<PAGE>
As filed with the Securities and Exchange Commission on March 5, 1999
Registration No. 333-69207
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- -------------------------------------------------------------------------------
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
----------------
AMENDMENT NO. 4 TO
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
----------------
CARESIDE, INC.
(Exact name of registrant as specified in its charter)
Delaware 3841 23-2863507
(Primary Standard (I.R.S. Employer
(State or other Industrial Identification No.)
jurisdiction of Classification Code
incorporation or Number)
organization)
6100 Bristol Parkway, Culver City, CA 90230
(310) 338-6767
(Address, including zip code, and telephone number,
including area code, of registrant's principal executive offices)
----------------
W. Vickery Stoughton
Chairman of the Board of Directors and
Chief Executive Officer
Careside, Inc.
6100 Bristol Parkway
Culver City, CA 90230
(310) 338-6767
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
----------------
With copies to:
Barry M. Abelson, Esq. Jonathan L. Kravetz, Esq.
Julia D. Corelli, Esq. Mintz, Levin, Cohn, Ferris,
Pepper Hamilton LLP Glovsky and Popeo, P.C.
3000 Two Logan Square One Financial Center
Philadelphia, PA 19103 Boston, MA 02111
(215) 981-4000 (617) 542-6000
----------------
Approximate date of commencement of proposed sale to the public: As soon as
practicable after this Registration Statement becomes effective.
If any of the securities being registered on this Form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act,
check the following box. [_]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, check the following box and
list the Securities Act registration statement number of the earlier effective
registration statement for the same offering. [_]
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [_]
If this Form is a post-effective amendment filed pursuant to Rule 462(d)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [_]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
check the following box. [_]
----------------
The Registrant hereby amends this Registration Statement on such date or
dates as may be necessary to delay its effective date until the Registrant
shall file a further amendment which specifically states that this
Registration Statement shall thereafter become effective in accordance with
Section 8(a) of the Securities Act of 1933, as amended, or until this
Registration Statement shall become effective on such date as the Securities
and Exchange Commission, acting pursuant to Section 8(a), may determine.
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<PAGE>
This Amendment No. 4 to the Registration Statement No. 333-69207 is being filed
solely to file Exhibit Nos. 4.1, 10.16, 10.21 and 10.32.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution.
The following table sets forth an itemization of all estimated expenses, all
of which we will pay, in connection with the issuance and distribution of the
securities being registered:
<TABLE>
<CAPTION>
Nature of Expense Amount
----------------- ----------
<S> <C>
SEC Registration Fee............................................. $ 9,174
Nasdaq National Market Listing Fee............................... 72,875
NASD Fee......................................................... 3,720
Printing and engraving fees...................................... 150,000
Registrant's counsel fees and expenses........................... 320,000
Accounting fees and expenses..................................... 125,000
Spencer Trask Fee................................................ 100,000
Underwriters' Expenses........................................... 250,000
Blue Sky expenses and counsel fees............................... 25,000
Transfer agent and registrar fees................................ 8,000
Miscellaneous.................................................... 36,231
----------
TOTAL.......................................................... $1,100,000
==========
</TABLE>
Item 14. Indemnification of Directors and Officers.
Our Amended and Restated Certificate of Incorporation (the "Charter")
provides that we shall indemnify and advance expenses to the fullest extent
permitted by Section 145 of the Delaware General Corporation Law ("DGCL"), as
amended from time to time, to each person who is or was one of our directors or
officers and the heirs, executors and administrators of such a person. Any
expenses, including attorneys' fees, incurred by a person who is or was one of
our directors or officers, and the heirs, executors and administrators of such
a person in connection with defending any such proceeding in advance of its
final disposition shall be paid by us; provided, however, that if the DGCL
requires, an advancement of expenses incurred by an indemnitee in his capacity
as a director or officer, and not in any other capacity in which service was or
is rendered by such indemnitee, including, without limitation, service to an
employee benefit plan, shall be made only upon delivery to us of an undertaking
by or on behalf of such indemnitee, to repay all amounts so advanced, if it
shall ultimately be determined that such indemnitee is not entitled to be
indemnified for such expenses. Notwithstanding the aforementioned
indemnification provisions, we may, at the discretion of our Chief Executive
Officer, enter into indemnification agreements with directors or officers.
Section 145 of the DGCL provides that a corporation has the power to
indemnify any director or officer, or former director or officer, who was or is
a party or is threatened to be made a party to any threatened, pending or
completed action, suit or proceeding, whether civil, criminal, administrative
or investigative, other than an action by or in the right of the corporation,
by reason of the fact that such director or officer or former director or
officer is or was a director, officer, employee or agent of the corporation,
against expenses, including attorneys' fees, judgments, fines and amounts paid
in settlement actually and reasonably incurred by them in connection with such
action, suit or proceeding, if such person shall have acted in good faith and
in a manner reasonably believed to be in or not opposed to the best interests
of the corporation, and, with respect to any criminal action or proceeding,
provided that such person had no reasonable cause to believe his or her conduct
was unlawful, except that, if such action shall be in the right of the
corporation, no such indemnification shall be provided as to any claim, issue
or matter as to which such person shall have been judged to have been liable to
the corporation unless and to the extent that the Court of Chancery of the
State of Delaware, or any court in which such suit or action was brought, shall
determine upon application that, in view of all of the circumstances of the
case, such person is fairly and reasonably entitled to indemnity for such
expenses as such court shall deem proper.
II-1
<PAGE>
The Charter, which will be filed prior to the completion of our initial
public offering of securities, contains a provision to limit the personal
liability of our directors to the fullest extent permitted by Section 102(b)(7)
of the DGCL, as amended. In addition, the Amended and Restated By-Laws, which
will become effective prior to the completion of the offering of securities,
provide that we shall indemnify any person who was or is a party or is
threatened to be made a party to any threatened, pending or completed action,
suit or proceeding, whether civil, criminal, administrative or investigative,
other than an action by us or in our right, by reason of the fact that he is or
was one of our directors, officers, employees or agents, or is or was serving
at our request as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise, against
expenses, including attorneys' fees, judgments, fines and amounts paid in
settlement actually and reasonably incurred by him in connection with such
action, suit or proceeding if he acted in good faith and in a manner he
reasonably believed to be in or not opposed to our best interests, and, with
respect to any criminal action or proceeding, had no reasonable cause to
believe his conduct was unlawful. See Exhibit 3.1c, "Form of Amended and
Restated Certificate of Incorporation of Careside, Inc."
As permitted by the DGCL, the Charter, which will be filed prior to the
completion of the offering, provides that, subject to certain limited
exceptions, none of our directors shall be liable to us or our stockholders for
monetary damages for breach of fiduciary duty as a director, except for
liability (1) for any breach of the director's duty of loyalty to us or our
stockholders, (2) for acts or omissions not in good faith or which involve
intentional misconduct or a knowing violation of law, (3) for the unlawful
payment of dividends on or redemption or repurchase of our capital stock or (4)
for any transaction from which the director derived an improper personal
benefit. The effect of this provision is to limit our ability and our
stockholders' ability through stockholder derivative suits on our behalf, to
recover monetary damages against a director for the breach of certain fiduciary
duties as a director, including breaches resulting from grossly negligent
conduct. In addition, the Charter and Amended and Restated By-Laws provide that
we shall, to the fullest extent permitted by the DGCL, indemnify all of our
directors and officers and that we may, to the extent permitted by the DGCL,
indemnify our employees and agents.
We have agreed to indemnify the underwriters against certain liabilities,
including civil liabilities under the Securities Act.
Item 15. Recent Sales of Unregistered Securities.
Since our formation in July 1996, we have issued the following securities,
giving retroactive effect to a 1-for-5.2 reverse stock split to be effected in
connection with the offering described in the prospectus, without registration
under the Securities Act:
1. In July 1996 and October 1996, we issued an aggregate of 659,342 shares
of common stock to our founder group for no consideration.
2. In November 1996, pursuant to an asset purchase agreement, SmithKline
Beecham Diagnostics Systems Co. and SmithKline Beecham Clinical
Laboratories, Inc. sold us certain fixed and intangible assets used in
connection with our point-of-care development program. As consideration
for the purchase of the assets, we issued to SBDS 34,702 shares of
common stock, representing 5% of our total common stock outstanding at
that time.
3. In December 1996, in connection with the establishment of a $1.0 million
working capital facility, we issued Exigent Partners, L.P. 557,600
shares of common stock for an aggregate purchase price of $98,995. In
the same month, we issued (1) 30,936 shares of common stock to
SmithKline Beecham Corporation pursuant to certain anti-dilution
protections granted to SmithKline Beecham Corporation in connection with
a credit facility and asset transfer and (2) 30,173 shares of common
stock to Philip B. Smith for the investment banking services he provided
in connection with our equity financing.
4. In January 1997, our credit facility from SmithKline Beecham
Corporation, pursuant to its terms, was converted into 129,555 shares of
common stock, representing 2% of our total common stock outstanding at
that time.
II-2
<PAGE>
5. In March 1997, we completed a private placement of securities through
Spencer Trask Securities Incorporated which resulted in our issuance of
1,923,077 shares of common stock at $5.20 per share to 203 investors who
were deemed to be accredited investors under Rule 501(a) of Regulation D
of the Securities Act of 1933 based upon representations made to us by
such investors. In connection with the private placement in February 1997,
we issued warrants to Spencer Trask Securities Incorporated to purchase
384,615 shares of common stock at an exercise price of $5.20 per share as
partial consideration for its services in the private placement. These
warrants expire three (3) years after closing of the offering. Of the
proceeds of this private placement, which totalled in the aggregate
approximately $10 million, we received approximately $9 million with the
remainder paid as a commission to Spencer Trask for its services in the
private placement.
6. In February 1997, we granted stock options to purchase an aggregate of
256,370 shares of common stock under our 1996 Incentive and Non-Qualified
Stock Option Plan and 1996 Key Executive Stock Option Plan (collectively,
the "1996 Stock Option Plans") to ten employees and directors. The
weighted average per share exercise price of these stock options is $5.29.
7. In May 1997, we granted stock options to purchase 192 shares of common
stock under our 1996 Incentive and Non-Qualified Stock Option Plan to one
employee. The per share exercise price of these stock options is $5.20.
8. In June 1997, we granted stock options to purchase an aggregate of 31,731
shares of common stock under our 1996 Stock Option Plans to an individual
who was both one of our employees and a director. The per share exercise
price of these stock options is $6.76.
9. In August 1997, we granted Cedar Capital Investors, options to purchase
1,154 shares of common stock at an exercise price of $.052 per share.
These options remain exercisable until August 8, 2007. These options were
granted to Cedar Capital Investors in consideration for providing certain
financial consulting services to us in connection with a private placement
of securities in 1998.
10. In December 1997, we granted stock options to purchase an aggregate of
27,716 shares of common stock under our 1996 Incentive and Non-
Qualified Stock Option Plan to 20 employees. The weighted average per
share exercise price of these stock options is $6.09.
11. In January 1998, we granted stock options to purchase an aggregate of
1,923 shares of common stock under our 1996 Incentive and Non-Qualified
Stock Option Plan to one employee. The per share exercise price of
these stock options is $6.76.
12. In February 1998, we granted stock options to purchase an aggregate of
13,702 shares of common stock under our 1996 Incentive and Non-
Qualified Stock Option Plan to six employees. The per share exercise
price of these stock options is $6.76.
13. In May 1998, we granted stock options to purchase an aggregate of
17,713 shares of common stock under our 1996 Incentive and Non-
Qualified Stock Option Plan to 18 employees which were immediately
exercised. The per share exercise price of these stock options was
$6.76 per share.
14. In June 1998, we completed a second private placement of securities
through Spencer Trask Securities Incorporated which resulted in our
issuance of 1,701,183 shares of common stock at $6.76 per share to 311
investors, of whom 101 invested in the 1997 private placement of
securities, who were deemed to be accredited investors under Rule
501(a) of Regulation D of the Securities Act of 1933 based upon certain
representations made to us by such investors. In connection with the
private placement in 1998, we issued warrants to Spencer Trask
Securities Incorporated to purchase 340,238 shares of common stock at
an exercise price of $6.76 per share as partial consideration for our
services in these private placements. These warrants expire three years
from the date of closing of the offering. Of the proceeds of this
private placement, which totalled in the aggregate approximately $11.5
million, we received approximately $10 million with the remainder paid
as a commission to Spencer Trask Securities Incorporated for its
services in the private placement.
15. In July 1998, we granted stock options to purchase an aggregate of
67,068 shares of common stock under our 1996 Stock Option Plans to 29
employees and directors. The per share exercise price of these stock
options is $6.76.
II-3
<PAGE>
16. In November 1998, we granted stock options to purchase an aggregate of
11,538 shares of common stock under our 1996 Incentive and Non-
Qualified Stock Option Plan to six employees. The per share exercise
price of these stock options is $7.28.
17. In December 1998, we entered into a bridge loan agreement with S.R.
One, Limited for a $3.0 million loan. Draw down of $1.5 million on this
loan occured on December 28, 1998 with the remaining $1.5 million drawn
down in January 1999. The bridge loan matures on the date of completion
of the offering or January 31, 2000, whichever occurs sooner. The
bridge loan carries an interest rate of 8% per annum. We issued a
warrant to S.R. One, Limited which will be based upon the price of the
offering, less a 15% discount as partial consideration for providing
the bridge loan. Such warrant will not be exercisable until at least
twelve months after completion of the offering.
18. In January 1999, we granted stock options to purchase an aggregate of
1,202 shares of common stock under our 1996 Incentive and Non-Qualified
Stock Option Plan to one employee. The per share exercise price of
these stock options is $8.00.
We believe that the transactions described in paragraphs 1 through 18 above
were exempt from registration under Section 3(b) or 4(2) of the Securities Act
because the subject securities were either (1) issued pursuant to a
compensatory benefit plan pursuant to Rule 701 under the Securities Act or (2)
issued to a limited group of persons, each of whom was believed to have been a
sophisticated investor or to have had a preexisting business or personal
relationship with us or our management and to have been purchasing for
investment without a view to further distribution. In addition, the recipients
of securities in each such transaction represented their intentions to acquire
the securities for investment only and not with a view to or for sale in
connection with any distribution thereof and appropriate legends were affixed
to the share certificates issued in such transactions. All recipients had
adequate access, through their relationships with us, to information about us.
Item 16. Exhibits and Financial Statement Schedules.
(a) Exhibits:
<TABLE>
<CAPTION>
Exhibit No. Description
- ----------- -----------
<S> <C>
1.1* Form of Underwriting Agreement
3.1a* Amended and Restated Certificate of Incorporation of Careside, Inc.
3.1b* Form of Certificate of Amendment of Certificate of Incorporation of Careside, Inc. (to be filed
immediately prior to completion of the offering)
3.1c* Form of Amended and Restated Certificate of Incorporation of Careside, Inc. (effective upon
the completion of the offering)
3.2a* Amended and Restated Bylaws of Careside, Inc.
3.2b* Form of Amended and Restated Bylaws of Careside, Inc. (effective upon completion of the offering)
4.1 Specimen Stock Certificate
4.2* Placement Agent Warrant Agreement dated as of January 31, 1997 by and between
Careside, Inc. and Spencer Trask Securities Incorporated (including Form of Warrant)
4.3* Placement Agent Warrant Agreement dated as of March 6, 1998 by and between Careside,
Inc. and Spencer Trask Securities Incorporated (including Form of Warrant)
4.4* Securities Purchase Agreement dated as of December 17, 1998 by and between S.R. One,
Limited and Careside, Inc. (including Form of Note)
4.5* Warrant Issued to S.R. One, Limited on December 17, 1998
4.6* Form of Warrant Agreement to be dated as of the closing date of the offering, by and among Careside,
Inc., Fahnestock & Co. Inc., Wedbush Morgan Securities, Inc. and Southeast Research Partners, Inc.
(including Form of Warrant)
5.1* Opinion of Pepper Hamilton LLP
10.1* Registration Rights Agreement dated as of November 7, 1996 by and among SmithKline
Beecham Diagnostic Systems Co., SmithKline Beecham Corporation and Careside, Inc.
</TABLE>
II-4
<PAGE>
<TABLE>
<CAPTION>
Exhibit No. Description
----------- -----------
<C> <S>
10.2* Registration Rights Agreement dated as of December 4, 1996 by and
among Careside, Inc.,
Exigent Partners, L.P., W. Vickery Stoughton, Thomas H. Grove,
Kenneth B. Asarch,
William S. Knight, Donald S. Wong, Ashok K. Sawhney and Philip B.
Smith
10.3* Amendment No. 1 to Registration Rights Agreement dated as of
January 31, 1997 by and among
Careside, Inc. Exigent Partners, L.P., W. Vickery Stoughton,
Thomas H. Grove,
Kenneth B. Asarch, William S. Knight, Donald S. Wong, Ashok K.
Sawhney and Philip B. Smith
10.4* Registration Rights Agreement dated as of December 4, 1996 by and
between Careside, Inc.
and Spencer Trask Securities Incorporated
10.5* Registration Rights Agreement dated as of January 31, 1997 by and
among Careside, Inc.
and the Investors signatory thereto
10.6* Stockholders Agreement dated as of December 4, 1996 by and among
the Careside, Inc.,
SmithKline Beecham Corporation, SmithKline Beecham Diagnostic
Systems Co., Spencer Trask
Securities Incorporated, Exigent Partners, L.P., W. Vickery
Stoughton, Thomas H. Grove,
Kenneth B. Asarch, William S. Knight, Donald S. Wong, Ashok K.
