AGREEMENT
THIS AGREEMIENT is made and entered into as of the 1st day of June,
1998, by and between Biocontrol Technology, Inc., a Pennsylvania corporation
("Biocontrol") and IDT, Inc., a Pennsylvania corporation ("IDT"). Biocontrol
and IDT are sometimes hereinafter referred to as the "Parties."
WITNESSETH:
WHEREAS, IDT is desirous of completing the development of, obtaining
regulatory approval for, and having manufactured a device intended to be used
for the regional treatment of cancers, known as the "'ThermoChem-HT"; and
WHEREAS, IDT desires to retain Biocontrol to assist in the completion of
these tasks for the ThermoChem-HT; and
WHEREAS, Biocontrol desires to perform such services for IDT by completing
the development and applying for regulatory approval in a timely manner, and to
undertake to manufacture the ThermoChem-HT for IDT based on the terms and
conditions set forth herein.
NOW THEREFORE, in consideration of the mutual covenants and agreements set
forth herein, and other good and valuable consideration, the receipt and
adequacy of which is hereby acknowledged, and intending to be legally bound
hereby, the Parties hereto agree that this Agreement shall be governed as
follows:
1.1 DUTIES OF BIOCONTROL.
a. Biocontrol agrees to use its best efforts to complete the development
of the ThermoChem-HT in a period not to exceed six (6) months from the date of
this Agreement (the "Development") Development will be considered complete when
one successful manufacturing prototype has been fabricated and operates in
accordance with IDT-provided specifications. The costs of Development will be
reimbursed by IDT in accordance with the following formula:
Actual labor costs (less benefits) plus 100% overhead
Actual material or service purchase costs (less freight) plus 15%
override
General and Administrative fee of 15% on the above costs
b. Biocontrol shall complete the Development in accordance with ISO and
FDA standards and will assume the responsibility for the ThermoChem-HT design
(the "Design Authority") and, providing Development has been successful, will
use its best efforts to obtain the CE Xxxx, FDA approval, and any other
regulatory approval deemed desirable by IDT (the "Regulatory Approval") for the
ThermoChem-HT. In addition, Biocontrol will endeavor to obtain patents as
directed by IDT. Biocontrol shall charge IDT for these services in accordance
with the above formula.
c. Biocontrol will take whatever steps are necessary to assure ongoing
regulatory compliance for the ThermoChem-HT, including, but not limited to,
adherence to ISO and FDA standards.
d. Biocontrol agrees to manufacture the ThermoChem-HT (the
"Manufacturing") and sell it to IDT at a price to be determined in accordance
with the following formula:
Costs of Goods Sold (defined as Biocontrol's aggregate cost of
materials, labor and associated manufacturing overhead) plus a sixty
percent (60%) markup.
This formula may be amended from time to time by mutual consent of
both Parties, set forth in writing and attached hereto as an amendment
to this Agreement, and shall be reviewed at least annually from the
date of the initial schedule.
2. DUTIES OF IDT.
a. IDT assigns Design Authority to Biocontrol.
b. IDT will provide Biocontrol with specifications, drawings, notes,
prototype, components, patents, and any other items which will assist Biocontrol
in completing the Development and agrees that Biocontrol shall be the design
authority for the ThermoChem-HT.
c. IDT agrees to assume responsibility and costs for conducting clinical
and other testing AS required to collect data to be used by Biocontrol in the
submittal of reports, applications, notifications, and other documents for
approval by and compliance with any regulatory body.
d. IDT agrees and covenants to use Biocontrol as the exclusive
manufacturer of the ThermoChem-HT and other related products in the future and
will not engage or contract with any other entity to perform any manufacturing
services related to the ThermoChem-HT without the express prior written consent
of Biocontrol.
e. IDT agrees to use due diligence in providing timely notice to
Biocontrol of quantities of ThermoChem-HT and will submit a projection of
anticipated quantities to be manufactured by Biocontrol at least once per
quarter.
f. IDT will pay invoices submitted upon shipment of ThermoChem-HT within
thirty (30) days of date of shipment.
g. Except for disposables used up in the operation of a system, BDT
agrees that Biocontrol shall have first rights of refusal for development and/or
manufacture of any future devices IDT may intend
to market.
