04 April 2000
PROFESSIONAL SERVICES and CONFIDENTIALITY AGREEMENT
between
Lexon, Inc.
&
DIAGNOSTIC ONCOLOGY CRO, Inc.
PARTIES
The parties to this Professional Services and Confidentiality Agreement are
Lexon, Inc., a Delaware corporation, and its affiliates, subsidiaries and the
like ("LEXON") with headquarters located in Tulsa, Oklahoma, and DIAGNOSTIC
ONCOLOGY CRO, Inc. ("DOCRO"), a Delaware corporation, located in Seymour,
Connecticut.
PURPOSES
LEXON is engaged in the business of commercializing medical devices, in
particular, reagents and in vitro diagnostic assays such as the assays for the
EbafTM tumor marker used as an aid in the detection of colorectal cancer.
DOCRO is engaged in providing professional services to manufacturers of in vitro
diagnostic medical device manufacturers, in particular, providing tactical and
strategic clinical trial services in support of efforts to obtain federal
regulatory approval for medical devices.
LEXON desires to have DOCRO assist with the review and analysis of existing
technical and clinical data related to the EbafTM tumor marker assays in order
for DOCRO to provide LEXON with written executive summary of a plan to gain
clearance/approval from the United States Food and Drug Administration to
commercialize an ebaf tumor marker immunoassay, and DOCRO is willing to do so.
In consideration of the mutual promises specified below, DOCRO offers to provide
professional services to LEXON in accordance with the terms and conditions of
this Agreement, which LEXON accepts.
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DEFINITIONS
"Confidential & Proprietary Information" shall include any information owned by
LEXON.
"DOCRO" shall mean the entity identified in the PARTIES section, including any
entities affiliated with DOCRO, (or any purchaser of substantially all of
DOCRO's assets), including but not limited to DOCRO's employees, agents,
officers or principals, and, its contractors.
"FDA" shall mean the United States Food and Drug Administration, or other
foreign or domestic judicial, governmental or regulatory bodies having
jurisdiction over matters for which DOCRO is providing services under this
Agreement.
"LEXON" shall mean the entity identified in the PARTIES section, including any
entities affiliated with LEXON (or any purchaser of substantially all of LEXON's
assets), including but not limited to LEXON's employees, agents, officers or
principals, and, its contractors.
TERMS AND CONDITIONS
1.0 Services to be Provided by DOCRO
1.1. Review of Technical and Clinical Data Related to the EbafTM Tumor Marker
Assays - DOCRO shall provide to LEXON assistance with the review and analysis of
existing technical and clinical data related to the EbafTM tumor marker assys in
order for DOCRO to provide LEXON with a written executive summary of a plan to
gain clearance/approval from the United States Food and Drug Administration to
commercialize an EbafTM tumor marker immunoassay.
1.2. The parties agree that DOCRO shall provide LEXON with its services under
this Agreement on a non-exculsive basis. Subject to the limitations of this
Agreement, DOCRO and LEXON may provide or obtain professional and advisory
services to or from any third party.
1.3. Pursuant to the terms of this Agreement, DOCRO shall commence work
immediately upon receipt of a fully executed original of this Agreement and any
initial moneys set forth herein.
2.0 Term
2.1. The terms of this Agreement shall commence on 04 April 2000, and shall
expire on 05 June 2000, but may be terminated at will by either party giving
thirty (30) days written notice to the other. In the event of such termination,
LEXOn's sole obligation to DOCRO shall be to pay DOCRO any fees and expenses for
services either (i) rendered by the date of termination or (ii) at least
partially rendered and committed by DOCRO, such fees and expenses to be
subtracted from the advance payment made by LEXON pursuant to Section 3.3
hereof.
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2.2. This termination provision shall not apply to the Section 3.0. through
14.0., which shall survive in perpetuity.
3.0 Compensation & Reimbursement
3.1. DOCRO shall be compensation by LEXON at a rate of three hundred,
twenty-five dollars (US$ 325.00) per hour for professional services rendered by
DOCRO's President and Chief Executive Officer, Xxxxxx X. Xxxxxxx, DOCRO's Vice
President of Biostatistics and Clinical Affairs, Xxxxx X. Xxxxx, Ph.D., or
DOCRO's Vice President of Laboratory Operations, Xxxxxx X. Xxxxxxx, Ph.D., under
the provisions of this Agreement and this Section 3.0.
