TISSUE RECOVERY AGREEMENT BETWEEN OSTEOTECH, INC. AND COMMUNITY BLOOD CENTER d/b/a COMMUNITY TISSUE SERVICES
Exhibit 10.1
TISSUE RECOVERY AGREEMENT BETWEEN
OSTEOTECH, INC.
AND
COMMUNITY BLOOD CENTER d/b/a COMMUNITY TISSUE SERVICES
AGREEMENT
This Agreement is made as of March 1, 2006 by Community Blood Center d/b/a Community Tissue
Services, a nonprofit corporation organized under the laws of the state of Ohio (“CTS”), and
Osteotech, Inc. (“Osteotech”), a Delaware corporation as follows:
WHEREAS, Osteotech provides high-quality tissue processing services (“Processing” or
“Process(es)”) and other related services to entities engaged in recovering human bone and related
connective soft tissue for transplantation (collectively, “Bone Tissue”); and
WHEREAS, Osteotech is engaged in the distribution of Bone Tissue which it Processes to
hospitals, surgeons and other end-users (collectively, “End-Users”); and
WHEREAS, CTS currently recovers Bone Tissue and other human cadaveric tissue (such tissue
together with Bone Tissue being called “Tissue”); and
WHEREAS, CTS desires to provide certain of the Bone Tissue it receives to Osteotech for
processing and distribution; and
WHEREAS, Osteotech desires to process and distribute the Bone Tissue provided to it by CTS.
NOW, THEREFORE, the parties agree as follows:
1. | DELIVERY AND PROCESSING OF BONE TISSUE. |
1.1 CTS Commitment to Deliver Bone Tissue to Osteotech.
1.1.1. Osteotech Engagement of CTS.
(a) Osteotech hereby engages CTS to provide to Osteotech, and CTS agrees to provide to
Osteotech, the following type of Bone Tissue: cortical shafts * * * * * *, as more fully specified on Exhibit B hereto (the
“Specifications”) which are recovered by, on behalf or under the supervision of CTS (the “CTS
Recovered Tissue”). The CTS Recovered Tissue provided by CTS to
Osteotech shall be * * * * * * by CTS in accordance with the Recovery Standards,
provided that in no event will the CTS Recovered Tissue provided to
Osteotech be * * * * * * * * * * * *. Osteotech shall be entitled to reject CTS Recovered
Tissue in the event CTS does not comply with the Recovery Standards (as hereinafter defined).
Eligibility for transplant shall be the responsibility of CTS’ Medical Director. CTS shall not be
required to provide Osteotech with a full chart regarding eligibility for transplant.
(b) Osteotech
shall have * * * days to reject CTS Recovered Tissue. Osteotech shall have
the right to reject CTS Recovered Tissue in the event CTS fails to perform the processes set forth
in subsection (a) and/or in the event of damage during shipping, or failing to meet the
specifications stated on Exhibit B. In the event of rejection, no Tissue
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Recovery Fee shall be payable by Osteotech to CTS and Osteotech shall return such rejected Bone
Tissue to CTS.
(c) CTS shall provide tissue to Osteotech in accordance with this subsection, provided that
tissue is available after the needs of all of the local communities served by CTS have been fully
met and after all of CTS’ other contractual commitments for the provision of tissue have been
fulfilled. CTS shall provide * * * units of donor Bone Tissue per calendar month. From
time-to-time, either party may provide non-binding forecasts to assist the parties in their
respective business planning, but any such forecasts shall not be binding until the issuance of a
written purchase order by Osteotech and written acceptance of such purchase order by CTS.
1.1.2. Costs of Recovery and Delivery; Services to be Provided by CTS.
Osteotech will reimburse
CTS in accordance with the fee schedule set forth in Exhibit
C for its costs of (i) recovering CTS Recovered Tissue and (ii) performing the additional
services set forth in Exhibit C (the “Tissue Reimbursement Fees”). CTS shall have the right
* * * * * * * * * * * *.
Notwithstanding the foregoing, in the event of an extraordinary event (e.g. changes in laws,
regulations, etc.) which substantially increase CTS’ costs, and such costs are documented to
Osteotech’s satisfaction, the parties will negotiate in good faith new prices, which such new price
would be effective for any future Bone Tissue deliveries, and failing agreement on such price
changes either party may terminate this Agreement. Osteotech shall pay all invoices for tissue
received by it from CTS within not more than * * * days of the date on each invoice. CTS
shall have the right to impose a charge of * * * % per month on the unpaid balance of any past due
amount owed by Osteotech and the right to refuse to respond to future orders issued by Osteotech
until all such past due amounts have been paid in full.
