Exhibit 10.1


 


TWELFTH
AMENDMENT AND CONSENT TO SECOND AMENDED AND RESTATED CREDIT AGREEMENT


 


THIS TWELFTH
AMENDMENT AND CONSENT TO SECOND AMENDED AND RESTATED CREDIT AGREEMENT, dated as
of March 15, 2005 (this “Amendment”), to the Second Amended and
Restated Credit Agreement, dated as of September 30, 2003 (as amended,
supplemented or otherwise modified from time to time, the “Credit Agreement”),
by and among General Electric Capital Corporation, as Agent and Lender (“Agent”),
Inverness Medical Innovations, Inc. (“Innovations”), Wampole
Laboratories, Inc. and Inverness Medical (UK) Holdings Limited, as borrowers (“Borrowers”),
the other Credit Parties signatory thereto, Merrill Lynch Capital, a division
of Merrill Lynch Business Financial Services Inc., as documentation agent,
co-syndication agent and lender, UBS Securities LLC, as co-syndication agent,
and the lenders signatory thereto from time to time (collectively, the “Lenders”).


 


W  I
T  N  E  S  S  E  T  H


 


WHEREAS,
Borrowers have notified Agent that Inverness Medical Innovations, Inc., a
Delaware corporation (“Innovations”), through a newly formed
wholly-owned subsidiary (“Binax Newco”), desires to acquire one hundred
percent (100%) of the issued and outstanding stock of Binax, Inc., a Delaware
corporation (“Binax”), by way of a merger (the “Binax Merger”)
into Binax Newco in exchange for consideration (the “Binax Closing Date
Consideration”) of $8,600,000 in cash and 1,433,333 shares of Stock of
Innovations, pursuant to which merger Binax Newco shall be the surviving
entity;


 


WHEREAS, in
addition to the Binax Closing Date Consideration, under the terms of that
certain Agreement and Plan of Merger, dated February 8, 2005, by and among
Innovations, Binax, Binax Newco and the other parties listed on the signature pages
thereto (the “Binax Merger Agreement”), Innovations shall be required to
pay the Contingent Cash Consideration (as defined in the Binax Merger
Agreement) of up to $11,000,000 at such time, if any, as the conditions to such
payment have been met as set forth in the Binax Merger Agreement;


 


WHEREAS, the
Binax Merger is not a Permitted Acquisition and therefore is prohibited under Section 6.1
of the Credit Agreement;


 


WHEREAS, the
formation of Binax Newco (the “Binax Newco Formation”) is prohibited
under Section 6.1 of the Credit Agreement;


 


WHEREAS, the
issuance of Stock of Innovations (the “Binax Stock Issuance”) as
contemplated by the Binax Merger Agreement is prohibited under Section 6.5
of the Credit Agreement;


 


WHEREAS,
Borrowers have requested that Agent and Requisite Lenders consent to the Binax
Merger, Binax Newco Formation and the Binax Stock Issuance on the terms and
subject to the conditions set forth herein;


 


WHEREAS,
Borrowers have notified Agent that Innovations, through a newly formed wholly-owned
subsidiary (“Ischemia Newco”), desires to acquire one hundred percent


 


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(100%) of the issued and
outstanding stock of Ischemia Technologies, Inc.., a Delaware corporation (“Ischemia”),
by way of a merger (the “Ischemia Merger”) with and into Ischemia Newco
in exchange for consideration (the “Ischemia Closing Date Consideration”)
of approximately 968,482 shares of Stock of Innovations and the payment of
certain obligations of Ischemia in an amount not to exceed $4,000,000, pursuant
to which merger Ischemia shall be the surviving entity;


 


WHEREAS, the Ischemia
Merger is not a Permitted Acquisition and therefore is prohibited under Section 6.1
of the Credit Agreement;


 


WHEREAS, the
formation of Ischemia Newco (the “Ischemia Newco Formation”) is
prohibited under Section 6.1 of the Credit Agreement;


 


WHEREAS, the
issuance of Stock of Innovations (the “Ischemia Stock Issuance”) as
contemplated by that certain Agreement and Plan of Merger, dated as of February 15,
2005, by and among Innovations, Ischemia Newco and Ischemia (the “Ischemia
Merger Agreement”) is prohibited under Section 6.5 of the
Credit Agreement;


 


WHEREAS,
Borrowers have requested that Agent and Requisite Lenders consent to the Ischemia
Merger, Ischemia Newco Formation and the Ischemia Stock Issuance on the terms
and subject to the conditions set forth herein;


 


WHEREAS,
notwithstanding the definition of EBITDA as contained in the Credit Agreement
as amended by Paragraph 2 below, Agent and Requisite Lenders have agreed that the
proceeds of that certain judgment in an amount equal to $8,429,705.60 (the “IMN
Settlement Proceeds”) received by IVC Industries, Inc. during the Fiscal
Quarter ended March 31, 2005 from Merk, Sumitomo, Tanabe, Reilly, Lonza,
Degussa and Nepera  in connection with
the Vitamin Products Settlement shall not be required to be subtracted from the
consolidated net income of the Reporting Credit Parties; and


 


WHEREAS, Agent
and Requisite Lenders have agreed to amend the Credit Agreement in the manner,
and on the terms and conditions, provided for herein.


