Exhibit 10(ii)
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EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT
----------------------------------------------------
This Agreement, made as of December 18, 2000 (the "Effective Date"), between
ORGANOGENESIS INC., a company organized under the laws of the State of
Delaware, having a present principal address at 000 Xxx Xxxx, Xxxxxx,
Xxxxxxxxxxxxx 00000, XXX (hereinafter "Organogenesis"), and Royce Medical
Company, a corporation organized under the laws of the State of California,
having a present principal address at 000 Xxxxxx Xxxx, Xxxxxxxxx, XX 00000
(hereafter "Royce");
WITNESSETH:
-----------
WHEREAS, Organogenesis has developed a proprietary natural acellular
biomaterial ("ECM(tm)"), defined below, that has applications as a wound
dressing; and
WHEREAS, Royce wishes to purchase products, devices, or processes which
incorporate ECM and are covered by a Valid Patent Claim from Organogenesis
exclusively for resale in the United States as a wound dressing from supplies
purchased by Organogenesis from an entity of Organogenesis' choosing; and
WHEREAS, Royce desires to obtain an exclusive license from Organogenesis in the
United States to distribute ECM, as described herein;
NOW, THEREFORE, the parties agree that:
ARTICLE 1. CERTAIN DEFINITIONS
------------------------------
The following terms shall have the following meanings whenever used in this
Agreement:
1.1 "Affiliate" means any corporation or other entity that controls, is
-----------
controlled by, or is under common control with, a party to this
Agreement. A corporation or other entity shall be regarded as in
control of another corporation or entity if it owns or directly or
indirectly controls more than fifty percent (50%) of the voting
stock or other ownership interest of the other corporation or
entity, or if it possesses, directly or indirectly, the power to
direct or cause the direction of the management and policies of the
corporation or other entity.
1.2 "Alternate Site Market" means general and family practitioners',
-----------------------
orthopedists', dermatologists', Home Healthcare Agencies',
diabeticians', obstetricians', gynecologists', cosmetic surgeons'
and podiatrists' offices or clinics; and nursing homes.
1
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1.3 "Collagen Wound Dressing" means any article that is (i) regulated
-------------------------
by FDA as a wound dressing, and (ii) consists primarily of
non-human collagen.
1.4 "Development Plan" shall mean the plan for the development and FDA
------------------
Approval of Products, as hereinafter defined, as set forth in
Schedule A. The parties shall modify and extend Schedule A from
time to time throughout the Term as required to assure successful
commercialization.
1.5 "ECM" means a natural acellular biomaterial derived from porcine
-----
small intestine, which biomaterial is covered by a Valid Patent
Claim, as hereinafter defined.
1.6 "FDA" means the United States Food and Drug Administration.
-----
1.7 "Field" means distribution of ECM to the Alternate Site Market for
-------
use solely as a Collagen Wound Dressing.
1.8 "First Commercial Sale" of any Product means the first bona-fide
-----------------------
commercial sale for use or consumption of that Product in the
Territory after FDA has cleared or approved marketing of that
Product, if required.
1.9 "Marketing Plan" means the financial projections and timelines for
----------------
commercializing any Product as set forth in Schedule B, along with
supporting plans for selling strategies, promotional plans and
other related sales and marketing initiatives. The parties shall
modify and extend Schedule B from time to time throughout the Term
as required to facilitate successful commercialization.
1.10 "Net Sales" means the gross invoice price of any Product sold to
-----------
independent, third-party customers in bona fide, arms-length
transactions, less all credits including (i) quantity and/or cash
discounts actually allowed or taken; (ii) freight, postage and
insurance (allocated in accordance with generally acceptable
accounting principles consistently applied (GAAP)); (iii) amounts
repaid or credited by reasons of rejections or return of goods;
(iv) amounts payable resulting from Government (or government
agency) mandated rebate programs; (v) third-party rebates to the
extent actually allowed; (vi) customs duties and taxes (excluding
income, value-added and similar taxes), if any, directly related to
the sale; (vii) bad debts from Products sold in accordance with
Royce's standard credit policies; and (viii) Product samples.
2
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1.11 "Patent(s)" means the patents and patent applications relating to
-----------
Products owned or controlled by Organogenesis or its Affiliates as
indicated in Schedule C, attached, any divisions, continuations,
continuations-in-part, reissues, reexaminations, extensions,
supplemental protection certificates or other governmental actions
which extend the subject matter or the term of the patent
applications or patents, and any confirmations, registrations or
revalidations of any of the foregoing Patents also include any
patent derived from any Product Improvement.
1.12 "510(k)" means any application to FDA for clearance and/or approval
--------
to manufacture, sell and ship any Product commercially.
1.13 "510(k) Approval" means approval and/or clearance by FDA to
-----------------
manufacture, sell and ship Product commercially.
1.14 "Product(s)" means any Collagen Wound Dressing containing ECM, the
------------
sale of which would, but for the licenses herein, infringe a Valid
Patent Claim, as hereinafter defined, and includes any component
part to any such device.
1.15 "Product Improvements" means any enhancement or improvement invented
----------------------
or conceived by, or on behalf of either party to any Product.
1.16 "Proprietary Information" means all materials, products, trade
-------------------------
secrets, confidential or proprietary information designated as such
in writing by the parties, whether by letter or by the use of an
appropriate proprietary stamp or legend. Notwithstanding the
foregoing, information which is orally or visually disclosed to the
Recipient by the Disclosing Party, or is disclosed in writing
without an appropriate letter, proprietary stamp or legend, shall
be deemed Proprietary Information if the Disclosing Party, within
thirty (30) days after such disclosure, delivers to the Recipient a
writing summarizing the orally, visually or written disclosed
information in sufficient detail to advise the Recipient adequately
of its proprietary nature or confidentiality.
1.17 "Recipient" means that party to this Agreement that receives
-----------
Proprietary Information from the other party.
1.18 Specification(s)" means the characteristics for any formulation of
----------------
Product agreed to by the parties to which each Product is
manufactured for commercial sale, consistent with regulatory
requirements such as FDA Quality System regulations. As agreed to,
Specifications for each Product shall be attached to this Agreement
as Schedule D, and be deemed a part hereof.
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1.19 "Supply Price" means the price charged to Royce by Organogenesis for
--------------
a single commercial unit of any Product.