(a) Compliance with Recovery Standards. All CTS Recovered Tissue delivered to
Osteotech for Processing and distribution hereunder shall conform to all standards, guidelines,
rules, regulations and laws applicable to the donation, recovery, and eligibility of Tissue (the
“Recovery Standards”). Without limiting the generality of the foregoing, CTS will (i) audit all
Tissue recovery sites and ensure that they comply with AATB standards, and (ii) audit laboratory
test sites for compliance with all Recovery Standards. CTS will provide to Osteotech external audit
reports which result in unfavorable results. Except as set forth in Section 1.1.1 (a), the Recovery
Standards shall include applicable standards and requirements relating to donor referral, informed
consent, tissue recovery, pre-processing storage, packaging and shipping of pre-processed Tissue
and all records, activities and standards related to obtaining, testing, documenting and evaluating
serological test results and microbiological testing results; obtaining, documenting and evaluating
medical history and lifestyle data; and related organizational, management and quality assurance
activities as may be contained in: (i) applicable laws, regulations, and guidelines of the United
States Food and Drug Administration (“FDA”); (ii) applicable standards and guidelines promulgated
by the American Association of Tissue Banks (“AATB”); (iii) applicable laws and regulations of
other U.S. federal, state and local government agencies with jurisdiction over the recovery and
distribution of human musculoskeletal tissue; (iv) applicable laws and regulations where such CTS
Recovered Tissue
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delivered to Osteotech hereunder is recovered by, or on behalf or under the supervision of, CTS;
(v) CTS’s standard operating procedures (“SOPs”), as they may be amended from time to time by CTS;
and (vi) Osteotech’s standards for recovered Tissue, as defined in Exhibit A, to the extent
applicable to CTS Recovered Tissue, as specified in Osteotech’s SOPs, as such standards may be
amended from time to time by Osteotech and as provided to CTS in advance of their effectiveness. If
interpretation of the Recovery Standards is required or if there is a disagreement about the
interpretation of the Recovery Standards, CTS and Osteotech will attempt to negotiate a resolution
in good faith in accordance with Section 20.
(b) Standard Operating Procedures. CTS and Osteotech shall each make available to the
other party for such other party’s review a copy of its current SOPs relating to Tissue recovery
upon reasonable prior notice of a request to review such SOPs made by such other party.
Notwithstanding anything else in this Agreement to the contrary, Osteotech will review CTS’ SOPs
and inform CTS if the SOPs are deficient.
(c) Audit Rights. Upon reasonable prior notice to CTS, and at its own expense,
Osteotech shall have the right to conduct audits of CTS’s facilities and records to ensure CTS’s
compliance with the terms of this Agreement, as well as with all applicable laws, regulations and
standards enumerated in Section 1.1.2(a) and (b) above. CTS will consider all reasonable actions
necessary to correct any deficiencies identified in any of such audits. If CTS decides not to
implement any recommended actions, Osteotech’s sole remedy shall be termination of this Agreement
(d) Certificate of Donor Eligibility. CTS shall provide Osteotech with a copy of the
serological test results, pre-processing culture results, donor consent, process quality checklist,
and a Certificate of Donor Eligibility (but not a full chart) with each donor of Bone Tissue that
is delivered to Osteotech. Such Certificate of Donor Eligibility, in a form acceptable to both CTS
and Osteotech, shall be signed by CTS’ Medical Director. Osteotech shall review the eligibility of
each such donor for release to processing by Osteotech, utilizing the serological test results and
the Certificate of Donor Eligibility provided by CTS. After such review, Osteotech will have * * * days from receipt to reject Bone Tissue for Processing by written notice to CTS.
1.2 Processing Responsibilities and Distribution Rights of Osteotech.
1.2.1. General Undertaking. Processing and packaging of CTS Recovered Tissue received
and accepted by Osteotech pursuant to this Agreement into then currently available finished units
of Bone Tissue shall be conducted by Osteotech. Osteotech hereby agrees and acknowledges that the
Bone Tissue provided by CTS will require further * * * * * * * * * *
* *.
(a) Osteotech shall promote and distribute all finished Tissue forms processed from Bone
Tissue delivered to Osteotech by CTS hereunder to End-Users as
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determined solely by Osteotech. Osteotech shall distribute such Bone Tissue and related products
and shall be entitled to charge End-Users fees for Osteotech’s Bone Tissue Processing, distribution
and education services as determined by Osteotech in accordance with all applicable laws and
regulations.
(b) Osteotech shall be entitled to use Bone Tissue provided to it by CTS for research and
development purposes if the informed consent signed at the time such Bone Tissue was recovered
allows such Bone Tissue to be used for medical research and development purposes.
(c) Osteotech represents and warrants that it will comply with all (i) applicable laws,
regulations, and guidelines of the FDA; (ii) applicable standards and guidelines promulgated by the
AATB; (iii) applicable laws and regulations of other U.S. federal, state and local government
agencies with jurisdiction over the recovery and distribution of human musculoskeletal tissue; (iv)
CTS’s SOPs, as they may be amended from time to time by CTS; (v) Osteotech’s standards for
recovered Tissue, to the extent applicable to CTS Recovered Tissue, as specified in Osteotech’s
SOPs, as such standards may be amended from time to time by Osteotech and as provided to CTS in
advance of their effectiveness; and (v) CTS Processing standards.
2. | STORAGE, SHIPPING, REGULATORY COMPLIANCE AND LABELING. |
2.1 Possession and Storage of Tissue.
(a) CTS Recovered Tissue delivered by CTS to Osteotech for Processing and any finished units
or other byproducts derived from such Bone Tissue shall be held by Osteotech in the public trust at
all times until distributed by Osteotech. Neither CTS nor Osteotech shall have any ownership or
other property right in any such Bone Tissue, finished units or other by-products and shall not
allow any third party to obtain any such right (whether in the nature of a lien, security interest,
encumbrance, or otherwise). Neither CTS nor Osteotech shall sell, trade, or otherwise dispose of or
imply that it is selling, trading or otherwise disposing of, banked human tissue, provided,
that this shall not prohibit Osteotech from (i) distributing Processed or unprocessed Bone Tissue
or marketing its Processing techniques and other services; (ii) utilizing Bone Tissue for medical
research and development purposes; and (iii) properly disposing of Bone Tissue that does not meet
quality assurance standards or regulatory requirements, in compliance with applicable law.
