the right to renew, upon
mutual agreement, a SERVICE LEVEL AGREEMENT for successive renewal terms
of duration equal to the original agreement.
(ii) In the event of any expiration or termination of this Agreement NeoRx
Corporation shall pay CR Strategies, L.L.C. on or before the effective
date of termination all fees due, including but not limited to any out-of
pocket expenses and reasonable travel and related expenses incurred up to
the date of termination. Notwithstanding any termination or expiration of
this Agreement, Sections 2, 4, 5, 6, 7, 8, 9, 10, 11, 12(c)(ii), 16, and
17 shall survive termination.
13. GOVERNING LAW. Interpretation, construction and enforcement of this
Agreement shall be pursuant to the laws of Washington, U.S.A. The parties
agree that the United Nations Convention for the International Sale of
Goods shall not apply to this Agreement. Both parties agree to submit to
the exclusive jurisdiction and venue of and agree that any cause of action
arising under this Agreement shall be brought in a court in Washington.
14. NOTICES. All notices required to be given under this Agreement shall be in
writing and shall be deemed effective when received and shall be delivered
in person, by facsimile, with a confirmation copy sent as provided herein,
or by mail, postage prepaid, for delivery as registered or certified mail
addressed, return receipt requested. All notices shall be deemed received
(i) if given by hand, immediately, (ii) if given by registered mail, 3
business days after posting, (iii) if given by express courier service,
the next business day, or (iv) if given by facsimile, upon receipt thereof
by the recipient's facsimile machine as indicated either in the sender's
identification line produced by the recipient's facsimile machine or in
the sender's transmission confirmation report as produced electronically
by the sender's facsimile machine. Notices to CR Strategies, L.L.C. shall
be sent to:
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XX Xxxxxxxxxx, X.X.X.
000 Xxxxx Xxxxxx
Xxxxxxxx, XX 00000
Attn: Xxxxxxx X. Xxxxxxxxx, PhD, MBA
FAX Number (000) 000-0000
or, in the case of NeoRx Corporation, to:
NeoRx Corporation
000 Xxxx Xxxxxxxx Xxxxxx
Xxxxxxx, XX 00000-0000
Attn: Xxxx X. Xxxxxx, M.D., X.X.
or to such other address as either party may designate in writing to the
other from time to time.
15. ENTIRE AGREEMENT. This Agreement and the SERVICE LEVEL AGREEMENT
referenced herein constitute the full and final expression of agreement
between the parties with respect to the subject matter hereof and
supersede all previous agreements and understandings, whether written or
oral, relating to the subject matter hereof. This Agreement may not be
altered, amended or modified except by written instrument signed by the
duly authorized representatives of both parties. Any different, additional
and/or pre-printed terms contained on purchase orders or other terms and
conditions submitted by NeoRx Corporation shall be void. As used herein,
"include" and its derivatives shall be deemed to mean, "including but not
limited to".
16. SEVERABILITY. Should any term of this Agreement, for any reason, be held
to be illegal or unenforceable by a court of competent jurisdiction, the
remaining terms of this Agreement will continue in full force and effect,
and the offending term shall be limited or modified to the extent
necessary to make it enforceable.
17. GENERAL. (a) Either party may disclose that NeoRx Corporation has retained
CR Strategies, L.L.C.'s services, and CR Strategies, L.L.C. may describe
in general, non-confidential terms, CR Strategies, L.L.C.'s work under the
Agreement in its marketing materials. Any other disclosure as to the
nature of this Agreement or the work being performed hereunder shall be
subject to the prior approval of both parties. (b) No waiver of or
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failure to act regarding any breach of this Agreement shall constitute a
waiver of any other breach. (c) Subject to applicable law, no action,
other than an action for nonpayment, arising out of or relating to this
Agreement may be brought by either party more than 2 years after the cause
of action has accrued, provided that neither party shall be precluded from
making a counterclaim or cross-claim in an action commenced by the other
party or by a third party. CR Strategies, L.L.C.'s contractors may be
direct and intended third party beneficiaries of this Agreement and may be
entitled to enforce this Agreement directly against NeoRx Corporation to
the extent that (i) this Agreement relates to the acquisition of CR
Strategies, L.L.C. contractor's services, and (ii) CR Strategies, L.L.C.
fails to enforce the terms of this Agreement on CR Strategies, L.L.C.
contractors' behalf. This Agreement may be amended or modified only by a
written instrument signed by an authorized representative of CR
Strategies, L.L.C. and NeoRx Corporation.
By the signatures of their duly authorized representatives below, CR
Strategies, L.L.C. and NeoRx Corporation, intending to be legally bound,
agree to all of the provisions of this Agreement.
ACCEPTED & AGREED TO:
CR Strategies, L.L.C. NeoRx Corporation
By: By:
Xxxxxx X. Xxxxxxxx, MD, MPH
Title: CEO Title:
Date: February 28, 2001 Date:
By:
Xxxxxxx X. Xxxxxxxxx, PhD, MBA
Title: President and COO
Date: February 28, 2001
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ATTACHMENT A. SERVICE LEVEL AGREEMENT
BETWEEN
CR STRATEGIES, L.L.C. AND NEORX CORPORATION
FEBRUARY 28, 0000
XXXXXXXX
XX Strategies, L.L.C. will function as the Senior Management of Medical and
Regulatory Affairs for NeoRx Corporation through the end of December 2001 and
will perform the specific tasks listed under Section B below.
