Exhibit 10.1
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

AMENDED AND RESTATED
CONTRACT MANUFACTURING AND SUPPLY AGREEMENT
This Amended and Restated Contract Manufacturing and Supply Agreement (the
“Agreement”) amends and restates in its entirety as of April 20, 2016 (the
"Amendment Effective Date") the agreement made and entered into as of November
8, 2010 by and between Vericel Corporation (formerly Aastrom Biosciences, Inc.),
a Michigan corporation having a principal place of business· at Domino's Farms,
Lobby K, 24 Frank Lloyd Wright Drive, Ann Arbor, Ml, 48105 ("Vericel") and
Vention Medical Inc. (formerly ATEK Medical, LLC), having its principal place of
business at 620 Watson SW, Grand Rapids, Ml, 49504 ("Supplier").
RECITALS
WHEREAS, Vericel manufactures a stem cell product for use in clinical trials;
WHEREAS, Supplier desires to manufacture Vericel's proprietary cell cassette
(the "Product") for use in their manufacturing process; and
NOW, THEREFORE, in consideration of the foregoing and of the mutual covenants
and agreements hereinafter set forth, and subject to the terms and conditions of
this Agreement, the parties agree as follows:
1.
PRODUCTS

Vericel shall purchase from Supplier and Supplier shall manufacture for Vericel
the Product as further set forth on Appendix A attached hereto at the facility
specified therein, (the “Facility”), and assemble, package, label, and
coordinate the sterilization of the Product in facilities approved by Vericel,
in accordance with the terms of this Agreement.
2.
OBLIGATIONS

2.1
Supplier's Obligations.

2.1.1
Sterilization Cost. Supplier will include the cost of gamma sterilization in the
Product unit cost. Supplier shall arrange for initial sterilization validations
and Vericel requested re-validations using mutually approved protocols. The cost
for development of protocols, execution of the validation, and writing of the
sterilization final report shall be paid for by Vericel at a pre-approved cost.
Supplier will coordinate sterilization schedules and will generate purchase
orders for sterilization to a Vericel approved contract sterilization company.
Subsequent certificates of sterilization will be provided by the contract
sterilization company to Supplier. Supplier shall forward such certificates to
Vericel upon shipment of Product and will be included in the Product unit price.
In the event of a failed sterilization, Vention shall be responsible for the
sterilization costs of such product.

2.1.2
Quarterly Dose Audits. Supplier will coordinate the execution of quarterly dose
audits related to sterilized Product using a mutually approved standard
operating procedure. Vericel will provide a purchase order for the periodic dose
audits with associated bioburden and sterility testing. Any Supplier requested
modifications requiring re-validation will be performed at Supplier's expense.

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

2.1.3
Purchasing. Supplier is responsible for obtaining all Vericel approved
components pertaining to the Product including those for manufacturing,
assembly, packaging, labeling and sterilization in accordance with the schedule
and quantities outlined on Appendix A attached hereto and Sections 10.1 and
10.2, unless otherwise noted in Appendix A of this Agreement. Supplier will
order components against pre-approved purchase specifications and will receive
components against pre-approved incoming inspection plans.

2.1.4
Schedule. Supplier will ship the Product in accordance with Sections 10.1 and
10.2 of this Agreement.

2.1.5
Production Affecting Events. Supplier will notify Vericel of any plant shut
down, manufacturing delay, or other event about which Supplier is aware that
would result in the inability of Supplier to provide Product. Vericel will be
notified within two days of any shutdown or other information that may impede
Supplier in the manufacture of the Product.

2.1.6
Sustaining. Supplier shall provide reasonable ongoing manufacturing support of
the Product in order to satisfy production requirements outlined in Appendix A
and Section 10.

2.2
Vericel Obligations.

2.2.1
Purchasing. Vericel shall order and purchase the Product from Supplier as
provided in Appendix A attached hereto and Section 10, as amended from time to
time by mutual consent.

2.2.2
Engineering Support. Vericel shall provide Supplier with reasonable engineering
support to initiate, maintain and ramp up manufacturing of the Product,
including training, substitute part validation and sterilization validation.

2.2.3
Obsolescence. If Vericel decides to make obsolete a component of the Product,
Vericel shall reimburse Supplier at cost for any remaining inventory of such
component and work in process to the extent that such inventory and work in
process can be converted into finished Products, but not to exceed [***] months
of the Forecast (as defined in Section 10) Product demand or as agreed to in
writing by both parties.

2.2.4
Tooling for External Suppliers. Vericel shall be responsible for costs in
connection to routine tooling maintenance performed by any external supplier
appointed by Vericel.