(b) Specifications for all Bone Tissue products to be Processed by Osteotech from CTS
Recovered Tissue will be developed by Osteotech.
(c) ***** will provide
storage for all Bone Tissue donors recovered for
Osteotech *****.
(d) *** shall pay all shipping costs associated with delivery by CTS to Osteotech. ***
shall pay all shipping costs associated with Bone Tissue rejected in accordance with Section
1.1.1(b).
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2.2 Certain Joint Compliance Responsibilities.
(a) CTS shall comply with applicable laws, regulations and guidelines as required under
Section 1. Osteotech shall comply with applicable laws regulations and guidelines as required under
Section 1. In instances where the parties’ compliance responsibilities overlap, or where otherwise
necessary and appropriate, each party shall use commercially reasonable efforts to cooperate with
and assist the other party in such other party’s regulatory compliance activities.
(b) If either party becomes aware of anything which affects the eligibility assessment of a
donor, compliance with Recovery Standards, or problems with Processing, it shall promptly notify
the other party thereof in writing.
(c) The Tissue from Bone Tissue delivered by CTS, shall conform to the Recovery Standards. CTS
and Osteotech shall provide each other a copy of its SOPs and copies of any material amendments to
its SOPs promptly after such amendments are adopted; provided, however, that doing so will not
require such party to disclose any trade secrets, technical know how or unpublished scientific data
or technical art. If interpretation of the Standards is required or if there is a disagreement
about the interpretation of the Standards, CTS and Osteotech will attempt to negotiate a resolution
in good faith in accordance with Section 20. In the event the FDA, any other applicable regulatory
agency or the AATB, implements new or additional regulations applicable to Tissue, Osteotech and
CTS shall each implement such changes to its SOPs as are necessary to comply with such regulations.
In the event that either party has failed to or is unable to implement such changes in respect of
Tissue by the effective date of such changes, the other party shall have the remedy set forth in
Section 7.
2.3 Regulatory Issues
(a) Osteotech will handle all complaints with respect to any Tissue distributed to End-Users
hereunder. Any issues arising under such complaints relevant to initial processing or eligibility
will be forwarded to CTS for response, with both parties cooperating to resolve any such complaints
in a timely manner.
(b) Osteotech will address all recalls, deviations, adverse reactions, and the like, with the
costs of recall or any corrective action to be borne by the party responsible for the error or
failure causing such recall.
(c) Osteotech will address all regulatory requirements regarding processed Bone Tissue, with
CTS providing any assistance or information necessary for Osteotech to do so effectively and in a
timely manner.
(d) CTS will promptly provide Osteotech with a list of all testing laboratories used for
serological and microbiological testing, copies of applicable tissue bank registrations and
certifications, and a list of any tissue recovery organizations utilized by it other than CTS
itself or its staff, and notify Osteotech promptly of any changes thereto.
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2.4 Labeling.
(a) Individual packages of finished units of CTS Recovered Tissue Processed by Osteotech will
bear a standard Osteotech bone product label that contains the product name and identity code,
donor number and expiration date, and to the extent required by applicable laws or regulations, a
statement that such Bone Tissue was recovered by CTS. The label shall also indicate that such Bone
Tissue was Processed and distributed by Osteotech.
2.5 Indemnification.
(a) Osteotech agrees to defend, hold harmless, and indemnify CTS against any damages,
litigation costs (including, without limitation, reasonable attorney’s fees and costs), losses,
obligations, liabilities, claims, actions or causes of action sustained or suffered by CTS arising
from: (i) a breach of Osteotech’s obligations hereunder; or (ii) a defect in any finished unit of
CTS Recovered Tissue processed by Osteotech under this Agreement to the extent such defect results
from an error or omission by Osteotech (including any employee or agent of Osteotech or other
person to whom Osteotech has delegated any Processing or Processing related activities hereunder),
or from a failure of workmanship by Osteotech.
(b) CTS agrees to defend, hold harmless, and indemnify Osteotech against any damages,
litigation costs (including, without limitation, reasonable attorney’s fees and costs), losses,
obligations, liabilities, claims, actions or causes of action sustained or suffered by Osteotech
arising from (i) a breach of CTS’s obligations hereunder; (ii) a defect in any finished unit of CTS
Recovered Tissue processed by Osteotech under this Agreement to the extent such defect results from
an error or omission by CTS (including any employee or agent of CTS or other person to whom CTS has
delegated any Bone Tissue recovery or Bone Tissue recovery related activities hereunder), in
connection with CTS’s Bone Tissue recovery activities, including without limitation any testing
performed by or at the direction of CTS; or (iii) any donor eligibility determination made by CTS
(including any employee or agent of CTS or other person to whom CTS has delegated any donor
eligibility determination responsibility).
