EXHIBIT 10.4
DEVELOPMENT AND SUPPLY AGREEMENT
THIS DEVELOPMENT AND SUPPLY AGREEMENT (the "AGREEMENT") is made and
entered into as of January 5, 2000 (the "EFFECTIVE DATE") between MACROPORE,
INC. ("MACROPORE"), a Delaware corporation, and MEDTRONIC, INC. (as defined
below, "MEDTRONIC"), a Minnesota corporation.
WITNESSETH:
WHEREAS, MacroPore has developed bioabsorbable surgical implants for
use in, among other areas, bone fixation and reconstruction in the
craniofacial skeleton and, on even date herewith, MacroPore and Medtronic
have entered into a Distribution Agreement (the "DISTRIBUTION AGREEMENT")
pursuant to which Medtronic is granted exclusive worldwide distribution
rights with respect to such products; and
WHEREAS, the parties desire MacroPore to develop bioabsorbable
spinal implants and [**************] pursuant to Medtronic's designs and
specifications and to manufacture and supply such developed products to
Medtronic; and
WHEREAS, MacroPore and Medtronic's Affiliate, Medtronic Asset
Management, Inc. ("MAMI"), intend to enter into a Series D Preferred Stock
Purchase Agreement (the "INVESTMENT AGREEMENT") pursuant to which MAMI will
purchase Series D Preferred Stock of MacroPore and receive various rights; and
WHEREAS, it is a condition to MAMI's willingness to purchase such
MacroPore Series D Preferred Stock that the parties enter into this Agreement.
NOW, THEREFORE, in consideration of the representations, warranties,
covenants and agreements contained herein, and for other valuable
consideration, the receipt and adequacy of which is hereby acknowledged, the
parties mutually agree as follows:
ARTICLE 1
DEFINITIONS
1.1 SPECIFIC DEFINITIONS. As used in this Agreement, the following
terms shall have the meanings set forth or as referenced below:
"AFFILIATE" of a specified person (natural or juridical) means a person that
directly, or indirectly through one or more intermediaries, controls, or is
controlled by, or is under common control with, the person specified.
"Control" shall mean ownership of more than 50% of the shares of stock
entitled to vote for the election of directors in the case of a corporation,
and more than 50% of the voting power in the case of a business entity other
than a corporation.
"AGREEMENT" means this Agreement and all Exhibits and Schedules hereto.
"CONFIDENTIAL INFORMATION" means know-how, trade secrets, and unpublished
information disclosed (whether before or during the term of this Agreement)
by one of the parties (the "disclosing party") to the other party or such
other party's designee pursuant to Section 11.5 (the
PORTIONS OF THIS EXHIBIT MARKED AS [***] HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE SEC.
"receiving party"), and which is marked as proprietary or confidential as
provided below, excluding information that:
(a) was already in the possession of receiving party prior to its
receipt from the disclosing party (provided that the receiving party is able
to provide the disclosing party with reasonable documentary proof thereof);
(b) is or becomes part of the public domain by reason of acts not
attributable to the receiving party;
(c) is or becomes available to receiving party from a source other than
the disclosing party which source, to the best of receiving party's
knowledge, has rightfully obtained such information and has no obligation of
nondisclosure or confidentiality to the disclosing party with respect thereto;
(d) is made available by the disclosing party to a third party
unaffiliated with the disclosing party on an unrestricted basis;
(e) is independently developed by the receiving party completely without
reference to any Confidential Information of the disclosing party, as
evidenced by the receiving party's written records; or
(f) has been or must be publicly disclosed by reason of legal,
accounting or regulatory requirements beyond the reasonable control, and
despite the reasonable efforts, of the receiving party.
All Confidential Information disclosed by one party to the other under
this Agreement shall be in writing and bear a legend "Proprietary,"
"Confidential" or words of similar import or, if disclosed in any manner
other than writing, shall be followed by confirmation that such information
is confidential by the disclosing party within 30 days.
Specific aspects or details of Confidential Information shall not be
deemed to be within the public domain merely because the aspects or details
of the Confidential Information is embraced by general disclosures in the
public domain. In addition, any combination of Confidential Information shall
not be considered in the public domain or in the prior possession of the
receiving party merely because individual elements thereof are in the public
domain or in the prior possession of the receiving party unless the
combination and its principles are in the public domain or in the prior
possession of the receiving party.
"DEVELOPED PRODUCTS" means as defined in Section 2.3.
"FAILURE OF SUPPLY" means (i) MacroPore's failure, for any reason other than
Force Majeure, to deliver any Developed Product ordered in accordance with
the provisions of Article 5 by the date scheduled for delivery thereof,
including but not limited to a failure to deliver Developed Products which
conforms to the Specifications therefor, which failure is not cured within
two months after MacroPore is notified of such failure, (ii) MacroPore's
failure due to Force Majeure to deliver any Developed Product ordered in
accordance with the provisions of Article 5 by the date scheduled for
delivery thereof, including but not limited to a failure to deliver Developed
Product which
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conforms to the Specifications therefor, which failure is not cured within
three months after MacroPore is notified of such failure, or (iii)
MacroPore's failure on any five occasions within any 24-month period, for any
reason other than Force Majeure, to deliver any Developed Product ordered in
accordance with the provisions of Article 5 within 30 days after the
respective dates scheduled for delivery thereof, including but not limited to
a failure to deliver Developed Product which conforms to the Specifications
therefor.
"FDA" means the United States Food and Drug Administration.
"FORCE MAJEURE" means any event or condition, not existing as of the date of
this Agreement, not reasonably foreseeable as of such date and not reasonably
within the control of either party, which prevents in whole or in material
part the performance by one of the parties of its obligations hereunder, such
as an act of government, war or related actions, civil insurrection, riot,
sabotage, strike, epidemic, fire, flood, windstorm, and similar events.
"GMP" means Good Manufacturing Practices as defined in 21 CFR Parts 210
through 226 and Parts 600 through 680.
"INTELLECTUAL PROPERTY" means letters patent and patent applications;
trademarks, service marks and registrations thereof and applications
therefor; copyrights and copyright registrations and applications; mask works
and registrations thereof, all inventions, discoveries, ideas, technology,
know-how, trade secrets, data, information, processes, formulas, drawings and
designs, licenses, computer programs and software; and all amendments,
modifications, and improvements to any of the foregoing.
"[***************]" means those medical devices (other than Spinal Implants)
designed to be [***************************************************************
******] as the parties may agree to develop hereunder.
"INVENTION" means any invention, discovery, know-how, trade secret, data,
information, technology, process or concept, whether or not patented or
patentable, and whether or not memorialized in writing.
"KNOWLEDGE" means actual knowledge of a fact or the knowledge that such
person could reasonably be expected to have based on reasonable inquiry. The
"knowledge" of an entity shall include the knowledge of such entity's
employees.
"LICENSED INTELLECTUAL PROPERTY" means, with respect to a Failure of Supply
of a particular Developed Product, all Intellectual Property used by
MacroPore in connection with the manufacture or sale of such Developed
Product at the time of such Failure of Supply.
