Exhibit 10.31


 


MANUFACTURING SERVICES AGREEMENT


 


THIS MANUFACTURING SERVICES
AGREEMENT (the “Agreement ) is made effective
as of November 3, 2010 (the “Effective Date”)
between PRECISION ONE MEDICAL, INC., a California corporation, on behalf
of itself and its affiliates, (“Manufacturer”),
and BIOHORIZONS, INC. a Delaware corporation having a place of business at
2300 Riverchase Center, Birmingham, AL 35244, on behalf of itself and its
affiliates, (“BioHorizons” and together
with Manufacturer, the “Parties”).  Capitalized terms used herein without
definition shall have the respective meanings ascribed thereto in Section 10.


 


WHEREAS, BioHorizons desires
Manufacturer to manufacture, assemble and supply the Products for purchase by
BioHorizons; and


 


WHEREAS, Manufacturer desires to
manufacture, assemble and supply the Products for sale to BioHorizons, all as
further set forth herein;


 


NOW, THEREFORE, for good and
valuable consideration,


 


the receipt and sufficiency of which
is hereby acknowledged, the Parties agree as follows:


 


Section 1.               Manufacture and Supply of
Products.


 


(a)           Requirements; Manufacture of
Products.  During the Term and
subject to the terms and conditions set forth herein, (i) Manufacturer
shall manufacture and supply all of BioHorizons’s requirements of Products, and
(ii) except as otherwise provided herein, BioHorizons shall purchase all
of its requirement for Products exclusively from Manufacturer, including
Products for studies, demonstration/sample purposes and commercial sale.


 


(b)           Forecasts.  From time to time BioHorizons shall furnish
Manufacturer with a good faith estimate of the quantities of each Product that
BioHorizons intends to purchase from Manufacturer during the average month of
the upcoming four (4) calendar quarters (the “Forecast”).  The
initial forecast as of the Effective Date is attached as Exhibit A.  Notwithstanding the foregoing, BioHorizons
shall notify Manufacturer of any revision to a Forecast already furnished to
Manufacturer as soon as commercially practicable after BioHorizons becomes
aware that its likely or actual requirements for one or more Products have
materially changed.  It is understood
that the quantities specified in the Forecasts are intended to be estimates
only and shall not be binding on BioHorizons.


 


(c)           Orders.  BioHorizons shall make all purchases by
submitting purchase orders to Manufacturer which shall be firm and
binding.  Each purchase order shall
specify the quantity of each Product ordered by item number.  BioHorizons will use commercially reasonable
efforts to place purchase orders [***] prior to their required delivery date.


 


(i)            To the extent the quantity of
Products ordered is consistent with the applicable Forecast or within the
inventory maintained by Manufacturer in accordance with Section 1(i) (a
“Qualifying Order”)
Manufacturer shall deliver the ordered Products on the schedule specified in
the purchase order.


 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 

















 


(ii)           Manufacturer shall notify BioHorizons
within [***] ([***]) [***] after receipt of a purchase order that is not a
Qualifying Order if Manufacturer is unable to deliver such excess quantity
within the time period specified in the purchase order, and the Parties will
work together in good faith to enable Manufacturer to meet the terms of the
order as closely as possible.


 


(iii)          Manufacturer shall use commercially
reasonable efforts to fill purchase orders issued by BioHorizons that are not
Qualifying Orders.


 


(d)           Price.  Unless modified pursuant to the provisions of
this Agreement or otherwise agreed in writing by both Parties, the price for
each Product shall be as set forth on Exhibit A.


 


(e)           Supply.  Manufacturer shall supply the Products in
accordance with the Specifications then in effect.  Manufacturer shall manufacture the Products
in compliance with cGMP and applicable Quality Standards.


 


(f)            Delivery.  All Products delivered to BioHorizons shall
be FCA (INCOTERMS 2000) Manufacturer’s facility.  Manufacturer shall deliver ordered Products
within the time frame agreed to by the Parties. 
BioHorizons shall arrange all insurance and transportation as specified
in writing from time to time by BioHorizons. 
Manufacturer shall package the Products in accordance with their
Packaging Specifications.  Manufacturer will
(i) retain all original quality and testing records, which shall be in a form
reasonably acceptable for submission to all applicable Regulatory Authorities
and shall be available for inspection by BioHorizons from time to time upon
reasonable notice to Manufacturer, and (ii) include with each shipment
copies of all applicable quality and testing records and a Certificate of
Conformity signed by a Manufacturer administrator with authority to bind
Manufacturer that manufacture was in accordance with applicable Quality
Standards and that the Products conform to the Specifications and have been
packaged in conformance with the Packaging Specifications.


 


(g)           Rejection of Product in Case of
Nonconformity.


 


(i)            Within [***] ([***]) [***] of
receipt of any shipment of Products, BioHorizons may reject any portion of such
shipment which is (a) not conforming to the Specifications or Packaging
Specifications, (b) damaged during shipment as a result of Manufacturer
having not packaged the Products in conformance with the Packaging
Specifications or (c) adulterated or misbranded within the meaning of the
Federal Food, Drug and Cosmetic Act (the “Act”) or any similar provisions of any other Applicable
Law.  If no notice of intent to reject is
timely received by Manufacturer, BioHorizons shall be deemed to have accepted
such delivery of Products; provided, however, in the case of Products having
latent defects which upon visual examination, without opening the packaging, by
BioHorizons upon receipt could not reasonably have been discovered, BioHorizons
must give notice of BioHorizons’s intent to reject within [***] ([***]) [***]
after discovery of such defects; provided that such notice may in no event be
given later than [***] ([***]) [***] after the earlier of (a) [***]
([***]) [***] from the delivery date, and (b) the expiration date on the
label of such Product.


 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.


 


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(ii)           In order to reject a shipment,
BioHorizons must (a) give notice to Manufacturer of BioHorizons’s intent
to reject the shipment within [***] ([***]) [***] of receipt together with a
written indication of the reasons for such rejection, and (b) as promptly
as commercially reasonable thereafter, provide Manufacturer with notice of
final rejection and the full basis therefor.


 


(iii)          Manufacturer shall replace as soon as
reasonably practicable and at its cost, including shipping and insurance, all
Products that have been properly rejected by BioHorizons.


