Exhibit 10.33


Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company's application requesting confidential treatment under Rule 406 of
the Securities Act. Asterisks denote omissions.


PRIVATE
LABEL DISTRIBUTION AGREEMENT


This DISTRIBUTION AGREEMENT is entered
into as of March __, 2006 (the “Effective Date”) by and between Alphatec Spine,
Inc., a California corporation (“ASI”), and OsteoBiologics, Inc., a Delaware
corporation (“OBI”).


Background


WHEREAS, OBI has developed and
manufactures certain Products (as defined herein) used to fill bony voids or
gaps caused by trauma or surgery; and


WHEREAS, ASI desires to market the
Products as private labeled products in the Field within the Territory (as
defined herein) as an exclusive distributor for a period of time;


NOW, THEREFORE, in consideration of the
promises and the mutual covenants contained herein, and for other good and
valuable consideration, the receipt and sufficiency of which are hereby
acknowledged by each of the parties hereto, OBI and ASI agree as follows:.


1.             DEFINITIONS


1.1           Defined
Terms


Capitalized terms used in this Agreement
and not otherwise defined herein shall have the respective meanings set forth
below.


“Act” means the United States
Food, Drug and Cosmetic Act and similar laws and regulations in foreign
jurisdictions, all as may be amended from time to time.


“Affiliate” means, with respect to
any person, any person that, directly or indirectly, through one or more intermediaries,
controls, is controlled by, or is under common control with, such person.  For purposes of this Agreement, “control”
means, with respect to any person, the direct or indirect ownership of more
than 50% of the voting or income interest in such person or the possession
otherwise, directly or indirectly, of the power to direct the management or
policies of such person.


“Agents” shall mean sublicensees,
sub-distributors, agents, representatives or co-promoters of ASI or OBI, as
applicable.


“Agreement” means this
Distribution Agreement, including all Exhibits, Annexes and Schedules hereto
(which are hereby incorporated by reference herein), as the same may be amended
or supplemented from time to time in accordance herewith.


 “Change
of Control” means a sale of OBI or ASI, whether by merger, consolidation or
other transaction or series of related transactions, in which, in each case,
the holders of OBI’s or ASI’s voting securities outstanding immediately prior
to the consummation of the transaction or the series of related transactions
own securities with less than a majority of the voting power of OBI or ASI or a
successor immediately after the transaction or such series of related
transactions, or by sale of all or substantially all of OBI’s or ASI’s assets.


 


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“Competitive Product” shall mean a
product utilizing bioresorbable polymers in combination with ceramic materials
for bone grafting and/or osteochondral repair applications.     


“Confidential Information” means
all data, specifications, training materials and other know how related to the
design, use, implementation, performance or manufacture of the Products, as
well as all other information and data provided by either Party to the other
Party hereunder in written or other tangible medium and marked as confidential,
or if disclosed orally or displayed, identified as confidential prior to or at
the time of disclosure and confirmed in writing as confidential within thirty
(30) days after disclosure or any other information which a reasonable person
would deem to be confidential based on the nature of the information or the
circumstances of the disclosure, in each case except any portion thereof
which:  (a) is known to the receiving
Party before receipt thereof under this Agreement as evidenced by the receiving
Party’s written records; (b) is properly and lawfully disclosed to the
receiving Party by a third person who has the legal right to make such
disclosure; (c) is or becomes generally known in the trade through no fault of
the receiving Party; or (d) is independently developed by the receiving Party
without use of such information, as evidenced by the receiving Party’s written
records.


“FDA” means the United States Food
and Drug Administration, or any successor entity.


“Field” shall mean, with respect
to the Products, medical uses of the Products for reconstructive surgical
procedures of the spine.


 “Gross
Sales” shall mean, for a given period, the gross amount received on sales
invoiced, net of refunds, by ASI or any Affiliate or Agent on behalf of ASI, or
by OBI in the case of Section 2.3, for the sale of the Products anywhere in the
Territory during such period, excluding freight, insurance charges and sales
taxes and other transfer taxes.


“Minimum Quarterly Order Requirements”
are set forth in Exhibit B with respect to the periods indicated, as such
amounts may be adjusted and agreed upon by both Parties from time to time.


“OBI Patent Rights” means all
patents, patent applications and rights to file patent applications associated
with or relating to any Products, their manufacture, sale, use or composition
and are licensed to, owned or controlled by OBI now or in the future.


“Parties” shall mean both ASI and
OBI, and “Party” shall mean either of them as the context indicates.


“Products” means the OBI
PolyGraftTM Synthetic Bone Graft Substitute (BGS) products listed in Exhibit A
and associated OBI disposable instrumentation listed in Exhibit A.  Products may be changed, discontinued or
added from time to time by mutual agreement of the Parties.


“Product Approvals” means, for any
country or other jurisdiction in the Territory, those authorizations by the
appropriate Regulatory Authority(ies) required for importation, promotion,
pricing, marketing and sale of the Products in such country or other
jurisdiction.


 


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“Product Improvements” means any
modifications to Products or subsequent version of Products that may replace
such Products and be intended for use in the same or related spine surgery applications.  Prior to the commercial release of Product
Improvements under this Agreement, Exhibit A shall be amended to include the
Product Improvements as Products.


“Proprietary Rights” means all
proprietary rights and interests of every nature, whether now existing or
hereafter arising, including OBI Patent Rights, in, to, related to or covering
or incorporated into any Product, including those relating to their
manufacture, sale, use or design, to the extent that such rights and interests
are of such legal status and nature to be capable of being lawfully licensed or
sold and shall include without limitation inventions, ideas, improvements
(including Product Improvements), manufacturing know how, technology,
copyrights, trade secrets, trademarks or service marks (including Trademarks)
and Confidential Information.


“Regulatory Authority” means any
national, supra-national, regional, state or local regulatory agency,
department, bureau, commission, council or other governmental entity,
regulating the manufacture, sale or use of medical devices, including the FDA.


“Reimbursement Approvals” means
governmental and other approvals in any country or jurisdiction, for a buyer to
claim reimbursement at any level for the purchase of the Products, from private
or public health insurance organizations in such country or jurisdiction.


 “Territory”
means the United States of America and its territories and possessions. 


“Trademarks” means those
trademarks and service marks that OBI uses, owns or controls with respect to
the Products, and any additional trademarks or service marks (other than ASI’s
trademarks) that the Parties agree in the future may be used in connection with
the sale of Products.


