EXHIBIT 10.2
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (the "AGREEMENT") is entered into as of May 18,
2007 (the "EFFECTIVE DATE"), by and between IsoTis Inc., a corporation organized
under the laws of Delaware, having a principal place of business at 2 Goodyear,
Xxxxxx, XX 00000 and AlloSource, a not-for-profit corporation organized under
the laws of Illinois, having a principal place of business at 0000 X. Xxxx
Xxxxxx, Xxxxxxxxxx, XX 00000 ("ALLOSOURCE"). IsoTis and AlloSource are sometimes
referred to herein individually as a "PARTY" and collectively as the "PARTIES."
1. BACKGROUND
1.1 IsoTis owns or has the right to grant rights and licenses under
certain intellectual property rights, including, without limitation, Licensed
Know-How and Patent Rights as more particularly set forth in Schedule 2.14,
relating to certain bone regeneration technologies, including without limitation
the development, production, and distribution of proprietary natural and
synthetic bone graft substitutes and that certain bioassay necessary for such
production.
1.2 AlloSource desires to obtain from IsoTis, and IsoTis is willing to
grant to AlloSource certain rights and licenses under the Licensed Intellectual
Property under the terms and conditions set forth in this Agreement.
1.3 In consideration of the mutual covenants and agreements contained
herein, the parties hereto agree to the following terms and conditions.
2. DEFINITIONS
2.1 "AFFILIATE" of a Party shall mean any Person controlled by,
controlling, or under common control with such Party, including any Wholly Owned
Subsidiary of such Party. For this purpose, "control" means direct or indirect
beneficial ownership of at least fifty percent (50%) of the voting stock, or at
least fifty percent (50%) interest in the profits of such Person.
2.2 "ALLOFUSE" means DBM combined with a reverse phase medium poloxamer
and configured in either putty or gel formulation in accordance with the
Licensed Intellectual Property that is distributed solely under AlloSource's
trademark "ALLOFUSE(R)".
2.3 "ALLOSOURCE DISTRIBUTORS" means any Person and/or Third Party with
which AlloSource has a then-current agreement for distribution of AlloSource
products including but not limited to Licensed Products.
2.4 "ALLOSOURCE IMPROVEMENT" means any and all discoveries, inventions,
contributions, findings, or improvements to the Licensed Intellectual Property
or modifications to the Licensed Product, whether or not patentable or otherwise
protectable by intellectual
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
property rights, and all related know-how, conceived, reduced to practice, or
otherwise developed by AlloSource or its Affiliates or a Person or Third Party
engaged by AlloSource or its Affiliates whether developed alone or with another
Person(s) related to the (i) percentage of DBM, (ii) amount or use of bone
chips, including, without limitation, cancellous or cortical bone, (iii) the
demineralization process for the production of DBM which does not include the
process of making Accell(R) materials from DBM which is described in U.S. Patent
No. ****, (iv) changes in the composition or formulation of the reverse phase
medium, and/or (v) changes in or use of hydroxyapatite, tricalcium phosphate,
biphasic calcium, calcium sulfate and/or biological glasses. AlloSource
Improvement shall not include any IsoTis Improvement or any Joint Improvement.
2.5 "ALLOSOURCE PARTNERS" means any Person or Third Party with which
AlloSource has an agreement arranging for the manufacture of Licensed Products
that is distributed under a trademark owned or otherwise controlled by the
applicable AlloSource Partner so long as such arrangement is not in violation of
Section 4.4 of this Agreement.
2.6 "CONFIDENTIAL INFORMATION" means any information, including but not
limited to each Party's know-how, invention disclosures, patent applications,
proprietary materials and/or technologies, economic information, business or
research strategies, trade secrets, and material embodiments thereof, of a
confidential and proprietary nature disclosed by a Party to the other Party in
written form marked "confidential," or in oral form if summarized in a writing
marked "confidential" and delivered to the receiving Party within **** after
such oral disclosure. Confidential Information also shall include any
unpublished patent application within the Licensed Intellectual Property.
2.7 "DBM" means demineralized bone matrix.
2.8 "DEFAULT NOTICE" means a written notice provided by AlloSource to
IsoTis informing IsoTis that it has failed to order, accept, and submit payment
when due for the minimum amount of tissue required to be ordered by IsoTis
pursuant to Section 2.3 of the Tissue Agreement.
2.9 "DEFAULT NOTICE DATE" means the date on which the Default Notice is
delivered to IsoTis. IsoTis shall have **** from the date of the Default Notice
Date to cure the failure set forth in the Default Notice to the satisfaction of
AlloSource.
2.10 "DENTAL FIELD" means ****, ****, ****, ****, ****, and other dental
applications. The Dental Field specifically does not include ****.
2.11 "DYNAGRAFT(R) II" means that certain product defined by the
Specifications attached hereto as Schedule 2.9.
2.12 "FIELD" means the use of bone grafting materials outside of and/or
excluding the Dental Field.
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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2.13 "ISOTIS" means IsoTis, Inc., IsoTis OrthoBiologics, Inc. and its
Affiliates.
2.14 "ISOTIS DISTRIBUTORS" means any Person and/or Third Party with which
IsoTis has a then-current agreement for distribution of IsoTis' bone grafting
products including but not limited to Products.
2.15 "ISOTIS IMPROVEMENT" means any discoveries, inventions,
contributions, findings, or improvements to the Licensed Intellectual Property
conceived, reduced to practice, or otherwise developed by IsoTis or jointly by
IsoTis with another Person or Third Party other than AlloSource or its
Affiliates.
2.16 "JOINT IMPROVEMENT" means any discoveries, inventions, contributions,
findings or improvements to the Licensed Intellectual Property developed by
joint efforts of (1) IsoTis or its Affiliates or a Person or Third Party engaged
by IsoTis or its Affiliates whether developed alone or with another Person(s)
and (2) AlloSource or its Affiliates or a Person or Third Party engaged by
AlloSource or its Affiliates whether developed alone or with another Person(s).
2.17 "LICENSED KNOW-HOW" means all technical, scientific, and other
know-how, information, trade secrets, knowledge, technology, ideas, inventions
(whether or not patentable), concepts, formulae, procedures, methods, processes,
protocols, techniques, materials, and results of experimentation and testing,
including without limitation, samples, data, results, and other materials
(whether or not patentable), 510(k) applications and files, documents and other
information relating to such 510(k) applications, including all correspondence
with and supplemental submissions to the FDA relating to the 510(k), all
research and other supporting material in support of the 510(k) and all notes
and work product relating to the 510(k), device master records and design
history files in written, electronic, or any other form, and all intellectual
property rights therein other than Patent Rights, solely to the extent that the
foregoing are necessary or useful for the manufacture or distribution of
Licensed Products as set forth in Schedule 2.15.