3.
EQUIPMENT & CALIBRATION

All manufacturing equipment will be supplied by Vericel. Supplier's calibration
group will calibrate all applicable equipment within its capabilities.
Calibration requirements for each piece of equipment will be agreed upon
individually and provided in writing to Supplier by Vericel. For all special
equipment or processes requiring calibration, Supplier will consult with Vericel
on requirements prior to taking action towards setup and routine calibration.
Additional expenses required for special calibration requirements will be agreed
upon in advance and submitted to Vericel for payment.
4.
CONFIDENTIALITY

It is anticipated that Vericel and Supplier will need to exchange confidential
information. All such information concerning the subject matter of this
Agreement is to be considered confidential by the receiving party whether
received orally, visually, or in written form. In the event of any conflict

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

between this Section 4 and any prior confidentiality agreement entered into
between the parties, the confidentiality provisions herein shall control.
During the Term (as defined in Section 8) all confidential information disclosed
hereunder shall be used by the recipient solely for the purpose of this
Agreement and shall not be used in any way for its own account or for the
account of any third party, or disclosed to third parties, nor to those within
the recipient's company who do not have a need to know such information.
Said obligations of confidentiality shall not apply to any information which:
a)
was in the possession of the recipient before disclosure hereunder as evidenced
by written records; or

b)
is or becomes known to the public through no fault of the recipient party; or

c)
is information received by the recipient from a third party who is under no
obligation to the disclosing party to maintain such information as confidential;
or

d)
is developed by the recipient independent of any disclosure hereunder as
evidenced by written records.

All confidential information shall at all times remain the property of the
disclosing party, and shall be returned to the disclosing party along with all
copies thereof, immediately upon request by the disclosing party.
No disclosure of confidential information shall be deemed to vest in the
receiving party any rights in any patents, trade secrets, or intellectual
property or other property of the disclosing party, other than as set forth in
this Agreement.
5.
DESIGN CONTROL AND SPECIFICATIONS; RECORDS; REGULATORY CONTACT

5.1
General. Supplier shall only manufacture the Product to Vericel's specifications
and shall not change materials, specifications, design/configuration,
procedures, packaging or labeling without Vericel’s prior written consent.
Vericel may reject any Product lots that are defective or otherwise do not
conform to Vericel's specifications, drawings, or to Vericel's purchase orders.

5.2
Changes by Vericel. Vericel may change specifications from time to time as
needed, (e.g. to meet market requirements, comply with regulatory requirements,
improve Product function or quality, or lower Product cost). Any changes in
specifications shall be conveyed to Supplier in writing. Supplier shall confirm,
in writing, its receipt of Vericel's changes and shall use its commercial best
efforts to implement the documented changes within forty-five (45) days of
notification unless otherwise agreed upon. Once changes are implemented,
Supplier shall immediately advise Vericel in writing of the first Product lot to
contain the changes.

Vericel shall purchase from Supplier any affected finished goods that are in a
usable condition and comply with all Vericel specifications, components or raw
materials inventory and work in process to the extent that such inventory and
work in process can be converted into finished Products, that Supplier has
purchased or completed at Supplier's actual cost, in aggregate quantities not to
exceed the actual accumulated monthly production from Vericel purchase orders
for [***] days preceding

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

notice of discontinuation of the affected components of the Product or unless
otherwise mutually agreed in writing. However, Supplier agrees to make
commercially best efforts to minimize the financial impact to Vericel by
optimizing the procurement of materials for minimal scrap once Vericel notifies
Supplier of such changes.
If any Vericel specification change directly affects the prices or schedule of
the Product, a reasonable adjustment for such increased costs of Supplier shall
be made, provided that Supplier makes and Vericel accepts a written claim for an
adjustment prior to manufacturing the Product. Price adjustments shall be
limited to the affected component or process and shall not constitute an
opportunity to renegotiate any other aspects of this Agreement or the
manufacture of the Product. If the parties are unable to agree upon the amount
of the adjustment, Vericel may, without liability to Supplier, terminate this
Agreement as to all or part of the affected Products.
5.3
Changes by Supplier. Supplier may recommend design or specification changes to
Vericel but no such changes will be incorporated into the Product without
Vericel's prior written approval and without following appropriate documentation
change procedures. Such Supplier proposed changes shall be made at Vericel's
expense.

5.4
Discontinuation of Product. Vericel may discontinue the manufacture of the
Product at its sole discretion. In the event Vericel decides to discontinue the
manufacture of the Product, Vericel shall use commercially reasonable efforts to
notify Supplier at least one hundred eighty (180) days prior to Vericel's
intention to discontinue manufacture of the Product. Failure to provide Supplier
prior notice shall not be a breach of this Agreement; provided, however, if
Vericel does not give Supplier one hundred eighty (180) days prior notice,
Vericel agrees to purchase from Supplier any finished goods that are in a usable
condition and comply with all Vericel specifications, component or raw materials
inventory and work in process to the extent that such inventory and work in
process can be converted into finished Products, that Supplier has purchased or
completed at Supplier's actual cost, in aggregate quantities not to exceed the
actual accumulated monthly production from Vericel purchase orders for [***]
days preceding notice of discontinuation of the Product.

