Exhibit 10.20
CONFIDENTIAL TREATMENT
REQUESTED
PRIVATE LABEL SUPPLY
AGREEMENT
THIS PRIVATE LABEL SUPPLY AGREEMENT
(“ Agreement ”) is entered into as of
July 1, 2006 (the “ Effective Date ”), by
and between IsoTis OrthoBiologics, Inc., a Washington corporation
(“ Supplier ”) and Alphatec Spine, Inc., a
California corporation (“ Distributor
”).
R E C I T A L S
WHEREAS, Supplier is engaged in the
business of bone regeneration technologies including the
development, production and distribution of proprietary natural and
synthetic bone graft substitutes.
WHEREAS, Distributor is engaged in
the business of designing, manufacturing and selling products and
instruments to treat diseases and injuries to the human skeletal
system.
WHEREAS, Distributor desires to
acquire and distribute Supplier’s DynaGraft
®
II Demineralized Bone Matrix Putty
and Gel (each a “ DBM ” and collectively the
“ DBMs ”) under the Distributor’s own
respective brand names, and Supplier is willing to supply such DBMs
to Distributor, in accordance with the terms and conditions set
forth in this Agreement.
AGREEMENT
NOW, THEREFORE, in consideration of
the mutual covenants and agreements contained herein and for other
good and valuable consideration, the receipt and adequacy of which
are hereby acknowledged, the parties agree as follows:
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1.
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Manufacture
and Supply .
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(a) General . During the term
of this Agreement, Supplier shall produce, package and supply the
DBMs to Distributor, and Distributor shall acquire the DBMs from
Supplier, pursuant to the terms and provisions set forth herein.
Under this Agreement, Distributor engages Supplier as a technology
and value added tissue-processing provider. The buying and selling
of human tissue is generally prohibited by law, and any fees
associated with providing human tissue for implantation are the
reasonable payment for removal, processing, disposal, preservation,
quality control, packaging and storage of such tissue plus the
application of technologies and operating costs associated with
providing such technologies, to which human tissue has been added,
for implantation and other surgical uses.
(b) Specifications . The DBMs
shall be final packaged by Supplier and sterile when delivered.
Supplier shall produce the DBMs to the specifications relating to
the manufacture and quality of the DBMs set forth on
Schedule 1 , as the same may be modified from time to
time, (the “ Specifications ”).
(c) Packing and Brand Names .
The DBMs shall be finally packaged by Supplier using the trade
names and artwork specified on Schedule 2 , as the name
may be modified from time to time (the “ Private Label
Brands ”). Supplier’s name shall not appear on
labels unless required by law and, if required by law, shall be
included only to the extent (including size and location)
specifically required. Any changes to Supplier’s existing
packaging or labeling, including any artwork changes, will be paid
for by Distributor. Distributor shall pay to Supplier the
non-refundable sum of $[***] for packaging, labeling, labeling
content and artwork concurrently with the execution of this
Agreement (the “ Initial Packaging Fee ”).
Notwithstanding the foregoing sentence, the Initial Packaging Fee
shall be refundable in the event that Distributor terminates this
Agreement during the first twelve (12) months following the
Effective Date due to Supplier’s breach of this Agreement. In
the event Distributor makes additional changes to packaging,
labeling, labeling content or artwork after purchase by Supplier
that result in obsolescence or in the event of termination of this
Agreement for any reason by Distributor, Distributor shall pay
Supplier 100% of the actual cost of these components remaining in
stock.
(d) Shelf Life . DBMs shall
have a minimum of seventy percent (70%) remaining shelf-life
at time of delivery to Distributor.
(e) Obsolescence . If
Supplier plans to discontinue any DBM, Supplier shall provide
Distributor written notice at least 180 days in advance of the
effect of such change (unless impractical for regulatory reasons,
in which case such notice shall be provided immediately after the
need to discontinue the DBM is determined by Supplier).
