TISSUE PROCUREMENT, PROCESSING AND SUPPLY AGREEMENT Entered into this 1st day of October, 2007 Between AlloSource Centennial, Colorado 80111 And Tutogen Medical (US), Inc. 13709 Progress Blvd. Alachua, Florida 32615
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 ””
[***]”.
Entered
into this 1st day of October, 2007
Between
AlloSource
0000
X. Xxxx Xxxxxx
Xxxxxxxxxx,
Xxxxxxxx 00000
And
Tutogen
Medical (US), Inc.
00000
Xxxxxxxx Xxxx.
Xxxxxxx,
Xxxxxxx 00000
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 0000 X. Xxxx
Xxxxxx, Xxxxxxxxxx, XX 00000, and Tutogen Medical (US), Inc. (“Tutogen”), a
Florida corporation, with offices located at 00000 Xxxxxxxx Xxxx. Xxx 00,
Xxxxxxx, XX 00000, (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:
|
1.
|
Definitions:
|
Unless
otherwise stated in this Agreement:
|
1.1.
|
“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.
|
|
1.2.
|
"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.
|
|
1.3.
|
“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.
|
|
1.4.
|
“Products”
shall mean Tissue, Processed Tissue and
Allografts.
|
|
1.5.
|
"Tissue"
shall mean human musculoskeletal tissues (soft tissue and bone)
recovered
by AlloSource for Tutogen which meet the Acceptance Criteria described
in
Exhibit C.
|
|
2.
|
Term
and Termination:
|
|
2.1.
|
Term.
This Agreement shall commence on the Effective Date and continue
in full
force and effect for five (5) years (“Initial
Term”).
|
-2-
|
2.2.
|
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.
|
|
2.3.
|
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.
|
|
2.4.
|
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.
|
|
2.5.
|
Termination. This
Agreement may further be terminated as
follows:
|
|
2.5.1.
|
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;
|
|
2.5.2.
|
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;
|
|
2.5.3.
|
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
|
|
2.5.4.
|
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.
|
|
2.6.
|
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.
|
|
3.
|
Responsibilities
and Obligations:
|
|
3.1.
|
Supply
of Tissue and Processed Tissue
|
-3-
|
3.1.1.
|
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.
|
|
3.1.2.
|
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.
|
|
3.1.3.
|
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.
|
|
3.2.
|
Supply
of Allografts
|
|
3.2.1.
|
Tutogen
has supplied AlloSource with Allograft designs, which AlloSource
shall
treat as confidential, in accordance with the provisions of Section
7.
|
|
3.2.2.
|
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.
|
|
3.2.3.
|
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.
|
|
3.2.4.
|
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.
|
|
3.3.
|
Forecasts
and Orders
|
|
3.3.1
|
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.
|
|
3.3.2
|
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.
|
|
3.3.3
|
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).
|
-4-
|
3.3.4
|
AlloSource
shall ship Products to Tutogen at the following
address:
|
Tutogen
Medical, Inc.
13709
Progress Blvd., Box 19
South
Wing
Xxxxxxx,
XX 00000
|
|
3.3.5
|
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.
|
|
|
3.3.6
|
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.
|
|
4.
|
Distribution:
|
|
4.1
|
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.
|
|
4.2
|
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 xxxx
of
AlloSource, shall appear on the label or documentation of the Products
unless required by law.
|
|
4.3
|
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.
|
|
5.
|
Regulatory
Compliance:
|
|
5.1.
|
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 distribution, date of transplantation
(if known), date of disposition, or date of expiration of the Products
(whichever is longer) or longer if required by applicable federal,
state
and local laws or regulations. Information shall include such
records as may be appropriate and necessary to assure that the
identification and notification of recipients of Products provided
under
this Agreement may occur, in the event that it becomes necessary
and
appropriate to make such identification and
notification.
|
|
5.2.
|
Both
Parties agree to comply with all applicable federal, state and
local
standards, laws and regulations, such as the AATB Standards for
Tissue
Banking and FDA regulatory
requirements.
|
-5-
|
5.3.
|
Tutogen
shall obtain at its expense all regulatory approval of the FDA
or other
authority necessary or required for the manufacture and distribution
of
Products. Tutogen shall be the sole and exclusive owner of all
regulatory approvals in the United States necessary or required
for the
manufacture and distribution of
Products.
|
|
5.4.
|
Each
Party is obligated to notify the other Party, within ten (10) calendar
days, of receipt of any written notification from the AATB, U.S.