1.2           Other
Defined Terms


Each of the following terms shall have
the respective meaning ascribed to such term in the section of this Agreement
set forth opposite such term below:


	
   

  	
  “ASI”

  	
   

  	
  Introductory paragraph

  
	
   

  	
  “Cure Payment”

  	
   

  	
  Section 3.5

  
	
   

  	
  “Effective Date”

  	
   

  	
  Introductory paragraph

  
	
   

  	
  “Indemnifying Party”

  	
   

  	
  Section 9.1

  
	
   

  	
  “Indemnitees”

  	
   

  	
  Section 9.1

  
	
   

  	
  “Losses”

  	
   

  	
  Section 9.1

  
	
   

  	
  “OBI”

  	
   

  	
  Introductory paragraph

  
	
   

  	
  “Offer Notice”

  	
   

  	
  Section 2.6

  
	
   

  	
  “Post-Change of Control Period

  	
   

  	
  Section 10.5

  
	
   

  	
  “Product Information”

  	
   

  	
  Section 6.1

  
	
   

  	
  “Product Transfer Price”

  	
   

  	
  Section 3.6

  
	
   

  	
  “Samples”

  	
   

  	
  Section 3.7

  



 


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2.             DISTRIBUTION


2.1           Appointment.  Subject to the terms and conditions set forth
in this Agreement, OBI hereby appoints ASI and its Affiliates as OBI’s
exclusive distributor (with the full right to appoint sub-distributors and
Agents to sell the Products under ASI’s private label) of the Products under
ASI’s private label for use in the Field within the Territory during the term
of this Agreement, and ASI hereby accepts such appointment.  Subject to the terms and conditions set forth
in this Agreement, as OBI’s distributor of Products under ASI’s private label
in the Territory, ASI shall have the exclusive right to promote, market,
distribute and sell Products as ASI’s private label products, with such
labeling specifically including “Manufactured by OsteoBiologics, Inc.” or “Manufactured
by OBI”, for use in the Field within the Territory.


2.2           Certain
Restricted Parties; Distribution Relationship.  During any period in which ASI is appointed
as the exclusive distributor of Products under ASI’s private label for use in
the Field within the Territory, OBI agrees not to sell Products under ASI’s
private label to any third party. 
However, nothing in this Agreement shall limit, prohibit or otherwise
restrict OBI, its Affiliates, Agents or distributors from promoting, marketing,
distributing or selling any of OBI’s products, including, without limitation,
any of OBI’s products that are the same or substantially similar to the
Products, provided such products are not (i) packaged under ASI’s private label;
or (ii) or sold in the in the Territory for use in the Field, except as
permitted in this Agreement.


2.3           Intentionally
Omitted.


2.4           ASI
Marketing Efforts.


(a)           ASI
shall use its commercially reasonable best efforts to market and sell the
Products for use in the Field within the Territory during such time as ASI’s
exclusive appointment within the Territory in the Field remains in effect.


(b)           The
Parties agree that in the event of a material breach by ASI of its covenants set
forth in Sections 2.4(a) and/or 2.4(c), OBI may terminate ASI’s exclusive
appointment hereunder with respect to distribution of Products; provided that
OBI shall have delivered to ASI written notice of such material failure, which
notice shall set forth in reasonable detail the nature of the alleged material
failure and such material breach has not been cured or waived within sixty (60)
calendar days, or if such breach is of a nature that it can not be cured within
such sixty day period ASI shall not be taking commercially reasonable measures
to remedy or cure, following delivery of such notice.


(c)           ASI
and its Affiliates or Agents shall not during the term of this Agreement,
directly or indirectly, market, promote, sell or enter into any agreements (whether
written or oral) with respect to any Competitive Products for use in the Field
within the Territory without the written consent of OBI.


2.5           Audits.  Periodically during each calendar year, but
only once during each twelve (12) month period and within one hundred and
eighty (180) days following any termination or expiration of this Agreement,
OBI shall have the right, upon prior written notice of at least ten (10)
business days delivered to ASI, to review and audit all documentation that is
retained by ASI in the ordinary course of business and relates to ASI’s
performance under this Agreement.  Such
audit shall be at


 


4





















 


the
expense of OBI, unless such audit reveals a difference in favor of OBI of at
least five percent (5%) between (i) the actual Transfer Prices paid by ASI to
OBI in accordance with Section 3.6 and (ii) the Transfer Prices calculated
using the unit prices based on actual Gross Sales for Products, in which case
ASI shall bear all reasonable costs of the audit.  ASI shall pay OBI the amount of any
difference discovered in the audit in favor of OBI within fifteen (15) business
days of OBI’s request.  In the event an
overpayment by ASI is reflected by the audit, then the amount of such overpayment
shall be repaid to ASI by OBI within fifteen (15) business days of discovery of
the same.  ASI shall maintain all books
of account or records that it maintains in the ordinary course of business in
its usual and customary practice or as otherwise required by applicable law and
in actual practices with respect to Gross Sales of Products for a period of at
least one (1) year following the calendar year to which such calculation
relates.


2.6           Strategic
Alliance.


(a)           [***]


(b)           [***]


(c)           [***]


(d)           [***]


3.             TERMS OF ORDER AND SALE OF PRODUCTS


3.1           Supply
Forecasts.  Commencing on the
Effective Date, and continuing during the remainder of the term of this
Agreement, ASI shall provide to OBI, on a quarterly basis, a twelve (12) month
nonbinding rolling forecast of expected orders of Products.  Such forecasts shall be consistent with ASI’s
Minimum Quarterly Order Requirements and with purchase orders provided by ASI
to OBI in accordance with this Agreement.


3.2           Product
Orders.  All orders of Products shall
be on ASI’s standard purchase order which ASI may employ from time to time (as
may be modified by ASI from time to time), a current copy of which is attached
hereto as Exhibit C, and OBI shall deliver the Products in accordance
therewith, provided, that provisions of this Agreement shall prevail over any
inconsistent statements, additional statements or provisions or rights and
obligations contained in any document related to this Agreement passing between
the Parties hereto including any purchase order, acknowledgment, confirmation
or notice.  ASI will be required to
submit purchase orders for Products to OBI in writing which shall set forth the
quantity, requested delivery dates and shipping instructions.  ASI shall submit purchase orders at least [***]
prior to the delivery dates requested in the order.  All deliveries of Product shall be F.O.B. at
OBI’s offices in San Antonio, Texas.  ASI
shall be responsible for all shipping costs. 
Payment for ASI purchase orders subsequent to the initial stocking
purchase order will be due within thirty (30) days of the date Products are
shipped to ASI from OBI.