(f) Changes to DBM for Regulatory
Reasons . Supplier shall have the right to modify the DBM as
necessary to comply with changes in applicable law or regulatory
approvals. If Supplier is required to materially modify any DBM or
its Specifications, Supplier shall provide Distributor written
notice at least thirty (30) days in advance of the effect of
such change (unless impractical for regulatory reasons, in which
case such notice shall be provided immediately after the need to
materially modify the DBM or its Specifications is determined by
Supplier). In the event that Supplier makes a change to the DBM in
accordance with this Section 1(f), Supplier shall provide
Distributor with information on the changes, and corresponding
updated guidelines and instructions for use. In addition, in the
event of a recall, Supplier shall provide replacement DBM and
Samples for Distributor’s current stock, and Distributor
shall return all old stock to Supplier at Supplier’s
expense.
(g) Changes to DBM for Other
Reasons by Supplier . If Supplier desires to modify any DBM or
its Specifications for reasons other than to comply with law or
regulatory approvals, Supplier shall provide Distributor written
notice at least thirty (30) days in advance of the desired
effect of such change and shall not implement such change unless
Distributor approves of such change, such approval not to be
unreasonably withheld or delayed. Approval shall be deemed given if
Distributor does not respond within fifteen (15) days after
notice from Supplier. In the event that Supplier makes a change to
the DBM in accordance with this Section 1(g), Supplier shall
provide Distributor with information on the changes, and
corresponding updated guidelines and instructions for use. If such
change renders Distributor’s stock of DBM unsaleable, as
determined by Supplier in its sole discretion, Supplier shall, at
Supplier’s expense, provide Distributor with replacement DBM
and Samples sufficient to replace such stock.
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(h) Changes to DBM for Other
Reasons by Distributor . If Distributor desires changes to be
made to the DBM or its Specifications, Distributor shall provide
Supplier with written notice at least sixty (60) days in
advance of the desired effect of such change. Within thirty
(30) days after such notice, Supplier will approve or
disapprove such change (such approval not to be unreasonably
withheld or delayed) and estimate the cost and lead times required
to make such change. Supplier shall provide Distributor with
written notice of its approval or disapproval, the cost to
implement such change, any resulting change in the Distribution
Fees (defined below) for such DBM and the time reasonably necessary
to implement such change. If such change is approved by Supplier,
Distributor shall have ten (10) days to determine whether or
not it desires to proceed with such change at Distributor’s
sole cost and expense. If Distributor elects to proceed with such
approved change, Supplier shall promptly implement such approved
change and the Distribution Fees shall be modified
accordingly.
(i) Samples . Supplier shall
make available for acquisition by Distributor a reasonable number
of samples of non-implantable DBM, produced from bovine or human
bone (at Supplier’s sole discretion) for use only for
demonstration and training purposes (“ Samples
”).
(j) Inspection . Distributor
shall have the right, on written notice given not less than fifteen
(15) days in advance, during Supplier’s regular business
hours, to inspect Supplier’s production facilities relating
to the performance of Supplier’s duties hereunder.
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2.
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Price,
Orders, and Terms Of Payment .
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(a) Distribution Fees .
Distributor shall acquire the DBMs for the amount set forth on
Schedule 3 , which represent Supplier’s list
price for the respective DBMs discounted by [***]%) for each DBM
unit delivered to Distributor (the “ Distribution Fee
”) as may be amended from time to time. The Distribution Fees
may be increased annually by Supplier with sixty (60) days
advance notice in writing provided that such change to the
Distribution Fee is the result of Supplier increasing its list
price for the respective DBM.
(b) Sample Fees . Distributor
shall acquire Samples at the amounts for such Samples set forth on
Schedule 3 , as may be amended from time to time (the
“ Sample Fees ”). The Sample Fees may be
increased by not more than [***]%) annually by Supplier with sixty
(60) days advance notice in writing.
(c) Minimum Acquisition
Commitment .