NeoRx Corporation and CR Strategies, L.L.C. have agreed that CR Strategies,
L.L.C. will endeavor to achieve the following objectives for this engagement:
- Identify, propose, and build systems, processes and human resources
internally at NeoRx Corporation toward establishing an NDA-ready
organization.
- Manage, through direct reporting and supervision, all Medical & Regulatory
Affairs personnel. Mentor the STR program and its personnel through the term
of the engagement.
One of CR Strategies, L.L.C.'s principal members will be [*] for the
duration of the engagement.
CR Strategies, L.L.C. will report to Dr. Xxxx Given for the duration
of the engagement.
[*] DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION.
Services provided by CR Strategies, L.L.C. will commence on the date on which
NeoRx Corporation signs the Master Service Agreement to which this SERVICE LEVEL
AGREEMENT is attached and will terminate not later than December 31, 2001.
WORK PRODUCT
CR Strategies, L.L.C. will perform the following specific tasks for NeoRx
Corporation:
- Identify and procure, according to the terms in Section D below, a complete
problem-solving team to manage the STR clinical and regulatory program.
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- Form [*] capable of crossing the threshold acceptable to FDA. All consulting
costs for these experts will be billed by the consultants directly to NeoRx
Corporation.
- Prepare for [*] with FDA.
- Develop [*] acceptable to FDA.
- Identify and set up clinical sites appropriate to performing [*].
- Manage the performance of the [*] clinical study.
- Analyze, submit to FDA, and defend clinical data developed in [*].
- Develop a protocol for performing [*] for a subsequent [*] clinical trial.
- Initiate the [*] clinical trial.
- Manage the relationship with PPD Contract Research Organization.
- Perform potential problem analysis and develop a plan to manage regulatory
risk.
- Develop internal NeoRx systems to prepare for NDA submission.
- Assist in identifying, recruiting, and training NeoRx human resources to
complete the [*] clinical trial and submit the NDA.
NeoRx Corporation will provide CR Strategies, L.L.C. with full access to its STR
project employees, subcontractors, and consultants, and all necessary STR
project data and documentation to allow CR Strategies, L.L.C. to fulfill its
obligations under this SERVICE LEVEL AGREEMENT.
MATERIALS, SHIPPING, TRAVEL, SITE VISITS, PHOTOCOPYING
Expenses incurred by CR Strategies, L.L.C. in providing these services are
anticipated to not exceed approximately 20% of the price of this SERVICE LEVEL
AGREEMENT and will be separately billed to NeoRx Corporation on a bi-weekly
basis. If for any reason prices exceed 20% of the price of this SERVICE LEVEL
AGREEMENT, CR Strategies, L.L.C. will obtain NeoRX Corporation's approval prior
to proceeding. Expected costs include, but are not limited to, travel, travel
expenses (meals and lodging), telephone, fax, courier, shipping costs, copying,
materials, etc. When either party to this agreement deems travel necessary, CR
Strategies, L.L.C. will contact NeoRx Corporation to reach agreement about costs
and trip duration.
PRICING AND PAYMENT SCHEDULE
CR Strategies, L.L.C. will perform the tasks indicated in Section B for [*],
plus [*] stock options ([*] for each CR Strategies, L.L.C. principal member),
plus expenses as described in Section C. The cost breakdown for the engagement
is as follows:
CR Strategies Salaries [*]
Administrative Overhead (25%) [*]
Total [*]
One hundred percent of Administrative Overhead [*] will be invoiced immediately
upon commencement of the engagement. [*] of the CR Strategies, L.L.C. salaries
shown above ([*]) will be invoiced at the end of each calendar quarter,
commencing March 30, 2001. In addition, it is anticipated that the following
professionals will subcontract directly with NeoRx, but be managed by CR
Strategies, L.L.C., for approximately the following salaries in order to further
the objectives listed in Section A:
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Fully-
Position Loaded
Annualized Hours/ Hourly Weeks/ 10-Month
Salary Week Rate Year Total
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Ph.D. Regulatory Director [*] [*] [*] [*] [*]
MD Safety Reviewer [*] [*] [*] [*] [*]
M.S. Statistician [*] [*] [*] [*] [*]
M.S. Senior CRA [*] [*] [*] [*] [*]
B.S. Senior CRA Safety Reviewer [*] [*] [*] [*] [*]
B.S. Regulatory Specialist [*] [*] [*] [*] [*]
B.S. Medical Writer [*] [*] [*] [*] [*]
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Total [*]
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CR Strategies, L.L.C. will invoice NeoRx Corporation a one-time charge of 10% of
the 10-month salary for each of these, or other similar, professionals that CR
Strategies, L.L.C. successfully recruits as subcontractors to the STR project.
The price in this quotation is valid for 30 days from the date on the cover
sheet of this SERVICE LEVEL AGREEMENT.