3. DISPUTE RESOLUTION WITH REGARD TO PRICE DETERMINATION. Prior to
invoking arbitration as outlined in Paragraph 9, in the event of a dispute
between the Parties with regard to payment for the Development Regulatory
Approval, and Manufacturing, the following remedy is provided:
Direct or indirect overhead items shall be initially defined by
Biocontrol. In the event that IDT disagrees with the characterization of
any such item, IDT shall so notify Biocontrol in writing, and, for a period
of thirty (30) days following such notification, Biocontrol's independent
certified public accountants and IDT's independent accountants will
negotiate with one another in an attempt to resolve the matter. During the
pendency of such negotiations, any disputed items shall continue to be
treated in accordance with the characterization given to them by
Biocontrol. Following the expiration of said thirty (30) day period, if
negotiations between the accountants have not been successfully concluded,
either Party shall have the right to request that the matter be submitted
to and determined by arbitration board as provided for in Paragraph 9.
4. APPLICABLE LAWS, ORDERS AND REGULATIONS. It is agreed that all
obligations herein undertaken are with a view to compliance by both Parties with
all pertinent provisions of applicable laws, orders and regulations relating to
the development manufacture, use and sale of medical devices.
5. ABILITY TO SUBCONTRACT. In the event Biocontrol desires to
subcontract or assign all or part of its rights to manufacture the
ThermoChem-HT, then Biocontrol shall provide ninety (90) days written notice to
EDT of the identity of such subcontractor or assignee and shall not enter into
any such
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agreement without the express prior written consent of IDT. IDT agrees that the
subcontracting of subassemblies or components shall not require such consent
when the assembly is completed by Biocontrol, unless such subassembly requires
regulatory notification.
IDT shall have the right to contract another manufacturer for the
ThermoChem-HT only as set forth in Paragraph 2 herein, or upon the occurrence of
an Event of Default by Biocontrol under the terms of this Agreement which is not
cured and results in the termination of this Agreement as set forth in Paragraph
5 herein.
6. TERMINATION AND DEFAULT. Either Party shall have the right during the
term of this Agreement to terminate the Agreement effective after thirty (30)
days written notice to the other in the event of the occurrence of an Event of
Default, as defined below:
a. Either Party's failure to use its best efforts to perform its
obligations under this Agreement; or
b. IDT fails to make payments to Biocontrol as described herein; or
c. If a petition under the federal bankruptcy laws or any state
insolvency law is filed by or against either Party, or a receiver, fiscal agent
or similar officer if appointed for either Party; or
d. If either Party is unable to fulfill its obligations as set forth
herein for any reason, including regulatory, patent, or enforcement activities
of any agency or unit or similar body of any state, local or federal government;
or
e. A material breach of representation set forth in this Agreement.
Each Party shall have a thirty (30) day period following the receipt of a
Notice of Default from the other Party in which to cure or remedy the stated
default. If the default is not cured during such period it shall be deemed as
Event of Default for which the Agreement may be terminated.
No failure of omission to carry out or to observe any of the terms of this
Agreement shall give rise to any claim by one Party hereto against the other, or
be deemed an event of default if the same shall be caused by FORCE MAJEURE or
other circumstances beyond the control of the Party affected and in the absence
of gross negligence.
In the event of termination pursuant to this Paragraph 6, IDT will pay for
any prior commitments made or expenses incurred by Biocontrol pursuant to this
Agreement which cannot be reasonably negated by Biocontrol, and Biocontrol shall
use its best efforts to mitigate any such commitments.
