LICENSE AND TECHNICAL ASSISTANCE AGREEMENT
EXHIBIT 10.1
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR THE REDACTED PORTIONS OF THIS EXHIBIT, AND SUCH
CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
This License and Technical Assistance Agreement (“Agreement”), effective as of the 10th day of
September, 2010, is by and between ABT Holding, Inc., a Delaware corporation and subsidiary of
Athersys, Inc. having its principal place of business at 0000 Xxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxx
00000-0000 (“Athersys”), and RTI Biologics, Inc., a Delaware corporation having its principal place
of business at 00000 Xxxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxx 00000 (“RTI”). As used herein, RTI and
Athersys may be referred to collectively as “the Parties” or individually as a “Party
WHEREAS, RTI is a processor of orthopedic and other biologic matrix surgical implants, and has
experience in, and certain proprietary technology related to, the generation and characterization
of efficacious and safe in-vivo applications of biomaterials for the repair and natural healing of
human bone and other human tissues (“RTI Capabilities”);
WHEREAS, Athersys possesses expertise, know-how, trade secrets, and other valuable
intellectual property related to, among other things, the isolation, culture, expansion and use of
Multipotent Adult Progenitor Cells (“Athersys Capabilities”);
WHEREAS, RTI and Athersys anticipate that this Agreement will enable them to jointly develop a
commercially viable product combining RTI Technology with Athersys Technology, as defined herein
below, and utilizing RTI Capabilities and Athersys Capabilities as further described in this
Agreement;
WHEREAS, it is the intent of RTI and Athersys that the work performed as a result of this
Agreement, and any intellectual property derived therefrom, shall be afforded the benefits provided
for by the CREATE Act of 2004, as codified by 35 USC 103(c), if requested by the appropriate Party.
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NOW, THEREFORE, in view of the foregoing premises, and in consideration of the mutual
covenants, terms and conditions hereinafter set forth, the Parties hereto agree as follows:
Definitions
For purposes of this Agreement, capitalized terms used in this Agreement shall have the meaning
ascribed to them in the preamble and Recitals above, in the listing immediately below, or in the
various Articles that follow.
“Affiliate(s)” shall mean, in relation to a Party, any person, corporation or other business entity
presently or in the future controlled by, controlling, or under common control with that Party, but
only for so long as such control shall continue. For purposes hereof, a person, corporation or
other business entity who beneficially owns or controls, directly or indirectly, at least 50% of
the voting, interests, including securities, of another business entity shall be presumed to
“control” such other business entity. As of the Effective Date of this Agreement, the Parties
respective Affiliates include those listed in Exhibit C.
“Athersys Technology” shall mean the MAPC Licensed Patents, the MAPC Technology, the Collaboration
Technology, and Collaboration Patents. Athersys Technology excludes RTI Technology.
“Collaboration” shall mean any research, experimentation and evaluation performed by RTI and/or
Athersys pursuant to Section 3.1 of this Agreement and the Collaboration Plan attached hereto as
Exhibit B, as it may be amended from time to time, or pursuant to the MTA.
“Collaboration Data” shall mean all data produced in the course of undertaking and performing the
Collaboration, including data generated by either RTI and/or Athersys, or any of their respective
employees, agents or contractors in the course of undertaking and performing the Collaboration, but
in each case to only to the extent that such data does not otherwise constitute Collaboration
Technology.
“Collaboration Patent” shall mean any patent application or patent that claims any Collaboration
Invention.
“Collaboration Technology” shall mean, whether tangible or intangible, every technology,
biological, chemical or other material, formula, process, routine, subroutine, technique,
specification, instruction, concept, method, algorithm, know-how, use, device, article of
manufacture, work of authorship, invention, discovery and Athersys’ Confidential Information that
(a) is or was newly discovered, developed, perfected, improved, designed, engineered, devised,
conceived, or first reduced to practice by Athersys and/or RTI or any of their employees, agents or
contractors in the course of undertaking and performing the Collaboration, including all
Collaboration Inventions, regardless of whether any of the foregoing constitutes a
trade secret or copyrightable or patentable subject matter in any foreign or domestic jurisdiction
and (b) is not RTI Technology.
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“Cumulative Net Revenue” (also referred to as “CNR”) shall mean gross revenues (i) received by RTI
and its Affiliates from End Users to whom or to which RTI or RTI Affiliates directly transferred or
sold MAPC Technology Products, or (ii) received by Third Parties from End Users to whom or to which
were transferred or sold MAPC Technology Products, in each case, less the following: (a) amounts
refunded, rebated or credited to End Users after their receipt by RTI, the Affiliate or the Third
Party, as applicable, in the ordinary course of RTI’s, the Affiliate’s or the Third Party’s
business, as applicable; (b) customary charges for taxes, transportation, shipping and shipping
insurance to the extent separately identified on the invoice to the End User; (c) commissions on
transfers or sales actually paid by RTI, the Affiliate or the Third Party, as applicable, to
distribution or sales agents (whether an employee or independent contractor of RTI, the Affiliate
or the Third Party, as applicable) not to exceed (i) [*%] of the gross revenues
(excluding anything that would be permitted to be deducted therefrom under the foregoing clauses
(a) and (b)) of the associated MAPC Technology Products until the cumulative CNR under this
Agreement from the Effective Date reaches [$*] and (ii) [*%] of such gross
revenues thereafter.
“End User” shall mean the health care facility or other health care provider to whom the MAPC
Technology Product is provided for implantation or administration to a patient(s) for treatment in
the Field.
“Field” shall mean the repair and/or (re)generation of osseous tissue for use in general
orthopedic, sports medicine, spine, trauma, reconstructive, and maxillo-facial repair applications.
“MAPC Licensed Patents” shall mean those patents and patent applications that are, as of the
Effective Date or during the Term, (a) either owned by or licensed to Athersys or any of its
Affiliates with the right to license/sublicense to RTI upon the terms hereof, and (b) necessary for
RTI to make, have made, use, sell, offer for sale or import MAPC Technology Products in accordance
with the terms of this Agreement. MAPC Licensed Patents include those patents and applications
listed on Exhibit A, as such exhibit may be updated from time to time by Athersys.
“MAPC Technology” shall mean any trade secrets, technology, biological, chemical or other
materials, formulas, processes, routines, subroutines, techniques, specifications, instructions,
concepts, methods, algorithms, know-how, uses, devices, article of manufactures, inventions, or
discoveries that are (a) not patented or subject to a published patent application, (b) either
owned by or licensed to Athersys or any of its Affiliates with the right to license/sublicense to
RTI upon
the terms hereof as of the Effective Date or during the Term, (c) necessary for RTI to research,
develop, make, have made, use, sell or transfer, offer for sale or transfer, distribute, import, or
export in accordance with the terms of this Agreement or are otherwise disclosed to RTI or its
Affiliate by Athersys or its Affiliate in the course of undertaking and performing the
Collaboration, and (d) relate to the use, extraction, isolation, expansion, maintenance, or culture
of MAPCs.
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“MAPC Technology Product” shall mean any product resulting in whole or in part from the undertaking
and performance of the Collaboration that (a) contains [ * ]. Culture expanded cell
products, including MultiStem® products and related products, are excluded from this definition and
the Collaboration.
“MTA” shall mean that Amended Material Transfer Agreement, effective as of 3 April, 2007, between
Athersys, Inc. (predecessor to Athersys) and Regeneration Technologies, Inc. (predecessor to RTI),
as amended thereafter from time to time, including Amendment No. 1 effective as of 17 July, 2008,
Supplement to Exhibit C of such Amendment No. 1, and Amendment No. 2 effective as of 2 April, 2010.