Sawhney, Philip B. Smith
and each Investor signatory thereto
10.7* Consulting Agreement by and between Careside, Inc. and Cedar
Capital Investors dated August 8, 1997
10.8* Employment Agreement dated as of March 3, 1997 between Careside,
Inc. and W. Vickery Stoughton
10.9* Employment Agreement dated as of March 3, 1997 between Careside,
Inc. and Thomas H. Grove
10.10* Employment Agreement dated as of July 30, 1998 between Careside,
Inc. and James R. Koch
10.11* 1996 Incentive and Non-Qualified Stock Option Plan, as amended and
restated
10.12* 1996 Key Executive Stock Option Plan, as amended and restated
10.13* 1998 Incentive and Non-Qualified Stock Option Plan
10.14* 1998 Director Stock Option Plan
10.15* Standard Industrial/Commercial Single-Tenant Lease-NET dated as of
October 14, 1996,
by and between Fox Hills Business Park, a California Limited
Partnership and Careside, Inc.
10.16 Agreement dated as of August 23, 1996, by and between Fuji Photo
Film Co., Ltd. and Careside, Inc.+
10.17* Agreement dated as of December 12, 1995, by and between United
Medical Manufacturing
Company and SmithKline Beecham Corporation and assignment
10.18* Product Development and Supply Agreement dated as of July 18,
1997, by and between
Careside, Inc. and UMM Electronics, Inc.
10.19* Agreement executed December 7, 1995 and February 28, 1996, by and
between SmithKline
Beecham Corporation and Hauser, Inc. and assignment
10.20* Agreement Number CP032284 Cost Type executed December 5 and 17,
1996 by and between
Battelle Memorial Institute and Careside, Inc.
10.21 Joint Research and Development Agreement dated as of October 28,
1996 by and between
Careside, Inc. and International Technidyne Corporation
10.22 [INTENTIONALLY OMITTED]
10.23* Distribution and Supply Agreement dated as of November 7, 1996, by
and between SmithKline
Beecham Clinical Laboratories, Inc. and Careside, Inc, as amended
on February 12, 1999.+
10.24* Asset Purchase Agreement dated as of November 7, 1996, by and
among SmithKline Beecham
Clinical Laboratories, Inc., SmithKline Beecham Diagnostic Systems
Co. and Careside, Inc.
10.25* Loan and Security Agreement dated as of October 1, 1996, by and
between Careside, Inc. and
SmithKline Beecham Corporation
10.26* Placement Agency Agreement dated as of December 10, 1996, by and
between Careside, Inc.
and Spencer Trask Securities Incorporated
10.27* Placement Agency Agreement dated as of January 29, 1998, by and
between Spencer Trask
Securities Incorporated and Careside, Inc.
</TABLE>
II-5
<PAGE>
<TABLE>
<CAPTION>
Exhibit No. Description
----------- -----------
<C> <S>
10.28* Investment Banking Agreement dated as of January 31, 1997, by and
between Careside, Inc.
and Spencer Trask Securities Incorporated
10.29* Agreement of Limited Partnership of Exigent Partners, L.P. dated
as of October 1996,
by and between Kevin Kimberlin and those persons listed on
Schedule A attached thereto
10.30* The Lincoln National Life Insurance Company Standardized 401(k)
Salary Reduction Plan
and Trust Prototype Plan Adoption Agreement Plan #008, effective
January 1, 1997, by and
between Careside, Inc. W. Vickery Stoughton and Thomas Grove
10.31* Employee Stock Purchase Plan
10.32 Registration Rights Agreement dated as of March 6, 1998 by and
among Careside, Inc. and the Investors signatory thereto
10.33* Registration Rights Agreement dated as of March 6, 1998 by and
between Careside, Inc. and Spencer Trask Securities Incorporated
10.34* Registration Rights Agreement dated as of December 17, 1998 by and
between Careside, Inc. and S.R. One, Limited
10.35* Waiver Letter Agreement dated as of December 8, 1998 by and
between Careside, Inc. and Spencer Trask Securities Incorporated
23.1* Consent of Arthur Andersen LLP
23.2* Consent of Pepper Hamilton LLP (included in Exhibit 5.1)
23.3* Consent of Oppenheimer Wolff & Donnelly LLP
24.1* Power of Attorney (included on Signature Pages)
27.1* Financial Data Schedule
</TABLE>
- --------
* Previously filed with the Securities and Exchange Commission.
+ Portions of these documents have been omitted pursuant to a request for
confidential treatment. The material has been filed separately with the
Securities and Exchange Commission.
(b) Financial Statement Schedules:
Financial Statement Schedules are omitted because the information is included
in the Financial Statements or notes thereto.
Item 17. Undertakings.
Insofar as indemnification for liabilities arising under the Securities Act
may be permitted to directors, officers and controlling persons of the
registrant pursuant to the foregoing provisions, or otherwise, the registrant
has been advised that in the opinion of the Securities and Exchange Commission
such indemnification is against public policy as expressed in the Securities
Act and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the
registrant of expenses incurred or paid by a director, officer or controlling
person of the registrant in the successful defense of any action, suit or
proceeding) is asserted by such director, officer or controlling person in
connection with the securities being registered, the registrant will, unless in
the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the
Securities Act and will be governed by the final adjudication of such issue.
The undersigned registrant hereby undertakes that:
(1) For purposes of determining any liability under the Securities Act, the
information omitted from the form of prospectus filed as part of this
registration statement in reliance upon Rule 430A and contained in a
form of prospectus filed by the registrant pursuant to Rule 424(b)(1)
or (4) or 497(h) under the Securities Act shall be deemed to be part of
this registration statement as of the time it was declared effective.
II-6
<PAGE>
(2) For purposes of determining any liability under the Securities Act,
each post-effective amendment that contains a form of prospectus shall
be deemed to be a new registration statement relating to the securities
offered therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof.
In addition, the undersigned registrant hereby undertakes to provide to the
underwriters at the closing specified in the underwriting agreements,
certificates in such denominations and registered in such names as required by
the underwriters to permit prompt delivery to each purchaser.
II-7
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on Form S-1 and has duly caused this Amendment No. 4 to
the Registration Statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in Culver City, California, on the 5th day of March,
1999.
CARESIDE, INC.
/s/ W. Vickery Stoughton
By: _________________________________
W. Vickery Stoughton
Chairman of the Board of
Directors
and Chief Executive Officer
Pursuant to the requirements of the Securities Act of 1933, this Amendment
No. 4 to the Registration Statement has been signed by the following persons in
the capacities and on the dates indicated.
<TABLE>
<CAPTION>
Signature Title Date
--------- ----- ----
<S> <C> <C>
/s/ W. Vickery Stoughton Chairman of the Board of March 5, 1999
______________________________________ Directors, Chief
W. Vickery Stoughton Executive Officer and
Director (principal
executive officer)
/s/ Thomas H. Grove Executive Vice President-- March 5, 1999
______________________________________ Research and Development
Thomas H. Grove and Director
/s/ James R. Koch Chief Financial Officer, March 5, 1999
______________________________________ Treasurer, Executive Vice
James R. Koch President and Director
(principal financial and
accounting officer)
* Director March 5, 1999
______________________________________
Anthony P. Brenner
* Director March 5, 1999
______________________________________
William F. Flatley
* Director March 5, 1999
______________________________________
Kenneth N. Kermes
* Director March 5, 1999
______________________________________
C. Alan MacDonald
* Director March 5, 1999
______________________________________
Diana Mackie
* Director March 5, 1999
______________________________________
Philip B. Smith
</TABLE>
/s/ W. Vickery Stoughton
*By: ________________________________
W. Vickery Stoughton
Attorney-in-Fact
II-8
<PAGE>
EXHIBIT 4.1
[STOCK CERTIFICATE APPEARS HERE]
[CARESIDE LOGO APPEARS HERE]
CUSIP 141728 10 5
- --------------------------------------------------------------------------------
This Certifies that
is the owner of
- --------------------------------------------------------------------------------
FULLY PAID AND NON-ASSESSABLE SHARES OF COMMON STOCK,
PAR VALUE $.01 PER SHARE, OF
CARESIDE, INC.
transferable only on the books of the Corporation by the holder hereof in person
or by duly authorized Attorney upon surrender of this Certificate properly
endorsed. This Certificate is not valid unless countersigned and registered by
the Transfer Agent and Registrar.
Witness the facsimile signatures of its duly authorized officers.
Dated
/s/Thomas H. Grove /s/W. Vickery Stoughton
SECRETARY CHAIRMAN AND CHIEF EXECUTIVE OFFICER
<PAGE>
CARESIDE, INC.
The record holder of this Certificate may obtain from the Secretary of the
Corporation, upon request and without charge, a full statement of the
designations, relative rights, preferences and limitations of the shares of each
class authorized to be issued; the designations, relative rights, preferences
and limitations of each series of preferred shares authorized to be issued so
far as the same have been fixed; and the authority of the Board of Directors to
designate and fix the relative rights, preferences and limitations of other
series.
The following abbreviations, when used in the inscription on the face of
the certificate, shall be construed as though they were written out in full
according to applicable laws or regulations:
<TABLE>
<S> <C>
TEN COM- as tenants in common UNIF GIFT MIN ACT- ________________________ Custodian _______________________
TEN ENT- as tenants by the entireties (Cust) (Minor)
JT TEN- as joint tenants with under Uniform Gifts to Minors
right of survivorship and
not as tenants in common Act _____________________________________________________
(State)
</TABLE>
Additional abbreviations may also be used though not in the above list.
For Value received ___________________________________ hereby sell, assign
and transfer unto.
PLEASE INSERT SOCIAL SECURITY OR OTHER
IDENTIFYING NUMBER OF ASSIGNEE
___________________________________________
________________________________________________________________________________
________________________________________________________________________________
PLEASE PRINT OR TYPEWRITE NAME AND ADDRESS OF ASSIGNEE
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
_________________________________________________________________________ Shares
of the capital stock represented by the within Certificate and do hereby
irrevocably constitute and appoint ____________________________________ Attorney
to transfer the said stock on the books of the within-named Corporation with
full power of substitution in the premises.
Dated, _________________________ X ______________________________________
X ______________________________________
NOTICE: THE SIGNATURE(S) TO THE
ASSIGNMENT MUST CORRESPOND WITH THE
NAME(S) AS WRITTEN UPON THE FACE OF
THE CERTIFICATE. IN EVERY PARTICULAR,
WITHOUT ALTERATION OR ENLARGEMENT, OR
ANY CHANGE WHATEVER.
SIGNATURE GUARANTEED: ___________________________________________
THE SIGNATURE(S) MUST BE GUARANTEED BY AN
ELIGIBLE GUARANTOR INSTITUTION (BANKS,
STOCKBROKERS, SAVINGS AND LOAN ASSOCIATIONS
AND CREDIT UNIONS WITH MEMBERSHIP IN AN
APPROVED SIGNATURE GUARANTEE MEDALLION
PROGRAM), PURSUANT TO S.E.C. RULE 17AD-15.
<PAGE>
EXHIBIT 10.16
AGREEMENT
This Agreement made and entered into the 23rd day of August, 1996 by
and between Fuji Photo Film Co., Ltd., a corporation duly organized and existing
under the laws of Japan and having its principal office at 26-30, Nishiazabu 2-
chome, Minato-ku, Tokyo, Japan (hereinafter referred to as "FUJI") and Exigent
Diagnostics, Inc., a corporation duly organized and existing under the laws of
State of Delaware and having its principal office at 709 Swedeland Road, King of
Prussia, Pennsylvania, the United States of America (hereinafter referred to as
"EXIGENT"),
WITNESSETH:
Whereas FUJI has been engaged in, among other businesses, developing
and manufacturing DRI-CHEM films and has proprietary technology and know-how
related thereto;
Whereas EXIGENT has been engaged in commercial lab business' in
clinical diagnostic field and in developing a human diagnostic testing so-called
Point of Care Testing system and has proprietary technology and know-how related
thereto;
Whereas FUJI and SmithKline Beecham Corporation, which is the
predecessor of EXIGENT have executed the Letter of Intent dated March 19, 1996
to confirm the parties' intent to enter into a definitive agreement concerning
supply of DRI-CHEM films, film-based chemistry tests and immunodiagnostic tests
and exchange of various technology for use in Point of Care Testing system;
NOW, THEREFORE, in consideration of the premises and their mutual
covenants hereinafter set forth, the parties hereto agree as follows:
Article 1 Definitions
-----------
1.1. "POCT (Point of Care Testing)" shall mean a human or animal
diagnostic testing performed in the immediate vicinity of the patient at the
time a test sample is obtained. POCT shall exclude any diagnostic testing, which
is performed at a central fixed laboratory within hospitals, other health care
facilities or commercial laboratories.
1.2. "FDC Film" shall mean films used in FUJI DRI-CHEM system applicable
to the tests listed in Schedules A and B.
1.3. "FUJI Technology" shall mean FUJI's technology, know-how and
technical assistance relating to the use of FDC Film, including but not limited
to the specifications of FDC Film, its quality assurance and other information
listed in Schedule B, as may be amended from time to time by agreement of the
parties.
1.4. "EXIGENT POCT System" shall collectively mean a system and products
thereof developed by EXIGENT for POCT, including but not limited to chemistry,
immunochemistry, coagulation, and optionally hematology tests, test cartridge
for separating blood and metering samples, analyzer(s) for said tests including
data management components and software and a mobile cart.
1.5. "EXIGENT Materials" shall mean the immunodiagnostic testing reagents,
which utilize any of the technology EXIGENT has developed, or develops or
acquires in the future, including but not limited to technology as to tests in
Hemoglobin Alc, Digoxin and HCG.
<PAGE>
1.6. "Competing Instruments" shall mean diagnostic instruments and the
disposables they use, which instruments and disposables are designed for use in
POCT and which directly compete with the EXIGENT POCT System.
1.7. "Southeast Asia" shall mean the People's Republic of China, the
Republic of China, South Korea, Vietnam, Thailand, Myanmar, India, the
Philippines, Indonesia, Malaysia and Singapore.
Article 2 Supply of FDC Film
------------------
2.1. FUJI shall supply EXIGENT with and EXIGENT shall purchase from FUJI
FDC Film for the development of EXIGENT POCT System in accordance with the terms
and conditions detailed in Schedules D and E. The terms and conditions for
supply of FDC Film to be required for marketing of EXIGENT POCT System shall be
separately agreed upon between the parties hereto. The FDC Film applicable to
the tests in Sodium, Potassium and Chloride shall be supplied to EXIGENT by FUJI
in a slide form on which such FDC Film is mounted.
2.2. EXIGENT shall supply FUJI with and FUJI shall purchase from EXIGENT
EXIGENT Materials under the terms and conditions of a separate supply/purchase
agreement in which the EXIGENT Materials shall be priced as the highest at cost
plus fifty percent (50%) on CIF TOKYO basis.
2.3. FUJI shall supply EXIGENT exclusively with FDC Film until December
31, 2003, provided that such exclusive supply shall be changed to non-exclusive
supply if EXIGENT fails to obtain by December 31, 1999 approvals from the Food
and Drug Administration ("FDA") which should be necessary for distribution of
EXIGENT POCT system using FDC Film in the United States of America to
professional market for more than eighty percent (80%) of the tests listed in
Schedule A, B and G.
2.4. In the event that exclusive supply is changed to non-exclusive supply
under Article 2.3, FUJI shall supply EXIGENT with FDC Film in accordance with
the terms and conditions to be separately agreed upon between the parties
hereto.
2.5. During the period of exclusive supply of FDC Film as provided in
Article 2.3, FUJI shall not supply FDC Film to any third party which the both
parties hereto agree may develop and sell Competing Instruments.
2.6. EXIGENT shall use FDC Film supplied by FUJI hereunder only for
development of EXIGENT POCT System and shall not supply FDC Film to or use for
any third party for any purpose.
2.7. EXIGENT agrees that it shall use only FDC Film in its POCT System for
those tests listed in Schedule A and B and shall not use other reagents or
technologies for carrying out said tests and shall not be supplied with by any
third party any chemistry reagents for development of EXIGENT POCT System or
performance of the tests listed in Schedules A and B. For POCT Systems tests
other than those listed in Schedules A and B, EXIGENT shall have
<PAGE>
the right to manufacture or purchase from others its needs for reagents or
technologies for carrying out those tests.
2.8. Nothing in this Article shall be construed to prohibit or otherwise
affect FUJI's development for or distribution to any third party of FDC Film and
FUJI Technology for use with any products other than Competing Instruments.
FUJI and EXIGENT further confirms that FUJI DRI-CHEM systems and their
disposables shall in no event be construed as Competing Instruments and that
FUJI shall in no way be restricted to market FUJI DRI-CHEM systems and their
disposables.
Article 3 Inspection and Acceptance of FDC Film
-------------------------------------
Upon the receipt of FDC Film supplied by FUJI, EXIGENT shall promptly
inspect the FDC Film in accordance with the standards mutually agreed upon
between the parties as provided in Schedule D. Such inspection by EXIGENT shall
be considered as final. In the event that EXIGENT finds during the inspection
any defects in FDC Film that could be caused prior to the receipt thereof and it
notifies FUJI to that effect within thirty (30) days of the receipt and returns
such defective FDC Film to FUJI, FUJI shall replace such defective FDC Film with
non-defective FDC Film without cost to EXIGENT. It is expressly agreed and
understood that for such defective FDC Film FUJI shall assume no other or
further liability of any kind whatsoever other than that expressly undertaken by
it in Article 3.