1.20 "Technical Information" means any or all results and technical
-----------------------
information, including but not limited to Proprietary Information,
including preclinical, manufacturing, clinical or regulatory
information relating to Product.
1.21 "Term" means the period during which this Agreement is in effect,
------
commencing on the Effective Date and ending on the date of the last
to expire of any Valid Patent Claim.
1.22 "Territory" means the 00 Xxxxxx Xxxxxx.
-----------
1.23 "Trademark(s)" means any proprietary xxxx or marks jointly agreed to
--------------
by the parties to be applied to or identified with any Product as a
proprietary identification thereof.
1.24 "Valid Patent Claim" means either (a) a claim of an issued and
--------------------
unexpired Patent that has not been held permanently revoked,
unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, and which has not
been admitted to be invalid or unenforceable through reissue or
disclaimer or otherwise; or (b) a claim of a pending patent
application included within Patents that was filed in good faith
and has not been abandoned or finally disallowed.
ARTICLE 2. SUPPLY OF PRODUCT
----------------------------
2.1 CONDITIONS OF SUPPLY AND EXCLUSIVE PROVISION OF PRODUCT.
2.1.1 Organogenesis shall manufacture or have manufactured
Products according to the Specifications and shall sell them
exclusively to Royce for resale by Royce or its Affiliate to
the Alternate Site Market in the Territory for use in the
Field during the Term.
2.1.2 Notwithstanding Royce's entitlement to exclusivity,
Organogenesis shall manufacture or have manufactured
Products according to the Specifications and shall sell to
Royce for resale by Royce or its Affiliate to the Alternate
Site Market in the Territory for use in the Field during the
Term.
4
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2.2 SUPPLY DURING AND FOLLOWING THE TERM.
2.2.1 During the Term. Royce shall not itself manufacture and
shall purchase all of its requirements of Products which
meet Specifications from Organogenesis throughout the Term in
accordance with and subject to the remedies provided for
non-compliance with minimums in Schedule E at prices to be
agreed upon by the parties as described herein, and on such
other terms and conditions, acceptable to both parties, that
do not conflict with the terms of this Agreement
2.2.2 Remedy for failure to buy Products from Organogenesis. If
Royce fails to purchase all of its requirements of Product
from Organogenesis, then Organogenesis, in addition to any
other available remedy provided herein, may terminate this
Agreement and all the licenses granted herein as provided in
the Article hereof governing termination.
2.2.3 Purchase of Collagen Wound Dressings. Royce shall also
purchase all of its requirements of Collagen Wound
Dressings from Organogenesis throughout the Term. If Royce
does not purchase all of its requirements of Collagen Wound
Dressings exclusively from Organogenesis throughout the
Term, and fails to cure said failure within 60 days of
receiving notice from Organogenesis, then in lieu of all
other legal or equitable remedies available to
Organogenesis, Organogenesis may appoint one or more
additional distributors of Products in the Territory for
sale in the Alternate Site Market in the Field during the
Term.
2.2.4 Supply after the Term. Twelve months prior to the end of the
Term, both parties will need to negotiate a supply
agreement to take effect after the Term. If the parties are
unable to agree upon the provisions of a supply agreement
between the parties respecting sales of Product to Royce
after the Term, Organogenesis shall have no obligation to
continue to supply or cause any other entity to supply
Product to Royce, but will use its reasonable business
efforts to assist Royce in obtaining an adequate source of
Products meeting the Specifications from a qualified source.
2.3 Price. During the Term the parties shall agree to an initial Supply
Price for each Product which shall be equal to Organogenesis'
actual net cost for that Product. This price shall remain in
effect for twelve months from
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the date on which Organogenesis first sells that Product to Royce
for First Commercial Sale. For the remainder of the Term,
Organogenesis may, with 120 days prior written notice to Royce,
which notice shall be accompanied by supporting documentation,
adjust the Supply Price from time to time to reflect actual
increases or decreases in Organogenesis' actual production costs
net of any additional xxxx up.
2.4 Reasonable Business Efforts. Organogenesis shall use its reasonable
business efforts throughout the Term to meet Royce's order and
delivery requirements for Product.
2.5 Payment. Royce agrees to pay for each quantity of shipped and
accepted Product within 45 days of receipt by Royce of each such
quantity shipped and invoiced.
2.6 Purchase Orders. Royce throughout the Term shall order Product by its
purchase orders sent from time to time to Organogenesis. Royce
will forward its purchase orders for Product to Organogenesis by
facsimile, mail or otherwise.
2.7 Conflicting Forms. Any term of any document, including but not
limited to a purchase order or acceptance, sent to either party by
the other in connection with either's performance under this
Agreement, shall, only to the extent inconsistent herewith, or to
the extent that it purports to impose requirements on a party
beyond or different from those imposed by this Agreement, be null,
void and of no effect.
2.8 F.O.B. and Risk of Loss. All prices for Products are F.O.B. the dock
of the entity from which any Product is shipped to Royce. Title
and risk of loss shall pass to Royce upon delivery of product to a
common carrier for shipment to Royce.
2.9 Forecasts. Throughout the Term Royce shall provide Organogenesis
with a rolling four-quarter forecast of its estimate of its demand
for Product, within 30 days of the beginning of each calendar
quarter, for the next four quarters. Royce's forecast for the
first such subsequent quarter of each such forecast shall be
binding on Royce. Organogenesis shall advise Royce within ten
business days of receipt of each such forecast if the forecasted
requirements exceed Organogenesis' ability to supply.
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ARTICLE 3. MANUFACTURE OF PRODUCT
---------------------------------
3.1 Selection. Products shall be manufactured by an entity or entities
selected and qualified from time to time by Organogenesis.
Organogenesis shall use reasonable business efforts to locate and
qualify an entity or entities competent and willing to manufacture
Products according to the Specifications at the most
cost-effective price.
ARTICLE 4. EXCLUSIVE LICENSE GRANTS
-----------------------------------
4.1 Patents and Technical Information. Organogenesis hereby grants to
Royce an exclusive license, or, where applicable, an exclusive
sublicense, under its Patents and Technical Information, to use,
offer to sell and sell, but not to make, have made or sublicense
to any entity not its Affiliate, Products for use in the Field to
the Alternate Site Market throughout the Territory during the Term.