FDA or
other applicable regulatory body of a failure to comply with any
applicable standards or requirements. Failure to provide such
notification may result in termination of this Agreement as indicated
in
Section 2.5.3.
|
|
5.5.
|
Tutogen
shall be responsible for maintaining traceability for all Products
provided by AlloSource and distributed by Tutogen. Tracking records
shall
be maintained by Tutogen in accordance with applicable AATB and
U.S. FDA
standards and regulations. Tutogen shall promptly notify
AlloSource of any product complaint or adverse event alleging serious
patient injury or risk that is associated with Products provided
to
Tutogen by AlloSource. Such notification shall include
necessary tracking data, on a per Donor basis, for all implicated
Products
recovered by AlloSource and shipped to
Tutogen.
|
|
5.6.
|
Both
Parties reserve the right to conduct reasonable, periodic audits
of the
other Party’s operations to assess compliance with AATB, FDA, or other
regulatory agency requirements. Such audits shall be scheduled
in advance
and shall be performed at a date and time convenient to the audited
Party. Results of all audits will be provided to the audited
Party within thirty (30) days following completion of the audit
and may
include recommendations for improvement. Results of such audits
will be considered confidential in nature and will not be released
to any
third party without the prior written consent of the other
Party.
|
|
5.6.1.
|
In
connection with an audit, without limitation, AlloSource shall
permit
Tutogen, or any authorized agent of Tutogen, to review recovery
data
maintained by AlloSource. The audited data shall be limited to
those records and standard operating procedures pertaining to the
Tissue
recovered for Tutogen.
|
|
5.6.2.
|
In
connection with an audit, without limitation, Tutogen shall permit
AlloSource, or any authorized agent of AlloSource, to review product
traceability data for Products provided by AlloSource. The audited
data
shall be limited to those records and standard operating procedures
pertaining to the Products provided by AlloSource to Tutogen or
needed for
an Allograft.
|
|
5.7.
|
Policies
and Procedures. Each Party shall have coordinated policies
and procedures for handling Products covered by this Agreement,
including,
but not limited to: (i) customer complaints; (ii) the reporting
and
investigation of errors or adverse events that may affect the safety,
purity, or potency of a Product; (iii) implementation of corrective
and
preventive action; (iv) Product process investigations; and (v)
Product
recalls. These procedures shall outline notification timelines
that are
consistent with all applicable laws and regulations. Upon
written request a Party shall make such policies and procedures
available
to the other Party for review and comment. In accordance with Section
7 of
this agreement, the receiving Party shall treat all such policies
and
procedures as confidential.
|
|
5.8.
|
Complaints. Tutogen
and AlloSource shall each provide the other with written notification
of
any formal complaint or adverse event alleging serious patient
injury or
risk related to Products supplied by AlloSource to Tutogen, or
any product
incorporating such Products, within five (5) working days of the
Party’s
receipt of notification of such complaint or adverse
event. Each Party agrees to provide reasonable assistance and
cooperation to the other Party in the investigation and resolution
of any
such complaint or adverse event; provided that, Tutogen shall have
final
authority over all decisions concerning products that it manufactured
from
the Tissue, Processed Tissue or Allografts in question and responsibility
for all communication with any third party related to such
products.
|
-6-
|
5.9.
|
Product
Recalls. In the event either Party believes it
may be necessary to conduct a recall, field correction, market
withdrawal,
stock recovery, or other similar action with respect to any Products,
or
any product incorporating such Tissue or Processed Tissue (a
“Recall”), Tutogen and AlloSource shall consult with each other as to how
best to proceed. It is understood and agreed that the final
decision relative to any Recall of product(s) manufactured by Tutogen
shall be made by Tutogen and the final decision as to any Recall
of
Products provided by AlloSource shall be made by AlloSource; provided,
however, that either Party shall not be prohibited hereunder from
taking
any action that it feels may be necessary in order to comply with
applicable laws or regulations, or, in its opinion, to maintain
its
reputation in the industry. In the event of a product or
Product recall, the following shall
apply:
|
|
5.9.1.
|
If
a recall is due solely to negligence, error, omission or action
on the
part of Tutogen, then Tutogen shall bear the entire cost associated
with
such recall, including the costs incurred by AlloSource. Such AlloSource
expenses shall be itemized and provided to Tutogen for payment
or credit
issuance.
|
|
5.9.2.
|
If
a recall is due solely to negligence, error, omission or action
on the
part of AlloSource, then AlloSource shall bear the entire cost
associated
with such recall, including the costs incurred by Tutogen. Such
Tutogen expenses shall be itemized and provided to AlloSource for
payment
or credit issuance.