 


(h)           Product Warranty.  Manufacturer represents and warrants to
BioHorizons that at the time of delivery to BioHorizons the Products will: (i) be
new and conform in all respects to the Specifications in effect at the time of
shipment; (ii) have been manufactured in accordance with the Quality
Agreement and in accordance with the Quality Standards and all other Applicable
Law; (iii) be packaged in accordance with the Packaging Specifications in
effect at the time of shipment, (iv) not be adulterated or misbranded
within the meaning of the Act, and (v) be free and clear of any and all
liens and encumbrances of whatsoever nature and kind.  Manufacturer further represents and warrants
that the Products will be free from all defects in workmanship and materials at
the time of delivery to BioHorizons and for the period from the date of
delivery until the earlier of (a) the expiration date on the labels of the
Products, and (b) [***] ([***]) [***] from the date of delivery of the
Products, provided that the Products are stored under the conditions stated on
their labels.


 


(i)            Inventory.  Manufacturer shall manufacture and maintain
on hand at all times during the Term a two (2) month inventory for each
item number included on the list of Products included on Exhibit A.  Within [***] ([***]) [***] of receipt of any
Forecast that requires a material increase in the amount of inventory required
to be maintained by Manufacturer pursuant to this Section, Manufacturer shall
maintain, for each item number included on the list of Products (as updated by
such Forecast), the lesser of (i) [***]% of the number of parts purchased
by BioHorizons during the previous twelve (12) calendar months or (ii) a
[***] ([***]) [***] supply based on such Forecast.


 


(j)            Liquidated Damages.  The Parties acknowledge and agree that the
delivery of the Products by Manufacturer is one step in a multi-part supply
chain and that any delay in delivery of Products will require BioHorizons to
revise schedules with multiple other vendors, pay for expedited handling and
undertake other actions that will be costly and distracting and could harm
relations between BioHorizons and its vendors, customers and distributors.  The Parties acknowledge and agree that it
would be impracticable and extremely difficult to ascertain the amount of
actual damages caused by the occurrence of a breach of Section 1(c)(i) and
that the amount of damages sustained by BioHorizons would generally be
proportionate to the value of the order that is not timely filled.  Therefore, the Parties agree that upon the
occurrence of a breach of Section 1(c)(i), Manufacturer shall credit
BioHorizons, as liquidated damages and not as a penalty, an amount equal to the
product of (x) [***]% of the invoice price of Late Parts and (y) the
number of days elapsed between the date of receipt of a Late Notice and the
date of delivery of the Late Parts, but in no case to exceed [***]%.  The Parties further agree that this
liquidated damages provision represents reasonable compensation for the loss
which would be incurred by BioHorizons due to any such breach.


 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 


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(k)           Priority.  Orders for Products, whenever received, will
have priority over orders from any other customer of Manufacturer, whenever
received.  Manufacturer will change the
priority of manufacture of Products as requested by BioHorizons without any
additional charge to BioHorizons.


 


(l)            Location of Manufacture.  Manufacturer shall manufacture the Products
only in the United States unless the manufacture of Products elsewhere is
authorized in writing by BioHorizons in its sole discretion.


 


(m)          Exclusivity.  Manufacturer shall be the exclusive supplier of
Products to BioHorizons during the Term, except as provided in Section 1(n).


 


(n)           Alternative Manufacturing.  Notwithstanding anything to the contrary
herein, BioHorizons shall have the right, in its sole discretion, to have part
of its requirements for the Products manufactured by itself or third parties if
in the good faith judgment of BioHorizons having a second source is reasonably
required in order to maintain an appropriate supply chain.


 


(o)           Payment Terms.  Manufacturer will issue one invoice for each
purchase order.  All payments to
Manufacturer under this Agreement are to be made in US dollars and shall be
paid within forty-five (45) days of invoice, which Manufacturer shall issue, as
applicable, monthly or when or after it ships the Products to BioHorizons or
its designee.  Interest at a monthly rate
of one percent (1%) shall accrue on all payments that are not the subject of a
dispute in good faith and are not made within the aforementioned forty-five
(45) day period.


 


(p)           Specification Changes.


 


(i)            In the event that BioHorizons
changes any Specifications, then the Parties will negotiate any appropriate
change in pricing based on such changes. 
In the event that the Parties cannot agree on revised pricing, BioHorizons
shall be relieved of its obligation pursuant to Section 1(m).


 


(ii)           In the event that BioHorizons changes
any Specifications such that inventory stored at Manufacturer’s facility
pursuant to (i) becomes obsolete, then within ninety (90) days of the date
BioHorizons notified Manufacturer of such change, BioHorizons will (x) order
any Products that were finished product stored at Manufacturer’s facility
pursuant to (i) or (y) pay Manufacturer for such Products and request
that Manufacturer discard or destroy such Products at no charge to
BioHorizons.  With respect to any
Products that were work in progress based on a purchase order or compliance
with (i) on the date BioHorizons notified Manufacturer of such change,
BioHorizons will make payment, within ninety (90) days of the date BioHorizons
notified Manufacturer of such change, of the price of such Products less a
discount to be determined in good faith by Manufacturer based on its cost
savings from not having to finish such Products.  BioHorizons will notify manufacturer of its
decision to have Manufacturer deliver such work in progress to BioHorizons or
have Manufacturer discard or destroy such Products at no charge to BioHorizons.


 


(iii)          In no event will BioHorizons be liable
to Manufacturer pursuant to this Section 1(p) for inventory in excess
of the sum of (x) the minimum required to be maintained by 


 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 


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Manufacturer in accordance
with Section 1(i) plus (y) the amount subject to an open
purchase order at the time of the Specification change.


 


Section 2.               Benchmarking.


 


(a)           At any time or from time to time, but
not more than [***] ([***]) times in any calendar year, BioHorizons may
benchmark the prices, service levels, and processes offered by peer service
providers in the industry to peer customers in the industry.


 


(b)           In the event that BioHorizons
reasonably determines, with respect to one or more Products, that (a) BioHorizons
could contract for materially more favorable service levels from a peer service
provider at lower pricing as the then current pricing pursuant to this
Agreement or (b) the then current pricing pursuant to this Agreement is
materially less favorable to BioHorizons as compared to the fees available from
peer service providers in the industry for substantially equivalent services,
then BioHorizons shall notify Manufacturer in writing of the results of its
benchmarking review (such notice, the “Benchmarking
Notice”).