5.5
Records. Supplier will keep complete and accurate records (including reports,
accounts, notes, raw data, and records of all information and results obtained
from performance of services) of all work done by it under this Agreement, in
form and substance as specified in the applicable Quality Agreement and this
Agreement (collectively, the “Records”). All such Records will be the property
of Vericel. Supplier will not transfer, deliver or otherwise provide any such
Records to any party other than Vericel, without the prior written approval of
Vericel. Records will be available at reasonable times for inspection,
examination and copying by or on behalf of Vericel. All original Records of the
Manufacture of Product under this Agreement will be retained and archived by
Supplier in accordance with cGMP (if applicable) and Applicable Law, but in no
case for less than a period of five (5) years. Upon Vericel’s request, Supplier
will promptly provide Vericel with copies of such Records. Five (5) years after
completion of services, all of the aforementioned Records will be sent to
Vericel or Vericel’s designee; provided, however, that Vericel may elect to have
such Records retained in Supplier’s archives for an additional period of time at
a reasonable charge to Vericel.

5.6
Regulatory Approvals. Vericel will be responsible for obtaining, at its expense,
all regulatory and governmental approvals and permits necessary for Vericel’s
use of any Product developed and/or manufactured under this Agreement, including
investigational new drug application, biologics license application, new drug
application, and abbreviated new drug application submissions and

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

any analogous submissions filed with the appropriate regulatory authority of a
country other than the United States. Supplier will be responsible for providing
Vericel with all supporting data and information relating to the development
and/or manufacture of Product necessary for obtaining such approvals, including
all (i) Records, (ii) batch documentation, (iii) authorizations, certificates,
methodologies, raw material specifications, SOPs, standard test methods, and
other documentation (collectively, “Supporting Documentation”) in the possession
or under the control of Supplier relating to the development and manufacture of
Product (or any intermediate or component of Product).

5.7
Regulatory Inspections. Supplier will promptly notify Vericel of any visit or
inspection by any regulatory authority of the Facility. Supplier will provide
Vericel with a copy of any report or other written communication received from
such regulatory authority in connection with such visit or inspection (assuming
the same relates to Product), and any written communication received from any
regulatory authority relating to any Product, the Facility (if it relates to or
affects the development and/or manufacture of Product) or the manufacturing
process, within [***] after receipt, and will consult with Vericel prior to
submitting a response to the applicable regulatory authority; provided, however,
that the response specifically relates to Product. Supplier will provide Vericel
with a copy of its final responses within [***] business days after submission.

6.
FACILITY; QUALITY

6.1
Supplier will perform all services at the Facility, provide all staff necessary
to perform the services in accordance with the terms of this Agreement, and hold
at such Facility all equipment, Vericel materials and other items used in the
services. Supplier will not change the location of such Facility or use any
additional facility for the performance of services under this Agreement without
at least one hundred eighty (180) days prior written notice to, and prior
written consent from, Vericel, which consent will not be unreasonably withheld
or delayed (it being understood and agreed that Vericel may withhold consent
pending satisfactory completion of a quality assurance audit and/or regulatory
impact assessment of the new location or additional facility, as the case may
be). Supplier will maintain, at its own expense, the Facility and all equipment
required for the manufacture of Product in a state of repair and operating
efficiency consistent with the requirements of cGMP (if applicable) and all
applicable law. For clarification, no Facility shall be located outside of the
continental United States.

6.1.1
Validation. Supplier will be responsible for performing all validation of the
Facility, equipment and cleaning and maintenance processes employed in the
manufacturing process in accordance with cGMP (if applicable), Supplier’s SOPs,
the applicable Quality Agreement (if any), applicable law, and in accordance
with any other validation procedures established by Vericel and made known in
writing to Supplier. Supplier will also be responsible for ensuring that all
such validated processes are carried out in accordance with their terms.

6.1.2
Licenses and Permits. Supplier will be responsible for obtaining, at its
expense, any Facility or other licenses or permits, and any regulatory and
government approvals necessary for the performance of services by Supplier under
this Agreement. At Vericel’s request, Supplier will provide Vericel with copies
of all such approvals and submissions to regulatory authorities, and Vericel
will have the right to use any and all information contained in such approvals
or submissions in connection with regulatory approval and/or commercial
development of Product.

6.2
Access to Facility. Supplier will permit Vericel or its duly authorized
representatives to observe and consult with Supplier during the performance of
services under this Agreement, including the

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

manufacturing of any batch of Product. Supplier also agrees that Vericel and its
duly authorized agents will have reasonable access upon advance prior notice, at
a mutually agreeable date and time, during operational hours and during active
manufacturing, to inspect the Facility and manufacturing process to ascertain
compliance by Supplier with the terms of this Agreement, including inspection of
(i) the equipment and materials used in the performance of services; (ii) the
warehouse facilities for such materials and Equipment; and (iii) all Records
directly relating to such services and the Facility. Vericel will also have the
right, at its expense (including payment for the time and expenses incurred by
Vention personnel in supporting the “mock” pre-approval audits (“Mock Audits”),
to be invoiced by Vention and paid by Vericel), to conduct Mock Audits upon
reasonable prior notice, and upon a date and time agreed to by Supplier, and
Supplier agrees to cooperate with Vericel in such Mock Audits at Vericel’s
expense.

6.3
Quality Agreement. A separate written Quality Agreement will be drafted and
mutually agreed upon between Vericel and Supplier.

