EXHIBIT 10.1
 

CONTRACT AMENDMENT NO. 1

This Contract Amendment No. 1 (“Amendment”) dated June 1, 2007 (“Amendment
Date”) by and between Inverness Medical Innovations, Inc. with offices at 51
Sawyer Road, Suite 200, Waltham, MA 02453 on behalf of itself and its
subsidiaries (“Inverness”) and Matritech, Inc., a Delaware corporation with its
principal place of business at 330 Nevada Street, Newton, MA 02460
(“Matritech”).

WHEREAS Inverness and Matritech are parties to a Supply Agreement dated as of
November 3, 2006 (the “Agreement”), and wish to amend such agreement on the
terms and conditions set forth in this Amendment;

NOW THEREFORE the parties agree as follows:

1.           Section 3.2 of the Agreement is amended by adding the sentence:
“Each such monthly forecast shall be provided to Inverness by the fifth business
day of the month in which such forecast is due to be provided.”

2.           Section 4.4 of the Agreement is amended and restated as
follows:  “Inverness shall submit to Matritech for approval a minimum of [ ** ]
samples of Product from each trial production run.  For the avoidance of doubt,
Matritech shall pay for such samples in accordance with Section 3
above.  Approval shall not be unreasonably withheld or delayed by
Matritech.  Once Matritech has advised Inverness in Writing of its approval of
the trial production run samples or if Matritech fails to provide the Written
approval or rejection of the same within 10 Business Days, Inverness shall cause
the full production run of the Product to be manufactured and delivered to
Matritech.”

3.           Section 4.6 of the Agreement is amended by deleting the words
“thirty (30) calendar months” in the last sentence, and replacing them with the
words “[ ** ], or such longer period as is equal to the shelf life of the
Product which may be extended in accordance with Section 4.7 hereof”.

4.           Section 4.7 of the Agreement is amended and restated as follows:

“The Parties agree that upon the Effective Date, the shelf life of the Products
manufactured by Unotech Diagnostics, Inc. as Approved Custom Manufacturer shall
be [ ** ] and the Specification for the Product manufactured by Unotech
Diagnostics, Inc. as Approved Custom Manufacturer shall provide for a [ ** ]
shelf life.  The shelf life of the Products manufactured by any other Approved
Custom Manufacturer shall, at the time of commencement of supply by such
Approved Custom Manufacturer, be [ ** ] and the Specification initially
applicable to Products manufactured by such other Approved Custom Manufacturer
shall provide for a [ ** ] shelf life.  The Parties agree that the shelf life of
the Products manufactured by such other Approved Custom Manufacturer shall be
extended during the term of this Agreement (and the corresponding revision of
the Specification to a shelf life longer than [ ** ] shall be effected) based
upon accumulation of accelerated and/or real time data related to the Products,
by written agreement of the Parties, which agreement shall not be unreasonably
withheld, conditioned or delayed.  In the event that the Parties do not, for any
reason, agree to extend the shelf life of Products manufactured by such other
Approved Custom Manufacturer to at least [ ** ] by a date no later than [ ** ]
after commencement of manufacture by such other Approved Custom Manufacturer,
then Matritech shall have the right to designate the particular Approved Custom
Manufacturer for any order rather than merely expressing a preference as
provided in Section 3.1 hereof.  Commencement of manufacture shall mean the
manufacture of the first validation pilot of the Product by the Approved Custom
Manufacturer.”

 
 