(c) For purposes of subsection (a) above, Osteotech shall be the “indemnifying party” and CTS
shall be the “indemnified party” and for the purposes of subsection (b) above, CTS shall be the
“indemnifying party” and Osteotech shall be the “indemnified party.” The obligations and
liabilities of the indemnifying party hereunder with respect to claims resulting from the assertion
of liability by third parties shall be subject to the following terms and conditions:
(i) The indemnified party shall give written notice to the indemnifying party of any
assertion of liability by a third party which might give rise to a claim by the indemnified
party against the indemnifying party based on the indemnity contained in Section 2.5(a)
hereof, or Section 2.5(b) hereof, as the case may be, stating the nature and basis of said
assertion and the amount thereof, to the extent known, within five (5) business days after an
officer of the indemnified party learns of the claim or receives notice thereof. Failure to
give such notice within five (5) business days may, at the indemnifying party’s option, result
in a reduction in any subsequent
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indemnification payment by an amount equivalent to the expenses and/or losses demonstrated to
have been caused by such delay in notification.
(ii) In the event any action, suit or proceeding is brought against the indemnified
party, with respect to which the indemnifying party may have liability under the indemnity
agreement contained in Section 2.5(a) or Section 2.5(b) hereof, as the case may be, the
action, suit or proceeding shall, upon the written agreement of the indemnifying party that it
is obligated to indemnify under the indemnity agreement contained in Section 2.5(a) or Section
2.5(b) hereof, as the case may be, be defended (including all proceedings on appeal or for
review which counsel for the defendant shall deem appropriate) by the indemnifying party. The
indemnified party shall have the right to be represented by advisory counsel and accountants,
at its own expense, and shall be kept fully informed of such action, suit or proceeding at all
stages thereof, whether or not it is so represented. The indemnifying party shall make
available to the indemnified party and its attorneys and accountants all books and records of
the indemnifying party relating to such proceedings or litigation. The parties will render to
each other such assistance as they may reasonably require in order to ensure the proper and
adequate defense of any such action, suit or proceeding.
(iii) The indemnifying party shall not make any settlement of any claims without the
written consent of the indemnified party, which consent shall not be unreasonably withheld or
delayed.
(iv) The indemnified party shall not make any settlement of any claims without the
written consent of the indemnifying party.
(d) The provisions of this Section 2.5 shall survive termination of this Agreement.
3. | RECORDS AND REPORTS. |
(a) CTS will obtain and maintain complete and accurate records as required of CTS by the
Recovery Standards (including without limitation donor medical and behavioral history, donor life
style information, and, if applicable, serology and microbiological testing). CTS will retain such
records for the time periods required by the Recovery Standards. Such records shall be available to
Osteotech, only to the extent required by the Recovery Standards, during normal business hours upon
reasonable advance notice at Osteotech’s expense.
(b) Each of Osteotech and CTS shall maintain an SOP which will set forth procedures pursuant
to which it will provide information to regulatory authorities as may be required by applicable
laws and regulations. Such SOP will specify the contact person at each of Osteotech and CTS who
will be responsible for providing such information and interacting with such regulatory
authorities.
(c) Osteotech shall maintain complete and accurate records concerning CTS Recovered Tissue
received by Osteotech, Processed and in storage at Osteotech and finished units of CTS Recovered
Tissue stored and distributed by Osteotech. Osteotech shall retain such records for the time
periods required by the Recovery Standards. Such records shall
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be available to CTS, only to the extent required by the Recovery Standards, during normal business
hours upon reasonable advance notice at CTS’s expense.
(d) Osteotech shall ensure that all information pertaining to CTS will be disclosed only to
those Osteotech personnel with a need-to-know who have signed Osteotech’s standard confidentiality
agreement.
(e) Osteotech shall notify CTS prior to the release of any CTS donor identifying information,
such as the donor identifying number, where such release is legally required by a regulatory or
governmental agency or court or administrative order or subpoena. The provisions of this Section
3(e) shall survive termination of this Agreement.
4. | Section intentionally left blank. |
5. CONFIDENTIALITY AND CERTAIN OTHER COVENANTS.
5.1 Non-Disclosure of Confidential Information.
(a) For purposes of this Agreement, “Confidential Information” means all general and specific
knowledge, experience and information that is confidential and of value to CTS or to Osteotech,
including without limitation, formulations, designs, products, processes, supplies, methods of
manufacture or processing, SOPs, cost data, master files, the nature of research and/or development
projects, as well as data relating thereto, marketing or business plans, donor data and financial
data. It shall also mean any information disclosed to either party by any third party which either
CTS or Osteotech is obligated to treat as confidential or proprietary.
(b) Both parties agree that neither party will, at any time, without the express written
agreement of the other party, or except as expressly permitted by this Agreement, disclose to any
other person or use any Confidential Information of the other party, except for the purposes of
performing this Agreement or any successor Agreement or as may be required by law, governmental
regulation or court order. Information shall not be considered to be Confidential Information of a
party if it can be established that (i) such information was in the possession of the other party
prior to disclosure to such other party by the party claiming that it is Confidential Information
and such information is not otherwise subject to a confidentiality agreement, (ii) such information
is then part of the public domain and became so without the breach of this or any other
confidentiality agreement by such other party or any of its affiliates, or (iii) such information
is developed independently by such other party or becomes known to or acquired by such other party
by means other than as a result of a breach of a confidentiality agreement or any fiduciary
obligation.
(c) CTS and Osteotech will hold in confidence, and each agree to take commercially reasonable
steps to cause its employees, consultants or others granted access to such Confidential Information
to hold in confidence, all information identified as Confidential Information consistent with the
obligations of CTS and Osteotech under this section 5.1.
