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EXHIBIT 10.13
SERVICE AGREEMENT
This AGREEMENT is entered into between MEDICAL SCIENCE SYSTEMS, 0000
XXXXXXXXX XXXX., XXX. 000, XXXXXXX XXXXX, XX 00000 (hereinafter referred to as
"COMPANY"), and BAYLOR COLLEGE OF MEDICINE, DEPARTMENT OF MOLECULAR AND HUMAN
GENETICS, DNA DIAGNOSTIC LABORATORY, located at Xxx Xxxxxx Xxxxx, Xxxxxxx, Xxxxx
00000-0000 (hereinafter referred to as "BAYLOR"), with C. XXX XXXXXXXX, PH.D.
(herein referred to as "PRINCIPAL INVESTIGATOR"). COMPANY, PRINCIPAL
INVESTIGATOR, and BAYLOR may hereinafter be referred to individually as a
"PARTY" and collectively as the "PARTIES".
WHEREAS, COMPANY has developed a genetic test for screening patients for
predisposition to severe periodontal disease (the "PERIODONTAL TEST", defined as
IL1alpha and IL1-beta), the description for which is set forth in Exhibit A
hereto;
WHEREAS, BAYLOR has adequate laboratory facilities and skilled personnel
to perform the PERIODONTAL TEST in accordance with an assay which was developed
at Baylor, using specimens collected from patients, as described in Exhibit A,
under the supervision and direction of PRINCIPAL INVESTIGATOR;
WHEREAS, COMPANY desires to retain BAYLOR to perform the PERIODONTAL TEST
based upon specimens sent to BAYLOR by COMPANY or its customers and to deliver
the results of such tests back to COMPANY on the terms and conditions set forth
in this AGREEMENT ("TEST SERVICES");
WHEREAS, it is anticipated that representatives of each PARTY will receive
or have access to technical and scientific information which is in writing and
is labeled as being confidential by the disclosing PARTY (hereafter referred to
as the "CONFIDENTIAL INFORMATION");
WHEREAS, the PARTIES are willing to maintain such CONFIDENTIAL INFORMATION
in confidence and each believes it would be seriously harmed if the CONFIDENTIAL
INFORMATION were disclosed to third parties;
NOW, THEREFORE, in consideration of the foregoing and the mutual
benefits to be derived from the above-mentioned services and other good and
valuable consideration, the PARTIES do hereby agree as follows:
1.0 Each PARTY agrees to:
1.1 restrict CONFIDENTIAL INFORMATION received solely to its
employees and consultants on a need-to-know basis and solely to
the extent reasonably necessary to enable the PARTIES and their
employees to perform their obligations under this AGREEMENT;
and
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* Confidential Treatment requested.
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1.2 not disclose CONFIDENTIAL INFORMATION to any third party unless
prior to such disclosure the PARTY from whom the CONFIDENTIAL
INFORMATION was received shall have expressly agreed in writing
to such a disclosure; and
1.3 use the CONFIDENTIAL INFORMATION solely for the performance of
the PARTIES' obligations under this AGREEMENT and not make
copies thereof, except as necessary to perform such
obligations; and
1.4 instruct all recipients of the CONFIDENTIAL INFORMATION that it
is subject to a Non-Disclosure and Confidentiality Agreement
and cannot be used or disclosed except pursuant to a written
agreement; and
1.5 use, and require all recipients to use, the same degree of
care to protect the CONFIDENTIAL INFORMATION against
unauthorized use or disclosure as the receiving PARTY uses to
protect its own proprietary CONFIDENTIAL INFORMATION.
BAYLOR agrees that the PERIODONTAL TEST, whether disclosed to BAYLOR
in writing or orally, and all results of performing the PERIODONTAL
TEST on specimens hereunder, shall be deemed to be CONFIDENTIAL
INFORMATION subject to the restrictions of this AGREEMENT.