 


NOW THEREFORE,
in consideration of the premises and for other good and valuable consideration,
the receipt, adequacy and sufficiency of which are hereby acknowledged, the
parties hereto agree as follows:


 


1.                                       Definitions.  Capitalized terms not otherwise defined
herein shall have the meanings ascribed to them in the Credit Agreement.


 


2.                                       Amendment to Credit Agreement.  Annex
A of the Credit Agreement is hereby amended as of the Effective Date (as
hereinafter defined) by adding the following to the end of the definition of “EBITDA”:


 


“For purposes of clarifying clause
(b)(iii) of this definition, “gains from extraordinary items” shall include
any amounts realized by any Person during any fiscal period that are not
generated by the operation of such Person’s business in the ordinary course, as
well as any judgments, settlements, proceeds or other


 


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consideration derived, by
such Person during such fiscal period, from any claim, counterclaim,
cross-claim or other cause of action of any kind or nature whatsoever, except
to the extent that such judgments, settlements, proceeds or other consideration
either (A) do not in the aggregate exceed the aggregate amount of legal fees
and costs incurred by such Person during the 24-month period ending with such
fiscal period in connection with the prosecution of such claims, counterclaims,
cross-claims or other causes of action or (B) represent the recovery of items
that would otherwise have been included in consolidated net income of that
Person had a third party not breached or defaulted on its obligations to such
Person.”


 


3.                                       Consent
Regarding IMN Settlement Proceeds. 
Agent and Requisite Lenders agree that, notwithstanding the terms of the
Credit Agreement and to the extent such amounts are included in consolidated
net income, Borrowers shall not be required to subtract the IMN Settlement
Proceeds from the consolidated net income of the Reporting Credit Parties for
purposes of determining EBITDA of the Reporting Credit Parties.


 


4.                                       Binax
Consent.  As of the Effective Date
(as hereinafter defined), Agent and Requisite Lenders (a) consent to the Binax
Newco Formation and the consummation of the Binax Merger and the Binax Stock
Issuance in accordance with the Binax Merger Agreement and related
documentation previously provided to and approved by Agent (the “Draft Binax
Merger Documents”), and (b) agree that none of the Binax Newco Formation,
the consummation of the Binax Merger or the Binax Stock Issuance on or before April 15,
2005, in each case in accordance with the Draft Binax Merger Documents, shall
constitute a breach of the Credit Agreement, provided, however,
that the consents and agreements of Agent and Requisite Lenders set forth above
are expressly conditioned on satisfaction of all of the following conditions in
Agent’s reasonable discretion, and the Borrowers and the other Credit Parties
hereby covenant and agree as follows:


 


(i)                                     that
the Credit Parties do not expend any cash in connection with the Binax Merger,
the Binax Newco Formation or the Binax Stock Issuance other than (x) for costs
and expenses not to exceed $500,000 in the aggregate and (y) pursuant to the
Binax Merger Agreement, cash payments to current stockholders of Binax, which
shall not exceed (1) $8,600,000 on or about the date the Binax Merger is
consummated plus (2) the required withholding amount pursuant to section 2.7
of the Binax Merger Agreement in an amount not to exceed $500,000 plus (3) the
amount of the Contingent Cash Consideration as identified in the Binax Merger
Agreement at the time the conditions to the payment of the Contingent Cash
Consideration (or a portion thereof) have been met under the Binax Merger Agreement;
and


 


(ii)                                  the
noncash consideration payable by the Credit Parties in connection with the
Binax Merger shall be limited to the issuance of Stock of Innovations pursuant
to the Binax Stock Issuance.


 


5.                                       Agreement
by Borrowers and Other Credit Parties Regarding Binax Merger.  The Borrowers and each of the other Credit
Parties hereby acknowledge and agree that, on or prior to the effective date of
the Binax Merger (or on or prior to such other date as may be expressly
provided below):


 


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(a)                                  Satisfaction
of Conditions.  Agent shall have
received evidence satisfactory to Agent that each of the conditions precedent
to a Permitted Acquisition set forth in Section 6.1(ii) – (xi) of
the Credit Agreement have been satisfied in connection with the Binax Merger
(other than the conditions set forth in Sections 6.1(v) and 6.1(ix),
which are hereby waived).


 


(b)                                 Guaranty
and Joinder.  Agent shall have
received a guaranty and joinder agreement, in form and substance satisfactory
to Agent, duly executed by Binax Newco pursuant to which, inter  alia,
Binax Newco joins the Credit Agreement and the other Loan Documents as a US
Credit Party and agrees to guaranty the Obligations of the Credit Parties under
the Loan Documents.


 


(c)                                  Security
Interest and Code Filings.  