(d) CTS and Osteotech each recognize that violation in any material respect of any provision
of this Section 5.1 may cause irreparable injuries to Osteotech or CTS
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and agree that CTS or Osteotech shall be entitled to preliminary and final injunctive relief
against such violation. Such injunctive relief shall be in addition to, and in no way in limitation
of, any and all remedies or rights which CTS or Osteotech shall have at law or in equity for the
enforcement of the provisions of this Section 5.1. In addition, CTS and Osteotech agree that the
party responsible for the breach of confidentiality shall be responsible for all legal fees and
other costs and expenses incurred in the successful enforcement of the non-breaching party’s rights
and remedies under this Section 5.1. The provision of this Section 5.1 shall survive the
termination of this Agreement in accordance with its terms.
5.2 Certain Representations and Warranties..
(a) Each of Osteotech and CTS represents and warrants to the other that (i) its execution of
this Agreement and the performance of its obligations hereunder will not conflict with or result in
the breach of or default under any other agreement to which it is subject or by which it is bound,
(ii) it will, in the performance of its obligations hereunder, comply with all applicable laws,
rules and regulations, (iii) its performance of its obligations hereunder will not violate or
infringe the intellectual property rights of any third party, and (iv) it has all the rights and
licenses necessary to perform its obligations hereunder without violating or infringing such
rights.
5.3 AATB Accreditation. CTS and Osteotech will maintain (a) AATB accreditation as
tissue banks and (b) FDA tissue bank registration.
6. | TERM OF AGREEMENT. |
This Agreement shall become effective as of the date first above written and continue for a
period of five (5) years; unless terminated earlier in accordance with the provisions hereof. This
Agreement shall renew for successive two (2) year renewal terms, unless either party shall have
notified the other party in writing of its intention not renew the Agreement no later than one
hundred and eighty (180) days prior to the end of the initial term or any renewal term.
7. | TERMINATION. |
Either party may terminate this Agreement at any time upon:
(a) The material breach by the other party of any of its obligations under this Agreement, if
such breach shall not be cured within thirty (30) days after written notice thereof is given by the
non-breaching party to the breaching party; or
(b) An adjudication of the other party as bankrupt or insolvent; or the admission in writing
by such other party of its inability to pay its debts as they mature; or an assignment by such
other party for the benefit of its creditors; or such other party applying for or consenting to the
appointment of a receiver, trustee or similar officer for its assets; or the appointment of a
receiver, trustee or similar officer for such other party’s assets without the application or
consent of such other party, if such appointment shall continue undischarged for a period of ninety
(90) days; or such other party instituting (by petition, application, answer, consent or otherwise)
any bankruptcy, insolvency arrangement or similar proceeding relating to it under the laws of any
jurisdiction; or the institution of any bankruptcy, insolvency arrangement
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or similar proceeding relating to such other party, if such proceeding shall remain
undismissed for a period of ninety (90) days; or the issuance or levy of any judgment, writ,
warrant of attachment or execution or similar process against a substantial part of the property or
assets of such other party, if such judgment, writ, warrant of attachment or execution or similar
process shall not be released, vacated or fully bonded within ninety (90) days after its issue or
levy.
(c) CTS may terminate this Agreement at any time upon one hundred eighty (180) days prior
written notice to Osteotech if CTS makes a determination to end its program of recovering Bone
Tissue; provided that if CTS resumes such program at any time during the original term of this
Agreement, either under the name of CTS or any other name, it shall provide prompt written notice
of such resumption to Osteotech and this Agreement shall become effective again in accordance with
its terms as soon as is practicable, but in no event later than ninety (90) days after such notice
is received by Osteotech. It is understood and agreed that CTS’s sale, assignment or other transfer
of its Bone Tissue recovery operations or its assets shall not provide CTS or its successor to such
operations or assets with the right to terminate this Agreement under this Section 7. or otherwise.
In the event of any such assignment sale or transfer by CTS of its Bone Tissue recovery operations
or its assets, CTS must assign this Agreement to such successor and such successor shall be
required to comply with all of CTS’s obligations hereunder. Osteotech shall have the right to
approve any such assignment and assumption.
(d) Either Party may terminate this Agreement at any time upon 30 days’ prior written notice
to Osteotech if the FDA or any applicable regulatory agency has made the determination (after any
good faith appeal of such determination by Osteotech) described in Section 2.2(c) to the extent
such provisions are applicable to Osteotech. Osteotech may terminate this Agreement at any time
upon 30 days’ prior written notice to CTS if the FDA or any applicable regulatory agency has made
the determination (after any good faith appeal of such determination by CTS) described in Section
2.2(c) to the extent such provisions are applicable to CTS.
(e) In the event that Osteotech is directly or indirectly acquired or directly or indirectly
becomes controlled by the Musculoskeletal Transplant Foundation Inc. (MTF) or Biocon Inc. (whether
by asset purchase, equity purchase, merger, consolidation or otherwise) during the term of this
Agreement, or during any renewal period, CTS shall have the immediate right to terminate this
Agreement.