2.0 EXCEPTIONS. Notwithstanding anything to the contrary contained
herein, the PARTY receiving CONFIDENTIAL INFORMATION shall have no
obligation to preserve the confidentiality of any CONFIDENTIAL
INFORMATION (whether received before or after the date of this
AGREEMENT) which:
2.1 has passed into the public domain prior to or after its
disclosure to the PARTY, other than through acts or omissions
attributable to the receiving PARTY; or
2.2 was rightfully obtained subsequent to the date of this
AGREEMENT, other than under binder of secrecy from a third
party not acquiring the CONFIDENTIAL INFORMATION under an
obligation of confidentiality from the disclosing PARTY; or
2.3 the receiving PARTY can show the CONFIDENTIAL INFORMATION was
previously in its possession prior to disclosure thereof by the
disclosing Party; or
2.4 the receiving PARTY is required to disclose by law or legal
process, provided that, prior to any such disclosure the
receiving PARTY will notify the disclosing PARTY that it
intends to make such disclosure; or
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2.5 developed by the recipient independent of the information
received, or performed under, this AGREEMENT.
3.0 RETURN OF CONFIDENTIAL INFORMATION. Upon request, PRINCIPAL
INVESTIGATOR will return all CONFIDENTIAL INFORMATION provided by
COMPANY and all copies thereof. Nothing contained in this AGREEMENT
shall be construed as granting or conferring any rights, by license
or otherwise, in any CONFIDENTIAL INFORMATION disclosed to the
receiving PARTY other than to use such CONFIDENTIAL INFORMATION
in the performance of obligations under this AGREEMENT, in
accordance with Section 1.0 above. Not withstanding the above, a
party may retain a copy of any confidential information of the other
party to the extent required by any regulation or law.
4.0 BAYLOR SERVICES. BAYLOR agrees to perform the PERIODONTAL TEST based
upon specimens shipped to BAYLOR by COMPANY or its customers in
accordance with the requirements set forth in Exhibit A for the
PERIODONTAL TEST. Pricing and payment terms for the performance of
the PERIODONTAL TEST is specified in Exhibit X. XXXXXX will report
the results of the performance of such tests directly to COMPANY,
in accordance with the terms set forth in Exhibit X. XXXXXX warrants
that it has adequate laboratory facilities and skilled personnel to
perform the PERIODONTAL TEST properly developed by Baylor. BAYLOR
warrants that all TEST SERVICES will be performed in accordance
with current laboratory standards, and in compliance with all
applicable federal, state and local laws and regulations.
5.0 NOTICE OF PUBLICATION. BAYLOR agrees to submit a copy to COMPANY of
any proposed publication or presentation relating to the PERIODONTAL
TEST, INVENTIONS, or JOINT INVENTION to COMPANY, for its review, at
least sixty (60) days prior to the estimated date of publication or
presentation of such material to a journal, editor, or other third
party, and if no response is received within thirty (30) days of the
date submitted to COMPANY, it will be conclusively presumed that the
presentation or publication may proceed without delay. If COMPANY
determines that the proposed presentation or publication contains
patentable subject matters which require protection or CONFIDENTIAL
INFORMATION, COMPANY may request the delay of the presentation or
publication for a period of time not to exceed ninety (90) days for
the purpose of allowing the pursuit of such protection. In the event
that COMPANY identifies CONFIDENTIAL INFORMATION contained in the
proposed presentation or publication, the PARTIES shall discuss
changes which shall prevent disclosure of CONFIDENTIAL INFORMATION.
Title to any copyrightable material produced or composed in relation
to such presentation or publication by BAYLOR or its RESEARCHERS
shall remain with BAYLOR and RESEARCHERS, provided that BAYLOR and
its RESEARCHERS shall grant to
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COMPANY an irrevocable, royalty-free, non-exclusive right to
reproduce, distribute and use all such copyrighted material in
conjunction with the approval, registration, marketing or sale of
the PERIODONTAL TEST or any INVENTION or JOINT INVENTION. In all
such cases, COMPANY will use its best efforts to implement such
protection in ways that minimize the impact on planned publication
schedules.