 


(i)                                     Binax
Newco shall have granted a valid first priority perfected security interest
(subject to Permitted Encumbrances) in all of its assets to secure the
Obligations of the Credit Parties and shall have executed or authorized (as
applicable) all documents (including financing statements under the Code (or
foreign equivalent) and other applicable documents under the laws of any
jurisdiction with respect to the perfection of Liens in form and substance
reasonably acceptable to Agent) as Agent may request in order to perfect its
security interest in such assets.


 


(ii)                                  Binax
Newco shall provide copies of Code (or the foreign equivalent thereof) search
reports listing all effective financing statements (or equivalent information)
that name Binax Newco or Binax as debtor, together with copies of such
financing statements (or equivalent information), none of which shall cover the
assets of Binax Newco or Binax.


 


(iii)                               Within
sixty (60) days of the effective date of the Binax Merger or such longer period
as Agent shall consent to in its sole discretion, Binax Newco shall provide
Control Letters from (A) all issuers of uncertificated securities and financial
assets held by Binax Newco, (B) all securities intermediaries with respect to
all securities accounts and securities entitlements of Binax Newco, and (C) all
futures commission agents and clearing houses with respect to all commodities
contracts and commodities accounts held by Binax Newco.


 


(d)                                 Waivers.  Within sixty (60) days of the effective date
of the Binax Merger or such longer period as Agent shall consent to in its sole
discretion, Agent, on behalf of Lenders, shall have received landlord waivers
and consents, bailee letters and mortgagee agreements in form and substance
reasonably satisfactory to Agent, in respect of Binax Newco; provided,
that a landlord waiver shall not be required with respect to that certain
property located at 217 Read Street,
Portland, ME 04103 so long as such premises is vacated within 120 days
following the effective date of the effective date of the Binax Merger.


 


(e)                                  Pledge
Amendment.  Agent shall have received
a pledge amendment to that certain Amended and Restated Pledge Agreement, dated
as of September 30, 2003, by and among Agent and the Credit Parties listed
on the signature pages thereto (as


 


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amended, restated,
supplemented or modified from time to time, the “Pledge Agreement”), in
form and substance satisfactory to Agent, duly executed by an authorized
officer of Innovations, pursuant to which Innovations pledges one hundred
percent (100%) of the issued and outstanding Stock of Binax Newco (the “Binax
Newco Stock”) to Agent, together with all collateral and ancillary
documentation required by the Pledge Agreement, including, without limitation,
original certificates representing the Binax Newco Stock pledged by Innovations
(with duly executed, undated assignments separate from certificates).


 


(f)                                    Cash
Management.  Within sixty (60) days
of the effective date of the Binax Merger or such longer period as Agent shall
consent to in its sole discretion, Agent shall have received tri-party blocked
account agreements, in form and substance reasonably satisfactory to Agent,
duly executed and delivered by Binax Newco and each bank where Binax Newco has
established a deposit or disbursement account (other than payroll accounts), in
accordance with the requirements set forth in Section 1.8 and Annex
C of the Credit Agreement; provided, that tri-party blocked account
agreements shall not be required to be delivered with respect to any deposit accounts
currently held by Binax at Key Bank National Association (“Key Bank”) so
long as (i) all amounts held in such account shall be swept to an account subject
to a tri-party blocked account over which Agent has control no less than 1 time
per week and (ii) any such deposit account held by Binax at Key Bank shall be
closed within 120 days of the effective date of the Binax Merger.  In addition, so long as any deposit account
remains open at Key Bank, Borrowers shall provide Agent with a copy of a
monthly statement from Key Bank showing activity in such account for such
month.


 


(g)                                 Schedules.  Agent shall have received updated Schedules
to the Credit Agreement, the Amended and Restated Security Agreement, dated as
of September 30, 2003, as amended from time to time, by and among Agent
that the Credit Parties listed on the signature page thereto, the Pledge
Agreement, the Amended and Restated Intellectual Property Security Agreement,
dated as of September 30, 2003, as amended from time to time, by and among
Agent and the Credit Parties listed on the signature page thereto, and such
other Loan Documents as may be required in connection with the joinder of Binax
Newco, to reflect the joinder of Binax Newco to such agreements, in form and
substance satisfactory to Agent.


 


(h)                                 Organizational
Documents and Good Standing.  Agent
shall have received a copy of each of Binax Newco’s and Binax’s (i)
organizational documents and all amendments thereto and (ii) good standing
certificates or the foreign equivalent and certificates of qualification to
conduct business in each jurisdiction where its ownership or lease of property
or the conduct of its business requires such qualification, each dated a recent
date and certified by the applicable authorized Governmental Authority.