4.2 Trademarks.
4.2.1 Use on Products. Products shall be marketed and sold by Royce
throughout the Term under a Trademark or Trademarks jointly
agreed to by the parties and owned and registered by
Organogenesis at its expense. Organogenesis hereby grants an
exclusive license of all Trademarks to Royce for use by it
in sales of Products in the Alternate Site Market in the
Field and Territory throughout the Term, and thereafter
pursuant to paragraph 7.3, infra.
4.2.2 Organogenesis use. Subject to the parties' mutual consent,
Organogenesis may at any time use any Trademark on any
Product if it is not sold in the Territory for use in the
Field.
4.3 Minimum Royalties. Solely to retain its exclusive rights to
distribute Product to the Alternate Site Market in the Territory
for use in the Field, Royce shall:
4.3.1 Make minimum quarterly royalty payments to Organogenesis
during each 12-month period commencing on the date of First
Commercial Sale as shown in Schedule E, attached.
4.3.2 Receive unused credit(s) towards minimums due in any year
for all royalties paid in prior years in excess of the
minimums due in those prior years. Any shortfall not cured
by the application of credits
7
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created by the preceding sentence must be cured, if at
all, within 12 months of the end of the calendar year to
which the minimum applies.
4.3.3 If Royce shall not timely make the minimum royalty payments
required by Schedule E, then, in lieu of any and all
other legal or equitable remedies available to
Organogenesis, Organogenesis may at its option, invoke the
remedies described in Schedule E.
ARTICLE 5. DEVELOPMENT OF PRODUCT
---------------------------------
5.1 Responsibilities. The parties will cooperate to develop and
improve Product to assure the greatest likelihood of success in
commercializing Product by undertaking and completing the tasks
required of each as set forth in the Development Plan. Except as
set forth in this Article, the costs incurred by either party in
such development will be borne by that party. The parties agree to
use their reasonable business efforts to provide to each other the
most appropriate personnel in a timely manner at the cost of the
party providing the personnel, to enhance this development and
commercialization.
5.2 Requests for Development Assistance. Requests from either party to
the other for the assistance described in Article 5.1 shall be
made, in the case of Royce to Xxxxxxx Xxxxxx, and in the case of
Organogenesis to Xxxxxx Xxxxxxx or to such other senior manager as
either party may designate from time to time. The failure of
either party to provide any specific employee to the other at any
specific time or place shall not, however, be a breach of this
Agreement.
5.3 PRECLINICAL AND CLINICAL TRIALS.
5.3.1 Pre-commercialization. Organogenesis shall prepare, conduct
and pay for any preclinical or clinical trial required for
regulatory clearance of any Product, and shall be
responsible for the analysis of the data derived therefrom
or the submission thereof to FDA of any 510(k).
Organogenesis shall periodically and timely report in
writing to Royce on the progress and outcome of each trial
it undertakes. Each such report shall be deemed to be
Proprietary Information.
5.3.2 Post-Commercialization. The parties shall confer to agree
upon a protocol or protocols for post-marketing clinical
trials that shall be undertaken by Organogenesis and paid
for equally by the parties.
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5.4 Ownership of Submissions. Organogenesis shall own each 510(k) and
all other regulatory submissions and approvals relating to any
Product, and shall upon request provide Royce with copies of the
regulatory approval documents certified by an appropriate
representative of Organogenesis.
5.5 Reasonable Business Efforts: Organogenesis agrees to use reasonable
business efforts to obtain 510(k) Approvals for any Product
requiring approval.
5.6 Excused Performance. The obligations of either party with respect
to any Product are expressly conditioned upon the absence of any
adverse conditions relating to the safety, quality or efficacy of
that Product that would reasonably justify that party, after
consulting with the other, in exercising prudent and justifiable
business judgement, in concluding that development or marketing of
Product should be delayed, suspended or stopped altogether. The
obligation to develop or market Product shall be delayed or
suspended only so long as any such condition or event exists.
5.7 Product Improvements. Each party agrees to disclose and furnish to
the other, without charge, information on Product Improvements
made during the Term. Each such Product Improvement shall
thereupon be deemed to be part of Patents or Proprietary
Information, as the case may be, for all purposes hereunder.
Notwithstanding the foregoing, Organogenesis may make, have made,
use, and sell, or have sold Product Improvements, outside the
Territory and Field. The license provisions of Article 4 and the
royalty and record provisions of Articles 7 and 8 together with
all other applicable provisions shall apply to any such Product
Improvement.
ARTICLE 6. MILESTONE PAYMENT
----------------------------
6.1 Subject to the requirements of Schedule D relating to healthcare
professionals' advice with respect to specifications for Products
in partial consideration for the development costs for Product
incurred by Organogenesis, Royce shall pay to Organogenesis,
within thirty days of the later of FDA Approval of the first
Product or the delivery to Royce of the first 1500 units of
Product for commercial sale, [***] Royce shall submit its initial
purchase order for at least 1500 units of Product within 30 days
of notification by Organogenesis that Product is available for
commercial sale.
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ARTICLE 7. ROYALTIES
--------------------
7.1 Royalty Levels and Term. In partial consideration for the exclusive
licenses granted and Technical Information provided by
Organogenesis hereunder, Royce shall pay Organogenesis royalties
on Royce's or its Affiliates' Net Sales of all Products sold by
Royce as described by the formula in Schedule F, attached, until
the expiration of the last Valid Patent Claim.
7.2 Related Entity Sales. For the purposes of this Article, Net Sales by
Royce to an Affiliate shall not be counted for royalty purposes
(unless the Affiliate is the end user of the Product). Instead,
the Net Sales of such Affiliate to the first unrelated third party
shall be considered Net Sales for royalty purposes.
7.3 Paid-up License. Following expiration of Royce's obligation to pay
royalties, Royce shall have a perpetual, non-exclusive, paid-up,
royalty-free license, under any remaining Technical Information of
Organogenesis, to sell Product and/or use Trademarks in the
Territory. After expiration of this Agreement (but not
termination), Royce shall have a perpetual, non-exclusive,
paid-up, royalty-free license, under any remaining Technical
Information of Organogenesis, to make or have made Product, and to
use Trademarks, throughout the world in perpetuity, so long as
Royce shall pay to Organogenesis a royalty of [***] of Net Sales
of Product (paid and accounted for as described in Article 8) for
the use of any Trademark.