6.0 INDEMNIFICATION
6.1 BAYLOR'S INDEMNIFICATION. COMPANY shall indemnify, defend and
hold harmless BAYLOR and its researchers, their affiliates,
officers, directors, employees and agents from any and all
claims, demands, suits or proceedings arising out of any side
effect, adverse reaction or illness occurring as a result of
the performance of the PERIODONTAL TEST, provided, however,
any such injury, loss or damage is not due to the negligence
or intentional misconduct of BAYLOR or its RESEARCHERS,
and the PERIODONTAL TEST has been administered in accordance
with the assay supplied by COMPANY and any other protocol or
instructions that COMPANY may supply from time to time to
BAYLOR for the performance of the PERIODONTAL TEST. The
foregoing indemnity is subject to the conditions that (i)
BAYLOR and its RESEARCHERS promptly notify COMPANY in writing
after BAYLOR or its RESEARCHERS receives notice of any claim;
(ii) COMPANY is given the opportunity, at its option at any
time during the pendency of such claim, to have the sole
control of the defense, trial and/or any related settlement
negotiations; and (iii) BAYLOR and its RESEARCHERS fully
cooperate with COMPANY in the defense, trial and/or settlement
of any such claim.
6.2 COMPANY'S INDEMNIFICATION. BAYLOR shall indemnify, defend and
hold harmless COMPANY and its affiliates, officers, directors,
employees and agents from any and all claims, demands, suits or
proceedings arising out of the negligence or willful act of
BAYLOR or its RESEARCHERS or the performance of this AGREEMENT.
The foregoing indemnity is subject to the conditions that (i)
COMPANY promptly notifies BAYLOR in writing after COMPANY
receives notice of any claim; (ii) BAYLOR is given the
opportunity, at its option at any time during the pendency of
such claim, to have the sole control of the defense, trial
and/or any related settlement negotiations; and (iii) COMPANY
fully cooperates with BAYLOR in the defense, trial and/or
settlement of any such claim.
7.0 TERM AND TERMINATION
7.1 EFFECTIVE DATE. This AGREEMENT shall become effective as of
its execution by both PARTIES and shall continue in effect
until terminated as set forth herein.
7.2 TERMINATION. Either PARTY may, upon thirty (30) days written
notice to the other PARTY, terminate this Agreement in the
event of a material breach of this
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AGREEMENT by the other PARTY; provided, however, if such breach
is cured within such thirty (30) day period, this AGREEMENT
shall not be terminated. Either PARTY may terminate this
AGREEMENT for any reason or no reason, at any time, upon six
(6) months advance written notice to the other PARTY.
7.3 RETURN OF CONFIDENTIAL INFORMATION. Upon AGREEMENT termination,
each PARTY shall return all CONFIDENTIAL INFORMATION and copies
of CONFIDENTIAL INFORMATION of the other PARTY within its
possession or under its control to the other PARTY, within ten
(10) days thereof. COMPANY shall,within thirty (30) days of
termination, pay any sums due and owing to BAYLOR hereunder.
The provisions of Paragraphs 3.0, 5.0-7.0, 8.1, and 9.0-15.0
shall survive the termination of expiration of this AGREEMENT.
The provisions of Paragraph 1.0 of this AGREEMENT shall
survive. In accordance with Paragraph 12.0 below. Not
withstanding the above, a party may retain a copy of any
confidential information of the other party to the extent
required by any regulation or law.
8.0 RECORD KEEPING. PARTIES agree that unauthorized disclosure of
CONFIDENTIAL INFORMATION would result in irreparable harm.
Accordingly, in the event that a PARTY breaches its obligations
as provided under the AGREEMENT by disclosure or use of CONFIDENTIAL
INFORMATION, it is agreed by the PARTIES that the injured PARTY
shall be entitled to enjoin any further breach and may take such
additional action as it deems necessary and appropriate, including
seeking damages in any court of competent jurisdiction.
8.1 CONFIDENTIALITY. Either PARTY may disclose CONFIDENTIAL
INFORMATION to the extent, but only to the extent, that
disclosure is reasonably necessary in prosecuting or defending
litigation where material harm to the disclosing PARTY would
otherwise result (but such disclosure shall be subject to an
appropriate protective order in such litigation) or in
complying with or demonstrating compliance with government
regulations.
8.2 RECORD ACCESS. Each PARTY shall keep and allow the other
PARTY reasonable access to full and accurate books and records
of all services rendered under this AGREEMENT as required by
state and/or federal law.
9.0 USE OF BAYLOR NAME. COMPANY agrees that it will not at any time
during or following termination of this AGREEMENT use the name of
BAYLOR or any other names, insignia, symbol(s), or logotypes
associated with BAYLOR or any variant, or variants thereof, or the
names of the Principal Investigator, or any other BAYLOR faculty
member or employee, orally or in any literature, advertising, or
other materials (other than simply to state that BAYLOR will perform
the PERIODONTAL TEST for COMPANY and its customers) without the
prior written consent of BAYLOR, which consent may be withheld at
BAYLOR'S sole discretion.