Article 4 License Exchange
----------------
4.1. FUJI shall from time to time during the term of this Agreement
disclose to EXIGENT on a non-exclusive basis FUJI Technology, written or oral,
to the extent that both EXIGENT and FUJI consider such disclosure is necessary
for EXIGENT to develop test cartridge of EXIGENT POCT System which incorporates
FDC Film supplied by FUJI (hereinafter referred to as "EXIGENT POCT
Cartridge(s)"). EXIGENT shall use FUJI Technology so disclosed only for
EXIGENT's development, manufacture and sale of EXIGENT POCT Cartridges and shall
not use it for any other purpose than such development, manufacture and sale.
4.2. FUJI shall grant EXIGENT a fully paid-up, non-exclusive license in the
world excluding Japan to make, have made, use, sell and offer to sell EXIGENT
POCT Cartridges under FUJI's patents directed to FDC Film and under FUJI's other
rights directed to FUJI Technology disclosed to EXIGENT.
4.3. In exchange for the rights and licenses granted by FUJI in accordance
with Article 4.1 and 4.2 above, EXIGENT shall grant FUJI:
-3-
<PAGE>
(1) a fully paid-up, irrevocable, worldwide, exclusive license
during the term of this Agreement, and a royalty-bearing, worldwide, exclusive
license thereafter, to make, have made, use, sell and offer to sell any dry
reagents under EXIGENT's patents which are directed to the tests listed in
Schedule A and B and which are applied and issued based on inventions made
during EXIGENT's development and/or manufacture of EXIGENT POCT Cartridges. The
royalty of the royalty-bearing license above shall be established in good faith
negotiation by the parties hereto; provided, however, that an amount of the
royalty shall be reasonable and favorable to FUJI compared with a similar
license to the others. In spite of FUJI's exclusive license, EXIGENT itself
shall be able to make, have made, use, sell and offer to sell any dry reagents
under EXIGENT's said patents;
(2) a fully paid-up, exclusive sub-license in Japan and a fully
paid-up, non-exclusive sub-license in the rest of the world during the term of
this Agreement, and a royalty-bearing, exclusive sub-license in Japan and a
royalty-bearing, non-exclusive sub-license in the rest of the world thereafter,
to make, have made, use, sell and offer to sell any dry reagents for
immunoassays under EXIGENT's right to grant such sublicense which right EXIGENT
has acquired, acquires or will acquire from any third party(s) under such third
party(s)'s patent(s). The royalty of the royalty-bearing license above shall be
established in good faith negotiation by the parties hereto; provided, however,
that an amount of the royalty shall be reasonable and favorable to FUJI compared
with a similar license to the others. EXIGENT shall make best efforts to acquire
such right from such third party(s) in case EXIGENT acquires a license under
such patent(s); and
(3) upon FUJI's request, a royalty-bearing, world-wide license
to make, have made, use, sell and offer to sell any dry reagents for coagulation
under EXIGENT's patent(s) and/or know-how applied or acquired before termination
of this Agreement. In case that EXIGENT acquires before termination of this
Agreement from any third party(s) a right to grant sub-licenses under such third
party(s)'s patents and/or know-how regarding coagulation, EXIGENT also shall
grant FUJI a sub-license under such right, upon FUJI's request. Other terms and
conditions of the license and/or the sub-license shall be established in good
faith negotiation by the parties hereto; provided, however, that an amount of
royalty shall be reasonable and favorable to FUJI compared with a similar
license to the others.
Article 5 Development of EXIGENT POCT System
----------------------------------
EXIGENT shall make best efforts to develop and complete EXIGENT POCT
System which incorporates FDC Film and/or FUJI Technology supplied hereunder in
accordance with the time schedule provided in Schedule H. During the term of
this Agreement, EXIGENT shall submit to FUJI a report in writing every three
months that describes the progress of development of EXIGENT POCT System. FUJI
and EXIGENT shall discuss the schedule of development of EXIGENT POCT System if
FUJI considers it necessary.
-4-
<PAGE>
Article 6 Distribution Rights
-------------------
EXIGENT shall grant FUJI right of the first refusal to distribute
EXIGENT POCT System exclusively in Japan and non-exclusively in Southeast Asia
subject to a distribution agreement to be negotiated separately. Such
distribution agreement shall include, among other terms and conditions, an
indemnification by EXIGENT with regard to EXIGENT POCT System which
indemnification shall be the same as that provided in Articles 7.4 and 7.5
below.
Article 7 Indemnification
---------------
7.1. FUJI shall indemnify and hold EXIGENT harmless from and against any
damages and costs incurred by EXIGENT which arises out of any claim or legal
action threatened or taken by any third party alleging that EXIGENT's use and/or
sale of FDC Film supplied by FUJI under this Agreement constitutes an
infringement of any intellectual property right of such third party, provided
that EXIGENT shall promptly notify FUJI of such claim or legal action in
writing, give FUJI sole control and authority with respect to the defense or
settlement of any such claim or legal action, and give FUJI reasonable
assistance with respect to the defense or settlement of any such claim or legal
action. FUJI shall have the right, with respect to any FDC Film supplied to
EXIGENT under this Agreement which becomes or is likely to become the subject of
such claim or legal action, to replace or modify such FDC Film, or in case
injunction is granted by court or FDC to withhold further shipment of such FDC
Film. The indemnification above shall be applied also to any claim or legal
action threatened or taken by any third party alleging that EXIGENT's use and/or
sale of FDC Film which is to be supplied by FUJI to EXIGENT under a separate
agreement regarding supply of FDC Film to be required for marketing of EXIGENT
POCT System.
7.2. The provision of Article 7.1 shall not apply in case where the
infringement exists as a result of:
(1) any combination of FDC Film with other material(s), part(s)
or product(s) which is not supplied by FUJI;
(2) any use of FDC Film which is not intended by FUJI;
(3) any modification of FDC Film made by any party other than
FUJI; or
(4) EXIGENT's breach of this Agreement, or any act or negligence
of EXIGENT, its employee or agent.
7.3. Notwithstanding the provision of Article 7.1, FUJI shall in no event
be liable for:
-5-
<PAGE>
(1) consequential or incidental damages; or
(2) labor costs or lost profits.
7.4. EXIGENT shall indemnify and hold FUJI harmless from and against any
damages and costs incurred by FUJI which arises out of any claim or legal action
threatened or taken by any third party alleging that FUJI's use and/or sale of
EXIGENT Materials supplied by EXIGENT under this Agreement constitutes an
infringement of any intellectual property right of such third party, provided
that FUJI shall promptly notify EXIGENT of such claim or legal action in
writing, give EXIGENT sole control and authority with respect to the defense or
settlement of any such claim or legal action, and give EXIGENT reasonable
assistance with respect to the defense or settlement of any such claim or legal
action. EXIGENT shall have the right, with respect to any EXIGENT Materials
supplied to EXIGENT under this Agreement which become or are likely to become
the subject of such claim or legal action, to replace or modify such EXIGENT
Materials or to withhold further shipment of such EXIGENT Materials.
7.5. The provision of Article 7.4 shall not apply in case where the
infringement exists as a result of:
(1) any combination of EXIGENT Materials with other materials,
part(s) or product(s) which is not supplied by EXIGENT;
(2) any use of EXIGENT Materials which is not intended by
EXIGENT;
(3) any modification of EXIGENT Materials made by any party
other than EXIGENT; or
(4) FUJI's breach of this Agreement, or any act or negligence of
FUJI, its employee or agent.
7.6. Notwithstanding the provision of Article 7.4, EXIGENT shall in no
event be liable for:
(1) consequential or incidental damages; or
(2) labor costs or lost profits.
Article 8 Regulatory Approvals
--------------------
8.1. FUJI shall comply with FDA's Good Manufacturing Practices in
manufacturing and supplying FDC Films to EXIGENT hereunder.
-6-
<PAGE>
8.2. If FUJI is granted an exclusive right to distribute the EXIGENT POCT
System in a country, FUJI shall obtain all regulatory approvals required for
marketing EXIGENT POCT System in any country.
8.3. EXIGENT shall obtain all regulatory approvals required for marketing
EXIGENT POCT System in any other countries or areas than those for which FUJI
shall do under Article 8.2.
Article 9 Confidentiality
---------------
9.1. Each party shall hold in confidence this Agreement and any and all
proprietary technical and business information furnished or disclosed by the
other party hereunder, and shall not use such information for any other purpose
than that provided herein.
9.2. The confidential obligation provided in Article 14.1 shall not apply
to:
(1) information which is known to the public or generally
available to the public prior to the date it is received;
(2) information which is known to the receiving party prior to
the date it is received from the other party;
(3) information which becomes known to the public or generally
available to the public after the date it is received through no fault of the
receiving party;
(4) information which the receiving party obtains without
restriction on disclosure from a third party having a bona fide right to
disclose such information; or
(5) information which must be disclosed by law or regulation in
order to obtain approval to sell EXIGENT POCT System, or otherwise required to
be disclosed by law, regulation or court order.
Article 10 Term
----
This Agreement shall continue in full force and effect until
December 31, 2003 from the date first above written, and will automatically be
renewed for additional periods of one (1) year, unless either party notifies the
other party of its intention not to renew this Agreement in writing at least six
(6) months before the expiration of the initial term or any successive renewal
term of this Agreement.
Article 11 Termination
-----------
-7-
<PAGE>
11.1. In the event that FUJI decides to discontinue manufacturing and
marketing FDC Film, FUJI may terminate this Agreement by giving a written one
year notice to EXIGENT, provided that, to protect the welfare of the customers
of EXIGENT POCT Systems sold by EXIGENT before such termination, FUJI shall
consult with EXIGENT and establish the necessary measures to be taken, to ensure
that EXIGENT has continued access to FDC Film and FUJI Technology, before such
termination.
11.2. In the event that either party is adjudicated bankrupt or insolvent,
or enters into an agreement for the benefit of creditors, or in the event that a
petition in bankruptcy or for corporate reorganization or for any similar relief
shall be filed by or against either party hereto or receiver is appointed with
respect to any of the assets of either party, or if all or a significant part of
the assets of either party are transferred to a third party, then the other
party hereto may immediately terminate this Agreement by giving written notice
to that effect.
11.3. In the event that there arises a material change in control or
ownership of either party which would adversely affect the transaction hereunder
between the parties hereto, specifically as regards an acquisition by a
competitor whose resulting access to the trade secrets, confidential
information, know-how or patent rights licensed hereunder would result in a loss
of competitive advantage, or a competitor that sells competing dry film
technology for chemistry tests, the other party may, at its sole discretion,
immediately terminate this Agreement by giving a written notice to such party.
11.4. In the event that either party breaches or fails to perform any of
material obligations, terms or conditions of this Agreement or Individual
Agreement and fails to cure such breach or default within thirty (30) days after
its receipt from the other party of written notice specifying the nature of such
breach or default, the other party may, without prejudice to any other remedies
available to it hereunder or under law or otherwise, terminate this Agreement
effective immediately by giving the defaulting party written notice to that
effect.
11.5. Termination of this Agreement shall not affect or diminish in any
way either party's rights, duties or obligations under any other agreements
between the parties, nor shall the breach or cancellation of any other
agreements between the parties affect or diminish in any way either party's
rights, duties or obligations under this Agreement.
Article 12 Force Majeure
-------------
Neither party hereto shall in any way be held liable to the other
party for any loss or damage sustained by the other party due to any failure or
delay on its part in performance of this Agreement caused by force majeure, such
as but not limited to strikes, lock outs, sabotage, fires, explosions, floods,
elements, acts of God, wars, hostilities, civil commotions, riots, acts,
regulations or orders of any governmental agency or authority, epidemics, and
any other
-8-
<PAGE>
circumstances, whether similar or dissimilar to any at the foregoing, beyond
reasonable control of the first party.
Article 13 Surviving Clauses
-----------------
The provisions of Article 4.3(i), (ii) and (iii), 6, 7, 9, 14.4,
14.5, 14.6 and 14.7 shall survive any termination or expiration of this
Agreement.
Article 14 General Provisions
------------------
14.1. If any provision of this Agreement is held to be ineffective,
unenforceable or illegal for any reason, such decision shall not affect the
validity or enforceability of any or all of the remaining portions hereof.
14.2. This Agreement constitutes the entire agreement between the parties
as to the subject matter hereof, and supersedes and replaces all prior or
contemporaneous agreement, written or oral, regarding such subject matter.
14.3. No amendment or modification of this Agreement shall be valid unless
set forth in a writing stating that it is such an amendment or modification and
signed by an authorized representative of each of the parties hereto.
14.4. This Agreement shall inure to the benefit of and be binding upon any
successors or assigns of either party hereto; however neither party may transfer
or assign this Agreement or any of its rights or obligations hereunder without
the prior written consent of the other party.
14.5. Any and all disputes, controversies or differences arising between
the parties hereto out of or in relation to this Agreement or for any breach
thereof which cannot be amicably settled between the parties hereto shall be
finally settled by arbitration in Tokyo, Japan in accordance with the Rules of
Conciliation and Arbitration of the International Chamber of Commerce. Any
award of the arbitration shall be final and conclusive and binding upon the
parties hereto.
14.6. This Agreement and its validity, performance and interpretation
shall be governed by the laws of Japan.
14.7. Any notice required or permitted by either party hereunder shall be
made in writing and shall be delivered in person, sent by registered mail or
sent by facsimile with confirmation by registered mail within ten (10) days to
the respective party as follows:
FUJI: Fuji Photo Film Co., Ltd.
11-46, Senzui 3-chome
-9-
<PAGE>
Asaka-shi, Saitama 351, Japan
Attention : Mr. Junichi Matsuyama
(Associate Director)
Fax number: 81-468-468-2307
EXIGENT: Exigent Diagnostics, Inc.
709 Swedeland Road
King of Prussia, PA 19406, USA
Attention : Mr. W. Vickery Stoughton
(Chairman & C.E.O.)
Fax number: 1-610-270-6150
IN WITNESS WHEREOF the parties have caused this Agreement to be
executed by their authorized representatives.
Fuji Photo Film, Co., Ltd. Exigent Diagnostics, Inc.
Title: Associate Director Title: Chairman & C.E.O.
By: /s/ Junichi Matsuyama By:/s/ W. Vickery Stoughton
------------------------------ ----------------------------
Junichi Matsuyama W. Vickery Stoughton
Date: September 10, 1996 Date: August 23, 1996
-10-
<PAGE>
Schedule A: The tests to which FDC Film is or to be applicable
--------------------------------------------------
1. Total Bilirubin 14. Triglycerides
2. Hemoglobin 15. Cholesterol
3. Uric Acid 16. HDL Cholesterol
4. Ammonia 17. Glucose
5. AST 18. Total Protein
6. GGT 19. Albumin
7. LDH 20. Creatinine
8. ALT 21. Urea Nitrogen
9. LAP 22. Inorganic Phosphorus
10. Amylase 23. Magnesium
11. Alkaline Phosphatase 24. Carbon Dioxide
12. Creatine Kinase 25. Ionized Calcium
13. Total Calcium
Schedule B: The tests to which FDC Electrolyte Slide is applicable
------------------------------------------------------
1. Sodium
2. Potassium
3. Chloride
-11-
<PAGE>
Schedule C: FUJI Technology
---------------
1. Specifications of FDC Film
1-1 List of test menu
1-2 Reaction Scheme
1-3 Structure
1-4 Assay characteristics
1-5 Principle of determination of analyte activity
1-6 Performance
2. Quality control system
2-1 Quality control standards of FDC Film (slide)
2-2 Pre-calibration QC system
3. Handling and assembling conditions of FDC Film
3-1 Archival properties in reel and slide form
3-2 Room conditions of handling FDC Film
3-3 Mechanical handling conditions
4. Specific comments on each test and measuring instrument
-12-
<PAGE>
Schedule D: Conditions of supplying FDC Film
---------------------------------------------
1. Estimate of order volume: SB shall submit to FUJI a non-binding estimate of
semi-annual order volume by, January 31 and July 31 every year.
2. Order schedule: SB shall submit to FUJI semi-annual orders twice a year by
April 30 and October 31 not later than three months prior to its desired
delivery date.
3. Acceptance of order: Order shall be subject to FUJI's acceptance.
4. Bulk form: Supplied in reel form with 12mm width. Length shall be decided
by FUJI according to the ordered volume.
5. Packing: Sealed in aluminum laminated polyethylene film and packed in
cardboard box
6. Freight: (Cool 2(degrees)C - 8(degrees)C) air cargo
7. Place of delivery: (To be designated by SB, but should somewhere in the
US)
8. [Omitted pursuant to a request for confidential treatment. The material has
been filed separately with the Securities and Exchange Commission.]
9. Payment term: Paid within thirty (30) days of the custom clearance in the
banking account designated by FUJI
10. Shelf life: The shelf life of eighteen (18) months from the shipment date
is guaranteed, provided that the storage condition instructed by FUJI is
met.
-13-
<PAGE>
Schedule E: Conditions of supplying FDC Electrolyte Slide
---------------------------------------------
1. Estimate of order volume: Same as Schedule D
2. Order schedule: Same as Schedule D
3. Acceptance of order: Same as Schedule D
4. Slide form: Supplied in the same form as used in FUJI DRI-CHEM System.
One slide contains Na, K, Cl electrode.
5. Packing: Packed in the case proposed by SB and agreed by FUJI
6. Freight: Same as Schedule D
7. Place of delivery: Same as Schedule D
8. [Omitted pursuant to a request for confidential treatment. The material has
been filed separately with the Securities and Exchange Commission.]
9. Payment term: Same as Schedule D
10. Shelf life: Same as Schedule D
-14-
<PAGE>
Schedule F: Inspection criteria of FDC Film
-------------------------------
1. Criteria for inspection by FUJI prior to shipment: (To be agreed by the
parties based on FUJI's proposal)
2. Criteria for inspection by SB after delivery:
2-1 Site of inspection: (To be designated by SB)
----------------------
2-2 Time of inspection: Inspected within seven (7) days of the custom
clearance
2-3 Method of inspection: Inspected in accordance with detailed operation
manual provided by FUJI. Cleared if meet the inspection standards agreed
upon between the parties.