7.
PRICING

7.1
General. The Product shall be purchased and sold in US dollars. Prices per unit
of Product are listed in Appendix A.

7.2
Extension Option; Quarterly Charge. As of the Amendment Effective Date, Vericel
hereby exercises its right to extend the Term for an additional five (5) years
subject to the terms of this Section 7.2. Commencing with the calendar quarter
in which the initial QDA/Sterility production runs are shipped and for each
calendar quarter thereafter during the Term, Vericel shall pay Supplier a
quarterly charge equal to [***] Dollars ($[***]), provided Supplier is not in
material breach of its supply obligations as provided hereunder, subject to
Supplier’s right to cure as provided in Section 9. The first such quarterly
charge shall be pro-rated based upon the date of the shipment of the
QDA/Sterility production runs required to re-qualify the Supplier’s cleanroom
and production processes.

7.3
Annual Price Adjustment Notification At least forty-five (45) days prior to the
end of the first year of the Term and each year thereafter that this Agreement
remains in effect, Supplier shall notify Vericel of any proposed Product unit
price increase or decrease for the next succeeding year. Any increase or
decrease in Product unit price shall be applicable only to those production lots
of the Product of which the production process is completed after the change and
cost becomes effective and shall remain in effect until another price change
occurs. Additionally, any increase shall be limited to actual, documented
increases in materials costs or shall not exceed the then current consumer price
index for non-material related costs, without Vericel’s prior approval.

7.4
Justification of Price Increases. Supplier will provide written rationale for
its price increases for the Product any year during the Term upon Vericel's
request. Vericel and Supplier will work collaboratively and in good faith to
mitigate any potential cost increases.

7.5
Scrap. Supplier unit cost shall assume a scrap rate of [***]%. If during the
Term, actual scrap rate exceeds [***]% for a period of thirty (30) days or more,
Supplier will notify Vericel in writing of the actual scrap rate and failure
mode. Supplier and Vericel will work collaboratively to determine root cause of
the increased scrap. When the supplier and Vericel agree on the root cause,
financial responsibility shall remain with the party at cause. Best efforts
shall be made by both parties to resolve all scrap issues within ninety (90)
days from occurrence.

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

7.6
Cost Reduction. Both parties shall continuously work towards reducing costs. Any
cost reduction efforts researched and implemented by both parties shall result
in a 50/50 gain sharing of the savings realized. When a cost saving measure is
solely driven by Vericel the savings will benefit Vericel 100%. Vericel and
Supplier will meet periodically to review cost reduction efforts and define an
action plan for driving improvement.

8.
TERM

The term of this Agreement shall commence on November 8, 2010 and shall expire
on November 7, 2021 (the "Term"). At the end of the Term, this Agreement shall
terminate automatically without notice, unless, prior to that time, the Term is
extended by mutual written consent of the parties delivered at least six (6)
months prior to the termination date. Sections 4, 5.5, 5.6, 5.7 (with the
exception of the first sentence), 9.4, and 11 through 28 shall survive the
expiration or termination of this Agreement.
9.    TERMINATION

9.1
Procedure for Termination: This Agreement may be terminated as follows:

•
Either party may terminate this Agreement if the other party materially defaults
in the performance of any provision of this Agreement. Should any such default
occur, and then the non-defaulting party may give written notice to the
defaulting party that if the default is not cured within forty-five (45) days,
the Agreement will be terminated. If the non-defaulting party gives such notice
and the default is not cured during the forty-five (45) day period, then the
Agreement shall automatically terminate at the end of such period unless an
extension is mutually agreed to by both parties.

•
In addition to other remedies, either party may terminate the Agreement at any
time if either breaches its confidentiality obligations under Section 4, in
which case termination shall be effective immediately upon receipt of notice of
the breach and of termination.

•
Commencing on the first anniversary of the Amendment Effective Date, Vericel
shall have the right to terminate this Agreement in its sole discretion upon
twelve (12) months’ prior written notice to Supplier.

•
Commencing on the first anniversary of the Amendment Effective Date, Vention
shall have the right to terminate this Agreement in its sole discretion upon
eighteen (18) months’ prior written notice to Vericel.

•
Either party may immediately terminate this Agreement by written notice upon the
occurrence of any of the following events: (i) the other party is or becomes
insolvent or unable to pay its debts as they become due within the meaning of
the United States Bankruptcy Code (or any successor statute) or any analogous
foreign statute; or (ii) the other party appoints or has appointed a receiver
for all or substantially all of its assets, or makes an assignment for the
benefit of its creditors; or (iii) the other party files a voluntary petition
under the United States Bankruptcy Code (or any successor statute) or any
analogous foreign statute; or (iv) the other party has filed against it an
involuntary petition under the United States Bankruptcy Code (or any successor
statute) or any analogous foreign statute, and such petition is not dismissed
within ninety (90) days.

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

9.2
Return of Confidential Information and Equipment. Upon termination of this
Agreement for any reason, each party shall return all confidential information,
including, but not limited to technical information, and any equipment belonging
to Vericel, each party shall make no further use of such information.