ARTICLE 8. RECORDS AND PAYMENTS
-------------------------------
8.1 Royalties. Royalties as provided in Article 8 shall be calculated
quarterly on the last day of each calendar quarter during the Term
and shall be paid by check to Organogenesis within forty five (45)
days after said last day together with an accounting report
showing the amount of Product sold by Royce and its Affiliates
during each quarterly period.
8.2 Records. Royce shall keep accurate records and books of account in
accordance with generally accepted accounting principles
consistently applied (GAAP) and containing all the data reasonably
required for calculation and verification of payments made
hereunder. During the Term and for two years thereafter, Royce
shall retain accounting records for the previous three years.
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8.3 Audit. At Organogenesis' request, Royce shall make records
available, no more than twice per year, during reasonable working
hours, for review by an independent accounting firm reasonably
acceptable to both parties, at Organogenesis' expense, for the sole
purpose of verifying the accuracy of such reports. In the event that
any such review indicates an underpayment of royalties by Royce in
excess of 10%, Royce shall pay the cost of such review, as well as
the amount of the underpayment.
8.4 Taxes. All royalty amounts required to be paid to Organogenesis
pursuant to this Agreement shall be paid without deduction for
withholding for or on account of any taxes (other than taxes imposed
on or measured by net income).
ARTICLE 9. PATENT PROSECUTION AND MAINTENANCE
---------------------------------------------
9.1 Responsibility. Organogenesis hereby warrants that it will fulfill
the responsibility for the timely and effective prosecution and
maintenance of the Patents in the Territory.
9.2 Discontinuation. If, in spite of the warranty in Article 9.1,
Organogenesis discontinues or fails to prosecute any of the Patents,
Trademarks, or Product Improvements Royce shall have the right to
prosecute and maintain such patent applications and patents. Royce
may deduct from any royalties or other consideration otherwise due
Organogenesis the amounts of such prosecution.
ARTICLE 10. PATENT INFRINGEMENT
-------------------------------
10.1 Enforcement. Each party shall promptly notify the other of its
knowledge of any potential infringement of the Patents or any
Trademark by a third party. Organogenesis has the initial obligation
to take all reasonable legal actions necessary to enforce the
Patents or Trademarks licensed hereunder against infringements by
third parties. If within 3 months following receipt of such notice
Organogenesis fails to take such action to halt any material
infringement, Royce shall, in its sole discretion, have the right,
at its expense, to take such action in its own name or in the name
of Organogenesis. In that case Organogenesis agrees to render such
reasonable assistance as the prosecuting party may request. Royce
may deduct from any royalties or other consideration otherwise due
Organogenesis the amounts of such prosecution. Damages recovered
therefrom shall be paid by and belong to the party bringing the
action, after any costs of such litigation, including but not
limited to attorneys fees, that have been previously deducted from
any royalties or other
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consideration otherwise due a party have been refunded to that
party. Neither party shall enter into any settlement that admits or
concedes that any aspect of any Patent or licensed trademark is
invalid or unenforceable without the prior written consent of the
other, which consent will not be unreasonably withheld.
10.2 Infringement Claims. If the manufacture, sale or use of Product
pursuant to this Agreement results in any claim, suit or proceeding
lodged by a third party alleging patent infringement by
Organogenesis or Royce (or the Affiliates of either), Royce shall
promptly notify Organogenesis in writing of receipt of any
information regarding any such claim. Organogenesis shall have the
exclusive right to defend and control the defense of any action
derived from any such claim, suit or proceeding, at its own expense,
using counsel of its own choice. Organogenesis shall have the
exclusive right, at any time and on any terms or conditions it deems
in its sole discretion advisable, including agreeing to the
cross-licensing of one or more of the Patents to the owner of those
patents alleged to be infringed by the sale of Products, to settle
or compromise any such claim, suit or proceeding. Organogenesis
shall timely keep Royce informed of all material developments in
connection with any such claim, suit or proceeding. The provisions
of this section 10.2 shall not apply to any claim, suit or
proceeding alleging infringement or misuse of any Trademark.
ARTICLE 11. REPRESENTATIONS AND WARRANTIES
-------------------------------------------
11.1 Joint Representations and Warranties. As an inducement to the
parties to enter into this Agreement and to consummate the
transactions contemplated hereby, each party hereby represents and
warrants solely to the other that:
11.1.1 Organization and Qualification. Each party is a corporation
duly organized, validly existing and in good standing under
the laws of the state of its jurisdiction or organization and
is duly licensed or qualified to transact business as a
foreign corporation and is in good standing in each
jurisdiction in which the laws of that jurisdiction requires
it to be so licensed or qualified, except where the failure
to be so licensed or qualified would not have a material
adverse effect.
11.1.2 Corporate Power and Authority; Validity. Each party has the
corporate power and authority to own and hold its assets and
properties. Each party has the corporate power and authority
to
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execute, deliver and perform this Agreement. The
execution, delivery and performance of this Agreement and the
consummation of the transactions contemplated hereby have
been duly authorized and approved by each party. This
Agreement has been duly executed and delivered by each party.
This Agreement constitutes and when so duly executed and
delivered will constitute, the legal, valid and binding
obligation of each party enforceable against each party in
accordance with its respective terms except as enforceability
may be subject to the application of general equitable
principles and to bankruptcy, insolvency, moratorium or other
similar laws affecting creditors' rights.
11.1.3 No Conflict. Neither the execution and delivery by each party
to the other of this Agreement, the consummation by each
party of the transactions contemplated hereby, nor the
performance by each party of this Agreement in compliance
with the terms and conditions hereof, will (ii) violate,
conflict with or result in any breach of its Certificate of
Incorporation or bylaws, (ii) require by or on behalf of each
party any consent, approval, authorization or permit of, or
filing with or notification to, any governmental authority,
(iii) violate, conflict with or result in a breach, default
or termination (or give rise to any right of termination,
cancellation or acceleration of the maturity of any payment
date of any of the obligations of each party or increase or
otherwise affect the obligations of each party) under any
law, rule, regulation or any governmental permit, license or
order or any of the terms, conditions or provisions of any
mortgage, indenture, note, license, agreement or other
instrument or obligation to which each party is a party or by
which each party or any of its assets are bound or affected
or (iv) result in the creation of any encumbrance upon any of
the Patents.
11.1.4 Litigation. There is no legal action pending or, to the
knowledge of either party, threatened against, contemplated
or affecting the transactions contemplated hereby (whether or
not each party is a party or prospective party thereto).