(1) Sample: Using the end part of the reel in slide form
(2) Analyser: FDC 3000 for colorimetric film
(3) Specimen: Control serum for FDC
-15-
<PAGE>
Schedule G: SB POCT Systems tests other than Schedules A and B
--------------------------------------------------
1. Theophylline
2. Digoxin
3. Phenytoin
4. Phenobarbital
5. T4
6. Thyroid Uptake
7. HCG
8. Troponin
9. Myglobin
10. PSA
11. Hemoglobin Alc
-16-
<PAGE>
Schedule H: Time Schedule of the development of POCT System
-----------------------------------------------
September 1996 10mcl Test Cartridge completed
October 1996 First breadboard of instrument
May 1997 Second breadboard version completed
July 1997 Prototype completed (without closed tube sampling)
October 1997 FDA submission of 11-12 tests
March 1998 FDA submission of next 20-28 tests
-17-
<PAGE>
EXHIBIT 10.21
[LETTERHEAD OF ITC APPEARS HERE]
Joint Research and Development Agreement
This Agreement (the "Agreement") is made as of Oct 28, 1996 (the "Effective
Date") by and between Exigent Diagnostics, Inc. ("Exigent"), a Delaware
corporation having its principal place of business at 6100 Bristol Parkway
Culver City, Calif, and International Technidyne Corporation ("ITC"), a Delaware
corporation having its principal place of business at 8 Olsen Avenue, Edison, NJ
08820.
WITNESSETH
WHEREAS, ITC has certain proprietary know-how, skilled laboratory
researchers and manufacturing expertise in the field of plasma coagulation and
other diagnostic assays; and
WHEREAS, Exigent has certain proprietary know-how and skilled laboratory
researchers in the field of diagnostic assays; and
WHEREAS, ITC and Exigent desire to enter into an agreement for the
research, development and evaluation of point-of-care coagulation assay test
cartridges and coagulation detector (the research, development and evaluation
hereafter referred to as "Research" and the procedures and processes resulting
from the Research hereafter referred to as the "Products").
NOW THEREFORE, for and in consideration of the promises and mutual
covenants and agreements hereinafter set forth and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged and
accepted, the parties hereto agree as follows:
1. CONTRACT PURPOSE
1.1. The goal of the joint research, development and evaluation effort to
be conducted is to develop cost-effective point-of-care plasma coagulation
assays, for the benefit of both parties hereto. The principal objectives of the
research and development efforts are more particularly set forth in the
Coagulation Assays Development Plan attached hereto as Annex I and incorporated
herein by this reference. The parties may amend Annex I from time to time by
executing a revised, restated, dated Annex I and attaching it hereto.
1.2. The parties agree that ITC and Exigent, through the respective
employees of each will perform the tasks specified hereto and in Annex I. The
parties agree periodically, but not less frequently than quarterly, commencing
on the date three months from the Effective Date of
1
<PAGE>
this Agreement, to review and revise Annex I, as needed.
2. RESEARCH
2.1. The employees of each party hereto, in their respective laboratories,
shall perform the tasks specified in Annex I, collaborating at all times in such
performance by, without limitation, exchanging materials and information and
providing all relevant data, information and results useful to the purposes of
this Agreement, to each party hereto, without restriction, other than as
specified in this Agreement.
2.2. Exigent will reimburse ITC for each hour of Research work (as per
2.3.) performed by an ITC employee, representative or agent, at the rate of $100
per hour, plus expenses, including, without limitation, the cost of dedicated
equipment (inclusive of, without limitation, design, installation and validation
costs and exclusive of depreciation costs) and materials and research and
development expenses. ITC shall render an invoice each month for such services
and expenses and Exigent shall pay such invoice in full within 30 days of
receipt thereof. Exigent shall pay ITC interest at the rate of one and one half
(1 1/2%) percent per month on any amount not timely paid.
2.3. ITC agrees to responsibility for sections 22, 27, 53 and 68 of Annex
I except for subsection 60 of section 53, which is being developed by Battelle
Research as part of a contract with Exigent. The estimated budget for ITC based
on Annex I work totals $336,000 which includes $48,000 contingency. Approval of
use of any portion of the contingency requires the sole approval of Exigent.
2.4. Neither party hereto makes any representation or warranty to the
other with respect to the purity, activity, safety, accuracy or usefulness of
the materials or information exchanged under this Agreement.
3. PRODUCTS
3.1. Subject to the exclusivity provision of Sections 3.2. and 3.3. below
and the patent and other intellectual property provisions set forth in Section 4
below, either party hereto shall have the right to develop, make, use, license
and/or sell Products for the equal benefit of both parties hereto. Subject to
the exclusivity provisions of Sections 3.2. and 3.3. below and the Royalty
provision of section 4.2., any consideration accruing as a result of the
development, use, license or sale of Products shall be shared equally by the
parties hereto. Any sale or license arrangement or agreement relating to a
Product shall be subject to the approval of the party not originating such
arrangement or agreement, such approval shall not be unreasonably withheld,
delayed or conditioned. This right shall include the right to grant sublicenses
with respect to the use or sale of Products to third parties.
2
<PAGE>
3.2. Exigent shall have the exclusive right to, and benefit of, the
inventions and discoveries, including Products, resulting from the Research in
the field of multitest device point-of-care testing. Multitest devices shall
mean those devices capable of performing more than one type of diagnostic assay
in a given run. As an example, a device which can test for blood chemistries and
coagulation time or combination of chemistry, electrochemistry, coagulation and
immunoassay, in which several samples are placed in the same device and the
device is instructed to perform the preprogrammed assay without reloading, is a
multitest device.
3.3. ITC shall have the exclusive right to, and benefit of, the inventions
and discoveries, including Products, resulting from the Research, as it pertains
to coagulation in the field of single patient point-of-care testing. Single
patient point-of-care testing shall mean cartridge technology with single or
multiple coagulation assays or such multiple assays in a single cartridge for a
single patient. The Agreement does not restrict ITC from performing coagulation,
chemistry, immunoassay or hematology tests, on whole blood or plasma, in
cartridges of ITC design provided that if the coagulation cartridge designed as
part of this project is used, a royalty will be paid to Exigent as per section
4.2.
3.4. For purposes of this Agreement, point-of-care shall mean a diagnostic
test performed in the vicinity of a patient (regardless of species) at the time
a sample is obtained from the patient and is expressly contrasted with, and
distinguished from, testing performed at a central laboratory within a hospital,
or commercial laboratory.
4. PROPRIETARY RIGHTS
4.1. The parties hereto agree promptly to disclose to the other party any
and all inventions or discoveries, including Products, made by it in the course
of or as a result of the Research, whether discovered or conceived by an
employee, agent or representative. The parties hereto acknowledge that the
Research and Products will result from the collaboration between the parties and
that the right, title and interest in the Research and Products, including the
right to domestic and foreign copyright, copyright renewal, trademark and/or
patent protection therein and the right to register and claim priority therein
under any applicable law, treaty or conventions, shall be equally and jointly
owned. Each party hereto will equally share the expenses of prosecuting any
patent or otherwise developing or protecting any intellectual property right
related to the Research or Products. The processes and strategies of development
or protection of intellectual property rights related to the Research and/or
Products, including without limitation the scope of protection and/or
international activity, shall be the responsibility of both parties equally and
each party shall use its best efforts to agree on such processes and strategies.
4.2. Each party hereto shall have, subject to the contrary provisions in
Sections 3.2. and 3.3. of this Agreement, the irrevocable right to use all
inventions and discoveries (including Products) resulting from the Research.
Exigent's rights shall be royalty free. ITC's rights shall be royalty free after
ITC has compensated Exigent in cash for 50% of the technology development costs
for coagulation assays as contained in this Agreement which payment shall be
made prior to ITC's commercialization of inventions and discoveries. Each party
hereto shall ensure that the individuals under the control of each shall assign
to such party, or to the parties hereto jointly,
3
<PAGE>
all right, title and interest in each invention and/or discovery, such that the
parties hereto become the joint owner of any such invention and/or discovery,
including all patent or other proprietary rights relating thereto.
4.3. The parties hereto each agree to execute and deliver to the other all
reasonable copyright, patent and other applications, assignments and instruments
tendered by the other and perform such acts as may be reasonably necessary or
advisable for obtaining such rights and/or of vesting and maintaining the title
to the rights as specified in this Agreement.
4.4. The parties will keep a monthly schedule of all costs incurred which
will be subject to audit if desired by the other party and which will form the
basis of calculating the total Research and Development Cost. Any change to the
Research and Development Cost that results in changes exceeding $336,000 will
require approval of both parties before incurring the cost. Such cost will
include all expenses, capital costs, material costs and interest charged. This
cost, once the project is complete, will form the basis to set the Royalty
payment due Exigent by ITC if ITC chooses to use the inventions and discoveries.
4.5. The provisions of Section 4 hereof shall survive the expiration or
other termination of this Agreement.
5. CONFIDENTIALITY
5.1. The term "Confidential Information" shall mean all confidential,
proprietary or non-public information of either party hereto, including all
materials and technical information exchanged in connection with the Research,
information developed as a result of the Research known-how, data and/or trade
secrets, regardless of form, however disclosed, and all samples or prototypes of
any Products, furnished by one party to the other, either directly or
indirectly. Confidential Information shall not include information or materials
which (i) at the time of disclosure are in the public domain, (ii) after
disclosure become part of the public domain by publication or otherwise, other
than by reason of a breach of this Agreement, (iii) the recipient can establish
by reasonable proof were in its possession at the time of disclosure or were
subsequently and independently developed by the recipient, by persons not having
access to the Confidential Information or (iv) the recipient receives from a
third party who has the right to disclose such information.
5.2. Neither party receiving Confidential Information of the other (the
"Recipient") shall use the Confidential Information for any purpose other than
to fulfill the purposes and/or obligations of this Agreement and shall not
disclose the information to any person other than a person over whom Recipient
has control, who has a need to know the information in order for Recipient to
fulfill the purposes and/or obligations of this Agreement and who agrees to be
bound by the terms of this confidentiality provision.
5.3. All originals and copies of any of the foregoing however and whenever
produced, shall be the sole property of the originator of such Confidential
Information, subject to Sections 3 and 5 hereto regarding the ownership of the
results of the Research. Upon the expiration or
4
<PAGE>
earlier termination of this Agreement, each party shall promptly surrender to
the other party all Confidential Information of such other party that is reduced
to one or more writings, drawings, schematics, tapes, disks, or other form of
documentation, together with any documents, materials and equipment belonging to
the other party and such party shall not thereafter retain or deliver to any
other person or entity any of the foregoing or any summary or memorandum
thereof.
5.4. Each party hereby agrees that it shall be responsible for the
obligations of its employees, representatives and agents hereunder and executes
this Agreement on behalf of itself and such employees, representatives and
agents. In addition to its other obligations under this Section 5, each party
shall use at least the same degree of care (which at a minimum shall be
reasonable) to avoid unauthorized dissemination of Confidential Information as
it employs for its own information of a similar nature that it does not want to
have disseminated. The parties shall not put the Confidential Information of the
other to commercial use, except as expressly provided under this Agreement.
5.5 The provisions of Section 5 shall survive expiration or earlier
TERMINATION OF THIS AGREEMENT.
6. LAWS AND REGULATIONS
6.1. The parties hereto agree that each will conduct the research, provide
materials, develop and manufacture Products strictly in compliance with all
applicable federal, state and local laws, regulations, ordinances.
6.2. Each party hereto shall obtain and maintain, at its own expense, any
non-United States governmental consents, authorizations, approvals, filings,
permits or licenses required for it to export any Product it develops and for
which it arranges a foreign sale and for it to exercise its rights and to
discharge its obligation under this Agreement, including, without limitation,
all consents and filings with any non-United States governmental body. Each
party acknowledges that the Products and all related technical information,
documents and material are subject to export controls under the US Export
Administration Act of 1969, as amended, and the rules and regulations
promulgated from time to time thereunder (collectively the "Export Act"),
restricting exports and reexports of technical data, direct products of
technical data and software media. Each party hereto will, with respect to
Products it develops and for which it arranges a foreign sale, (i) comply
strictly with all legal requirements established under the Export Act, (ii)
cooperate fully with the other party in any official or unofficial audit or
inspection relating to the Export Act and (iii) not distribute or supply any
Product to any person if there is reason to believe that such person intends to
export, reexport or otherwise take such Products to, or use such Products in,
any country in violation of the Export Act.
Each party agrees not to knowingly export or re-export the Products or any
party thereof, directly or indirectly, without first obtaining permission to do
so from the United States Office of Export Administration and other appropriate
governmental agencies, into any of those countries listed, from time to time at
the time of any shipment of Products, in Title 15 of the Code of Federal
Regulations of the United States of America (or any successor or additional
5
<PAGE>
provision) as "prohibited or restricted" countries or any other country to which
such exports or re-exports may be restricted (collectively the "Restricted
Countries"). Each party hereto agrees not to distribute the Products or any
part thereof to any person if it has reason to believe that such person intends
to export, re-export or otherwise take the same to, or to use the same in, any
of the Prohibited Countries and each such party agrees to seek reasonable
written assurances in the form of binding covenants from customers as may from
time to time be requested by the other party hereto.
7. TERM AND TERMINATION
7.1. The term of this Agreement shall be for a period of one year
commencing on the Effective Date hereof and end on the one year anniversary of
the Effective Date; provided that this agreement shall be renewed automatically
for one year increments unless terminated by either party hereto upon one-month
written notice to the other, which may be given at any time after the one year
anniversary of the Effective Date.
7.2. ITC may terminate this Agreement upon 30 days written notice to
Exigent within the first year of the Agreement upon the occurrence of any
termination event as follows: (i) Exigent or any of its employees,
representatives or agents breaches any material obligation under this Agreement,
including, without limitation, violation of any payment terms, if such breach is
not cured to ITC's satisfaction within the 30 day notice period, (ii) Exigent
ceases to conduct business in the the normal course, becomes insolvent, enters
into suspension of payments, moratorium, reorganization or bankruptcy, makes a
general assignment for the benefit of creditors, admits in writing its inability
to pay debts as they mature, suffers or permits the appointment of a receiver
for its business or assets, or avails itself of or becomes subject to any other
judicial or administrative proceeding related to insolvency or protection of
creditors' rights (and, if such action or proceeding is involuntary on the part
of Exigent, such action or proceeding is not dismissed within 90 days), (iii)
the failure of Exigent to obtain any required permit or consent required to
perform the Research.
7.3. Exigent may terminate this Agreement upon 30 days written notice to
ITC within the first year of the Agreement upon the occurrence of any
termination event as follows: (i) ITC or any of its employees breaches any
material obligation under this Agreement, if such breach is not cured to
Exigent's satisfaction within the 30 day notice period, or (ii) ITC ceases to
conduct business in the normal course, becomes insolvent, enters into suspension
of payments, moratorium, reorganization or bankruptcy, makes a general
assignment for the benefit of creditors, admits in writing its inability to pay
debts as they mature, suffers or permits the appointment of a receiver for its
business or assets, or avails itself of or becomes subject to any other judicial
or administrative proceeding related to insolvency or protection of creditors'
rights (and, if such action or proceeding is involuntary on the part of ITC,
such action or proceeding is not dismissed within 90 days).
7.4. The provisions of Sections 3, 4, 5 and 7 shall survive the expiration
or earlier termination of this Agreement. From and after the date of any such
expiration or earlier
6
<PAGE>
termination, neither party shall have any further rights, privileges or
obligations hereunder except that: (i) such expiration or earlier termination
shall not relieve either party of any liability or obligation accrued prior to
the expiration or termination date, including without limitation, Exigent's
obligation to purchase the components and/or raw materials purchased or
manufactured pursuant to Exigent's forecasts, if any, (ii) such expiration or
earlier termination shall not affect the continued operation or enforcement of
any provision of this Agreement which is to survive expiration or termination,
and (iii) upon such expiration or earlier termination, each party shall
immediately return to the other party all Confidential Information as required
by Section 5 of this Agreement. In no event upon the expiration or termination
of this Agreement shall the terminating party (or in the event of an expiration,
either party) be liable to the other party for any damages, indemnities, loss of
profits, loss of revenues, or other losses by reason of any such expiration or
termination.
8. MISCELLANEOUS
8.1 Exigent's representative with respect to Exigent's rights and
obligations hereunder shall be Dr. Tom Grove, or such other representative as
Exigent designates to ITC, in writing, and Exigent represents that Dr. Grove is
authorized to bind Exigent in connection with this Agreement. Likewise, ITC's
representative is Gerald Feldman who has the same authority within ITC as
affects the execution and operation of this Agreement. Each party hereto
represents and warrants to the other that it has the right and has obtained all
necessary corporate approvals, to enter into this Agreement and perform the
obligations to be performed by it under this Agreement and that this Agreement
constitutes its valid, binding and enforceable obligation, enforceable against
it in accordance with its terms.
8.2 The failure of either party hereto to perform any obligation under
this Agreement (except any payment obligation hereunder of Exigent to ITC) due
to acts of God, acts of government, civil disturbances, wars, strikes,
transportation problems, unreasonable delays by ITC's vendors in delivery,
failure to provide products or material to ITC by its vendors, or other causes
beyond its reasonable control shall not be deemed to be a breach of this
agreement; provided, however, that the party so prevented from complying
herewith shall immediately give notice thereof to the other party and shall
continue to take all commercially reasonable action to comply as fully as
possible herewith. After removal of the basis for the non-performance, the party
failing to perform shall resume performance within a reasonable time.