|
|
5.9.3.
|
In
all other cases, the cost associated with a recall shall be borne
in
proportion to the negligence, error, omission or action of each
Party that
resulted in the Recall.
|
|
6.
|
Fees
and Payments:
|
Tutogen
shall reimburse AlloSource for Products ordered by Tutogen as indicated in
Exhibit D (Reimbursement Fee Schedule). The reimbursement fee
is limited to costs associated with obtaining, handling and providing such
Products; there is no charge associated with the Tissue itself, which is
donated. The Reimbursement Fee is due and payable to AlloSource
within thirty (30) days following receipt of invoice. Tutogen may
withhold payment of any amounts that it has notified AlloSource in writing
are
in dispute, pending resolution by both Parties. Any amounts past due (other
than
amounts subject to a bona fide dispute) shall accrue interest at a rate of
the
lesser of one and one-half percent (1.5%) per month or the maximum rate allowed
by law.
|
7.
|
Confidentiality:
|
Each
Party shall ensure the confidentiality of the other Party’s Confidential
Information it receives by taking substantially the same precautions as it
does
with its own Confidential Information, but not less than a reasonable standard
of care. Neither Party shall, during the period of this Agreement and
for three (3) years thereafter, use the other Party’s Confidential Information
for any purpose other than to carry out its obligations
hereunder. The obligations of confidentiality shall not apply to
information that the receiving Party is required by applicable laws to disclose;
provided, however, that the receiving Party shall so notify the disclosing
Party
of its intent to disclose and cooperate with the non-disclosing Party at
the
non-disclosing Party’s expense on reasonable measures to protect the
confidentiality of the non-disclosing Party’s Confidential
Information. Each Party may disclose Confidential Information
received pursuant to this Agreement to its directors, officers, employees,
consultants, attorneys and accountants provided that such persons and entities
are obligated to hold the Confidential Information in confidence in accordance
with restrictions and procedures no less stringent than provided for
herein. The Parties hereto understand and agree that this Section 7
is reasonable and necessary to protect AlloSource’s and Tutogen’s respective
business interests. The Parties further agree that the other may
suffer irreparable harm from a breach of this Section 7. Thus, in
addition to any other rights or remedies, all of which shall be deemed
cumulative, a Party shall be entitled to pursue injunctive relief to enforce
the
terms of this Section 7. For purposes of this Section, “Confidential
Information” means information, which is disclosed by a Party to the other Party
in whatever media, and is marked, identified or otherwise acknowledged to
be
confidential at the time of disclosure; provided that information shall not
be
deemed “Confidential Information” which is (a) publicly known, through no fault
of the other party, (b) received by the other party from a source having
the
right to disclose such information, (c) known by the other party prior to
disclosure of such information, or (d) independently developed by the other
party without use of the disclosing party’s information.
-7-
|
8.
|
Notices:
|
Required
notices to be given under this Agreement shall be deemed duly administered
upon
personal delivery or receipt by certified mail, return receipt requested
and
addressed as follows:
Tutogen:
XXXXXX
XXXXXX
TUTOGEN
MEDICAL (US), INC.
00000
XXXXXXXX XXXXXXXXX
XXXXX
XXXX
XXXXXXX,
XXXXXXX 00000
AlloSource:
XXXXX
XXXXX
ALLOSOURCE
0000 X. XXXX XXXXXX
XXXXXXXXXX, XX 00000
Or
such other person or address as
either Party may designate in writing.
-8-
|
9.
|
Entire
Agreement:
|
This
Agreement sets forth the entire agreement between the Parties. Any
prior agreements, promises, negotiations, or representations, either oral
or
written, relating to the subject matter of this Agreement and not expressly
set
forth in this Agreement are of no force or effect. This Agreement
specifically supersedes the Recovery Agreement, which is hereby terminated
as of
the Effective Date of this Agreement.
|
10.
|
Modification:
|
This
Agreement, or any part or section of it, may not be amended or modified except
by the mutual written consent of both Parties.
|
11.
|
Applicable
Law:
|
This
Agreement shall be governed by and construed in accordance with the laws
of the
State of Colorado.
|
12.
|
Waiver:
|
Waiver
of
a breach of any provision of this Agreement shall not be deemed a waiver
of any
other breach of the same or a different provision of this
Agreement.
|
13.
|
Severability:
|
The
individual provisions of this Agreement shall be severable and, if a court
of
competent jurisdiction holds any provision(s) of this Agreement to be in
violation of any applicable law, the remaining provisions shall remain in
full
force and effect.