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10.0 CONFIDENTIALITY OF TRADE SECRETS AND OTHER INTELLECTUAL PROPERTY.
BAYLOR agrees to make no public presentations about the PERIODONTAL
TEST or this AGREEMENT outside of appropriate scientific meetings,
to issue no news releases about the PERIODONTAL TEST or this
AGREEMENT, and neither PARTY shall make use of the other's name, in
any form of public information, without the written permission of
the other PARTY, except as permitted in this paragraph or in
paragraph 10.0 above.
11.0 SURVIVAL. Except as provided in Paragraph 2.0, the provisions of
this AGREEMENT shall continue as to any item of CONFIDENTIAL
INFORMATION disclosed for a period of five (5) years following
termination or expiration of this AGREEMENT.
12.0 INSURANCE.
12.1 BAYLOR'S INSURANCE OBLIGATIONS. Throughout the term of this
AGREEMENT, BAYLOR shall provide the following insurance or
equivalent coverage through the self-insurance program of
BAYLOR:
12.1.1 Worker's compensation and employer's liability insurance
covering its statutory and legal obligations for
employee, job-related injuries. Said policy shall
provide at least for statutory benefits;
12.1.2 General liability insurance coverage for third-party
claims for bodily injury and property damage with
limits of at least one million dollars ($1,000,000)
per occurrence and two million dollars ($2,000,000)
annual aggregate.
All such insurance shall contain a waiver of subrogation pursuant
to which the insurer waives all express and implied rights of
subrogation against COMPANY and its directors, officers, staff
members, employees, and agents. Upon receipt of COMPANY's written
request, BAYLOR shall provide COMPANY with certificates evidencing
the above insurance or equivalent coverages.
12.2 COMPANY'S INSURANCE OBLIGATIONS. During the term of this
Agreement, COMPANY shall provide the following insurance:
12.2.1 Worker's compensation and employer's liability insurance
covering its statutory and legal obligations for
employee job-related injuries. Said policy shall at
least provide for statutory benefits;
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12.2.2 General liability insurance coverage for third-party
claims for bodily injury and property damage with
limits of at least one million dollars ($1,000,000)
per occurrence and two million dollars ($2,000,000)
annual aggregate;
All such insurance shall contain a waiver of subrogation
pursuant to which the insurer waives all express and implied
rights of subrogation against BAYLOR and its trustees,
officers, employees, residents, faculty, and agents.
12.3 Proof of Insurance. Upon receipt of a written request from
either PARTY, the other PARTY shall provide the requesting
PARTY with certificates evidencing the above insurance
coverage.
13.0 NOTICES. Except as otherwise expressly provided herein, all notices
required or permitted to be given under this AGREEMENT must be in
writing and must either be delivered personally to the designated
agent of the PARTY to whom the notice is directed or be mailed by
registered or certified mails, return receipt requested, addressed
as shown below. Either PARTY may, at any time, change the address
for notices by delivering or mailing, as aforesaid, a notice stating
the change and setting forth the changed address. Any notice
hereunder shall be deemed effective when personally delivered or
when deposited, postage prepaid, with the United States Postal
Services, addressed as herein before provided. Notice must be given
to the following:
MEDICAL SCIENCE SYSTEMS BAYLOR COLLEGE OF MEDICINE
ATTN: XXXX XXXXX, X.X. ATTN: C. XXX XXXXXXXX, PH.D.
President Laboratory Director
Medical Science Systems Baylor DNA Diagnostic Laboratory
0000 XxxXxxxxx Xxxx, Xxxxx 000 Department of Molecular and Human
Xxxxxxx Xxxxx, XX 00000 Genetics
Xxx Xxxxxx Xxxxx
Xxxxxxx, XX 00000-0000
14.0 This AGREEMENT shall inure to the benefit of and be binding upon
the PARTIES.
15.0 ASSIGNMENT. This AGREEMENT and all rights and obligations hereunder
are personal to the PARTIES hereto and may not be assigned without
the express prior written consent of the other PARTY. Any assignment
or attempt to assign in the absences of such written consent shall
be void and without effect.