(i) Distributor agrees to acquire
and pay for the following minimum quantities of DBM(s) in any mix,
including Samples (the “ Minimum Acquisition
Commitment ”):
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Calendar Year
2006:
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$[***]
minimum
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Calendar Year
2007:
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$[***]
minimum
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Calendar Year
2008:
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$[***]
minimum
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(ii) In the event Distributor fails
to acquire the Minimum Acquisition Commitment specified above in
any Calendar Year, Supplier may (but shall not be obligated to)
notify Distributor in writing of the amount of any shortfall
between the Minimum Acquisition Commitment for such Calendar Year
and the amount of DBM actually acquired in such Calendar Year (the
“ Shortfall Amount ”) and request Distributor to
order and pay within forty-five (45) days of the date of the
notice the amount of DBM that is at least equal to the Shortfall
Amount. Following such payment, the Supplier shall deliver to
Distributor, at times and in any mix (including Samples) requested
by Distributor, DBM and Samples with an aggregate value equal to
such Shortfall Amount payment. If Distributor does not pay the
Shortfall Amount within such forty-five-day period, Supplier shall
have the right to terminate this Agreement for cause at any time
effective upon written notice to Distributor.
(iii) Without limiting the
requirements of Sections 2(c)(i) and (ii) above, Distributor
shall purchase not less than $[***] worth of DBMs each calendar
month throughout Calendar Year 2006, $[***] worth of DBMs each
calendar month throughout Calendar Year 2007, and $[***] worth of
DBMs each calendar month throughout Calendar Year 2008 and during
any extension of the Term of this Agreement.
(d) Forecast and Orders
.
(i) Rolling Forecast . Prior
to the first day of each calendar month during the Term,
Distributor will provide Supplier with a three (3) month
rolling forecast, by calendar month, of its anticipated quantities
needed of the DBMs and Samples. The forecast will supersede, if
applicable, forecasts provided by Distributor for months previously
included in the forecasts. The parties anticipate the first
delivery of DBMs and Samples to occur within ninety (90) days
from Distributor’s date of delivery of camera ready artwork
for labeling and packaging.
(ii) Commitment and Acquisition
Order . The forecast for the first calendar month in each
forecast shall be a binding commitment on Distributor to acquire
that quantity of DBMs and Samples (the “ Commitment
”). The forecast will be accompanied by an acquisition order
for the Commitment. Each acquisition order shall be in writing and
set forth the names and quantities of each of the DBMs and Samples
to be acquired, the delivery dates, shipping instructions and fees,
delivery addresses and address to which the invoices should be
sent. No other terms or any pre-printed terms or conditions of any
acquisition order shall apply. The terms and conditions of this
Agreement shall govern all matters between the parties. Distributor
will give Supplier an acquisition order no less than thirty
(30) days prior to the date on which the delivery is
requested.
(iii) Initial Acquisition Order
and Forecast . The initial acquisition order shall be $[***],
and shall be submitted to Supplier along with the estimated mix of
DBMs and Samples and the first rolling forecast concurrently upon
the signing of this
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Agreement. Distributor shall order a minimum of
$[***] of DBMs and/or Samples prior to the end of Calendar Year
2006. The initial acquisition order shall be confirmed by
Distributor not later than thirty (30) days after the
Effective Date. The parties anticipate the first delivery of DBMs
and Samples to occur within ninety (90) days from
Distributor’s date of delivery of camera ready artwork for
labeling and packaging.
(iv) Variances in Orders . In
any forecast, the quantities for the first and second month will
not be ten percent (10%) more or less than the forecast for
that month provided in the immediately previous forecast. If the
variance is more than ten percent (10%) then Supplier is not
obligated to supply Distributor with the amount of DBMs or Samples
in excess of the forecast provided in the immediately prior
forecast for the month when the forecast becomes a Commitment.