8.3 This Agreement, together with its Annexes, constitutes the sole and
entire agreement between the parties relating to the subject matter herein, does
not operate as an acceptance of any conflicting terms or provisions of any
Exigent purchase orders or any other instrument or document and terminates and
supersedes any and all prior agreements and understandings between the parties.
8.4 No change in, addition to, or waiver of any of the terms and
provisions herein shall be binding upon any party unless approved by it in
writing.
7
<PAGE>
8.5. The failure by either party to exercise or to enforce any of the terms
or condition of this Agreement shall not constitute or be deemed a waiver of
that party's right thereafter to enforce each and every term and condition of
this Agreement.
8.6. Should a court of law or arbitrator hold that any one or more of the
provisions in this Agreement is invalid, illegal or unenforceable, no other
provision of this Agreement shall be affected thereby, and the remaining
provision of this Agreement shall be both construed and reformed and shall
continue with the same effect as if such unenforceable, illegal or invalid
provision shall not have been inserted in this Agreement.
8.7. This Agreement and the respective rights and obligations of the
parties hereto shall be governed by and determined in accordance with the
domestic internal laws of the Commonwealth of Pennsylvania, without giving
effect to conflict of laws principles thereof.
8.8. ITC and Exigent are independent parties. It is understood and agreed
that neither party hereto is, by this Agreement or anything herein contained,
constituted or appointed the legal representative of the other, nor shall either
party hereto have the right or authority to make any representation, warranty,
covenant, guarantee or commitment or assume, create or incur any liability or
any obligation of any kind, expressed or implied, in the name of or otherwise on
behalf of the other, whether directly or indirectly. This Agreement is not
intended to create a joint venture, partnership or agency relationship between
the parties hereto.
8.9. All notices and other communications which are required or permitted
under this agreement shall be in writing and sent by facsimile (confirmed by
mail), overnight courier, or registered or certified mail, postage prepaid, to
the receiving party at the following addresses:
If to ITC: International Technidyne Corporation
8 Olsen Avenue
Edison, NJ 08820
Attention: Mr. William Schwarzlow
with a copy to: Thermo Electron Corporation
81 Wyman Street
Waltham, MA 02254
Attention: General Counsel
with copy to Pepper Hamilton Scheetz LLP
3000 Two Logon Square
Philadelphia, PA
19103
Attn: Barry Abelso
If to Exigent: Exigent Diagnostics, Inc.
6100 Bristol Parkway
Culver City Calif
92660
Attention: Dr. Tom Grove
or to any other address that the receiving party may have provided to the
sending party in writing as provided aforesaid. Any notice or other
communication delivered by facsimile shall
8
<PAGE>
be deemed to have been received the day it is sent, if sent before 5:00 p.m. on
a business day and the next business day thereafter, if sent on a weekend,
holiday or after 5:00 p.m. Any notice or other communication sent by overnight
courier shall be deemed to have been received on the business day after it is
delivered to the courier. Any notice or other communication sent by registered
or certified mail shall be deemed to have been received on the third business
day after its date of posting. The facsimile number to which notices should be
sent are:
ITC (908) 632-9299
Thermo (617) 622-1283
Exigent (610) 270-6150
Pepper Hamilton 215 981-4750
8.10. This Agreement and each and every covenant, term and condition shall
be binding upon and inure to the benefit of both parties hereto and their
respective successors. Neither this Agreement nor any right hereunder may be
assigned or otherwise transferred by either party without first receiving the
express prior written consent of the other party, except that ITC may transfer
or assign this Agreement, or any of the rights and/or obligations thereunder to
any parent, sister, subsidiary or sister entity.
8.11. This Agreement may be executed in one or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute
one and the same instrument.
8.12. It is expected that upon completion of this Research and Development
Agreement, Exigent will enter into a manufacturing agreement with ITC for
production of coagulation reagents in a cuvette, subject to competitive pricing
as offered by ITC.
IN WITNESS WHEREOF, ITC and Exigent have caused this Agreement to be
executed by their duly authorized representatives as of the date first set forth
above.
Exigent Diagnostics, Inc. International Technidyne Corporation
By: /s/ W. Vickery Stoughton By: /s/ Gerald Feldman
----------------------------- ----------------------------------
Name: W. Vickery Stoughton Name: Gerald Feldman
--------------------------- --------------------------------
Title: Chairman & CEO Title: President
-------------------------- -------------------------------
Date: Oct 26, 1996 Date: Oct 27, 1996
--------------------------- --------------------------------
9
<PAGE>
Annex I REV.2 Coagulation Tests Development Plan - Confidential Information
<TABLE>
<CAPTION>
- ------------------------------------------------------------------------------------------------------------------------------------
ID TASK NAME TIME RESOURCE DEVELOP. $ BILLED $
- ------------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
1 COAGULATION TESTS DEVELOPMENT PLAN (4 METHODS) APTT, PT, THROMBIN TIME, FIBRINOGEN 190D $336,000.00 $463,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
2
- ------------------------------------------------------------------------------------------------------------------------------------
3 NOTE: THE RESOURCE ESTIMATES ARE NOT RELATED TO ELAPSED TIME. MORE THAN ONE PERSON
CAN BE ASSIGNED 1D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
4 TO A TASK TO SHORTEN THE ELAPSED TIME. 1D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
5
- ------------------------------------------------------------------------------------------------------------------------------------
6
- ------------------------------------------------------------------------------------------------------------------------------------
7 PROOF OF CONCEPT - COAGULATION ASSAYS BY REFLECTOMETRY - EXIGENT (COMPLETE) OD $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
8 Reflectance spectra of clotted and unclotted plasma samples Od $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
9 Preliminary evaluation of CORE System detection angles Od $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
10 Evaluate reference titles to zero and/or blank the Cary reflectometer Od $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
11 DETERMINE CLOTTING TIME FOR PT AND APTT USING COMMERCIAL COAGULATION REAGENTS
(LIQUID) OD $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
12 Evaluate incubation temperature vs. clot time Od $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
13 Evaluate incubation temperature vs. clot time Od $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
14 Evaluate commercial coagulation reagents and sample mixing vs. clot time Od $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
15 Evaluate commercial coagulation reagents and sample volumes vs. clot time Od $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
16 Estimate precision - Ortho PT and APTT controls Od $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
17 Perform method comparison (MLA vs. Reflectometry) Od
- ------------------------------------------------------------------------------------------------------------------------------------
18
- ------------------------------------------------------------------------------------------------------------------------------------
19
- ------------------------------------------------------------------------------------------------------------------------------------
20
- ------------------------------------------------------------------------------------------------------------------------------------
21
- ------------------------------------------------------------------------------------------------------------------------------------
22 SELECTION OF COAGULATION REAGENTS (PRELIMINARY STUDIES) - ITC 25D $40,000.00 $40,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
23 Create experimental lots & evaluate dried or lyophilized PT and APTT reagents 5w ITC $20,000.00 $20,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
24 REVIEW DIFFERENCES BETWEEN APTT AND PT (HOMOGENEOUS REAGENTS) 25D $20,000.00 $20,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
25 Determine mixing and/or homogeneity requirements 5w ITC $20,000.00 $20,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
</TABLE>
Annex I Rev.2 Coagulation Tests Development Plan - Confidential Information
<TABLE>
<CAPTION>
- ------------------------------------------------------------------------------------------------------------------------------
ID TASK NAME TIME RESOURCE DEVELOP. $ BILLED $
- ------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
26
- ------------------------------------------------------------------------------------------------------------------------------
27 DIAGNOSTIC PRODUCT SPECIFICATIONS - ITC/EXIGENT 0.63D $0.00 $2,000.00
- ------------------------------------------------------------------------------------------------------------------------------
28 APTT 5h ITC $0.00 $500.00
- ------------------------------------------------------------------------------------------------------------------------------
29 PT 5h ITC $0.00 $500.00
- ------------------------------------------------------------------------------------------------------------------------------
30 Fibrinogen 5h ITC $0.00 $500.00
- ------------------------------------------------------------------------------------------------------------------------------
31 Thrombin Time 5h ITC $0.00 $500.00
- ------------------------------------------------------------------------------------------------------------------------------
32
- ------------------------------------------------------------------------------------------------------------------------------
33
- ------------------------------------------------------------------------------------------------------------------------------
34
- ------------------------------------------------------------------------------------------------------------------------------
35
- ------------------------------------------------------------------------------------------------------------------------------
36
- ------------------------------------------------------------------------------------------------------------------------------
37 TEST CUVETTE DESIGN AND EVALUATION - ITC/BATTELLE/EXIGENT 15D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------
38 model coag cuvette - ITC/Battelle 3w $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------
39 Sample volume accuracy studies - Battelle 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------
40 Select and evaluate cuvette materials - ITC/Battelle 2w $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------
41 TEST REFLECTANCE OF CUVETTE MATERIALS - EXIGENT 0D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------
42 Evaluate detection angles 0d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------
43 Wavelengths (420, 505, 540, 600, 625, 650, 800 and "X" nm) 0d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------
44 Zero or blank reference 0d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------
45 Sample size (thickness) vs. ramp time vs. delta reflectance 0d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------
46 Detection of temperature of cuvette 0d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------
47 Develop CORE system for ITC 0d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------
48 TEST CUVETTE DESIGN ON CORE SYSTEM WITH LIQUID REAGENTS &
PLASMA 15D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------
49 APTT 3w $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------
50 PT 3w $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------
</TABLE>
Annex I REV.2 Coagulation Tests Development Plan - Confidential Information
<TABLE>
<CAPTION>
- ------------------------------------------------------------------------------------------------------------------------------------
ID TASK NAME TIME RESOURCE DEVELOP. $ BILLED $
- ------------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
51 Fibrinogen (if std. reagents 2w; if novel reagents add 4w) 3w $ 0.00 $ 0.00
- ------------------------------------------------------------------------------------------------------------------------------------
52 Thrombin time 3w $ 0.00 $ 0.00
- ------------------------------------------------------------------------------------------------------------------------------------
53 DESIGN CUVETTE MANUFACTURING PROCESS - ITC/;BATTELLE 50D $ 0.00 $ 99,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
54 Pilot manufacturing process description/definition - Battelle 0d $ 0.00 $ 0.00
- ------------------------------------------------------------------------------------------------------------------------------------
55 Preliminary cuvette design documents - Battelle 0d ITC $ 0.00 $ 0.00
- ------------------------------------------------------------------------------------------------------------------------------------
56 Preliminary manufacturing process design/layout/capital estimates - ITC 2w ITC $ 0.00 $ 8,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
57 PRELIMINARY COST ESTIMATES 3.75D $ 0.00 $ 3,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
58 5 year forecast - Exigent 0d $ 0.00 $ 0.00
- ------------------------------------------------------------------------------------------------------------------------------------
59 cost estimate - ITC 30h ITC $ 0.00 $ 3,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
60 Design the integration of the cuvette into test cartridge assemble
line - ITC/Battelle 6w BAT $ 0.00 $ 0.00
- ------------------------------------------------------------------------------------------------------------------------------------
61 NOTE: THESE NEXT 2 ITEMS ARE NOT WELL DEFINED, ROUGH ESTIMATE 1d $ 0.00 $ 0.00
- ------------------------------------------------------------------------------------------------------------------------------------
62 Design process equipment - Battelle/ITC ?? 6w ITC $ 0.00 $ 24,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
63 Prepare tooling - Battelle/ITC ?? 10w ITC $ 0.00 $ 40,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
64 Produce test lots (proof of manufacturing equipment) - ITC ?? 6w ITC $ 0.00 $ 24,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
65
- ------------------------------------------------------------------------------------------------------------------------------------
66
- ------------------------------------------------------------------------------------------------------------------------------------
67
- ------------------------------------------------------------------------------------------------------------------------------------
68 FORMULATE COAGULATION REAGENTS IN A DRY FORMAT (4 METHODS) - ITC 190D $248,000.00 $248,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
69 Determine the need for any liquid reagents 2w ITC $ 8,000.00 $ 8,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
70 If so, utilize test cartridge reagent pouch ??? (assume not
necessary, if required then add 12w) 0d ITC $ 0.00 $ 0.00
- ------------------------------------------------------------------------------------------------------------------------------------
71 Formulate and optimize reagent combinations 38w ITC $152,000.00 $152,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
72 Test stabilizers and preservative 10w ITC $ 40,000.00 $ 40,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
73 Define stability and storage conditions - (part of spec.) 0d ITC $ 0.00 $ 0.00
- ------------------------------------------------------------------------------------------------------------------------------------
74 Design calibration procedure - how does the reflection system get
calibrated 4w ITC $ 16,000.00 $ 16,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
75 Design reagent manufacturing process following GMP guidelines 8w ITC $ 32,000.00 $ 32,000.00
- ------------------------------------------------------------------------------------------------------------------------------------
</TABLE>
Annex I REV.2 Coagulation Tests Development Plan - Confidential Information
<TABLE>
<CAPTION>
- ------------------------------------------------------------------------------------------------------------------------------------
ID TASK NAME TIME RESOURCE DEVELOP. $ BILLED $
- ------------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
76
- ------------------------------------------------------------------------------------------------------------------------------------
77
- ------------------------------------------------------------------------------------------------------------------------------------
78
- ------------------------------------------------------------------------------------------------------------------------------------
79 DEVELOP COAGULATION ASSAYS USING DRIED REAGENTS ON CORE SYSTEM - EXIGENT/ITC 25D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
80 Determine reflectance spectra of clotted and unclotted samples - Exigent 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
81 CONFIRM DETECTION ANGLES AND WAVELENGTH(S) - EXIGENT 1D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
82 Complementary with chemistry slides 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
83 Evaluate bandwidth - enhance precision, delta R and ramp time 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
84 Check interferences 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
85 Set algorithm to calculate clotting time - Exigent 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
86 Evaluate incubation temperature and time profiles: compare temperature/time
vs. clot time vs. delta R vs. ramp time - Exigent 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
87 HYDRATING DRIED REAGENTS (IF REQUIRED ITC/EXIGENT WORK TOGETHER) 25D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
88 Evaluate volumes of sample and/or diluent (if requires diluent, work
with Battelle) 5w $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
89 Formulate and optimize diluent (if required) - ITC 5w $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
90 AGITATION FORCE AND TIME OD $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
91 Preliminary mixing studies - ITC/Battelle/Exigent 3w $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
92 Sample size (thickness, depended on the cuvette design) vs. clot time vs. delta
R vs. ramp time - Exigent 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
93 Sample types - compare clot time of citrated blood and citrated plasma of same
individuals - Exigent 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
94 Establish assay imprecision - Exigent 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
95 Method comparison study - Exigent 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
96
- ------------------------------------------------------------------------------------------------------------------------------------
97
- ------------------------------------------------------------------------------------------------------------------------------------
98
- ------------------------------------------------------------------------------------------------------------------------------------
99
- ------------------------------------------------------------------------------------------------------------------------------------
100
- ------------------------------------------------------------------------------------------------------------------------------------
</TABLE>
Annex I REV.2 Coagulation Tests Development Plan - Confidential Information
<TABLE>
<CAPTION>
- ------------------------------------------------------------------------------------------------------------------------------------
ID TASK NAME TIME RESOURCE DEVELOP. $ BILLED $
- ------------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
101 INSTRUMENT/SOFTWARE CONTROL - EXIGENT/UMM/BATTELLE/ITC 10D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
102 TEMPERATURE CONTROL 37 degrees C+/0.25 degrees C - UMM 1D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
103 Time to reach 37 degrees C - less than 2 min 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
104 Verify temperature 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
105 Control time of adding plasma and/or reagent into cuvette - Battelle 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
106 Control plasma and/or reagent volumes - Battelle 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
107 Control mixing (speed and time) - UMM/Battelle 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
108 Control light sources and detection angles - UMM 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
109 DETERMINE THE CLOT TIME - EXIGENT/ITC 10D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
110 Reference samples - Exigent 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
111 Guard interval 2d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
112 Clot formation 3d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
113 Initial and final sensitivity settings 1w $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
114 Clot verification 2w $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
115 Default settings: minimum and maximum observation times 2w $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
116 Test throughput 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
117 Detect overfill or underfill of cartridge - Battelle 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
118 Detect foaming or air bubbles in sample - Battelle 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
119
- ------------------------------------------------------------------------------------------------------------------------------------
120
- ------------------------------------------------------------------------------------------------------------------------------------
121 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
122 SAMPLE COLLECTION - EXIGENT 1D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
123 Follow the ITC methods for collecting specimens 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
124 Evaluate blood volumes to sodium citrate volumes (10.9-12.9 mmol/L dehydrate
trisodium citrate) vs. clot time vs. delta R vs. ramp tim 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
125 Mixing method 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
</TABLE>
Annex I REV.2 Coagulation Tests Development Plan - Confidential Information
<TABLE>
<CAPTION>
- ------------------------------------------------------------------------------------------------------------------------------------
ID TASK NAME TIME RESOURCE DEVELOP.$ BILLED $
- ------------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
126 Evaluate closed tube sampling 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
127 Evaluate sample handling, transport temperature, storage and time prior to assay
(cold and glass activation) recovery after storage? 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
128 EVALUATE CENTRIFUGE SPEED AND TIME TO OBTAIN PLATELET-FREE CITRATE PLASMA-(WORK
WITH UMM) 1D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
129 Hemolyzed samples-lipidemia, diluted samples, icteric samples 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
130 Check and remove clot 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
131 EVALUATE CENTRIFUGATION TEMPERATURE (WORK WITH UMM) 1D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
132 Instrument 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
133 Blood and citrate plasma stability as RT and 2-8 degreesC (for every assay) 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
134 PATIENTS ON HEPARIN/WARFARIN THERAPY (WORK WITH ITC) 1D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
135 Half-life of heparin in blood and plasma 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
136 Baseline value (clot time) before therapy 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
137 Clot time 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
138 Sample drawn through an in-dwelling catheter 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
139
- ------------------------------------------------------------------------------------------------------------------------------------
140 QUALITY CONTROL MATERIAL - ITC 60D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
141 FORMULATE/PREPARE NORMAL AND ABNORMAL CONTROLS FOR EVERY ASSAY 60D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
142 DEVELOP 8 PLASMA CONTROLS (4 METHODS *2 CONTROLS) 60D $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
143 note: assumes minor modification to existing controls & repackage Od $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
144 Negative for HBsAg and antibody to HIV Od $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
145 Modification of existing formulation and testing on CORE system 4w $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
146 Develop manufacturing documentation following GMP guidelines 3w $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
147 manufacturing pilots and scale-up 4w $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
148 Establish clot times on mercury system 60d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
149 Preparation, manufacturing and packaging - GMP guidelines 1d $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
150 Stability and storage (definition and testing) 10w $0.00 $0.00
- ------------------------------------------------------------------------------------------------------------------------------------
</TABLE>
ANNEX I REV.2 COAGULATION TESTS DEVELOPMENT PLAN - CONFIDENTIAL INFORMATION
<TABLE>
<CAPTION>
- --------------------------------------------------------------------------------------------------------------------------------
ID TASK NAME TIME RESOURCE DEVELOP. $ BILLED $
- --------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
151
- --------------------------------------------------------------------------------------------------------------------------------
152
- --------------------------------------------------------------------------------------------------------------------------------
153 IN-HOUSE VALIDATION OF THREE LOTS OF COAGULATION TEST
CARTRIDGE ON "MERCURY" ANALYZER - EXIGENT 10D $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
154 Determine reference intervals and compare to literature values 1d $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
155 PERFORM METHOD COMPARISON STUDY 1D $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
156 vs. SBCL - Ortho kits (MLA-1000) 1d $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
157 vs. ITC 1d $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
158 vs. other reference methods 1d $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
159 DETERMINE INTERFERING SUBSTANCES 1D $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
160 Analytical specificity - hemolyzed, icteric or lipemic specimens,
anticoagulants, aspirin, vitamin K antagonists, estrogen therapy, ? 1d $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
161 Clinical specificity - liver disease, Factor deficiencies etc. 1d $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
162 PERFORM ANALYTICAL AND CLINICAL VALIDATION FOR REGULATORY APPROVAL
FOR INTENDED USE IN HOSPITALS AND AT ALTERNATIVE SITES SUCH 1D $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
163 Physiological or hereditary coagulation abnormalities - hemophilia
and von Willebrand's disease 1d $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
164 Drug induced coagulation abnormalities - warfarin, heparin, Coumadin 1d $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
165 DETERMINE STABILITY AND STORAGE CONDITIONS (WORK WITH ITC) 0.25D $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
166 Sample (blood and Plasma) 2h $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
167 Reagents and test cartridges 2h $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
168 Determine assay imprecision (inter and intra) 2h $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
169 Determine analytical sensitivity and linearity 2d $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
170 Determine procedural and diagnostic limitations 1w $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
171 Clinical utility (intended use) 1w $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
172 REPORTING 6D $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
173 Clot time to nearest 10th of a second 1d $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
174 International normalized ratio (PT assay) 1w $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
175 International sensitivity index or each lot of PT reagents - ITC 1w $0.00 $0.00
- --------------------------------------------------------------------------------------------------------------------------------
</TABLE>
<TABLE>
<CAPTION>
ANNEX I REV.2 COAGULATION TESTS DEVELOPMENT PLAN - CONFIDENTIAL INFORMATION
- ----------------------------------------------------------------------------------------------------------------------------
ID TASK NAME TIME RESOURCE DEVELOP. $ BILLED $
- ----------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
176 Quality control and quality assurance procedure 2w $0.00 $0.00
----------------------------------------------------------------------------------------------------------------------------
177 Calibration procedure 1w $0.00 $0.00
- ----------------------------------------------------------------------------------------------------------------------------
178 Labeling 1w $0.00 $0.00
- ----------------------------------------------------------------------------------------------------------------------------
179
- ----------------------------------------------------------------------------------------------------------------------------
180
- ----------------------------------------------------------------------------------------------------------------------------
181 Contingency estimate 30w $48,000.00 $74,000.00
- ----------------------------------------------------------------------------------------------------------------------------
</TABLE>
Page 1
<PAGE>
EXHIBIT 10.32
COMPOSITE REGISTRATION RIGHTS AGREEMENT
---------------------------------------
REGISTRATION RIGHTS AGREEMENT originally dated as of March 6, 1998
(the "Effective Date") between Exigent Diagnostics, Inc., a Delaware corporation
(the "Company"), and each Investor executing a copy hereof (each a
"Stockholder"; collectively, are the "Stockholders"), as amended on February 17,
1999 ("Agreement").