|
14.
|
Assignability:
|
This
Agreement shall be binding upon and inure to the benefit of the Parties and
their successors and assigns. This Agreement and all rights under it
shall not be assignable by either Party without the prior written consent
of the
other, provided that AlloSource may assign this Agreement in whole or in
part to
a subsidiary or affiliate of AlloSource without the prior written consent
of
Tutogen.
|
15.
|
Indemnification:
|
Tutogen
agrees to indemnify, defend and hold harmless, AlloSource, its officers,
directors, employees, subsidiaries, agents and affiliates from and against
any
and all claims, liability and expenses, including reasonable attorneys’ and
experts’ fees and costs, which arise as a result of (i) Tutogen’s negligence or
willful misconduct, (ii) Tutogen’s processing, labeling, packaging or
distribution of allografts produced from Tissue or Processed Tissue shipped
to
Tutogen by AlloSource under this Agreement, (iii) any breach of this Agreement
by Tutogen, (iv) the distribution of Allografts by Tutogen, (v) the Allograft
Specifications attached hereto as Exhibit B, or (vi) any actual or alleged
infringement of any patent or other property right relating to any actual
or
apparent intellectual property of Tutogen, including, without limitation,
the
methods of processing the Tissues or producing the
Allografts. AlloSource agrees to indemnify, defend and hold harmless,
Tutogen, its officers, directors, employees, subsidiaries, agents and affiliates
from and against any and all claims, liability and expenses, including
reasonable attorneys’ and experts’ fees and costs, which arise as a result of
(i) AlloSource’s negligence or willful misconduct, (ii) any breach of this
Agreement by AlloSource (iii) non-compliance with the Allograft Specifications
set forth in Exhibit B or (iv) any actual or alleged infringement of any
patent or other property right relating to any actual or apparent intellectual
property of AlloSource, including, without limitation, the methods of processing
the Tissues or producing the Allografts.
-9-
|
16.
|
Insurance:
|
Each
Party agrees to procure and maintain in full force and effect during the
term of
this Agreement, at its sole cost and expense, general and professional liability
and product liability insurance in amounts of not less than $5,000,000 per
incident and $5,000,000 annual aggregate, which insurance shall be written
on a
“occurrence” basis policy form, with a reputable insurance carrier and name the
other Party as an additional insured. Each Party shall, on request,
provide to the other Party a copy of a certificate of coverage or other written
evidence reasonably satisfactory to such requesting Party of such insurance
coverage.
|
17.
|
Limitation
of Liability:
|
In
no
event shall either Party be liable, whether as a result of contractual breach,
tort or otherwise, to the other Party for any consequential, special, or
incidental damages incurred by such other Party, including but not limited
to
injury to goodwill, or indirect or speculative lost profits unless such
liability results from the gross negligence or willful misconduct of the
other
Party. The foregoing Limitation of Liability shall not apply to the
Parties’ respective confidentiality obligations hereunder or to the Parties’
indemnification obligations regarding infringement of third party intellectual
property rights.
|
18.
|
Force
Majeure:
|
In
the
event that one Party fails to perform any obligation under this Agreement
as a
result of a strike, lockout or other labor difficulty, fire, explosion, flood,
earthquake, embargo, act of war, terrorism, Act of God, regulation or
restriction of Government or law, failure of suppliers, public utilities
or
common carrier or any other occurrence or circumstances beyond the reasonable
control of such Party (“Force Majeure”), that Party shall not be liable in
damages or otherwise for failure to perform its obligations hereunder and,
in
addition, such failure shall constitute grounds for the other Party to terminate
this Agreement only if such Force Majeure event prevents the other Party
from
performing its obligations under this Agreement for more than ninety (90)
consecutive days. In the event of a protracted strike, lockout or
other labor difficulty, lasting for six (6) months or longer, AlloSource
or
Tutogen may elect to terminate this Agreement immediately by providing written
notice to the other Party. Both Parties hereby agree that each will
use reasonable business efforts to remedy a Force Majeure event.
|
19.