3.3           Product
Specifications.  All Products
delivered by OBI hereunder shall be ready for end-user sale, including all
packaging, labeling, instructions-for-use and sterilization as approved by
ASI.  OBI shall consult with ASI
regarding the packaging and instructions-for-use of the Products and all
Products will be sold under the ASI name and using ASI’s service marks and/or
trademarks, but will bear a marking reasonably acceptable to OBI indicating
that the Products were


 


5





















 


manufactured
by OBI.  All Products shall be labeled
(including bar coding/UPN numbers) in accordance with the procedures specified
from time to time, and with all Product Approvals, and OBI shall have the right
to approve the final form of any proposed labeling for Products, such approval
not to be unreasonably withheld, conditioned or delayed.


3.4           Obligation
to Supply.  OBI shall deliver
Products to ASI in accordance with the terms of this Agreement.  If ASI submits a purchase order with respect
to which no corresponding delivery schedule has been provided, OBI shall make
every reasonable effort to deliver Products under such purchase order within [***]
after receipt of ASI’s purchase orders for Products.  OBI shall have no obligation to deliver
Products to ASI prior to [***] after receipt of the applicable purchase order
from ASI.


3.5           Minimum
Orders.  As consideration for its
appointment as exclusive sales distributor of Products for use in the Field
within the Territory, ASI agrees to meet the Minimum Quarterly Order
Requirements set forth on Exhibit B attached hereto.  During the term of this Agreement, as long as
ASI meets the Minimum Quarterly Order Requirements, OBI shall not provide the
Products to any other person or entity to sell, distribute or otherwise use for
applications in the Field within the Territory. 
ASI’s Minimum Quarterly Order Requirements will be measured on a
quarterly basis for Product ordered by ASI from OBI (as opposed to sold by
ASI).  ASI must satisfy the Minimum
Quarterly Order Requirements each quarter, and there shall be no carry over of
orders from one quarter to the next quarter for purposes of determining whether
the Minimum Quarterly Order Requirements for a quarter have been met.  ASI will not be allowed to return unsold
Products, except as otherwise specifically provided in this Agreement.  If ASI fails to meet the Minimum Quarterly
Order Requirements for any individual Product, and the shortage is less than [***]
of the requirement, then ASI will have the right to cure the shortage with a
cash payment to OBI equal to [***] of the Product Transfer Price effective at
the time of the shortage for the applicable volume of  ordered Product (“Cure Payment”).  The Cure Payment shall be paid to OBI within
five (5) days of the end of the quarter in which such shortage is
calculated.  The Cure Payment will not be
considered a prepayment of Product orders by ASI.  If ASI elects not to make the applicable Cure
Payment, then OBI will have the right to convert ASI’s rights to be
non-exclusive for such Product for the duration of this Agreement (and allow
ASI to maintain its limited exclusivity on all other Products).  If ASI fails to meet the Minimum Quarterly
Order Requirements for any individual Product, and the shortage is more than [***]
of the requirement, then OBI will have the right to either (a) require ASI to
pay OBI the applicable Cure Payment; or (b) convert ASI’s rights to be non-exclusive
for such Product for the duration of this Agreement (and allow ASI to maintain
its limited exclusivity on all other Products). If, following a Change of
Control of ASI, the acquirer of ASI fails to meet the aggregate Minimum
Quarterly Order Requirements and that shortage is more than [***] of the
aggregate Minimum Quarterly Order Requirements for the applicable quarter, then
OBI shall have the right to terminate this Agreement with [***] written notice
to ASI or ASI’s acquiring party, as applicable. 
The Parties agree to meet no less than once every [***] in order to
evaluate the Minimum Quarterly Order Requirements in good faith and make any
modifications that are mutually agreed upon by the Parties following such
evaluation.


3.6           Product
Pricing and Payment.  Payment for ASI
purchase orders subsequent to the initial stocking purchase order will be due
within thirty (30) days of the date Product is shipped to ASI from OBI.  With respect to Product, ASI will pay to OBI
a transfer price for each individual Product as indicated under “Transfer Price”
on Exhibit A  (“Product Transfer Price(s)”).  The Product Transfer Prices will be
established each year on the anniversary of the Effective Date by


 


6





















 


mutual
agreement to  an updated version of
Exhibit A by no later than [***] prior to such anniversary.   The Parties agree and acknowledge, that it
is the intention of the Parties that the Transfer Price shall be approximately [***]
of ASI’s published list prices of each of the Products.


3.7           Samples.  OBI will provide to ASI [***] demo kits
containing non-sterile samples of the Products at no charge to ASI, for use in
sales demonstrations and trade shows (“Samples”).  ASI may order additional Samples from OBI, as
reasonably requested by ASI, at pre-agreed prices representing a significant
discount to sterile Products, under the same payment terms as provided in
Section 3.6.


3.8           Inspection
upon Delivery.


(a)           Product
shipments from OBI to ASI shall include a certificate of compliance from OBI
confirming that the Products meet product specifications and OBI’s quality
standards, which are in compliance with the relevant requirements of applicable
Regulatory Authorities.  Notwithstanding
any prior inspection or payments, all Products capable of being inspected prior
to use may, at ASI’s sole discretion, be subject to final inspection and
acceptance at ASI’s designated location or other destination point within [***]
after delivery.  If ASI elects to inspect
Product, then ASI shall notify OBI within such [***] period of any defect in
materials or workmanship or non-conformity of any Product to the Product
Specifications or purchase order.  If ASI
inspects Product and fails to so notify OBI, ASI will be deemed to have accepted
the Product; provided, that the warranty set forth in Section 8.2 hereof shall
survive acceptance of the Product by ASI.


(b)           Notwithstanding
any prior inspections or payments, all Products incapable of being inspected
until use will be subject to final inspection upon use.  ASI shall notify OBI within fifteen (15) days
after the inspection-at-use of the defect in materials or workmanship or
non-conformity of any Product to the Product Specifications or purchase order.
If ASI fails to so notify OBI, ASI will be deemed to have accepted the Product;
provided, that the warranty set forth in Section 8.2 hereof shall survive
acceptance of the Product by ASI.


