EXHIBIT 10.6
AGREEMENT
WHEREAS, Ajinomoto Co., Inc. ("Ajinomoto") of Tokyo, Japan desires to
sponsor and fund a research and development program and BTRL Contracts and
Services, Inc., doing business as Biotech Research Laboratories (BTRL) a wholly
owned subsidiary company of Boston Biomedica, Inc., desires to provide the
necessary services to perform such research (The Project), this Contract
Agreement is made this 1st day of October 1995 by Ajinomoto and BTRL. In
consideration of the mutual promises set forth herein, the parties hereto state
and agree as follows:
1. BTRL agrees, that in return for the payments to be made thereunder, it
shall provide services including labor, materials and supplies,
facilities and administrative support necessary to perform the Project as
described in Attachment I, using its best efforts therein. This work will
be performed under the direction of the Project Officer (Ajinomoto) and
facilitated by a Principal Investigator (BTRL).
2. In consideration of the services to be performed by BTRL during the
Project, Ajinomoto will pay BTRL in accordance with the budget specified
in Attachment II.
a. The Labor, Materials and Supplies and Other Direct Charges will
reflect the actual usage on the Contract, and will be burdened
with a [Language Deleted Due To Confidential Treatment Request.]
Fringe Benefit Rate, an [Language Deleted Due To Confidential
Treatment Request.] G&A Rate and a [Language Deleted Due To
Confidential Treatment Request.] Fee as indicated. Fringe benefits
will include: long-term disability, life insurance, earned time,
tuition reimbursement, usually ten paid holidays, 401K plan and
short term disability. No health insurance coverage will be
offered to this class of employee ( "Project At-Will").
b. The Rental and Other Fixed Overhead Costs will remain fixed in the
course of the Project as indicated.
c. Any required equipment purchases which are not billed directly to
this contract, but which come from a Supplementary Budget, will
not be burdened with G&A or Fee.
The payments on each year's budget shall be payable in two equal
semi-annual installments, the first of which shall be due as of the
effective date of this Agreement and the remaining installments due at
six month intervals thereafter. BTRL will provide Ajinomoto with monthly
statements indicating the actual expenditures incurred on this Project.
In the event that substantial changes in the proposed budget are
requested by Ajinomoto, (such as hiring additional personnel or requiring
substantial increases in the cost of Materials or Services), and such
changes will exceed the proposed
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budget for the year, BTRL will request a Supplementary Budget and await
Ajinomoto's approval prior to incurring these costs. Approved payments
relating to the Supplementary Budget will be made in accordance with the
manner detailed in a., b., c., above.
3. BTRL agrees that in the performance of the Project, it shall provide the
personnel identified and required by Ajinomoto. Initially, this personnel
shall consist of a Principal Investigator (10% effort), two full-time
Technicians and one full-time Administrative Assistant. If requested by
Ajinomoto, a full-time Senior Scientist or other personnel may be added
at a subsequent time. Personnel hired by BTRL for the Project, other than
the P.I., will be "Project At-Will" employees directly reimbursed by the
Project. The scientific personnel working on the Project shall have the
necessary scientific training and experience to perform the Project.
4. In further consideration of the payments to be made in Paragraph 2 above,
BTRL shall provide two carpeted offices (designated as Room I and Ia on
BTRL's floor plan), one for [Language Deleted Due To Confidential
Treatment Request.], the on-site Project Officer employed by Ajinomoto,
and another for the Administrative Assistant and scientific personnel.
The offices will come equipped with a telephone extension connecting to
the Company switchboard for internal and local use and a computer network
connection. Private telephone line(s) will be provided by the Project as
will any additional office improvements. BTRL also agrees to provide to
the Project, laboratory space designated as Laboratory X and Xa on BTRL's
floor plan. Laboratory Xa comes equipped with laboratory casework and
cabinets. Laboratory X does not come equipped with laboratory casework or
cabinets. Any additional casework , cabinets or laboratory renovations
will be provided by the Project.