“Multipotent Adult Progenitor Cell” (also referred to as a “MAPC”) shall mean any multipotent adult
progenitor cell that (a) is extracted and isolated from human bone marrow, (b) has the potential to
develop into cells of the mesenchymal, endothelial and endodermal lineages, (c) has the potential
to be expanded in culture more than twenty doublings, and (d) is described in any of the patents
and patent applications owned by or licensed to Athersys or any of its Affiliates as of the
Effective Date, including those listed on Exhibit A.
“Pre-market Approval” means, in the United States, a Premarket Approval Application (PMA),
Investigational New Drug Application (IND), New Drug Application (NDA) or Biologic License
Application (BLA) under the United States Federal Food, Drug and Cosmetic Act and the regulations
promulgated thereunder, all as amended, and in any jurisdiction outside the United States, a
substantial equivalent to any of the foregoing applicable to such jurisdiction. For further
clarification, the definition of Pre-Market Approval shall not include a 510(k) application in the
United States or its foreign equivalent.
“Regulatory Authority” means, with respect to a jurisdiction, any governmental authority or agency
or department thereof charged with the responsibility of regulating drugs and/or medical devices,
including, in the United States the United States Food and Drug Administration and in any other
jurisdiction, any foreign equivalent(s) thereto.
| * | Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission. |
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“RTI Technology” shall mean the patents, patent applications, technology, biological, chemical
or other materials, formulas, processes, routines, subroutines, techniques, specifications,
instructions, concepts, methods, algorithms, know-how, uses, devices, articles of manufacture,
inventions, discoveries, works of authorship and RTI’s Confidential Information that are, as of the
Effective Date or during the Term, either owned by or licensed to RTI or any of its Affiliates with
the right to license/sublicense to Athersys upon the terms hereof. RTI Technology excludes
Athersys Technology, MAPC Technology and Collaboration Technology, but includes all RTI Technology
Inventions and all patent rights claiming RTI Technology Inventions.
“Territory” shall mean worldwide.
“Third Party” shall mean any person or entity other than a Party to this Agreement and its
respective Affiliates.
Article I: Grants of Rights
1.1 Athersys Technology. Subject to the terms and conditions of this Agreement, Athersys,
on behalf of itself and its Affiliates, hereby grants to RTI an Exclusive license or sublicense (as
the case may be) to the Athersys Technology solely to research, develop, make, have made, use, sell
or transfer, offer for sale or transfer, distribute, import, and export MAPC Technology Products in
the Field in the Territory. This license includes the right to sublicense solely to Affiliates of
RTI. As used in this Section 1.1, the term “Exclusive” shall mean exclusive of all others,
including Athersys, subject to (a) the rights reserved for Athersys, its Affiliates and their
respective contractors, to develop, make, have made, and use MAPC Technology Products in the Field
in the Territory in connection with the Collaboration and (b) rights granted to Third Parties
before the Effective Date for research purposes, and (c) the right reserved for Athersys and its
Affiliates to grant rights to the Athersys Technology for research purposes.
1.2 Stand-by Licenses. To ensure continuity of the rights granted herein, upon reasonable
request by RTI, RTI and Athersys will work cooperatively to enter into stand-by license agreements
with Third Parties from whom Athersys has been licensed intellectual property rights within the
Athersys Technology.
1.3 No Use of MultiStem Trademark. RTI will not, and will cause its Affiliates and its and
their respective direct and indirect distributors not to, use “MultiStem®” or any other word
confusingly similar thereto as or as part of a trademark or service xxxx in any form, including in
marketing or promotional literature, packaging, labels, presentations, or other tangible materials,
regardless of the media upon which such materials are created, stored, presented or distributed.
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1.4 Limited Use of MAPC and Multipotent Adult Progenitor Cell. To the extent that RTI, any
of its Affiliates or its sublicensees, or any of their respective direct and indirect distributors
desires to use or uses either or both of the terms “MAPC” or “Multipotent Adult Progenitor Cell,”
such uses shall be limited to the following forms: “MAPC-based,” “MAPC Technology Product,” “MAPC
Technology Implant,” “MAPC Technology-based,” Multipotent Adult Progenitor Cell-based,” or other
variations of the terms upon consent of Athersys, such consent not to be unreasonably withheld.
For the sake of clarity, this limitation is intended to reinforce and support the distinctiveness
of the MAPC Technology Product relative to Athersys’s culture expanded cell products, including
MultiStem products and related products, and to limit any confusion in the marketplace and with
clinicians and regulators, among others. As reasonably requested by Athersys from time to time,
RTI shall, at its own expense, submit copies, photographs or representative samples of any
materials used by RTI or its sublicensees to promote MAPC Technology Products.
1.5 Other Opportunities. Athersys, on behalf of itself and its Affiliates, hereby grants
to RTI a right of first negotiation with respect to the use of MAPC Technology and MAPC Licensed
Patents in other product development and marketing opportunities for HCT/Ps not in the Field but
involving cartilage, tendons and ligaments applications (“Other Opportunities”). Should the
Parties fail to reach an agreement within a prescribed reasonable time frame for negotiation to be
established by the Parties at the beginning of negotiations with respect to the Other
Opportunities, Athersys and its Affiliates may negotiate with Third Parties. In the event the
foregoing negotiations between the Parties are unsuccessful, Athersys will nevertheless agree to
further discussions in good faith related to such Other Opportunities for so long as it is not
prohibited by any contractual or other legal obligation. Furthermore, Athersys agrees to notify
RTI within fifteen (15) business days of the receipt of a written proposal with defined terms from
a Third Party to research, develop, or commercialize a cell-based product constituting Other
Opportunities.
1.6 RTI Technology. Subject to the terms and conditions of this Agreement, RTI, on behalf
of itself and its Affiliates, hereby grants to Athersys and its Affiliates a non- exclusive license
and or sublicense (as the case may be) to the RTI Technology solely to research, develop, make,
have made, and use MAPC Technology Products in connection with the Collaboration. This license
includes the right to sublicense solely to Affiliates of Athersys.
1.7 Reservation of Rights. Except as expressly stated in this Article I, no rights or
licenses are granted under this Agreement by either Party or its Affiliates under any intellectual
property of such Party or its Affiliates to the other Party or its Affiliates, whether by
implication, estoppel or otherwise, and all such rights not expressly stated are hereby reserved by
each Party and its Affiliates.
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Article II: Consideration, Reports and Records
2.1 License Fee. In consideration of the rights and benefits granted to RTI herein, RTI
shall pay to Athersys a one-time license fee of Five Million Dollars ($5,000,000) (hereinafter the
“License Fee”) payable in installments upon the dates indicated below (there being no penalty for
pre-payment in RTI’s sole discretion) or upon satisfaction of the following conditions precedent:
2.1.1 One Million Dollars ($1,000,000) concurrently with the execution of this Agreement;
2.1.2
One Million Dollars ($1,000,000) on or before December 31, 2010;
2.1.3
One Million Dollars ($1,000,000) on or before March 31, 2011;
2.1.4
One Million Dollars ($1,000,000) [ * ];
2.1.5
One Million Dollars ($1,000,000) [ * ].
2.2 Royalties.
2.2.1 Subject to Section 2.2.2, RTI shall pay royalties to Athersys as follows based on CNR,
as CNR is accumulated during the Term:
2.2.1.1 For CNR in the range of [$*], RTI shall pay Athersys [*%] of said CNR.
2.2.1.2 For CNR in the range of [$*], RTI will pay Athersys [*%] of said CNR.
2.2.1.3 For CNR in excess of [$*], RTI will pay Athersys [*%] of said CNR.
2.2.2 In the event of a change in market conditions beyond RTI’s control, such as that arising
from, for example purposes only, a force majeure event or disruptive technology, that results in a
[ * ], then RTI’s royalty rate will be [ * ].