3.2. DOCRO shall xxxx LEXON monthly for services rendered and expenses incurred
under this Agreement. LEXON shall reimburse DOCRO for services rendered and
expenses incurred under the provision of this Agreement on a net fifteen (15)
day basis, time commencing from submission to LEXON of invoice and statement of
work completed or expenses incurred. If timely payment for invoiced fees is not
made, in addition to other remedies, DOCRO may impose and LEXON shall pay, a
late payment charge equal to one and one-half percent (1.5%) of the overdue
amount each month.
3.3. DOCRO and LEXON will agree to an estimated maximum limit to fees (Fee Cap)
of two thousand, six hundred dollars (US $ 2,600.00) based upon an estimate of a
total of eight (8) billable hours required for the professional services
described herein to be rendered by DOCRO's President and Chief Executive
Officer, Xxxxxx X. Xxxxxxx, DOCRO's Vice President of Biostatistics and Clinical
Affairs, Xx. Xxxxxx X. Xxxxx, Ph.D., or DOCRO's Vice President of Laboratory
Operations, Xxxxx X. Xxxxxxx, Ph.D. If in the performance of its obligations
described herein DOCRO shall exceed the Fee Cap, DOCRO shall provide LEXON a
written Project Extension Authorization (PEA) describing the new aspects or
tasks required to complete the project. The Fee Cap shall not include any fees
or expenses applicable to meetings with LEXON or its partners, or fees for
follow-up or additional data requests from LEXON or any affiliate of LEXON. Fees
and expenses for follow-up or additional data requests from LEXON or any
affiliate of LEXON shall be billed to LEXON according to Section 3.0 of this
Agreement.
3.4. DOCRO shall not initiate any work the cost of which shall exceed the Fee
Cap prior to obtaining LEXON's written approval of a PEA. A PEA shall describe
the aspects of the project to be performed by DOCRO, including a description of
the specific personnel and other resources needed to perform the new tasks of
the project, the time or schedule needed to complete such tasks, and a proposed
schedule for project related payments. The Fee Cap shall be increased by the
amount of any approved PEA.
3.5. DOCRO shall ensure that all charges are allocated accurately to the
activity or project for which such charges were incurred, and are supported by
documents. The nature and purpose of all invoice items shall be identified in
the supporting documents.
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3.6. DOCRO shall be paid for reasonable and necessary business expenses that are
incurred by DOCRO in the course of performing the obligations of this Agreement
as described in this Agreement. Such costs may include, (but are not limited
to), the following: computer research; laboratory expenses; legal expenses
related to obtaining opinions or any other request by LEXON; long distance
telephone and telefacsimile charges; postage, printing and courier charges; and
travel expenses, (including the cost of transportation, meals and lodging).
LEXON shall compensate DOCRO fully for all travel and living expenses which are
agreed to in advance in writing by LEXON and are incurred for site visits to the
premises of LEXON, any clinical investigator, any laboratory investigator, or
any other location that may be requested or are required in order for DOCRO to
fulfill its obligations described in this Agreement.
4.0 Confidential & Proprietary Information
4.1. DOCRO and LEXON hereby agree with respect to Confidential & Proprietary
Information: (1) DOCRO agrees to maintain the confidentiality of any
Confidential & Proprietary Information disclosed by LEXON; (2) DOCRO agrees not
to make any disclosure of LEXON's Confidential & Proprietary Information to any
third party; (3) DOCRO agrees not to use Confidential & Proprietary Information
except for the purpose contemplated in this Agreement, unless such further use
is specifically authorized in writing by LEXON; (4) DOCRO agrees to protect
LEXON's Confidential & Proprietary Information whether in storage or in use,
with the same degree of care as is exercised to protect its own against public
disclosure (but in no case with any less degree than reasonable care); and (5)
DOCRO agrees not to disclosure LEXON's Confidential & Proprietary Information to
any personnel other than those for whom such knowledge is essential for the
purposes contemplated in this Agreement, and such disclosure to them shall be
made only under conditions of strict confidentiality.