 


(c)           Manufacturer shall have [***] from
the date of the Benchmarking Notice to provide a written response (the “Benchmarking Response”) to (i) propose
revised service levels, (ii) propose revised pricing and/or (iii) set
forth a description of the nature of any dispute with respect to the contents
of the Benchmarking Notice in sufficient detail so as to enable BioHorizons to
assess the merit of the dispute.


 


(d)           The Parties agree to work together
collaboratively for a period of [***] from the date of the Benchmarking
Response.  In the event that the Parties
are unable or unwilling to reach agreement on actions to be taken to address
the issues raised in the Benchmarking Notice, then BioHorizons may, in its sole
discretion, be relieved of its obligations under Section 1(m).  All other provisions of this Agreement would
continue without change.


 


(e)           Manufacturer will actively work to
achieve reductions in its costs of manufacturing Products.  At least once per calendar year, manufacturer
and BioHorizons will review the costs of manufacturing Products in a good faith
effort to reduce such costs.  Any
resulting savings will be shared equally by the Parties.


 


Section 3.               Intellectual Property.


 


(a)           Ownership.  As between the Parties, BioHorizons
exclusively shall have all right, title and interest in any Inventions made or
conceived or reduced to practice by BioHorizons or on behalf of BioHorizons by
Manufacturer, or by the Parties jointly, in the course of performing this
Agreement.


 


(b)           Patent Filings.  BioHorizons, has the right, but not the
obligation to file all patent applications relating to the Inventions.


 


(c)           Assignment.  Manufacturer hereby agrees to make any
assignments necessary to accomplish the ownership provision set forth for the
Inventions in this Section 3 and shall promptly sign all documents and
provide, at BioHorizons’s expense, information reasonably requested by
BioHorizons in connection with the patent applications as described in this Section 


 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting confidential
treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.


 


5

















 


3.  Manufacturer, as of the Effective Date and
throughout the Term, has and will have appropriate agreements with all employees
and contractors necessary to fully effect the provisions of this Section 3.  BioHorizons will have the exclusive right to,
and, at BioHorizons’s expense, Manufacturer agrees to assist BioHorizons in
every proper way (including becoming a nominal party) to, evidence, record and
perfect the assignment and to apply for and obtain recordation of and from time
to time enforce, maintain and defend such proprietary rights.  In the event that BioHorizons is unable for
any reason whatsoever to secure Manufacturer’s signature to any document it is
entitled to under this Section, Manufacturer hereby irrevocably designates and
appoints BioHorizons and its duly authorized officers and agents, as its agents
and attorneys-in-fact to act for and in its behalf and instead of Manufacturer,
to execute and file any such document and to do all other lawfully permitted
acts to further the purposes of the foregoing with the same legal force and
effect as if executed by Manufacturer.


 


(d)           Enforcement of Patent Rights.  BioHorizons, in the case of all BioHorizons
Technology and all Inventions, shall have the right, at its expense, to
determine the appropriate course of action to enforce such rights or otherwise
abate the infringement thereof, to take (or refrain from taking) appropriate
action to enforce such rights, to control any litigation or other enforcement
action and to enter into, or permit, the settlement of any such litigation or
other enforcement action with respect to such rights, and in good faith shall
consider the interests of the other Party, if any, in so doing.  In the case of actions by Manufacturer to
enforce the Manufacturer Technology, BioHorizons shall have the right to
participate fully with Manufacturer in the conduct of the action, including any
settlement discussions or decisions, at BioHorizons’s expense and with counsel
of its choice; provided that, only Manufacturer shall make decisions with
respect to settlements that result in any payment by Manufacturer or the
imposition of any other obligation or restriction on Manufacturer, including an
injunction.  Notwithstanding the
foregoing, BioHorizons and Manufacturer shall fully cooperate with each other
in any action to enforce any such rights.


 


(e)           Licenses.


 


(i)            BioHorizons License to
Manufacturer.  Subject to the terms
and conditions of this Agreement and for the Term, BioHorizons hereby grants to
Manufacturer a revocable, royalty-free, worldwide, nonexclusive,
nontransferable, nonassignable license, with no right to sublicense, to use the
BioHorizons Technology and the Inventions, solely to manufacture, assemble and
deliver the Products to BioHorizons or to its designated agents.


 


(ii)           Manufacturer License to
BioHorizons.  With respect to any
Intellectual Property Rights of Manufacturer relating to a Product that is
developed or assigned hereunder and is based on, or incorporates, or is an
improvement or derivative of, or cannot be reasonably made, used, modified,
maintained, supported, reproduced or distributed without using or violating,
any Intellectual Property Rights of Manufacturer or any other rights of
Manufacturer, Manufacturer hereby grants BioHorizons a perpetual, worldwide,
royalty-free, nonexclusive, sublicensable right and license (the “Background License”) to
exploit and exercise all such rights in support of BioHorizons’s or its
sublicensees’ exercise or exploitation of such Invention only for purposes of
making, using, maintaining, supporting, reproducing, offering to sell, selling,
distributing or otherwise exploiting the related Product.


 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 


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Section 4.               Representations and Warranties.


 


(a)           Corporate Existence.  Manufacturer hereby represents and warrants
to BioHorizons that Manufacturer is a corporation duly organized, validly
existing and in good standing under the laws of the State of California.


 


(b)           Corporate Power.  Manufacturer hereby represents and warrants
to BioHorizons that Manufacturer (a) has the corporate power and authority
and the legal right to own and operate its property and assets, to lease the
property and assets it operates under lease, and to carry on its business as it
is now being conducted and (b) is in compliance with all requirements of
Applicable Law.


 


(c)           Authorization and Enforcement of
Obligations.  Manufacturer hereby represents
and warrants to BioHorizons that Manufacturer (a) has the corporate power
and authority and the legal right to enter into this Agreement and to perform
its obligations hereunder and (b) has taken all necessary corporate action
on its part to authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder. 
This Agreement has been duly executed and delivered on behalf of
Manufacturer, and constitutes a legal, valid, binding obligation, enforceable
against Manufacturer in accordance with its terms.


