Exhibit 10.98
Master Agreement
This Agreement ("Agreement") is entered into as of this 23rd day of December,
1999 ("Effective Date"), by and between ClinTrials BioResearch Ltd. ("CTBR"),
having a place of business at 00 Xxxxxxxxxx Xxxx, Xxxxxxxxxx, Xxxxxx, Xxxxxx,
X0X 0X0, and Inspire Pharmaceuticals, Inc. ("Sponsor"), having a place of
business at 0000 Xxxxxxx Xxxxxxxxx, Xxxxx 000, Xxxxxx, XX 00000, X.X.X.
With respect to all studies conducted under this Agreement and in consideration
of mutual covenants set forth herein, CTBR and Sponsor agree as follows:
GENERAL CONDITIONS
1.1. Conduct of Study: CTBR will conduct the work described in the letter
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of agreement ("Letter of Agreement") and the protocol ("Protocol") in
accordance with the general conditions hereinafter described.
1.2. Price Adjustments/Verification: Prices quoted pursuant to this
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Agreement shall be subject to verification or adjustment if accepted
more than sixty (60) days after the date of any offer. If not accepted
by the Sponsor prior to sixty (60) days after the date of the offer,
CTBR reserves itself the right to terminate this offer by providing
written notice to the Sponsor, without any recourse whatsoever being
available to the Sponsor. The price quoted is also conditional on CTBR
receiving all necessary test material and other data required to
conduct the study described in the Protocol within ninety (90) days of
the date of this offer.
1.3. Timeline of Study: The date of commencement of work and the issuance
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date of the audited draft report ("Draft Report") will be mentioned in
the Letter of Agreement.
1.4. Price: The price for the work is detailed in the Letter of Agreement
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and each payment shall be payable by Sponsor within 30 days of receipt
of invoice.
1.5. Confidentiality Information
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(a) Confidential Obligation: CTBR agrees that all materials,
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documents, data, reports and information provided to it by the
Sponsor and, except as provided herein, all materials, documents,
data, reports and information developed by CTBR pursuant to this
Agreement, is and shall be considered as confidential information
of the Sponsor (collectively, the "Sponsor Confidential
Information") and the sole property of the Sponsor. The Sponsor
agrees that all information disclosed to the Sponsor about CTBR's
internal operations and systems, including but not limited to
CTBR Property described in this Section, is and shall be
considered as confidential information of CTBR (collectively, the
"CTBR Confidential Information") and is the sole property of
XXXX.
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Each party agrees to hold the Confidential Information of the
other party in strict confidence during the term of this
Agreement and for 10 years after the termination of this
Agreement and shall not, without the consent of the other party,
(a) reveal, publish, report or disclose any Confidential
Information to any person or entity, or (b) use any of such
party's Confidential Information for the benefit of any person or
entity, or for any purpose, other than as may reasonably be
necessary for the conduct of the Services and the Studies as
contemplated by this Agreement.
(b) Exceptions: The obligation of the parties regarding Confidential
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Information shall not apply to information which: (a) is or
becomes available to the public other than as a result of
disclosure by the receiving party: (b) becomes available to the
receiving party on a non-confidential basis from a source which
is not obligated to hold such information in confidence; (c) is
developed by the receiving party independently, and not as part
of the Services provided under this Agreement, as evidenced by
written records; (d) was in the possession of the receiving party
prior to the receipt from the disclosing party or the creation of
the information pursuant to this Agreement; or (e) is required by
law to be disclosed, provided that the owner of the Confidential
Information shall be notified in advance, when possible, and
given a reasonable opportunity to oppose such disclosure.
(c) Return of Confidential Information: Upon the completion or
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earlier termination of this Agreement, CTBR will promptly return
to the Sponsor, at the Sponsor's expense, all of the Sponsor
Confidential Information, as well as all applicable portions of
the written or computer stored material which incorporates any of
the Sponsor Confidential Information, provided that CTBR may
retain in its confidential files one copy of such documents as it
may determine reasonably necessary for regulatory, legal or
insurance purposes.
