CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTIONS ARE MARKED AS "[XXXX]" ALONG WITH A
FOOTNOTE INDICATING THAT THE INFORMATION HAS BEEN OMITTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT. THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
UNITED STATES SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION FOR
CONFIDENTIAL TREATMENT.
AMENDMENT
to
Distribution Agreement
by and between
Applied Biotech, Inc.
and
Synova Healthcare, Inc.
This Amendment ("AMENDMENT") to the Distribution Agreement (the "AGREEMENT")
made as of the 23rd day of June, 2003, by and between ABI and SYNOVA, is made,
entered into, and effective as of the February 3, 2005, by and between ABI (a
subsidiary of Inverness Medical Innovations, Inc.) and SYNOVA. Except for such
terms as are expressly defined herein, all capitalized terms in this Amendment
shall have the same meaning as those contained in the Agreement.
WHEREAS, ABI and SYNOVA are parties to the Agreement, which Agreement is in full
force and effect; and,
WHEREAS, ABI and SYNOVA desire to extend their contractual relationship beyond
the term set forth in the Agreement, to expand the territory in which SYNOVA
shall be authorized under the Agreement to market, promote, solicit, sell, and
distribute the "Product" (but no other products which were included in Exhibit
1.9 of the Agreement), and to amend certain other terms and conditions of the
Agreement;
NOW THEREFORE, for and in consideration of the mutual covenants and conditions
herein contained, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, and intending to be bound legally,
ABI and SYNOVA agree as follows:
1. In the Preamble of the Agreement, the address given for SYNOVA is amended
to read, in its entirety:
0000 Xxxxx Xxxxxxxxxx Xxxx, Xxxxx 0000, Xxxxx, Xxxxxxxxxxxx 00000.
2. Section 1.12 of the Agreement is amended to read, in its entirety:
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"Territory" means the United States, except with respect to the Product
only, in which event "Territory" shall also include [XXXX](1) and
[XXXX](1). For the avoidance of doubt, the Territory shall not be expanded
for the remainder of the Product Line.
3. In Section 3.3(a) of the Agreement, the word "pieces" is replaced with
"Units."
4. The first sentence of Section 3.4(a) of the Agreement is amended to read,
in its entirety:
ABI shall ship Product that is ordered by SYNOVA, (i) FOB ABI's facility in
San Diego, California, or (ii) FOB the facility of ABI's designee, in
accordance with the quantities, delivery dates, and delivery and shipping
instructions specified in SYNOVA's purchase orders.
5. In the third sentence of Section 3.4(b) of the Agreement, the word "kits"
is replaced with "Units."
6. The seventh sentence of Section 3.4(b) of the Agreement is amended to read,
in its entirety:
SYNOVA shall pay all invoices within thirty (30) days of the shipment of
the product from ABI's warehouse (or, for shipments to be made from the
warehouse of ABI's designee, within thirty (30) days of the shipment of the
product from the warehouse of ABI's designee).
7. The first sentence of Section 4.6 of the Agreement is amended to read, in
its entirety:
SYNOVA reserves the right to audit ABI's facilities (and the facilities of
ABI's designee referenced in Section 3.4(a), above), at its own expense as
reasonably necessary.
8. The second sentence of Section 4.6 of the Agreement is amended to read, in
relevant part:
... SYNOVA shall be entitled to conduct only one audit of each facility per
Contract Year; ...
9. The second and third sentences of Section 6.1 of the Agreement are amended
to read, in their entirety:
SYNOVA will be responsible for and bear all of its costs related to any
registrations or other filings necessary with the applicable governments of
[XXXX](1) and [XXXX](1) in order for SYNOVA to market the Product in
[XXXX](1) and [XXXX](1). ABI shall own all 510(k) registrations and updates
and U.S. filings.
10. In Section 6.6 of the Agreement, the reference to "Section 1.4" is replaced
with a reference to "Section 6.6."
-----------
(1) Filed under an application for confidential treatment.
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11. Section 8.1 of the Agreement is amended to include a new subsection (d) to
read, in its entirety:
(d) No product in the Product Line and no exercise by SYNOVA of any of the
rights granted to it under this Agreement infringes, to the extent such
products and /or rights are granted by ABI, violates, or interferes
with any patent, trademark, copyright, trade secret, or other
intellectual property or proprietary right of any person or entity.