 


(d)           No Conflict.  Manufacturer hereby represents and warrants
to BioHorizons that the execution and delivery of this Agreement and the
performance of Manufacturer’s obligations hereunder (a) do not conflict
with or violate any requirement of Applicable Law or any contractual obligation
of Manufacturer and (b) do not conflict with, or constitute a default or
require any consent under, any contractual obligation of Manufacturer.


 


Section 5.               Compliance with Laws; Regulatory
Affairs; Recalls.


 


(a)           Compliance with Laws.  Each Party shall maintain in full force and
effect all necessary licenses, permits and other authorizations required by law
to carry out its duties and obligations under this Agreement.  Each Party shall comply with all Applicable
Laws in performing its obligations and exercising its rights under this
Agreement.  Manufacturer and BioHorizons
each shall keep all records and reports required to be kept by Applicable Law.  The parties will reasonably cooperate with
one another with the goal of ensuring full compliance with Applicable Law.  Each Party will cooperate with the other to
provide such letters, documentation and other information on a timely basis as
the other party may reasonably require to fulfill its reporting and other
obligations under Applicable Laws to applicable Regulatory Authorities.  Except for such amounts as are expressly
required to be paid by a party to the other under this Agreement, each Party
shall be solely responsible for any costs incurred by it to comply with its
obligations under Applicable Laws.


 


(b)           Reasonable Cooperation.  Manufacturer shall use its reasonable and
diligent efforts to (a) during clinical trials, support all modifications
to Products to the extent and in such manner as BioHorizons may request in an
effort to obtain regulatory approval of such Products, and (b) supply such
drawings and specifications of the Products as BioHorizons may reasonably
require to evaluate and obtain regulatory approval of the Products; provided,
however, that Manufacturer shall not be required to (i) pay money (other
than as expressly required pursuant to 


 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 


7

















 


this Agreement), or (ii) assume
any other material obligation not otherwise required to be assumed by this
Agreement.


 


(c)           Maintenance and Inspection of
Facilities and Records.  Manufacturer
shall maintain at its sole cost all government approvals of its facilities,
including all Regulatory Authority approvals, shall maintain adequate premises,
equipment, and experienced and competent personnel, and shall maintain accurate
and complete records of all methods, tests, procedures and results of its work,
that are required to manufacture and assemble the Products in compliance with
cGMP and applicable Quality Standards. 
BioHorizons shall have the right, upon reasonable notice and during
regular business hours, to conduct quality assurance audits of the facilities
used by Manufacturer for the manufacture of Products and records of
Manufacturer and of all third parties whose facilities are used for the
manufacture of any portion of the Product for compliance with Regulatory
Authority standards, including cGMP. 
Manufacturer will also (a) inform BioHorizons in writing in advance
of any proposed inspection by any governmental agency of the Manufacturer
facilities where the Product is manufactured or assembled and of the results of
any such inspection and (b) permit BioHorizons to participate in any such
inspection of the Manufacturer facilities.


 


(d)           Adverse Event Reporting and
Product Information Requests.


 


(i)            Adverse Reaction Reporting.  During the Term, each Party shall
immediately, but in any case within [***] ([***]) [***], notify the other
party, by facsimile or telephone, of any adverse patient experience involving
the Product of which it becomes aware.


 


(ii)           Product Information Requests.
Information concerning any complaints, inquiries and/or information requests
from consumers, clinicians, or other third parties regarding the Product shall
be forwarded to BioHorizons within [***] ([***]) [***] of Manufacturer’ receipt
of the information and/or inquiry. BioHorizons shall respond to such complaints
and inquiries, if necessary, in accordance with its usual and customary
procedures.


 


(iii)          Governmental Reports.
BioHorizons shall be responsible for filing with the appropriate Regulatory
Authorities any required adverse reaction reports that it receives directly
from third parties and any adverse reaction reports that it receives through
Manufacturer.


 


(e)           Recalls.


 


(i)            Recalls. In the event (i) any
government authority issues a request, directive or order that a Product be
recalled, or (ii) a court of competent jurisdiction orders such a recall,
or (iii) BioHorizons reasonably determines that a Product should be
recalled, the Parties shall take all appropriate corrective actions.  To the extent that such recall results,
directly or indirectly, from the manufacture, packaging, storage, testing and
handling of the Product by Manufacturer and such recall or event is due, in
whole or in part, to an act or omission of Manufacturer, including Manufacturer’s
failure to manufacture Products according to the Product Specifications or
package Products according to the Packaging Specifications, Manufacturer shall
be responsible for all expenses of the recall. 
For the purposes of this Agreement, the expenses of recall shall
include, without limitation, the expenses of notification 


 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 


8

















 


and destruction or return
of the recalled Product, and the amounts paid by BioHorizons for the Products
recalled.


 


(ii)           Recall Coordination. All
coordination of any recall or field correction activities involving Products
shall be handled by BioHorizons.


 


(iii)          Recall Records. Each of the
Parties shall maintain complete and accurate recall records of all the Products
sold by it for such periods as may be required by Applicable Law, but in no
event less than [***] ([***]) [***] after the date of the recall.


 


Section 6.               Confidential Information.


 


(a)           The Parties agree not to disclose or
use (except as permitted or required for performance by the Party receiving
such Confidential Information of its rights or duties hereunder or under other
agreements between the Parties or their affiliates) any Confidential Information
of the other Party obtained during the Term until the expiration of [***] after
the termination of this Agreement.  Each
Party further agrees to take reasonable measures (and in no event less than
measures taken by such Party with respect to its own Confidential Information)
to prevent any such prohibited disclosure of Confidential Information by its
present and future employees, officers, agents, subsidiaries, or consultants
during such period.


 


(b)           Notwithstanding the provisions of Section 6(a) or
Section 11(i), BioHorizons may describe the terms of this Agreement and
disclose the text hereof in any filing made with the Securities and Exchange
Commission.  BioHorizons will seek
confidential treatment to the extent such treatment is reasonably likely to be
granted, based on the advice of counsel.


 


Section 7.               Indemnification; Insurance.


 


(a)           Indemnification.  Manufacturer shall indemnify BioHorizons
against any and all liability, damages, cost and expenses, including reasonable
attorneys’ fees, made against or sustained by BioHorizons that arise, directly
or indirectly, from any act or omission of Manufacturer including Manufacturer’s
failure to deliver Products in accordance with Manufacturer’s warranties, the
infringement by the Manufacturer of any Intellectual Property Rights of any
third party; or Manufacturer’s violation of Applicable Law.