9.3
Inventory and Equipment Purchase Upon Termination. If the Agreement is
terminated by Supplier for material breach by Vericel then Vericel shall
purchase: (a) finished Products that are in a usable condition and comply with
all Vericel specifications, including sterility on the date of termination; and
(b) ninety (90) day work in process and component and raw materials inventory to
the extent that such work in process and inventory can be converted into
finished Products, all based on Vericel's Forecast needs. Such purchases shall
be made within sixty (60) days following the effective date of the termination.

9.4
Other Termination. If the Agreement terminates by mutual agreement of both
parties, then both parties will mutually agree upon the purchase and/or
disposition of raw component materials, Product and/or equipment. Supplier shall
provide reasonable technical support to transition Product to new manufacturing
facility. Such technical support will be provided at Supplier's published
engineering rates and shall be at Vericel's expense. If the Agreement terminates
by Vericel for material breach by Supplier, then Vericel shall have the option
to purchase any raw materials, inventory or Products at any stage of assembly as
long as all materials are within current Vericel specification.

10.
FORECAST, ORDERS AND QUANTITY

10.1
Purchase Orders. Orders by Vericel shall be initiated by purchase orders
executed by an authorized representative of Vericel. Supplier shall provide
written confirmation to Vericel within 3 business days. If Supplier is unable to
meet requested delivery date Supplier will provide alternative delivery date
based on current manufacturing schedule. Supplier will make best efforts to
achieve Vericel requested delivery date.

10.2
Delivery. Supplier shall use best efforts to ship the Product for delivery by
the requested date on the Vericel purchase order. In order for shipment to be
considered timely, a delivery must be shipped no earlier than three (3) days
prior or no days later to the requested date.

10.3
Production Forecast. Vericel will provide to Supplier a [***] month rolling
forecast ("Forecast'') upon the placement of initial production order. At all
times the first [***] months will represent a firm production demand.

11.
SHIPMENT, RISK OF LOSS AND PAYMENT TERMS

Supplier shall ship the Product in accordance with Vericel's delivery
instructions specified in Vericel’s purchase orders. Delivery shall be FOB
Supplier's dock in Grand Rapids, Ml. Supplier shall deliver all Products ordered
by Vericel in accordance with the requested delivery dates as indicated in
Vericel's purchase orders. Vericel shall be responsible for shipping costs.
All Products delivered by Supplier pursuant to this Agreement shall be packed as
per standard operating procedure for the designated carrier. All Product shipped
will include the Certificate of Conformance and will specify Vericel part
number, lot number and quantity. All Product will be shipped with appropriate
shipping documentation and clearly marked with part number, order

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

number, and quantity.
Payments for Products are due within thirty (30) days of the invoice date. In
the event that any terms and conditions on any Supplier invoice or Vericel
purchase order conflict with the terms of this Agreement, the terms of this
Agreement shall govern.
12.
INTELLECTUAL PROPERTY RIGHTS

All confidential information, including technical data and intellectual property
rights, including without limitation, patents, patents pending, patent
applications, trademarks, service marks, trade secrets and copyrights (the
"Intellectual Property"), associated with the development, design, and
manufacture of the Product are and shall remain the exclusive property of
Vericel, and may be used by Supplier only as specifically set forth in this
Agreement. Vericel reserves to itself and retains all right, title and interest
in and to the Intellectual Property embodied in the Product and to any
modifications, enhancements, improvements and upgrades thereto.
Supplier understands and agrees that it has no license to any Vericel product,
technology, Intellectual Property or other property, except as set forth in this
Agreement.
13.
WARRANTY AND REMEDIES FOR NON-CONFORMANCE

13.1
Warranty. Supplier warrants that upon delivery as provided for hereunder and for
the shelf life period ([***]months) of the Product after delivery that (i) the
Product shall be manufactured in compliance with document at ion provided and
certified by Vericel; (ii) the Product delivered shall conform to documented
specifications, including component inspection, test, and product release
testing; (iii) any components or parts shall be sourced from Vericel approved
vendors and inspected by mutually approved incoming inspection plans; (iv) the
Product will be free of defects related to internal sterilization, workmanship,
or material; (v) it shall not manufacture Product in advance of confirmed
purchase orders so that the Product is delivered with the longest possible
expiration date; and (vi) it shall manufacture the Product in a workmanlike
manner and in accordance with industry standards, applicable law and, to the
best of its knowledge, not in violation or infringement of any patent, copyright
or trademark laws (the "Product Warranty"). Should any failure to conform to the
Product Warranty become apparent, Vericel shall notify Supplier in writing, and
Supplier will either correct such nonconformity by replacement of the defective
Product or credit Vericel for any payments made with respect to the value of any
defective Product, including direct expenses to Vericel.

