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EXHIBIT
10.12
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO RULE
406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, AND
ARE SUBJECT TO A CONFIDENTIAL TREATMENT REQUEST. COPIES
OF THE EXHIBITS CONTAINING THE OMITTED INFORMATION HAVE BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION. THE OMITTED PORTIONS OF THIS DOCUMENT ARE
MARKED WITH ”” [***]”.
TISSUE PROCUREMENT, PROCESSING AND SUPPLY
AGREEMENT
Entered into this 1st day of October, 2007
Between
AlloSource
6278 S. Troy Circle
Centennial, Colorado 80111
And
Tutogen Medical (US), Inc.
13709 Progress Blvd.
Alachua, Florida 32615
TISSUE PROCUREMENT, PROCESSING AND SUPPLY
AGREEMENT
This
TISSUE PROCUREMENT, PROCESSING AND SUPPLY
AGREEMENT (the “Agreement”) is made and
entered into by and between AlloSource,
(“AlloSource”), an Illinois not-for-profit
corporation, with offices located at 6278 S. Troy Circle,
Centennial, CO 80111, and Tutogen Medical (US), Inc.
(“Tutogen”), a Florida corporation, with offices
located at 13709 Progress Blvd. Box 19, Alachua,
FL 32615, (collectively, the “Parties”
and each individually, a “Party”) as of this 1st
day of October 2007 (the “Effective
Date”).
WHEREAS , Tutogen and AlloSource have entered into that
certain Amended and Restated Tissue Recovery Agreement dated
October 10, 2005 (the “Recovery Agreement”), whereby
AlloSource supplies human tissue to Tutogen for further processing
and distribution for the treatment of human patients,
and
WHEREAS , the Parties desire to supersede the Recovery
Agreement with this Agreement to amend and restate the rights and
obligations of the Parties.
WHEREAS , AlloSource provides services related to the
screening, recovery, serological testing, and processing of human
tissues for transplantation; and
WHEREAS , AlloSource and Tutogen, in recognition of the
need for and benefits that result from the availability of tissue
for transplantation, desire to cooperate with each other in the
provision of tissue and allografts for transplantation;
and
NOW THEREFORE, in consideration of the mutual covenants
and agreements contained herein, the receipt and sufficiency of
which is hereby acknowledged, the Parties hereto agree as
follows:
Unless
otherwise stated in this Agreement:
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1.1.
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“Allografts”
shall mean those grafts described on Exhibit B ,
collectively or individually as the case may be. The term
“Allografts” shall not include any allografts that are
developed by AlloSource, solely or jointly with a third-party or
those allografts processed, marketed or distributed by AlloSource
in accordance with Section 4.3 hereof.
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1.2.
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"Donor"
shall mean a human, cadaveric Tissue donor that is the source of
Tissue for transplantation, in accordance with agreed upon and
established medical criteria and procedures and the Donor
Acceptance Criteria described in Exhibit E .
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1.3.
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“Processed
Tissue” shall mean human musculoskeletal tissues (soft tissue
and bone), after debridement, sectioning, and medical and
serological clearance, provided by AlloSource for further
processing and distribution by Tutogen, as further described in
Exhibit C .
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1.4.
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“Products”
shall mean Tissue, Processed Tissue and Allografts.
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1.5.
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"Tissue"
shall mean human musculoskeletal tissues (soft tissue and bone)
recovered by AlloSource for Tutogen which meet the Acceptance
Criteria described in Exhibit C .
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2.
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Term and Termination :
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2.1.
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Term . This Agreement shall commence on the Effective Date and
continue in full force and effect for five (5) years
(“Initial Term”).
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2.2.
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Renewal. At least sixty (60) days prior to the twenty-seven
(27) month anniversary of the Effective Date (the
“Negotiation Deadline”), the Parties shall meet and
negotiate in good faith the renewal terms and conditions of this
Agreement.
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2.3.