 


(b)           Insurance.  Manufacturer shall obtain liability insurance
with respect to its activities contemplated by this Agreement in such amounts
as are customary for companies engaged in similar activities.  Manufacturer shall provide evidence of such
insurance to BioHorizons upon reasonable request and shall maintain such
insurance throughout the Term.


 


Section 8.               Term and Termination.


 


(a)           Term.  This Agreement shall commence on the
Effective Date and remain in force until December 31, 2011, subject to the
rights of termination set forth in this Section 8.  After the initial term, this Agreement shall
be automatically renewed and continued from year to year unless either Party
gives the other written notice not to renew this Agreement at least 90 days
before the end of the term then in effect.


 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 


9














 


(b)           Termination.  Without prejudice to any other remedies that
either Party may have against the other, this Agreement may be terminated upon
the occurrence of any of the following events:


 


(i)            by either Party, if the other Party
commits a material breach (including delivery and quality performance that is
below the standards required by BioHorizons for other suppliers (if any) that
supply the same type of products) of any of the terms of this Agreement, and,
in the case of a material breach capable of remedy, fails to remedy the same
within 30 days after receipt of a written notice detailing the facts alleged to
give rise to the material breach and requiring it to be remedied;


 


(ii)           by either Party, if the other Party
will (A) apply for or consent to the appointment of a receiver, trustee,
custodian, intervenor or liquidator of itself or of all or a substantial part
of its assets, (B) file a voluntary petition in bankruptcy or admit in
writing that it is unable to pay its debts as they become due, (C) make a
general assignment for the benefit of creditors, (D) file a petition or
answer seeking reorganization of an arrangement with creditors or to take
advantage of any bankruptcy or insolvency laws, (E) file an answer
admitting the material allegations of, or consent to, or default in answering,
a petition filed against it in any bankruptcy, reorganization or insolvency
proceeding, or (F) take corporate action for the purpose of effecting any
of the foregoing.


 


(c)           Post-Termination Obligations.  Upon the expiration or termination of this
Agreement, the Parties’ rights and obligations hereunder shall terminate;
provided that (i) nothing herein shall be construed to release either
Party from any obligation that matured prior to the effective date of such
termination or expiration and (ii) the Parties’ rights and obligations
hereunder intended to be observed and performed by the Parties after the
termination or expiration hereof, shall survive such termination or expiration.


 


(d)           Disengagement Plan. 
Within [***] ([***]) [***] of the termination of this Agreement,
BioHorizons will order (i) any Products that were finished product stored
at Manufacturer’s facility pursuant to Section 1(i) and (ii) any
Products that were work in progress based on a purchase order or compliance
with Section 1(i) at the time of termination that are converted into
Products within [***] ([***]) [***] of termination.  The terms of this Agreement will continue to
apply to such products except that BioHorizons shall have the right to withhold
payment, for up to [***], in an amount equal to [***]% of its good faith
estimate of the value of all Products likely to be rejected.  BioHorizons will determine the amount to be
withheld based on the average rejection rate for the [***] before the date of
termination.  In no event will
BioHorizons be liable to Manufacturer pursuant to this Section 8(d) for
inventory in excess of the sum of (x) the minimum required to be
maintained by Manufacturer in accordance with Section 1Section 1(i) plus
(y) the amount subject to an open purchase order at the time of the
Specification change.


 


Section 9.               Right of First Refusal.  In the event that Manufacturer receives an
offer to enter into any transaction or series of transactions that would
reasonably be expected to result in a Change of Control of Manufacturer,
Manufacturer, prior to acceptance thereof, shall give BioHorizons, with respect
to each such offer, written notice thereof and a copy of said offer including
the name and address of the proposed purchaser and a summary of any terms that
have 


 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 


10

















 


not been reduced to
writing.  BioHorizons shall have the
following option and right of first refusal for [***] ([***]) [***] from
receipt of such notice (the “ROFR
Period”): during the ROFR period, BioHorizons shall have the
exclusive right to negotiate the terms of a transaction that would result in a
Change of Control of Manufacturer on the price and other terms set forth in
such notice and to enter into a definitive agreement with respect thereto.  During the ROFR period, Manufacturer shall
give BioHorizons full and complete access to Manufacturer’s books and records
including financial and operational records. 
Manufacturer shall make available its officers, attorneys and other
agents to discuss the business, operations and financial condition of
Manufacturer and to negotiate a definitive agreement with respect to the Change
of Control.


 


Section 10.             Certain Definitions.  For purposes of this Agreement, unless the
context otherwise requires, the term:


 


(a)           “Affiliate” means any person or entity which, directly or
indirectly, controls, is controlled by or is under common control with a Party
to this Agreement.  As used in this
Agreement, “control” means the possession, directly or indirectly, of the power
to direct or cause the direction of the policies and management of such person
or entity, whether by the ownership of securities, by contract or by any other
method.


 


(b)           “Applicable Law” means all laws, ordinances, rules and
regulations applicable to the manufacture of a Product or any other activities
of a Party under this Agreement, including the applicable regulations and
guidelines of any Regulatory Authority including the FDA and foreign
counterparts and all applicable cGMPs, in effect from time to time during the
Term.


 


(c)           “Acquiring Shareholder” means a shareholder or
shareholders of a Person that (i) merges or combines with such Person in a
transaction or series of transactions or (ii) is an affiliate of another
entity that merges or combines with such Person in a transaction or series of
transactions.


 


(d)           “BioHorizons Technology” means all technologies,
inventions, materials, and documents, and all Intellectual Property Rights in
the foregoing, owned by BioHorizons or its Affiliates at any time during the
Term (but only during the period of such ownership) that relate to the
manufacture or assembly of the Products.