4.2. The obligations in this Article shall not apply to Confidential &
Proprietary Information that DOCRO can show by previously existing
documentation: (a) is in the public domain on the date of this Agreement; (b)
comes into the public domain other than through DOCRO's fault or negligence; (c)
is lawfully obtained from a third party with full rights of disclosure; (d) was
already known to DOCRO at the date of receipt of the information pursuant to
this Agreement; or (e) becomes known independently to DOCRO without making use
of any of LEXON's Confidential & Proprietary information.
4.3. If this Agreement expires or is terminated, then DOCRO shall return
promptly all Confidential & Proprietary Information, together with all copies
thereof, except for the retention of one copy for archival purposes. Upon a
written request, DOCRO shall provide an accounting for the disposition of all
such documents or specimens, including a written certification attesting to
return of all such confidential information. DOCRO shall return such items
regardless of ny claims against LEXON.
4.4. No party shall make any press release or other public announcement
concerning the existence, terms, or execution of this Agreement without prior
written consent of the other party.
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4.5. If a disclosure of Confidential & Proprietary Information prohibited by
this Agreement is required specifically by law or by court order, DOCRO will
notify LEXON of such required disclosure and, if so requested, will executed all
necessary documents and provide all reasonable assistance necessary to defend
LEXON's lawful right to prevent or limit such disclosure. DOCRO shall be
entitled to reasonable compensation for assisting in such a defense.
5.0 Warranties & Certifications
5.1. DOCRO warrants that is aware of the obligations imposed under FDA
regulations and guidelines and other governmental laws, regulations and
guidelines which pertain to work DOCRO may perform under this Agreement. DOCRO
warrants that it will conduct all work in full compliance with such laws,
regulations and guidelines.
5.2. DOCRO certifies that neither the company, its affiliates, agents,
contractors nor any of its employees are subject to disbarment under the Generic
Drug Enforcement act, or have been disqualified, prohibited, suspended or
otherwise restric6ted by the FDA or other governmental agency from performing
its obligations under this Agreement.
5.3. DOCRO certifies that all of its employees, agents and contractors are bound
by the provisions of this Agreement, that it has obtained written agreements
from such employees and agents that are consistent with the provision of Section
4.0 of this Agreement, and that it will obtain written agreements from
employees, agents and contractors who in the future will become associated with
the project contemplated in this Agreement.
5.4. DOCRO represents and certifies to LEXON and that it is not restricted from
performing its obligations under this Agreement by its obligations to other
parties. DOCRO further represents and certifies that it will inform LEXON
immediately of any circumstance that might impair the ability of the DOCRO to
perform its obligations, including any actions that might result in FDA or other
government agency action against DOCRO.
5.5. LEXON warrants that it is aware of the obligations imposed under FDA
regulations and guidelines and other governmental laws, regulations and
guildlines which pertain to work DOCRO may perform under this Agreement. LEXON
warrants that it will support DOCRO in conducting all work in full compliance
with such laws, regualtipons and guildelines.
5.6. LEXON certifies that all of its employees, agents and contractors are bound
by the provisions of this Agreement, that it has obtained written agreements
from such employees and agents that are consistent with the provisions of
Section 4.0 of this Agreement, and that it will obtain written agreements from
employees, agents and contractors who in the future will become associated with
the project contemplated in this Agreement.
5.7. LEXON and DOCRO warrant that the signatories to this Agreement are
authorized to execute this Agreement on behalf of the respective parties.
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6.0 Modification of Agreement
6.1. No waiver or modification of this Agreement shall be valid, nor shall it be
offered or received in evidence in any proceeding, arbitration or litigation
between the parties arising out of or related to this Agreement, unless such
waiver or modification is in writing signed by authorized representative of both
parties, particularly pointing out any provisions to be added, deleted, or
modified.
6.2. Unless expressly approved by the waiving party in accordance with Section
6.1., the failure of either party to enforce any provision of this Agreement
shall not be construed as a waiver or limitation of that party's rights to
subsequently enforce and compel strict compliance with every provision of the
Agreement. No waiver (express or implied) by either party of any breach of this
Agreement shall constitute a waiver of any other or subsequent breach.