 


(i)                                     Bylaws
and Resolutions.  Agent shall have
received a copy of (i) each of Binax Newco’s and Binax’s bylaws (or foreign
equivalent thereof) and all amendments thereto, (ii) resolutions of Binax Newco’s
and Binax’s board of directors and, to the extent required under applicable
law, stockholders, approving and authorizing the Binax Merger and the
execution, delivery and performance of the transaction documents to be executed
in connection with the Binax Merger, and (iii) resolutions of Binax Newco’s
board of directors approving and authorizing the execution, delivery and
performance of the Loan Documents to which Binax Newco is, or will be a party
and the transactions to be consummated in connection therewith,


 


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each certified by an
authorized officer of Binax Newco and Binax, as applicable, as being in full
force and effect without any modification or amendment as of the Effective
Date.


 


(j)                                     Incumbency.  Agent shall have received a signature and
incumbency certificate of the officers of Binax Newco, certified by an officer
of Binax Newco as being true, accurate, correct and complete in all respects.


 


(k)                                  Binax
Merger Documents.  Agent shall have
received executed copies of the Binax Merger Agreement, together with all
amendments thereto, and all documentation delivered in connection therewith
(all of which shall be in form and substance reasonably satisfactory to Agent),
certified by an authorized officer of Binax Newco to be true and complete and
in full force and effect as of the Effective Date.


 


(l)                                     Opinion
of Counsel.  Agent shall have
received legal opinions of counsel acceptable to Agent, which shall provide
(subject to customary qualifications) that (i) the Loan Documents have been
duly authorized, executed and delivered by, and are enforceable against Binax
Newco, (ii) that the Binax Merger was approved by all requisite corporate
action by Binax Newco and Binax, and (iii) such other opinions as Agent may
reasonably request, all in form and substance satisfactory to Agent.


 


(m)                               Collateral
Assignment of Binax Merger Documents. 
Upon Agent’s request, Agent shall have received a collateral assignment
of the rights (but not the obligations) of Innovations and/or Binax Newco under
the Binax Merger Agreement and other documentation executed in connection with
the Binax Merger.


 


(n)                                 Payment
of Indebtedness.  Borrowers shall
provide evidence satisfactory to Agent that
all of the obligations of Binax to Key Bank under (A) that certain Promissory
Note and Line of Credit Agreement between Binax and Key Bank dated July 20,
2004 and (B) under that certain Master Equipment Line of Credit and Promissory
Note between Binax and Key Bank National dated July 20, 2004, as well as
all related financing documentation as in effect immediately prior to the
Effective Date, will be performed and paid in full immediately upon
consummation of the Binax Merger and all Liens upon any of the property of
Binax or any other Credit Party in respect thereof shall have terminated
immediately upon such payment.


 


(o)                                 Appointment
of Agent for Service of Process. 
Agent shall have received evidence that the Connecticut office of CT
Corporation has been appointed as agent for service of process for Binax Newco.


 


The
Borrowers and each of the other Credit Parties hereby acknowledge and agree
that the failure to satisfy any of the deliveries or conditions set forth above
in this Section 5 on or prior to the date required as set forth above in
connection with each such delivery or condition, as applicable, shall
constitute an immediate Event of Default under the Credit Agreement.


 


6.                                       Ischemia
Consent.  As of the Effective Date,
Agent and Requisite Lenders (a) consent to the Ischemia Newco Formation and the
consummation of the Ischemia Merger and the Ischemia Stock Issuance in
accordance with the Ischemia Merger Agreement and related documentation
previously provided to and approved by Agent (the “Draft Ischemia Merger 


 


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Documents”),
and (b) agree that none of the Ischemia Newco Formation, the consummation of
the Ischemia Merger or the Ischemia Stock Issuance on or before April 15,
2005, in each case in accordance with the Draft Ischemia Merger Documents,
shall constitute a breach of the Credit Agreement, provided, however,
that the consents and agreements of Agent and Requisite Lenders set forth above
are expressly conditioned on satisfaction of all of the following conditions in
Agent’s reasonable discretion, and the Borrowers and the other Credit Parties
hereby covenant and agree as follows:


 


(i)                                     that
the Credit Parties do not expend any cash in connection with the Ischemia
Merger, the Ischemia Newco Formation or the Ischemia Stock Issuance other than
(x) for costs and expenses not to exceed $4,000,000 in the aggregate,; and


 


(ii)                                  the
noncash consideration payable by the Credit Parties in connection with the Ischemia
Merger shall be limited to the issuance of Stock of Innovations pursuant to the
Ischemia Stock Issuance.


 


7.                                       Agreement
by Borrowers and Other Credit Parties Regarding Ischemia Merger.  The Borrowers and each of the other Credit
Parties hereby acknowledge and agree that, on or prior to the effective date of
the Ischemia Merger (or on or prior to such other date as may be expressly
provided below):


 


(a)                                  Satisfaction
of Conditions.  Agent shall have
received evidence satisfactory to Agent that each of the conditions precedent
to a Permitted Acquisition set forth in Section 6.1(ii) – (xi) of
the Credit Agreement have been satisfied in connection with the Ischemia Merger
(other than the conditions set forth in Sections 6.1(vi) and 6.1(ix),
which are hereby waived.