 


(e)           “Change of Control” means, with respect to any Person,
any reorganization, consolidation, merger or similar transaction or series of
related transactions in which such Person is a constituent entity or is a party
if, as a result of such transaction(s), the voting securities of such Person
that are outstanding immediately prior to the consummation of such transaction(s) (other
than any such securities that are held by an Acquiring Shareholder) do not
represent, or are not converted into, securities of the surviving entity of
such transaction(s) (or such surviving entity’s parent entity if the
surviving entity is owned, directly or indirectly, by the parent entity) that,
immediately after the consummation of such transaction(s), together possess at
least a majority of either (x) the total voting power or (y) the
right to receive economic benefits of all securities of such surviving entity
(or its parent entity, if applicable) that are outstanding immediately after
the consummation of such transaction(s), including securities of such surviving
entity (or its parent entity, if applicable) that are held by the Acquiring
Shareholder.


 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 


11

















 


(f)            “Confidential Information” means any written or tangible
information of one of the Parties (the “Disclosing
Party”) which is disclosed to the other Party (the “Receiving Party”) that is not
generally known to the public, including, without limitation, trade secrets and
know-how, but excluding information which: (a) was already in the
possession of or known by the Receiving Party prior to its receipt from the
Disclosing Party; (b) is or becomes part of the public domain by reason of
acts not attributable to the Receiving Party; (c) is or becomes available
to Receiving Party from a source other than the Disclosing Party which source
has rightfully obtained such information and, to the best of the Receiving
Party’s knowledge, has no obligation of non-disclosure or confidentiality to
the Disclosing Party with respect thereto; (d) has been independently
developed by the Receiving Party without breach of this Agreement or use of any
Confidential Information of the other Party; or (e) has been or must be
publicly disclosed by reason of legal, accounting or regulatory requirements
beyond the reasonable control of the Receiving Party provided the Receiving
Party provides the Disclosing Party notice of the intended disclosure in order
for the Disclosing Party to take such action it deems appropriate to protect
the confidentiality of the information to be disclosed.  Notwithstanding the foregoing, the Developed
Works and the BioHorizons IPR shall be the exclusive Confidential Information
of BioHorizons.


 


(g)           “cGMP”
or “current Good Manufacturing
Practices” means current good manufacturing practices applicable
from time to time to the manufacturing, packaging, labeling, holding and
quality control testing of a Product, including Good Manufacturing Practices as
promulgated by the United States Federal Food, Drug, and Cosmetic Act, 21
U.S.C. § 301 et seq, as amended, cGMP for medical devices (21 C.F.R. Part 820),
and other Applicable Law.


 


(h)           “FDA” means the United States Food and Drug
Administration.


 


(i)            “Intellectual Property Rights” means all rights, title,
and interest arising under U.S. common and statutory law and the laws of other
countries to all:  (a) patents and
all filed, pending or potential applications for patents, including any
reissue, reexamination, division, continuation, or continuation-in-part
applications throughout the world now or hereafter filed; (b) know-how,
trade secret rights and equivalent rights; (c) copyrights, moral rights,
other literary property or authors’ rights; (d) proprietary indicia,
trademarks, trade names, symbols, logos, or brand names; and (e) mask
works and mask work rights.


 


(j)            “Inventions” means all inventions, discoveries,
improvements or other technology conceived or reduced to practice during the
Term solely by Manufacturer or jointly by its employees or others acting on
behalf of Manufacturer and BioHorizons or their Affiliates to the extent
relating to the Product, the Manufacturing Know-How, or any improvements
thereto, and all Intellectual Property Rights in the foregoing.


 


(k)           “Late Notice” means a written notice delivered by
BioHorizons to Manufacturer with respect to Late Parts which provides the
following information in reasonable detail: (i) the applicable purchase
order number, (ii) the specific line item(s) on such purchase order
that BioHorizons has determined in good faith represent Late Parts, (iii) the
date on which BioHorizons has determined in good faith that the failure to
deliver such parts began to materially and adversely affect the business of
BioHorizons and (iv) references Section 1(j) of this Agreement.


 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 


12

















 


(l)            “Late Parts” means, with respect to any Products to be
delivered hereunder, parts that (i) are the subject of a Qualifying Order,
(ii) that are not delivered within the time period specified in the
applicable purchase order, (iii) such failure to deliver on time is not
based in whole or in part on any act or omission of BioHorizons and (iv) such
failure to deliver on time materially and adversely affects the business of
BioHorizons.  For the avoidance of doubt,
all of items (i)-(iv) must be true in order for any part to be deemed a
Late Part.


 


(m)          “Manufacturing Know-How” means all information, techniques,
practices, methods, knowledge, skill and data, which are not generally known
including, but not limited to, a proprietary “trade secret” or other
Intellectual Property Rights, whether or not patentable or copyrightable, used
or useful for the production, assembly, manufacture, storage and/or transport
of the Product.


 


(n)           “Manufacturer Technology” means all technologies,
inventions, materials, and documents, and all Intellectual Property Rights in
the foregoing, owned by Manufacturer or its Affiliates during the Term (but
only during the period of such ownership) that are used or useful in the
manufacture or assembly of the Product.


 


(o)           “Packaging Specifications” means the requirements,
standards, quality control testing and other attributes pertaining to the
packaging, labeling and shipping of a Product, as such specifications may be
amended by BioHorizons from time to time.


 


(p)           “Person” means an individual, corporation, partnership,
limited liability company, association, trust, unincorporated organization,
entity or group (as defined in the Securities Exchange Act of 1934, as
amended).


 


(q)           “Products” means those dental implant and prosthetic
products set forth on Exhibit A as updated from time to time by
BioHorizons.


 


(r)            “Quality Standards” means initial and continuing
compliance with: ISO 9001 or ISO 13485, as applicable; all local laws and
regulations affecting manufacturing; and internal identified manufacturing
policies, standard operating procedures and specifications; as any of the foregoing
are in effect from time to time; and no failure to comply with directions or
regulations of Regulatory Authorities  for
jurisdictions in which any Product is distributed for human use, and, with
respect to any Product intended for human use in the United States, Quality
Standards shall include cGMP and applicable FDA rules and regulations and
International Conference on Harmonization guidelines and requirements.


 


(s)           “Regulatory Authority” means any governmental regulatory
authority involved in regulating any aspect of the manufacture, market
approval, sale, distribution, packaging or use of any Product for each
jurisdiction in which such Product is distributed.


 


(t)            “Specifications” means the requirements, standards,
quality control testing and other attributes pertaining to a Product, as such
specifications are provided to Manufacturer by BioHorizons and as they may be
amended by BioHorizons, in its sole discretion at any time and from time to
time.