Notwithstanding the foregoing, during the first twelve
(12) months after the Effective Date, the Commitment will not
be less than eighty percent (80%) of the immediately previous
forecast for that month but may be up to twenty percent
(20%) more than the forecast for the prior month. After that
period, the Commitment will not be less than ninety percent
(90%) of the immediately previous forecast for that month but
may be up to ten percent (10%) more than the forecast for the
prior month.
(v) Variances due to Supply .
Due to variances in sizes of donor lots of demineralized bone
powder (“ Donor Lots ”), in filling any order
for Distributor, including the Commitment, Supplier has the right
to deliver to Distributor a quantity of DBM or Samples that is
larger or smaller than the Commitment. Regardless of the size of an
Order, all DBMs representing a single Donor Lot shall be shipped
together. Distributor will pay for the DBMs and Samples actually
delivered. The amount of DBMs and Samples actually delivered to
Distributor will not affect the forecast or Commitment requirements
if the difference is not more than ten percent (10%). In the event
that shipping DBM of a single Donor Lot results in a shipment in
excess of ten percent (10%) of the Commitment, such excess
shall be applied to the Commitment of the subsequent
month.
(e) Payment Terms . All
amounts are payable only in U.S. Dollars. Except as otherwise set
forth under this Agreement, payments shall be due to Supplier not
later than thirty (30) days from the date of invoice. Invoices
shall be issued no sooner than the date of DBM delivery.
Distributor shall have no right of deduction or offset. The
Distribution Fees and Sample Fees do not include shipping,
handling, insurance, taxes or duties, all of which shall be the
sole obligation of Distributor.
(a) Preparation for Shipment
. All DBMs and Samples shall be handled, packaged, and shipped as
required by applicable laws, rules, and regulations. They shall be
suitably packed for shipment in containers adequate to insure safe
arrival of the DBMs and Samples at Distributor’s designated
delivery destination, marked for shipment to the address specified
in Distributor’s acquisition order or such other address as
Distributor may specify in writing. Supplier shall mark all
containers with necessary shipping and handling information,
acquisition order numbers and date of shipment. An itemized packing
list shall accompany each shipment.
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(b) Shipping Terms . All DBMs
and Samples will be shipped either FOB Origin, Freight
Prepaid & Charged or FOB Origin, Freight Collect (at
Supplier’s sole discretion).
(c) Inspection and Returns for
Damage or Defect . Distributor will inspect each shipment of
DBMs and Samples for obvious damage when Distributor receives the
shipment. If Distributor finds an obviously damaged or defective
DBM or Sample, it will provide written notice to Supplier, describe
the damage or defect and request a return authorization form. The
notice and request for return must be provided within thirty
(30) days following receipt of the shipment (the day of
receipt will be counted as one of the days) or the DBMs and Samples
will be deemed accepted by Distributor. If there is no notice or
request for return by Distributor during the thirty-day period, or
the damage or defect is due to the act or omission of Distributor,
then Supplier will have no obligation to replace the DBMs and
Samples and Distributor will pay for the DBM and Samples. Supplier
will pay for the shipment and insurance for the authorized return
of DBMs and Samples. The only remedy available to Distributor for
an obviously damaged or defective DBM or Sample is to receive a
replacement. Distributor will not receive any refunds of amounts
paid or credits toward future payments to Supplier.
(a) Warranty Terms . Supplier
shall warrant the DBMs pursuant to the form of Limited Warranty
generally provided in connection with the distribution of the DBMs
by Supplier in effect at the time of delivery of such DBMs. A copy
of the Limited Warranty in effect as of the Effective Date is
attached as Schedule 4. Supplier shall have the right to make
revisions to the Limited Warranty from time to time, provided that
any such revision is applicable to other private label distributors
of DBMs for use in the same Field. The revised Limited Warranty
will apply only to DBMs shipped to Distributor after the
change.