12. Section 11.1 of the Agreement is amended to read, in its entirety:
a. GENERAL. This Agreement may be terminated only upon mutual agreement of
the parties or as otherwise expressly provided in this Section 11.
b. CONTRACT TERM FOR THE "PRODUCT LINE". For purposes of this subparagraph,
the "Product Line" shall refer to all products listed in Exhibit 1.9 the
Agreement with the sole exception of the Product. For purposes of the
Product Line, and subject to the other rights of termination set forth in
the Agreement (i) the initial term of this Agreement shall commence on the
Effective Date, and shall continue in effect until the last day of the
third (3rd) Contract Year; and (ii) thereafter the Agreement shall
automatically renew for a period of two (2) Contract Years each, unless one
party provides the other with a written notice of termination at least
sixty (60) days prior to the end of the third (3rd) Contract Year, or any
subsequent 2-year contract term extension,
c. CONTRACT TERM FOR THE PRODUCT. For purposes of the Product only, and
subject to the other rights of termination set forth in the Agreement, (i)
the initial term of this Agreement shall commence on the Effective Date,
and shall continue in effect until the last day of the tenth (10th)
Contract Year; and (ii) thereafter the Agreement shall automatically renew
for a period of two (2) Contract Years each, unless one party provides the
other with a written notice of termination at least sixty (60) days prior
to the end of the tenth (10th) Contract Year, or of any subsequent 2-year
contract term extension.
13. A new sentence shall be added at the end of Section 11.2 of the Agreement
to read, in its entirety:
If, for any Contract Year beginning in 2005, SYNOVA fails to purchase from
ABI at least 600,000 Units of Product, ABI shall have the right to serve
notice of termination of this Agreement at any time within the first sixty
(60) days of the following Contract Year, which notice shall become
effective thirty (30) days thereafter.
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14. Section 12.1(a) of the Agreement is amended to read, in its entirety:
If to SYNOVA: with a copy to:
Synova Healthcare, Inc. Xxxx Xxxxxx, Esquire
1400 North Providence Road, Ste. 6010 Blank Rome LLP
Media, PA 19063 One Xxxxx Square
Attn: Chief Executive Officer Xxxxxxxxxxxx, XX 00000
Facsimile: (000) 000-0000 Facsimile: (000) 000-0000
15. Section 12.1(b) of the Agreement is amended to read, in its entirety:
If to ABI: with a copy to:
Inverness Medical Innovations, Inc. Inverness Medical Innovations, Inc.
Attn: President Attn: General Counsel
00 Xxxxxx Xxxx 00 Xxxxxx Xxxx
Xxxxx 000 Xxxxx 000
Xxxxxxx, XX 00000 Xxxxxxx, XX 00000
Facsimile: (000) 000-0000 Facsimile: (000) 000-0000
16. Under the reference to Cat. # "FSH" in Exhibit 1.9 to the Agreement, the
phrase "100,000 piece minimum order" is replaced, in its entirety, with
"100,000 Unit minimum order."
17. Under the reference to Cat. # "FSH" in Exhibit 3.1 to the Agreement, the
phrase "100,000 piece minimum order" is replaced, in its entirety, with
"100,000 Unit minimum order."
18. This Amendment may be executed in any number of counterparts, each of which
shall upon delivery to the other party be deemed an original, but all of
which shall be deemed the same instrument.
19. This Amendment, including its preamble, constitutes the entire agreement
between the parties with respect to the presently contemplated amendment of
the Agreement and supersedes all prior agreements, negotiations,
representations, communications, and proposals, written or oral, express or
implied, between the parties regarding the contemplated amendment.
IN WITNESS WHEREOF, the parties have hereto by their duly authorized
representatives executed and delivered this Amendment.
SYNOVA HEALTHCARE, INC. APPLIED BIOTECH, INC.
By: /s/ Xxxxxxx X. Xxxx By: /s/ Xxxxxxx X. Xxxxxxxx
----------------------- --------------------------
Name: Xxxxxxx X. Xxxx Name: Xxxxxxx X. Xxxxxxxx
----------------------- --------------------------
Title: CEO Title: President
----------------------- --------------------------
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