 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 


13

















 


(u)           “Term” means the period between the Effective Date and
the date on which this Agreement terminates or expires.


 


Section 11.             Miscellaneous.


 


(a)           Entire Agreement: Amendments; No
Waiver.  This Agreement and any
related schedules contemplated in this Agreement constitute the complete and
exclusive statement of the terms and conditions of the agreement between
Manufacturer and BioHorizons and supersedes all prior representations,
agreements, or communications, either oral or written, between the Parties with
respect to the subject matter contained in this Agreement, including, but not
limited to, the Prior Agreement, which is hereby amended, restated and
superseded in its entirety by this Agreement.  
No modification, amendment, rescission, waiver or other change to this
contract will be binding on Manufacturer or BioHorizons, nor may any claim or
right arising out of breach of this contract be discharged, in whole or in
part, by waiver or renunciation of the claim or right, unless made in writing
and signed by a duly authorized representative of Manufacturer and
BioHorizons.  No field representative of
Manufacturer or BioHorizons has authority to sign such in writing.  The failure of any Party to enforce at any
time any of the provisions of this Agreement shall not, absent an express
written waiver signed by the Party making such waiver specifying the provision
being waived, be construed to be a waiver of any such provision, nor in any way
to affect the validity of this Agreement or any part thereof or the right of
the Party thereafter to enforce each and every such provision.  No waiver of any breach of this Agreement
shall be held to be a waiver of any other or subsequent breach.


 


(b)           Assignment; No Third Party
Beneficiaries.  Neither Party will
assign, delegate, or subcontract any of its obligations hereunder to any third
party without the express written consent of the other Party.


 


(c)           Validity.  In the event any one or more of the
provisions contained in this contract will for any reason be held to be
invalid, illegal, or unenforceable in any respect, such invalidity, illegality,
or unenforceability will not affect any other provision hereof, and this
contract will be construed as if such invalid, illegal, or unenforceable
provision had never been contained herein.


 


(d)           Notices.  Any notice, request, claim, demand or other
communication to be given by any Party hereunder will be in writing and will be
deemed sufficient if delivered personally or by facsimile (receipt confirmed
electronically) or sent by registered or certified mail, postage prepaid, or
sent by overnight courier addressed as follows:


 


If to Manufacturer:


 


Precision One Medical


1740 Ord Way


Oceanside, CA 92056


Attn: Chief Executive Officer


Fax: 760 945-7962


 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 


14

















 


If to BioHorizons:


 


BioHorizons, Inc.


2300 Riverchase Center


Birmingham, AL 35244


Attn: Chief Executive Officer


Fax: 205 870-0304


 


With a copy:


 


BioHorizons, Inc.


2300 Riverchase Center


Birmingham, AL 35244


Attn: General Counsel


Fax: 205 484-2242


 


or such other address as the person
to whom notice is given may have previously furnished to the other in writing
in the manner set forth above.  Such
communication will be deemed to have been delivered (i) on the day of
delivery if delivered personally or via facsimile, (ii) three business
days after mailing if sent by mail, or (iii) one business day after
delivery to an overnight courier service, if sent by overnight courier,
provided that notice of any change of address will be effective only upon
receipt thereof.


 


(e)           Governing Law; Venue.  This Agreement will be governed by and
construed in accordance with the domestic laws of the State of Alabama, without
regard to its conflicts of laws principles. 
Any legal action or proceeding with respect to this Agreement shall be
brought in the courts of the State of Alabama in a federal court located in the
State of Alabama.  By execution and
delivery of this Agreement, each of the Parties accepts for itself and in
respect of its property, generally and unconditionally, the exclusive
jurisdiction of the aforesaid courts.


 


(f)            Parties in Interest.  This Agreement will be binding upon and inure
to the benefit of each Party hereto and each of their respective permitted
successors and assigns.


 


(g)           Counterparts.  This Agreement may be executed in two or more
counterparts, each of which will be deemed to be an original, but all of which
will constitute one and the same agreement.


 


(h)           Force Majeure.  Neither Party will be responsible or liable
for losses or damages arising from any failure of such Party to perform or
delays in such Party’s performance due, in whole or in part, to causes beyond
its reasonable control, but only for the duration of such event.


 


(i)            No public announcement.  Neither Party shall issue any press release
or make any other public announcement (including any announcement to employees)
relating to the subject matter of this Agreement without first having received
the prior written approval of the other Party.


 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 


15

















 


IN WITNESS WHEREOF, the Parties have
set their hands as of the date first written above.


 


	
   

  	
  BioHorizons:

  
	
   

  	
  BIOHORIZONS, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  /s/ R.
  Steven Boggan

  
	
   

  	
  By:

  
	
   

  	
  Its:

  
	
   

  	
   

  
	
   

  	
  Manufacturer:

  
	
   

  	
  PRECISION ONE
  MEDICAL, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  /s/ John
  Tyszka 11-3-2010

  
	
   

  	
  By: John Tyszka

  
	
   

  	
  Its: Chief Executive Officer

  



 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 


16

















 


Exhibit A


 


	
  Item #

  	
   

  	
  Description

  	
   

  	
  Monthly Avg

  	
   

  	
  Unit

  	
   

  	
  Extended

  	
   

  	
  Yearly

  	
   

  
	
  PXAS-B

  	
   

  	
  Internal Abutment
  Screw Mch

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PBCC-B

  	
   

  	
  5.7mm Cover Cap, Machined

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PGCC-B

  	
   

  	
  4.5mm Cover Cap, Machined

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PYCC-B

  	
   

  	
  3.5mm Cover Cap, Machined

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PxCC-B

  	
   

  	
  Internal Cover
  Cap Total

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PBREA-B

  	
   

  	
  5.7mm 3inOne Abut Regular
  Emergence, Mach’d

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PGREA-B

  	
   

  	
  4.5mm 3inOne Abut Regular
  Emergence, Mach’d

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PYREA-B

  	
   

  	
  3.5mm 3inOne Abut Regular
  Emergence, Mach’d

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PxREA-B

  	
   

  	
  Internal 3inOne
  Total

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TMA3809-B

  	
   

  	
  3.8mm x 9mm Tapered Internal
  Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TMA3810-B

  	
   