"MACROPORE" means MacroPore, Inc. and its Affiliates.
"MEDTRONIC" means Medtronic, Inc. and its Affiliates.
"NET SALES" of Developed Products for purposes of Article 11 with respect to
a particular period means the amounts that Medtronic or any Affiliate of
Medtronic receives from third parties (eliminating transactions among
Affiliates of Medtronic and/or Medtronic) for net sales of
PORTIONS OF THIS EXHIBIT MARKED AS [***] HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE SEC.
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Developed Products during such period, excluding sales, use or excise tax,
freight, duty or insurance included therein, returns, discounts and
allowances, credits or repayments due to rejections, defects or returns,
provided that if Medtronic or any Affiliate of Medtronic sells at a single
price or rate a packaged combination of products, not all of which if sold
individually would be Developed Products, then "Net Sales" with respect to
such sales of packaged products shall equal the number of units of Developed
Products sold as part of such packaged products (less rejections, defects and
returns) multiplied by either (i) the respective average net selling price
during such period of the same type of Developed Product sold individually,
or (ii) the average net selling price during such period for a comparable
product (if the same type of Developed Product is not sold individually), in
either case excluding sales, use or excise tax, freight, duty or insurance
included therein.
"PMA" means a Premarket Approval Application as defined in 21 CFR Part 814.
"PRODUCT LIABILITY DAMAGES" means any liability, claim or expense, including
but not limited to reasonable attorneys' fees and medical expenses, arising
in whole or in part out of claims of third parties for personal injury or
loss of or damage to property relating to or arising out of the Developed
Products, whether based on strict liability in tort, negligent manufacture of
product, or any other allegation of liability arising directly from the
design, testing, manufacture, packaging, labeling (including instructions for
use), or sale of the Developed Products.
"SAFETY" means the relative freedom from harmful effect to persons affected,
directly or indirectly, by a product when prudently administered, taking into
consideration the character of the product in relation to the condition of
the recipient at the time. This definition of "safety" is essentially the
definition of "safety" as used in 21 CFR part 600.
"SPECIFICATIONS" means the specifications for the Developed Products as
determined by Medtronic.
"SPINAL IMPLANTS" means those medical devices (other than [**************])
designed to be implanted in the human body for the treatment of spinal
disease, deformity or trauma as the parties may agree to develop hereunder.
"STATEMENT OF WORK" means, with respect to each Spinal Implant and/or
[************], the mutually-agreed upon and signed written description of
the development process for such product, and shall include unless otherwise
agreed between the parties: a detailed description of such product; a
description of each phase in such development; a list of goals (or
"milestones") and target dates for achievement of such milestones and
completion of each phase; and such other details as the parties may agree in
writing. A Statement of Work shall include any mutually agreed-upon written
amendments thereto.
1.2 OTHER TERMS. Other terms may be defined elsewhere in the text of
this Agreement and shall have the meaning indicated throughout this Agreement.
PORTIONS OF THIS EXHIBIT MARKED AS [***] HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE SEC.
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1.3 DEFINITIONAL PROVISIONS.
The words "hereof," "herein," and "hereunder" and words of similar
import, when used in this Agreement, shall refer to this Agreement as a whole
and not to any particular provisions of this Agreement.
The terms defined in the singular shall have a comparable meaning when
used in the plural, and vice versa.
References to an "Exhibit" or to a "Schedule" are, unless otherwise
specified, to one of the Exhibits or Schedules attached to or referenced in
this Agreement, and references to an "Article" or a "Section" are, unless
otherwise specified, to one of the Articles or Sections of this Agreement.
The term "person" includes any individual, partnership, joint venture,
corporation, trust, unincorporated organization or government or any
department or agency thereof.
The term "dollars" or "$" shall refer to the currency of the United
States of America.
ARTICLE 2
LICENSE AND DEVELOPMENT OF PRODUCTS
2.1 LICENSE TO MACROPORE. Medtronic hereby grants MacroPore a
non-exclusive license to use all Intellectual Property owned by or licensed
to (with the right to sublicense) Medtronic used or usable in the development
or manufacture of the Spinal Implants and the [**************] during the Term
of this Agreement, solely for the purpose of development, manufacture and
sale to Medtronic of Developed Products. MacroPore shall not use any
Intellectual Property of Medtronic except for the development, manufacture
and sale to Medtronic of Developed Products.
2.2 EXCLUSIVITY. During the term of this Agreement, MacroPore shall not
develop manufacture or sell any products or devices for use in the field of
spinal fixation, stabilization and/or fusion, except for Developed Products
to be supplied to Medtronic hereunder.
2.3 DEVELOPMENT EFFORTS. MacroPore shall be responsible for developing
the ability, equipment and processes to manufacture Spinal Implants and
[*************] from poly-lactic acid (or other resorbable materials as
agreed to by Medtronic) pursuant to Statements of Work. Those Spinal Implants
and [**************] which MacroPore demonstrates to Medtronic's reasonable
satisfaction can be manufactured from poly-lactic acid on a commercially
feasible scale and without any material adverse effect on the functionality
thereof (versus the functionality of a product manufactured in the same
design but from other materials) are referred to as "Developed Products". If
either Medtronic or MacroPore notifies the other party in writing of a
proposal for a potential Developed Product, MacroPore and Medtronic shall,
within thirty (30) days thereafter, each designate the appropriate personnel
to meet and/or correspond with the appropriate personnel of the other party
with a view to evaluating the technical and commercial feasibility of such
proposed Developed Product. Attached hereto as Exhibit A is notice of
proposed potential Development Products to be initiated at the signing of
this Agreement. If the parties mutually determine in their discretion that
research and/or development of such proposed
PORTIONS OF THIS EXHIBIT MARKED AS [***] HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE SEC.
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Developed Product appears to be desirable and technically and commercially
feasible, MacroPore and Medtronic shall each use good faith reasonable
efforts to agree upon a Statement of Work for such proposed Developed
Product. Such Statement of Work shall, when signed by each of Medtronic and
MacroPore, become subject to the general terms and provisions of this
Agreement. Subject to the terms and conditions of this Agreement, Medtronic
and MacroPore shall each use good faith reasonable efforts to perform their
respective responsibilities under each Statement of Work within the
timeframes specified in such Statement of Work. Any changes to a Statement of
Work will require mutual written agreement by the parties.
2.4 REGULATORY APPROVALS.
(a) Medtronic shall be responsible obtaining all necessary regulatory
approvals for the commercial sale of the Developed Products, including the
preparation of the clinical study protocols, selection of investigational
sites, preparation of the investigator's brochures, instruction and training
of clinical investigators, monitoring the performance of clinical trials,
data collection and analysis, reporting of adverse events, preparation and
prosecution of regulatory submissions, and post approval clinical studies All
regulatory approvals for the Developed Products will be in Medtronic's name
and owned by Medtronic.