There are no outstanding governmental orders involving or
affecting the transactions contemplated hereby. There is no
legal action by either party pending or threatened against
others with respect to or relating in any way to the subject
matter of this Agreement.
11.2 Warranties of Organogenesis. Organogenesis warrants and represents
solely to Royce that:
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11.2.1 Patentability. With respect to Patents, to the best of the
knowledge of Organogenesis as at the Effective Date there
exists no publication or other reason that would adversely
affect the patentability of the subject matter or the
validity of its Patents. It has no information as of the
Effective Date to indicate that any entity licensed hereunder
by it with respect to its Patents would not be free to make,
use and sell Product or Product in the Territory without
infringing any third party patent.
11.2.2 Patent Rights. With respect to each Patent licensed to
Royce, it has good and marketable title, free and clear of
all encumbrances. To the best of its actual knowledge as at
the Effective Date, the use or sale by the other party of
Product or Product shall not infringe any patent, and shall
not violate any other intellectual property right of any
person or entity.
11.2.3 Default. It is not in default under any license, contract or
other agreement pertaining to its Patents, and to its
knowledge there are no defaults by it or any other entity to
any such license, contract or other agreement relating to its
Patents.
11.2.4 Interferences. None of its Patents is involved in any
interference or opposition proceeding, and, to its knowledge,
no such proceeding is pending or threatened.
11.2.5 Product use. When manufactured in accordance with the
Specifications and used in accordance with approved or
cleared labeling, Products will not cause injury or death to
any patient.
11.2.6 "Most Favored Nation" Treatment. Organogenesis will, during
the Term, or thereafter so long as Royce shall purchase any
Product from Organogenesis, charge Royce a price, inclusive
of all fees, including any licensing or cross-licensing fees
paid by Organogenesis, costs, and any other consideration,
for that Product which is no greater than the lowest net
price charged by Organogenesis to any third party for that
Product for resale in the Field.
11.3 Warranties of Royce. Royce warrants and represents solely to
Organogenesis that:
11.3.1 It will use its reasonable business efforts to market and
sell Products to the Alternate Site in the Territory
throughout the Term
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in a manner best suited to maximize the revenues and profits
therefrom.
11.3.2 It will not promote, market or sell Product in any manner
inconsistent with the claims in the labeling thereof, nor in
a manner in violation of any statute or regulation.
ARTICLE 12. PRODUCT LIABILITY
-----------------------------
12.1 Breach of Warranty. Each party hereby indemnifies and holds the
other harmless from all losses, costs or damages (including
attorney's fees) which the other may be held liable to pay as a
result of claims or suits arising out of any breach of any warranty
in this Agreement by the indemnifying party.
12.2 Negligence or Misconduct. Organogenesis hereby indemnifies and
holds Royce harmless from all losses, costs or damages (including
attorney's fees) which Royce may be held liable to pay as a result
of claims or suits arising out of any injuries or deaths to persons
and/or damage to property arising from Organogenesis' negligence or
misconduct with respect to the subject matter of this Agreement.
Royce hereby indemnifies and holds Organogenesis harmless from all
losses, costs or damages (including attorney's fees) which
Organogenesis may be held liable to pay as a result of claims or
suits arising out of any injuries or deaths to persons and/or damage
to property arising from Royce' negligence or misconduct with
respect to the subject matter of this Agreement.
12.3 Reporting. Each party hereto agrees to report promptly to the other
party any information concerning serious or unexpected side effects,
injury, toxicity, reactions or any unexpected event associated with
clinical, investigational or commercial use of any Product. Such
information shall also include pre-existing diseases, syndromes, or
abnormal diagnostic tests results which re-appear or are exacerbated
by use of Product. Upon receipt of such information by either party
hereto, both parties shall promptly consult each other and use best
efforts to arrive at a mutually acceptable procedure for taking the
appropriate actions under the circumstances; provided, however, that
nothing contained herein shall restrict the right of either party to
make a submission to a regulatory authority or take other actions it
deems to be appropriate or necessary. This Article shall survive
termination of this Agreement.
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ARTICLE 13. SECRECY
-------------------
13.1 Nondisclosure of All Shared Information. Organogenesis and Royce
shall each hold any information disclosed to it hereunder in
confidence and shall use at least the same level of care to prevent
any unauthorized use or disclosure of such information as it
exercises in protecting its own information of a similar nature.
13.2 Nondisclosure of Proprietary Information. The Recipient shall
disclose Proprietary Information received by it under this Agreement
only to persons within its organization who have a need to know such
Proprietary Information. The Recipient shall not disclose any
Proprietary Information to any person outside its organization who
is not bound by a similar written non-disclosure agreement
containing undertakings at least as stringent as those in this
Agreement. The Recipient shall use such Proprietary Information
only for the purpose for which it was disclosed and shall not use or
exploit such Proprietary Information for its own benefit or the
benefit of another without the prior written consent of the
Disclosing Party.
13.3 Return. The Recipient shall upon any termination or expiration of
this Agreement return to the Disclosing Party all documents,
materials, and other tangible manifestations of Proprietary
Information received pursuant to this Agreement (and all copies and
reproductions thereof).
13.4 Exceptions. The obligations of the Recipient shall not apply, and
the Recipient shall have no further obligations under this Article
with respect to any Proprietary Information to the extent that such
Proprietary Information:
13.4.1 is generally known to the public at the time of disclosure or
becomes generally known through no wrongful act on the part
of the Recipient;
13.4.2 is in the Recipient's possession at the time of disclosure
otherwise than as a result of Recipient's breach of any legal
obligation;
13.4.3 is or becomes known to the Recipient through disclosure by
sources other than the Disclosing Party having the legal
right to disclose such Proprietary Information;
13.4.4 is independently developed by the Recipient without
reference to or reliance upon the Proprietary Information; or,
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13.4.5 is required to be disclosed by the Recipient to comply with
applicable laws or regulations or the unappealed or
unappealable order of a court, provided that the Recipient
provides prior written notice of such disclosure to the
Disclosing Party and cooperates with the Disclosing Party at
its sole expense by taking any lawful action to avoid and/or
minimize the extent of such disclosure.
13.5 Permitted Use. Notwithstanding the provisions above, each party
shall have a right to use such information for development,
production and marketing of Product as provided in this Agreement
and further has a right to disclose such information to FDA pursuant
to the conditions in this Agreement.