(d) Remedies: Each party acknowledges that the disclosure of
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Confidential Information of the other party without such party's
express, written permission will cause such party irreparable
harm and that the breach or threatened breach of the
nondisclosure provisions of this Agreement will entitle the owner
of the Confidential Information to injunctive relief, in addition
to any other legal remedies that may be available to it.
1.6. Ownership of Property.
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(a) Ownership: All materials, documents, data, information, reports
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and suggestions of every kind and description supplied to CTBR by
the Sponsor or prepared or developed by CTBR pursuant to this
Agreement (except for CTBR Property described below) shall be the
sole and exclusive property of the Sponsor and the Sponsor shall
have the right to make whatever use it deems desirable, without
objection or liability to CTBR of any such materials, documents,
data reports and information. All such materials, records,
documents, data, information and reports are subject to audit by
the Sponsor during regular business hours, at the Sponsor's
discretion and upon reasonable notice to CTBR, to verify CTBR's
compliance with this Agreement and the Protocols. It is
acknowledged that CTBR is possessed of certain technical
expertise relating to computers, software, and drug development
which have been independently developed by CTBR without the
benefit of any information provided by the Sponsor. The parties
agree that any computer software programs, statistical,
methodologies, processes, methods and other analyses used by CTBR
under or during the term of this Agreement (except where such
program, methodology, process, method or analyses is created or
developed at the request and expense of the Sponsor or with the
assistance of the Sponsor) are the product of CTBR's technical
expertise possessed and developed by CTBR and are the sole and
separate property of CTBR (the "CTBR Property").
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(b) Data Retention: CTBR may retain copies of all such materials,
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records, documents, data, information and reports as required by
applicable laws, rules and regulations. Unless otherwise required
by law or by the terms of this Agreement, all such the Sponsor
property which CTBR shall have in its possessions shall be
maintained by CTBR for a period of not less than one (1) year
from the date of receipt thereof and shall be organized in such a
manner that it will be ready for immediate reference. After one
(1) year or such longer period as may be required by applicable
laws or regulations, CTBR may dispose of such property in
accordance with the Sponsor's instructions. If the Sponsor fails
to give said instructions, CTBR shall so notify the Sponsor; and
if said instructions are still not forthcoming within thirty (30)
days of said notification, then CTBR may destroy such property as
it determines.
1.7. Monitoring of Study. Authorized representatives of the Sponsor may
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inspect the Study at any time during normal business hours. CTBR will
notify the Sponsor, by telephone, telecopier or telex and subsequently
in writing, of any significant changes which occur during the course
of the Study.
1.8. Protocol Amendment. If, at a future date, changes in the Protocol
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appear desirable or become necessary due to governmental regulatory
requirements, such changes shall be made through prior written
agreement (protocol amendment) between the Sponsor and CTBR. If such
changes can be expected to affect the timing of the delivery of the
Draft or Final Report(s), then CTBR shall submit amended delivery
dates for the Sponsor's written approval. If such changes can be
expected to affect the price for the Study, CTBR shall submit a
written estimate; however, CTBR shall, in each case, recover the
additional charges arising out of the performance of such work. No
deviation from the Protocol may be made without specific written
authorization and approval of the Sponsor.
1.9. Additional Charges. The parties acknowledge that during the course of
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performing the Study in accordance with the Protocol, additional costs
may be incurred by CTBR as a result of procedural changes which do not
amount to or require a change in the Protocol, but which are deemed
necessary by CTBR to successfully perform said Study, and which could
not be foreseen at the time of the preparation of the Protocol. If
such procedural changes occur, CTBR shall advise the Sponsor prior to
their implementation and solicit the Sponsor's agreement as to the
necessity and additional cost thereof. Should CTBR be unable to
contact the Sponsor in advance, the Sponsor agrees that in order to
maintain the integrity of the Study, CTBR may proceed accordingly and
be entitled to recover such additional costs from the Sponsor upon
presentation of an explanation of such procedural changes and the
necessity thereof.
DUTIES OF THE SPONSOR
2.1. Raw Data. Should the Sponsor, during the course of the Study, request
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raw data, or certified copies of same, the Sponsor shall pay CTBR for
the preparation, verification, duplication and handling of such data,
in accordance with CTBR's established charges for such services at
that time and Sponsor may contact CTBR to support characterization
requirements..
