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.
Exhibit 10.36
PRIVATE LABEL DISTRIBUTION
AGREEMENT
This
DISTRIBUTION AGREEMENT is entered into as of March 15, 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
1
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.
"
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 PolyGraft™ 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.
2
"
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.
"
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
|
3
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
4
course of business and relates to ASI's
performance under this Agreement. Such audit shall be at 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) The
Parties will use their [***] to negotiate terms under which they
will collaborate on the [***] of new products for use in the [***].
OBI would have [***], and ASI would have [***] for use in the Field
within the Territory. The specific terms under which the Parties
will [***] and [***] will be defined in a separate
agreement.
(b) If,
at any time during the term of this Agreement [***], OBI shall send
a written notice to ASI (the "Offer Notice") not less than
forty-five (45) days prior to consummating any such activity.
The Offer Notice shall describe in reasonable detail the [***] and
all other material information.
(c) ASI
shall have thirty (30) days after receipt of the Offer Notice
in which to [***], the Parties agree to negotiate the terms of such
agreement in accordance with Section 2.6(a).
(d) If
ASI does not make a timely election within thirty (30) days to
negotiate a collaboration agreement, or if the Parties are unable
to reach mutual agreement regarding a collaboration agreement
following negotiations conducted pursuant to Section 2.6(a),
[***].
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
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.
5
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 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
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.
6
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 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.
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.
7
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
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 traceabi