(b) MacroPore shall supply to Medtronic such quantities of Developed
Products as is reasonably required by Medtronic to obtain necessary
regulatory approvals. Medtronic shall pay MacroPore an amount equal to
MacroPore's direct cost of materials and labor for such Developed Products
used in clinical trials.
(c) MacroPore will grant Medtronic the right of reference to MacroPore's
regulatory files with the FDA or other appropriate government agencies as
necessary or helpful for support of Medtronic's regulatory submissions with
respect to Developed Products and, upon Medtronic's request participate in
any discussions with the FDA or clinical investigators with respect thereto.
MacroPore represents and warrants to Medtronic that MacroPore's poly-lactic
acid material has been approved by the FDA for Safety in long term
implantable devices.
2.5 TERMINATION OF DEVELOPMENT STATEMENT OF WORK. Medtronic shall be
entitled to terminate any Statement of Work for a Developed Product or
potential Developed Product if Medtronic, in its sole discretion, determines
that such Developed Product will not be technically or commercially feasible
or will have only limited commercial value to Medtronic.
ARTICLE 3
GENERAL OBLIGATIONS OF MEDTRONIC
3.1 SALES OF DEVELOPED PRODUCTS. Medtronic shall be solely responsible
for marketing and selling all Developed Products.
3.2 QUALITY CONTROL. Medtronic agrees to follow reasonable quality
control standards with respect to the storage, preservation, sale and use of
the Developed Products purchased under this Agreement.
3.3 RECORDS AND RECALL. Medtronic shall maintain complete and accurate
records of all Developed Products sold by Medtronic and its subdistributors
in sufficient detail to enable
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Medtronic to conduct an effective recall of Developed Products if Medtronic
determines that such a recall is required or otherwise necessary or
appropriate. In the event of a recall of any of the Developed Products,
MacroPore will cooperate with and assist Medtronic in effecting such recall.
3.4 REGULATORY APPROVALS.
(a) CLINICALS. Medtronic shall be responsible for all clinical study
design, investigator selection, and data analysis in connection with clinical
trials of the Developed Products. MacroPore shall give Medtronic such
assistance in connection with such clinical studies as Medtronic may
reasonably request.
(b) DEVICE APPROVALS. Medtronic shall be responsible for filing,
obtaining and maintaining all necessary regulatory approvals for the
importation and sale of Developed Products. To the extent permitted by law,
all foreign regulatory approvals shall be owned by Medtronic and shall be in
the name of Medtronic.
(c) EXPORT. Medtronic shall be responsible for obtaining all export
licenses and permits as may be required to export the Developed Products from
the country of manufacture into the particular countries where such Developed
Products are delivered. MacroPore shall cooperate fully with Medtronic in its
efforts to obtain any such approvals.
ARTICLE 4
GENERAL OBLIGATIONS OF MACROPORE
4.1 MANUFACTURE AND SUPPLY OF DEVELOPED PRODUCTS. MacroPore shall use
commercially reasonable efforts to manufacture, or have manufactured,
Developed Products in accordance with the Specifications and to ship such
Developed Products to Medtronic in the quantities ordered by Medtronic
pursuant to Article 5 of this Agreement. MacroPore shall be responsible for
packaging in accordance with packaging specifications to be mutually agreed
upon by Medtronic and MacroPore, and for any necessary sterilization of
Developed Products purchased under this Agreement in accordance with the
Specifications.
4.2 GOOD MANUFACTURING PRACTICES/QUALITY SYSTEMS REGULATIONS. MacroPore
shall be responsible for compliance with present and future applicable
statutes, laws, ordinances and regulations of national, federal, state and
local governments now or hereafter in effect relating to the [design,]
manufacture and/or quality of Developed Products. Without limitation of the
foregoing, MacroPore represents and warrants to Medtronic that all Developed
Products sold and delivered to Medtronic under this Agreement will have been
manufactured in accordance with all applicable requirements. MacroPore shall
cause Medtronic's regulatory personnel to be provided with reasonable access
from time to time to the facilities and records of MacroPore for the purpose
of confirming MacroPore's compliance with this Section 4.2.
4.3 TRAINING. MacroPore shall provide Medtronic with such training as
Medtronic may reasonably request in connection with the sale of Developed
Products. Medtronic shall reimburse MacroPore for travel and other
out-of-pocket costs reasonably incurred by MacroPore in connection with such
training upon submission by MacroPore of appropriate documentation thereof.
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4.4 PRODUCT LITERATURE AND PACKAGING. MacroPore will give Medtronic such
assistance in connection with the preparation of Developed Product packaging,
labeling and operations and technical manuals for use with the Developed
Products as reasonably requested by Medtronic. Medtronic shall be responsible
for the preparation of sales and marketing materials as deemed appropriate by
Medtronic, and MacroPore shall supply any artwork or other materials
reasonably requested by Medtronic in connection therewith.
ARTICLE 5
ORDERS FOR PRODUCTS
5.1 PURCHASE ORDERS. Medtronic shall submit purchase orders for
Developed Products to MacroPore in writing, whether by mail, telecopier,
telegram or otherwise, at the time that each forecast is delivered to
MacroPore pursuant to Section 5.3. Each purchase order shall, at a minimum,
set forth the product numbers, quantities (subject to Section 5.3), delivery
dates, and shipping instructions and shipping addresses for all Developed
Products ordered. Purchase orders shall be binding upon MacroPore unless and
to the extent the quantities specified therein exceed the amounts specified
in the Plan. Each purchase order shall be subject to and governed by the
terms of this Agreement. No partial shipment of an order shall constitute the
acceptance of the entire order, absent the written acceptance of such entire
order. The terms and conditions of this Agreement shall so govern and
supersede any additional or contrary terms set forth in Medtronic's purchase
order or any MacroPore or Medtronic acceptance, confirmation, invoice or
other document unless duly signed by an officer of Medtronic and an officer
of MacroPore and expressly stating and identifying which specific additional
or contrary terms shall supersede the terms and conditions of this Agreement.
5.2 FIRST ORDER. The first purchase order for a Developed Product will
be placed by Medtronic approximately 90 days prior to commercial release of
the Developed Product. Subsequently, Medtronic will place orders for the next
succeeding months on a monthly basis, at the time that it provides its
forecast described in Section 5.3, with all such subsequent purchase orders
submitted at least 60 days in advance of the earliest scheduled delivery date
for such order.
5.3 MEDTRONIC'S FORECASTS. At the time that Medtronic places its first
order for a Developed Product, Medtronic shall provide MacroPore with a
six-month sales plan to be mutually agreed upon indicating by month the
number of such Developed Products anticipated to be sold by Medtronic or
purchased by Medtronic for use as demonstration units (as updated as provided
herein, the "Plan"). The Plan shall be updated by Medtronic on a quarterly
basis (on or before the first day of each subsequent month) for a rolling
successive six-month period. Each Plan shall be used for purposes of
facilitating Medtronic's marketing plans, MacroPore's manufacturing plans,
and meeting the lead times required by certain of MacroPore's suppliers, but
are not legally binding on Medtronic or MacroPore in any manner.