13.2
Vericel warrants that to Vericel’s knowledge the specifications and license
contemplated herein do not violate or infringe any applicable laws, regulations
or standards, including any patent copyright or trademark laws. Supplier's
Product Warranty does not extend to (i) any Product rendered defective by a
component provided by Vericel, unless Supplier is aware of the defect at or
before the time the Product is assembled, or (ii) to defects caused by improper
sterilization, use, transportation, maintenance or storage; third party
negligence; or unauthorized repair, service or modification; in each case unless
and to the extent caused by Supplier. EXCEPT FOR THE WARRANTIES SET FORTH IN
THIS AGREEMENT, EACH PARTY EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED
OR IMPLIED, ARISING BY OPERATION OF LAW OR OTHERWISE, INCLUDING IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

9

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

13.3
Remedies for Non-Conformance. In case of any disagreement between the parties as
to whether Product conforms to the applicable specifications or cGMP (if
applicable), warranties, or was manufactured in accordance with the
manufacturing process, the quality assurance and/or engineering representatives
of the parties will attempt in good faith to resolve any such disagreement and
Vericel and Supplier will follow their respective SOPs to determine the
conformity of the Product to the specifications and cGMP (if applicable) and
manufacture in compliance with the manufacturing process. If the foregoing
discussions do not resolve the disagreement in a reasonable time (which will not
exceed thirty (30) days), a representative sample of such Product and/or
relevant documentation will be submitted to an independent testing laboratory
(in the case of an alleged failure to meet Specifications) and/or independent
cGMP consultant (in the case of an alleged failure to comply with cGMP or the
manufacturing process), as appropriate, that are mutually agreed upon by the
parties for tests and final determination of whether such Product conforms with
such specifications and/or cGMP (if applicable). The laboratory must meet cGMP
(if applicable). The laboratory and consultant, as applicable, must be of
recognized standing in the industry, and consent to the appointment of such
laboratory and consultant will not be unreasonably withheld or delayed by either
party. Such laboratory will use the test methods contained in the applicable
specifications. The determination of conformance by such laboratory and/or cGMP
consultant, as applicable, with respect to all or part of such Product will be
final and binding on the parties absent manifest error. The fees and expenses of
the laboratory and/or consultant, as applicable, incurred in making such
determination will be paid by the party against whom the determination is made.

13.4
Product Non-Compliance and Remedies. If a lot of Product fails to conform to the
specifications or was not manufactured in compliance with cGMP (if applicable)
and the manufacturing process, then Supplier will, at Vericel’s sole option: (a)
at Supplier’s cost and expense, replace the Product by manufacture of a new lot
as soon as reasonably possible; or (b) refund in full the fees and expenses paid
by Vericel for such lot.

Moreover, the parties will meet to discuss, evaluate and analyze the reasons for
and implications of the failure to comply with cGMP (if applicable) and/or the
manufacturing process and will decide whether to proceed with the services via a
change order, or to terminate such services.
13.5
Disposition of Non-Conforming Product. The ultimate disposition of
non-conforming Product will be the responsibility of Vericel’s quality assurance
and/or engineering departments.

14.
INDEMNIFICATION AND LIMITATION OF LIABILITY

14.1
Indemnification. Each party (the "Indemnifying Party") will indemnify and hold
harmless the other party (the "Indemnified Party") from any claims, actions,
proceedings, awards, demands, losses, damages or expenses suffered by the
Indemnified Party ("Losses"), whether or not such Losses relate to any liability
to a third party, to the extent claimed or arising from or relating to a
material breach of the Indemnifying Party's representations, warranties or
covenants under this Agreement or the Indemnifying Party's negligence or willful
misconduct.

Supplier shall not indemnify Vericel for any Losses claimed or arising from or
relating to (A) the Intellectual Property provided by Vericel for the
manufacture of or incorporation into the Product, or (B) the use of the Product
by customers in any manner inconsistent with the Product's intended purposes; in
each case except and to the extent such Losses result from Supplier’s gross
negligence or willful misconduct.

10

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

14.2
Procedure. To obtain indemnification, the Indemnified Party shall: (a) provide
prompt notice in writing of any such Losses claimed to the Indemnifying Party
and permit the Indemnifying Party, through counsel chosen by the Indemnifying
Party, the opportunity to answer and defend such claims; and (b) provide the
Indemnifying Party information, assistance and authority, at the Indemnifying
Party's expense, to assist the Indemnifying Party in defending such claims.
Neither party shall be responsible for any settlement made by the other party
without the other party's prior written approval. Neither party shall admit any
liability of the other party without the other party's prior written approval.

14.3
Limitation of Liability. Notwithstanding any other provision of this Agreement,
neither party shall be liable to the other for, nor obligated to allow claims
for, special, incidental, consequential, or other indirect damages or expenses
of any kind.

15.
ADDITIONAL REPRESENTATIONS AND WARRANTIES OF THE PARTIES

15.1
Vericel hereby represents and warrants to Supplier that:

15.1.1
Vericel is a corporation duly incorporated, validly existing and in good
standing under the laws of the State of Michigan, and has all corporate power
and authority to own, lease and operate its properties and to carry on its
businesses as it is currently being conducted. Vericel has all necessary
corporate power and authority to enter into this Agreement and to perform its
obligations hereunder. This Agreement has been duly authorized, executed and
delivered by Vericel.