2.18 "LICENSED INTELLECTUAL PROPERTY" has the meaning set forth in
Schedule 2.15 hereof and includes, without limitation, formulations and
compositions of the Product and the Licensed Know-How and Patent Rights. The
parties agree that Licensed Intellectual Property includes, and that Schedule
2.16, shall be modified from time to time during the course of this Agreement to
add, any new intellectual property to which IsoTis obtains rights and which may
be necessary for the manufacture and distribution of the Licensed Products
and/or use of the Licensed Intellectual Property in accordance with the rights
and licenses granted to AlloSource in this Agreement. IsoTis shall promptly
provide AlloSource with such Licensed Intellectual Property from time to time as
it is available. AlloSource acknowledges that it does not intend to use ****
Intellectual Property for its manufacturing of the Licensed Product and that the
**** Intellectual Property is not included in this Agreement and is not
considered part of the Licensed Intellectual Property.
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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2.19 "LICENSED PRODUCT" means any Product that is marketed and distributed
under trademarks of AlloSource or its Affiliates or AlloSource Partners. The
Licensed Product has the same formulations and/or compositions as Product,
except that the Licensed Product may differ from the Product with respect to any
AlloSource Improvement that AlloSource may reduce to practice. The parties
acknowledge and agree that this Agreement permits AlloSource to use, make or
have made, sell or offer to sell Licensed Products that include AlloSource
Improvements.
2.20 "**** INTELLECTUAL PROPERTY" means the intellectual property licensed
by IsoTis from **** for use in its demineralization processes of Products.
2.21 "2007 SALES" means the number of units (defined based on the pricing
schedule set forth in Schedule 2.19 hereof) of AlloFuse distributed without
return, recall, recovery or rejection by AlloSource, its Affiliates and the
Strategic Partners between **** and ****, inclusive, multiplied by the
applicable price for such unit set forth on Schedule 2.19 hereof. An example
calculation of 2007 Sales is set forth in Schedule 2.19a hereof.
2.22 "MINIMUMS DEFAULT DATE" means the date which is the first business
day after **** from the Default Notice Date, provided that IsoTis has not cured
the failure set forth in the Default Notice to the satisfaction of AlloSource.
2.23 "ORTHOBLAST(R) II" means that certain product defined by the
Specifications attached hereto as Schedule 2.20.
2.24 "PATENT RIGHTS" means (i) the patent applications and patents set
forth on Schedule 2.20; (ii) divisions, continuations, continuations-in-part
substitute applications, and any corresponding foreign patents or patent
applications of any patents or patent applications described in (i); (iii)
patents that may issue from any patent applications described in (i) or (ii);
and (iv) reissues, reexaminations and extensions of patents described in (i) or
(iii).
2.25 "PERSON" means any individual, corporation, partnership, association,
joint-stock company, trust, unincorporated organization or government or
political subdivision thereof.
2.26 "PRODUCT" means DynaGraft(R) II and/or OrthoBlast(R) II.
2.27 "PRIVATE LABEL PARTNERS" means (i) until the earlier of **** or ****
any Person or Third Party with which IsoTis, now or in the future may have an
agreement arranging for the manufacture of Products that is distributed under a
trademark owned by the applicable Private Label Partner and AlloSource
acknowledges that Private Label Partners include but are not limited to the
following companies and its Affiliates: ****, ****, ****, ****, ****, ****,
****, ****, ****, ****, and ****; (ii) until **** ("****") and (iii) after the
earlier of **** or **** any Person or Third Party with which IsoTis has a
then-current agreement arranging for the manufacture of Products that is
distributed under a trademark owned or otherwise controlled by
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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the applicable Private Label Partner. The terms and conditions of this provision
shall expire on ****.
2.28 "STRATEGIC PARTNERS" means (i) (a) until the earlier of **** or ****,
****, ****, ****, ****, ****, ****, **** and **** and their affiliates, plus (b)
from **** until the earlier of **** or ****, **** unless **** entered into an
agreement with IsoTis during the period permitted by Section 2.25 hereof
arranging for the manufacture of Products that are distributed under a trademark
owned by ****; and (ii) after the earlier of **** or ****, any Person or Third
Party with which AlloSource has a then-current agreement arranging for the
manufacture of Licensed Products that is distributed under a trademark owned or
otherwise controlled by such Person or Third Party. The terms and conditions of
this provision shall expire on ****.
2.29 "TERRITORY" means the United States of America, Canada, Mexico, and
their respective territories and possessions.
2.30 `THIRD PARTY" means any Person other than a Party or an Affiliate of
either Party.
2.31 "TISSUE AGREEMENT" means that certain Amended and Restated Tissue
Procurement and Processing Agreement by and between IsoTis and AlloSource, dated
as of July 1, 2006, and as amended as of the Effective Date of this Agreement.
2.32 "WHOLLY OWNED SUBSIDIARY(IES)" of a Party shall mean any Person
controlled by such Party. For this purpose, "control" means direct beneficial
ownership of no less than one- hundred percent (100%) of the voting stock, or no
less than one-hundred percent (100%) interest in the profits of such Person.
3. GRANT
3.1 Subject to the terms and conditions of this Agreement, IsoTis hereby
grants to AlloSource the following:
3.1.1 An exclusive license to use the Licensed Intellectual
Property to make, or have made the Licensed Products in the Territory in
the Field.
3.1.2 A non-exclusive license to use the Licensed Intellectual
Property to use, sell, offer to sell and import Licensed Products inside
or outside of the Territory in the Field.
3.2 For the avoidance of doubt, Isotis reserves and retains the following
rights: (i) the right for IsoTis or its Wholly Owned Subsidiary(ies) to use the
Licensed Intellectual Property to make or have made Products in the Territory,
(ii) the right for Isotis, IsoTis' Wholly Owned Subsidiary(ies), Private Label
Partners and/or any Third Party designated by IsoTis to use the Licensed
Intellectual Property to use, sell, offer to sell or import Products in the
Territory in the Field; (iii) the right for IsoTis, IsoTis' Wholly Owned
Subsidiary(ies), Private Label Partners, and/or any Third Party designated by
IsoTis to use the Licensed Intellectual Property to make,
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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have made, use, sell, offer to sell, or import Products outside of the Territory
in the Field, and (iv) the right for IsoTis, IsoTis Wholly Owned
Subsidiary(ies), Private Label Partners, and/or any Third Party designated by
IsoTis to use the Licensed Intellectual Property to make, have made, use, sell,
offer to sell or import any item other than the Product.