5.4 ORDER LIMITATIONS. MacroPore shall not be required to deliver
quantities in excess of 100% of forecasted requirements for the first three
months of any Plan, provided, however, that MacroPore shall use all
commercially reasonable efforts to supply such excess.
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5.5 MODIFICATION OF ORDERS. Medtronic may cancel or reschedule purchase
orders for products only with MacroPore's prior written approval.
Notwithstanding the foregoing, any purchase order may be cancelled by
Medtronic as to any Developed Products that are not delivered within 60 days
after the delivery date requested by Medtronic pursuant to a purchase order,
and any such cancellation shall not limit or affect any contract remedies
available to Medtronic with respect thereto. Any such cancellation by
Medtronic must be by written notice to MacroPore given within 15 business
days after such 60th day.
5.6 DELIVERY TERMS. All deliveries of Developed Products shall be F.O.B.
MacroPore's facility in California. Except as otherwise provided in Article 7
or Article 9 below, MacroPore shall have no further responsibility for risk
of damage to or loss or delay of Developed Products after their delivery at
the aforesaid F.O.B. point. All Product deliveries shall be made by a common
carrier specified by Medtronic or, in the event that no carrier shall have
been specified by Medtronic on or before the date 15 days prior to the
requested shipment date, a reputable common carrier selected by MacroPore.
5.7 PRODUCT CHANGES. MacroPore shall not, without Medtronic's prior
written consent, modify the Specifications for a Product in a manner that
materially affects the performance or regulatory approval status of the
Product or materially increases Medtronic's costs or expenses.
5.8 CUSTOM DEVELOPED PRODUCTS. In the event Medtronic is requested by a
customer to provide customized Developed Products, Medtronic shall provide
the specifications for the customized Product to MacroPore. MacroPore will
determine and provide to Medtronic the additional cost, if any, and the
feasibility of providing the customized Product. Medtronic will thereafter
notify MacroPore if it intends to provide such customer with the customized
Developed Product.
ARTICLE 6
PRICES AND PAYMENTS
6.1 PRICES. Unless and until otherwise mutually agreed by the parties in
writing, the purchase prices per unit of Developed Products to Medtronic
under this Agreement (the "Transfer Price") shall be (i) for Developed
Products that are Spinal Implants, [***] of Medtronic's average net selling
price per unit during the six-month period following commercial release of
such Developed Product in such market, and (ii) for Developed Products that
are [**************], [***] of Medtronic's average net selling price per unit
during the six-month period following commercial release of such Developed
Product in such market; provided that in no event shall the Transfer Price
for any Developed Products be less than [****] of MacroPore's per unit direct
cost of manufacturing. Separate Transfer Prices will be established for sales
in the United States market and for each major international market. Until
six months after commercial release of a Developed Product in a particular
market, Medtronic's average net selling price per unit shall be based on
Medtronic's catalog list price. If Medtronic sells the Developed Product as
part of a packaged combination of products or instruments, then Medtronic's
sale price of the Developed Product shall equal either (i) the respective
average net selling price during such period of the same type of Developed
Product sold individually, or (ii) the average net selling price during such
period for a comparable product (if the same type of Developed Product is not
PORTIONS OF THIS EXHIBIT MARKED AS [***] HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE SEC.
9
sold individually). Medtronic's net selling price shall exclude sales, use or
excise tax, freight, duty or insurance included therein. MacroPore and
Medtronic agree to review the Transfer Price at least annually to determine
if adjustments are appropriate, taking into account then market conditions.
Medtronic and MacroPore agree to keep accurate written records sufficient in
detail to enable Medtronic's average selling price and MacroPore's direct
cost of manufacturing, respectively, of Developed Products to be determined
and verified. Such records for a particular quarter shall be retained for a
period of not less than three years. Upon reasonable notice and during
regular business hours, each party shall from time to time (but no more
frequently than once annually) make available such records for audit at the
other party's expense by independent representatives selected by such other
party to verify the accuracy of the reports provided to such other party.
Such representatives shall execute a suitable confidentiality agreement
reasonably acceptable to the party whose records are being audited prior to
conducting such audit. Such representatives may disclose to such other party
only their conclusions regarding the accuracy and completeness of records
related thereto, and shall not disclose confidential business information to
such other party without the prior written consent of Medtronic.
6.2 PAYMENT TERMS. Payments made by Medtronic for Developed Products
purchased hereunder shall be due and payable in full within 30 days after the
date of invoice by MacroPore. Any payments due hereunder which are not paid
on the date such payments are due shall be subject to interest at the rate of
one and one-half percent (1 1/2%) per month calculated on the number of days
such payment is delinquent.
6.3 TAXES. The transfer prices for Developed Products established
pursuant to this Article 6 do not include any sales, use, value added or
similar taxes, customs, duties, or tariffs imposed by any governmental
authority or agency on Developed Products or any components thereof that are
imported by Medtronic into any country (other than taxes on the net income of
MacroPore), and Medtronic shall bear all such taxes and duties. MacroPore
shall be required to take appropriate steps to minimize imposition of such
taxes by filing sales exemption certificates and taking similar actions where
applicable to the seller. When MacroPore has the legal obligation to collect
and/or pay such taxes, the appropriate amount shall be added to Medtronic's
invoice and paid by Medtronic, unless Medtronic provides MacroPore with a
valid tax exemption certificate authorized by the appropriate taxing
authority. Medtronic shall not be obligated to pay or reimburse MacroPore for
taxes that are not imposed on the sale of Product to Medtronic.
ARTICLE 7
INSPECTION, WARRANTY AND SERVICE
7.1 INSPECTION OF PRODUCT. Medtronic shall inspect all Developed
Products promptly upon receipt thereof, and in the event of any shortage,
damage or discrepancy in or to a shipment of Developed Products or in the
event any of the Developed Products fail to comply with the then current
Specifications for the Developed Products (except for latent defects not
readily observable by Medtronic), Medtronic shall report the same to
MacroPore within 60 days after delivery thereof to Medtronic and furnish such
written evidence or other documentation as MacroPore reasonably may deem
appropriate. If the substantiating evidence delivered by Medtronic reasonably
demonstrates that such shortage, damage or discrepancy or nonconformity with
Specifications existed at the time of delivery of the Developed Products,
Medtronic may return the Developed Products to MacroPore, at MacroPore's
expense, and, at Medtronic's
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request, MacroPore shall use all reasonable efforts to deliver promptly
replacement Developed Products to Medtronic in accordance with the delivery
procedures set forth herein. Any Developed Products not rejected by Medtronic
by written notice given to MacroPore within such 60-day period (other than
Developed Products containing latent defects not readily observable by
Medtronic) shall be deemed to have been accepted by Medtronic. Following any
such acceptance, the sole remedies of Medtronic with respect to damage to or
defects in the Developed Products shall be those set forth in Sections 7.2
and 9.1.