(b) Warranty From Distributor to
End-Users . Distributor shall not pass through Supplier’s
Limited Warranty to End-Users of the DBMs. Distributor shall be
free to establish the terms of any warranty it wishes to extend to
its End-User customers. Supplier’s Limited Warranty hereunder
shall not be construed to give a right of action based on such
warranty to End-User customers of Distributor.
(c) Limitations . The Limited
Warranty will be void and Supplier will not have any obligation to
honor the Limited Warranty, or have liability for any breach of
Warranty to Distributor, if DBMs are used for any use outside the
Field, as defined below, or if Distributor: (a) alters,
changes or damages the DBMs or any component of the DBMs;
(b) distributes, advertises or promotes the DBMs for uses
outside the Field; (c) uses Marketing Materials, as defined
below, not approved by Supplier as provided in Section 6(b),
(d) misrepresents the nature of the DBMs, their intended uses
or scope of the Field, components, or makes any statement,
representation or warranty to any person or entity regarding the
DBMs that breaches this Agreement; or (e) distributes a DBM
for which it has actual knowledge of defect or damage.
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(d) Destruction of DBMs In Breach
of Warranty . All DBMs in breach of the Limited Warranty, shall
be, at Supplier’s option and after a reasonable opportunity
for Supplier to inspect such DBMs, destroyed or returned to
Supplier at Supplier’s expense.
(e) Disclaimer . EXCEPT FOR
THE EXPRESS WARRANTIES CONTAINED IN THIS SECTION 4 AND SECTION
9, SUPPLIER MAKES NO OTHER WARRANTIES OR REPRESENTATIONS WITH
RESPECT TO THE DBMS, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
ALL SUCH OTHER WARRANTIES ARE HEREBY DISCLAIMED.
(f) No Limitation on
Indemnity . The provisions of this Section 4 are not
intended to, and shall not, limit the obligations of the parties
under Section 8.
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5.
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Regulatory
Approvals .
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(a) Marketing Approval .
Supplier shall be solely responsible for maintaining regulatory
approval for DBMs in the U.S. Supplier will supply proof of such
market approval for the U.S. to Distributor. Distributor shall be
solely responsible for setting reimbursement fees with health
regulatory authorities, and for billing and for collecting fees
associated with distribution of the Private Label Branded DBMs.
Supplier agrees to supply to Distributor all reasonable information
and documentation necessary to obtain such reimbursement approval.
All costs for obtaining the reimbursement approvals are the
Distributor’s financial responsibility.
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6.
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Distribution
and Marketing by Distributor .
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(a) Marketing Rights .
Distributor shall have the right to distribute the DBMs under its
respective private label, either directly or, subject to the
provisions of Section 6(d), through independent
representatives, distributors or sub-distributors, anywhere in the
United States of America (the “Territory”), to
hospitals, surgery centers or clinics at which surgery using the
DBMs is conducted, or to any licensed surgeons or other licensed
healthcare professionals who perform such surgery (“ End
Users ”). Distributor shall distribute the DBMs to its
End Users at prices and on terms Distributor determines in the
exercise of its sole discretion. The DBMs shall be sold strictly
for use in surgical applications involving the human spine as
approved by the U.S. Food and Drug Administration (“
FDA ”) or other applicable regulatory authorities (the
“ Field ”). The DBMs shall not be sold for use
outside of the Field. Distributor acknowledges that the FDA or
other applicable regulatory authorities may narrow the Field at any
time. Distributor shall not sell any Samples.
(b) Promotion and Marketing .
Distributor will market, promote, advertise and distribute the DBMs
in the Field with the goal of maximizing distribution of the DBMs.
All marketing, advertising, promotion and education documentation
(including training materials) used by Distributor (“
Marketing Materials ”) shall be technically accurate
and shall comply with the requirements of this Agreement. Before
Distributor uses any Marketing Materials, Distributor shall give
copies to Supplier (at least ten (10) business days before
anticipated use) for the approval of Supplier solely for technical
accuracy of the Marketing