Distribution Agreement
EXHIBIT
10.2
Distribution
Agreement made this 3rd day of November, 2006 by and between Inverness Medical
Innovations, Inc., with offices at 00 Xxxxxx Xxxx, Xxxxx 000, Xxxxxxx, XX 00000
on behalf of itself and its subsidiaries (“Inverness”) and Matritech, Inc., a
Delaware corporation with its principal place of business at 000 Xxxxxx Xxxxxx,
Xxxxxx, XX 00000 (“Matritech”).
Whereas,
the parties are desirous of entering into arrangements for the distribution
by
Inverness of the NMP22®
BladderChek®
Test to
OTC Customers in the event that clearance for such sales is obtained from the
FDA (as hereinafter defined) in the United States,
Now,
therefore, in consideration of the premises and for other good and valuable
consideration, the receipt and legal sufficiency of which are hereby
acknowledged, the parties agree as follows:
1.0 Definitions
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1.1
FDA
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means
the United States Food and Drug Administration.
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1.2
Field
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means
the non-prescription, over the counter (OTC), direct to consumer
market
which includes but may not be limited to retail
pharmacies.
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1.3
Identified
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Confidential
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Information
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means
any information or data, regardless of whether it is in tangible
form,
disclosed by either party (the “disclosing party”) that the disclosing
party has either marked as confidential or proprietary, or has
identified
in writing as confidential or proprietary within thirty (30) days
of
disclosure to the other party (the “receiving party”); provided,
however,
that reports and/or information related to a disclosing party’s business
plans, strategies, technology, research and development, current
and
prospective customers, billing records, and products or services
shall be
deemed Identified Confidential Information of the disclosing party
even if
not so marked or identified. Confidential Information shall not
include
any information which a) can be demonstrated to have been in the
public
domain or publicly known prior to the date of disclosure by disclosing
party; or b) can be demonstrated, from written records, to have
been in
the receiving party’s possession from another source not under obligation
of secrecy to the disclosing party prior to disclosure by the disclosing
party; or c) becomes part of the public domain or publicly known
by
publication or otherwise, not due to any unauthorized act by
the
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| receiving party; or d) can be demonstrated to have been independently developed by the receiving party without the use of the disclosing party’s Confidential Information; | |
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1.4
Products
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means
Matritech’s NMP22 BladderChek Test, a point of care, urine test, an aid in
the detection and management of bladder cancer, and subsequent
versions
thereof.
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1.5
Territory
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United
States of America.
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2.0 Regulatory
Approvals
Matritech
shall secure all necessary regulatory approvals for the marketing and sale
of
the Product within the Field in the Territory. Matritech shall be responsible
for and shall the conduct of all necessary clinical trials and the submission
of
all regulatory filings with the FDA or elsewhere to obtain regulatory approvals
for marketing and sale of the Product within the Field in the Territory. The
first $[ ** ] of the documented costs of any such trials shall be borne by
Matritech, after which Inverness shall pay any such costs. Inverness agrees
to
cooperate with Matritech in its efforts to secure regulatory approval.
3.0 Appointment
as Distributor
On
the
date of this Agreement and subject to commercially reasonable minimum purchase
requirements to be negotiated in good faith at a later date, Matritech appoints
Inverness as, and Inverness accepts appointment as, Matritech’s exclusive
distributor of the Product within the Field in the Territory.
4.0 Orders
Inverness
agrees to place all orders for the Product in writing to Matritech for a
delivery date at least thirty (30) days after the Order date. Matritech shall
use commercially reasonable efforts to deliver the Product on the specified
delivery date plus or minus 10 days. Delivery is F.O.B. place of manufacture.
Inverness may select carrier for shipment. Transportation and insurance charges,
expenses and costs are not included in the prices of the Product. All sales
are
net thirty days of delivery. Title and risk of loss automatically passes to
Inverness when the Product is placed with a common carrier for shipment to
Inverness or shipment to another party as directed by Inverness. Inverness
agrees to submit to Matritech, on or before the first of each month, non-binding
forecasts, advising Matritech of its estimated order activity during the
succeeding twelve (12) month period. All Product sold by Inverness shall be
sold
with the original labels provided by Matritech.