(c)           Without
prejudice to any other right or remedy of ASI, in case any item is determined
to be defective in accordance with Section 3.8(a) or 3.8(b), ASI will have the
right to reject it.  Any item that has
been rejected must be replaced by and at the expense of OBI promptly after
notice.  ASI will not be required to pay
for any rejected item or its shipping costs. 
ASI will return all rejected Products to OBI at OBI’s expense.


3.9           Product
Returns.  OBI shall not be obligated
to accept returns of any Product except as provided in Section 3.8 and Section
8.2.


3.10         Maintenance
of Inventory.  ASI shall maintain its
inventory of Products in a manner that meets all storage and other standards
required by applicable governmental authorities and as reasonably required by
OBI, including OBI’s requirement that Products be stored at less than 140
degrees Fahrenheit.  OBI shall provide
ASI with any such requirements, and any amendments thereto, in advance in
writing.


4.             PRODUCT APPROVALS AND COMPLIANCE


4.1           Regulatory.  OBI shall be responsible, at its cost and
expense, for obtaining, maintaining and complying with all regulatory
requirements and approvals (including all Product


 


7





















 


Approvals
and Reimbursement Approvals) necessary to promote, market, sell, distribute or
deliver the Products in the Territory. 
ASI shall market and promote all Products in compliance with all FDA
clearances, specifically the Indications for Use relating to the Products, as
provided in Exhibit D and as subsequently may be provided in writing by OBI to
ASI.


4.2           Marketing
Materials.  Upon written request of
ASI, OBI shall provide to ASI copies of its existing, and subsequently
developed, marketing materials such as artwork, video and other media related
to the Products to the extent necessary to assist ASI’s marketing activities
and to the extent OBI is not prohibited from providing such information by
applicable law or regulation.  Upon
request, each Party shall provide the other any market information relating to
the performance, design or use of the Products, including customer feedback,
received by such Party, or other information in such Party’s possession that
relates to the safety or performance of any Product, to the extent that such
Party is not prohibited from providing such information by applicable law or
regulation.  Each Party hereby grants to
the other Party a non-exclusive, fully paid, perpetual, irrevocable license to
use all such information that such Party is provided in accordance with the
immediately preceding sentence in such Party’s business, including, without
limitation, in OBI’s continued development, design, manufacturing, marketing
and sale of the Products, Product Improvements and also to disclose the same to
the extent reasonably necessary for such use.


4.3           Traceability
Program.  ASI shall be responsible
for maintaining the records required for the traceability of the distribution
of the Products by part or catalog number and lot or serial number.  All Products entered into commercial
distribution shall be traceable to the end user with sufficient detail that
product can be located and retrieved as may be required.  ASI shall be responsible for maintaining
medical device vigilance systems in the Field within the Territory as required
by local regulations and/or applicable law, and shall provide OBI with
reasonable access to such records.  Each
Party shall inform the other promptly if it becomes aware of any complaint
regarding any Product o required to be reported to any Regulatory Authority in
the Territory.


4.4           Product
Recalls.  Notwithstanding anything in
this Agreement to the contrary, OBI shall have the responsibility for all
regulatory decisions and reporting with regard to any reporting required by the
applicable Regulatory Authorities and/or recalls, including the obligation to
manage any recall of any and all Products, and ASI shall have the
responsibility and obligation to provide OBI with product feedback and the
responsibility and obligation to cooperate fully with OBI in coordinating
recall activity of any and all Products in accordance with OBI’s requests.  The Parties agree to provide reasonable
assistance to one another in the event of any recall or issuance of any
advisory letter.  OBI shall be
responsible for all costs and liabilities relating to the recall activity, except
to the extent that any of the costs are directly attributable to the negligence
of ASI, which costs shall be the responsibility of  ASI. 
In the event of a recall of any Product caused by a manufacturing issue,
OBI shall use commercially reasonable efforts to correct any deficiency
relating to its manufacturing, packaging, testing, labeling, storing or
handling of such Product, if applicable, and shall, at OBI’s option, either, at
OBI’s cost replace each unit of the Product recalled (including units held in
inventory by ASI, its Affiliates or Agents, or its customers) with a corrected
Product within a reasonable period of time, or refund the transfer price
therefor.


4.5           Notices.  OBI and ASI shall notify the other within
twenty-four (24) hours if it becomes aware of any material issue with a Product
or its manufacture, labeling or packaging, including any issue relating to
regulatory compliance, safety or efficacy of a Product.  Without limiting the generality of the
foregoing, OBI and ASI will notify the other immediately if it becomes


 


8





















 


aware
of any death or bodily injury caused by a Product (or suspected to be caused by
a Product) or within three (3) days if it becomes aware of any malfunction of a
Product that would reasonably impact the safety of the Product.


4.6           Compliance
with Laws.  OBI will comply with all
applicable laws and regulations in the jurisdictions in the Territory in which
ASI is marketing and selling Products a pertaining to the manufacture of the
Products and in any other manner pertaining to performance by OBI of its
obligations under this Agreement, including the maintenance of ongoing quality
assurance and testing procedures to comply with applicable regulatory
requirements, provided that nothing in this Section 4.6 shall be deemed to
require OBI to seek any Product Approvals in any countries beyond those in
which OBI is required to seek approvals pursuant to Section 4.1.


4.7           Complaints.  Both ASI and OBI must maintain a customer
complaint handling system meeting the requirements of the applicable Regulatory
Authorities.  ASI will be responsible for
gathering initial complaint information and for providing such information to
OBI in a timely manner.  ASI will
maintain complete and accurate records of such information gathered.  ASI will notify OBI of any complaint of which
ASI becomes aware in accordance with Section 4.5.  Within thirty days after such notification
from ASI, OBI shall perform a complete investigation that contains a root cause
analysis, to the extent reasonably possible, and corrective action
recommendations.  OBI will inform ASI
immediately of the results of any such investigation and OBI’s
recommendations.  ASI will enter all
complaints, as well as recommendations and analyses of OBI, into ASI’s
complaint handling system.  ASI will
return to OBI, at OBI’s expense, the Product that is the subject of a complaint
if such Product has been made available to ASI. 
OBI will also maintain a cross reference system from OBI’s complaint
handling system to ASI’s complaint handling system.  Unless otherwise required in OBI’s
recommendation, OBI will complete all corrective actions, including corrective
actions identified in a response to ASI pursuant to this Section 4.7 or
corrective actions reasonably requested by ASI, within ninety (90) days.  ASI shall provide OBI with reasonable
cooperation in filing complaint reports, investigating complaints, and taking
corrective actions.