2.2.3 Payments to be made in accordance with Section 2.2 shall be calculated quarterly by RTI
and made to Athersys within sixty (60) days following the end of the given calendar quarter for
which said payments were calculated. The Parties will work in good faith to resolve any questions
or disputes related to the payments.
2.3 Milestone Payments. Upon first achieving specific CNR milestones, as defined herein
below, RTI shall make milestone payments to Athersys as follows:
2.3.1 If CNR greater than [$*] is achieved [ * ], RTI shall pay Athersys
a one-time milestone payment of [$*].
2.3.2 If CNR greater than [$*] is achieved [ * ], RTI shall pay Athersys
a one-time milestone payment of [$*].
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2.3.3 If CNR greater than [$*] is achieved [ * ], RTI shall pay Athersys
a one-time milestone payment of [$*].
2.3.4 If CNR greater than [$*] is achieved [ * ], RTI shall pay Athersys
a one-time milestone payment of [$*].
2.3.5 If CNR greater than [$*] is achieved [ * ], RTI shall pay Athersys
a one-time milestone payment of [$*].
2.3.6 Nothing in this Agreement shall be interpreted so as to create any obligation for RTI to
pay more than a cumulative total of $35,500,000.00 in milestone payments under this Section 2.3.
2.3.7 For the purposes of this Section 2.3, the total amount of CNR shall be measured as [
* ].
2.3.8 Payments to be made in accordance with Section 2.3 shall be made to Athersys within
sixty (60) days following achievement of the milestone.
2.4 [ * ].
2.5 Inter-Company Sales or Transfers. Sales or transfers between or among RTI and its
Affiliates and their respective direct and indirect distributors shall not by subject to, nor used
for calculating, CNR or payments due under Section 2.2 or 2.3 unless RTI, the Affiliate or the
distributor is an End User. Instead, only the first sale or transfer for fee to an End User or
Third Party shall be used to calculate CNR and said payments.
2.6 Payment Instructions. Payments pursuant to this Article II shall be made via bank wire
transfer to:
Bank:
|
PNC | |
| Cleveland, Ohio | ||
| [ * ] | ||
Account Name:
|
Athersys, Inc. | |
Account Number:
|
[ * ] |
| * | Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission. |
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With respect to any payments to be made pursuant to this Agreement, and where said payment would
otherwise become due and owing on a weekend, an RTI recognized holiday, or a holiday recognized by
the United States government, said payment shall become due and owing on the next following
business day.
2.7 Reports. Within thirty (30) business days following the end of each calendar quarter,
RTI will provide Athersys with a written report listing, on a country by country basis, the number
of MAPC Technology Products transferred or sold by RTI and its Affiliates in the quarter, the
gross revenues of transfers or sales of MAPC Technology Products to End Users in the quarter, the
CNR achieved for the quarter, the amount of royalties due for such transfers or sales pursuant to
Section 2.2, any milestones that were achieved in such quarter under Section 2.3, and any offsets
or reductions in royalties being applied pursuant to Section 2.2.2 or 2.4 and the basis therefor.
2.8 Records and Inspection Rights. During the Term and for at least three (3) years
thereafter, RTI shall keep complete and accurate business records with respect to the MAPC
Technology, MAPC Technology Products, all gross revenues derived from sales or transfers to End
Users thereof, the calculation of CNR and all payments due to Athersys hereunder; such records
shall include all documentation required to adequately demonstrate the accuracy of RTI’s
calculations of the amounts due to Athersys hereunder. With no greater frequency than twice per
calendar year, and with at least thirty (30) days advance written notice by Athersys to RTI, RTI
shall allow Athersys or its representatives to inspect such business records to ensure compliance
with this Agreement. Said records will be made available for inspection Monday through Friday
(excluding holidays observed by RTI) during the hours of 9:00 a.m. to 5:00 p.m. Eastern Standard
Time. If such inspection reveals that RTI has underpaid any amount due hereunder for any reporting
period by more than [ * ], then, in addition to prompt payment of the amount due, RTI
shall reimburse Athersys for its actual, reasonable out of pocket costs and expenses for such
inspection.
2.9 Currency. All payments due under this Agreement are stated in, and shall be computed
and paid in, United States Dollars. For the purposes of determining the amount of any CNR received
in any foreign currency, such CNR shall be converted into United States Dollars in a manner
consistent with the selling entity’s normal practices used to prepare its audited financial
statements; provided that such practices use a widely accepted source of published exchange rates.
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2.10 Taxes. If any payments made by RTI pursuant to this Agreement become subject to
withholding taxes under the laws or regulation of any jurisdiction, RTI shall deduct and withhold
the amount of such taxes for the account of Athersys to the extent required by applicable Law or
regulations; such amounts payable to Athersys shall be reduced by the amount of taxes deducted and
withheld; and RTI shall pay the amounts of such taxes to the proper governmental authority in a
timely manner and promptly transmit to Athersys an official tax certificate or other evidence of
such tax obligations together with proof of payment from the relevant governmental authority of all
amounts deducted and withheld sufficient to enable Athersys to claim such payment of taxes. RTI
will provide Athersys with reasonable assistance to enable Athersys to recover such taxes as
permitted by applicable Law or regulations.
2.11 Interest. Any payment received after the date due hereunder shall bear interest at
the [ * ], compounded monthly, from the date due until the full amount including any
interest thereon is paid.
Article III – Collaboration and Technical Assistance
3.1 Collaboration Plan. With technical assistance from Athersys (as described in Section
3.4), RTI shall use commercially reasonable efforts to develop for commercialization in the Field a
MAPC Technology Product utilizing RTI Technology and Athersys Technology. To the extent not
otherwise provided in this Agreement, details of the Collaboration between the Parties shall be as
set forth in the Collaboration Plan attached to this Agreement as Exhibit B.
(“Collaboration Plan”).
3.2 Costs. Except as may be otherwise expressly provided for in this Agreement, including
the Collaboration Plan, both Parties shall bear their own expenses related to the performance of
this Agreement. If after [ * ] Athersys and its Affiliates incur costs greater than
[$*] related to tasks performed under the Collaboration Plan, RTI will reimburse
Athersys for said costs provided (1) Athersys notifies RTI in advance of incurring such excess
costs and RTI approves the expenditures, and (2) such excess costs are not attributable to
negligence on the part of Athersys.
3.3 Technical Assistance. In addition to the responsibilities and obligations of the
Parties as set forth in the Collaboration Plan, Athersys agrees to make its employees reasonably
available to consult with RTI regarding issues related to the extraction, isolation, maintenance
and preparation of cells using the MAPC Technology, including requests from any regulatory agency
with respect to regulatory, scientific, technical and clinical testing issues, and shall permit its
contractors knowledgeable in the extraction, isolation, maintenance and preparation of cells using
the MAPC Technology to consult with RTI in the presence of (but not without any) such
Athersys employees. In addition to the foregoing, representatives of RTI and Athersys may, upon
reasonable notice and at times reasonably acceptable to the other Party (i) visit the facilities
where the Collaboration is being conducted, and (ii) consult informally with personnel of the other
Party performing work on the Collaboration during such visits, by telephone, by facsimile or
electronic transmission, or in any other such manner as the Parties may agree. If so requested by
one Party, the other Party shall cause appropriate individuals working on the Collaboration to be
available for meetings at the location of the facilities where such individuals are employed at
times reasonably convenient to the Party responding to such request.