 


(b)                                 Guaranty
and Joinder.  Agent shall have
received a guaranty and joinder agreement, in form and substance satisfactory
to Agent, duly executed by Ischemia pursuant to which, inter  alia,
Ischemia joins the Credit Agreement and the other Loan Documents as a US Credit
Party and agrees to guaranty the Obligations of the Credit Parties under the
Loan Documents.


 


(c)                                  Security
Interest and Code Filings.  


 


(i)                                     Ischemia
shall have granted a valid first priority perfected security interest (subject
to Permitted Encumbrances) in all of its assets to secure the Obligations of
the Credit Parties and shall have executed or authorized (as applicable) all
documents (including financing statements under the Code (or foreign
equivalent) and other applicable documents under the laws of any jurisdiction
with respect to the perfection of Liens in form and substance reasonably
acceptable to Agent) as Agent may request in order to perfect its security
interest in such assets.


 


(ii)                                  Ischemia
shall provide copies of Code (or the foreign equivalent thereof) search reports
listing all effective financing statements (or equivalent information) that
name Ischemia Newco or Ischemia as debtor, together with copies of such
financing statements (or equivalent information), none of which shall cover the
assets of Ischemia Newco or Ischemia.


 


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(iii)                               Within
sixty (60) days of the effective date of the Ischemia Merger or such longer
period as Agent shall consent to in its sole discretion, Ischemia shall provide
Control Letters from (A) all issuers of uncertificated securities and financial
assets held by Ischemia Newco, (B) all securities intermediaries with respect
to all securities accounts and securities entitlements of Ischemia Newco, and
(C) all futures commission agents and clearing houses with respect to all
commodities contracts and commodities accounts held by Ischemia.


 


(d)                                 Waivers.  Within sixty (60) days of the effective date
of the Ischemia Merger or such longer period as Agent shall consent to in its
sole discretion, Agent, on behalf of Lenders, shall have received landlord
waivers and consents, bailee letters and mortgagee agreements in form and
substance reasonably satisfactory to Agent, in respect of Ischemia; provided
that a landlord waiver shall not be required with respect to that certain
property located at 4600 West 60th Avenue, Denver CO 80003 so long as the
aggregate net book value of all assets held at such property at any time does
not exceed $750,000.


 


(e)                                  Pledge
Amendment.  Agent shall have received
a pledge amendment to that certain Amended and Restated Pledge Agreement, dated
as of September 30, 2003, by and among Agent and the Credit Parties listed
on the signature pages thereto (as amended, restated, supplemented or modified
from time to time, the “Pledge Agreement”), in form and substance
satisfactory to Agent, duly executed by an authorized officer of Innovations,
pursuant to which Innovations pledges one hundred percent (100%) of the issued
and outstanding Stock of Ischemia (the “Ischemia Stock”) to Agent,
together with all collateral and ancillary documentation required by the Pledge
Agreement, including, without limitation, original certificates representing
the Ischemia Stock pledged by Innovations (with duly executed, undated
assignments separate from certificates).


 


(f)                                    Cash
Management.  Within sixty (60) days
of the effective date of the Ischemia Merger or such longer period as Agent
shall consent to in its sole discretion, Agent shall have received tri-party
blocked account agreements, in form and substance reasonably satisfactory to
Agent, duly executed and delivered by Ischemia and each bank where Ischemia has
established a deposit or disbursement account (other than payroll accounts), in
accordance with the requirements set forth in Section 1.8 and Annex
C of the Credit Agreement; provided, that tri-party blocked account
agreements shall not be required to be delivered with respect to any bank
accounts currently held by Ischemia at Silicon Valley Bank, First National Bank
of Colorado or Silicon Valley Bank Securities so long as (i) the aggregate
value of all amounts held in any such accounts does not exceed $250,000 at any
time, and (ii) such accounts are closed within 10 Business Days of the date
that any checks written against such accounts on or before the effective date
of the Ischemia Merger have been deposited by the payee of such checks and such
checks have cleared.


 


(g)                                 Schedules.  Agent shall have received updated Schedules
to the Credit Agreement, the Amended and Restated Security Agreement, dated as
of September 30, 2003, as amended from time to time, by and among Agent
that the Credit Parties listed on the signature page thereto, the Pledge
Agreement, the Amended and Restated Intellectual Property Security Agreement,
dated as of September 30, 2003, as amended from time to time, by and among
Agent and the Credit Parties listed on the signature page thereto, and such
other Loan


 


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Documents as may be
required in connection with the joinder of Ischemia, to reflect the joinder of Ischemia
to such agreements, in form and substance satisfactory to Agent.


 


(h)                                 Organizational
Documents and Good Standing.  Agent
shall have received a copy of each of Ischemia Newco’s and Ischemia’s (i)
organizational documents and all amendments thereto and (ii) good standing
certificates or the foreign equivalent and certificates of qualification to
conduct business in each jurisdiction where its ownership or lease of property
or the conduct of its business requires such qualification, each dated a recent
date and certified by the applicable authorized Governmental Authority.