15.1.2
Vericel is the lawful owner of all right, title and interest in and to the
applicable Intellectual Property incorporated in the Product, free and clear of
all liens, claims, security interests or other restrictions or encumbrances.

15.2
Supplier hereby represents and warrants to Vericel that:

15.2.1
Supplier is a company duly organized and existing under the laws of the State of
Minnesota, and has all power and authority to own, lease and operate its
properties and to carry on its businesses as currently conducted. Supplier has
all necessary power and authority to enter into this Agreement and to perform
its obligations hereunder. This Agreement has been duly authorized, executed and
delivered by Supplier.

15.2.2
Supplier has the manufacturing and assembly facilities and personnel reasonably
necessary to perform its functions and otherwise carry out its obligations under
the terms of this Agreement.

15.2.3
All Products manufactured, sold and shipped pursuant to this Agreement shall,
upon delivery, have been manufactured and shipped by Supplier in compliance with
applicable law and regulations, including the U.S. Food and Drug Administration
regulations and current Good Manufacturing Practices requirements set forth in
the Quality System promulgated under the U.S. Food, Drug & Cosmetic Act.

15.2.4
The conduct and the provision of the services will not, to the best of its
knowledge, violate any patent, trade secret or other proprietary or intellectual
property rights of any third party and Supplier will promptly notify Vericel in
writing should it become aware of any claims asserting such violation.

15.2.5
Supplier, its affiliates, approved subcontractors, and each of their respective
officers and directors,

11

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

as applicable, and any person used by Supplier, its affiliates or approved
subcontractors to perform services under this Agreement: (i) have not been
debarred and are not subject to a pending debarment pursuant to section 306 of
the United States Food, Drug and Cosmetic Act, 21 U.S.C. § 335a; (ii) are not
ineligible to participate in any federal and/or state healthcare programs or
federal procurement or non-procurement programs (as that term is defined in 42
U.S.C. § 1320a-7b(f)); (iii) are not disqualified by any government or
regulatory authorities from performing specific services, and are not subject to
a pending disqualification proceeding; and (iv) have not been convicted of a
criminal offense related to the provision of healthcare items or services and
are not subject to any such pending action. Supplier will notify Vericel
immediately if Supplier, its affiliates, or approved subcontractors, or any
person used to perform services under this Agreement, or any of their respective
officers or directors, as applicable, is subject to the foregoing, or if any
action, suit, claim, investigation, or proceeding relating to the foregoing is
pending, or to the best of Supplier’s knowledge, is threatened.

16.
RELATIONSHIP OF THE PARTIES

The parties understand and agree that Supplier is a vendor to Vericel and that
neither party is an agent of the other nor are the parties to be legal partners,
joint venturers or otherwise. Except as expressly set forth in this Agreement,
no rights or licenses are granted by either party to the other. Neither party
shall be entitled to participate in any plans, arrangements or distributions
offered by the other party to its employees, including without limitation any
bonus, profit sharing, insurance or similar benefits. Each party shall be solely
responsible to purchase any required insurance on behalf of its employees and to
pay any applicable taxes. Neither party has authority to bind the other by
contract or agreement, of any kind, nor to undertake any obligation on behalf of
the other party.
17.
SUCCESSORS, ASSIGNS AND SUBCONTRACTORS

This Agreement shall be binding upon and inure to the benefit of the parties
hereto and their respective successors and assigns. Neither party may assign
rights nor delegate duties, including to a subcontractor, under this Agreement
without the prior written consent of the other party except in the event of a
merger, consolidation or sale of all or substantially all of its assets relating
to this Agreement and the assignee agrees to be bound to the terms of this
Agreement. Any assignee or delegate must agree to be bound by the terms of this
Agreement.
18.
NO WAIVER

None of the terms of this Agreement shall be deemed to be waived by any party
unless such waiver is in writing duly executed by the party to be charged with
such waiver and such writing recites specifically that it is a waiver of the
terms of this Agreement. The waiver by either party of any breach of any
agreement, warranty or covenant contained in this Agreement shall not be
construed to act as a waiver of any subsequent breach. The failure or delay of
either party to exercise any right, power or remedy shall not operate as a
waiver thereof, and all rights, powers and remedies shall continue in full force
and effect. All rights, powers and remedies of both parties provided for in this
Agreement are cumulative and non-exclusive, except as otherwise expressly
provided.
19.
NO INVALIDITY

The unenforceability or invalidity of any one or more provisions hereof shall
not render any other provision herein contained unenforceable or invalid.