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Partial Termination. AlloSource may suspend the performance of
its obligations under this Agreement for a period of sixty (60)
days if it reasonably determines that the performance of its
obligations under this Agreement could (i) jeopardize its status as
a tax-exempt organization under Section 501 of the Internal Revenue
Code of 1986, as amended (the “Code”), (ii) result in
“unrelated business taxable income,” as defined in
Section 512 of the Code, (iii) result in a default under
AlloSource’s tax-exempt bonds (the “Bonds”) or
(iv) result in a violation of the National Organ Transplant Act (42
U.S.C., Section 274(e)). During such 60-day suspension
period, the Parties will negotiate in good faith in an attempt to
amend this Agreement such that AlloSource’s performance will
not (i) jeopardize its tax-exempt status, (ii) result in unrelated
business taxable income, (iii) result in a default under the Bonds
or (iv) result in a violation of the National Organ Transplant
Act. If, after not less than sixty (60) days, AlloSource
reasonably determines that AlloSource’s performance hereunder
could jeopardize its status as a tax-exempt organization under
Section 501 of the Code, result in unrelated business taxable
income, result in a default under the Bonds, or result in a
violation of the National Organ Transplant Act, AlloSource may
immediately terminate this Agreement without penalty.
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2.4.
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AlloSource Termination. AlloSource may immediately
terminate this Agreement by written notice if payments due
AlloSource, in accordance with Section 6 of this Agreement, are
past due for more than thirty (30) days.
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2.5.
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Termination. This Agreement may further be
terminated as follows:
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2.5.1.
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At
any time, by either party, in the event the other Party files any
petition for bankruptcy or similar proceeding or, if the other
Party has a petition for bankruptcy or similar proceeding filed
against it and such proceeding continues unstayed for sixty (60)
days after the filing thereof;
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2.5.2.
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At
any time, by either Party, in the event a Force Majeure
circumstance, as defined in Section 18 hereof, prevents the other
Party from performing for a period of more than ninety (90)
consecutive days;
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2.5.3.
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Upon
thirty (30) days written notice by either Party, in the event the
other Party receives notification from an applicable regulatory
body or court of competent jurisdiction, that it is not in
compliance with any applicable federal, state, or local law or
regulation and fails to cure such noncompliance, to the
satisfaction of the applicable regulatory body within ninety (90)
days of such notification; or
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2.5.4.
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Upon
thirty (30) days written notice by either Party, in the event the
other Party materially breaches any representation, warranty,
covenant or obligation under this Agreement and fails to cure such
breach to the satisfaction of the other Party within ninety (90)
days following receipt of written notice of such breach from the
other Party.
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2.6.
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Effect of Termination . After either Party provides
written notice of its intent to terminate this Agreement to the
other Party, the Parties shall continue to perform their respective
obligations hereunder until the effective date of such
termination. Upon termination of this Agreement,
AlloSource shall supply Products to Tutogen, pursuant to this
Agreement, in accordance with pending orders submitted to
AlloSource prior to the effective date of termination and Tutogen
shall pay the applicable fees in accordance with the terms and
conditions of this Agreement.
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3.
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Responsibilities and Obligations:
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3.1.
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Supply of Tissue and Processed Tissue
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3.1.1.
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Tutogen
shall order and AlloSource shall make commercially reasonable
efforts to procure for and supply to Tutogen Tissue and Processed
Tissue as defined in the Tissue Acceptance Criteria ( Exhibit
C ) and as specified in the Tissue and Allograft Requirements (
Exhibit A ), pursuant to Tutogen’s orders in
accordance with Section 3.3 below.
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3.1.2.
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Tutogen
agrees to accept Tissue and Processed Tissue from AlloSource that
have been recovered in accordance with the applicable criteria set
forth in section 3.1.1 above.
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3.1.3.
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AlloSource
reserves the right to procure, process and supply Tissue, Processed
Tissue and similar products to third parties. AlloSource
will consider the fulfillment of Tutogen requirements on an equal
priority basis with all other AlloSource customers which did not
have an agreement with AlloSource prior to October 10,
2005.
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3.2.
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Supply of Allografts
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3.2.1.
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Tutogen
has supplied AlloSource with Allograft designs, which AlloSource
shall treat as confidential, in accordance with the provisions of
Section 7.
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3.2.2.
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In
accordance with Tutogen’s Allograft designs, AlloSource has
developed Allograft Specifications, which have been approved by
Tutogen and which are set forth in Exhibit B .
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3.2.3.
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AlloSource
shall use commercially reasonable efforts to commence production of
the Allografts within thirty (30) days of the Effective Date of
this Agreement. AlloSource shall promptly notify Tutogen if
AlloSource determines that, despite its commercially reasonable
efforts, it is unable to timely fabricate, process and package the
Allografts in conformance with the Allograft
Specifications.