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3.4 Collaboration Data. Collaboration Data shall be shared and disclosed between the
Parties on a regular basis through the Term of the Collaboration. Collaboration Data that relate
specifically and exclusively to RTI Technology shall be considered the Confidential Information of
RTI owned by RTI, notwithstanding which Party first disclosed such data to the other Party.
Collaboration Data that relate to Athersys Technology, including data regarding cell media, cell
potency, cell differentiation and cell performance characteristics, shall be considered the
Confidential Information of Athersys owned by Athersys, notwithstanding which Party first disclosed
such data to the other Party. Collaboration Data that would be used ordinarily for regulatory,
business development, or commercialization purposes, including the MAPC Technology Product’s
identity, application and performance, or any other Collaboration Data that are not specified as
the Confidential Information of RTI or Confidential Information of Athersys shall be considered the
Confidential Information of both Parties and owned jointly by both Parties (“Jointly Owned
Collaboration Data”), notwithstanding which Party first disclosed such data or information to the
other Party.
3.5 Use of Contractors. RTI shall not use contractors to perform any activities under the
Collaboration Plan related to the use, extraction, isolation, expansion, maintenance, or culture of
MAPCs without the prior written consent of Athersys, which consent shall not be unreasonably
withheld. If RTI seeks to use a contractor for any such activities, it shall provide to Athersys a
copy of the proposed contract between RTI and the contractor before entering into any such
agreement so that Athersys can ensure it contains provisions consistent with the requirements of
this Agreement.
Article IV: Confidentiality
4.1 Athersys Confidential Information. With respect to Athersys, the term “Confidential
Information” refers to the Collaboration Data solely or jointly owned by Athersys pursuant to
Section 3.4, Athersys’ and its Affiliates’ specialized and proprietary trade secrets, formulas,
processes, methods, technology, know-how, customer and vendor information and lists, financial
data, undisclosed and unreleased products, and other items or information related to or that
constitutes the Athersys Technology and any manufacturing, laboratory and clinical testing and
research methodologies or models; in each case that when furnished, shown, or disclosed to RTI or
its Affiliate is designated, whether in writing or orally (followed by a written confirmation and
summary), as “Confidential,” or which is of such nature and character that a reasonable person in
the trade would understand it to be confidential without the necessity of it being so designated.
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4.2 RTI Confidential Information. With respect to RTI, the term “Confidential Information”
refers to the Collaboration Data solely or jointly owned by RTI pursuant to Section 3.4, RTI’s and
its Affiliates’ specialized and proprietary trade secrets, formulas, processes, methods,
technology, know-how, customer and vendor information and lists, financial data, undisclosed and
unreleased tissue lines or products, and other items or information related to its allograft
tissue, xenograft tissue, surgical implants, devices, associated processing and sterilization
technologies for each, instrumentation, and any manufacturing, laboratory and clinical testing and
research methodologies or models; in each case that when furnished, shown, or disclosed to Athersys
is designated, whether in writing or orally (followed by a written confirmation and summary), as
“Confidential,” or which is of such nature and character that a reasonable person in the trade
would understand it to be confidential without the necessity of it being so designated.
4.3 Confidential ad infinitum. The Parties recognize and agree that each Party may possess
certain trade secrets that will likely continue to have commercial and competitive value for an
indeterminate period of time, and perhaps in perpetuity. Therefore, a Party may in its sole
discretion designate as “Confidential ad infinitum” those certain trade secrets it reasonably
believes fit such criteria. Any provision of this Agreement to the contrary not withstanding,
trade secrets must be designated in writing as “Confidential ad infinitum” within one (1) month of
disclosure to the receiving Party, unless a later designation is otherwise consented to by the
receiving Party, such consent not to be unreasonably withheld. Trade secrets that are Confidential
ad infinitum shall at a minimum be given all the same protections as Confidential Information, with
certain added or heightened requirements as further described below. Election not to designate a
trade secret as Confidential ad infinitum, or failure to so designate, shall not be deemed to erode
or abrogate a trade secret’s underlying status as Confidential Information.
4.4 Joint Confidential Information. The Jointly Owned Collaboration Data and content of
the negotiations between the Parties concerning this Agreement shall be the Confidential
Information of both Parties. A Party wishing to disclose any part of this joint Confidential
Information must first obtain written permission from the other Party by contacting the designated
corporate representative for such purpose as set forth in Section 4.7. Such written permission
will not be unreasonably denied or delayed. The foregoing notwithstanding, either Party may
disclose the Jointly Owned Collaboration Data in connection with any of its activities permitted
under Article V or as otherwise specified in this Article IV.
4.5 Survival. The obligations and rights of the Parties under this Article 4 shall survive
any expiration or termination of this Agreement for any reason whatsoever (including, without
limitation, termination by either party for a material breach by the other Party of its obligations
hereunder) for, in the case of Confidential Information, a period of seven (7) years, or, in the
case of trade secrets that are Confidential ad infinitum, for an initial period of ten (10) years
with options to renew the Confidential ad infinitum designation for additional terms of five (5)
years for as long as the disclosing Party reasonably and in good faith believes such continuing
status is competitively advantageous. The disclosing Party must submit thirty (30) days advance
written notice of its intent to renew the Confidential ad infinitum designation. Because of the
unique and proprietary nature of the information that is Confidential and/or Confidential ad
infinitum, it is understood and agreed that either Party’s remedies at law for a breach by the
other Party of its obligations under Article 4 will be inadequate and that the non-breaching Party
shall, in the event of any such breach, be entitled to seek equitable relief (including, without
limitation, injunctive relief and specific performance), in addition to all other remedies provided
under this Agreement or available at law. A Party seeking relief pursuant this Section 4.5 shall
not be required to post a bond as a condition for obtaining and/or exercising such relief.
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4.6 Restrictions on Use and Disclosure. Each Party agrees not to use the Confidential
Information of the other Party, excluding Jointly Owned Collaboration Data, for any purpose except
for the purposes of the Collaboration and as necessary to carry out the terms of any business
relationship between the Parties hereto. Each Party further agrees that it will not disclose the
Confidential Information of the other Party, including the Jointly Owned Collaboration Data, to any
Third Party other than such Party’s employees, agents or contractors who are directly involved in
the business relationship between the Parties hereto, and then only on a need-to-know basis and
under an obligation of confidentiality that restricts further disclosure consistent with the
obligations of non-use and non-disclosure provided herein. Each Party agrees that it will take
reasonable security measures and use reasonable care to preserve and protect the secrecy of the
other Party’s Confidential Information, including the Jointly Owned Collaboration Data.
4.7 Return of Information. Upon request after termination of this Agreement by a Party for
return of the Confidential Information of such Party, excluding Jointly Owned Collaboration Data,
the other Party shall, within fifteen (15) business days of the request, either return or destroy
all written or tangible material containing or reflecting Confidential Information of the
requesting Party (whether prepared by the requesting Party or otherwise), without retaining any
copies, summaries, analyses, or abstracts thereof except that each Party’s independent outside
counsel may retain one copy for attorney’s eyes only. An authorized officer of the recipient shall
confirm in writing recipient’s compliance with this Section 4.7 with twenty (20) business days
after the disclosing Party’s request for the return of Confidential Information.