7. TERM. This Agreement shall remain effective for a period of 1 year
from the date of the initial production delivery of the ThermoChem-HT, and may
be renewed for additional terms by the Parties in writing.
8. WARRANTY. Biocontrol warrants the ThermoChem-HT to be free from
defects in materials and workmanship for a period of one year from the date of
delivery to IDT's customer. Biocontrol shall maintain an inventory control
system in order to keep adequate records in accordance with ISO9001 and FDA
Quality System requirements. Biocontrol's obligation under this warranty as
limited to making good as its factory on product returned intact to it, with
transportation charges prepaid and which upon examination shall be determined to
be a defective product. This warranty is expressly in lieu of all other
warranties expressed or implied and of all other obligations or liabilities on
its part, and Biocontrol neither assumes nor authorizes any other person to
assume for it any other liability in connection with the sale of ThermoChem-HT.
This warranty shall not apply to items purchased complete
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and installed in ThermoChem-HT (such as disposable components) without
Biocontrol's alteration. In those cases the warranty of the original
manufacturer shall be applicable.
9. ARBITRATION. The Parties agree that any and all disputes, claims or
controversies arising out of or relating to this Agreement shall be submitted to
J.A.M.S./ENDISPUTE, or its successor, for mediation, and if the matter is not
resolved through mediation, then it shall be submitted to J.A.M. S./ENDISPLTIE,
or and the other party a written request for mediation, setting forth the
subject of the dispute and the relief requested. The Parties will cooperate
with J.A.M.S./ENDISPUTE and with one another in selecting a mediator from
J.A.M.S./ENDISPUTE's panel of neutrals, and in scheduling the mediation
proceedings. The Parties covenant that they will participate in the mediation
in good faith, and that they will share equally in its costs. All offers,
promises, conduct and statements, whether oral or written, made in the course of
the mediation by any of the Parties, their agents, employees, experts and
attorneys, and by the mediator of any J.A.M. S/ENDISPUTE employees, are
confidential, privileged and inadmissible for any purpose, including impeachment
in any arbitration or other proceeding involving the Parties, provided that
evidence that is otherwise admissible or discoverable shall not be rendered
inadmissible or non-discoverable as a result of its use in the mediation.
Either Party may initiate arbitration with respect to the matters submitted to
mediation by filing a written demand for arbitration at any time following the
initial mediation session or 45 days after the date of filing the written
request for mediation, whichever occurs first. The mediation may continue after
the commencement of arbitration if the Parties so desire. Unless otherwise
agreed by the Parties, the mediator shall be disqualified from serving as
arbitrator in the case. The provisions of this Paragraph may be enforced by any
Court of competent jurisdiction, and the Party seeking enforcement shall be
entitled to an award of all costs, fees and expenses, including attorneys' fees,
to be paid by the Party against whom enforcement is ordered.
10. NOTICES. Any notice given pursuant to this Agreement shall be deemed
given (I) when received, if personally delivered to the Party to receive such
notice, or (ii) when received, if sent by overnight courier service or by
registered or certified mail, to the Party to receive such notice at the address
set forth below, or (iii) on the first business day following confirmed receipt
when transmitted by facsimile, with hard copy forwarded by United States mail or
overnight courier service, addressed as follows:
If to Biocontrol: Biocontrol Technology, Inc.
000 Xxxxxx Xxxxxxx Xxxx
Xxxxxxx, XX 00000
Attention: President
Fax No.: 000-000-0000
If to IDT: IIDT, Inc.
0000 Xxxxxxx X-Xxx Xxxx Xxxx. 0000
Xxxxxxxxxx, XX 00000
Attention: President
Fax No.: 000-000-0000
11. MISCELLANEOUS.
a. This Agreement shall be governed by and construed in accordance with
the laws of the Commonwealth of Pennsylvania.
b. Either Biocontrol or IDT may assign this Agreement to any party which
acquires substantially all of its assets and business. Otherwise, this
Agreement shall be non-assignable by either Party. This Agreement shall be
binding upon and inure to the benefit of the successors and permitted assigns of
the Parties.