5.             TRADEMARKS; INFRINGEMENT OF
INTELLECTUAL PROPERTY


5.1           Trademark
License


(a)           OBI
hereby grants to ASI a fully paid up and royalty-free right and license to use
the Trademarks in connection with the promotion, marketing, sale, distribution,
and delivery of the Products in the Field in the Territory during the period in
which ASI is authorized to distribute Products hereunder.  ASI hereby grants to OBI a fully paid up and
royalty-free right and license to use any and all of the trademarks, service
marks, copyrights and logos owned, used or controlled by ASI in connection with
the performance of OBI’s obligations under this Agreement.  ASI shall not be required to use the
Trademarks in connection with the promotion, marketing, sale, distribution, or
delivery of any Product.  ASI shall be
entitled to use its own service marks and trademarks, in ASI’s sole discretion,
subject to its obligations to identify the Products as manufactured by OBI as
set forth in Section 2.1, in connection with the promotion, marketing, sale,
distribution, and delivery of Products, which service marks and trademarks
shall remain at all times the exclusive property of ASI.  ASI, its Affiliates and Agents shall not
obscure, change or otherwise modify the Trademarks of OBI and other information
that appears on the Products or their packaging as provided by OBI to


 


9





















 


ASI.  OBI, its Affiliates and Agents shall not
obscure, change or otherwise modify ASI’s trademarks, service marks, copyrights
and logos that appear on the Products or their packaging.


(b)           All
of ASI’s rights with respect to the Trademarks provided hereunder are as set
forth in this Section 5.1.  There are no
implied rights with respect to the Trademarks. 
All use of the Trademarks inures to the benefit of OBI and such
Trademarks shall remain the exclusive property of OBI.  All use of any service marks or trademarks of
ASI in connection with the promotion, marketing, sale, distribution and
delivery of Product shall inure to the benefit of ASI and such service marks
and trademarks shall remain the exclusive property of ASI, and neither Party
shall contest the validity, enforcement, or registration of any such service
marks or trademarks.  ASI shall not
contest the validity, enforcement, or registration of any of the Trademarks or
any new Trademarks which the Parties agree to use in connection with the sale
of the Products.


5.2           Infringement


(a)           Each
of ASI and OBI will notify the other Party in writing of any infringement of a
Patent Right, Trademark, ASI trademark or unauthorized disclosure or use of any
Confidential Information within thirty (30) days after it becomes aware of such
infringement, unauthorized disclosure or use. 
OBI shall have the exclusive right (after consultation with ASI) at its
own cost to take all legal action it deems necessary or advisable to eliminate
or minimize the consequences of any infringement of a Proprietary Right.  ASI agrees to provide OBI, at OBI’s cost and
expense, with reasonable cooperation in connection with any such legal action.


(b)           OBI
shall permit ASI to participate at its own cost in any legal action brought by
OBI to eliminate or minimize the consequences of any infringement of a Patent
Right or Trademark relating to Products for use in the Field within the
Territory; provided, that OBI shall maintain the right to control the prosecution
of such action.


6.             CERTAIN OBLIGATIONS OF OBI


6.1           Product
Information.  OBI will furnish to ASI
any and all Product handling manuals, sales literature, and other applicable
information relating to the Products that is reasonably necessary in OBI’s
discretion for ASI to formulate any other manuals, promotional materials and
warning labels reasonably deemed necessary or appropriate by ASI (collectively,
the “Product Information”).  ASI shall
have the right with OBI’s prior written approval, which approval shall not be
unreasonably withheld or delayed to revise, or to cause OBI to revise, any such
Product Information that ASI reasonably determines to be necessary or
advisable, or otherwise inaccurate or misleading, and OBI will promptly
incorporate such revisions into the Product Information.  ASI shall have the right to produce, at its
expense, promotional material, Product handling manuals, instructions for use,
warning labels and other written information relating to the Products which is
based in whole or in part on, or derived from, the Product Information supplied
by OBI.  OBI shall be entitled to review
such information solely for the purpose of verifying that such information (a)
is consistent with the Product Information and Product Approvals, (b) contains
no material inaccuracies with respect to a Product’s performance/use or the
Product Information, (c) does not disclose material Confidential Information of
OBI; and (d) does not, in OBI’s reasonable discretion, make claims about the
performance or use of the Product beyond those contained in the Product
Information, except to the extent otherwise authorized by OBI, and OBI shall be
entitled to prohibit ASI from disseminating any such information prepared by
ASI to the extent such information (i) is


 


10





















 


inconsistent
with the Product Information or any Product Approvals, (ii) contains material
inaccuracies with respect to the Product’s performance/use or the Product
Information, (iii) discloses material Confidential Information of OBI, or (iv)
makes unauthorized claims about the performance of the Product that are not
contained in the Product Information.


6.2           Training
Advice and Assistance.  OBI will
provide reasonable technical assistance and training regarding the Products to
ASI’s representatives as ASI reasonably requests at ASI’s facilities, for up to
[***] per year; provided that, ASI shall reimburse OBI for the reasonable
travel and lodging expenses incurred by OBI personnel to provide such
assistance and training.


7.             CERTAIN OBLIGATIONS OF ASI


Within
three (3) business days of the execution of this Agreement, ASI shall pay to
OBI a non-refundable production set-up fee of [***] payable either by company
check or bank wire transfer. 
Notwithstanding the preceding sentence, this production set-up fee shall
be refundable if OBI fails to deliver the initial stocking order in accordance
with this Agreement.  Upon execution of
this Agreement, ASI shall issue the initial stocking purchase order to OBI for
Products in the quantities listed in Exhibit A. 
Payment for the initial stocking purchase order will be due within [***]
of the date Products are shipped to ASI from OBI.