5. Ajinomoto agrees and shall require the Project Officer and any other
Ajinomoto representative entering BTRL's premises to agree to the
following:
a. The presence of such person(s) in BTRL's premises is for the
benefit of Ajinomoto and though BTRL will use reasonable efforts
to maintain its premises in a safe condition, BTRL shall not be
liable for any illness or injury suffered by such person(s) while
in, on or around BTRL's premises, including its laboratories where
infectious biological materials are or may be used.
b. In the event of any illness or injury to such person(s) occurring
on, in or around BTRL's premises, BTRL shall be released from any
and all responsibility or liability for such illness or injury
except to the extent such illness or injury occurred as a result
of any intentional misconduct by BTRL. Ajinomoto shall defend BTRL
against any such claims by such persons and indemnify BTRL from
any liability arising from such claims.
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c. Ajinomoto shall have the responsibility of providing statutory
workers compensation insurance and any other insurance coverage
that may apply to such person(s).
d. BTRL shall have no obligation to provide any insurance coverage
whatsoever for the benefit of Ajinomoto or such person(s).
e. Such person(s) shall abide by all BTRL policies and procedures,
including those concerning health, security and safety, and any
violation of such policies and procedures shall entitle BTRL to
refuse to allow such person(s) on its premises and/or to require
Ajinomoto to substitute other representatives for those who
violate such policies and procedures.
f. Any non-public information learned about any aspect of the
business of BTRL and/or its affiliated companies (other than
information concerning the Project) shall be held in full and
complete confidence and shall not be used, or disclosed to any
person or entity whatsoever, without the prior written consent of
BTRL. The foregoing restriction shall apply to technical
information, and financial and non-financial information including
but not limited to know-how, formulae, patents, processes,
procedures, sales information, manufacturing data and names of
customers or vendors.
6. This Agreement and the Project shall extend for an initial term of three
(3) years, which may be extended by mutual agreement for additional terms
of one year each.
Ajinomoto shall have the right to terminate this Agreement prior to
September 30, 1998 by giving three (3) months prior written notice to
BTRL. If however, Ajinomoto terminates this Agreement without cause for
its own convenience BTRL shall be due the balance of all Fee as specified
in the Project Budget (Attachment II). Except as otherwise provided above
or unless explicitly agreed otherwise between the parties, neither party
shall have the right to terminate this Agreement on or before October 30,
1998, except that either party may terminate this Agreement forthwith:
a. in the event the other party shall breach any of its obligations
under this Agreement and fails to remedy such breach within sixty
(60) days from receipt of notice of such breach by the party not
in default:
b. in case of the other party's liquidation, bankruptcy or state of
insolvency; or
c. in the event the other party assigns this Agreement without the
written consent of the terminating party.
Upon expiration or termination of this agreement for any reason
whatsoever, all claims each party may have against the other party shall
become due. The parties
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shall make up a list of such claims of each against the other. Such
claims shall be offset and the net amount arrived at shall be settled
within sixty (60) days from the termination of this agreement.
7. In order to protect the confidentiality of all confidential subject
matter, the parties agree not to disclose or release such confidential
subject matter to any person, laboratory, institution, corporation or
other entity that is not directly participating in this Project; and, to
not use or permit the use of said confidential subject matter for any
purpose other than for the Project without first obtaining the express
written permission of the other party, except under the following
circumstances:
a. Subject matter that, as of the signing of this agreement, is in
the public domain;
b. Subject matter that, as of the date of the signing of this
agreement, can be shown by written evidence to have been known to
either party;
c. Subject matter that, at any time is received in good faith by
either party from a third party who was lawfully in possession of
the same and had the right to disclose the same; and
d. Subject matter that the parties mutually agree in writing to
release from the terms of this agreement.
8. Any and all discoveries and/or inventions arising from performance of the
Project shall belong to Ajinomoto. BTRL shall, however, be entitled to a
royalty of [Language Deleted Due To Confidential Treatment Request.] of
the net sales of those products which are covered by a product patent
arising out of the Project; and BTRL shall be entitled to a royalty of
[Language Deleted Due To Confidential Treatment Request.] of the net
sales of products covered by only a process patent arising from the
Project. In the event a product is covered by both a product patent and a
process patent, BTRL shall receive a royalty of [Language Deleted Due To
Confidential Treatment Request.]. Royalty payments on products covered by
patents shall continue for the life of the applicable patent. BTRL shall
be entitled to a [Language Deleted Due To Confidential Treatment
Request.] royalty on net sales of products utilizing technology developed
under the Project if there is no patent on either the product or the
process utilized therein. Royalty payments applicable to unpatented
products or processes shall continue for a period of ten years from the
date of the first commercial sale of a product utilizing the unpatented
technology.