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c. If any portion of this Agreement is adjudged illegal or unenforceable,
the remainder of this Agreement shall continue to be enforceable, if such
enforceability is commercially reasonable.
IN WITNESS WBEREOF, the Parties have caused this Agreement to be executed
by their fully authorized representatives as of the date first above written.
ATTEST: BIOCONTROL TECHNOLOGY, INC.
By
------------------------------ --------------------------------------
Title:
----------------------------------
ATTEST: IDT, INC.
By
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Title:
----------------------------------
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AGREEMENT
THIS AGREEMENT is made as of the 21st day of June, 1999 by and between
IDT, INC., a Pennsylvania corporation whose address is 0000 Xxxxxxx Xxxx Xxxx,
Xxxxxxxx 0000, Xxxxxxxxxx, XX 00000 (hereinafter referred to as "IDT"), and
BIOCONTROL TECHNOLOGY, INC., a Pennsylvania corporation with an address at 0000
Xxxxxxx Xxxx Xxxx, Xxxxxxxx 0000, Xxxxxxxxxx, XX 00000 (hereinafter referred to
as "Biocontrol").
WHEREAS, Biocontrol is presently the owner of _________ shares of the
common capital stock of the IDT (the "Shares"), fully paid and non-assessable;
and
WHEREAS, Biocontrol has loaned to IDT the sum of $10,232,991.00 to be
repaid in accordance with the terms and conditions of a promissory note in the
form attached hereto;
WHEREAS, the Directors of IDT and Biocontrol believe that it is in the
best interests of and will be a benefit to both parties to enter into an
Agreement, by which Biocontrol will agree not to sell or otherwise transfer the
shares of IDT owned by Biocontrol during the lifetime of the loan;
NOW, THEREFORE, in consideration of the mutual promises and covenants
contained herein, the parties hereto, with the intent to be legally bound,
hereby agree as follows:
1. Biocontrol hereby agrees that, without the prior written consent
of IDT, Biocontrol will not, during the three year period commencing on the date
hereof: (a) offer, pledge, sell, contract to sell, sell any option or contract
to purchase, purchase any option or contract to sell, grant any option, right or
warrant to purchase, or otherwise transfer or dispose of, directly or
indirectly, more than ten (10) percent of the Shares
in any one twelve month period, or (b) enter into any swap or other arrangement
that transfers to another, in whole or in part, any of the economic consequences
of ownership of more than ten (10) percent of the Shares in any one twelve month
period, whether or not any such transaction described in clause (a) or (b) above
is to be settled by delivery of such Shares, in cash or otherwise. The
undersigned agrees and consents to the entry of stop transfer instructions with
the Company's transfer agent against the transfer of the Shares except in
compliance with the terms and conditions of this Agreement.
2. This Agreement shall terminate upon (i) the repayment of all
outstanding principal and interest due to Biocontrol under the promissory note,
or (ii) the expiration of the three year period referenced in Paragraph 1.
3. This Agreement (i) contains the entire understanding and
agreement of the parties with respect to the subject matter hereof, and may not
be modified or amended except by a subsequent written agreement executed by the
parties hereto, (ii) along with all its terms and conditions shall inure to the
benefit of and be binding upon the parties hereto, their respective heirs,
successors and assigns, and (iii) shall be governed by Pennsylvania law and
enforceable in the state and federal courts of Pennsylvania in Pittsburgh,
Pennsylvania.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as
of the day and year first above written.
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ATTEST: IDT, INC.
By: XXXXX XXXXXXX-PRESIDENT/s/
----------------------------------- --------------------------
Xxxxx Xxxxxxx, President
ATTEST: BIOCONTROL TECHNOLOGY, INC.
By: Xxxx Xxxxxx /s/
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Xxxx Xxxxxx, President
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