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16.0 SEVERABILITY. Each provision of this AGREEMENT shall be considered
separable and, if for any reason, a provision which is not essential
to the effectuation of the basic purposes of the AGREEMENT is
determined to be invalid or contrary to any existing or future law,
such invalidity shall not impair the operation of or affect those
provisions of this AGREEMENT that are valid.
17.0 FORCE MAJEURE. Neither PARTY shall be liable nor deemed to be in
default for any delay or failure in performance under this AGREEMENT
or other interruption of service deemed resulting, directly or
indirectly, from acts of God, acts of public enemy, war, accidents,
fires, explosions, hurricanes, floods, failure of transportation,
strikers, or other work interruptions by either PARTY's employees,
or any similar cause beyond the reasonable control of either PARTY.
18.0 WAIVER. A waiver by either PARTY of breach or violation of any
provision or clause of this AGREEMENT shall not operate as, or be
construed to be, a waiver of any subsequent breach of this
AGREEMENT. No delay in acting with regard to any breach of this
AGREEMENT shall be construed to be a waiver of such breach.
19.0 NON-DISCRIMINATION. The PARTIES hereby agree that neither PARTY
shall fail or refuse to hire or to discharge any individual, or
otherwise to discriminate against any individual with respect to his
or her compensation, terms, conditions or privileges OF employment
under any provision of this AGREEMENT, because of such individual's
race, color, religion, sex, age, veteran status, handicap or
national origin.
20.0 AGREEMENT EXECUTION. Each multiple original of this document shall
be deemed an original, but all multiple copies together shall
constitute one and the same instrument.
21.0 ENTIRE AGREEMENT. This AGREEMENT sets forth the entire agreement of
the PARTIES with respect to the subject matter contained herein and
may not be modified, amended, or discharged, except as expressly
stated herein or by a written agreement duly executed by all PARTIES
hereto.
22.0 CAPTIONS. All captions in this Agreement are solely for convenience
and are not part of this agreement.
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IN WITNESS WHEREOF, the PARTIES hereto have caused this AGREEMENT to be
executed in duplicate and delivered this AGREEMENT as of the date and year as
executed below.
MEDICAL SCIENCE SYSTEMS BAYLOR COLLEGE OF MEDICINE
Department of Molecular and Human
Genetics.
/s/ XXXX XXXXX /s/ C. XXX XXXXXXXX
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Signature C. Xxx Xxxxxxxx, Ph.D
Laboratory Director
Baylor DNA Diagnostic Laboratory
Xxxx Xxxxx, X.X.
President
Date: 12-7-96 Date: 12-3-97
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EXHIBIT A
REFERRAL SERVICE
Performing the PERIODONTAL TEST of COMPANY.
DEFINITION OF PERIODONTAL TEST:
IL-1alpha and IL-1 beta
SPECIMEN REQUIREMENTS
Buccal Swab: two swabs per patient, 40 seconds each from both cheeks
Blood: Blood spots on filter paper/cardboard mounts from finger sticks
SHIPPING SAMPLES
Overnight shipping (within the United States only) will be provided BY Baylor
via AIRBORNE EXPRESS. Company will be responsible for all international
shipping. Company will arrange for specimens to be shipped directly to Baylor.
Specimens will not be received on weekends. Company will request referring
physicians to xxxx packages appropriately for weekday arrival at Baylor.
Specific information should be preprinted on Airborne air-bills:
- the TO section should have the Baylor DNA Lab's address filled in
- the XXXX RECEIVER box should be checked and the Baylor DNA Lab's
account # should be printed on the line next to it
- the NUMBER OF PKGS box should say 1
- the WEIGHT box should say 1 xx
Xxxxxx will not pay for shipping of unmarked packages
- LAB PACK should be checked
- TYPE of service should be checked Express
REPORTING
BAYLOR will report batched test results directly to COMPANY via diskette. BAYLOR
will provide patient and doctor data agreed to by both parties to COMPANY.
WEEKLY TESTING
AS of the Effective Date, the Baylor DNA laboratory plans to run the PST(TM)
weekly. Sample shipments will need to be scheduled to arrive no later than
Friday afternoon in order to make the next run date.
BILLING
BAYLOR will xxxx COMPANY monthly for submitted samples.
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