4.8 Permitted Disclosures. When Confidential Information of the other Party or Jointly
Owned Collaboration Data is required to be disclosed by a Party to comply with (i) applicable
laws and regulations, (ii) the rules of a national securities exchange on which the shares of such
Party are listed, or (iii) the order of a court or administrative law judge or tribunal of
competent jurisdiction, such Party shall (a) provide to the other Party, to the extent reasonably
practicable, prior written notice of such required disclosure and, (b) upon request by the other
Party, provide such Party assistance with taking all reasonable and lawful actions to obtain
confidential treatment for the Confidential Information, and (c) take all reasonable and
practicable steps to minimize the extent of such disclosure. A Party may disclose the Confidential
Information of the other Party and the Jointly Owned Collaboration Data to any actual or bona fide
potential lender, private investor, licensee/sublicensee, acquiror or successor under an obligation
of confidentiality that restricts further disclosure consistent with the obligations of non-use and
non-disclosure provided herein. A Party may disclose the Jointly Owned Collaboration Data to an
regulatory authority as reasonably required in connection with seeking or obtaining any approvals
for any of its products.
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4.9 Exceptions. The obligations of a Party under this Article 4 will not apply to
information which such Party can affirmatively show:
(a) was independently developed or discovered by such Party without use or benefit of
the other Party’s Confidential Information, as demonstrated by written records;
(b) is already available to the public;
(c) becomes available to the public through no fault of such Party; or
(d) was independently developed by an employee or consultant of such Party who had no
previous direct or indirect knowledge or benefit of the disclosures made under this
Agreement.
4.10 Press Releases. Except as may be deemed to be required by applicable laws or
regulations by counsel to a Party, neither Party shall issue any press releases about the
relationship of the Parties under this Agreement other than in a form or with content as mutually
agreed. Each Party may issue the press release attached hereto at Exhibit D upon or
promptly after this Agreement becomes effective.
Article V: Ownership and Use of Inventions
5.1 Inventions and Inventorship. Inventorship of inventions or discoveries that are
conceived during the performance of the Collaboration (“Inventions”), whether or not patentable,
shall be determined in accordance with U.S. patent laws. To facilitate proper
determination of inventorship and ownership of Inventions in accordance with this Article V,
the Parties shall fully and promptly disclose, in confidence, any and all Inventions conceived by
such Party, its Affiliate or its or their respective employees and contractors in writing to the
other Party. A subsequent invention or discovery shall be deemed an “improvement” of an earlier
invention or discovery if the practice of the subsequent invention would infringe upon or
constitute misappropriation of any intellectual property rights in the earlier invention or
discovery (in the absence of a license to such intellectual property rights).
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5.2 RTI Technology Inventions. [ * ].
5.3 Other Inventions. [ * ].
5.4 Patent Prosecution for Inventions. [ * ]. Each Party agrees to cooperate
in timely completion and execution of all documents or other items necessary to further the
domestic and/or international intellectual property protection available to the Inventions.
5.5 Prior Inventions. Nothing contained in this Agreement shall be deemed to grant either
Party, directly or by implication, estoppel, or otherwise, any right, title, interest or license to
any patents, patent applications, copyrights, trademarks, trade dress, trade secrets or other
intellectual property owned or developed by the other Party before the Effective Date.
Article VI: Term
6.1 Term. Unless terminated sooner pursuant to Sections 6.1.1 – 6.1.4, the term of this
Agreement shall be for the longer of (i) five (5) years from the Effective Date of this Agreement,
(ii) two (2) years after the last sale or distribution of a MAPC Technology Product by RTI or any
of its Affiliates, (iii) the active life of any past, present, or future issued patents within the
Athersys Technology, wherein said claims would be infringed by the MAPC Technology Products but for
the licenses granted pursuant to this Agreement, or (iv) the life of trade secrets within the
Athersys Technology applicable to RTI’s manufacture of MAPC Technology Products. The period from
the Effective Date until expiration or termination of this Agreement is the “Term.”
6.1.1 Bankruptcy. Athersys may, in its sole discretion, choose to terminate this
Agreement in the event RTI is subject to a bankruptcy event. RTI may, in its sole discretion,
choose to terminate this Agreement in the event Athersys is subject to a bankruptcy event. For
purposes hereof, a “bankruptcy event” means, with respect to a Party, if the Party shall have
become insolvent or bankrupt, or shall have an assignment for the benefit of its creditors, or
there
shall have been appointed a trustee or receiver of the Party or for all or a substantial part of
its property or any case or proceeding shall have been commenced or other action taken by or
against the Party in bankruptcy or seeking reorganization, liquidation, dissolution, winding up,
arrangement or readjustment of its debts or any other relief under any bankruptcy, insolvency,
reorganization or other similar act or law of any jurisdiction now or hereafter in effect, or there
shall have been issued a warrant of attachment, execution, restraint or similar process against any
substantial part of the property of the Party, and any such event shall have continued for sixty
(60) days undismissed, unbonded and undischarged.
| * | Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission. |
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6.1.2 Abrogation of Rights. In the event any of Athersys’ or, where applicable, its
Affiliates’ rights to the Athersys Technology expire or are otherwise terminated, diminished,
revoked, rescinded, repealed, or invalidated such that there is a material effect on the
development and commercialization of the MAPC Technology Products, RTI may, in its sole discretion,
choose to terminate this Agreement.
6.1.3 Diligence. Athersys may, in its sole discretion, choose to terminate this
Agreement, upon notice to RTI, if (i) RTI and its Affiliates have not made their first commercial
sale or distribution of a MAPC Technology Product after the passage of [ * ] from the
Effective Date and no longer continue to make commercially reasonable efforts to develop a MAPC
Technology Product, (ii) RTI and its Affiliates have not had more than [$*] of CNR after
the passage of [ * ] from the Effective Date, or (iii) after the passage of [
* ] from the Effective Date, RTI and its Affiliates have not had more than
[$*] of CNR during any calendar year.
6.1.4 Breach. If either Party materially breaches any of its respective obligations
under this Agreement, and such breach is not cured within sixty (60) days after the giving of
written notice by the other Party specifying such breach, then such other Party shall have the
right to terminate this Agreement by providing the breaching Party written notice within ten (10)
days following the expiration of such sixty (60)-day period (such termination to be effective upon
receipt of such termination notice). For the purpose of this Section, a material breach shall
include a material inaccuracy in any warranty or representation contained herein.
6.2 Survival of Obligations. The termination or expiration of this Agreement shall not
relieve the Parties of any obligations accruing prior to such expiration or termination, and any
such expiration or termination shall be without prejudice to the rights of any Party against
another Party. Upon termination of this Agreement for any reason other than by RTI pursuant to
Section 6.1.4, any unpaid portion of the License Fee due under Sections 2.1.1, 2.1.2, and 2.1.3
shall become due and payable within thirty (30) days after termination, whether or not the time or
other condition for any portion of such payment has been satisfied. In addition, the following
provisions shall survive any expiration or termination of this Agreement for any reason:
“Definitions” section; section 1.7; sections 2.5 — 2.11 (with respect to any payments accrued
prior to or upon termination); section 3.4; article IV (for the period specified in section 4.5);
article V; this section 6.2; article VII; and sections 8.2, 8.3, 8.5- 8.11.
| * | Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission. |
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Article VII: Insurance and Indemnification
7.1 Insurance. Each Party hereby represents and warrants that it now maintains, and will
continue to maintain, primary commercial general liability insurance, including products liability
coverage, in a minimum amount of [$*] per occurrence and [$*] in the
aggregate. At a minimum, each Party shall maintain the policy(ies) required hereunder for the
entire term of this Agreement and, if any such policy(ies) shall provide coverage on a claims made
basis, the Party holding such policy will be required to maintain a claims made policy(ies)
providing such coverage for an additional period of not less than [ * ] following the
end of the term of this Agreement.