 


(i)                                     Bylaws
and Resolutions.  Agent shall have
received a copy of (i) each of Ischemia Newco’s and Ischemia’s bylaws (or
foreign equivalent thereof) and all amendments thereto, (ii) resolutions of Ischemia
Newco’s and Ischemia’s board of directors and, to the extent required under
applicable law, stockholders, approving and authorizing the Ischemia Merger and
the execution, delivery and performance of the transaction documents to be
executed in connection with the Ischemia Merger, and (iii) resolutions of Ischemia’s
board of directors approving and authorizing the execution, delivery and
performance of the Loan Documents to which Ischemia is, or will be a party and
the transactions to be consummated in connection therewith, each certified by
an authorized officer of Ischemia Newco and Ischemia, as applicable, as being
in full force and effect without any modification or amendment as of the
Effective Date.


 


(j)                                     Incumbency.  Agent shall have received a signature and
incumbency certificate of the officers of Ischemia, certified by an officer of Ischemia
as being true, accurate, correct and complete in all respects.


 


(k)                                  Ischemia
Merger Documents.  Agent shall have
received executed copies of the Ischemia Merger Agreement, together with all
amendments thereto, and all documentation delivered in connection therewith
(all of which shall be in form and substance reasonably satisfactory to Agent),
certified by an authorized officer of Ischemia to be true and complete and in
full force and effect as of the Effective Date.


 


(l)                                     Opinion
of Counsel.  Agent shall have
received legal opinions of counsel acceptable to Agent, which shall provide
(subject to customary qualifications) that (i) the Loan Documents have been
duly authorized, executed and delivered by, and are enforceable against Ischemia,
(ii) that the Ischemia Merger was approved by all requisite corporate action by
Ischemia Newco and Ischemia, and (iii) such other opinions as Agent may
reasonably request, all in form and substance satisfactory to Agent.


 


(m)                               Collateral
Assignment of Ischemia Merger Documents. 
Upon Agent’s request, Agent shall have received a collateral assignment
of the rights (but not the obligations) of Innovations and/or Ischemia under
the Ischemia Merger Agreement and other documentation executed in connection
with the Ischemia Merger.


 


(n)                                 Payment
of Indebtedness.  Borrowers shall
provide evidence satisfactory to Agent that all of the obligations of Ischemia
to Silicon Valley Bank will be performed and paid in full immediately
upon consummation of the Ischemia Merger and all


 


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Liens upon any of the
property of Ischemia or any other Credit Party in respect thereof shall have
terminated immediately upon such payment.


 


(o)                                 Appointment
of Agent for Service of Process. 
Agent shall have received evidence that the Connecticut office of CT
Corporation has been appointed as agent for service of process for Ischemia.


 


The
Borrowers and each of the other Credit Parties hereby acknowledge and agree
that the failure to satisfy any of the deliveries or conditions set forth above
in this Section 7 on or prior to the date required as set forth above in connection
with each such delivery or condition, as applicable, shall constitute an
immediate Event of Default under the Credit Agreement.


 


8.                                       Covenant.  The Credit Parties shall not amend the Draft
Binax Merger Documents, the executed Binax Merger Agreement, the Draft Ischemia
Merger Documents or the executed Ischemia Merger Agreement without the prior
written consent of Agent.  Any failure of
the Credit Parties to comply with this covenant (a) with respect to the Draft
Binax Merger Documents or the Draft Ischemia Merger Documents shall result in
this Amendment becoming immediately null and void and of no further force and
effect and (b) with respect to the Binax Merger Agreement or the Ischemia
Merger Agreement shall constitute an immediate Event of Default under the
Credit Agreement.


 


9.                                       Representations
and Warranties.  To induce Agent and
Requisite Lenders to enter into this Amendment, the Credit Parties hereby,
jointly and severally, represent and warrant that:


 


(a)                                  The
execution, delivery and performance by each Credit Party of this Amendment and
the performance of the Credit Agreement, as amended by this Amendment (the “Amended
Credit Agreement”): (i) are within such Person’s corporate, company or
partnership power; (ii) have been (or will be prior to execution thereof)
duly authorized by all necessary corporate, limited liability company or
limited partnership action; (iii) do not contravene any provision of such
Person’s charter, bylaws or equivalent constitutive documents or partnership or
operating agreement, as applicable; (iv) do not violate any law or
regulation, or any order or decree of any court or Governmental Authority;
(v) do not conflict with or result in the breach or termination of,
constitute a default under or accelerate or permit the acceleration of any
performance required by, any indenture, mortgage, deed of trust, lease,
agreement or other instrument to which such Person is a party or by which such
Person or any of its property is bound; (vi) do not result in the creation
or imposition of any Lien upon any of the property of such Person, other than a
Lien in favor of Agent; and (vii) do not require the consent or approval
of any Governmental Authority or any other Person except those which will have
been duly obtained, made or complied with prior to the Effective Date.


 


(b)                                 This
Amendment has been duly executed and delivered by or on behalf of each of the
Credit Parties.