3.3 The licenses and rights granted by Isotis to AlloSource are personal
to AlloSource and AlloSource's Wholly Owned Subsidiary(ies). AlloSource shall
not have any right to transfer or sublicense the license and rights granted
hereunder, provided that AlloSource shall have the right to sublicense the
license and rights granted hereunder to (i) one or more Wholly Owned
Subsidiary(ies) (ii) to a Third Party as necessary for AlloSource to have made
the Licensed Product but such Third Party shall not have the right to sell or
offer to sell the Licensed Product, or (iii) an AlloSource Affiliate or
AlloSource Partner to sell or offer to sell the Licensed Product. However,
AlloSource's sublicense(s) granted to such Wholly Owned Subsidiary, AlloSource
Affiliate or AlloSource Partner shall immediately terminate upon a change of
control (as defined below) of such Wholly Owned Subsidiary, AlloSource Affiliate
or AlloSource Partner if such change of control occurs prior to **** and IsoTis
has not provided its written consent for such change of control. If IsoTis does
not provide such written consent, then IsoTis shall pay to AlloSource an amount
equal to **** or **** associated with such sublicense for the **** preceding
such termination. For purposes of this section, "change of control" shall mean
any consolidation or merger of the Wholly Owned Subsidiary, AlloSource Affiliate
or AlloSource Partner or a sale, lease, exchange or other transfer (in one
transaction or a series of related transactions) of all or substantially all the
assets of the Wholly Owned Subsidiary, AlloSource Affiliate or AlloSource
Partner.
3.4 IsoTis retains full ownership of the Licensed Intellectual Property.
This Agreement confers no right, license, or interest, by implication, estoppel
or otherwise, under any Licensed Intellectual Property, AlloSource Improvements,
IsoTis Improvements, Joint Improvements, or other intellectual property rights
except as expressly set forth in this Agreement. Each Party hereby expressly
retains and reserves all of its respective rights and interests with respect to
the Licensed Intellectual Property, AlloSource Improvements, IsoTis
Improvements, Joint Improvements, or other intellectual property rights not
expressly granted to the other Party under this Agreement. Each Party covenants
that it shall use and practice the intellectual property rights granted to such
Party by the other Party under this Agreement only for the purposes expressly
permitted under the applicable license and for no other purpose.
4. EFFORTS AND RESTRICTIONS
4.1 AlloSource shall comply with all governmental laws and regulations
applicable to the manufacturing and/or distribution of Licensed Products in the
Territory.
4.2 AlloSource shall not knowingly distribute Licensed Products for use
outside of the Field. AlloSource shall use commercially reasonable diligence to
ensure that no Licensed Product is distributed for use outside of the Field.
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
6
4.3 IsoTis agrees not to directly or indirectly by any Affiliate or Third
Party enter into an agreement with any of the Strategic Partners to distribute
Products under any trademarks owned or otherwise controlled by such Strategic
Partners, IsoTis, or others. AlloSource is entitled to protection from
violations of this Section 4.3, including protection by injunctive relief, in
addition to other remedies available under law. In case of any breach by IsoTis
of Section 4.3, in addition to injunctive relief and other remedies available
under the law, IsoTis agrees to pay to AlloSource an immediately payable,
non-reducible and non-offsetable penalty of **** ($****) for each **** that a
Strategic Partner distributes Products.
4.4 AlloSource agrees not to directly or indirectly by any Affiliate or
Third Party enter into an agreement with any of the Private Label Partners to
distribute Licensed Products under any trademarks owned or otherwise controlled
by such Private Label Partners, AlloSource, or others. IsoTis is entitled to
protection from violations of this Section 4.4, including protection by
injunctive relief, in addition to other remedies available under law. In case of
any breach by AlloSource of Section 4.4, in addition to injunctive relief and
other remedies available under the law, AlloSource agrees to pay to IsoTis an
immediately payable, non-reducible and non-offsetable penalty of **** ($****)
for each **** that a Private Label Partner distributes Licensed Products.
4.5 AlloSource agrees not to directly or indirectly by any Affiliate or
Third Party (but without restriction on Strategic Partners as long as there is
no ownership interest by AlloSource, Wholly Owned Subsidiary, and/or AlloSource
Affiliate of such Strategic Partners) enter into an agreement with any of the
IsoTis Distributors to distribute Licensed Products. IsoTis is entitled to
protection from violations of this Section 4.5, including protection by
injunctive relief, in addition to other remedies available under law. In case of
any breach by AlloSource of Section 4.5, in addition to injunctive relief and
other remedies available under the law, AlloSource agrees to pay to IsoTis an
immediately payable, non-reducible and non-offsetable penalty of **** ($****)
for each **** that an IsoTis Distributor distributes Licensed Products. The
terms and conditions of this provision shall expire on ****.
4.6 IsoTis agrees not to directly or indirectly by any Affiliate or Third
Party (but without restriction on Private Label Partners as long as there is no
ownership interest by IsoTis and/or IsoTis Affiliate of such Private Label
Partners) enter into an agreement with any of the AlloSource Distributors to
distribute Products. AlloSource is entitled to protection from violations of
this Section 4.6, including protection by injunctive relief, in addition to
other remedies available under law. In case of any breach by IsoTis of Section
4.6, in addition to injunctive relief and other remedies available under the
law, IsoTis agrees to pay to AlloSource an immediately payable, non-reducible
and non-offsetable penalty of **** ($****) for each **** that an AlloSource
Distributor distributes Products. The terms and conditions of this provision
shall expire on ****.