7.2 WARRANTY.
(a) MacroPore represents and warrants to Medtronic that all Developed
Products sold under this Agreement will have been manufactured and packaged
in accordance with all applicable laws and regulations, including (as
applicable) FDA GMP requirements, European Medical Device Directive
requirements, ISO 9001 certification or successor requirements, and all other
applicable manufacturing requirements. Upon prior written notice, MacroPore
shall cause Medtronic's regulatory personnel to be provided with reasonable
access from time to time to the facilities and records of MacroPore for the
purpose of confirming MacroPore's and the Product's compliance with all
applicable laws and regulations.
(b) MacroPore warrants to Medtronic and to Medtronic's customers that
Developed Products shall, when delivered to Medtronic, meet the
Specifications and, for a period of one year after delivery of the Product to
the customer but not more than two years after receipt by Medtronic, be free
from defects in materials and workmanship. The foregoing express warranty is
contingent upon proper use of the Developed Products in the applications for
which they were intended as indicated in the Product label claims. Medtronic
shall invoice MacroPore for, and MacroPore shall promptly pay, all shipping,
transportation, insurance and other expenses actually incurred in replacing
defective Developed Products that were under warranty. MacroPore will repair,
replace or credit Medtronic's account for any Product that it reasonably
determines was defective at the time of shipment to Medtronic or that does
not conform to the express warranties herein; provided, however, that
MacroPore shall have no obligation under this warranty to repair or make
replacements or grant credits necessitated in whole or in part by accidents;
failure to maintain in accordance with any transportation, storage, handling,
or maintenance, instructions supplied by MacroPore; damage by acts of nature,
vandalism, burglary neglect or misuse; or other fault or negligence of
Medtronic or (except for any strict liability of MacroPore) the customer or
user. Prior to returning any Product alleged to be defective, Medtronic shall
notify MacroPore in writing of the claimed defect and shall include the model
and lot/serial number of such Product, as well as the number and date of the
invoice therefor. No Product shall be returned without first obtaining a
returned goods authorization from MacroPore, which authorization shall not be
unreasonably withheld.
7.3 LIMITED WARRANTY. THE EXPRESS WARRANTIES SET FORTH ABOVE ARE IN LIEU
OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, WHICH ARE HEREBY SPECIFICALLY
DISCLAIMED, INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE. IN NO EVENT SHALL
MACROPORE'S LIABILITY FOR PRODUCT WARRANTY INCLUDE ANY INDIRECT, SPECIAL,
INCIDENTAL OR CONSEQUENTIAL DAMAGES.
11
ARTICLE 8
CERTAIN REPRESENTATIONS, WARRANTIES AND INDEMNITIES
8.1 REPRESENTATIONS AND WARRANTIES.
(a) MacroPore represents and warrants to Medtronic that the execution
and delivery by MacroPore of this Agreement and the performance by MacroPore
of its obligations hereunder have been duly authorized by all requisite
corporate action and will not violate any provision of law, any order of any
court or other agency of government, the Articles of Incorporation or Bylaws
of MacroPore, as amended, or any provision of any indenture, agreement or
other instrument to which MacroPore or any of its properties or assets is
bound, or conflict with, result in a breach of or constitute (with due notice
or lapse of time or both) a default under any such indenture, agreement or
other instrument, or result in the creation or imposition of any lien,
charge, restriction, claim or encumbrance of any nature whatsoever upon any
of the properties or assets of MacroPore. This Agreement has been duly
executed and delivered by MacroPore and constitutes the legal, valid and
binding obligation of MacroPore, enforceable in accordance with its terms,
subject, as to the enforcement of remedies, to the discretion of the courts
in awarding equitable relief and to applicable bankruptcy, reorganization,
insolvency, moratorium and similar laws affecting the rights of creditors
generally.
(b) Medtronic represents and warrants to MacroPore that the execution
and delivery by Medtronic of this Agreement and the performance by Medtronic
of its obligations hereunder have been duly authorized by all requisite
corporate action and will not violate any provision of law, any order of any
court or other agency of government, the Articles of Incorporation or Bylaws
of Medtronic, as amended, or any provision of any indenture, agreement or
other instrument to which Medtronic or any of its properties or assets is
bound, or conflict with, result in a breach of or constitute (with due notice
or lapse of time or both) a default under any such indenture, agreement or
other instrument, or result in the creation or imposition of any lien,
charge, restriction, claim or encumbrance of any nature whatsoever upon any
of the properties or assets of Medtronic. This Agreement has been duly
executed and delivered by Medtronic and constitutes the legal, valid and
binding obligation of Medtronic, enforceable in accordance with its terms,
subject, as to the enforcement of remedies, to the discretion of the courts
in awarding equitable relief and to applicable bankruptcy, reorganization,
insolvency, moratorium and similar laws affecting the rights of creditors
generally.
(c) Medtronic represents and warrants to MacroPore that the requirements
it specifies for Developed Products and the information or designs it
provides to MacroPore for incorporation into Developed Products under this
Agreement will not infringe any Intellectual Property rights of any third
party. MacroPore represents and warrants to Medtronic that the Intellectual
Property related to poly-lactic acid used by MacroPore in the manufacture of
Developed Products under this Agreement will not infringe any Intellectual
Property rights of any third party.
ARTICLE 9
INDEMNIFICATION
9.1 MACROPORE'S LIABILITY. MacroPore shall indemnify, defend and hold
harmless Medtronic and each of its subsidiaries, officers, directors,
employees, shareholders and
12
distributors from and against and in respect of any and all demands, claims,
actions or causes of action, assessments, losses, damages, liabilities,
interest and penalties, costs and expenses (including, without limitation,
reasonable legal fees and disbursements incurred in connection therewith and
in seeking indemnification therefor, and any amounts or expenses required to
be paid or incurred in connection with any action, suit, proceeding, claim,
appeal, demand, assessment or judgment) finally awarded ("Indemnifiable
Losses"), resulting from, arising out of, or imposed upon or incurred by any
person to be indemnified hereunder by reason of (i) any breach of
representation, warranty, or agreement on the part of MacroPore under this
Agreement, or (ii) other negligence or intentional misconduct of MacroPore;
provided that in no event shall MacroPore be liable for matters for which
Medtronic is responsible under Section 9.2 below or for punitive or exemplary
damages. MacroPore shall maintain product liability insurance or
self-insurance in such amounts as ordinary good business practice for its
type of business would make advisable and shall provide Medtronic with
evidence of this coverage.
9.2 MEDTRONIC'S LIABILITY. Medtronic shall indemnify, defend and hold
harmless MacroPore and each of its subsidiaries, officers, directors,
employees, shareholders and suppliers from and against and in respect of any
and all Indemnifiable Losses resulting from, arising out of, or imposed upon
or incurred by any person to be indemnified hereunder by reason of (i) any
breach of representation, warranty, or agreement on the part of Medtronic
under this Agreement, (ii) Product Liability Damages with respect to the
Developed Products (except to the extent Medtronic has a claim against
MacroPore pursuant to Section 9.1 above) or (iii) other negligence or
intentional misconduct of Medtronic; provided that in no event shall
Medtronic be liable for matters for which MacroPore is responsible under
Section 9.1 above or for punitive or exemplary damages. Medtronic shall
maintain product liability insurance or self-insurance in such amounts as
ordinary good business practice for its type of business would make advisable
and shall provide MacroPore with evidence of this coverage.