W I T N E S S E T H:
- - - - - - - - - -
WHEREAS, the Company sold to the Stockholders shares of common stock, $.01
par value per share (the "Common Stock"), all upon the terms set forth in the
Company's Confidential Private Placement Memorandum dated January 29, 1998 (as
subsequently amended, the "Memorandum") (the "Purchase Shares");
WHEREAS, to induce the Stockholders to purchase the Purchase Shares,
the Company has agreed to register shares of Common Stock pursuant to the terms
and conditions set forth below; and
WHEREAS, on February 17, 1999, the Registration Rights Agreement was
amended pursuant to the terms hereof;
NOW, THEREFORE, in consideration of the mutual covenants and
agreements made herein, and other good valuable consideration, the receipt and
sufficiency of which are hereby acknowledged and accepted, the parties hereto
agree as follows:
1. Definitions. As used herein, unless the context otherwise requires,
-----------
the following terms have the following respective meanings:
"Affiliate" has the meaning set forth in Rule 12b-2 under the Exchange
Act.
"Commission" means the United States Securities and Exchange
Commission or any other federal agency at the time administering the Securities
Act.
"Common Stock" has the meaning set forth in the first WHEREAS clause
of the Recitals.
"Demand" has the meaning set forth in Section 2.1.1.
<PAGE>
"Exchange Act" means the Securities Exchange Act of 1934, as amended,
or any similar federal statute, and the rules and regulations of the Commission
promulgated thereunder, as the same shall be in effect at the time. Reference
to a particular section of the Securities Exchange Act of 1934, as amended,
shall include reference to the comparable section, if any, of any such
subsequent similar federal statute.
"Initial Public Offering" means the first offering of securities
registered with the Commission under the Securities Act.
"Joint Stockholders" means the Stockholders who are or may from time
to time become a party to this Agreement, together with the "Stockholders" who
are or may from time to time become a party to the Prior Agreement.
"Participating Holder" has the meaning set forth in Section 2.1.4.
"Person" means any individual, partnership, joint venture,
corporation, trust. unincorporated organization, government or department or
agency of a government.
"Placement Agent" means Spencer Trask Securities Incorporated.
"Prior Agreement" means that certain Registration Rights Agreement
executed by the Company and each Person who purchased Common Stock pursuant to
the Prior Offering.
"Prior Offering" means the Company's initial private placement of
Common Stock through the Placement Agent.
"Public Offering" means a public offering of the securities registered
with the Commission under the Securities Act.
"Registrable Common Securities" means the Purchase Shares, together
with any other shares of Common Stock purchased by any Joint Stockholder in the
Prior Offering.
"Registrable Securities" means collectively the Registrable Common
Securities and any other securities issuable in connection therewith or in
replacement thereof by way of a dividend, distribution, recapitalization,
exchange, merger, consolidation or other reorganization. As to any particular
Registrable Securities, once issued such securities shall cease to be
Registrable Securities when (a) a registration statement with respect to the
sale of such securities shall have become effective under the Securities Act and
such securities shall have been disposed of in accordance with such registration
statement, (b) they shall be permitted to be sold by, and in compliance with,
Rule 144 (or any successor provision) promulgated under the Securities Act
(unless the Placement Agent and the Company consent to their being considered
"Registrable Securities" notwithstanding their ability to sell such securities
by, and in compliance with, Rule 144 (or any successor provision) or (c) they
shall have ceased to be outstanding.
-2-
<PAGE>
"Registration Expenses" means all expenses incident to the Company's
performance of or compliance with Section 2, including, without limitation, all
registration, filing and National Association of Securities Dealers, Inc. fees,
all listing fees, all fees and expenses of complying with securities or blue sky
laws (including, without limitation, reasonable fees and disbursements of
counsel for the underwriters in connection with blue sky qualifications of the
Registrable Securities), all word processing, duplicating and printing expenses,
messenger and delivery expenses, the fees and disbursements of counsel for the
Company and counsel for the Participating Holders comprising not more than one
outside law firm which shall be selected by the Participating Holders of a
majority of the Registrable Securities sought to be registered in such
registration ("Selling Stockholder Counsel"), and of the Company's independent
public accountants, including the expenses of "comfort" letters required by or
incident to such performance and compliance, and any fees and disbursements of
underwriters customarily paid by issuers or sellers of securities.
"Securities Act" means the Securities Act of 1933, as amended, or any
subsequent similar federal statute, and the rules and regulations of the
Commission thereunder, all as the same shall be in effect at the time.
References to a particular section of the Securities Act of 1933, as amended,
shall include a reference to the comparable section, if any, of any such
subsequent similar federal statute.
2. Registration Rights.
-------------------
2.1 Initial Registration and Registration on Demand.
-----------------------------------------------
2.1.1 Initial Registration. In the event the Company shall
--------------------
complete an Initial Public Offering of its securities prior to the fifth (5th)
anniversary of the Final Closing Date (as defined in the Memorandum), the
Company shall, subject to and in accordance with the terms, conditions,
procedures and requirements set forth herein, cause to be filed and take all
commercially reasonable efforts to effect the registration under the Securities
Act of all Registrable Securities not later than 360 days after the closing of
such Initial Public Offering, or such later date as shall be negotiated on
behalf of the Joint Stockholders by the Placement Agent, the Company and any
underwriter for such Initial Public Offering as shall be determined by the terms
hereof (the "Holdback Period"); provided, however, that a holder of Registrable
Securities may inform the Company in writing that it wishes to exclude all or a
portion of its Registrable Securities from such registration.
2.1.2. Demand. In the event that by the fifth (5th) anniversary
------
of the Effective Date the Company has not yet completed an Initial Public
Offering, subject to Section 2.1.7, upon the written request (the "Demand") of
the holders of a majority of Registrable Securities that the Company effect the
registration under the Securities Act of all or part of the Registrable
Securities, the Company shall cause to be filed, and shall take all commercially
reasonable actions to effect, as soon as practicable and in any event, subject
to the reasonable
-3-
<PAGE>
cooperation of the Joint Stockholders, within 120 days after the Demand is
received from the Joint Stockholders, the registration under the Securities Act,
of the Registrable Securities which the Company has been so requested to
register by the Joint Stockholders. Whenever the Company shall effect a
registration pursuant to Section 2.1 in connection with an underwritten Public
Offering by the Joint Stockholders of Registrable Securities, holders of
securities of the Company who have "piggyback" registration rights may include
all or a portion of such securities in such registration, offering or sale. If
the managing underwriter of any such Public Offering shall inform the Company by
letter of its belief that the number or type of securities of the Company
requested by holders of the securities of the Company other than the Joint
Stockholders to be included in such registration would materially and adversely
affect the underwritten Public Offering, then the Company shall include in such
registration, to the extent of the number and type of securities which the
Company is so advised can be sold in (or during the time of) such Public
Offering, first, all of the Registrable Securities specified by the Joint
Stockholders in the Demand and second, for each holder of the Company's
securities other than the Joint Stockholders, the fraction of each holder's
securities proposed to be registered which is obtained by dividing (i) the
number of the securities of the Company that such holder proposes to include in
such registration by (ii) the total number of securities proposed to be included
in such registration by all holders other than the Joint Stockholders. Prior to
such registration being declared effective, the Joint Stockholders holding a
majority of the Registrable Securities requesting such Demand registration may
withdraw such Demand registration, subject to the provisions of Section 2.1.4
below.
2.1.3. Registration Statement Form. Registrations under this Section
---------------------------
2.1 shall be on such appropriate registration form of the Commission as shall be
selected by the Company. The Company shall include in any such registration
statement all information which. in the opinion of counsel to the Company, is
required to be included.
2.1.4. Expenses. The Company shall pay the Registration Expenses in
--------
connection with any registration effected pursuant to this Section 2.1, other
than underwriting discounts and selling commissions relating to the sale or
disposition of Registrable Securities. if the registration pursuant to Section
2.1.2 is withdrawn at the request of a majority of the Joint Stockholders
requesting registration and if such Joint Stockholders elect not to have such
registration count as its Demand registration under Section 2.1.2, the Joint
Stockholders shall pay all the Registration Expenses of such registration, other
than the fees and expenses of counsel to the Company or of any other holder of
Common Stock participating in the registration (a "Participating Holder"). At
no time shall the Joint Stockholders be required to pay the underwriting
discounts or selling commissions relating to the sale or disposition of shares
of Common Stock by other Persons, or the fees and expenses of any Participating
Holder's or the Company's counsel, except as required by Section 2.6.2 below.
2.1.5. Effective Registration Statement. A registration requested
--------------------------------
pursuant to this Section 2.1 shall not be deemed to have been effected (i)
unless a registration statement with respect thereto has become effective, (ii)
if after it has become effective, such registration is
-4-
<PAGE>
interfered with by any stop order, injunction or other order or requirement of
the Commission or other governmental agency or court for any reason and has not
thereafter become effective, or (iii) in the case of an underwritten Public
Offering, if the conditions to closing specified in the underwriting agreement,
if any, entered into in connection with such registration are not satisfied or
waived.
2.1.6. Selection of Underwriters. In connection with each
-------------------------
underwritten Public Offering, (a) the Company shall promptly select the managing
underwriter subject to the approval of the Joint Stockholders (by the holders of
a majority of the Registrable Securities sought to be registered by the
Participating Holders), which approval shall not be unreasonably withheld,
delayed or conditioned by the Joint Stockholders, and (b) if they so desire, the
Joint Stockholders shall promptly (by the holders of a majority of the
Registrable Securities sought to be registered by the Participating Holders in
such Demand) select the co-managing underwriter subject to the approval of the
Company (which approval shall not be unreasonably withheld, delayed or
conditioned by the Company).
2.1.7. Limitations on Registration. The Company shall not be
---------------------------
required to file a registration statement pursuant to this Section 2.1(a) which
would become effective within (i) the Holdback Period, or such shorter period as
agreed to by the lead managing underwriter for the Company's Initial Public
Offering, following the effective date of a registration statement filed by the
Company with the Commission pertaining to an Initial Public Offering for the
account of the Company, provided that no other holder of the Company's
securities shall have been permitted to participate in such Initial Public
Offering, or (ii) 120 days following the effective date of a registration
statement (other than a registration statement filed on Form S-4 or S-8) filed
by the Company with the Commission pertaining to any subsequent Public Offering
for the account of the Company or another holder of securities of the Company if
the Joint Stockholders were afforded the opportunity to include all of its
Registrable Securities in such subsequent registration pursuant to Section 2.2,
or (b) if it would violate any restriction or prohibition requested by any
managing underwriter for the Company's Initial Public Offering. In no event
shall the Company be required to effect more than one (1) registration pursuant
to Section 2.1.1 and one (1) registration pursuant to Section 2.1.2.
Notwithstanding the foregoing, if, in the good faith determination of the
Company's Board of Directors, a registration would adversely affect certain
activities of the Company to the material detriment of the Company, then the
Company may at its option direct that such registration be delayed for a period
not in excess of 90 days in the aggregate from the date of the Company's receipt
of the Demand or from the first date upon which the Company is required to
effect the registration contemplated by Section 2.1.1, as applicable (the
"Period of Delay"); provided, however, if there shall occur any such delay in
the registration hereunder, then the holders of the Registrable Securities shall
be entitled, (i) for a period of thirty (30) days after the Period of Delay, to
effect a Demand registration under Section 2.1.2 prior to any other holder of
registration rights (other than SmithKline Beecham Corporation, its affiliates
and their permitted transferees, as to which the rights hereunder shall be pari
----
pasu) or prior to a registered Public Offering by the Company (other than such a
- ----
Public Offering by the Company on Form S-4 or S-8), and (ii) to effect a
registration under Section 2.
-5-
<PAGE>
1.1 prior to any other holder of registration rights (other than SmithKline
Beecham Corporation, its affiliates and their permitted transferees, as to which
the rights hereunder shall be pari pasu) or prior to a registered Public
---- ----
Offering by the Company (other than such a Public Offering by the Company on
Form S-4 or S-8).
2.1.8 Notwithstanding anything in this Agreement to the
contrary, the Company shall not have any obligation to file a registration
statement or otherwise effect a registration pursuant to this section until one
year after the Initial Public Offering.