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3.2.4.
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AlloSource
shall use commercially reasonable efforts to process, package and
supply Allografts in accordance with the requirements shown in
Exhibit B and with the orders of Tutogen that have been
accepted by AlloSource.
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3.3.
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Forecasts and Orders
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3.3.1
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In
accordance with the requirements set forth in Exhibit A , at
least ten (10) days prior to the first day of each calendar quarter
during the Initial Term and any renewal term, Tutogen shall provide
AlloSource with a written non-binding forecast as to
Tutogen’s estimated requirements of Products for each of the
following twelve (12) calendar months, the first three (3) months
of which shall be binding. On or before the first day of
each month, Tutogen shall issue binding orders for such month for
the quantities of Products set forth in such
forecast. AlloSource shall have five (5) business days
to notify Tutogen of rejection of such binding order and reason for
such rejection. If no notice of rejection is given
within such five (5) business day period, the binding order shall
be considered accepted by AlloSource. AlloSource shall
make reasonable business efforts to fill such binding orders within
thirty (30) days, but no later than ninety (90) days of such
binding orders. If AlloSource fails to fill a binding
order that was accepted by AlloSource within ninety (90) days of
the date of such binding order, then Tutogen may cancel such
binding order and may fill such order from another
source.
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3.3.2
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In
the event that Tutogen does not place and accept orders for
Products in accordance with the minimum monthly requirements
specified in Exhibit A, Tutogen shall be required to pay AlloSource
the reimbursement fees, in accordance with Section 6 below, for the
minimum monthly requirements less the number of Products which are
ordered and accepted by Tutogen.
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3.3.3
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AlloSource
may supply and Tutogen shall accept from AlloSource Tissues,
Processed Tissues and Allografts in an amount equal to or up to ten
percent (10%) greater than the quantities set forth in Exhibit A
hereto and set forth in each binding order (or such higher quantity
if mutually agreed in writing).
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3.3.4
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AlloSource
shall ship Products to Tutogen at the following
address:
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Tutogen
Medical, Inc.
13709
Progress Blvd., Box 19
South
Wing
Alachua,
FL 32615
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3.3.5
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Tutogen
shall be responsible for expenses associated with the shipment of
Products from AlloSource to Tutogen. Risk of loss and
title to such Products shall pass to Tutogen upon
shipment.
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3.3.6
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EXCEPT
AS SET FORTH HEREIN, ALLOSOURCE MAKES NO WARRANTIES, EXPRESS OR
IMPLIED, WITH RESPECT TO THE PRODUCTS INCLUDING, WITHOUT
LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR WARRANTY OF FITNESS
FOR A PARTICULAR PURPOSE.
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4.1
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Tutogen
shall have the right to process all Tissue and Processed Tissue for
distribution and to further process and distribute all Allografts
supplied by AlloSource under this Agreement.
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4.2
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Products
supplied to Tutogen shall be packaged and labeled by AlloSource in
accordance with all applicable laws and
regulations. Tutogen shall be solely responsible for the
content of all final product labeling. No identifying
information of AlloSource, including, without limitation, the name
AlloSource or any proprietary mark of AlloSource, shall appear on
the label or documentation of the Products unless required by
law.
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4.3
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Tutogen
acknowledges and agrees that AlloSource has in the past and shall
be permitted currently and in the future to distribute tissue and
allografts that are similar to or substantially the same as the
Products in the same and different territories as
Tutogen. Notwithstanding anything to the contrary in
this Agreement, Tutogen agrees that AlloSource has the right to
directly or indirectly recover, process, market, distribute and
perform research utilizing any and all tissue and allografts
worldwide. The Parties acknowledge and agree that
AlloSource may continue to process human bone and tissue to produce
tissue and allografts under any other agreements or arrangements
AlloSource has now or in the future and that the provision of such
tissue, bone and allografts may adversely affect AlloSource’s
ability to meet its requirements under this
Agreement. AlloSource will use reasonable business
efforts to mitigate such a situation and supply as much of the
ordered Tissue and Processed Tissue as possible.
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5.
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Regulatory Compliance:
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5.1.
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AlloSource
shall maintain Donor specific information (including information
supplied to Tutogen) in accordance with AlloSource specifications
and all applicable laws and regulations. This
responsibility shall survive the expiration or termination of this
Agreement for a period of ten (10) years beyond the date of
distr
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