9. BTRL shall have a right of first refusal on an exclusive or
semi-exclusive (with Ajinomoto) basis in the event Ajinomoto decides to
license any patented technology arising from the Project. BTRL shall have
the right to use unpatented technology in exchange for payment of a sum
to be agreed upon by both parties during the term of its use; however,
after ten years of royalty payments BTRL shall be deemed to have a paid
up license to use such technology.
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10. In the event that either of the parties hereto, at any time during the
term of this Agreement, commits a breach of any provision thereunder, and
fails to rectify such breach within sixty (60) days from the receipt of
written notice thereof from the other party, such other party may be
entailed to terminate this Agreement.
11. In the event of any dispute, the parties shall use their best efforts to
resolve such dispute. If such dispute is not resolved within sixty (60)
days of the first written notice thereof, either party may request
arbitration, with such arbitration to take place in Rockville, Maryland,
in accordance with the Commercial Mediation rules of the American
Arbitration Association. The parties agree that they will be represented
at the oral proceedings of such mediation by at least one of their
authorized officers who may be assisted by one or more advisors. The cost
of such mediation shall be shared equally by the parties, and each party
shall bear its own expenses in connection with such mediation. The
parties shall endeavor and shall instruct the mediator to have the
mediation proceedings completed and a final resolution reached within 60
days of the date the mediator is appointed.
This Agreement shall be governed by and construed in accordance with the
laws of the State of Maryland. In the event of an unsettled dispute, the
parties mutually agree to the use of any federal or state court in the
State of Maryland having jurisdiction over the subject matter thereof,
and the parties hereby waive any and all rights to object to the laying
of venue in any such court and to the right to claim that any such court
may be an inconvenient forum. The parties hereby submit themselves to the
jurisdiction of each such court and agree that service of process on them
in any such action may be effected by notice in writing to the officials
or their replacements who have signed this Agreement.
12. In the event of termination of or at the end of the Agreement Ajinomoto
agrees to reimburse BTRL for those expenses incurred by the Project after
the winding down of the Project. Sixty days prior to the end of the
agreement BTRL will submit to the on-site Project Officer a list of
expenses to be approved that will be incurred as a result of the end of
the project
13. Attachment I is a description of the Project.
14. Attachment II is the Project Budget.
15. Attachment III is the List of Equipment.
16. Attachment IV is a Building Floor Plan designating office and laboratory
space to be assigned to the Project.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed as of the date set forth above by their duly authorized
representatives.
AJINOMOTO CO., INC. BTRL CONTRACTS AND SERVICES, INC.
BY BY
---------------------------- ------------------------------------------
Masakatsu Nakamura Richard T. Schumacher
TITLE TITLE
------------------------- ---------------------------------------
Managing Director President
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ATTACHMENT 1
Research Objectives
a. Relationship between immunodeficiency and plasma levels of
L-cystine
There is evidence to support the idea that persons with
immunodeficiencies, such as Low Natural Killer Syndrome (LNKS),
advanced and terminal stage cancers, HIV-1 infections, etc., have
significantly lower plasma levels of certain essential amino
acids, i.e., L-cystine and L-glutamine compared to those of
healthy individuals. Since current assays for immunodeficiencies,
specifically NK activity assays, require the use of radioisotopes
and viable biological samples, a chemical assay to measure amino
acids would be both simpler and easier. Our group is developing a
colorimetric assay to determine plasma levels of L-cystine. This
assay can be used in place of the more time-consuming NK activity
assay to determine a person's immune status. The results we have
obtained thus far using this colorimetric assay lend further
support to the above hypothesis.
The ultimate goal of this project is to develop a diagnostic kit
that makes use of plasma levels of L-cystine as a marker for
immunodeficiency.
b. Support of clinical trials of Low NK Syndrome patients by
treatment with Lentinan.