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5.           Section 4.12 of the Agreement is amended by adding the following
sentences at the end of the existing provision: “Before manufacture of the
Product manufactured by any new Approved Custom Manufacturer commences,
Matritech, Inverness and the new Approved Custom Manufacturer shall arrange for
a cross function design review team made up of personnel of Matritech, Inverness
and the new Approved Custom Manufacturer to assess whether Technical Information
Transfer (as hereinafter defined) has taken place.  Inverness’s obligations to
supply the Product manufactured by a new Approved Custom Manufacturer shall not
begin until Matritech, Inverness and the new Approved Custom Manufacturer have
agreed in writing that Technical Information Transfer has taken place; provided
that the agreement of Inverness and the new Approved Custom Manufacturer that
Technical Information Transfer has taken place shall not be unreasonably
withheld, conditioned or delayed.   Promptly after Technical Information
Transfer or after any Change agreed pursuant to Section 6, Inverness will
identify to Matritech any specific manufacturing processes necessary for the
manufacture of the Product and different from the manufacturing processes used
by its Approved Custom Manufacturer for the manufacture of similar products.  If
Inverness, its Approved Custom Manufacturer and Matritech agree that such
manufacturing processes are different from the manufacturing processes used by
its Approved Custom Manufacturer for the manufacture of similar products and
ought reasonably to be excluded from Inverness’s indemnification set forth in
Section 9.1(b)(such agreement of Matritech not to be unreasonably withheld), the
parties shall record such processes in writing, and such processes will be
“Specific Manufacturing Processes” for the purposes of Section 9
hereof.  “Technical Information Transfer” shall mean the provision to Inverness
and the new Approved Custom Manufacturer of technical information and
explanations relating to the manufacturing processes used for the Product, for
the purpose of assisting the new Approved Custom Manufacturer to manufacture the
Product in accordance with the Specification.”

6.           Insert the following new Section 4.15, and re-number current
Section 4.15 as 4.16: “Notwithstanding any other provision of this Agreement
Inverness shall have no liability whatsoever under any provision of Section 4,
Section 9 or any other provision of this Agreement in the event that any of the
Products fail to conform in all material respects to the Specification at the
time of manufacture and/or at the time of delivery and/or during the period of
the shelf life of the Product, if such failure to conform results from any
failure at any time of the Matritech Raw Materials and/or such Matritech Raw
Materials failing to comply to the Specification insofar as it relates to them
and in particular without prejudice to the generality of the foregoing Inverness
shall have no liability whatsoever in respect of any Product failing to conform
to the Specification which results from any failure in the reproducibility or
the stability of any gold materials which form part of the Matritech Raw
Materials which are utilized in the Products.”
 
7. Sections 9.1 and 9.2 are deleted in their entirety and replaced with the
following:

“9.1           Inverness shall indemnify and hold Matritech harmless from and
against any and all third party suits, actions, losses, obligations,
deficiencies, liabilities, claims, damages, cost and expense (including court
costs and reasonable attorney fees) (collectively, “Claims”) which arise out of,
are caused by, relate to or result or occur from or in connection with (a) the
failure of any Product manufactured by Inverness or an Approved Custom
Manufacturer to comply with the warranty set forth in clause 4.1 above, unless
such failure is caused by the Matritech Raw Materials or (b) a claim that the
manufacturing processes of Inverness or any Approved Custom Manufacturer (except
any Specific Manufacturing Process agreed pursuant to Section 4.12) infringes or
misappropriates the Intellectual Property of a Third Party.   For purposes of
clarity, a Third Party is a party other than Inverness and Matritech.

9.2           Except for liability which is contemplated by Section 9.1,
Matritech agrees to indemnify and hold Inverness and each Approved Custom
Manufacturer harmless from and against any and all Claims which arise out of,
are caused by, relate to or result or occur from or in connection with any and
 
 
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all Products and components thereof, including, without limitation, all
Biologicals, including without limitation, Claims which arise out of, are caused
by, relate to or result or occur from or in connection with (a) the use and/or
sale of the Products; (b) any allegation that the Products infringe the
Intellectual Property Rights of a Third Party (except to the extent that such
allegations concern a Claim for which Matritech is entitled to indemnification
pursuant to clause 9.1) (c) any failure of the Matritech Raw Materials; and (d)
any allegation that any Specific Manufacturing Process agreed pursuant to
Section 4.12 infringes the Intellectual Property Rights of a Third Party.”

9.           This Amendment is effective as of the date of the original
Agreement.

10.           Except as expressly set forth in this Amendment, all provisions of
the Agreement shall continue in full force and effect.

In witness whereof, the parties have executed this Amendment as of the date
first above written.

 
Inverness Medical Innovations, Inc. 
 
By:__________________________
 
Its:__________________________
 
 
By:__________________________
 
Its:__________________________
 
Matritech, Inc.
 
By:_____________________________
 
Its:_____________________________
 

 
 
 
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