9.3 PROCEDURE. If a claim by a third party is made and a party (the
"Indemnitee") intends to claim indemnification under this Article 9, the
Indemnitee shall promptly notify the other party (the "Indemnitor") in
writing of any claim in respect of which the Indemnitee or any of its
subsidiaries, directors, officers, employees, shareholders, suppliers or
distributors intends to claim such indemnification and the Indemnitor shall
have sole control of the defense and/or settlement thereof, provided that the
Indemnitee may participate in any such proceeding with counsel of its choice
at its own expense. The indemnity agreement in this Article 9 shall not apply
to amounts paid in settlement of any Indemnifiable Losses if such settlement
is effected without the consent of the Indemnitor, which consent shall not be
withheld unreasonably. The failure to deliver written notice to the
Indemnitor within a reasonable time after the commencement of any such
action, if adversely prejudicial to its ability to defend such action, shall
relieve such Indemnitor of any liability to the Indemnitee under this Article
9 but the omission to so deliver written notice to the Indemnitor shall not
relieve the Indemnitor of any liability that it may otherwise have to any
Indemnitee other than under this Article 9. If the Indemnitor fails to
provide defense of the claim, and diligently defend or settle the same after
receipt of notice from Indemnitee of, and a reasonable opportunity to cure,
such failure, the Indemnitee may defend or settle the claim without prejudice
to its rights to indemnification hereunder, provided that the Indemnitee does
so diligently and in good faith and further does not enter into any
settlement or agree to any stipulation that would adversely affect the rights
of the Indemnitor or impose any additional obligation on the Indemnitor
without the Indemnitor's prior
13
written consent (which consent will not be unreasonably withheld). The
Indemnitee under this Article 9, its employees and agents, shall cooperate
fully with the Indemnitor and its legal representatives and provide full
information in the investigation of any Indemnifiable Losses covered by this
indemnification.
ARTICLE 10
TERM AND TERMINATION
10.1 TERM. This Agreement shall take effect as of the date hereof and
shall continue in force until the fifth anniversary of the date hereof, and
shall automatically renew for successive five-year periods unless either
party gives the other party written notice of non-renewal at least 180 days
prior to such renewal date (the "Term").
10.2 TERMINATION. Notwithstanding the provisions of Section 10.1 above,
this Agreement may be terminated in accordance with the following provisions:
(a) A party may terminate this Agreement by giving notice in writing to
the other party if the other party is in breach of any material
representation, warranty or covenant of this Agreement and, except as
otherwise provided herein, shall have failed to cure such breach within 60
days after receipt of written notice thereof from the first party;
(b) A party may terminate this Agreement at any time by giving notice in
writing to the other party, which notice shall be effective upon dispatch,
should the other party become insolvent, make an assignment for the benefit
of creditors, go into liquidation or receivership or otherwise lose legal
control of its business; or
(c) A party may terminate this Agreement by giving notice in writing to
the other party should an event of Force Majeure preventing performance by
such other party continue for more than 180 consecutive days as provided in
Article 11 below.
10.3 RIGHTS AND OBLIGATIONS ON TERMINATION. In the event of termination
of this Agreement for any reason, the parties shall have the following rights
and obligations:
(a) Termination of this Agreement shall not release either party from
the obligation to make payment of all amounts previously due and payable.
(b) The terminating party shall have the right, at its option, to cancel
any or all purchase orders that provide for delivery after the effective date
of termination.
(c) The parties' obligations pursuant to Articles 7, 9 and 12 and
Sections 3.3, 10.3 and 13.1 hereof and any and all other terms and provisions
hereof intended to be observed and performed by the parties after the
termination hereof, shall survive termination of this Agreement. All other
provisions of this Agreement shall terminate upon termination of this
Agreement.
14
ARTICLE 11
FAILURE TO SUPPLY AND FORCE MAJEURE
11.1 NOTICE OF FORCE MAJEURE. Upon giving notice to the other party, a
party affected by an event of Force Majeure shall be released without any
liability on its part from the performance of its obligations under this
Agreement, except for the obligation to pay any amounts due and owing
hereunder, but only to the extent and only for the period that its
performance of such obligations is prevented by the event of Force Majeure.
11.2 SUSPENSION OF PERFORMANCE. Subject to Section 11.3 below, during
the period that the performance by one of the parties of its obligations
under this Agreement has been suspended by reason of an event of Force
Majeure, the other party may likewise suspend the performance of all or part
of its obligations hereunder (except for the obligation to pay any amounts
due and owing hereunder) to the extent that such suspension is commercially
reasonable.
11.3 EXERCISE OF LICENSE UPON FAILURE OF SUPPLY. Upon a Failure of
Supply, Medtronic shall have the right to exercise its license rights granted
pursuant to Section 11.4 below to manufacture and sell such Developed Product
(but not any other Developed Product) itself or have such Product
manufactured by others.
11.4 LICENSE GRANT.
(a) MacroPore hereby grants Medtronic (i) an exclusive, sublicensable,
worldwide, license to the Licensed Intellectual Property to make, have made,
use, distribute, sell, offer for sale, have sold, import and otherwise
commercialize and exploit Developed Products during the Term. Medtronic may
not exercise such license unless and until the occurrence of a Failure of
Supply.
(b) The license granted herein shall be royalty free with respect to any
Developed Products manufactured or supplied to Medtronic by MacroPore or any
Affiliate of MacroPore. If Medtronic exercises its right pursuant to Section
11.3 to make or have made by a third party a Developed Product, then subject
to the terms of this Agreement, Medtronic shall pay to MacroPore a royalty
equal to [*************] of Medtronic's Net Sales of such Developed Product.
(c) Within sixty (60) days after the end of each Medtronic fiscal
quarter, Medtronic shall provide MacroPore with a written report indicating
the amount of Net Sales of Developed Products during such quarter and the
amount of the royalties due for such quarter. Simultaneously with making such
report, Medtronic shall pay to MacroPore the amount of royalties then due.
(d) Medtronic agrees to keep accurate written records sufficient in
detail to enable the royalties payable under this Agreement by Medtronic to
be determined and verified. Such records for a particular quarter shall be
retained by Medtronic for a period of not less than three years after the end
of such quarter.
(e) Upon reasonable notice and during regular business hours, Medtronic
shall from time to time (but no more frequently than once annually) make
available the records referred to in
PORTIONS OF THIS EXHIBIT MARKED AS [***] HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE SEC.
15
subsection (d) above for audit at MacroPore's expense by independent
representatives selected by MacroPore to verify the accuracy of the reports
provided to MacroPore. Such representatives shall execute a suitable
confidentiality agreement reasonably acceptable to Medtronic prior to
conducting such audit. Such representatives may disclose to MacroPore only
their conclusions regarding the accuracy and completeness of royalty payments
and of records related thereto, and shall not disclose Medtronic's
confidential business information to MacroPore without the prior written
consent of Medtronic.