8.             REPRESENTATIONS AND WARRANTIES


8.1           Mutual
Representations and Warranties.  Each
of OBI and ASI hereby represents and warrants to the other that:


(a)           it
is a duly and validly organized and existing corporation in good standing, in
the case of ASI under the laws of the state of California, and in the case of
OBI, under the laws of the State of Delaware, and that it or its Affiliates
that may be performing its obligations under this Agreement are legally
qualified to do business in each jurisdiction in which this Agreement may be
performed and its activities hereunder requires such qualification, except
where the failure to have such qualification would not have a material adverse
effect,


(b)           the
performance of this Agreement and the consummation of the transactions
contemplated herein will not result in any breach or violation of any terms or
provisions of, or constitute a default under, its Certificate or Articles of
Incorporation or By-Laws, or other formation documents,


(c)           all
requisite corporate action has been taken for the due authorization, execution,
delivery, and performance of this Agreement by it, and this Agreement
constitutes a legal binding obligation, enforceable against such Party, in
accordance with its terms, except insofar as enforceability may be limited by
bankruptcy, insolvency, reorganization, or similar laws affecting the rights of
creditors generally, and


(d)           it
is not a Party to any litigation relating to, or that could reasonably be
expected to affect, its ability to perform its obligations under this
Agreement.


 


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8.2           Product
Warranty


(a)           OBI
represents and warrants to ASI that all Products supplied to ASI hereunder
shall:  (i) be manufactured, labeled,
packaged and tested (while in the possession or control of OBI) in accordance
with the applicable Product Approvals therefor and the applicable laws and
regulations in each jurisdiction in the Territory relating to the manufacture,
labeling, packaging and testing of the Products; provided that nothing in this
Section 8.2 shall be deemed to require OBI to obtain any Product Approvals in
any countries outside the Territory, (ii) be free from defects in materials and
workmanship for a period of ninety (90) days from delivery to ASI,  (iii) be free and clear of all liens and
encumbrances created by OBI, and (iv) conform in all material respects to all
specifications published by OBI and approved by ASI, such approval not to be
unreasonably withheld.


(b)           Upon
notification by ASI of any breach of Section 8.2(a) above, OBI will repair the
non-conforming Products without charge to ASI, or replace the non-conforming
Products with a credit to ASI for the replaced unit.  If OBI does not repair or replace the
non-conforming Products within thirty (30) days from receipt of notice from
ASI, OBI shall refund the Transfer Price actually paid by ASI for the
non-conforming Products and shall reimburse ASI for any shipping costs incurred
in connection with the original delivery of such Products.  ASI shall, upon the request of OBI, return
any non-conforming Product to OBI, to the extent practicable.


8.3           Ownership.  OBI represents and warrants to ASI that OBI
owns or has licensed such rights, title and interests in OBI’s proprietary
rights included in the Products necessary to grant the rights set forth in
Section 2.1 of this Agreement.  ASI
represents and warrants to OBI that ASI owns or has licensed such rights, title
and interests in the trademarks, service marks, copyrights and logos to be
printed on or otherwise included with the Products.


8.4           No
Other Warranty.  EXCEPT AS STATED IN
THIS ARTICLE 8, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY, EXPRESS,
IMPLIED, OR STATUTORY, WITH RESPECT TO THE PRODUCTS OR SERVICES CONTEMPLATED
HEREUNDER, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE.


8.5           ASI
Warranties.  ASI, its Affiliates and
Agents shall make no representations, warranties or guaranties of any kind with
respect to the Products other than those specifically provided by OBI with
respect to the Products in Section 8.2, and ASI shall ensure that all other
representations and warranties with respect to the Products are disclaimed
under applicable law.  ASI represents and
warrants that it, its Affiliates and Agents will comply with all laws, rules,
ordinances, requirements of governmental agencies, and regulations applicable
to the promotion, pricing, marketing, distribution and sale of the Products,
including, without limitation, the requirements of the United States Federal
Drug Administration set forth on Exhibit D attached hereto.


9.             INDEMNIFICATION


9.1           Indemnified
Claims.  Subject to the provisions of
Section 9.2 below, each of OBI and ASI (each, an “Indemnifying Party”) will
defend, indemnify and hold harmless the other Party, its subsidiaries, parent
corporations, Affiliates, officers, directors, partners, shareholders,
employees,


 


12





















 


and
their respective successors and assigns (collectively, the “Indemnitees”) from
and against any claim, suit, demand, loss, damage, expense (including
reasonable attorneys’ fees and those that may be asserted by a third party) or
liability (collectively, “Losses”), including, without limitation, Losses
imposed upon the Indemnitee(s) by any third party, arising from or related to:
(a) any material breach of such Indemnifying Party’s representations,
warranties, covenants, and obligations under this Agreement; (b) any negligence
or intentional misconduct by such Indemnifying Party (or its employees, agents
or representatives) in performing its obligations under this Agreement; or (c)
any trademark or copyright infringement claim. 
The foregoing indemnification shall not apply in the event and to the
extent that a court of competent jurisdiction determines that such Losses arose
as a result of any Indemnitee’s negligence, intentional misconduct or breach of
this Agreement.


9.2           Procedure.  A Party seeking indemnification shall
promptly notify the other Party in writing of a claim or suit; provided that a
Party’s failure to give such notice or delay in giving such notice shall not
effect such Party’s right to indemnification under this Section 9 except to the
extent that the other Party has been prejudiced by such failure or delay.  Neither Party has any obligation to indemnify
the other Party in connection with any settlement made without the Indemnifying
Party’s written consent.  The Indemnitee
has the right to participate at its own expense in the claim or suit and in
selecting counsel therefor.  The
Indemnitee shall cooperate with the Indemnifying Party as reasonably requested,
at Indemnifying Party’s sole cost and expense. 
The Indemnifying Party shall not settle any claim or suit without the
Indemnitee’s prior written consent unless such settlement is limited to the
payment of cash by the Indemnifying Party and contains a full release of the
Indemnitee.


9.3           Insurance.  At all times during which any Product is
being clinically tested with human subjects or commercially distributed or sold
by ASI hereunder, as well as for a period of two years thereafter, both Parties
shall procure and maintain from a reputable insurer insurance, including
product liability insurance, adequate to cover its obligations hereunder and
which is consistent with normal business practices of prudent companies
similarly situated.  Such insurance
policy shall at all times name the other Party as an additional insured
thereunder.  It is understood that such
insurance shall not be construed to create a limit of either Party’s liability
with respect to its indemnification obligations under this Section 9.  Upon request, either Party shall provide the
other Party with written evidence of such insurance (or financial information
that describes the amounts available under any self insurance facility) upon
request.  Either Party shall provide the
other Party with written notice at least fifteen (15) days prior to the
cancellation, non-renewal or material change in such insurance.