7.2 Indemnification by Athersys. Athersys shall indemnify, defend, and hold RTI and, as
applicable, its Affiliates, and its and their respective employees, officers and directors (“RTI
Indemnitees”) harmless from and against any and all claims, suits, and demands of Third Parties and
any and all associated losses, damages or costs (including attorneys’ fees) arising out of or
incurred in connection with (i) Athersys Indemnitees’ gross negligence or willful misconduct in the
performance of Athersys’ obligations under the Agreement, (ii) a breach by any Athersys Indemnitee
of the covenants, warranties and/or representations made by Athersys in this Agreement or an act or
failure to act by a sublicensee of Athersys that if done or not done by Athersys would constitute a
breach of any of the covenants, warranties and/or representations made by Athersys in this
Agreement, or (iii) the use of Athersys Technology, RTI Technology, Collaboration Technology by any
of the Athersys Indemnitees; provided, however, all of the foregoing is only to the extent that
such claims, suits, or demands (a) do not result from a breach of any of the provisions of the
Agreement by any of the RTI Indemnitees, or (b) do not result from the gross negligence or willful
misconduct of any of the RTI Indemnitees.
7.3 Indemnification by RTI. RTI shall indemnify, defend, and hold Athersys and, as
applicable, its Affiliates, and its and their respective employees, officers and directors
(“Athersys Indemnitees”) harmless from and against any and all claims, suits, and demands of Third
Parties and any and all associated losses, damages or costs (including attorneys’ fees) arising out
of or incurred in connection with (i) RTI Indemnitees’ gross negligence or willful misconduct in
the performance of RTI’s obligations under the Agreement, (ii) a breach by any RTI Indemnitee of
the covenants, warranties and/or representations made by RTI in this Agreement or an act or failure
to act by a sublicensee of RTI that if done or not done by RTI would constitute a breach of any of
the covenants, warranties and/or representations made by RTI in this Agreement, or (iii) the use of
Athersys Technology, RTI Technology, or
Collaboration Technology by any of the RTI Indemnitees and/or the development, manufacture, use,
storage, handling, distribution or sale of a MAPC Technology Product on, by or on behalf of any RTI
Indemnitee or sublicensee; provided, however, all of the foregoing is only to the extent that such
claims, suits, or demands (a) do not result from a breach of any of the provisions of the
Agreement by any of the Athersys Indemnitees, (b) do not result from the gross negligence or
willful misconduct of any of the Athersys Indemnitees, or (c) [ * ].
| * | Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission. |
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7.4 Notice and Cooperation. To receive the benefit of the foregoing indemnities, the Party
seeking indemnification must promptly notify the other Party in writing of a claim, suit or demand,
and provide reasonable cooperation (at the indemnifying Party’s expense) and full authority to
defend or settle that portion of a claim, demand or suit indemnified by the indemnifying Party;
provided, however, the indemnifying Party shall not be entitled to defend or settle any claim,
demand or suit on behalf of the indemnified Party in any manner that admits liability, requires any
action, or involves and restriction from action of the indemnified Party, without first obtaining
written permission from the indemnified Party. Failure of the Party seeking indemnification to
provide prompt notice shall not relieve the indemnifying Party of any of its obligations under this
Article VII, except to the extent the indemnifying Party is prejudiced by such failure. The
indemnifying Party shall have no obligation to indemnify the indemnified Party with respect to any
settlement made without the indemnifying Party’s written consent, or with respect to any portion of
a claim, demand or suit that is not covered by the indemnification provision of Section 7.2 or 7.3,
whichever is applicable. In the event a claim, demand or suit contains both indemnified and
non-indemnified elements, each Party shall be responsible for its own costs and expenses related to
the portion of the claim, demand or suit for which it is responsible. Costs and expenses that are
attributable to both indemnified and non-indemnified elements of a claim (i.e. the costs and
expenses cannot reasonably be disaggregated and assigned to distinct elements), demand or suit
shall be borne equally by the Parties.
Article VIII: Miscellaneous Provisions
8.1 Representations, Covenants and Warranties. In addition to any other covenant,
representation and/or warranty provided for elsewhere in this Agreement, the Parties represent,
covenant and warrant as follows.
8.1.1 Athersys represents, covenants and warrants that: (i) Athersys has the right (both in
law and equity) to grant the licenses, covenants and warranties set forth in this Agreement; (ii)
neither Athersys nor its Affiliates have any outstanding encumbrances or agreements, including any
agreements with any Third Parties, which would be inconsistent with the licenses, covenants and
warranties set forth in this Agreement; (iii) as of the Effective Date, neither Athersys nor its
Affiliates are aware of any pending or threatened claims of infringement related to the
Athersys Technology; (iv) as of the Effective Date, to Athersys’ knowledge, no issued or granted
patent rights licensed to RTI pursuant to this Agreement are presently invalid or unenforceable;
(v) Athersys and its Affiliates have
| * | Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission. |
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taken,
and will continue to take, commercially reasonable measures that Athersys deems appropriate under the circumstances to attempt to maintain the
confidentiality and trade secret status of all trade secrets within the Athersys Technology
material to the success of the MAPC Technology Products; (vi) as of the Effective Date, to
Athersys’ knowledge, the research, development, manufacture, use, sale, or distribution of a MAPC
Technology Product as contemplated hereby will not infringe any United States patents owned by a
Third Party and issued or granted as of the Effective Date and, to Athersys’ knowledge, there are
no material facts that are in the possession of Athersys as of the Effective Date, that Athersys
has not disclosed to RTI, and that would lead a reasonable person to conclude that the research,
development, manufacture, use, sale, or distribution of a MAPC Technology Product as contemplated
hereby will infringe any United States patents owned by a Third Party and issued or granted as of
the Effective Date; (vi) no employee or agent of Athersys or any of its Affiliates will make an
untrue statement of a material fact to any governmental authority with respect to the MAPC
Technology Products, Athersys Technology, or RTI Technology; and (vii) Athersys and its Affiliates
will comply materially with all applicable laws, rules, regulations, permits, governmental
licenses, registrations, approvals, concessions, franchises, authorizations, orders, injunctions
and decrees, including the Federal Food, Drug and Cosmetic Act, in the research, development,
manufacture, and use of the MAPC Technology Products, and will promptly inform RTI in writing if
either Athersys or any of its Affiliates receive any written notice from any regulatory authority
claiming that any such activities as conducted by them are not in such compliance.
8.1.2 RTI represents, covenants and warrants that: (i) RTI has the right (both in law and
equity) to grant the licenses, covenants and warranties set forth in this Agreement and to use the
RTI Technology to develop and commercialize any MAPC Technology Product contemplated by this
Agreement; (ii) neither RTI nor its Affiliates have any outstanding encumbrances or agreements,
including any agreements with any Third Parties, which would be inconsistent with the licenses,
representations, covenants and warrants set forth in this Agreement; (iii) as of the Effective
Date, neither RTI nor its Affiliates are aware of any pending or anticipated claims of infringement
related to the RTI Technology or its anticipated use in the development and commercialization of a
MAPC Technology Product; (iv) RTI and its Affiliates have taken, and will continue to take,
commercially reasonable measures that RTI deems appropriate under the circumstances to attempt to
maintain the confidentiality and trade secret status of all trade secrets within the RTI Technology
material to the commercial success of the MAPC Technology Products; (v) as of the Effective Date,
to RTI’s knowledge, the research, development, manufacture, use, sale, or distribution of a MAPC
Technology Product as contemplated by this Agreement will not infringe any United States patents
owned by a Third Party and issued or
granted as of the Effective Date; (vi) no employee or agent of RTI or any of its Affiliates
will make an untrue statement of a material fact to any governmental authority with respect to the
MAPC Technology Products, Athersys Technology, or RTI Technology; and (vii) RTI and its Affiliates
will comply materially with all applicable laws, rules, regulations, permits, governmental
licenses, registrations, approvals, concessions, franchises, authorizations, orders, injunctions
and decrees, including the Federal Food, Drug and Cosmetic Act, in the research, development,
manufacture, use, offer for sale or transfer, sale or transfer, distribution, marketing and other
activities in connection with the MAPC Technology Products and Athersys Technology, and will
promptly inform Athersys in writing if either RTI or any of its Affiliates receive any written
notice from any regulatory authority claiming that any such activities as conducted by them are not
in such compliance.