12

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

20.
ENTIRE AGREEMENT; NO OTHER AGREEMENTS

This Agreement constitutes the entire agreement between the parties relating to
the subject matter herein, and all oral or written, prior and contemporaneous
proposals, understandings, course of conduct and writings by and between the
parties and relating to the subject matter herein is superseded hereby.
Neither party has any other Agreement of any kind or nature with any other
person, corporation or entity which would or might prevent it from entering into
this Agreement with the other party hereto.
21.
MODIFICATION

This Agreement may be modified or altered through written instrument duly
executed by Supplier and Vericel.
22.
NOTICES

All notices must be in writing and sent to the address for the recipient set
forth in this Agreement below or at such other address as the recipient may
specify in writing under this procedure. All notices must be given by (a)
personal delivery, with receipt acknowledged; or (b) prepaid certified or
registered mail, return receipt requested; or (c) prepaid recognized next
business day or express delivery service. Notices will be effective upon receipt
or at a later date stated in the notice:
If to Vericel, to: Vericel Corporation
24 Frank Lloyd Wright Drive Ann Arbor, Michigan 48105
Attn: Director of Engineering
Attn: Director, Supply Chain

With a copy to: General Counsel
Vericel Corporation
64 Sidney Street
Cambridge, MA 02139

If to Supplier, to:

Vention Medical, LLC 620 Watson SW
Grand Rapids, Ml 49504-6393
Attn: VP Business Development
Facsimile: 616 643-1044

With a copy to:
Vention Medical
29 Northwestern Drive

13

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

Salem, NH 03079
Attention: Corporate Counsel

23.    CHOICE OF LAW

This Agreement will be governed, construed and enforced in accordance with the
laws of the State of Michigan, without regard to the principles of conflicts of
laws.
24.
DISPUTE RESOLUTION

Final and binding arbitration of any dispute shall be conducted in the State of
Michigan. Except with respect to any disputes relating to the provisions on
confidentiality and Vericel's intellectual property rights, any disputes arising
hereunder, if not resolved after good faith negotiation between the parties,
shall be finally settled by binding arbitration in accordance with the
commercial rules and under the auspices of one arbitrator of the American
Arbitration Association. The award thereof shall be final and binding upon both
parties. Each party shall bear its own expenses of the arbitration, unless the
arbitration award states that the expense shall be otherwise assessed, including
its own attorneys' fees and costs. The parties shall share equally the expenses
of the arbitration, including payment to the arbitrator(s).
Notwithstanding the foregoing, in the event both parties hereto are named as
defendants by an arm’s length third party plaintiff asserting a claim against
both parties, then and in such event, either party may seek the resolution of
their respective indemnity rights and obligations as herein set forth, arising
from such claim in said proceedings.
Notwithstanding the foregoing, both parties acknowledge that any breach by it of
its confidentiality obligations or of the provisions governing Vericel's
intellectual property rights will cause Vericel irreparable harm for which
injunctive relief is the only adequate remedy. Supplier therefore agrees that
Vericel shall have the right to seek injunctive or other immediate relief from
any United States court or tribunal of competent jurisdiction to prevent or stop
any violations of those Supplier obligations. Should Vericel desire to seek
injunctive relief after an arbitration proceeding is commenced by either party,
Supplier hereby agrees to the filing of such action according to the terms of
this paragraph.
25.
FORCE MAJEURE

Failure of either party to perform its obligations under this Agreement shall
not subject such party to any liability to the other party if such failure is
caused by any cause beyond the reasonable control of such nonperforming party,
including, but not limited to, acts of God, fire, explosion, flood, drought,
war, riot, terrorism, sabotage, embargo, strikes or other labor trouble or a
national health emergency.
26.
RISK MITIGATION

Upon termination of Agreement, Supplier agrees to provide reasonable technical
support at Supplier's published engineering rates for the transfer of
manufacturing technology to an alternative manufacturer chosen by Vericel to
conduct final manufacture, package and test of the Product, in the event that:

14

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

(a) Supplier, for a period of one hundred and fifty (150) days from the date of
receipt of the associated purchase order, is unable to manufacture all of
Vericel’s orders for any reason, or
(b) Supplier fails or refuses to meet Vericel’s orders for the Product pursuant
to the terms of this Agreement.
27.
INSURANCE

Supplier shall maintain during the Term, and for a reasonable period thereafter,
general liability insurance and product liability insurance, which insurances
shall be in amounts and of a type customarily maintained by companies similarly
situated. Each such insurance shall provide at least [***] ($[***]) U.S. Dollars
in coverage per occurrence combined single limit, bodily injury/property damage
and [***] ($[***]) U.S. Dollars aggregate liability limits. Additionally,
Supplier warrants that such insurance will not be changed or canceled without at
least thirty (30) days prior written notice to Vericel.
28.
APPENDIX TO THIS AGREEMENT

Included in this Agreement are the following Appendices:
Appendix A - Schedule

* * *

15

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed and
delivered by their respective duly authorized officers on the day and year first
above written.

 
VERICEL CORPORATION
 
By: /s/ Dominick Colangelo
 
Name: Dominick Colangelo
 
Title: President and CEO
 
 
 
VENTION MEDICAL INC.
 
By: /s/ Bill Flaherty
 
Name: Bill Flaherty
 
Title: President

    

16

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"[***]". A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI L ED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RU LE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

APPENDIX A

1)
Facilities:

a.
[***]

1.
[***]

2.
[***]

b.
[***]

3.
[***]

4.
[***]

5.
[***]

2)
Supplier Molded Components: [***]:

a.
[***]

b.
[***].

c.
[***]

3)
Pricing: [***]

a.
[***]

i.
[***]

b.
[***]

i.
[***]

Additional facilities: [***]

17