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
7
5. PAYMENTS, REPORTS, AND RECORDS
5.1 In partial consideration of the rights and licenses granted herein,
AlloSource shall pay to IsoTis, within **** after the Effective Date, a
nonrefundable, noncreditable license fee of One Million Five Hundred Thousand
U.S. Dollars ($1,500,000) (the "Initial Royalty Payment"), and deposit with Key
Bank as escrow agent (the "Escrow Agent") the amount of One Million U.S. Dollars
($1,000,000) (the "Escrow Payment Amount") in accordance with the terms of a
properly executed escrow agreement (the "Escrow Agreement") by and between
IsoTis, AlloSource and the Escrow Agent. The Escrow Agreement shall provide that
the Escrow Agent, upon issuance of a disbursement request signed by AlloSource
on or after ****, shall pay to AlloSource the Escrow Payment Amount, less the
amount of cash payments for amounts owed by IsoTis as of the Effective Date and
received by AlloSource following the Effective date through **** pursuant to the
Tissue Agreement up to the Escrow Payment Amount and shall pay to IsoTis any of
the Escrow Payment Amount remaining after payments to AlloSource. The Parties
acknowledge and agree that, as of the Effective Date, the amount owed by IsoTis
to AlloSource is **** ($****). In the event of a dispute regarding the amount of
cash paid by IsoTis to AlloSource from the Effective Date through **** pursuant
to the Tissue Agreement, the Parties shall use good faith efforts to resolve the
dispute for a period of ****. If the dispute is not resolved within such ****
period, the Parties shall discuss in good faith the submission of the dispute to
binding arbitration, and if the Parties agree in writing to submit the dispute
to such arbitration then such dispute shall be resolved in accordance with
Section 5.5 hereof. Nothing set forth herein shall obligate either Party to
submit to arbitration or any other alternative dispute resolution procedure with
respect to the dispute, and in the absence of an agreement by the Parties to
arbitrate the dispute, such dispute shall be resolved in a state or federal
court in accordance with this Agreement.
5.2 In partial consideration of the rights and license granted herein,
AlloSource shall pay to IsoTis, before May 1, 2008, the lesser of ("The Deferred
Royalty Payment"):
5.2.1 Two Million Five Hundred Thousand U.S. dollars
($2,500,000); or
5.2.2 An amount equal to the sum of (i) **** the amount equal
to 2007 Sales ****; and (ii) **** the amount of 2007 Sales **** . An
example of the calculation set forth in this Section 5.2.2 is set
forth in Schedule 5.2.2.
5.3 AlloSource shall provide, with the payments due under Section 5.2, a
statement of 2007 Sales and the calculation of the Deferred Royalty Payment.
5.4 AlloSource shall keep complete, true, and accurate books of account
and records for the purpose of showing the derivation of the Deferred Royalty
Payment to IsoTis under this Agreement. Such books and records shall be kept at
AlloSource's principal place of business for at least **** following the
delivery of the Deferred Royalty Payment and shall be open at all reasonable
times mutually agreed to in advance for inspection by a representative of IsoTis
for the purpose of verifying AlloSource's calculation of the Deferred Royalty
Payment.
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
8
5.5 If, as set forth in Section 5.1, the Parties mutually agree to submit
the dispute to binding arbitration, the arbitration shall be conducted by a
single arbitrator (the "Arbitrator") in accordance with the Commercial Rules of
the American Arbitration Association (the "Commercial Rules") in effect from
time to time and the following provisions.
5.5.1 In the event of any conflict between the Commercial
Rules in effect from time to time and the provisions of this Agreement,
the provisions of this Agreement shall prevail and be controlling.
5.5.2 The Parties shall commence the arbitration by jointly
filing a written submission with the Denver, Colorado office of the
AAA in accordance with Commercial Rule 5 (or any successor
provision).
5.5.3 No depositions or other discovery shall be conducted in
connection with the arbitration.
5.5.4 Not later than **** after the conclusion of the
arbitration hearing, the Arbitrator shall prepare and distribute to
the parties a writing setting forth the arbitral award and the
Arbitrator's reasons therefor. Any award rendered by the Arbitrator
shall be final, conclusive and binding upon the parties, and judgment
thereon may be entered and enforced in any court of competent
jurisdiction, provided that the Arbitrator shall have no power or
authority to grant injunctive relief, specific performance or other
equitable relief.
5.5.5 The Arbitrator shall have no power or authority, under
the Commercial Rules or otherwise, to (x) modify or disregard any
provision of this Agreement, or (y) address or resolve any issue not
submitted by the Parties.
5.5.6 In connection with any arbitration proceeding pursuant
to this Agreement, each Party shall bear its own costs and expenses,
except that the fees and costs of the AAA and the Arbitrator, the
costs and expenses of obtaining the facility where the arbitration
hearing is held, and such other costs and expenses as the Arbitrator
may determine to be directly related to the conduct of the arbitration and
appropriately borne jointly by the Parties (which shall not include any
Party's attorneys' fees or costs, witness fees (if any), costs of
investigation and similar expenses) shall be shared equally by the
Parties.
6. TERM AND TERMINATION
6.1 The term of this Agreement shall be perpetual beginning on the
Effective Date, provided, however, the Parties acknowledge and agree that the
exclusivity of the licenses set forth in Sections 3.1.1 and 3.1.2 shall apply as
to the Patent Rights only for the life of each applicable Patent Right.
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
9
6.2 In the event that AlloSource fails to make the Initial Royalty Payment
or the Deferred Royalty Payment when due and payable, IsoTis may terminate this
Agreement immediately and automatically in the case of the Initial Royalty
Payment and by **** written notice to AlloSource in the case of the Deferred
Royalty Payment. Such notice shall become effective at the end of such period
unless during such period AlloSource cures such defect or default and in such
case IsoTis shall not have the right to terminate this Agreement. In the event
this Agreement is terminated due to a failure to pay the Initial Royalty
Payment, the Deferred Royalty Payment shall not be due and payable.
6.3 The following Articles and Sections of this Agreement shall survive
its expiration: Articles 2, 7, 8 and 10 and Sections 3.2, 3.4, 5.3, 5.4, 6.3 and
9.3.
7. OWNERSHIP AND PATENT RIGHTS
7.1 Subject to the rights granted under this Agreement, IsoTis owns and
shall own all right, title, and interest in, to, and under the Licensed
Intellectual Property and IsoTis Improvements. AlloSource shall own all right,
title, and interest in any AlloSource Improvements. IsoTis acknowledges and
agrees that (i) AlloSource shall have no obligation to disclose any AlloSource
Improvement to IsoTis and (ii) IsoTis shall not bring any claim against
AlloSource or its Affiliates, Wholly Owned Subsidiaries or AlloSource Partners
on the basis that an AlloSource Improvement infringes on the Licensed
Intellectual Property except to the extent that this Agreement is terminated
pursuant to Section 6.2 hereof and then IsoTis shall be permitted to bring such
a claim for infringement following such termination. The Joint Improvements
shall be owned jointly by IsoTis and AlloSource.