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8.2 Remedies Cumulative. Except as specifically provided herein, no remedy made available
to either Party hereunder is intended to be exclusive of any other remedy, and each and every
remedy shall be cumulative and shall be in addition to every other remedy provided hereunder or
available at law or in equity.
8.3 Notices. Any notice, report, or consent required or permitted by this Agreement to be
given or delivered, shall be in writing and shall be deemed given or delivered if delivered in
person, sent by courier, expedited delivery service, registered or certified mail(postage prepaid,
return receipt requested), or by telecopy (if confirmed), as follows:
| RTI: | ATHERSYS: | |||||
| Xxxxxx X. Xxxxxxxx | Xxxxxxx Xxxxxxx | |||||
| Executive VP and CFO | President and COO | |||||
| RTI Biologics, Inc. | ABT Holding, Inc. | |||||
| 00000 Xxxxxxxx Xxxxxx | 0000 Xxxxxxxx Xxxxxx | |||||
| Xxxxxxx, Xxxxxxx 00000 | Xxxxxxxxx, XX 00000-0000 | |||||
| Fax: (000) 000-0000 | Fax: (000) 000-0000 | |||||
| With a copy to: | With a copy to: | |||||
| Legal Department | Xxxxxx X. Xxxxxx | |||||
| RTI Biologics, Inc. | Xxxxx Day | |||||
| 00000 Xxxxxxxx Xxxxxx | 00000 Xx Xxxxxx Xxxx, Xxx 000 | |||||
| Xxxxxxx, Xxxxxxx 00000 | Xxx Xxxxx, XX 00000 | |||||
| Fax: (000) 000-0000 | Fax: (000) 000-0000 | |||||
8.4 Counterparts. This Agreement may be executed in one or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute one and the same
agreement.
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8.5 Waivers. Performance of any obligations required of a Party hereunder may be waived
only by a written waiver signed by the other Party, which waiver shall be effective only with
respect to the specific obligations described therein. Anything contained herein to the contrary
notwithstanding, the Parties shall be excused from performing their obligations under this
Agreement if performance is delayed or prevented by any event beyond such Party’s reasonable
control and without the fault or negligence of the Party seeking to excuse performance, including,
but not limited to, acts of God, fire, terrorism, explosion, weather, plague, war, insurrection,
civil strife or riots, provided, however, such performance shall be excused only to the extent of
and during such disability and such Party makes commercially reasonable efforts to remove the
disability. Any Party seeking to excuse or delay performance under this section shall provide
detailed written notice to the other Party of the nature and anticipated duration of the delay.
8.6 Assignment. Neither Party may assign this Agreement or any of its rights or
obligations hereunder (including, without limitation, its rights and duties of performance) to any
Third Party without the prior written consent of the other Party hereto. Notwithstanding the
foregoing, this Agreement and the rights, interests and obligations hereunder may be assigned by
RTI or Athersys to (i) any entity that is an Affiliate as of the Effective Date of this Agreement
and remains an Affiliate as of the proposed date of Assignment, or (ii) any entity that is not a
competitor of the non-assigning Party (or its Affiliates) and that either becomes an Affiliate or
successor in interest after the Effective Date by operation of a merger, acquisition,
change-in-control, or reorganization or that purchases all or substantially all of the assets of
the assigning Party to which this Agreement relates. Assignees to whom this Agreement is assigned
pursuant to the foregoing Sections 8.6(i) and (ii) shall receive all of the Assignor’s rights,
benefits, interest, and obligations provided for in this Agreement. In the event of assignment,
the assigning Party shall remain bound to all provisions of this Agreement under Article IV.
8.7 Entire Agreement; Amendments. This Agreement constitutes the entire agreement between
the Parties with respect to the subject matter hereof, and supersedes and cancels all prior
agreements, communications and understandings, whether written or oral. This Agreement may not be
modified or amended except by an instrument in writing signed by both of the Parties hereto.
8.8 Severability. Should any part or provision of this Agreement be found invalid or held
unenforceable, the remainder shall remain valid and in full force. The Parties agree to negotiate
in good faith an amendment of such part or provision in a manner consistent with the intention of
the Parties as expressed in this Agreement.
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8.9 Independent Contractors. Nothing contained in this Agreement shall be construed as
creating a joint venture, partnership or employment relationship between the Parties hereto. Except
as specified herein, neither Party shall have the right, power or implied authority to create any
obligation or duty, express or implied, on behalf of the other Party hereto.
8.10 Governing Law. This Agreement shall be construed and enforced in accordance with the
laws of the State of New York, without application of its conflicts of laws principles.
8.11 Drafting and Interpretation of Agreement. This Agreement shall be treated as having
been drafted through the equal participation of both Parties, and no provision shall be interpreted
against any Party on the basis that the Party is deemed to be the sole or primary drafter of the
provision. The following rules of interpretation apply to this Agreement: (i) “include”, “includes”
and “including” are not limiting and mean include, includes and including, without limitation; (ii)
definitions contained in this Agreement are applicable to the singular as well as the plural forms
of such terms; (iii) references to an agreement, statute or instrument mean such agreement, statute
or instrument as from time to time amended, modified or supplemented; (iv) references to a person
or entity are also to its permitted successors and assigns; (v) references to an “Article”,
“Section”, “Exhibit” or “Schedule” refer to an Article or Section of, or any Exhibit or Schedule
to, this Agreement unless otherwise indicated; (vi) the word “will” shall be construed to have the
same meaning and effect as the word “shall”; and (vii) the word “any” shall mean “any and all”
unless otherwise indicated by context. All money in this Agreement is stated in and shall be
reported and paid in United States Dollars.
<signatures follow on next page>
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IN WITNESS WHEREOF, this Agreement has been executed by the Parties hereto as of the last date
written below.
| RTI Biologics, Inc. | ABT Holding, Inc. | |||||||
By:
|
/s/ Xxxxxx X. Xxxxxxxx | By: | /s/ Xxxxxxx Xxxxxxx | |||||
| Xxxxxx X. Xxxxxxxx | Xxxxxxx Xxxxxxx | |||||||
| Executive VP and CFO. | President and COO. | |||||||
| Date: September 10, 2010 | Date: September 10, 2010 | |||||||
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EXHIBIT A
[ * ]
[ * ]
| * | Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission. |
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EXHIBIT B
[ * ]
[ * ]
| * | Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission. |
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EXHIBIT C
Affiliates
Affiliates
RTI Affiliates:
Tutogen Medical, Inc.
Tutogen Medical (US), Inc.
Tutogen Medical, GmbH
Tutogen Medical, SARL
RTI Donor Services, Inc.
RTI Services, Inc.
Tutogen Medical, Inc.
Tutogen Medical (US), Inc.
Tutogen Medical, GmbH
Tutogen Medical, SARL
RTI Donor Services, Inc.
RTI Services, Inc.
Athersys Affiliates:
Athersys, Inc.
ABT Holding Company
ReGenesys BVBA
Advanced Biotherapeutics, Inc.
Athersys Limited
ReGenesys LLC
Athersys, Inc.
ABT Holding Company
ReGenesys BVBA
Advanced Biotherapeutics, Inc.