11.5 TECHNOLOGY TRANSFER. Upon Medtronic's request any time after a
Failure of Supply, MacroPore shall promptly provide to Medtronic, or a third
party designated by Medtronic, as applicable, copies of such technical
documentation and related know-how and trade secrets, and training as is
reasonably necessary for a skilled manufacturer to make such Product;
provided that any such third party shall agree to maintain the
confidentiality of all such information to the same extent that Medtronic is
obligated to do so under this Agreement, and Medtronic will reimburse
MacroPore for salary and reasonable travel and lodging expenses for MacroPore
personnel with respect to training requested by Medtronic at a location other
than MacroPore's facility to the extent such expenses are substantiated by
expense receipts.
11.6 MAINTAIN LICENSES IN FORCE. MacroPore shall comply with all of the
provisions of, and shall maintain in full force and effect, all license
agreements with third parties pursuant to which MacroPore is licensee of
intellectual property included in the Licensed Intellectual Property.
MacroPore shall promptly notify Medtronic if any such third party licensor
alleges any breach by MacroPore of any such license agreement. Medtronic
shall be entitled, but not obligated, to cure any alleged breach by MacroPore
of such license agreement and set-off the cost of such cure against amounts
otherwise owed to MacroPore hereunder.
11.7 NO LIABILITY. MacroPore shall have no obligation or any liability
under Section 7.2 with respect to any Developed Products produced by
Medtronic or its third party designee pursuant to the license granted in this
Article 11.
ARTICLE 12
INTELLECTUAL PROPERTY
12.1 TRADEMARKS. MacroPore hereby grants Medtronic a royalty-free
license to use all trademarks, trade names and logotypes of MacroPore
relating to the Developed Products solely in connection with the sale or
other distribution, promotion, advertising and/or maintenance of the
Developed Products. Medtronic shall acquire no right, title or interest in
such MacroPore trademarks, trade names and logotypes, other than the license
provided for above, and Medtronic shall not use any MacroPore trademarks,
trade names and logotypes as part of Medtronic's corporate or trade name, or
trademark or logotype or permit any third party under Medtronic's control to
do so without the prior written consent of MacroPore. To the extent permitted
by local law, any statutory powers which would be granted to Medtronic by
virtue of its local use of MacroPore's trademarks or its licensee status are
excluded. Medtronic shall, in addition, have the right to promote and sell
the Developed Products under trademarks, trade names and logotypes of
Medtronic selected by Medtronic, which trademarks, trade names and logotypes
shall be and shall remain the property of Medtronic.
16
12.2 TRADEMARK INFRINGEMENT. Each party shall promptly notify the other
party of any use by any third party of such other party's trademarks, trade
names or logotypes or any use by such third parties of similar marks that may
constitute an infringement or passing off of such other party's trademarks,
trade names or logotypes of which such first party has knowledge. The owner
of such trademark(s) reserves the right in its sole discretion to institute
any proceedings against such third-party infringers and the other party shall
refrain from doing so. Each party agrees to cooperate fully with the other
party in any action taken by such other party against such third parties,
provided that all expenses of such action shall be borne by such other party
and all damages that may be awarded or agreed upon in settlement of such
action shall accrue to such other party.
12.3 TERMINATION OF USE OF TRADEMARKS. Medtronic acknowledges
MacroPore's proprietary rights in and to MacroPore's trademarks, trade names
and logotypes, and Medtronic hereby waives all right to any trademarks, trade
names and logotypes now or hereafter originated by MacroPore. Medtronic shall
not after the date of this Agreement adopt, use or register any words,
phrases or symbols that are identical to or confusingly similar to any of
MacroPore's trademarks. Upon termination of this Agreement, Medtronic shall
cease using MacroPore's trademarks, trade names and logotypes in any manner,
subject to Medtronic's right, if any, to continue to sell its remaining
inventory of Developed Products.
12.4 MEDTRONIC PROPERTY. All tooling, patterns, dies, gauges, jobs,
fixtures, and all specifications, drawings, samples, designs, software,
firmware, programs, formulae, and other items and information, including,
without limitations improvements to the Developed Product furnished by
Medtronic to MacroPore in connection with this Agreement shall only be used
in the performance of work for Medtronic; and shall remain the property of
Medtronic; and together with all copies thereof shall be disposed of or
returned in good repair, normal wear and tear excepted, by MacroPore to
Medtronic at Medtronic's direction and expense upon Medtronic's request.
MacroPore assumes risk of loss and damage to said items while in its
possession or under its control. MacroPore shall notify Medtronic promptly
whenever any items of Medtronic's tangible property are in need of repair or
replacement. Medtronic's property shall be marked or otherwise adequately
identified by MacroPore as property of Medtronic for use only under this
Agreement and shall be safely stored. MacroPore waives any right it may have
in law or equity to withhold Medtronic's property.
12.5 PATENT RIGHTS.
(a) DEFENSE OF CLAIMS. Medtronic shall defend, or at its option settle,
any suit instituted against Medtronic that is based on an allegation that any
Developed Product constitutes an infringement of any patent or any other
intellectual property right. Medtronic shall have sole control of defense of
any such action, including any appeals and negotiations for the settlement or
compromise thereof and shall have full authority to enter into a binding
settlement or compromise; provided that Medtronic shall not enter into any
settlement or compromise that may adversely affect MacroPore without
MacroPore's consent, which consent shall not be unreasonably withheld.
Medtronic shall indemnify, subject to the limitations set forth herein,
MacroPore against any final award of damages and costs made against MacroPore
and any settlement amounts as a result of any such action. MacroPore shall
notify Medtronic promptly in
17
writing of such claim, suit or proceeding and give Medtronic such information
and assistance as Medtronic may reasonably request to settle and defend any
such claim.
(b) LIMITATION OF LIABILITY. Medtronic shall have no liability of any
kind to MacroPore under Section 10.5 or based upon any other claim MacroPore
may have to the extent any such claim is based upon or arises out of the use
of poly-lactic acid or any manufacturing or processing of Developed Product.
12.6 PROTECTION OF INTELLECTUAL PROPERTY. Each party shall be
responsible for and have control of filing, prosecuting and maintaining all
US and foreign patents and copyrights and applications therefor owned by it,
and no party shall have any obligation to obtain or maintain any patent or
copyright except as it deems necessary or appropriate to protect such party's
Intellectual Property.
12.7 OWNERSHIP OF INVENTIONS. Subject to the terms of this Agreement,
(a) any Invention conceived, reduced to practice or otherwise made, developed
or acquired by one or more employees or agents of MacroPore shall be the
property of MacroPore, (b) any Invention conceived, reduced to practice or
otherwise made, developed or acquired by one or more employees or agents of
Medtronic shall be the property of Medtronic, and (c) MacroPore and Medtronic
shall each have an undivided one-half interest in any Invention jointly
conceived, reduced to practice or otherwise made, developed or acquired by
one or more employees or agents of MacroPore and one or more employees or
agents of Medtronic; provided that neither party shall exploit such
jointly-owned Invention without the written consent of the other party.