10.          TERM AND TERMINATION


10.1         Term.  The term of this Agreement shall be for a
period commencing on the Effective Date and ending four (4) years thereafter,
and subject to the provisions of this Article 10, shall be extended
automatically for three (3) additional two (2) year terms, unless either Party
gives the other Party written notice of its intention not to extend this
Agreement at least sixty (60) days prior to the expiration of the initial term
or any renewal term.  This Agreement may
also be terminated earlier in accordance with the provisions of this Article 10
or as expressly provided elsewhere in this Agreement.


10.2         Termination
for Material Breach.  Either Party
shall have the absolute right to terminate this Agreement upon sixty (60) days
prior written notice to the other if the other Party


 


13





















 


fails
to perform or breaches, in any material respect, any material terms or
provisions of this Agreement; provided, however, that such termination shall
become effective only if such Party shall fail to remedy or cure the breach
within such sixty (60) day period, or initiate commercially reasonable measures
to remedy or cure within such period if it is not practicable to complete the
cure in such period.


10.3         Insolvency.  Each Party shall have the absolute right to
terminate this Agreement in the event the other Party shall become insolvent,
or if there is instituted by or against the other Party procedures in
bankruptcy that are not dismissed within sixty (60) days, or under insolvency
laws or for reorganization, receivership or dissolution, or if the other Party
loses any franchise or license to operate its business as presently conducted
in any part of the Territory.


10.4         Force
Majeure.  Each Party shall have the
right to terminate this Agreement as permitted in Section 11.14.


10.5         Change
of Control of OBI.  In the event of
the consummation of a Change of Control of OBI during the term of this
Agreement, both ASI and OBI or OBI’s acquiring party, as applicable,  shall continue operating under this Agreement
for a period of time equal to the greater of (i) [***] or (ii) [***] years from
the date of the consummation of the Change of Control (collectively,
subsections (i) and (ii) shall be referred to as the “Post-Change of Control
Period”).  During the [***] of the
Post-Change of Control Period, the terms of this Agreement shall remain in full
force and effect.  Following the [***] of
the Post-Change of Control Period, and until the expiration of the Post-Change
of Control Period, the terms of this Agreement shall remain in full force and
effect, however, ASI’s distribution rights shall be co-exclusive with OBI or
OBI’s acquiring party, as applicable (which rights may not be assigned,
transferred or delegated by the acquiring party outside of the distribution
channels of the acquiring party that existed on the date of the execution of
the definitive agreement relating to such Change of Control).  In the event of a Change of Control of OBI or
OBI’s acquiring party (or the successor in interest thereto), as applicable,
during the Post-Change of Control Period, the Post-Change of Control Period
shall renew and the terms of this Agreement shall remain in force and effect in
accordance with this Section 10.5.  This
Agreement shall expire at the end of the applicable Post-Change of Control
Period.


10.6         Rights after Termination.  Upon expiration
or termination of this Agreement for any reason, ASI and any successor or
acquiring party of ASI, shall have no further right to promote, market,
distribute or sell Product, except as set forth in Section 10.7.


10.7         Inventory Liquidation after Termination.  During the [***] period following the
expiration or termination of this Agreement, any inventory of Products owned by
ASI or its acquiring party, as applicable, at such expiration or termination
may be sold by ASI or its acquiring party to customers in the Territory in the
ordinary course; provided, however, that for the period required to liquidate
such inventory, all of the provisions contained herein governing ASI’s and OBI’s
obligations and rights shall remain in effect. 
In order to accelerate the liquidation of any such inventory, OBI or its
acquiring party, as applicable, shall have the option, but not the obligation,
to purchase all or any part of such remaining inventory at the price at which
the inventory was originally purchased by ASI from OBI.


 


14





















 


10.8         Sections Surviving Termination.  The termination of this Agreement shall not
impair the rights or obligations of either Party hereto which shall have
accrued hereunder prior to such termination. 
The provisions of Sections 3.8, 5.2, 8, 9, 10.7 and 11, and the rights
and obligations of the Parties thereunder shall survive the expiration or
termination of this Agreement.


11.          GENERAL
PROVISIONS


11.1         Governing Law. 
This Agreement shall be governed and construed in accordance with the
laws of the State of New York without giving effect to its rules regarding
conflicts of laws.


11.2         Confidentiality. 
It is contemplated that in the course of the performance of this
Agreement each Party may, from time to time, disclose Confidential Information
to the other.  Each Party agrees to take
all reasonable steps to prevent disclosure of Confidential Information and not
to use any Confidential Information except for the limited purposes set forth
in this Agreement; provided, that no provision of this Agreement shall be
construed to preclude such disclosure of Confidential Information as may be
required by court order, or to the extent necessary and appropriate to divulge
such Confidential Information to obtain governmental approval for the
investigation or marketing of the Products; provided further that notice of
such disclosure is provided to the other Party sufficiently in advance of such
disclosure to provide the other Party opportunity to seek confidential
treatment or other protective measures.


11.3         Waiver.  Except
as otherwise expressly set forth herein, no provision of or right under this
Agreement shall be deemed to have been waived by any act or acquiescence on the
part of either Party, its agents or employees, except by an instrument in
writing signed by an authorized officer of such Party.  No waiver by either Party of any breach of
this Agreement by the other Party shall be effective as to any other breach, whether
of the same or any other term or condition and whether occurring before or
after the date of such waiver.


11.4         Independent Contractors.  Each Party represents that it is acting on
its own behalf as an independent contractor and is not acting as an agent for
or on behalf of any third Party.  This
Agreement and the relations hereby established by and between OBI and ASI do
not constitute a partnership, joint venture, franchise, agency or contract of
employment.


11.5         Assignment. 
Neither Party may assign or transfer by operation of law or otherwise
its rights or obligations hereunder without the prior written consent of the
other; provided, that notwithstanding the foregoing, either Party may assign
its rights and obligations together hereunder to a person that acquires all of
the capital stock, or substantially all of the assets, of the such Party, and
either Party may assign the Agreement to an Affiliate, provided that such
person assumes this Agreement, in writing, and agrees to be bound by and to
comply with all the terms and conditions hereof.