Athersys Limited
ReGenesys LLC
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EXHIBIT D
Initial Press Release
Initial Press Release
FOR RELEASE AT 7:00 AM ET
|
For more information, contact: | |
SEPT. 13, 2010
|
RTI BIOLOGICS: | |
| Xxxxxx Xxxxxxxx | ||
| Chief Financial Officer | ||
| xxxxxxxxx@xxxx.xxx | ||
| Xxxxx Xxxxxx Xxxxxx, APR | ||
| Corporate Communications | ||
| xxxxxxx@xxxx.xxx | ||
| Phone (000) 000-0000 | ||
| ATHERSYS: | ||
| Xxxxxxx (X.X.) Xxxxxxx, X.X. | ||
| President and Chief Operating Officer | ||
| xxxxxxxxx@xxxxxxxx.xxx | ||
| (000) 000-0000 | ||
| Investor Relations: | ||
| Xxxx X. Xxxxxx | ||
| In-Site Communications | ||
| xxxxxxx@xxxxxxxxxx.xxx | ||
| (000) 000-0000 | ||
| Media Relations: | ||
| Xxx Xxxxxxx | ||
| Pure Communications, Inc. | ||
| xxx@xxxxxxxxxxxxxxxxxxxxx.xxx | ||
| (000) 000-0000 |
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RTI BIOLOGICS AND ATHERSYS ANNOUNCE COLLABORATION IN THE ORTHOPEDIC MARKET
Applying Complementary Stem Cell and Regenerative Medicine Technologies
ALACHUA, Fla. and CLEVELAND (Sept. 13, 2010) – RTI Biologics Inc. (RTI) (Nasdaq: RTIX), a
leading provider of orthopedic and other biologic implants, and Athersys Inc. (Athersys) (Nasdaq:
ATHX), a leader in regenerative medicine and cell therapy research and development, announced today
an agreement under which Athersys will provide RTI access to its Multipotent Adult Progenitor Cell
(MAPC) technologies.
Under the agreement, RTI has licensed Athersys’ technology to isolate and preserve cells from organ
and tissue donors. This will enable RTI to develop and commercialize MAPC technology-based biologic
implants exclusively for certain orthopedic applications. With this license, RTI expands its
capabilities for accessing the fastest growing segment of the bone graft substitutes market, while
Athersys extends the application of its robust stem cell technology platform to an important
segment of the orthopedic market.
“We are very excited about our collaboration with Athersys and the potential to apply its MAPC and
related technologies in the orthobiologics market,” said Xxxxx X. Xxxxxxxxx, RTI’s chairman and
CEO. “After significant research into stem cells and the evaluation of multiple technologies, we
have determined that the MAPC technology offers the greatest potential to create high quality,
innovative implants for our surgeons and their patients. Licensing this technology is an important
step in enhancing and further differentiating RTI’s orthobiologics offering, an area of strategic
focus for the company.”
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“We are enthusiastic about our relationship with RTI and this application of our proprietary stem
cell technologies to the orthopedic market,” said Xxxxxxx Xxxxxxx, Xx., president and COO of
Athersys. “Our primary focus is the development and commercialization of expanded, “off-the-shelf”
cell products, such as MultiStem®, for the treatment of certain cardiovascular, central
nervous system-related, inflammatory and immune system disorders, diseases and conditions. This
collaboration allows for the utilization of our already developed stem cell technologies in an
additional area. Further, it provides potential near term revenues from the orthopedic market.”
Under the agreement, Athersys will receive a $3 million license fee and is also eligible to receive
payments up to a cumulative total of $37.5M as follows: $2 million contingent upon successful
achievement of certain development and commercialization milestones, and an additional maximum
total of $35.5 million contingent upon achievement of certain cumulative revenue milestones, which
will reflect the ultimate commercial success of the product in this fast growing market. In
addition, Athersys will receive tiered royalties from the distribution of implants using Athersys’
technologies.
RTI plans to make MAPC technology-based biologic implants available to its customers for use in
orthopedic surgeries in the first half of 2012.
About RTI Biologics Inc.
RTI Biologics Inc. is a leading provider of sterile biological implants for surgeries
around the world with a commitment to advancing science, safety and innovation. RTI prepares human
donated tissue and bovine tissue for transplantation through extensive testing and
screening, precision shaping and using proprietary, validated processes. These allograft and
xenograft implants are used in orthopedic, dental, hernia and other specialty surgeries.
RTI’s innovations continuously raise the bar of science and safety for biologics – from being the
first company to offer precision-tooled bone implants and assembled technology to maximize each
gift of donation, to inventing validated sterilization processes that include viral inactivation
steps. Two such processes – the BioCleanse® Tissue Sterilization Process and the
Tutoplast® Tissue Sterilization Process – have a combined record of more than two million
implants distributed with zero incidence of allograft-associated infection. These processes have
been
validated by tissue type to inactivate or remove viruses, bacteria, fungi and spores from the
tissue while maintaining biocompatibility and functionality.
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RTI’s worldwide corporate headquarters are located in Alachua, Fla., with international locations
in Germany and France. The company is accredited by the American Association of Tissue Banks in the
United States.
RTI Forward Looking Statement
This communication contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are based on management’s current
expectations, estimates and projections about our industry, our management’s beliefs and certain
assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,”
“believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to
identify such forward-looking statements. In addition, except for historical information, any
statements made in this communication about anticipated financial results, growth rates, new
product introductions, future operational improvements and results or regulatory approvals or
changes to agreements with distributors also are forward-looking statements. These statements are
not guarantees of future performance and are subject to risks and uncertainties, including the
risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our
actual results may differ materially from the anticipated results reflected in these
forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the
company or the SEC or by visiting RTI’s website at xxx.xxxx.xxx or the SEC’s website at
xxx.xxx.xxx.
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About Athersys Inc.
Athersys is a clinical stage biopharmaceutical company engaged in the discovery and development of
therapeutic product candidates designed to extend and enhance the quality of human life. The
company is developing MultiStem®, a patented, adult-derived “off-the-shelf” stem cell
product platform for multiple disease indications, including damage caused by myocardial
infarction, bone marrow transplantation and oncology treatment support, ischemic stroke, and
inflammatory bowel disease. The company is also developing a portfolio of other
therapeutic programs, including orally active pharmaceutical product candidates for the treatment
of metabolic and central nervous system disorders, utilizing proprietary technologies, including
Radom Activation of Gene Expression (RAGE®). Athersys has forged strategic alliances and
collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned
research institutions in the United States and Europe to further develop its platform and products.
More information is available at xxx.xxxxxxxx.xxx.
Athersys Forward Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 that involve risks and uncertainties. We have attempted to identify
forward-looking statements by using such words as “anticipates,” “believes,” “can,” “continue,”
“could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” or other
similar expressions. These forward-looking statements are only predictions and are largely based on
our current expectations. A number of known and unknown risks, uncertainties, and other factors
could affect the accuracy of these statements. Some of the more significant known risks that we
face are the risks and uncertainties inherent in the process of discovering, developing, and
commercializing products that are safe and effective for use as human therapeutics, the uncertainty
regarding market acceptance of any MAPC technology-based biologic implants in orthopedic
applications under the agreement with RTI and our ability to reach milestones and realize any
additional payments under such agreement. These risks may cause our actual results, levels of
activity, performance, or achievements to differ materially from any future results, levels of
activity, performance, or achievements expressed or implied by these forward-looking statements.
You should not place undue reliance on forward-looking statements contained in this press release,
and we undertake no obligation to publicly update forward-looking statements, whether as a result
of new information, future events or otherwise.
###
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