7.2 IsoTis shall have sole discretion, and the responsibility and
obligation, to prepare, file, prosecute, and maintain patent applications or
patents within the Licensed Intellectual Property and IsoTis Improvements, and
shall be responsible for related interference proceedings. AlloSource shall have
sole discretion, and the responsibility and obligation, to prepare, file,
prosecute, and maintain patent applications or patents within any AlloSource
Improvements, and shall be responsible for related interference proceedings.
Neither Party shall make any oral, written, or electronic disclosure of the
inventions claimed in any pending patent applications or patents. IsoTis shall
bear all costs incurred pursuant to this Section 7.2 for patent applications and
patents within the Licensed Intellectual Property and IsoTis Improvements, and
AlloSource shall bear all costs incurred pursuant to this Section 7.2 for patent
applications and patents within any AlloSource Improvements. The Parties shall
share equally the costs incurred for patent applications and patents for Joint
Improvements. In the event that IsoTis decides not to prepare, file, prosecute,
and maintain patent applications or patents within the Licensed Intellectual
Property, IsoTis shall notify AlloSource at least **** prior to any deadline for
payment or other action, and AlloSource shall have the right, but not the
obligation, in its sole discretion and at its expense to undertake to prepare,
file, prosecute, and maintain such patent applications or patents within the
Licensed Intellectual Property. IsoTis agrees to cooperate with AlloSource as
necessary in the preparation, filing and prosecution of any such patents or
patent applications at AlloSource's expense.
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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7.3 If either Party believes in good faith that any of the Patent Rights
is infringed by a Third Party, the Party first having knowledge of such
infringement shall promptly notify the other Party in writing thereof, which
notice shall set forth the facts of such infringement in reasonable detail.
IsoTis shall have the responsibility to prosecute suits by reason of
infringement of the Licensed Intellectual Property. AlloSource agrees to
cooperate with IsoTis in the prosecution of any such suit at the expense of
IsoTis. IsoTis shall have the right, in its sole discretion, to make all
decisions regarding prosecution or settlement of any such suit.
7.4 In the event that IsoTis does not bring a suit for infringement within
a reasonable time after it learns of infringement of the Licensed Intellectual
Property, AlloSource shall have the right, but not the obligation, in its sole
discretion and at its expense, to prosecute suits by reason of infringement of
the Licensed Intellectual Property. If necessary, AlloSource shall have the
right to join IsoTis in any such suit as a party and to seek damages for past
infringement. IsoTis agrees to cooperate with AlloSource in the prosecution of
any such suit and AlloSource shall pay reasonable expenses incurred by IsoTis as
a result of such cooperation. AlloSource shall have the right, in its sole
discretion, to make all decisions regarding prosecution or settlement of any
such suit.
7.5 In the event that damages are actually recovered as a result of a suit
brought by AlloSource for infringement of the Licensed Intellectual Property as
provided in paragraph 7.4, all amounts recovered shall belong to AlloSource.
7.6 If the manufacture, distribution, or offer for distribution of
Licensed Products pursuant to this Agreement results in a claim, action, suit,
or proceeding alleging that such activity infringes or misappropriates the
patent rights or other intellectual property rights of a Third Party ("THIRD
PARTY CLAIM"), the Party first having notice shall promptly notify the other
Party in writing. The notice shall set forth the facts of the Third Party Claim
in reasonable detail. The Parties shall promptly meet and confer in good faith
regarding the defense against such Third Party Claim. In the event that any
Third Party Claim is defended by only one of the Parties, the nondefending Party
shall cooperate with the defending Party, at such defending Party's request and
expense, and shall have the right to be represented by counsel of its own
choice, at such nondefending Party's expense. Any settlement that could
reasonably affect adversely the nondefending Party shall require the
nondefending Party's prior consent, not to be unreasonably withheld or delayed.
7.7 Indemnification by IsoTis. IsoTis shall defend, indemnify and hold
AlloSource harmless from and against all liability, demands, damages, expenses
and losses (including reasonable attorneys' fees) arising out of (i) any Third
Party Claim of infringement or misappropriation related to the Licensed Product,
except to the extent such claim of infringement or misappropriation arises from
an AlloSource Improvement that AlloSource has reduced to practice (ii) any
material breach by IsoTis or its Affiliates of any of its representations or
warranties under this Agreement or (iii) any material violation of laws or
regulations by IsoTis or its Affiliates. AlloSource shall promptly inform IsoTis
in writing of any claim within the scope of this Section 7.7. IsoTis shall be
given control of the defense of such claim and all negotiations
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
11
relating to any settlement, provided that AlloSource may, at its own expense,
retain separate counsel and participate in its defense. AlloSource shall
reasonably assist IsoTis in all necessary respects in conduct of the defense.
7.8 Indemnification by AlloSource. AlloSource shall defend, indemnify and
hold IsoTis harmless from and against all liability, demands, damages, expenses
and losses (including reasonable attorneys' fees) arising out of (i) any Third
Party Claim of infringement or misappropriation related to the AlloSource
Improvements that AlloSource has reduced to practice; (ii) any material breach
by AlloSource or its Affiliates of any of its representations or warranties
under this Agreement or; (iii) any material violation of laws or regulations by
AlloSource or its Affiliates;. IsoTis shall promptly inform AlloSource in
writing of any claim within the scope of this Section 7.8. AlloSource shall be
given control of the defense of such claim and all negotiations relating to any
settlement, provided that IsoTis may, at its own expense, retain separate
counsel and participate in its defense. IsoTis shall reasonably assist
AlloSource in all necessary respects in conduct of the defense.
8. CONFIDENTIALITY
8.1 The Parties have provided to each other prior to the Effective Date,
and in connection with this Agreement may in the future provide to each other,
Confidential Information.
8.2 The receiving Party shall maintain the Confidential Information of the
disclosing Party in confidence, shall not disclose such Confidential Information
to any Third Party, and shall not use such Confidential Information for any
purpose except as expressly permitted under the terms and conditions of this
Agreement. Notwithstanding the previous sentence, the receiving Party may
disclose the Confidential Information of the disclosing Party to its employees,
agents, consultants, and professional, scientific, medical, and legal advisors
who have a reasonable need to know such Confidential Information to carry out
such Party's obligations or to exercise such Party's rights under this
Agreement; provided that any such person to whom disclosure is made is bound by
written obligations of non-disclosure and non- use no less restrictive then
those set forth herein. The receiving Party shall take the same degree of care
that such Party uses to protect its own confidential and proprietary information
of a similar nature and importance, but in no event shall such care be less than
reasonable care.