 


(c)                                  This
Amendment constitutes a legal, valid and binding obligation of each of the
Credit Parties, enforceable against each of them in accordance with its terms.


 


10





















 


(d)                                 No
Default or Event of Default has occurred and is continuing or would result
after giving effect to the provisions of this Amendment.


 


(e)                                  No
action, claim or proceeding is now pending or, to the knowledge of any Credit
Party, threatened against such Credit Party, at law, in equity or otherwise,
before any court, board, commission, agency or instrumentality of any foreign,
federal, state, or local government or of any agency or subdivision thereof, or
before any arbitrator or panel of arbitrators, which (i) challenges any
Credit Party’s right or power to enter into or perform any of its obligations
under this Amendment or any other Loan Document to which it is or will be, a
party, or the validity or enforceability of this Amendment, the Credit
Agreement or any Loan Document or any action taken thereunder, or (ii) has
a reasonable risk of being determined adversely to any Credit Party and that,
if so determined, could reasonably be expected to have a Material Adverse
Effect after giving effect to this Amendment.


 


(f)                                    The
representations and warranties of the Credit Parties contained in the Amended Credit
Agreement and each other Loan Document shall, after giving effect hereto, be
true and correct on and as of (i) the date hereof, and (ii) the Effective Date,
in each case, with the same effect as if such representations and warranties
had been made on and as of such date, except that any such representation or warranty
which is expressly made only as of a specified date need be true only as of
such date.


 


10.                                 No
Amendments/Waivers/Consents.  Except
as expressly provided herein (a) the Credit Agreement and the other Loan
Documents shall be unmodified and shall continue to be in full force and effect
in accordance with their terms, (b) the consents and agreements of the Agent
and Requisite Lenders set forth herein shall be limited strictly as written and
shall not constitute a consent or agreement to any transaction not specifically
described in connection with any such consent and/or agreement, and (c) this Amendment
shall not be deemed a waiver of any term or condition of any Loan Document and
shall not be deemed to prejudice any right or rights which Agent or any Lender
may now have or may have in the future under or in connection with any Loan
Document or any of the instruments or agreements referred to therein, as the
same may be amended from time to time.


 


11.                                 Affirmation of Obligations.  Each
of the Credit Parties hereby acknowledges, agrees and affirms (a) its
obligations under the Credit Agreement and the other Loan Documents, including, without limitation, its guaranty
obligations thereunder, (b) that such guaranty shall apply to the Obligations
in accordance with the terms thereof, (c) the grant of the security interest in
all of its assets pursuant to the Loan Documents and (d) that such liens and
security interests created and granted are valid and continuing and secure the
Obligations in accordance with the terms thereof.


 


12.                                 Outstanding
Indebtedness; Waiver of Claims.  Each
of Borrowers and the other Credit Parties hereby acknowledges and agrees that
as of March 14, 2005, (a) the outstanding balance of the European
Revolving Loan is $11,000,000 and (b) the outstanding balance of the US
Revolving Loan is $20,000,000.  Borrowers
and each other Credit Party hereby waive, release, remise and forever discharge
Agent, Lenders and each other Indemnified Person from any and all claims,
suits, actions, investigations, proceedings or demands arising out of or in
connection with the Credit Agreement (collectively, “Claims”), whether
based in


 


11





















 


contract, tort, implied
or express warranty, strict liability, criminal or civil statute or common law
of any kind or character, known or unknown, which any Borrower or any other
Credit Party ever had, now has or might hereafter have against Agent or Lenders
which relates, directly or indirectly, to any acts or omissions of Agent,
Lenders or any other Indemnified Person on or prior to the Effective Date, provided,
that no Borrower nor any other Credit Party waives any Claim solely to the
extent such Claim relates to Agent’s or any Lender’s gross negligence or
willful misconduct.


 


13.                                 Fees
and Expenses


 


(a)                                  Amendment
Fee.  To induce Agent and the Lenders
to enter into this Amendment, Borrowers hereby agree to pay Agent, for the
ratable benefit of the Lenders, an amendment fee in the amount of $50,000.00 in
immediately available funds, payable on the Effective Date (the “Amendment
Fee”).


 


(b)                                 Expenses.  Borrowers hereby reconfirm their obligations
pursuant to Section 11.3 of the Credit Agreement to pay and
reimburse Agent for all reasonable costs and expenses (including, without limitation,
reasonable fees of counsel) incurred in connection with the negotiation,
preparation, execution and delivery of this Amendment and all other documents
and instruments delivered in connection herewith..


 


14.                                 Effectiveness.  Effectiveness.  Upon satisfaction in full in the judgment of
Agent of each of the following conditions, this Amendment shall be deemed
effective as of March 10, 2005 (the “Effective Date”):


 


(a)                                  Amendment.  Agent shall have received four (4) original
signature pages to this Amendment, duly executed and delivered by Agent,
Lenders, and each of the Credit Parties.