2.2 Piggyback Registration.
----------------------
2.2.1. Right to Include Registrable Securities. If the
---------------------------------------
Company at any time after the Initial Public Offering proposes to register any
of its securities under the Securities Act by registration on Forms S- 1, S-2,
S-3) or any successor or similar form(s) (except registrations on such Forms or
similar forms solely for registration of securities in connection with (i) an
employee benefit plan or dividend reinvestment plan or a merger or consolidation
or (ii) debt securities which are not convertible into Common Stock), whether or
not for sale for its own account, it shall each such time give written notice to
the Joint Stockholders of its intention to do so at least 30 days prior to the
anticipated filing date of a registration statement with respect to such
registration with the Commission. Upon the written request of the Joint
Stockholders made as promptly as practicable and in any event within 10 business
days after the receipt of any such notice, which request shall specify the
Registrable Securities intended to be disposed of by the Joint Stockholders, the
Company shall use commercially reasonable efforts to effect the registration
under the Securities Act of all Registrable Securities which the Company has
been so requested to register by the Joint Stockholders; provided, however, that
if, at any time after giving written notice of its intention to register any
securities and prior to the effective date of the registration statement filed
in connection with such registration, the Company shall determine for any reason
not to register or to delay registration of such securities, the Company may, at
its election, give written notice of such determination to the Joint
Stockholders and (i) in the case of a determination not to register, shall be
relieved of its obligation to register any Registrable Securities in connection
with such registration (but not from any obligation of the Company to pay the
Registration Expenses in connection therewith), without prejudice, provided,
however, that the Joint Stockholders may request that such registration be
effected as a registration under Section 2.1.2 hereof if such registration right
was then available to the Joint Stockholders under Section 2.1.2 hereof) and
(ii) in the case of a determination to delay registering, shall be permitted to
delay registering any Registrable Securities for the same period as the delay in
registering such other securities. The Company shall pay all Registration
Expenses in connection with registration of Registrable Securities requested
pursuant to Section 2.2, other than underwriting discounts and selling
commissions relating to the sale or disposition of Registrable Securities.
2.2.2. Priority in Piggyback Registrations. Priority in
----------------------------------- -----------
Piggyback Registrations. Notwithstanding anything in Section 2.2.1 above to the
- -----------------------
contrary, if the managing underwriter of any underwritten Public Offering shall
inform the Company by letter of its belief that the number or type of
Registrable Securities requested to be included in such registration would
materially and adversely affect such Public Offering, then the Company shall
promptly notify the Joint Stockholders of such fact. If the managing underwriter
does not agree to include
-6-
<PAGE>
all (or such lesser amount as the Joint Stockholders shall, in their discretion,
agree to) of the number of the Registrable Securities initially requested by the
Joint Stockholders to be included in such registration, then the Company shall
include in such registration, to the extent of the number and type which the
Company is so advised can be sold in (or during the time of) such Public
Offering first, all securities proposed by the Company to be sold for its
account, if the Company initiated such registration, or by the holder of
securities or initiated such demand registration, if any, second, for each
Initial Stockholder (other than the Waiving Initial Stockholders), the fraction
of such Initial Stockholder's securities proposed to be registered which is
obtained by dividing (i) the number of the securities of the Company that such
Initial Stockholder proposes to include in such registration by (ii) the total
number of securities proposed to be sold in such Public Offering by all such
Initial Stockholders, and third, for each of the Stockholders signatory hereto,
the Waiving Initial Stockholders and any other holders of contractual
registration rights, if any, the fraction of such holder's securities proposed
to be registered which is obtained by dividing (i) the number of the securities
of the Company that such holder proposes to include in such registration by (ii)
the total number of securities proposed to be sold in such Public Offering by
all such Stockholders signatory hereto, all such Waiving Initial Stockholders
and all such other holders of contractual registration rights. As used herein,
the term "Initial Stockholders" means each Person who prior to the date hereof
was a party to that certain Stockholders' Agreement dated as of December 4, 1996
and relating to the Company, and each such Person's successors and assigns. As
used herein, the term "Waiving Initial Stockholders" means those Initial
Stockholders who agree to waive their order of priority set forth in Section
2.2.2 of the Prior Agreement and agree to rank pari passu in order of priority
in regards to piggyback registration rights with the Stockholders signatory
hereto.
2.3 Registration Procedures.
-----------------------
2.3.1. In connection with the registration of any Registrable
Securities under the Securities Act as provided in Sections 2.1 and 2.2, the
Company shall as promptly as practicable:
(i) prepare and file with the Commission the
requisite registration statement to effect such registration and thereafter use
commercially reasonable efforts to cause such registration statement to become
and remain effective;
(ii) prepare and file with the Commission such
amendments and supplements to such registration statement and the prospectus
used in connection therewith as may be necessary to keep such registration
statement effective and to comply with provisions of the Securities Act with
respect to the disposition of all Registrable Securities covered by such
registration statement for 180 days or such shorter period as may be required
for the disposition of all of such Registrable Securities by the underwriters;
(iii) furnish to the Joint Stockholders such number of
conformed copies of such registration statement and of each such amendment and
supplement
-7-
<PAGE>
thereto (in each case including all exhibits), such number of copies of the
prospectus contained in such registration statement (including each preliminary
prospectus and any summary prospectus) and any other prospectus filed under Rule
424 under the Securities Act, in conformity with the requirements of the
Securities Act, and such number of copies of such other documents as the Joint
Stockholders may reasonably request;
(iv) use commercially reasonable efforts (x) to register or
qualify all Registrable Securities and other securities covered by such
registration statement under such other securities or Blue Sky laws of such
States of the United States of America where an exemption is not available and
as the Joint Stockholders shall reasonably request, (y) to keep such
registration or qualification in effect for so long as such registration
statement remains in effect, and (z) to take any other action which may
reasonably be necessary or advisable to enable the Joint Stockholders to
consummate the disposition in such jurisdictions of the Registrable Securities
to be sold by the Joint Stockholders, except that the Company shall not for any
such purpose be required to qualify generally to do business as a foreign
Company in any jurisdiction wherein it would not, but for the requirements of
this paragraph (iv), be obligated to be so qualified or to consent to general
service of process in any such jurisdiction;
(v) use commercially reasonable efforts to cause all
Registrable Securities covered by such registration statement to be registered
with or approved by such other federal or state governmental agencies or
authorities as may be necessary in the opinion of counsel to the Company and
counsel to the Joint Stockholders to consummate the disposition of such
Registrable Securities in accordance with their intended method of disposition;
(vi) furnish to the Joint Stockholders, (x) an opinion of
outside counsel for the Company, and (y) a copy of a "comfort" letter addressed
to the Company and/or any managing underwriter signed by the certified
independent public accountants who have certified the Company's financial
statements included or incorporated by reference in such registration statement,
each covering substantially the same matters with respect to such registration
statement (and the prospectus included therein) and, in the case of the
accountant's comfort letter, with respect to events subsequent to the date of
such financial statements, as are customarily covered in opinions of issuer's
counsel and in accountant's comfort letters delivered to the underwriters in
underwritten Public Offerings of securities (and dated the dates such opinions
and comfort letters are customarily dated);
(vii) notify the Joint Stockholders when a prospectus
relating thereto is required to be delivered under the Securities Act, upon
discovery that, or upon the happening of any event as a result of which, the
prospectus included in such registration statement, as then in effect, includes
an untrue statement of a material fact or omits to state any material fact
required to be stated therein or necessary to make the statements therein not
misleading, in the light of the circumstances under which they were made, and at
the request of the Joint Stockholders to use its best efforts to promptly
prepare and furnish to the Joint Stockholders such number of copies of a
supplement to or an amendment of such prospectus as
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<PAGE>
may be necessary so that, as thereafter delivered to the purchasers of such
securities, such prospectus shall not include an untrue statement of a material
fact or omit to state a material fact required to be stated therein or necessary
to make the statements therein not misleading in the light of the circumstances
under which they were made;
(viii) otherwise use its best efforts to comply with all
applicable rules and regulations of the Commission, and make available to its
security-holders, as soon as reasonably practicable, an earnings statement
meeting the requirements of Section 11(a) of the Securities Act, which the
Company shall be entitled to satisfy by complying with the requirements of Rule
158 promulgated thereunder, and promptly famish a copy of the same to the Joint
Stockholders;
(ix) provide and cause to be maintained a transfer agent
and registrar for all Registrable Securities covered by such registration
statement from and after a date not later than the effective date of such
registration statement; and
(x) use commercially reasonable efforts to list all
Registrable Securities covered by such registration statement on any national
securities exchange or over-the-counter market, if any, on which Registrable
Securities of the same class, and if applicable, series, covered by such
registration statement are then listed.
The Joint Stockholders agree that upon receipt of any notice from the
Company of the happening of an event of the kind described in Section 2.3.1
(vii), the Joint Stockholders shall forthwith discontinue its disposition of
Registrable Securities pursuant to the registration statement relating to such
Registrable Securities until the Joint Stockholders' receipt of the copies of
the supplemented or amended prospectus contemplated by Section 2.3.1(vii).
2.4 Underwritten Offerings.
----------------------
2.4.1. Requested Underwritten Offerings. If requested by the
--------------------------------
underwriters for any underwritten Public Offering by the Joint Stockholders
pursuant to a registration requested under Section 2.1, the Company shall enter
into an underwriting agreement with such underwriters for such Public Offering,
such agreement to be reasonably satisfactory in substance and form to the
Company, the Joint Stockholders and the underwriters, and to contain such
representations and warranties by the Company and the Joint Stockholders and
such other terms as are generally prevailing in agreements of that type,
including, without limitation, indemnities to the effect and to the extent
provided in Section 2.6 or as are generally prevailing in agreements of that
type. The Joint Stockholders shall cooperate with the Company in the
negotiation of the underwriting agreement and shall give consideration to the
reasonable suggestions of the Company regarding the form and substance thereof.
The Joint Stockholders shall be a party to such underwriting agreement. The
Joint Stockholders shall not be required to make any representations or
warranties to or agreements with the Company or the underwriters other than
representations, warranties or agreements regarding the Joint Stockholders, the
Joint
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<PAGE>
Stockholders' Registrable Securities, the Joint Stockholders' intended method of
distribution and any other representations or warranties required by law or
customarily given by selling shareholders in an Underwritten Public Offering or
as reasonably required by the managing underwriter of the Public Offering of
Registrable Securities.
2.4.2. Piggyback Underwritten Offerings. If the Company proposes
--------------------------------
to register any of its securities under the Securities Act as contemplated by
Section 2.2 and such securities are to be distributed by or through one or more
underwriters, subject to the other provisions of Section 2.2.2 the Company
shall, if requested by the Joint Stockholders such underwriters to include all
the Registrable Securities to be offered and sold by the Joint Stockholders
among the securities of the Company to be distributed by such underwriters. The
Joint Stockholders shall become a party to the underwriting agreement negotiated
between the Company and such underwriters. The Joint Stockholders shall not be
required to make any representations or warranties to or agreements with the
Company or the underwriters other than representations, warranties or agreements
regarding the Joint Stockholders, the Joint Stockholders' Registrable Securities
and the Joint Stockholders' intended method of distribution or any other
representations or warranties required by law or customarily given by selling
shareholders in an underwritten Public Offering or as reasonably required by the
managing underwriter of the Public Offering of Registrable Securities.
2.4.3. Holdback Agreements.
-------------------
(i) In connection with any underwritten offering of
securities registered under the Securities Act, including the Initial Public
Offering, each Joint Stockholder agrees, for the benefit of the Company and the
underwriters of an Initial Public Offering, without the prior written consent of
Careside, that he or it will not, during the period commencing on the date the
registration statement is first filed with the Commission and ending one year
after the date of the final prospectus relating to such offering, (i) 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, lend, or otherwise transfer or dispose of, directly or indirectly,
shares of Common Stock which are currently owned (beneficially or of record) by
it, any other shares of Common Stock as to which record or beneficial ownership
may hereafter be acquired by him or it, or any securities convertible into or
exercisable or exchangeable for Common Stock, or (ii) enter into any swap or
other arrangement that transfers to another, in whole or in part, any of the
economic consequences of ownership of the Common Stock, whether any such
transaction described in clause (i) or (ii) above is to be settled by delivery
of Common Stock or other securities, in cash or otherwise. The foregoing
sentence shall not apply to (A) the transfer of shares of Common Stock or other
securities by a Joint Stockholder as a gift or gifts, and (B) the transfer of
shares of Common Stock or other securities of Careside by a Joint Stockholder to
his or its affiliates, as such term is defined in Rule 405 under the Securities
Act; provided, that, in the case of clause (A) or (B) above, the recipient(s),
donee(s) or transferee(s), respectively, agrees in writing as a condition
precedent to such issuance, gift or transfer to be bound by an agreement setting
forth the terms of this Agreement.
(ii) If any registration of Registrable Securities shall
be in connection with an underwritten Public Offering, the Company agrees (x) if
required by the underwriter or underwriters, not to effect any public sale or
distribution of any of its equity securities or of any security convertible into
or exchangeable or exercisable for any equity security of the Company (other
than in connection with any employee stock option or other benefit plan which
has been duly adopted by the Company and which provides for the distribution to
participants in the plan of equity securities of the Company or securities
convertible or exchangeable or exercisable for equity securities of the Company,
or in connection with a merger or acquisition approved by the Board of Directors
of the Company) during the
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<PAGE>
Holdback Period, or such shorter period as the managing underwriter of such
Public Offering shall reasonably require, beginning on the effective date of
such registration statement (except as part of such registration) and (y) that
any agreement entered into after the date of this Agreement pursuant to which
the Company issues or agrees to issue any privately placed equity securities
shall contain a provision under which holders of such securities agree that, if
required by the underwriter or underwriters, they will not effect any public
sale or distribution of any such securities during the period referred to in the
foregoing clause (x), including any sale pursuant to Rule 144 under the
Securities Act (except as part of such registration, if permitted), if such
holder is participating in the Public Offering pursuant to such registration.
2.5. Preparation: Reasonable Investigation. In connection with the
--------------------------------------
preparation and filing of any registration statement under the Securities Act in
which the Joint Stockholders are or may be a selling shareholder, the Company
shall give the Joint Stockholders not less than 30 days prior written notice of
the preparation of such registration statement and give the Joint Stockholders
and its counsel and accountants the opportunity to participate, at the Joint
Stockholders' expense, in the preparation of such registration statement, each
prospectus included therein or filed with the Commission, and each amendment
thereof or supplement thereto @provided that the Joint Stockholders shall
furnish the Company with comments on any such amendment or supplement as
promptly as the Company shall reasonably require), and give each of them such
access to its books and records, such opportunities to discuss the business of
the Company with officers and the independent public accountants who have
certified its financial statements as shall be necessary, in the opinion of the
Joint Stockholders' counsel, to conduct a reasonable investigation within the
meaning of the Securities Act. Any expenses incurred by the Joint Stockholders
in connection with any such investigation shall be borne by the Joint
Stockholders other than the reasonable fees and disbursements of Selling
Stockholder Counsel incurred in connection with such investigation.
2.6. Indemnification.
---------------
2.6.1. Indemnification by the Company. In the event of any
------------------------------
registration of any securities of the Company under the Securities Act in which
the Joint Stockholders are selling shareholders, the Company shall, and hereby
does, indemnify and hold harmless, in the case of any registration statement
filed pursuant to Sections 2.1 or 2.2, the Participating Holders, its directors,
officers, employees, agents and affiliates and, to the extent required by any
underwriting agreement entered into by the Company, each other Person who
participates as an underwriter in the Public Offering or sale of such securities
and each other Person who controls a Participating Holder or any such
underwriter within the meaning of the Securities Act, insofar as losses, claims,
damages, or liabilities (or actions or proceedings, whether commenced or
threatened, in respect thereof) arise out of or are based upon (a) any untrue
statement or alleged untrue statement of any fact contained in any registration
statement under which such securities were registered under the Securities Act,
any preliminary prospectus, final prospectus, or summary prospectus contained
therein, or any amendment or supplement thereto, or any omission or alleged
omission to state therein a fact required to be stated therein or necessary to
make the statements therein in light of the circumstances in which thy were made
not misleading,
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<PAGE>
(b) any violation by the Company, its directors, officers, employees or agents
of this Agreement or any law applicable to and in connection with such
registration, and the Company shall reimburse the Joint Stockholders and each
such director, officer, agent or affiliate and, to the extent required by an
underwriting agreement entered into by the Company, any underwriter and
controlling Person for any legal or any other expenses reasonably incurred by
them in connection with investigating or defending any such loss, claim,
liability, action or proceeding described in clauses (a) and (b); provided,
however, that the Company shall not be liable in any such case to the extent
that any such loss, claim, damage, liability (or action or proceeding in respect
thereof) or expense arises out of or is based upon an untrue statement or
alleged untrue statement or omission or alleged omission made in such
registration statement, any such preliminary prospectus, summary prospectus,
amendment or supplement in reliance upon and in conformity with written
information furnished to the Company through an instrument duly executed by the
Participating Holders, specifically stating that it is for use in the
preparation thereof. Such indemnity shall remain in full force and effect
regardless of any investigation made by or on behalf of the Participating
Holders or any such director, officer, agent or affiliate or controlling Person
and shall survive the transfer of such securities by the Participating Holders.
2.6.2. Indemnification by the Joint Stockholders. If any Registrable
-----------------------------------------
Securities are included in any registration statement, the Participating Holders
shall indemnify and hold harmless (in the same manner and to the same extent as
set forth in Section 2.6.1 above) the Company, each director of the Company,
each officer of the Company and each employee of the Company and, to the extent
required by any underwriting agreement entered into by the Participating
Holders, each other Person who participates as an underwriter in the Public
Offering or sale of such securities and each other Person who controls any such
underwriter within the meaning of the Securities Act, with respect to any
statement or alleged statement in or omission or alleged omission from such
registration statement, any preliminary prospectus, final prospectus or summary
prospectus contained therein, or any amendment or supplement thereto, if such
statement or alleged statement or omission or alleged omission was made in
reliance upon and in conformity with written information furnished to the
Company through an instrument duly executed by the Participating Holders
specifically stating that it is for use in the preparation of such registration
statement, preliminary prospectus, final prospectus, summary prospectus,
amendment or supplement; provided, however, in no event shall the liability of
any Stockholder under this Section 2.6.2. exceed the proceeds obtained by the
sale of such Stockholder's Shares in any such registration.