ARTICLE 13
MISCELLANEOUS
13.1 NONDISCLOSURE. The parties agree not to disclose or use (except as
permitted or required for performance by the party receiving such
Confidential Information of its rights or duties hereunder) any Confidential
Information of the other party obtained during the during the term of this
Agreement until the expiration of five years after the receiving party's
receipt of such Confidential Information. Each party further agrees to take
appropriate measures to prevent any such prohibited disclosure of
Confidential Information by its present and future employees, officers,
agents, subsidiaries, or consultants during such period.
13.2 PUBLIC ANNOUNCEMENT. In the event any party proposes to issue any
press release or public announcement concerning any provisions of this
Agreement or the transactions contemplated hereby, such party shall so advise
the other parties hereto, and the parties shall thereafter use their best
efforts to cause a mutually agreeable release or announcement to be issued.
Neither party will publicly disclose or divulge any provisions of this
Agreement or the transactions contemplated hereby without the other party's
written consent, except as may be required by applicable law or stock
exchange regulation, and except for communications to such party's employees
or customers or investors or prospective investors (subject to appropriate
confidentiality obligations).
13.3 COMPLETE AGREEMENT. This Agreement, the Investment Agreement, the
Investors' Rights Agreement, the Supplemental Rights Agreement, the
Distribution Agreement, and the
18
Schedules and Exhibits hereto and thereto, constitute the entire agreement
between the parties hereto with respect to the subject matter hereof and
supersede all prior agreements whether written or oral relating hereto.
13.4 WAIVER, DISCHARGE, AMENDMENT, ETC. The failure of any party hereto
to enforce at any time any of the provisions of this Agreement shall not,
absent an express written waiver signed by the party making such waiver
specifying the provision being waived, be construed to be a waiver of any
such provision, nor in any way to affect the validity of this Agreement or
any part thereof or the right of the party thereafter to enforce each and
every such provision. No waiver of any breach of this Agreement shall be held
to be a waiver of any other or subsequent breach. Any amendment to this
Agreement shall be in writing and signed by the parties hereto.
13.5 SUCCESSORS AND ASSIGNS. This Agreement shall be binding upon and
inure to the benefit of the parties hereto and the successors or assigns of
the parties hereto; provided, that (i) the rights and obligations of
MacroPore herein may not be assigned except to any person who succeeds to
substantially all of the assets and business of MacroPore to which this
Agreement relates, and (ii) the rights and obligations of Medtronic herein
may not be assigned except to any person who succeeds to substantially all of
that portion of Medtronic's business to which this Agreement relates.
13.6 NOTICES. All notices or other communications to a party required or
permitted hereunder shall be in writing and shall be delivered personally or
by facsimile (receipt confirmed electronically) to such party (or, in the
case of an entity, to an executive officer of such party) or shall be sent by
a reputable express delivery service or by certified mail, postage prepaid
with return receipt requested, addressed as follows:
if to Medtronic, to:
Medtronic, Inc.
Corporate Center
0000 Xxxxxxx Xxxxxx X.X.
Xxxxxxxxxxx, XX 00000
Attention: General Counsel
Facsimile: (000) 000-0000
with a copy to:
Medtronic, Inc.
Corporate Center
0000 Xxxxxxx Xxxxxx X.X.
Xxxxxxxxxxx, XX 00000
Attention: Vice President and Chief Development Officer
Facsimile: (000) 000-0000
if to MacroPore, to:
19
MacroPore, Inc.
0000 Xxx Xxx Xxxxxx
Xxx Xxxxx, XX 00000
Attention: Xxxxxxxxxxx X. Xxxxxxx
Facsimile: (000) 000-0000
with a copy to:
MacroPore, Inc.
0000 Xxx Xxx Xxxxxx
Xxx Xxxxx, XX 00000
Attention: Vice President of Finance
Facsimile: (000) 000-0000
Any party may change the above-specified recipient and/or mailing address by
notice to all other parties given in the manner herein prescribed. All
notices shall be deemed given on the day when actually delivered as provided
above (if delivered personally or by telecopy) or on the day shown on the
return receipt (if delivered by mail or delivery service).
13.7 EXPENSES. Except as expressly provided herein, MacroPore and
Medtronic shall each pay their own expenses incident to this Agreement and
the preparation for, and consummation of, the transactions provided for
herein.
13.8 GOVERNING LAW. This Agreement shall be governed by and interpreted
in accordance with the laws of the State of Minnesota, including all matters
of construction, validity, performance and enforcement, without giving effect
to principles of conflict of laws.
13.9 TITLES AND HEADINGS; CONSTRUCTION. The titles and headings to the
Articles and Sections herein are inserted for the convenience of reference
only and are not intended to be a part of or to affect the meaning or
interpretation of this Agreement. This Agreement shall be construed without
regard to any presumption or other rule requiring construction hereof against
the party causing this Agreement to be drafted.
13.10 ILLEGALITY; SEVERABILITY. In case any provision of this Agreement
shall be invalid, illegal or unenforceable, the validity, legality and
enforceability of the remaining provisions shall not in any way be affected
or impaired thereby.
13.11 RELATIONSHIP. This Agreement does not make either party the
employee, agent or legal representative of the other for any purpose
whatsoever. Neither party is granted any right or authority to assume or to
create any obligation or responsibility, express or implied, on behalf of or
in the name of the other party. In fulfilling its obligations pursuant to
this Agreement, each party shall be acting as an independent contractor.
13.12 BENEFIT. Nothing in this Agreement, expressed or implied, is
intended to confer on any person other than the parties hereto or their
respective successors or assigns, any rights, remedies, obligations or
liabilities under or by reason of this Agreement.
20
13.13 SURVIVAL. All of the representations, warranties, and covenants
made in this Agreement, and all terms and provisions hereof intended to be
observed and performed by the parties after the termination hereof, shall
survive such termination and continue thereafter in full force and effect.
13.14 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which shall be deemed as original and all of which
together shall constitute one instrument.
13.15 EXECUTION OF FURTHER DOCUMENTS. Each party agrees to execute and
deliver without further consideration any further applications, licenses,
assignments or other documents, and to perform such other lawful acts as the
other party may reasonably require to fully secure and/or evidence the rights
or interests herein.
IN WITNESS WHEREOF, each of the parties has caused this Development and
Supply Agreement to be executed in the manner appropriate to each, as of the
date first above written.
MACROPORE, INC.
By: /s/ Xxxxxxxxxxx X. Xxxxxxx
-----------------------------------------
Its: Vice-Chairman and Chief Executive Officer
MEDTRONIC, INC.
By: /s/ Xxxxxxx X. Xxxxxxx
---------------------------
Its: VP and Chief Development Officer
21
EXHIBIT A
PROPOSED POTENTIAL DEVELOPMENT PRODUCTS
1. [*****************]
2. [********************]
3. [********************]
PORTIONS OF THIS EXHIBIT MARKED AS [***] HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE SEC.
22