 


(b)                                 Payment
of Fees and Expenses.  Borrowers
shall have paid to Agent all costs, fees and expenses owing in connection with
this Amendment and the other Loan Documents and due to Agent (including,
without limitation, the Amendment Fee and reasonable legal fees and expenses).


 


(c)                                  Representations
and Warranties.  The representations
and warranties of or on behalf of each of the Credit Parties in this Amendment
shall be true and correct on and as of the date hereof and the Effective Date.


 


15.                                 GOVERNING
LAW.  THIS AMENDMENT SHALL BE
GOVERNED BY, AND INTERPRETED IN ACCORDANCE WITH, THE LAW OF THE STATE OF NEW
YORK.


 


16.                                 Counterparts.  This Amendment may be executed by the parties
hereto on any number of separate counterparts and all of said counterparts
taken together shall be deemed to constitute one and the same instrument.


 


12





















 


IN WITNESS
WHEREOF, this Amendment has been duly executed as of the date first written
above.


 


	
   

  	
  BORROWERS

  
	
   

  	
   

  
	
   

  	
  WAMPOLE
  LABORATORIES, LLC.

  INVERNESS MEDICAL (UK) HOLDINGS

  LIMITED

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/Anthony J. Bernardo

  	
   

  
	
   

  	
  Name: Anthony J. Bernardo

  
	
   

  	
  Title: Duly Authorized Signatory

  



 





















 


	
   

  	
  AGENT AND LENDERS

  
	
   

  	
   

  
	
   

  	
  GENERAL ELECTRIC CAPITAL

  
	
   

  	
  CORPORATION, as Agent and Lender

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/Keith Kennedy

  	
   

  
	
   

  	
  Duly Authorized Signatory

  
	
   

  	
   

  
	
   

  	
  MERRILL LYNCH CAPITAL, a division of

  Merrill Lynch Business Financial Services Inc.,

  
	
   

  	
  as a Lender

  
	
   

  	
   

  
	
   

  	
  By: 

  	
  /s/illegible

  	
   

  
	
   

  	
  Duly Authorized Signatory

  
	
   

  	
   

  
	
   

  	
  UBS AG, CAYMAN ISLANDS BRANCH, as a Lender

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/Wilfred V. Saint

  	
   

  
	
   

  	
  Duly Authorized Signatory

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/Juan Zuniga

  	
   

  
	
   

  	
  Duly Authorized Signatory

  
						



 





















 


The following
Persons are signatories to this Amendment in their capacity as Credit Parties
and not as Borrowers.


 


 


	
   

  	
  INVERNESS MEDICAL INNOVATIONS, INC.

  
	
   

  	
  INVERNESS MEDICAL, INC.

  
	
   

  	
  UNIPATH DIAGNOSTICS, INC.

  
	
   

  	
  UNIPATH ONLINE, INC.

  
	
   

  	
  OSTEX INTERNATIONAL, INC.

  
	
   

  	
  INVERNESS MEDICAL INTERNATIONAL

  HOLDING CORP.

  
	
   

  	
  INVERNESS MEDICAL INTERNATIONAL

  HOLDING CORP. II

  
	
   

  	
  UNIPATH LIMITED

  
	
   

  	
  APPLIED BIOTECH, INC.

  
	
   

  	
  FOREFRONT DIAGNOSTICS, INC.

  
	
   

  	
  MORPHEUS ACQUISITION CORP.

  
	
   

  	
  MORPHEUS ACQUISITION LLC

  
	
   

  	
  INVERNESS MEDICAL CANADA INC.

  
	
   

  	
  MEDICALE INVERNESS CANADA INC.

  
	
   

  	
  INNOVATIONS RESEARCH LLC

  
	
   

  	
  ADVANTAGE DIAGNOSTICS CORPORATION

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/Anthony J. Bernardo

  	
   

  
	
   

  	
  Name: Anthony J. Bernardo

  
	
   

  	
  Title: Duly Authorized Signatory

  
	
   

  	
   

  
	
   

  	
  ORGENICS INTERNATIONAL HOLDINGS BV

  
	
   

  	
  INVERNESS MEDICAL SWITZERLAND LTD

  LIAB. CO

  
	
   

  	
  UNIPATH DIAGNOSTICS GMBH

  
	
   

  	
  CAMBRIDGE DIAGNOSTICS IRELAND

  LIMITED

  
	
   

  	
  PREGYMED GMBH

  
	
   

  	
  SCANDINAVIAN MICRO BIODEVICES APS

  
	
   

  	
  SELFCARE TECHNOLOGY, INC.

  
	
   

  	
  VIVA DIAGNOSTIKA – DIAGNOSTISCHE

  PRODUKTE – GMBH

  
	
   

  	
  DMD, DIENSTLEISTUNGEN & VERTRIEB FUR

  MEDIZIN UND DIAGNOSTIK GMBH

  
	
   

  	
  INVERNESS MEDICAL FRANCE, S.A.S.

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/Paul T.
  Hempel

  	
   

  
	
   

  	
  Name: Paul T.
  Hempel

  
	
   

  	
  Title: Duly
  Authorized Signator