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5.0 Price
The
price
Inverness will pay to purchase the Product from Matritech will be calculated
by
the parties in good faith prior to the sale thereof such that [ ** ].
6.0 Term
and Termination
The
term
of this Distribution Agreement shall be for five years from the date of this
Agreement. Notwithstanding the foregoing, Inverness may terminate this Agreement
at any time during the first year with 30 days notice. Thereafter, either party
may terminate this Agreement with or without cause during the term on 270 days
written notice. This Agreement may be extended by a mutual written agreement
entered into at least 270 days prior to the end of the Term.
In
addition to the foregoing, either party may terminate this Agreement if the
other commits any material breach of any of the provisions of this Agreement
and, in the case of such a breach which is capable of remedy, fails to remedy
the breach within thirty (30) days after receipt of a written notice giving
full
particulars of the breach and requiring it to be remedied. In the case of such
a
breach which is not capable of remedy, there will be no opportunity to remedy
and this Agreement will terminate upon receipt of such written notice. Either
party may also terminate this Agreement if the other shall be adjudicated
bankrupt, goes into receivership or trusteeship, makes a voluntary arrangement
with its creditors or enters into any similar proceeding of the same nature,
goes into liquidation (except for the purposes of an amalgamation,
reconstruction or other reorganization and in such manner that the company
resulting from the reorganization effectively agrees to be bound by or to assume
the obligations imposed on such party under this Agreement), or ceases, or
threatens to cease, to carry on business.
7.0 Warranty
Matritech
gives
a
limited warranty to Inverness that the Product will comply with the
specifications contained on its labelling and inserts until the date of
expiration of the Product, which is shown on the Product. Matritech specifically
disclaims on behalf of itself and any and all of its suppliers and assemblers,
all other conditions, warranties and other terms relating to the Product.
Matritech further warrants that the Product will not infringe the intellectual
property rights related to biologicals of any third party, other than those
rights belonging to Inverness. Inverness acknowledges that certain patent and
license rights are provided to Matritech under the manufacturing agreement
of
even date herewith, and agrees to amend such agreement to the extent permissible
if necessary to effect this agreement. Except for Matritech’s indemnity
regarding biologicals explicitly set forth above, neither party shall provide
an
indemnity to the other party regarding third party infringement. Except for
the
preceding warranties in the first sentence of this section, EACH PARTY DISCLAIMS
ANY AND ALL WARRANTIES OR CONDITIONS OF ANY KIND WHATSOEVER, EXPRESS, IMPLIED,
STATUTORY, OR OTHERWISE, INCLUDING WITHOUT LIMITATION THOSE FOR MERCHANTABILITY,
SATISFACTORY QUALITY, INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE, ALL
OF
WHICH ARE EXPRESSLY EXCLUDED.
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Inverness
agrees that it will not give (or purport to give) or enter into (or purport
to
enter into) on behalf of Matritech any representation or warranty in relation
to
the Product except to the extent provided by Matritech in the immediately
preceding paragraph. Inverness agrees to indemnify and hold Matritech harmless
from and against all liabilities relating to the Product and against all costs
and expenses associated with claims in respect of such liabilities, in each
case
to the extent that the liabilities result from a breach by Inverness of the
terms of the preceding sentence.
Inverness
may not return Product without prior approval from Matritech, which approval
may
not be unreasonably withheld. If, however, Product fails to perform in
accordance with its specifications then Inverness may return such defective
Product within (30) days after notification by Matritech. Inverness' sole remedy
in the event Product fails to perform (as documented by Matritech) is the return
at Matritech's expense of all or any portion of the Product that
failed to perform for a refund of the purchase price paid by Inverness plus
applicable shipping expenses.