8. INSURANCE.
(a) Osteotech
shall obtain and maintain in force during the term of this Agreement product
liability insurance coverage, under a policy or policies with minimum limits of $*** and no
more than a $*** deductible, on a claims made or occurrence basis. Osteotech shall immediately
notify CTS if coverage is cancelled. If a claims made policy is cancelled, Osteotech shall obtain
tail/extended reporting period coverage equivalent to two (2) policy years and provide proof of
such coverage to CTS. Upon execution of this Agreement, Osteotech shall provide CTS with a
certificate or certificates of insurance suitable to CTS which state(s) that the above required
coverage is in full force and effect and that the insurance carrier will provide not less than
thirty (30) days prior written notice of cancellation or material changes
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to the policy or policies to both the insured party and the party to whom such certificate is
issued. Maintenance of such insurance shall not relieve Osteotech of any liability under this
Agreement.
(b) CTS shall obtain and maintain in force during the term of this Agreement professional
liability insurance coverage, under a policy or policies with minimum limits of $*** and no
more than a $*** deductible, on a claims made or occurrence basis. CTS shall immediately notify
Osteotech if coverage is cancelled. If a claims made policy is cancelled, CTS shall obtain
tail/extended reporting period coverage equivalent to two (2) policy years and provide proof of
such coverage to Osteotech. Upon execution of this Agreement, CTS shall provide Osteotech with a
certificate or certificates of insurance suitable to Osteotech which state(s) that the above
required coverage is in full force and effect and that the insurance carrier will provide not less
than thirty (30) days prior written notice of cancellation or material changes to the policy or
policies to both the insured party and the party to whom such certificate is issued. Maintenance of
such insurance shall not relieve CTS of any liability under this Agreement.
(c) The parties acknowledge the difficulty in providing in this Agreement for all possible
future developments relating to the availability and cost of the required insurance policies.
Should a party discover during the term of this Agreement that meeting the insurance requirements
of this Section 8, including but not limited to the minimum limits or maximum deductibles, is in
its estimation commercially prohibitive, it shall give written notice to the other party. Key
executives from each party shall arrange to meet within 30 days of receipt of the notice to
determine if different insurance coverage is acceptable. The party not requesting a change in
insurance coverage shall have the right to give notice to terminate this Agreement immediately upon
the latter to occur of (i) the expiration of the aforementioned thirty (30) day period if the
notifying party had participated in negotiations in good faith and still the parties have failed to
come to a mutually agreeable resolution, and (ii) the date upon which the party receiving the
notice of termination actually fails to satisfy all of the applicable insurance requirements set
forth in this Agreement.
9. FORCE MAJEURE.
Neither party shall be responsible to the other for nonperformance or delayed performance of
the terms and conditions hereof due to acts of God, acts of government, wars, riots, accidents and
transportation, fuel or material shortages, or other causes (except strikes), in the nature of
force majeure which is beyond its control.
10. BINDING AGREEMENT; ASSIGNMENT.
Except as otherwise expressly herein provided, this Agreement may not be assigned in whole or
in part without the prior written consent of the other party, provided that either party may assign
its rights under the Agreement to any majority-owned subsidiary of such party without the consent
of the other party, provided that such subsidiary agrees in writing to be bound by the terms and
conditions of this Agreement. In any event Osteotech and CTS and their
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respective subsidiaries shall be subject to and bound by the terms and conditions of this Agreement
to the extent any of them are engaged in the recovery and distribution or Processing of Tissue, as
the case may be.
11. NAME, EMBLEM, PACKAGING, TECHNOLOGY AND TRADEMARK.
(a) The respective trademarks, trade names and other source identifiers of the parties are set
forth on Exhibit D hereto. Except to the extent Osteotech indicates in any literature, including
without limitation promotional materials, that CTS recovers Tissue Processed by Osteotech, that CTS
has provided particular Tissue to Osteotech and that CTS has determined its medical eligibility,
without the prior written consent of CTS, Osteotech shall have no right to use the trademark or
emblem of CTS in connection with its Processing or distribution activities or to use the name of
CTS for commercial purposes; provided, however, Osteotech may disclose CTS’s name as may be
required by law, government regulation or court order.
(b) CTS shall not have the right to use any trademark or emblem of Osteotech, including the
name Osteotech, without the prior written consent of Osteotech; provided, however, CTS may disclose
Osteotech’s name as may be required by law, government regulation or court order.
(c) (i) Nothing in this Agreement shall be interpreted to convey to CTS any trademark, patent
or proprietary technology owned by Osteotech;
(ii) Nothing in this Agreement shall be interpreted to convey to Osteotech any trademark,
patent, or proprietary technology owned by CTS.
12. NOTICES.
All notices and other communications provided for hereunder shall be in writing and shall be
mailed by certified mail, return receipt requested, telecopied, with a copy sent promptly
thereafter by U.S. mail, or delivered by hand or overnight delivery, as follows.
If to CTS: | Chief Executive Officer | |||
Community Blood Center, Community | ||||
Tissue Services | ||||
000 Xxxxx Xxxx Xxxxxx | ||||
Xxxxxx, Xxxx 00000-0000 | ||||
Telephone No. (000) 000-0000 | ||||
Telecopy No. (000) 000-0000 | ||||
If to Osteotech: | Chief Executive Officer | |||
Osteotech, Inc. | ||||
00 Xxxxx Xxx | ||||
Xxxxxxxxx, Xxx Xxxxxx 00000 | ||||
Telephone No. (000) 000-0000 | ||||
Telecopy No. (000) 000-0000 |
12
or such other person or address as either party may designate by written notice to the other
party complying as to delivery with the terms of this Section 12. All such notices and other
communications shall be effective (i) if mailed by certified or registered mail, when received as
indicated by the return receipt, (ii) if telecopied, when transmitted, as indicated by the
facsimile transmission report, provided same is on a business day in the U.S. (excludes weekends
and federal holidays) and, if not, on the next business day, or (iii) if delivered, upon delivery,
provided same is on a business day and, if not, on the next business day.