2.2. Product Characterization. It is the responsibility of the Sponsor to
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define the stability and other relevant characteristics of the test
article(s) including handling precautions and safe methods of disposal
of residual test article and/or test article preparation. Where
applicable, it is also the Sponsor's responsibility to define the
short-term stability of the test article(s) in the solvent or
suspending agent to be used.
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DUTIES OF CLINTRIALS BIORESEARCH
3.1. Patents and Inventions. All right and title to any inventions,
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procedures or techniques designed, developed, produced or manufactured
by CTBR in order to fulfill its obligations under this Agreement and
the Protocol shall be and remain the exclusive property of CTBR,
unless
(a) any such invention, procedure or technique is designed, developed,
produced or manufactured by CTBR at the specific request of the
Sponsor and reference to such fact is made in the Protocol, or
(b) any such invention, procedure or technique is a direct result of
the use of Confidential Information.
3.2. Contractual Obligations. The obligations of CTBR under this Agreement
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are limited to:
(a) performing the study in accordance with this Agreement and the
Protocol; and
(b) using its best efforts to ensure that the Study is conducted in
accordance with generally accepted standards of the industry and
government and regulatory standards applicable at the time of the
signature of this Agreement.
CTBR does not warrant or represent that the results of the Study will
be acceptable to any regulatory or governmental agency to which they
are presented nor that the results of the Study will enable the
Sponsor to market or otherwise exploit the test article(s). CTBR shall
not be liable for any delay in or failure of performance hereunder due
to any contingency beyond its control, including, without limiting the
generality of the foregoing, any act of God, war, mobilization, riot,
strike, fire, flood, disease, power failure, embargo or shortage of
supplies.
MATERIALS
4.1. Materials and Documentation. All raw data, documentation, protocols,
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specimens, test, control archive sample, final reports and all
Confidential Information, (the "Materials and Documentation")
generated as a result of this Study are the exclusive property of the
Sponsor and shall be retained by CTBR for a period of one (1) year
(the "Retention Period") following issuance of the Final Report. Upon
completion or termination of the Study, CTBR shall remit to the
Sponsor all Materials and Documentation in its possession or under its
control, other than any Materials and Documentation which CTBR is
required to retain by applicable law or regulation. During the
Retention Period, the Materials and Documentation shall be made
available for inspection by the Sponsor or any authorized agent
designated by the Sponsor.
If the Sponsor is in breach of any obligation towards CTBR, including
the non-payment of any sum owing to CTBR, CTBR shall be entitled to
withhold and keep in its possession the Materials and Documentation,
and the Report(s) until any such default is cured by the Sponsor.
4.2. Governmental Inspection. The Sponsor is to be notified as soon as
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practical in the event that CTBR's facilities are the subject of an
inspection by a duly authorized representative of a governmental
regulatory or administrative department or agency (the "Inspector")
which may involve the subject matter of this Agreement. CTBR shall
provide the Sponsor with the following data:
(a) purpose of the inspection;
(b) name and credential number of the Inspector; and
(c) a copy of form(s) issued by the Inspector, if any.
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In addition, CTBR agrees to cooperate with governmental authorities
unless otherwise required by law, CTBR shall not permit any
inspections involving the Study or the Confidential Information until
further instructions are received from the Sponsor or until the
Sponsor and the inspecting agency have reached an appropriate
agreement. Unless otherwise required by law, no copies of the Protocol
or other Confidential Information may be given by CTBR to the
Inspector. Any request for such information is to be redirected to the
Sponsor.
4.3. Limitation of Liability. CTBR, its officers, directors and employees
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shall not be responsible for any direct or indirect damages sustained
by the Sponsor resulting from any loss, destruction or damage to the
Materials and Documentation or of the test article(s), for any reason
whatsoever, except in the case of CTBR's own negligence, recklessness
or willful misconduct, nor shall CTBR be responsible for any direct or
indirect damage suffered by the Sponsor arising from causes beyond the
control of CTBR, including, without limiting the generality of the
foregoing, any act of God, war, mobilization, riot, strike, lock-out,
labour dispute, fire, flood, disease, power failure, embargo, shortage
of supplies or personnel.