8.3 The obligations of non-disclosure and non-use under Section 8.2 will
not apply as to particular Confidential Information of a disclosing Party to the
extent that such Confidential Information: (i) is at the time of receipt, or
thereafter becomes, through no fault of the receiving Party, published or
publicly known or available; (ii) is known by the receiving Party or its
Affiliates at the time of receiving such information, as evidenced by prior
written records; (iii) is hereafter furnished to the receiving Party or its
Affiliates by a Third Party without breach of a duty to the disclosing Party; or
(iv) is independently discovered or developed by the receiving Party or its
Affiliates without use of, application of, access to, or reference to
Confidential Information of the disclosing Party, as evidenced by prior written
records.
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
12
8.4 Disclosure of Confidential Information shall not be precluded if such
disclosure (i) is in response to a valid order of a court or other Government
Authority of competent jurisdiction or (ii) is required by applicable law;
provided, however, that the receiving Party shall first have given reasonable
prior written notice to the disclosing Party pursuant to Section 10.8, and shall
have made a reasonable effort to obtain a protective order, or to cooperate with
the disclosing Party's efforts, as applicable, to obtain a protective order
limiting the extent of such disclosure and requiring that the Confidential
Information so disclosed be used only for the purposes for which such order was
issued or as required by such applicable law.
8.5 The receiving Party agrees that its obligations under this Article 8
are necessary and reasonable to protect the disclosing Party's business
interests and that the unauthorized disclosure or use of Confidential
Information of a disclosing Party will cause irreparable harm and significant
injury, the degree of which may be difficult to ascertain. The receiving Party
further acknowledges and agrees that in the event of any actual or threatened
breach of this Article 8, the disclosing Party may have no adequate remedy at
law and, accordingly, that the disclosing Party will have the right to seek an
immediate injunction enjoining any breach or threatened breach of this Article
8, as well as the right to pursue any and all other rights and remedies
available at law or in equity for such breach or threatened breach.
8.6 The terms and conditions of this Agreement shall be Confidential
Information of the Parties, and subject to the terms of this Article 8.
Notwithstanding the foregoing, each Party may issue press releases during the
Term upon prior written consent of the other Party not to be withheld
unreasonably.
8.7 All obligations of nondisclosure and non-use imposed pursuant to the
terms and conditions of this Article 8 shall survive termination of this
Agreement and continue in full force and effect for a period of **** after the
effective date of such termination.
9. REPRESENTATIONS AND WARRANTIES AND INDEMNITY
9.1 IsoTis represents and warrants that, as of the date hereof:
9.1.1 IsoTis is a corporation, duly organized, validly
existing, and in good standing under the laws of the jurisdiction of
its incorporation;
9.1.2 IsoTis is the owner of or otherwise controls the
Licensed Intellectual Property;
9.1.3 IsoTis has the right and authority to grant the rights
and licenses granted pursuant to the terms and conditions set forth
herein;
9.1.4 The execution, delivery, and performance of this
Agreement have been duly authorized by all necessary corporate action on
the part of IsoTis;
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
13
9.1.5 The Licensed Intellectual Property and Licensed Products
(before any AlloSource Improvement that AlloSource has reduced to
practice) will comply in all respects with the terms of the OsteoTech
Settlement Agreement set forth in Schedule 9.1.5, which constitutes all of
the agreements by and between IsoTis and OsteoTech on the subject matter
hereof, and the performance of this Agreement by IsoTis and AlloSource
will not violate and is in compliance in all respects with the OsteoTech
Settlement Agreement;
9.1.6 The execution, delivery and performance of this
Agreement by IsoTis does not and will not (a) violate, conflict with
or result in the breach of any provision of its Certificate of
Incorporation or Bylaws, (b) conflict with or violate any law or order
applicable to IsoTis or (c) conflict with, result in any breach of,
constitute a default (or event which with the giving of notice or lapse of
time, or both, would become a default) under, require any consent under,
or give to others any rights of termination, amendment, acceleration,
suspension, revocation or cancellation of any note, bond, mortgage or
indenture, contract, agreement, license, permit, franchise or other
instrument or arrangement to which IsoTis is a party.
9.1.7 To the knowledge of IsoTis, use of the Licensed
Intellectual Property to make, have made, use, sell or offer to sell
or import the Licensed Product (but not the use of the Licensed
Intellectual Property by AlloSource to develop and/or incorporate an
AlloSource Improvement into the License Product) does not infringe
any rights of any Third Party.
9.2 AlloSource represents warrants and covenants that, as of the date
hereof:
9.2.1 AlloSource is a corporation, duly organized, validly
existing, and in good standing under the laws of jurisdiction of its
incorporation;
9.2.2 AlloSource has the right and authority to grant the
rights and license granted pursuant to the terms and conditions set forth
herein; and
9.2.3 The execution, delivery, and performance of this
Agreement have been duly authorized by all necessary corporate action on
the part of AlloSource.
9.3 EXCEPT AS EXPRESSLY PROVIDED FOR IN THIS AGREEMENT, ISOTIS AND
ALLOSOURCE EACH MAKES NO, AND HEREBY DISCLAIMS ANY AND ALL, REPRESENTATIONS AND
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION,
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND
NONINFRINGEMENT OF ANY THIRD PARTY'S PROPRIETARY RIGHTS.
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
14
10. GENERAL
10.1 The rights granted to AlloSource in this Agreement to use Licensed
Intellectual Property are rights to use "intellectual property" as defined in 11
U.S.C. Section 365(n), and AlloSource shall have all of the rights of a licensee
thereunder with regard to its rights to use the Licensed Intellectual Property.
10.2 Neither Party may waive or release any of its rights or interests in
this Agreement except in writing. Failure to assert any right arising from this
Agreement shall not be deemed or construed to be a waiver of such right. No
amendment or modification relating in any manner to this Agreement shall be
effective unless executed in writing and signed by the Parties.
10.3 This Agreement, that certain Amended and Restated Processing and
Supply Agreement dated July 1, 2006, and that certain Amended and Restated
Tissue Procurement and Processing Agreement dated July 1, 2006 constitute the
entire agreement between the Parties relating to the subject matter hereof, and
all prior and contemporaneous negotiations, representations, agreements and
understandings are merged into, extinguished by, and completely expressed by
them.