13. ENTIRE AGREEMENT.
This Agreement and the Exhibits thereto set 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 not expressly set forth in this Agreement are of no force
or effect. This Agreement may be executed in counterparts, both of which together shall constitute
a single agreement.
14. MODIFICATION.
This Agreement, or any part of section of it, may not be amended or modified except by the
written consent of both parties to the Agreement.
15. APPLICABLE LAW.
This Agreement shall be construed in accordance with the laws of the State of Ohio, without
giving effect to any conflict of laws principles.
16. WAIVER.
Waiver or 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.
17. INDEPENDENT CONTRACTOR.
CTS is providing its services hereunder as an independent contractor. Nothing herein shall
create any affiliation, partnership or joint venture between the parties hereto, or any
employer/employee relationship.
18. SEVERABILITY.
The provisions of this Agreement shall be severable, and if a court of competent jurisdiction
holds any provisions of this Agreement to be in violation of any applicable law, the remaining
provisions shall nevertheless remain in full force and effect.
19. SUCCESSORS.
This Agreement shall be binding upon and inure to the benefit of the parties and their
permitted successors and assigns.
13
20. DISPUTE RESOLUTION
Osteotech will arrange with CTS to hold regular meetings to discuss issues that may arise
under this Agreement. If a dispute arises between the parties under this Agreement, CTS and
Osteotech will first attempt to negotiate a resolution in good faith within thirty (30) days of
notice of such dispute. If the difference is not resolved by the parties, then any action brought
by either party hereto shall be brought only in the appropriate court in the State of Ohio.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly
authorized officers as of the date first written above.
COMMUNITY BLOOD CENTER d/b/a COMMUNITY TISSUE SERVICES |
||||
By: | /s/ Xxxxx X. Xxxxxx | |||
Print Name: | Xxxxx X. Xxxxxx | |||
Title: | COO Tissue | |||
OSTEOTECH, INC. |
||||
By: | /s/ Xxx Xxxxx-Akyaw | |||
Print Name: | Xxx Xxxxx-Akyaw | |||
Title: | Chief Executive Officer | |||
(Legal Stamp)
14
Exhibit A
Osteotech Eligibility Criteria
15
Criteria for Determining Donor Eligibility
Authorization for Anatomical Gift
Donation (Informed Consent) — ************
Age Criteria for Bone and
Soft Tissue The age criteria is *** years old and up. For specific details
refer to the incoming donor specification.
Time Limits for Tissue Recovery The following table indicates the maximum allowable times for
tissue recovery per current AATB Standards:
Item
|
Body Storage Conditions | Start Recovery Within:* | Warm Ischemic Time cannot exceed | |||
Musculoskeletal
Tissue
|
Cooled or refrigerated within 12 hours of asystole | 24 hours of asystole | N/A | |||
Not cooled or refrigerated | 15 hours of death | N/A |
* | Start time begins with first incision |
Donor Physical Assessment Criteria ************
Autopsy Report ************
Medical/Sexual/Social History — ************
Medical History and Medical Records Review — ************
Criteria for the Evaluation of Infectious
Disease Tests — ************
16
Screening Test Abbreviation
|
Screening Test Full Name | |
***
|
***** | |
***
|
***** | |
***
|
***** | |
***
|
***** | |
*** |
***** | |
*** |
***** | |
***
|
***** | |
***
|
***** | |
*** |
***** | |
*** |
***** |
1 | ***** ***** |
*****
*****
*****
Microbiological
Recovery Culture Criteria—
*****
*****
*****
*****
*****
*****
*****
*****
*****
*****
*****
*****
17
Doc. No. SDP 265-007 | Attachment A | |||
OSTEOTECH INC. LOGO)"/> |
||||
Rev. Date: xx/xx/2005 | Page 1 of 11 |
Osteotech Inc. Tissue Donor Medical/Behavioral Conditions
(For any unlisted conditions consultation of the Medical Director is required)
(For any unlisted conditions consultation of the Medical Director is required)
CONDITION/BEHAVIOR | DECISION | |||
***
|
***** | *** | ||
***
|
***** | *** | ||
***
|
***** | *** | ||
***
|
***** | *** | ||
***
|
***** | *** |
18
Doc. No. SDP 265-007 | Attachment A | |||
OSTEOTECH INC. LOGO)"/> |
||||
Rev. Date: xx/xx/2005 | Page 2 of 11 |
Osteotech Inc. Tissue Donor Medical/Behavioral Conditions
(For any unlisted conditions consultation of the Medical Director is required)
(For any unlisted conditions consultation of the Medical Director is required)