11.6         Successors and Assigns.  This Agreement shall bind and inure to the
benefit of the Parties hereto and their respective successors and permitted
assigns.


11.7         Publicity. 
Except as is necessary for governmental notification purposes or to
comply with applicable laws and regulations (including securities laws and
regulations applicable to a public reporting company) or to enforce their
respective rights under this Agreement, and except as otherwise consented to by
the Parties hereto in writing, such consent not to be unreasonably


 


15





















 


withheld, conditioned, or delayed, the Parties shall (a)
keep the material terms of this Agreement confidential and (b) agree upon the
text and the exact timing of any public announcement relating to the
transactions contemplated by this Agreement.


11.8         Notices.  All
notices, claims and demands hereunder, and all other communications which are
required to be given in writing pursuant to this Agreement, shall be in writing
and shall be given (and shall be deemed to have been duly given upon receipt)
by delivery in person or facsimile (received at the facsimile machine to which
it is transmitted prior to 5 p.m., local time, on a business day for the Party
to which it is sent, or if received after 5 p.m., local time, as of the next
business day) or by registered or certified mail (postage prepaid, return
receipt requested) to the respective Parties at the following addresses (or at
such other address for a Party as shall be specified in a notice given in
accordance with this Section 11.8):


if to ASI:


Alphatec Spine Inc.

2051 Palomar Airport Road, Suite 100

Carlsbad, CA 92011

Attention:  Vice President, Business
Development

Facsimile:  (760) 431-9132


with a copy not
constituting notice to:


Mintz Levin Cohn Ferris
Glovsky and Popeo

666 3rd Avenue, 32nd Floor

New York, NY 10017

Attention:  Stephen C. Curley, Esq.

Facsimile:  (212) 983-3115


if to OBI:


OsteoBiologics, Inc. 

12500 Network Boulevard

San Antonio, TX 78249

Attention:  Chief Financial Officer

Facsimile:  (210) 690 2559


with a copy not
constituting notice to:


Fulbright & Jaworski LLP

Attn: Daryl Lansdale


300 Convent Street, Suite 2200

San Antonio, TX 78205


Facsimile:  (210) 270-7205


 


11.9         Severability. 
In the event any provision of this Agreement shall for any reason be
held to be invalid, illegal or


 


16





















 


unenforceable in any respect, such invalidity, illegality or
unenforceability shall not affect any other term or provision hereof.  The Parties agree that they will negotiate in
good faith or will permit a court to replace any provision hereof so held
invalid, illegal or unenforceable with a valid provision which is as similar as
possible in substance to the invalid, illegal or unenforceable provision.


11.10       Headings. 
Headings of the sections and subsections of this Agreement are for
reference purposes only and shall not limit or affect the meaning or
construction of the terms and conditions hereof.


11.11       Interpretation. 
Words such as “herein”, “hereinafter”, “hereof’ and “hereunder” refer to
this Agreement as a whole and not merely to a section or paragraph in which
such words appear, unless the context otherwise requires.  The singular shall include the plural, unless
the context otherwise requires.  Whenever
the word “include”, “includes” or “including” appears in this Agreement, it
shall be deemed in each instance to be followed by the words “without
limitation.”


11.12       Entire Agreement; Amendment.  The terms and provisions contained in this
Agreement constitute the entire understanding of the Parties with respect to
the transactions and matters contemplated hereby and supersede all previous
communications, representations, agreements and understandings relating to the
subject matter hereof.  No agreement or
understanding amending, supplementing or extending this Agreement shall be
binding upon either Party unless it is in writing and signed by the duly
authorized representative of the applicable Party.  Without limiting the foregoing, the Parties
anticipate that the Exhibits, Annexes and Schedules hereto may be amended or
supplemented from time to time by mutual written agreement.


11.13       Counterparts. 
This Agreement may be executed in multiple counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and
the same instrument.


11.14       Further Assurances, Force Majeure.  Each Party covenants and agrees that,
subsequent to the execution and delivery of this Agreement and without any
additional consideration, it will execute and deliver any further legal
instruments and perform any acts which are or may become reasonably necessary
to effectuate the purposes of this Agreement. 
Any delay in the performance of any of the duties or obligations of
either Party hereto (except for any payment obligations) shall not be
considered a breach of this Agreement and the time required for performance
shall be extended for a period equal to the period of such delay; provided,
that such delay has been caused by or is the result of any act of God, embargo,
strike, fire, flood, act of terrorism or war, or other unforeseeable cause
beyond the control and without the fault or negligence of the Party so
affected.  The Party so affected shall
give prompt notice to the other Party of such cause, and shall take whatever
reasonable steps are necessary to relieve the effect of such cause as rapidly
as possible.  In the event that a force
majeure hereunder continues unabated for more than four (4) months, the Party
not initially claiming protection under this Section shall have the right to
terminate this Agreement upon written notice to the other Party.


11.15       Specific Performance. 
Each Party acknowledges that it will be impossible to measure in money
the damage to the other if a Party fails to comply with certain obligations
imposed by this Agreement, and that in the event of any such failure or breach,
the other Party will not have an adequate remedy at law or in damages.  Accordingly, each Party agrees that
injunctive relief or other equitable remedy, in addition to remedies at law or
damages, is an appropriate remedy for any such failure or breach.


 


17





















 


[Signature Page Follows]


 


18

















 


IN WITNESS WHEREOF, the parties hereto have caused this
Agreement to be executed by their respective duly authorized officers, and have
duly delivered and executed this Agreement under seal as of the date first set
forth above.


	
  OSTEOBIOLOGICS, INC.

  	
  ALPHATEC SPINE, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ Fred Dinger

  	
   

  	
  By:

  	
  /s/ Ronald Hiscock

  
	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  Fred Dinger

  	
   

  	
  Name:

  	
  Ronald Hiscock

  
	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  President and CEO

  	
   

  	
  Title:

  	
  President and CEO

  



 


19

















 


EXHIBIT
A


 


PRODUCTS


 


[***]


 


20

















 


EXHIBIT
B


 


MINIMUM
QUARTERLY PURCHASES


 


[***]


 


21

















 


EXHIBIT C


FORM OF
PURCHASE ORDER


 


 


22

















 


EXHIBIT D


FDA REQUIREMENTS


 


23