|
Intellectual
Property:
|
Tutogen
is the sole and exclusive owner of all right, title and interest in and to
its
products and in all of Tutogen’s patents, trademarks, inventions, copyrights,
know-how, and trade secrets. Tutogen does not grant AlloSource any
right to use such patents, trademarks, inventions, copyrights, know-how and
trade secrets except as set forth herein. To the best of its
knowledge, Tutogen represents and warrants that its patents, trademarks,
inventions, copyrights, know-how, and trade secrets do not infringe any property
right of any third party. AlloSource is the sole and exclusive owner
of all right, title and interest in and to its products and in all of
AlloSource’s patents, trademarks, inventions, copyrights, know-how and trade
secrets. AlloSource does not grant Tutogen any right to use such
patents, trademarks, inventions, copyrights, know-how and trade
secrets. To the best of its knowledge, AlloSource represents and
warrants that its patents, trademarks, inventions, copyrights, know-how,
and
trade secrets do not infringe any property right of any third
party. Tutogen and AlloSource each shall have the right, in its sole
discretion and at its own expense, to control the preparation, prosecution,
and
maintenance of patent applications and patents covering only its own
intellectual property, and to select all patent counsel or other professionals
to advise, represent or act for it in all matters relating to such patent
applications and patent prosecution.
|
20.
|
Independent
Contractors:
|
The
relationship between AlloSource and Tutogen, established by this Agreement,
is
that of independent contractors. Neither Party shall have authority
to conclude contracts or otherwise to act for or bind the other Party in
any
manner, whatsoever, as agent or otherwise.
-10-
|
21.
|
Representations
and Warranties:
|
Each
of
the Parties represents and warrants that (i) it is fully authorized to enter
into this Agreement; (ii) its entering into and performance under this Agreement
does not violate or breach its Certificate of Incorporation or corporate
bylaws
or any agreement or contract to which it is a party; (iii) there is no claim,
demand, action, suit, proceeding or investigation pending or currently
threatened against it or any of its affiliates involving or relating to any
tissues or products of Tutogen incorporating tissues, or which, if adversely
determined, would restrict it from entering into this Agreement and carrying
out
its obligations under this Agreement; and (iv) it has no legal obligations
which
would prevent this Agreement from being fully implemented in accordance with
its
terms.
|
22.
|
Disposal
of Tissues:
|
If
Products provided under this Agreement are deemed by Tutogen as not acceptable
for transplantation, Tutogen shall provide written notice to AlloSource of
the
reason for unacceptability. AlloSource shall either require return of Tissue
to
AlloSource or authorize Tutogen to dispose of the Tissue in accordance with
applicable laws and regulations. Tutogen shall provide to AlloSource a
disposition record for each such Tissue that is discarded and, at Tutogen’s
request, AlloSource will issue credit memos, where
appropriate. Notwithstanding the foregoing, Tutogen shall pay for all
Products delivered by AlloSource pursuant to this Agreement unless such Product
fails to substantially comply with the Allograft Specifications attached
as
Exhibit B or the Tissue Acceptance Criteria attached as Exhibit C.
|
23.
|
Signatures
and Counterparts:
|
Signatures
of the Parties may be transmitted via facsimile and this Agreement may be
executed in one or more counterparts, each of which shall be deemed an original
and all of which shall constitute together the same document.
|
24.
|
Survival:
|
The
covenants contained in Sections 2.6, 4, 5.1, 5.4, 5.5, 5.7, 5.8, 5.9 7, 8,
11,
15, 17, 19 and 22 shall survive any termination or expiration of this
Agreement.
IN
WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their
duly authorized officers as of the date first written
above.
ATTEST: TUTOGEN
MEDICAL (US), INC.
______________________________ By:
______________________________________
Date
XXXXXX
XXXXXX DATE
CHIEF OPERATING OFFICER
ATTEST:
ALLOSOURCE:
______________________________ By:_______________________________________
Date
J. XXXXX
XXXXX DATE
EXECUTIVE VICE PRESIDENT
-11-
TUTOGEN
MEDICAL (US), INC. – ALLOSOURCE
EXHIBITS
|
|
A.
|
Tissue
and Allograft Requirements
|
|
|
B.
|
Allograft
Specifications
|
|
|
C.
|
Tissue
Acceptance Criteria
|
|
|
D.
|
Reimbursement
Fee Schedule
|
|
|
E.
|
Donor
Acceptance
Criteria
|
-12-
EXHIBIT
A
TISSUE
AND ALLOGRAFT REQUIREMENTS
[***]
-13-
.
EXHIBIT B
ALLOGRAFT
SPECIFICATIONS
[***]
-14-
EXHIBIT
C
TISSUE
ACCEPTANCE CRITERIA
[***]
-15-
EXHIBIT
D
REIMBURSEMENT
FEE SCHEDULE
[***]
-16-
EXHIBIT
E
DONOR
ACCEPTANCE CRITERIA
(See
attached document)
[***]
-17-