7.0 Assignment
This Agreement shall be binding on and inure to the benefit of each party,
its successors or assigns.
8.0 Independent Contractor Status
8.1. The business relationship between DOCRO and LEXON shall be that of
independent contractors, and does not constitute a partnership, joint venture,
agency or contract of employment.
8.2. No party shall have the authority to make any statements, representations
or commitments of any kind, or to take any action that shall be binding on the
other, except as provided for herein or authorized in writing by the parties to
be bound.
8.3. DOCRO solely shall be responsible for provision of personnel, equipment,
and supplies, and, subject to the terms of this Agreement, for payment of
DOCRO's costs, suppliers, employees and contractors. In no case shall any party
have the authority, or represent themselves as having the authority, to bind
legally any other in contract, debt or otherwise.
9.0 Use of Third Party Service Providers
DOCRO will obtain prior written approval from LEXON of any third party that
DOCRO intends to use for any professional services provided to LEXON. LEXON on a
reasonable basis may reject the use of any such external DOCRO, affiliate, agent
or subcontractor.
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10.0 Notice
10.1. Any notice required under this Agreement shall be deemed given only upon
receipt of any letter of instrument sent by certified mail, return receipt
requested, postage prepaid by the sender, by overnight courier or by personal
delivery, unless prior notice is tenured by the sender that a signed telefaxed
response followed by confirmation by mail will satisfy the terms of this
provision.
If to DOCRO: If to LEXON:
------------ ------------
Xxxxxx X. Xxxxxxx Xxxxxx X. Xxxxxxxx, Xx.
President and Chief Executive Officer Medical Director
DIAGNOSTIC ONCOLOGY CRO, Inc. Lexon, Inc.
00 Xxxxxxxx Xxxx 0000 Xxxxx Xxxx Xxxxxx, Xxxxx 000
Xxxxxxx, XX 00000 Xxxxx, XX 00000
10.2. From time to time either party, by written notice to the other in
accordance with this Section 11.0, may designate different or alternative
addresses or manners of delivery that shall become the effective or alternative
addresses, or manner of delivery, for such party or project as so designated.
11.0 Entire Understanding
This Agreement contains the complete understanding between the parties
and shall, as of the date of execution of this Agreement, supersede all other
written or oral agreements between the parties concerning the subject matter of
this Agreement.
12.0 Severability
The terms of this Agreement are severable. If any term of this agreement
is held invalid or unenforceable, the valid and enforceable portion of such term
and the remaining provisions of this Agreement will remain in full force and
effect. The remaining contract shall be interpreted consistently with the intent
of the parties with respect to the entire Agreement when the contract was
executed.
13.0 Dispute Resolution
13.1. DOCRO and LEXON agree that a breach or threat of breach of any obligation
described under Section 4.0 necessarily will result in immediate, material and
irreparable damages to the other. Thus, each party agrees that the appearance or
threat of breach of Section 4.0 shall entitle a party to obtain, without bond,
injunctive or equitable relief in any court of competent jurisdiction to enforce
compliance with a party' obligations under that Section. Seeking or obtaining
such relief shall not prohibit or limit other remedies to which a party may be
entitled.
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13.2. Except when seeking injunctive relief for the breach of obligations under
Section 4.0 any claims brought by the parties on xxxxxx relating to or arising
out this Agreement shall be first submitted to binding arbitration. The
arbitration shall be conducted in the State of Connecticut, in conformance with
the rules of the American Arbitration Association, or, if mutually agreed to by
the parties, other rules of arbitration. Arbitration shall be conducted by three
arbitrators. Each party shall appoint one arbitrator and the third shall be
appointed jointly by parties' appointed arbitrators.
13.3. The confidentiality provisions of this Agreement shall not be enforceable
with respect ot affecting a dispute resolution proceeding between the parties.