  	
  3.8mm x 10.5mm Tapered Internal
  Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TMA3812-B

  	
   

  	
  3.8mm x 12mm Tapered Internal
  Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TMA3815-B

  	
   

  	
  3.8mm x 15mm Tapered Internal
  Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TMA4607-B

  	
   

  	
  4.6mm x 7.5mm Tapered Internal
  Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TMA4609-B

  	
   

  	
  4.6mm x 9mm Tapered Internal
  Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TMA4610-B

  	
   

  	
  4.6mm x 10.5mm Tapered Internal
  Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TMA4612-B

  	
   

  	
  4.6mm x 12mm Tapered Internal
  Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TMA4615-B

  	
   

  	
  4.6mm x 15mm Tapered Internal
  Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TMA5807-B

  	
   

  	
  5.8mm x 7.5mm Tapered Internal
  Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TMA5809-B

  	
   

  	
  5.8mm x 9mm Tapered Internal
  Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TMA5810-B

  	
   

  	
  5.8mm x 10.5mm Tapered Internal
  Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TMA5812-B

  	
   

  	
  5.8mm x 12mm Tapered Internal
  Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TMA5815-B

  	
   

  	
  5.8mm x 15mm Tapered Internal
  Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TMA Implants

  	
   

  	
  Tapered Internal
  Total

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PB5009-B

  	
   

  	
  5.0 x 9mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PB50105-B

  	
   

  	
  5.0 x 10.5mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PB5012-B

  	
   

  	
  5.0 x 12mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PB5015-B

  	
   

  	
  5.0 x 15mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PB6009-B

  	
   

  	
  6.0 x 9mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PB60105-B

  	
   

  	
  6.0 x 10.5mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PB6012-B

  	
   

  	
  6.0 x 12mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PB6015-B

  	
   

  	
  6.0 x 15mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PG4009-B

  	
   

  	
  4.0 x 9mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PG40105-B

  	
   

  	
  4.0 x 10.5mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PG4012-B

  	
   

  	
  4.0 x 12mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PG4015-B

  	
   

  	
  4.0 x 15mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PY3509-B

  	
   

  	
  3.5 x 9mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PY35105-B

  	
   

  	
  3.5 x 10.5mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PY3512-B

  	
   

  	
  3.5 x 12mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PY3515-B

  	
   

  	
  3.5 x 15mm Internal Implant

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  P-Series Implants

  	
   

  	
  Parallel Internal
  Total

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  



 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 


17

















 


	
  Item #

  	
   

  	
  Description

  	
   

  	
  Monthly Avg

  	
   

  	
  Unit

  	
   

  	
  Extended

  	
   

  	
  Yearly

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PBIA-B

  	
   

  	
  Internal 5.7 Implant Analog

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PGIA-B

  	
   

  	
  Internal 4.5 Implant Analog

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PYIA-B

  	
   

  	
  Internal 3.5 Implant Analog

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SBIA-C

  	
   

  	
  Single-stage 5.7mm Implant Analog

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SGIA-C

  	
   

  	
  Single-stage 4.5mm Implant Analog

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SYIA-C

  	
   

  	
  Single-stage 3.5mm Implant Analog

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  I & SS Analogs

  	
   

  	
  Analog Total

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SB5007-B

  	
   

  	
  5mm x 7mm Single-stage Implant,
  5.7mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SB5009-B

  	
   

  	
  5mm x 9mm Single-stage Implant,
  5.7mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SB50105-B

  	
   

  	
  5mm x 10.5mm Single-stage Implant,
  5.7mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SB5012-B

  	
   

  	
  5mm x 12mm Single-stage Implant,
  5.7mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SB5015-B

  	
   

  	
  5mm x 15mm Single-stage Implant, 5.7mm
  Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SB6007-B

  	
   

  	
  6mm x 7mm Single-stage Implant,
  5.7mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SB6009-B

  	
   

  	
  6mm x 9mm Single-stage Implant,
  5.7mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SB60105-B

  	
   

  	
  6mm x 10.5mm Single-stage Implant,
  5.7mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SB6012-B

  	
   

  	
  6mm x 12mm Single-stage Implant,
  5.7mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SB6015-B

  	
   

  	
  6mm x 15mm Single-stage Implant,
  5.7mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SG4007-B

  	
   

  	
  4mm x 7mm Single-stage Implant,
  4.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SG4009-B

  	
   

  	
  4mm x 9mm Single-stage Implant,
  4.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SG40105-B

  	
   

  	
  4mm x 10.5mm Single-stage Implant,
  4.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SG4012-B

  	
   

  	
  4mm x 12mm Single-stage Implant,
  4.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SG4015-B

  	
   

  	
  4mm x 15mm Single-stage Implant,
  4.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SG5007-B

  	
   

  	
  5mm x 7mm Single-stage Implant,
  4.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SG5009-B

  	
   

  	
  5mm x 9mm Single-stage Implant,
  4.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SG50105-B

  	
   

  	
  5mm x 10.5mm Single-stage Implant,
  4.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SG5012-B

  	
   

  	
  5mm x 12mm Single-stage Implant,
  4.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SG5015-B

  	
   

  	
  5mm x 15mm Single-stage Implant,
  4.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SY3507-B

  	
   

  	
  3.5mm x 7mm Single-stage Implant,
  3.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SY3509-B

  	
   

  	
  3.5mm x 9mm Single-stage Implant,
  3.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SY35105-B

  	
   

  	
  3.5mm x 10.5mm Single-stage
  Implant, 3.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SY3512-B

  	
   

  	
  3.5mm x 12mm Single-stage Implant,
  3.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SY3515-B

  	
   

  	
  3.5mm x 15mm Single-stage Implant,
  3.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SY4007-B

  	
   

  	
  4mm x 7mm Single-stage Implant,
  3.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SY4009-B

  	
   

  	
  4mm x 9mm Single-stage Implant,
  3.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SY40105-B

  	
   

  	
  4mm x 10.5mm Single-stage Implant,
  3.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SY4012-B

  	
   

  	
  4mm x 12mm Single-stage Implant,
  3.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SY4015-B

  	
   

  	
  4mm x 15mm Single-stage Implant,
  3.5mm Platform

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sing Stg Implants

  	
   

  	
  Single-stage
  Implant Total

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
  $

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  



 


Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as
amended.


 


18