13.6 Nondisclosure of terms. Each of the parties agrees not to disclose
to any third party the terms of this Agreement without the prior
written consent of the other party, except to such party's
attorneys, advisors, investors and others on a need to know basis
under circumstances that reasonably ensure the confidentiality
thereof, or to the extent required by law (including, but not
limited to, disclosure required by U.S. securities laws).
ARTICLE 14. TERM AND TERMINATION
--------------------------------
14.1 Term. Except as set forth below, the Term of this Agreement shall
begin on the Effective Date and continue in full force and effect,
unless terminated earlier as provided in this Article, until the
later of the expiration of the last Valid Patent Claim or the
expiration of any supply agreement respecting any Product.
14.2 Termination for Cause. Either party to this Agreement may terminate
this Agreement in the event that the other party shall have
materially breached or defaulted in the performance of any of its
material obligations hereunder, and such default shall have
continued for sixty (60) days after written notice thereof was
provided to the breaching party by the non-breaching party. Any
termination shall become effective at the end of such sixty-day
period unless the breaching party has cured any such breach or
default prior to the expiration of the sixty-day period.
14.3 TERMINATION FOR INSOLVENCY.
If voluntary or involuntary proceedings by or against a party are
instituted in bankruptcy under any insolvency law, or a receiver or
custodian is appointed for such party, or proceedings are instituted by or
against such party for corporate reorganization
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or the dissolution of such party, which proceedings, if involuntary, shall not
have been dismissed within sixty (60) days after the date of filing, or if such
party makes an assignment for the benefit of creditors, or substantially all of
the assets of such party are seized or attached and not released within sixty
(60) days thereafter, the other party may immediately terminate this Agreement
effective upon notice of such termination. Notwithstanding the foregoing, the
parties also agree as follows:
14.3.1 The parties agree that this Agreement is a license of
intellectual property subject to Section 365(n) of the
Bankruptcy Code.
14.3.2 In the event of Organogenesis' bankruptcy, Organogenesis
agrees that, notwithstanding Section 365(c)(1) of the
Bankruptcy Code, Royce may assume this Agreement and, subject
to Article 16.4 hereof governing assignment, may assign this
Agreement.
14.3.3 In the event of Organogenesis' bankruptcy, the parties
acknowledge and agree that the licensed rights hereunder are
fundamentally in the nature of "intellectual property" as
defined in the Bankruptcy Code; that Royce's continued
enjoyment of all licensed rights is fundamental to the basic
license hereunder; and therefore all licensed rights should
be deemed intellectual property subject to Royce's election
under Section 365(n)(1)(B).
14.3.4 The parties agree that upon any election by Royce pursuant to
Section 365(n)(1)(B) of the Bankruptcy Code, that Royce shall
be entitled to, on its own or through employees, contractors,
agents, or otherwise, upgrade, modify and develop derivative
works based upon the rights licensed hereunder and subject to
the terms of this Agreement.
14.4 EFFECTS OF TERMINATION.
14.4.1 Except as provided in 14.3, upon termination of this
Agreement in accordance with Article 14.1 or 14.2, the
licenses granted to Royce hereunder by Organogenesis shall be
forthwith terminated, and Royce shall discontinue the use of,
and return to Organogenesis within sixty (60) days after
termination, all Proprietary Information. Notwithstanding
the above, Royce may sell existing inventory of Product for
up to six (6) months after the date of termination, provided
royalties are paid thereon as required by this Agreement.
14.4.2 Termination of this Agreement for any reason shall not
release any party hereto from any liability which, at the
time of such termination,
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has already accrued to the other party or which is
attributable to a period prior to such termination nor
preclude either party from pursuing all rights and
remedies it may have hereunder or at law or in equity with
respect to any breach of this Agreement.
ARTICLE 15. INSURANCE
----------------------
15.1 Each party shall at all times during the Term, and for a period of
three years thereafter, maintain Product Liability Insurance and
Comprehensive General Liability Insurance, each with minimum
limits of [***] and shall name the other as an additional insured
on each such policy and shall, upon request from the other,
furnish a Certificate of Insurance and Additional Insured
Endorsement evidencing the aforementioned coverage.
ARTICLE 16. MISCELLANEOUS PROVISIONS
------------------------------------
16.1 Governing Law. This Agreement and any dispute arising from the
construction, performance or breach hereof shall be governed by and
construed and enforced in accordance with the laws of the
Commonwealth of Massachusetts.
16.2 No Implied Licenses. Only the licenses granted pursuant to the
express terms of this Agreement shall be of any legal force or
effect. No license rights shall be created by implication, estoppel
or otherwise.
16.3 Waiver. No waiver by any party hereto of any breach or default of
any of the covenants or agreements herein set forth shall be deemed
a waiver as to any subsequent and/or similar breach or default.
16.4 Assignment. This Agreement shall not be assignable by either party
to any third party hereto without the written consent of the other
party hereto, except that either party may assign this Agreement
without such consent to an entity that acquires all or
substantially all of the business and assets of such party, whether
by merger, reorganization, acquisition, sale, or otherwise. This
Agreement shall be binding upon and inure to the benefit of any
permitted assignee, and any such assignee shall agree to perform
the obligations of the assignor.
16.5 Independent Contractors. The relationship of the parties hereto is
that of independent contractors. The parties hereto are not deemed
to be agents, partners or joint venturers of the other for any
purpose as a result of this Agreement or the transactions
contemplated hereby.
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16.6 Compliance with Laws. In exercising their rights under this
license, the parties shall fully comply in all material respects
with the requirements of any and all applicable laws,
regulations, rules and orders of any governmental body having
jurisdiction over the exercise of rights under this license
including, without limitation, those applicable to the discovery,
development, manufacture, distribution, import and export and
sale of medical products pursuant to this Agreement.
16.7 Severability. In the event that any provision of this Agreement
becomes or is declared by a court of competent jurisdiction to
be illegal, unenforceable or void, this Agreement shall continue
in full force and effect without said provision in that
jurisdiction only, and the whole of this Agreement shall remain
in effect in every other jurisdiction. The parties shall amend
the Agreement to the extent feasible to lawfully include the
substance of the excluded term in the affected jurisdiction to as
fully as possible realize the intent of the parties and their
commercial bargain.