13.4. The parties agree that they will use their best efforts to resolve
amicably any dispute arising out of or relating to this Agreement. Any
controversy, claim or dispute that cannot be so resolved shall be settled by
final binding arbitration in accordance with the rules of the American
Arbitration Association and judgement upon the award rendered by the arbitrator
or arbitrators may be entered in any court having jurisdiction thereof. Any such
arbitration shall be conducted in Connecticut, or such other place as may be
agreed upon mutually by the parties. Within on e (1) month after the
commencement of the arbitration, each party shall select one person to act as
arbitrator, and the two arbitrators so selected shall select a third arbitrator
within on (1) month of their appointment. The Arbitration Period shall not
exceed three (3) months. Each party shall bear its own costs and expenses and an
equal share of the arbitrator's expenses and administrative fees of arbitration.
13.5. With respect to all other provisions of this Agreement, this Agreement
shall be governed by and construed in accordance with the law of the State of
Connecticut, without consideration of choice of law. Any claims of actions by
either party related to all provisions other than the confidentiality provisions
of Section 4.0 shall be brought before any court of competent jurisdiction in
the State of Connecticut.
14.0 Headings
The headings contained in this Agreement are only for the convenience of
the parties and are not to be construed as a substantive provision and will not
in any manner affect the interpretation of this Agreement.
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The parties execute this Agreement in accordance with all of the above terms and
conditions.
For Lexon ,Inc.:
By: /s/ XXXXXX X. XXXXXXXX Date: April 7, 2000
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Xxxxxx X. Xxxxxxxx, Xx.
Medical Director
For DIAGNOSTIC ONCOLOGY CRO, Inc.:
By: /s/ XXXXXX X. XXXXXXX Date: Tuesday, 04 April 2000
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Xxxxxx X. Xxxxxxx
President and Chief Executive Officer
DIAGNOSTIC ONCOLOGY CRO, Inc. 00 Xxxxxxxx Xxxx - Xxxxxxx XX 00000
Specialists in Oncology Voice (000) 000-0000 - Fax (000) 000-0000
in Vitro Diagnostics Page 01 of 02
Tuesday, 18 April 2000
Xxxxxx X. Xxxxxxxx, Xx. M.D. VIA FEDERAL EXPRESS
Medical Director
Lexon, Inc. e-mail: xxxxxx.xxxxxxxxxx@xxx.xxx
0000 X. Xxxx Xxxxxx, Xxxxx 000 Telephone: 000-000-0000
Xxxxx, XX 00000-0000 Telefacsimile: 000-000-0000
CONFIDENTIAL
RE: FOR EXECUTION - Project Extension Authorization to Existing Professional
Services and Confidentiality Agreement (Effective Date: 04 April 2000;
Expiration Date: 05 June 2000) - Extends DOCRO's Agreement an Additional
100 Billable Hours to 18 April 2001
Dear Xxxxxx:
I am pleased that Lexon, Inc.: ("LEXON") has decided to expand the scope of
LEXON's current Professional Servies and Confidentiality Agreement ("PSCA") with
Diagnostic Oncology CRO, Inc. ("DOCRO").
According to the terms of our current PSCA (Effective Date: 04 April 2000;
Expiration Date: 05 June 2000) LEXON and DOCRO now enter into a Project
Extension Authorization ("PEA") which expires on 18 April 2001. This PEA
authorized DOCRO to provide to LEXON up to an additional one hundred (100)
billable hours of professional services related to LEXON's business interests
form today through 18 April 2001. DOCRO shall xxxx LEXON at a rate of three
hundred, twenty-five dollars (US $325.00) per hour for services rendered. LEXON
and DOCRO agree to a Fee Cap of thirty-two thousand, five hundred xxxxxxx (US
$32,500.00) for this PEA.
Any billable hours described herein and any additional expenses incurred by
DOCRO (as described in Section 3.0 of the PSCA) shall be billed to LEXON on a
net fifteen (15) day basis according to the terms of the PSCA. All other terms
and conditions of the PSCA shall continue to apply to this PEA.
Please indicate LEXON's accedptance of the terms of this PEA by
countersigning in the place below both originals of this PEA. You may retain one
original for LEXON's records and return the other original to my attention at
the address shown above.
Best regards,
Xxxxxx X. Xxxxxxx
President and Chief Executive Officer
Accepted by: /s/ XXXXXX XXXXXXXX JR. Date: April 20, 2000
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Signature
Xxxxxx X. Xxxxxxxx, Xx. M.D. - Medical Director, Lexon, Inc.