CONDITION/BEHAVIOR | DECISION | |||
*** |
***** | *** | ||
***
|
***** | *** | ||
***
|
***** | *** | ||
***
|
***** | *** | ||
*** |
***** | *** |
19
Doc. No. SDP 265-007 | Attachment A | |||
OSTEOTECH INC. LOGO)"/> |
||||
Rev. Date: xx/xx/2005 | Page 3 of 11 |
Osteotech Inc. Tissue Donor Medical/Behavioral Conditions
(For any unlisted conditions consultation of the Medical Director is required)
(For any unlisted conditions consultation of the Medical Director is required)
CONDITION/BEHAVIOR | DECISION | |||
*** |
***** | *** | ||
*** |
***** | *** | ||
*** |
***** | *** | ||
*** |
***** | *** | ||
*** |
***** | *** | ||
20
Doc. No. SDP 265-007 | Attachment A | |||
OSTEOTECH INC. LOGO)"/> |
||||
Rev. Date: xx/xx/2005 | Page 4 of 11 |
Osteotech Inc. Tissue Donor Medical/Behavioral Conditions
(For any unlisted conditions consultation of the Medical Director is required)
(For any unlisted conditions consultation of the Medical Director is required)
CONDITION/BEHAVIOR | DECISION | |||
*** |
***** | *** | ||
*** |
***** | *** | ||
*** |
***** | *** | ||
*** |
***** | *** | ||
*** |
***** | *** | ||
21
Doc. No. SDP 265-007 | Attachment A | |||
OSTEOTECH INC. LOGO)"/> |
||||
Rev. Date: xx/xx/2005 | Page 5 of 11 |
Osteotech Inc. Tissue Donor Medical/Behavioral Conditions
(For any unlisted conditions consultation of the Medical Director is required)
(For any unlisted conditions consultation of the Medical Director is required)
CONDITION/BEHAVIOR | DECISION | |||
*** |
***** | *** | ||
*** |
***** | *** | ||
*** |
***** | *** | ||
*** |
***** | *** | ||
*** |
***** | *** | ||
22
Doc. No. SDP 265-007 | Attachment A | |||
Rev. Date: xx/xx/2005 | Page 6 of 11 |
Osteotech Inc. Tissue Donor Medical/Behavioral Conditions
(For any unlisted conditions consultation of the Medical Director is required)
(For any unlisted conditions consultation of the Medical Director is required)
CONDITION/BEHAVIOR | DECISION | |||
*** | ****
|
*** | ||
*** | ****
|
*** | ||
*** | ****
|
*** | ||
*** | ****
|
*** | ||
*** | ****
|
*** | ||
23
Doc. No. SDP 265-007 | Attachment A | |||
Rev. Date: xx/xx/2005 | Page 7 of 11 |
Osteotech Inc. Tissue Donor Medical/Behavioral Conditions
(For any unlisted conditions consultation of the Medical Director is required)
(For any unlisted conditions consultation of the Medical Director is required)
CONDITION/BEHAVIOR | DECISION | |||
*** | ****
|
*** | ||
*** | ****
|
*** | ||
*** | ****
|
*** | ||
*** | ****
|
*** | ||
*** | ****
|
*** | ||
24
Doc. No. SDP 265-007 | Attachment A | |||
Rev. Date: xx/xx/2005 | Page 8 of 11 |
Osteotech Inc. Tissue Donor Medical/Behavioral Conditions
(For any unlisted conditions consultation of the Medical Director is required)
(For any unlisted conditions consultation of the Medical Director is required)
CONDITION/BEHAVIOR | DECISION | |||
*** |
***** |
*** | ||
*** |
***** |
*** | ||
*** |
***** |
*** | ||
*** |
***** |
*** | ||
*** |
***** |
*** |
25
Doc. No. SDP 265-007 | Attachment A | |||
Rev. Date: xx/xx/2005 | Page 9 of 11 |
Osteotech Inc. Tissue Donor Medical/Behavioral Conditions
(For any unlisted conditions consultation of the Medical Director is required)
(For any unlisted conditions consultation of the Medical Director is required)
CONDITION/BEHAVIOR | DECISION | |||
*** |
***** |
*** | ||
*** |
***** |
*** | ||
*** |
***** |
*** | ||
*** |
***** |
*** | ||
*** |
***** |
*** |
26
Doc. No. SDP265-007 | Attachment A | |||
Rev. Date: xx/xx/2005 | Page 10 of 11 |
Osteotech Inc. Tissue Donor Medical/Behavioral Conditions
(For any unlisted conditions consultation of the Medical Director is required)
CONDITION/BEHAVIOR | DECISION | |||
*** |
***** |
*** | ||
*** |
***** |
*** | ||
*** |
***** |
*** | ||
*** |
***** |
*** | ||
*** |
***** |
*** |
27
Doc. No. SDP265-007 | Attachment A | |||
Rev. Date: xx/xx/2005 | Page 11 of 11 |
Osteotech Inc. Tissue Donor Medical/Behavioral Conditions
(For any unlisted conditions consultation of the Medical Director is required)
CONDITION/BEHAVIOR | DECISION | |||||
*** |
***** |
*** | ||||
*** |
***** |
*** | ||||
*** |
***** |
*** | ||||
*** |
***** |
*** | ||||
*** |
***** |
*** |
28
Exhibit B
Specification for Cortical Shafts
Age |
||||||
Males | *** | |||||
Females | *** | |||||
Bone Tissue |
||||||
***** | **** | |||||
***** | **** | |||||
If Available, |
||||||
***** | **** | |||||
***** |
29
Exhibit C
Tissue Reimbursement Fee Schedule
$*** per unit of donor Bone Tissue
30