10.4 This Agreement and its effects are subject to and shall be construed
and enforced in accordance with the laws of California without giving effect to
any choice or conflicts of laws principle that would result in the application
of the laws of any State other than California. The sole and exclusive venue for
any action brought under this Agreement shall be in a federal or state court
located in the Central District of California, and the Parties agree that such
courts shall have jurisdiction. Unless laws or rules strictly require different
service of process, service of process may be made by certified mail return
receipt requested sent to the address shown in Section 10.7.
10.5 The relationship of IsoTis and AlloSource established by this
Agreement is that of independent contractors. Nothing in this Agreement shall be
constructed to create any other relationship between IsoTis and AlloSource.
Neither Party shall have any right, power or authority to bind the other Party
or assume, create or incur any expense, liability or obligation, express or
implied, on behalf of the other Party.
10.6 If any provision of this Agreement is deemed invalid or unenforceable
by a court of competent jurisdiction, such invalidity or enforceability shall
not affect or limit the validity or enforceability of any other provision
hereof.
10.7 Except as otherwise required under applicable law, neither Party will
use the name of the other Party in its advertising, press releases or
promotional materials without the prior written consent of such other Party.
10.8 All notices required or permitted to be given by the terms of this
Agreement shall be given by (i) prepaid registered or certified mail properly
addressed to the other Party at the
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
15
address designated below or to such other address as may be designated in
writing by such other Party or (ii) facsimile followed by a copy delivered in
accordance with Section 10.7(i), and shall be effective **** after of the date
of the postmark of such mail notice if delivered in accordance with Section
10.7(i) or on the day of mailing if sent by facsimile.
IsoTis:
IsoTis OrthoBiologics, Inc.
0 Xxxxxxxx Xxxxx
Xxxxxx, XX 00000
Facsimile: 949 595 8711
Attention: Chief Executive Officer
cc: General Counsel
AlloSource:
AlloSource, Inc.
0000 X. Xxxx Xxxxxx
Xxxxxxxxx, XX 00000
Facsimile: 000 000 0000
Attention: Xxxxxx X. Xxxxxxx
10.9 This Agreement shall not be assigned except (i) with the advance
written consent of the Parties, which consent shall not be unreasonably
withheld, provided that such consent shall not be necessary (i) in the context
of an acquisition of IsoTis or AlloSource, by asset sale, merger, change of
control, operation of law or otherwise or (ii) to an Affiliate of AlloSource.
10.10 All headings and captions are inserted for convenience of reference
only and shall not affect the meaning or interpretation of any provision hereof.
10.11 This Agreement may be executed in any number of counterparts, each
of which once so executed and delivered shall be deemed an original, but all of
which shall constitute but one and the same Agreement.
10.12 IsoTis shall file with the FDA the appropriate notification and
authorization letter to the Device Listing Group within **** of the Effective
Date. The letter shall advise the FDA that AlloSource and in certain events
AlloSource's Wholly Owned Subsidiary(ies) is authorized to manufacture,
distribute, list and market the Products on AlloSource's and in certain events
AlloSource's Wholly Owned Subsidiary(ies) own behalf and for its AlloSource
Partners and to perform all manufacturing steps at AlloSource's own facilities
and in certain events facilities of AlloSource's Wholly Owned Subsidiary(ies).
The letter shall inform the FDA that IsoTis has authorized AlloSource and in
certain events AlloSource's Wholly Owned Subsidiary(ies) to
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
16
register as a device establishment for the manufacture of the License Products,
as provided in 21 C.F.R. Section 807.25 and to list the Licensed Products as
provided in 21 C.F.R. Section 807.20, and that IsoTis is the specification
developer of the Licensed Products and AlloSource and in certain events
AlloSource's Wholly Owned Subsidiary(ies) will manufacture the Licensed Products
for commercial distribution for itself and its AlloSource Partners. IsoTis
specifically authorizes AlloSource to register as an establishment and list the
Licensed Products. IsoTis shall provide AlloSource with a copy of the letter
that IsoTis submits pursuant to this Section. AlloSource shall have the right to
submit and is solely responsible for a 510(k) for the Licensed Product and any
AlloSource Improvements and IsoTis shall assist AlloSource with all reasonable
requests related to and shall make all information available as necessary for
the preparation, submission and finalization of such 510(k). IsoTis shall
prepare, file, or assist in filing all documents necessary to the extent
required to effectuate this Agreement under the terms and conditions as set
forth herein or as required by the FDA (but not preparing or filing AlloSource's
510(k)).
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed
by their respective officers thereunto duly authorized as of the Effective Date.
IsoTis OrthoBiologics, Inc. AlloSource
("ISOTIS") ("ALLOSOURCE")
By /s/ Xxxxxx Xxxxxxx By /s/ Xxxxxx X. Xxxxxxx
------------------------------ -------------------------------
Name Xxxxxx Xxxxxxx Name Xxxxxx X. Xxxxxxx
Title CEO Title President & CEO
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
17
Schedule 2.9
DynaGraph(R) II Specifications
FINISHED PRODUCT SPECIFICATION
GEL AND PUTTY:
ALLOFUSE DBM
DYNAGRAFT II
NEXUS
PROSPACE
ALPHAGRAFT
DYNAGRAFT D
1.0 PURPOSE
The purpose of this document is to detail the minimum manufacturing
requirements and acceptance criteria for the finished products referenced
above manufactured by IsoTis OrthoBiologics. This specification is
intended for use following final packaging, but prior to release of
product into finished goods (i.e., distribution).
2.0 RELATED DOCUMENTATION
All documents current revision unless otherwise specified.
2.1 ****
2.2 ****
2.3 ****
2.4 ****
2.5 ****
2.6 ****
2.7 ****
3.0 PRODUCT SAMPLING
3.1 Visual Inspection
****, ****. ****, **** (****,****).
Visual inspection shall be performed in accordance with section 4.0.
3.2 **** (****)
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
18
****, ****, ****.
4.0 VISUAL CLASSIFICATION OF DEFECTS
Visual inspection shall be performed at a distance of **** in a
well-lighted area with the unaided eye. ****. ****.