16.8 Survival. Articles 8, 10, 11, 12, 13, 15, and paragraphs 7.3, 16.3,
16.7, 16.11, and 16.13 of this Agreement (and the definition of any
term contained in any such article or paragraph) shall survive any
expiration or termination of this Agreement for any reason.
16.9 Notice. All notices required or permitted to be given hereunder
shall be in writing, shall refer specifically to this Agreement and
shall be personally delivered or sent by telecopy, e-mail or other
electronic facsimile, or by registered or certified mail, return
receipt requested, postage prepaid, in each case to the respective
address specified below (or such other address as may be specified
in writing to the other party hereto pursuant to the provisions
hereof), or, in the case of a telecopy or other electronic
transmission, to such party to a telephone number designated by the
recipient and by means confirmed in writing:
If to Organogenesis : If to Royce :
Organogenesis Inc. Royce Medical Company
Attention: Chief Financial Officer Attention: Xxxx Xxxxxx,
President
000 Xxx Xxxx 000 Xxxxxx Xxxx
Xxxxxx, XX 00000 Xxxxxxxxx, Xxxxxxxxxx 00000
Tel: 000-000-0000 Tel: (000) 000-0000
Fax: 000-000-0000 Fax: (000) 000-0000
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Any notice or communication given in conformity with this paragraph
shall be deemed to be effective when received by the addressee if
delivered by hand, telecopy, e-mail or other electronic
transmission, and three (3) days after mailing, if mailed.
16.10 Force Majeure. Nonperformance of either party (except for payment
obligations) shall be excused to the extent that performance is
rendered impossible by strike, fire, earthquake, flood,
governmental acts or orders or restrictions, failure of suppliers,
or any other reason where failure to perform is beyond the
reasonable control and not caused by the negligence, intentional
conduct or misconduct of the nonperforming party, provided such
party uses its best efforts to resume performance as promptly as
possible.
16.11 No Consequential Damages. In no event shall any party to this
Agreement have any liability to the other for any special,
consequential, incidental or punitive damages arising under this
Agreement under any theory of liability.
16.12 Integration. This Agreement with its schedules constitutes the
entire agreement between the parties with respect to the subject
matter hereof, and all prior agreements respecting the subject
matter hereof, either written or oral, expressed or implied, shall
be null and void and of no effect. Any proprietary information
agreement previously executed by the parties shall be null and void
only to the extent that it reasonably would be construed to
otherwise govern confidentiality of the subject matter of this
Agreement. No amendment or addition hereto shall be effective or
binding on either of the parties unless reduced to writing and
executed by the respective duly authorized representatives of
Organogenesis and Royce as of a date subsequent to the Effective
Date.
16.13 Dispute Resolution. The parties agree to attempt to settle any
dispute under this Agreement by mutual discussion and consent. If
such good faith discussions do not amicably resolve any such
dispute, it shall be finally settled by binding arbitration,
conducted in accordance with the Commercial Arbitration Rules, then
obtaining, of the American Arbitration Association, and judgment
upon the award rendered may be entered by any court of competent
jurisdiction. Any arbitration commenced by one party against the
other shall take place in the jurisdiction of the other, excluding
cross-actions. The costs of the arbitration, including
administrative and arbitrators' fees, shall be shared equally by
the parties. Each party shall bear its own costs and attorneys' and
witness' fees. A disputed performance or suspended performances
pending the resolution
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of the arbitration must be completed within thirty (30) days
following the final decision of the arbitrators or such other
reasonable period as the arbitrators determine in a written
opinion. Neither party shall commence any action in any court to
resolve any dispute hereunder except to confirm such an
arbitrator's award. Commencement of any such action shall be a
breach of this Agreement entitling the other party to terminate
this Agreement forthwith.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
duly executed by their authorized representatives and delivered in duplicate
originals as of the Effective Date, whereby they evidence their intent to be
legally bound.
ROYCE MEDICAL, INC. ORGANOGENESIS INC.
By: /S/ Xxxx Xxxxxx By: /S/ Xxxxxx Xxxxxxxx
------------------------- ----------------------
Xxxx Xxxxxx President/CEO Xxxxxx Xxxxxxxx
By: /S/ Xxxxxx Xxxxx
----------------------
Xxxxxx Xxxxx
for the Executive
Committee of the Board
of Directors
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SCHEDULE A
ENGINEERED COLLAGEN MATRIX(TM) WOUND DRESSING
DEVELOPMENT PLAN
Feasibility Animal Wound Dressing Study
Completed
Pivotal Animal Wound Dressing Study
Initiate 12/2000
Complete 2/2000
Technology Transfer to Contract Manufacturer
Complete 12/2000
Manufacturing Scale-Up (Documentation, Regulatory Compliance, Commercial Scale
Production)
Initiate: 1/2001
Complete: 6/2001
Shelf-Life Testing
Initiate: 12/2000
Interim: Analysis: 3/2001
Complete: 12/2002
FDA 510k Application
Submitted: 3/2001
Anticipated Approval: 7/2001
Clinical Marketing Evaluation
Initiate: 7/2001
Complete: 11/2001
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SCHEDULE B
Schedule B shall be drafted by Royce, agreed to by the parties and attached
hereto as soon as reasonable practicable. The failure of the parties to agree
on the contents of this schedule shall not be a basis of termination of the
Agreement by either party.
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SCHEDULE C
The following is a list as of December 1, 2000 of all patents and patent
applications, world-wide, for ECM.
US cases are listed along with the corresponding PCT filing information. In
some cases, a US continuation application is filed via PCT.
Peracetic acid sterilization.
-----------------------------
US Patent No. 5,460,962 issued October 24, 1995
*******
Tissue Repair Fabric
--------------------
US Patent No. 5,733,337 issued March 31, 1998
*******
Chemical Cleaning of Biological Material
----------------------------------------
US Patent No. 5,993,844 issued November 30, 1999
********
********
********
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SCHEDULE D
ENGINEERED COLLAGEN MATRIX(TM) WOUND DRESSING
PRELIMINARY PRODUCT DESCRIPTION AND SPECIFICATIONS
This product description and these specifications are preliminary and accurate
as at December 1, 2000. The parties will convene such focus groups or other
professional healthcare resources who are competent to advise on the
appropriateness of these specifications or the need for additional or revised
specifications.
PRODUCT DESCRIPTION
Engineered Collagen Matrix(tm) Wound Dressing is supplied sterile in peel-open
packages and is indicated for the management of partial and full-thickness
wounds. The product is intended for one-time use.