CURTAILMENT
5.1. Curtailment. The Sponsor may curtail or reduce the scope of the Study
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at any time upon thirty (30) days written notice to CTBR. In the event
of any curtailment, CTBR and the Sponsor shall negotiate reduced
charges for the remaining services, provided that in all cases these
reduced charges will not be less than CTBR's direct and indirect
costs.
TERMINATION OF THE STUDY
6.1. Cancellation/Early Termination. The Sponsor shall have the right, at
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any time, to terminate any Study prior to completion by giving written
notice to CTBR. In the event of notice, CTBR shall immediately use its
best efforts to reduce cost to the Sponsor. In case of termination,
the Sponsor shall pay CTBR all of its costs incurred or irrevocably
obligated plus a pro rata portion of applicable profits computed to
the date of termination.
MISCELLANEOUS
7.1. Delay in Preclinical Work. With respect to any animals purchased by
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CTBR, as authorized by the Sponsor, for preclinical work to be
performed under this Agreement, the parties hereto agree that the
acclimation period shall be mentioned in the Letter of Agreement (the
"Acclimation Period"). After the completion of the Acclimation Period,
should there be any delay in the commencement of the Study that is
attributable to the Sponsor, in any way, then the Sponsor agrees to
reimburse housing fees to CTBR for the said delay at rates prevailing
at the time of said delay.
7.2. Disposal of Materials and Documentation. After the Retention Period,
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CTBR shall contact the Sponsor to determine disposition of the
Materials and Documentation as follows:
(a) return of Materials and Documentation (shipping and insurance
charges at the Sponsor's expense);
(b) extended storage of Materials and Documentation (to be charged at
rates in effect at that time)
(c) disposal of Materials and Documentation (to be charged at rates
in effect at that time).
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7.3. Reports. Two (2) copies of the Final Report(s) in CTBR's standard
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format, as specified in the Protocol, shall be supplied. If any
changes to the standard report format are requested by the Sponsor and
agreed to by CTBR, or if additional copies of the Final Report(s) are
requested by the Sponsor, then there may be an additional charge to
the Sponsor for preparation, handling and dispatch of such reports. If
such changes can be expected to affect the timing of the delivery of
the Final Report(s), then CTBR shall submit amended delivery dates for
the Sponsor's written approval.
If the draft report is not delivered to the Sponsor within the time
frame agreed to by both parties, a penalty equal to 5% of final
payment for each month of delay will be applicable.
7.4. Advertising. Under no circumstances will the name of the Sponsor or
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CTBR, or any of its personnel, be used for promotional literature or
advertising without the prior written permission and approval of the
Sponsor or CTBR, as the case may be.
7.5 Publications. The Sponsor has the right to the initial publication of
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the results of the Study. The Sponsor may also request CTBR to publish
the results jointly with the Sponsor or independently. The Sponsor
shall be responsible for all costs associated with any such
publication. CTBR may only publish the results of a study with the
written permission of Sponsor.
7.6. Liability. The Sponsor recognizes that CTBR has not participated in
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the manufacture of materials supplied by the Sponsor nor has it
inspected, or been afforded the opportunity to inspect, the production
techniques of the Sponsor, and that its sole responsibility is to test
the test article in accordance with this Agreement and the Protocol.
Accordingly, the Sponsor hereby releases CTBR and its affiliates,
together with their officers, directors and employees, from any
liability arising from the work to be performed by CTBR under this
Agreement and the Protocol and the use which the Sponsor makes of the
results obtained by CTBR. For greater certainty, but not so as to
limit the generality of the foregoing, the Sponsor specifically
releases CTBR and its affiliates, together with their officers,
directors and employees, from any liability arising from:
(a) any decision to market the test article(s) based on the results of
the Study;
(b) the use of the test article(s), or any subsequent derivation of
it, by any party other than CTBR; and
(c) any direct or indirect damages or losses, economic or otherwise,
or any liability to third parties, which the Sponsor may incur
pursuant to this Agreement and the Protocol.