The University of Pittsburgh School of Medicine, in cooperation
with Ajinomoto Company, is planning clinical trials to gain FDA
approval to administer Lentinan, a polysaccharide extracted from
an edible Japanese mushroom, to patients with Chronic Fatigue
Syndrome (CFS) with or without LNKS. Use of Lentinan in Japan has
proven to be an effective immunopotentiator for the treatment of
CFS and LNKS.
c. Examination of etiology of Low NK Syndrome
Our group will also be collaborating with the University of
Pittsburgh School of Medicine to determine the etiology of LNKS.
As of now, there are three hypotheses as to the cause of LNKS: (1)
an undetermined virus, (2) a defective metabolic pathway and/or
(3) a genetic factor. Once the mechanism(s) that leads to LNKS has
been defined, a quantitative assay, e.g., PCR in the case of a
viral infection, can be utilized to further characterize the
etiologic agent(s).
ATTACHMENT II
YEARLY COST BREAKDOWN
SUMMARY OF ANNUAL COSTS
AJINOMOTO CONTRACT
3 YEAR
YEAR 1 YEAR 2 YEAR 3 TOTAL
DIRECT LABOR
Technician [Language Deleted Due To Confidential Treatment Request.]
Technician
Admin Assistant [Language Deleted Due To Confidential Treatment Request.]
P.I.
TOTAL DIRECT
LABOR [Language Deleted Due To Confidential Treatment Request.]
FRINGE BENEFITS
FACILITIES
OFFICE 272 SQUARE FT. [Language Deleted Due To Confidential Treatment Request.]
LABS 892 SQUARE FT.
OTHER FIXED OVERHEAD COSTS
MATERIALS [Language Deleted Due To Confidential Treatment Request.]
OTHER DIRECT
(HEALTH INSURANCE, POSTAGE, TRAVEL, PRIVATE TELEPHONE)
SUBTOTAL
G & A [Language Deleted Due To Confidential Treatment Request.]
TOTAL COSTS
[Language Deleted Due To Confidential Treatment Request.]
FEE
TOTAL COSTS PLUS
FIXED FEE [Language Deleted Due To Confidential Treatment Request.]
EQUIPMENT
DIRECT LABOR BASED ON 1856 PERON HOURS PER YEAR
ATTACHMENT III
FURNITURE/COMPUTER EQUIPMENT:
Ajinomoto owns desks, chairs, and file cabinets for Dr. Aoki and his staff; 2
IBM compatible computers, 1 laser printer, and 1 laserjet fax.
EQUIPMENT:
Ajinomoto owns the following equipment:
Miscellaneous equipment, supplies, disposable labware, chemicals, etc.
Locker
Scotsman Ice Maker
LKB Ultraspec Plus (Spectrophotometer)
Perkin Elmer Thermal Cycler (Gene Amp PCR System 9600)
Sorvall RT6000B Refrigerated Centrifuge
Ohaus balance
3x Forma Scientific Water-Jacketed Incubator
2x Olympus CK2 Microscopes
Olympus CK2 Microscope with Camera
Zeiss Axiophot Fluorescence Microscope
Skatron A/S Plate Washer
HPLC equipment
Branson 8200 Sonifier
Orion Research pH meter
Sartorius Balance
Ohaus GT480 Balance
2x Refrigerator/Freezers
Beckman 18-70M Ultracentrifuge
Revco (-70%C) freezer (Deep Freezer)
Napco 201 and 202 water baths
Beckman Microfuge 12
Power Supply
Fischer Biotech UV Box
HP Quiet Jet Printer
Titertek Multiskan Mcc/340 Plate Reader
Mistral 3000E Centrifuge
Beckman J2-M1 Centrifuge
Fire Safety Cabinet
Hoeffer Transfor
Packard Liquid Scintillation Analyzer
Branson Sonifier 250
LKB-HPLC Variable Monitor
LKB-HPLC Superac
LKB-HPLC LC Controller
LKB-HPLC HPLC Pump
Attachment IV
[FLOOR PLAN -- UPPER LEVEL]
Attachment IV
[FLOOR PLAN -- LOWER LEVEL]