8.0 Limitation
of Liability
EXCEPT
AS
PROVIDED UNDER WARRANTY ABOVE, EACH PARTY’S TOTAL LIABILITY UNDER THIS AGREEMENT
SHALL BE LIMITED TO THE AMOUNTS HAVING BEEN ACTUALLY PAID BY INVERNESS UNDER
THIS AGREEMENT. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY SPECIAL,
CONSEQUENTIAL, INCIDENTIAL, MULTIPLE OR PUNITIVE DAMAGES, HOWEVER CAUSED AND
ON
ANY THEORY OF LIABILITY, WHETHER OR NOT FOR BREACH OF CONTRACT, NEGLIGENCE
OR
OTHERWISE AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY
OF
SUCH DAMAGE. THESE LIMITATIONS SHALL APPLY NOTWITHSTANDING ANY FAILURE OF
ESSENTIAL PURPOSE OF ANY LIMITED REMEDY PROVIDED IN THIS AGREEMENT.
NOTWITHSTANDING ANYTHING CONTAINED HEREIN TO THE CONTRARY, THIS LIMITATION
ON
LIABILITY SHALL NOT APPLY TO DAMAGES ARISING FROM INFRINGEMENT OR BREACH OF
THE
CONFIDENTIALITY OBLIGATIONS OF EITHER PARTY.
9.0 Product
Liability Insurance
Each
party shall carry products liability insurance with respect to the Product
sold
or distributed by it in such amounts and against such risks and losses as are
commercially reasonable. Each party shall be solely responsible for any premium
for such insurance.
10.0 Indemnification
Each
of
the parties agree to indemnify, defend and hold the other party harmless against
any cost, loss, liability, or expense (including attorneys’ fees) arising out of
any third party claim, resulting from or relating to any breach of this
Agreement; provided
that the
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indemnifying
party is notified promptly in writing of the claim, has sole control over its
defense or settlement, and the party seeking indemnification provides reasonable
assistance in the defense of the same. Each party agrees, that it will not
settle any such claims, unless such settlement does not adversely affect the
other party’s rights under this Agreement or requires the indemnified party to
perform any actions.
11.0 Confidentiality
Except
in
accordance with the terms of this Agreement, neither party shall, either during
the period of this Agreement or at any subsequent time, disclose to any other
person any Identified Confidential Information disclosed to it by the other
party under this Agreement, and each party shall use commercially reasonable
efforts, and in any event at least as rigorous as those it uses to protect
its
own confidential information, to keep the other party’s Identified Confidential
Information confidential.
12.0 Assignment
This
Agreement is personal to the parties and neither of them may, without the
written consent of the other, assign or transfer any of its rights, or
sub-contract or otherwise delegate any of its obligations, under this Agreement;
provided, however, that a party may assign this Agreement to an entity or person
who acquires all or substantially all of its business (or segment, such as
Matritech’s NMP22 product line) by merger, sale of assets or otherwise.
Notwithstanding the foregoing, neither party may assign this Agreement to any
competitor of the other party (that is, neither party may assign it to any
company which sells bladder cancer diagnostic tests) without the prior written
consent of such party, which consent may be withheld by such party in its sole
discretion. Any attempted assignment, delegation or transfer by a party in
violation hereof shall be null and void. Subject to the foregoing, this
Agreement shall be binding on the parties and their successors and assigns.
13. Miscellaneous
Each
of
the parties agrees to comply with all applicable governmental laws, rules,
regulations and policies. This Agreement shall be governed by and construed
in
all respects in accordance with the laws of the Commonwealth of Massachusetts
without giving effect to its conflicts of law principles. Each of the parties
consents to venue and jurisdiction in any court of competent jurisdiction
sitting within the Commonwealth of Massachusetts.
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In
witness whereof, the parties executed this Agreement as of the date first
above
written.
| Matritech, Inc. | Inverness Medical Innovations, Inc. |
| By: /s/ Xxxxxxx X. Xxxxx | By: /s/ Xxx Xxxxxxxxx |
| Its:_ CEO | Its:_ CEO |
| By: /s/ Xxxx Warner__ _____________ | |
| Its: _Asst. Sec’y___________________ | |
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