The Sponsor shall take up and be responsible for all costs associated
with the defense of CTBR and its affiliates, together with their
officers, directors and employees, as the case may be, and indemnify
and hold CTBR and its affiliates, together with their officers,
directors and employees, as the case may be, harmless from any and all
liability, loss, damage (including loss of life), expense, causes of
action, suits, claims or judgments arising from injury to person or
property resulting from the performance by CTBR of this Agreement and
the Protocol, or in any other way relating to the performance by CTBR
of this Agreement or the Protocol, or from, or related to, the use of
the test article(s), whether such claims are rightfully or wrongly
brought or filed. The Sponsor agrees that CTBR may, if it so desires,
employ attorneys of its own selection to appear and defend the claim
or action, at the expense of CTBR. CTBR, at its option and expense,
shall have the sole authority for the direction of the defense, and
shall be the sole judge of the acceptability of any compromise or
settlement of any claim or actions.
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The foregoing two (2) paragraphs shall not apply in the event of
CTBR's negligence and recklessness or willful misconduct. CTBR shall
not be considered negligent where it is following recognized
procedures or performing the Study as required by the Sponsor.
CTBR's maximum liability arising from CTBR's negligence in the
performance of its obligations under this Agreement or the Protocol
shall be limited to the amount of the insurance proceeds received as a
result of any error or omission committed by CTBR in performance of
its obligations pursuant to this Agreement. Sponsor shall have the
option in any such instance to either (i) demanding indemnification
from CTBR in respect of such liability, subject to the limitation of
liability referred to above, or (ii) to reperform the Study at no
additional cost, or (iii) to refund the compensation paid for the
Study.
7.7. Survival of Obligations. The completion, curtailment or termination of
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this Agreement shall not relieve either party of its obligations to
the other in respect of (i) maintaining the confidentiality of
Confidential Information, (ii) obtaining consents for advertising
purposes and publications, (iii) indemnification, (iv) compensation
for services performed, and (v) appropriate reporting of any data
obtained.
7.8. Entire Agreement. This Agreement, together with any agreements and
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other documents to be delivered pursuant hereto, constitute the entire
agreement between the parties pertaining to the subject matter hereof
and supersede all prior agreements, understandings, negotiations and
discussions, whether oral or written, of the parties, including,
without limiting the generality of the foregoing, any Letter of
Authorization for the purchase of animals addressed by the Sponsor to
CTBR in respect of any preclinical work to be performed under this
Agreement.
7.9. Arbitration. Any mutual dispute, controversy or claim between both
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parties arising out of or relating to this contract, or the breach
thereof, shall be settled in the State of New York. However, if
Sponsor is bringing arbitration, such arbitration hearings shall be
conducted in the City of Montreal, Province of Quebec and if CTBR is
bringing arbitration, such arbitration hearings shall be conducted in
the State of North Carolina.
7.10. Conflict. If any conflict shall appear between the provisions of this
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Agreement and the Protocol, the provisions of this Agreement shall
govern and the conflicting provisions of the Protocol shall be deemed
to have been changed or modified so as to remove such conflict.
7.11. Languages. The parties acknowledge that they have required that the
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present Agreement, as well as all documents, notices and legal
proceedings executed, given or instituted pursuant to or relating
directly or indirectly hereto be drawn up in English. Les parties
reconnaissent avoir exige la redaction en anglais de la presente
convention, ainsi que de tous documents executes, xxxx xxxxxx et
procedures judiciaires intentees, directement ou indirectement, a la
suite ou relativement a la presente convention.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed as of the Effective Date.
Inspire Pharmaceuticals, Inc. CLINTRIALS BIORESEARCH, LTD.
By /s/ Xxxxxx X. Xxxxxxxxx By /s/ X.X. Xxxxxxx
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X. X. Xxxxxxx
Chairman, President and CEO
By /s/ Xxxx Xxxxxxxx
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Xxxx X. Xxxxxxxx
0-00-00 Xxxx President, Finance and
----------------------------------- Administration
Date
December 23, 1999
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Date
This format of a Letter of Agreement is to be use only for INS37217 and INS365
compound development programs
DATE
Inspire Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxxxxxx, Xxxxx 000
Xxxxxx, XX 00000
X.X.X.