PRODUCT SPECIFICATIONS
The product is comprised of a single-layer of Engineered Collagen Matrix with
no chemical cross-linking. The product is supplied dry and is intended to be
rehydrated on the wound. The product is fenestrated to allow wound exudate to
pass through the dressing.
Engineered Collagen Matrix(TM) Wound Dressing is supplied in two sizes:
.. 5cm [multiply] 5cm
.. 10cm [multiply] 10cm
INDICATIONS FOR USE
Engineered Collagen Matrix (TM) is indicated for the management of wounds
including:
. Partial and full-thickness wounds
. Venous ulcers
. Diabetic ulcers
. Drainage wounds
. Pressure ulcers
. Chronic vascular ulcers
. Trauma wounds (abrasions, lacerations, second-degree xxxxx, skin tears)
. Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser
surgery, podiatric, wound dehiscence)
STORAGE
The device should be stored in a clean, dry location at room temperature. The
shelf-life of the product has not yet been determined. The intended shelf-life
will be two years.
STERILIZATION
The device has been terminally sterilized with gamma irradiation. Viral
inactivation is achieved by chemical disinfection.
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SCHEDULE E
Subject to each lettered footnote in this schedule (describing remedies), Royce
shall achieve the following minimum sales of Products in each year following
First Commercial Sale:
Following First Commercial Royce must achieve minimum sales of:
Sale, for each year during
the Term:
Year 1 The lesser of **** units or ***** (a)
Year 2 The lesser of **** units or ***** (a)
Year 3 The lesser of **** units or ***** (b) and (c)
Year 4 The lesser of **** units or ***** (b) and (c)
Year 5 and each The lesser of **** units or ***** (b) and (c)
year thereafter
(a) Subject to Royce's right to cure in paragraph 4.3.2, Organogenesis' only
remedy is to appoint one or more additional distributors.
(b) Subject to Royce's right to cure in paragraph 4.3.2., Organogenesis may
appoint one or more additional distributors, and, if Royce does not make
at least the following minimum sales of Products, Organogenesis may
terminate this Agreement and recover all licenses granted hereunder:
Year 3 $*****
Year 4 $*****
Year 5 $*****
(c) If, but only if, Organogenesis decides to terminate this Agreement for non
-payment by Royce of the minimum royalties in subparagraph (b),
immediately above, Organogenesis must make a one-time termination cash
payment to Royce equal to ***** of the prior **** months Net Sales, and
repurchase at Royce's option, for cash at cost all in-date inventory of
Product.
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SCHEDULE F
Subject to the lettered footnotes in this Schedule, Royce shall pay
Organogenesis as a royalty:
[****] x (Net Sales- [COGS + M/S Credit])
(a) COGS = cost of goods sold = the Supply Price as defined in 1.19 of all
Products commercially sold.
(b) M/S Credit (marketing and sales expense credit) is defined according to the
following schedule, and includes the cost of samples and all other marketing
and sales expenses:
In each year during the Term The percent of Net Sales allowed
following First Commercial Sale: as a credit for sales and marketing
expenses shall be:
Year 1 [***] of Net Sales
Year 2 [***] of Net Sales
Year 3 [***] of Net Sales
Year 4 and each year
thereafter [***] of Net Sales
*CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
AMENDMENT AGREEMENT
-------------------
This Amendment Agreement made as of October 15, 2001 (the Effective Date)
between ORGANOGENESIS INC., a corporation organized under the laws of the State
of Delaware, having a present principal address at 000 Xxx Xxxx, Xxxxxx,
Xxxxxxxxxxxxx 00000 XXX (hereinafter Organogenesis), and Royce Medical Company,
a corporation organized under the laws of the State of California, having a
present principal address at 000 Xxxxxx Xxxx, Xxxxxxxxx XX 00000 (hereafter
Royce);
WITNESSETH:
-----------
WHEREAS, the parties entered into an Exclusive License and Distribution
Agreement dated December 18, 2000 (the "Agreement"); and
WHEREAS, the parties now wish to amend that Agreement to reflect an agreeable
method for the responsibility for the handling of any action that is brought by
third parties against Royce for infringement of patents from the sale or use by
Royce of Products, as described in this Agreement; and
WHEREAS, as amended hereby, the parties wish to continue in force the whole of
the Agreement;
NOW THEREFORE the parties agree that:
FIRST. Article 12, "Product Liability" is hereby amended to add at the end
thereof the following Article 12.4.
"12.4 Patent Indemnity. Organogenesis hereby indemnifies Royce, and its
officers, directors, and employees from any amounts it becomes obligated to pay
to any third party person or entity as part of a final and unappealable or
unappealed judgment of any court concluding that Royce's sale or use of Products
infringes the patent or patents of any third person. The obligations of this
indemnity are conditioned upon the compliance by Royce with all of the
provisions of Article 10.2."
SECOND. Article 10.2 is hereby amended in its entirety to read as follows:
"If the manufacture sale or use of Product pursuant to this Agreement results in
any claim, suit or proceedings lodged by a third party alleging patent
infringement by Organogenesis or Royce (or the Affiliates of either), Royce
*CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
shall promptly notify Organogenesis in writing of receipt of any regarding any
such claim. Organogenesis shall have the exclusive right and obligation to
defend and control the defense of any action derived from any such claim suit or
proceeding at its own expense using counsel of its own choice. Organogenesis
shall have the exclusive right at any time and on any terms or conditions it
deems in its sole discretion advisable, including agreeing to the cross
licensing of one or more of the Patents to the owner of those patents alleged to
be infringed by the sale of Products, to settle or compromise any such claim,
suit or proceeding. Organogenesis shall timely keep Royce informed of all
material developments in connection with any such claim, suit or proceeding. The
provisions of this section 10.2 shall not apply to any claim, suit or proceeding
alleging infringement or misuse of any trademark."
THIRD. All other terms and conditions of this Agreement are hereby continued in
full force and effect, and are confirmed as of the date hereof.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly
executed by their authorized representatives and delivered in duplicate
originals as of the Effective Date, whereby they evidence their intent to be
legally bound.
ROYCE MEDICAL COMPANY ORGANOGENESIS INC.
BY: /s/ Xxxx Xxxxxx By: /s/ Xxxx X. Xxxxxx
----------------------- -----------------------------