2.6.3. Notice of Claims, Etc. Promptly after receipt, by an
---------------------
indemnified party of notice of the commencement of any action or proceeding
involving a claim referred to in the preceding paragraphs of this Section 2.6,
such indemnified party shall, if a claim in respect thereof is to be made
against an indemnifying party, immediately give written notice to the latter of
the commencement of such action; provided, however, that the failure of any
indemnified party to give notice as provided herein shall not relieve the
indemnifying party of its obligations under the preceding paragraphs of this
Section 2.6, except to the extent that the indemnifying party is materially
prejudiced by such failure. The indemnified party shall be entitled to receive
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<PAGE>
the indemnification payments described in Section 2.6.6 after providing such
written notice to the indemnifying party. In case any such action is brought
against an indemnified party, unless in such indemnified party's reasonable
judgment a conflict of interest between such indemnified and indemnifying
parties may exist in respect of such claim, the indemnifying party shall be
entitled to participate in and to assume the defense thereof, jointly with any
other indemnifying party similarly notified to the extent that the indemnifying
parties may agree, with counsel reasonably satisfactory to such indemnified
party, and after notice from the indemnifying party to such indemnified party of
its election so to assume the defense thereof, the indemnifying party shall not
be liable to such indemnified party for any legal or other expenses subsequently
incurred by the latter in connection with the defense thereof other than
reasonable out of pocket costs related to the indemnified party's cooperation
with the indemnifying party, unless in such indemnified party's reasonable
judgment a conflict of interest between such indemnified and indemnifying
parties arises in respect of such claim after the assumption of the defense
thereof. No indemnifying party shall be liable for any settlement of any action
or proceeding effected without its written consent, which shall not be
unreasonably withheld, delayed or conditioned. Consent of the indemnified party
shall be required for the entry of any judgment or to enter into a settlement
only when such judgment or settlement does not include as an unconditional term
thereof the giving by the claimant or plaintiff to such indemnified party of a
release from all liability in respect such claim or litigation.
2.6.4. Contribution. If the indemnification provided for in this
------------
Section 2.6 shall for any reason be held by a court to be unavailable to an
indemnified party under Section 2.6.1 or 2.6.2 hereof in respect of any loss,
claim, damage or liability, or any action in respect thereof, then, in lieu of
the amount paid or payable under Sections 2.6.1 or 2.6.2 hereof, the indemnified
party and the indemnifying party under Sections 2.6.1 or 2.6.2 hereof shall
contribute to the aggregate losses, claims, damages and liabilities (including
legal or other expenses reasonably incurred in connection with investigating the
same), (i) in such proportion as shall be appropriate to reflect the relative
benefits received by the Company on one hand and the Joint Stockholders on the
other or (ii) if the allocation provided by clause (i) above is not permitted by
applicable law, in such proportion as is appropriate to reflect the relative
fault of the Company on one hand and the Joint Stockholders on the other that
resulted in such loss, claim, damage or liability, or action in respect thereof,
as well as any other relevant equitable considerations. No Person guilty of
fraudulent misrepresentation (within the meaning of the Securities Act) shall be
entitled to contribution from any Person who was not guilty of such fraudulent
misrepresentation. In addition, no Person shall be obligated to contribute
hereunder any amounts in payment for' any settlement of any action or claim,
effected without such Person's written consent, which consent shall not be
unreasonably withheld; provided, however, in no event shall the liability of any
Stockholder under this Section 2.6.4. exceed the proceeds obtained by the sale
of such Stockholder's Shares in any such registration.
2.6.5. Other Indemnification. Indemnification and contribution
---------------------
similar to that specified in the preceding paragraphs of this Section 2.6 (with
appropriate modifications) shall be given by the Company and the Participating
Holders with respect to any required
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<PAGE>
registration or other qualification of securities under any federal or state law
or regulation of any governmental authority other than the Securities Act.
3. Rule 144. With a view to making available the benefits of certain
--------
rules and regulations of the Commission that may permit the sale of the
Registrable Securities to the public without registration after an initial
Public Offering, the Company agrees to:
(a) provide information and such other assistance requested by
the Joint Stockholders as is customarily provided by issuers in connection with
sales of their common stock by directors or affiliates under Rule 144,
promulgated under the Securities Act;
(b) make and keep public information available, as those terms
are understood and defined in Rule 144 promulgated under the Securities Act at
all times;
(c) use its best efforts to file with the Commission in a timely
manner all reports and other documents required of the Company under the
Securities Act and the Exchange Act; and
(d) deliver a written statement as to whether it has complied
with such requirements of this Section, to the Joint Stockholders upon the Joint
Stockholders' request.
4. Remedies.
--------
(a) If the Company fails for any reason (other than reasons
relating to acts or omissions of any Shareholder) to register a Stockholder's
Registrable Securities subject and pursuant to the terms and conditions of this
Agreement, then, at the election of the Company, the Company shall (i) to the
extent of funds legally available therefor ("Available Funds"), repurchase all
of the Registrable Securities owned by all such Joint Stockholders for an amount
per share equal to the sum of the average of the appraised values of the Common
Stock (which shall not include any discount for minority interest) calculated by
each of two independent appraisal firms, one of which shall be selected by the
Placement Agent and the other of which shall be selected by the Company (the
"Fair Market Value"), or (ii) provide such Joint Stockholders with the rights
set forth in subsection (b) below. If the Company elects to purchase Registrable
Securities pursuant to clause (i) above and the aggregate Fair Market Value of
the Registrable Securities to be repurchased by the Company is greater than the
amount of Available Funds, then the number of Registrable Securities that the
Company shall so repurchase from each such Stockholder shall equal the product
obtained by multiplying the Available Funds by a fraction, the numerator of
which is the number of Registrable Securities owned by such Stockholder and the
denominator of which is the total number of Registrable Securities owned by such
Joint Stockholders.
(b) If the Company elects not to repurchase all of the
Registrable Securities which may be purchased pursuant to subsection (a) above,
then any Joint Stockholders
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<PAGE>
who thereafter continue to own shares of Common Stock and whose Registrable
Securities have not been registered shall have the right to nominate a majority
of the Board of Directors of the Company (including the right to remove
directors as necessary to create vacancies for the election of such nominees),
and the former partners of Exigent Partners, L.P., W. Vickery Stoughton and
Thomas H. Grove (the "Management Stockholders") hereby agree to vote their
shares of Common Stock, and the Company will cause any future purchaser of 5% or
more of the Common Stock of the Company to vote such shares of Common Stock, in
favor of the directors nominated by such Joint Stockholders at any meeting of
stockholders or pursuant to any written consent in which the election of
directors is submitted to the vote of the Company's stockholders (and to remove
directors as necessary to create vacancies therefor). The Company shall take all
steps necessary to cause a meeting of the Company's stockholders for the purpose
of effecting the foregoing. The obligations of the Partnership and the
Management Stockholders under this Section 5(b) shall terminate upon the earlier
of (i) the redemption of each such Stockholder's Registrable Securities or (ii)
the registration of each such Joint Stockholder's Registrable Securities. Upon
the termination of all the Joint Stockholder's rights set forth in this
subsection (b), all members of the Board of Directors of the Company who were
nominated and elected pursuant to the provisions of this subsection (b) shall,
immediately resign from the Board of Directors and the Company may remove any
such directors. The remaining members of the Board of Directors of the Company
are hereby authorized to fill any vacancies created as a result of any such
resignation or removal.
(c) For purposes of this Section 5, any Stockholder's Registrable
Securities shall be deemed to be so registered if such Stockholder elects not to
include his Registrable Securities in any registration statement in which such
Registrable Securities are eligible to be included pursuant to this Agreement.
(d) If Available Funds are insufficient to allow the Company to
repurchase all such Registrable Securities, each of the Management Stockholders,
the former partners of the Exigent Partners, L.P. and the Investors shall
perform such acts, execute such instruments, and vote his or its shares in such
manner as may be necessary to increase such surplus to an amount sufficient to
authorize such purchase, including but not limited to the following: (i) a
recapitalization of the Company so as to reduce its stated capital and increase
its surplus and (ii) a reappraisal of the Company's assets (including goodwill,
if any) to reflect the market value of such assets, in the event such value
exceeds the book value thereof.
(e) The rights of the Joint Stockholders pursuant to this Section
5 shall be in addition to all other rights and remedies that such Joint
Stockholders may have hereunder or at law or otherwise.
5. Modification: Waivers. This Agreement may be modified or amended
----------------------
only with the written consent of the Company and the holders of a majority of
the Registrable Securities. No party shall be released from its obligations
hereunder without the written consent of the Company and the holders of at least
a majority of the Registrable Securities. The observance of
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<PAGE>
any term of this Agreement may be waived (either generally or in a particular
instance and either retroactively or prospectively) by the party entitled to
enforce such term but any such waiver shall be effective only if in a writing
signed by the party against which such waiver is to be asserted. Except as
otherwise specifically provided herein, no delay on the part of any party hereto
in exercising any right, power or privilege hereunder shall operate as a waiver
thereof, nor shall any waiver on the part of any party hereto of any right,
power or privilege hereunder operate as a waiver of any other right, power or
privilege hereunder nor shall any single or partial exercise of any right, power
or privilege hereunder preclude any other or further exercise thereof or the
exercise of any right, power or privilege hereunder.
6. Entire Agreement. This Agreement represents the entire understanding
----------------
and agreement between the parties hereto with respect to the subject matter
hereof and supersedes all other prior agreements and understandings, both
written and oral, between the par-ties with respect to the subject matter
hereof.
7. Severability. If any provision of this Agreement, or the application
------------
of such provision to any Person or circumstance, shall be held invalid, the
remainder of this Agreement or the application of such provision to other
Persons or circumstances, to the extent permitted by law, shall not be affected
thereby; provided, that the parties shall negotiate in good faith with respect
to an equitable modification of the provision or application thereof held to be
invalid.
8. Notices.
-------
(a) Any notice or communication to any party hereto shall be duly
given if in writing and delivered in person, receipt requested, or courier
guaranteeing next day delivery, or facsimile (with written confirmation of
receipt) to such other party's address or facsimile number facsimile set forth
below.
If to EXIGENT DIAGNOSTICS, INC. or a MANAGEMENT STOCKHOLDER:
6100 Bristol Parkway
Culver City, CA 90230
Attention: W. Vickery Stoughton
Facsimile: 310-338-6789
with a copy to:
James D. Epstein, Esquire
Pepper Hamilton LLP
3000 Two Logan Square
Philadelphia, PA 19103-2799
Facsimile: 215-981-4750
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<PAGE>
If to the Partnership:
c/o Spencer Trask Securities Incorporated
535 Madison Avenue - 18th Floor
New York, New York 10022
Attention: Mr. Kevin Kimberlin
Facsimile: 212-751-3483
with a copy to:
John D. Vaughan, Esquire
Hertzog, Calamari & Gleason
100 Park Avenue
New York, New York 10017
Facsimile: 212-213-1199
If to a Stockholder, to such address set forth on the Stockholder's
signature page hereto, or if to an assignee or successor of a Stockholder, to
such address appearing in the records of the Company.
(b) All notices and communications shall be deemed to have been
duly given: at the time delivered by hand, if personally delivered or telecopied
(with written confirmation of receipt); and the next business day after timely
delivery to the courier, if sent by courier guaranteeing next day delivery.
9. Successors and Assigns. This Agreement shall inure to the benefit of
----------------------
and shall be binding upon the Company and the Joint Stockholders and their
respective successors and permitted assigns. Each Stockholder may assign its
rights under this Agreement to any Person to whom the Stockholder transfers any
of the Registrable Securities or any interest therein without the necessity of
obtaining any consent to such assignment, provided that such Person becomes a
party to that certain stockholders agreement, by and among the Company, the
Joint Stockholders and certain other holders of the Common Stock. In the event
that a Stockholder assigns its rights to a holder or holders of only a portion
of the Registrable Securities, then all references to the Stockholder herein
shall also be deemed to refer to such other holder or holders, but in such event
the Stockholder shall have the sole right to make all decisions by and give
notices for such holder or holders under this Agreement; provided, that if the
Stockholder no longer owns any Registrable Securities, then all decisions and
notices hereunder shall be made by the holders of not less than a majority of
the Registrable Securities outstanding and all other holders of Registrable
Securities shall be bound by any such decision.
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<PAGE>
10. Counterparts. This Agreement may be executed in two or more
------------
counterparts, each of which for all purposes shall be deemed to be an original
and all of which together shall constitute the same agreement.
11. Headings. The Section headings in this Agreement are for convenience
--------
of reference only, and shall not be deemed to alter or affect the meaning or
interpretation of any provisions hereof.
12. Construction. This Agreement shall be governed, construed and
------------
enforced in accordance with the laws of the State of New York without regard to
its principles of conflict of laws.
13. No Inconsistent Agreements. The Company has not previously, and shall
--------------------------
not hereafter, enter into any agreement with respect to its securities which is
inconsistent with the rights granted to the Joint Stockholders in this
Agreement.
14. Recapitalization, Etc. In the event that any capital stock or other
----------------------
securities are issued in respect of, in exchange for, or in substitution of, any
Registrable Securities by reason of any reorganization, recapitalization,
reclassification, merger, consolidation, spin-off, partial or complete
liquidation, stock dividend, split-up, sale of assets, distribution to
stockholders or combination of the shares of Registrable Securities or any other
similar change in the Company's capital structure, appropriate adjustments shall
be made in this Agreement so as to fairly and equitably preserve, as far as
practicable, the original rights and obligations of the parties hereto under
this Agreement.
15. Specific Performance. The parties hereto agree that the Registrable
--------------------
Securities of the Company cannot be purchased or sold in the open market and
that, for these reasons, among others, the holder or holders of the Registrable
Securities will be irreparably damaged in the event that this Agreement is not
specifically enforceable. The rights granted in this Section 16 shall be
cumulative and not exclusive, and shall be in addition to any and all other
rights which the parties hereto may have hereunder, at law or in equity. The
Company and the Joint Stockholders consent to the jurisdiction of the federal
courts in the City of New York in any suit, action or proceeding brought
pursuant to this Section 16, waives any objection it may have to the laying of
venue in any such suit, action or proceeding in any of such court, and agrees
that service of any court paper may be made in such manner as may be provided
under applicable laws or court rules governing service of process.
16. Term. This Agreement shall continue in full force and effect with
----
respect to any Stockholder for nine (9) years from the Final Closing (as defined
in the Memorandum), or the first date on which the such Stockholder and their
affiliates may sell all of the Securities held by them in a ninety (90) day
period pursuant to Rule 144 under the Securities Act.
17. Appointment of Agent. In connection with any Initial Public Offering,
--------------------
the holders of Registrable Securities appoint the Placement Agent to act as
their agent and attorney-
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<PAGE>
in-fact to negotiate with the Company and the underwriters for the Initial
Public Offering the terms and conditions of the holdback agreements of the
holders of Registrable Securities as they relate to the Initial Public Offering
(including, but not limited to, the length of the Holdback Period, and the other
rights of such holders of Registrable Securities to sell their Registrable
Securities), and to execute and deliver any and all documents, and to take any
and all actions, in the name and on behalf of the holders of Registrable
Securities, as may be necessary or appropriate, in the judgment of the Placement
Agent, to confirm any agreements reached relating to the subject matter
described in this Section 17.
18. Termination of Prior Registration Agreement. The execution and
-------------------------------------------
delivery of this Agreement shall automatically terminate the Prior Agreement
which, thereupon, shall no longer be in force or effect and no party thereto
shall have any rights or obligations thereunder; provided that with respect to
those stockholders which purchased shares of Common Stock in the Prior Offering
and which have not consented to the amendment of the Prior Agreement, the
termination of the Prior Agreement shall be null and void. As a result of the
termination of the
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<PAGE>
Prior Agreement, the registration rights of the Joint Stockholders shall be
governed exclusively by the terms and conditions of this Agreement.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed on the date first above written and delivered by their respective duly
authorized officers.
EXIGENT DIAGNOSTICS, INC.
By: /s/ Vickery Stoughton
--------------------------------
W. Vickery Stoughton
Chairman and Chief Executive Officer
As to Section 5 only:
/s/ Kevin Kimberlin
-----------------------------------
Kevin Kimberlin
/s/ Vickery Stoughton
-----------------------------------
W. Vickery Stoughton
/s/ Thomas Grove
-----------------------------------
Thomas H. Grove
As to Section 18 only:
On behalf of the Stockholders under the Prior
Agreement
By: Spencer Trask Securities Incorporated
Attorney-in-Fact
By: /s/ William Dioguardi
-------------------------
William P. Dioguardi
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<PAGE>
STOCKHOLDER SIGNATURE PAGE
TO REGISTRATION RIGHTS AGREEMENT
IN WITNESS WHEREOF, the undersigned has executed this Agreement as of
_________ __, 1998.
If the Holder is an INDIVIDUAL:
______________________________
Print Name
______________________________
Signature
______________________________
______________________________
Print Address
If the Holder is a PARTNERSHIP,
CORPORATION or a TRUST:
______________________________
Name of Partnership, Corporation or Trust
By:___________________________
Signature
Print Name:______________
Print Title:_____________
______________________________
______________________________
Print Address
Accepted and agreed to this
____ day of _______________, 199_
EXIGENT DIAGNOSTICS, INC.
By:___________________________
W. Vickery Stoughton
Chairman & CEO
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