LETTER OF AGREEMENT
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STUDY NO.:
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STUDY TITLE:
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PROTOCOL DATED:
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PRICE: $ U.S. (based on ___________ Protocol dated ____________
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and quote letter dated _________)
PAYMENT TERMS:
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"Refer to sample of Letter of Agreement for Payment Terms"
With respect to Inspire's INS37217 and INS365 compound development programs,
when the amount invoiced by CTBR reaches $800,000.00 U.S., CTBR will deduct from
the gross amount of every invoice (excluding animal cost) a discount of 7.5
percent (the "Applicable Discount").
This Applicable Discount shall be applicable against all invoices and shall come
into force as soon as the total of invoices issued exceeds the initial level of
$800,000.00 U.S. (excluding animal cost) on Inspire's INS37217 and INS365
compound development programs. The Applicable Discount will remain in force for
two (2) consecutive years from the issuance of the first invoice and shall
thereafter be renewed for periods of one (1) year each. However, CTBR reserves
the right to modify and/or terminate this Applicable Discount at any of the
renewal dates, with one (1) month prior written notice. CTBR will list as a
separate line item, the discount applied on each invoice and all prices quoted
shall be exclusive of this discount.
The terms and conditions of the present Applicable Discount are confidential and
Sponsor shall ensure that such terms and conditions are not disclosed by Sponsor
to third parties, except to the extent required by law, rule or regulation or
judicial or administrative decree or order. Failure to respect this
confidentiality will result in the immediate termination of any provisions
regarding Applicable Discount contained in this Letter of Agreement.
2
Inspire Pharmaceuticals, Inc.
Letter of Agreement
Study No.
COMMENCEMENT OF WORK:
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REPORTING TIME: We expect to deliver the audited draft report
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_________ weeks following last necropsy
ACCLIMATION PERIOD:
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This Letter of Agreement will be governed by the terms and conditions of the
Master Agreement dated December 23, 1999 between ClinTrials BioResearch Ltd. and
Inspire Pharmaceuticals, Inc.
For Inspire Pharmaceuticals, Inc. For ClinTrials BioResearch Ltd.
------------------------------------ ------------------------------------
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X.X. Xxxxxxx
Chairman, President and CEO
------------------------------------
Date Xxxx X. Xxxxxxxx
Vice President, Finance and
Administration
---------------------------
Date
DATE
Inspire Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxxxxxx, Xxxxx 000
Xxxxxx, XX 00000
X.X.X.
LETTER OF AGREEMENT
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STUDY NO.:
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STUDY TITLE:
-----------
PROTOCOL DATED:
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PRICE:
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PAYMENT TERMS:
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1) For studies six (6) months or less in duration:
50% - 1st installment, animal arrival
40% - 2nd installment, at necropsy
10% - 3rd installment, on receipt of audited or non-audited
draft report
2) For studies greater than six (6) months in duration:
For mouse/rat studies: 15% - 1st installment, animal arrival
or For dog/primate studies: 20% - 1st installment, animal
arrival
Thereafter equal quarterly installments with
the final installment due on receipt of the audited or
non-audited draft report
3) For analytical chemistry or drug metabolism and pharmacokinetic
studies only:
50% - 1st installment, upon commencement of work
40% - 2nd installment, upon completion of work
10% - 3rd installment, on receipt of audited or non-audited
draft report
2
Inspire Pharmaceuticals, Inc.
Letter of Agreement
Study No.
COMMENCEMENT OF WORK:
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REPORTING TIME:
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ACCLIMATION PERIOD:
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This Letter of Agreement will be governed by the terms and conditions of the
Master Agreement dated December 23, 1999 between ClinTrials BioResearch Ltd. and
Inspire Pharmaceuticals, Inc.
For Inspire Pharmaceuticals, Inc. For ClinTrials BioResearch Ltd.
------------------------------------ ------------------------------------
X.X. Xxxxxxx
Chairman, President and CEO
------------------------------------
Date Xxxx X. Xxxxxxxx
Vice President, Finance and
Administration
Date