4.1 **** (****)
4.1.1 ****
4.1.2 ****
4.1.3 ****
4.1.4 ****
4.1.5 ****
4.1.6 ****
4.2 **** (****)
4.2.1 ****
4.2.2 ****
4.2.3 ****
4.3 **** (****)
4.3.1 ****
4.3.2 ****
4.3.3 ****
4.4 **** (****)
4.4.1 ****
4.4.2 ****
4.4.3 ****
4.4.4 ****
****
5.0 BIOLOGICAL TESTING
5.1 ****
****. ****.
5.2 **** (****)
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
19
****, ****, **** , **** (****). ****.
Note: ****, ****.
SPECIFICATION: ****
****, ****. ****. ****.
6.0 SHELF LIFE
**** (****).
7.0 PRODUCT ARCHIVE SAMPLES
****, ****, ****, ****, ****, ****. ****. ****.
8.0 LOT DISPOSITION
****. ****, ****. ****. ****, ****, ****.
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
20
SCHEDULE 2.15
DESCRIPTION OF LICENSED KNOW-HOW
LICENSED KNOW-HOW INCLUDES BUT IS NOT LIMITED TO THE FOLLOWING:
I. Regulatory Documentation
****, ****, ****
****, ****, ****
****
****
****
****
II. Standard Operating Procedures
**** ****
**** ****
**** ****
**** ****
**** ****
III. Work Instructions
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
IV. Finished Product Specifications
**** ****
**** ****
V. In Process Specifications
**** ****
**** ****
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
21
**** ****
**** ****
VI. IsoTis Production Records
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
VII. Test Methods
**** ****
**** ****
**** ****
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
22
VIII. Process Flow Charts
**** ****
**** ****
**** ****
IX. Drawings
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
23
SCHEDULE 2.16
DESCRIPTION OF LICENSED INTELLECTUAL PROPERTY
Licensed Intellectual Property includes but is not limited to (1) the
formulations and/or compositions of DynaGraft(R) II and OrthoBlast(R) II as of
the Effective Date of the Agreement, and (2) the processes of making or
manufacturing the formulations and/or compositions of DynaGraft(R) II and
OrthoBlast(R) II as of the Effective Date of the Agreement; (3) the Licensed
Know-How set forth in Schedule 2.14 and the Patent Rights set forth in Schedule
2.20. The Licensed Intellectual Property does not include **** Intellectual
Property.
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
24
SCHEDULE 2.19
ALLOFUSE PROCESSING FEES*
Unit Pricing Per Unit
---- ----------------
**** $**** each
**** $**** each
**** $**** each
**** $**** each
**** $**** each
**** $**** each
**** $**** each
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
25
SCHEDULE 2.19A
EXAMPLE OF 2007 SALES COMPUTATION USING 2006 DATA
Units (CY 2006) Sales (CY 2006)
---------------------- ---------------------------------------
$/unit AlloSource Xxxxxx AlloSource Xxxxxx Total
------ ---------- ------ ---------- ------ -----
**** $**** **** **** $**** $**** $****
**** $**** **** $**** $**** $****
**** $**** **** **** $**** $**** $****
**** $**** **** **** $**** $**** $****
**** $**** **** **** $**** $**** $****
**** $**** **** **** $**** $**** $****
**** $**** **** **** $**** $**** $****
---- ---- ----- ----- -----
Total **** **** $**** $**** $****
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
26
SCHEDULE 2.20
OrthoBlast(R) II
Specifications
FINISHED PRODUCT SPECIFICATION
PASTE AND PUTTY:
ORTHOBLAST II
NEXUS IC
DYNABLAST
1.0 PURPOSE
The purpose of this document is to detail the minimum manufacturing
requirements and acceptance criteria for the finished products referenced
above manufactured by IsoTis OrthoBiologics. This specification is
intended for use following final packaging, but prior to release of
product into finished goods (i.e., distribution).
2.0 RELATED DOCUMENTATION
All documents current revision unless otherwise specified.
2.1 ****
2.2 ****
2.3 ****
2.4 ****
2.5 ****
2.6 ****
2.7 ****
2.8 ****
2.9 ****
3.0 PRODUCT SAMPLING
3.1 Visual Inspection
****, ****. ****, **** (****,****).
Visual inspection shall be performed in accordance with
section 4.0.
3.2 **** (****)
****, ****, ****.
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
27
4.0 VISUAL CLASSIFICATION OF DEFECTS
Visual inspection shall be performed at a distance of **** in a
well-lighted area with the unaided eye. ****. ****.
4.1 **** (****.)
4.1.1 ****
4.1.2 ****
4.1.3 ****
4.1.4 ****
4.1.5 ****
4.1.6 ****
4.2 **** (****)
4.2.1 ****
4.2.2 ****
4.2.3 ****
4.3 **** (****)
4.3.1 ****
4.3.2 ****
4.3.3 ****
4.4 **** (****)
4.4.1 ****
4.4.2 ****
4.4.3 ****
4.4.4 ****
****
5.0 BIOLOGICAL TESTING
5.1 ****
****, ****. ****.
5.2 **** (****)
****, ****, ****, ****. ****.
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
28
Note: ****, ****.
SPECIFICATION: ****
****, ****. ****. ****.
6.0 SHELF LIFE
**** (****).
7.0 PRODUCT ARCHIVE SAMPLES
****, ****, ****, ****, ****, ****. ****. ****.
8.0 LOT DISPOSITION
****. ****, ****. ****. ****, ****, ****.
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
29
SCHEDULE 2.21
PATENT RIGHTS
1. REVERSE PHASE CONNECTIVE TISSUE REPAIR COMPOSITION
- ****
- ****
- ****
- ****
2. END-CAPPED POLYMERS AND COMPOSITIONS CONTAINING SUCH COMPOUNDS
- ****
- ****
- ****
- ****
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
30
SCHEDULE 5.2.2
DEFERRED ROYALTY PAYMENT COMPUTATION
I. EXAMPLE 1 - IF 2007 SALES = ****
II. DEFERRED ROYALTY PAYMENT EQUALS LESSER OF
A. 2,500,000 OR
B. ****
1. ****
III. DEFERRED ROYALTY PAYMENT EQUALS ****
I. EXAMPLE 2 - IF 2007 SALES = ****
A. DEFERRED ROYALTY PAYMENT EQUALS LESSER OF
B. 2,500,000 OR
C. ****
1. ****
II. DEFERRED ROYALTY PAYMENT EQUALS ****
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
31
SCHEDULE 9.1.5
OSTEOTECH SETTLEMENT AGREEMENT
****Certain confidential information contained in this document, marked with
four asterisks, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
32
