CONFIDENTIAL
Exhibit 10.2
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS([**]), HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES ACT OF1933, AS
AMENDED
SUPPLY AGREEMENT
This SUPPLY AGREEMENT (this "Agreement") is entered into as of January 24,
2005 (the "Effective Date"), by and between Miltenyi Biotec GmbH, having an
address of ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇-▇▇▇. ▇▇, ▇-▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇
("MILTENYI") and ViaCell, Inc., having an address of ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇ ▇▇▇ ("VIACELL").
WHEREAS, MILTENYI has expertise in providing technology and technical
development capabilities relating to monoclonal antibodies and cell separation
and MILTENYI has developed the CliniMACS(R) system;
WHEREAS, MILTENYI and VIACELL, are simultaneously entering into an
agreement for MILTENYI to provide certain technology and technical development
and to develop for VIACELL certain cGMP cell separation reagents specifically
for VIACELL's use utilizing technology and reagents previously developed by
MILTENYI;
WHEREAS, MILTENYI has expertise in manufacturing products under cGMP
conditions and in filing Master Files with the U.S. Food and Drug Administration
("FDA");
WHEREAS, VIACELL is interested in the development, manufacturing and
commercialization of a pharmaceutical product containing cells separated from
umbilical cord blood and expanded using VIACELL's proprietary technology and
VIACELL desires to use for its manufacturing process the specific Cell
Separation Kit, which will be developed by MILTENYI for VIACELL; and
WHEREAS, the parties desire to enter into a supply agreement as set forth
herein pursuant to which MILTENYI will supply the cGMP cell separation reagents
to VIACELL for VIACELL to use in producing its pharmaceutical products for Phase
II and subsequent clinical trials and, subsequently, for commercial sale.
NOW, THEREFORE, in consideration of the mutual covenants contained herein,
and for other good and valuable consideration, the parties hereto, intending to
be legally bound, hereby agree as follows:
1. DEFINITIONS
Whenever used in this Agreement with an initial capital letter, the terms
defined in this Section 1 shall have the meanings specified.
1.1 "AFFILIATE" means any corporation, firm, partnership or other entity which
directly or indirectly controls or is controlled by or is under common control
with a Party to this Agreement.
CONFIDENTIAL
"Control" means ownership, directly or through one or more Affiliates, of fifty
percent (50%) or more of the shares of stock entitled to vote for the election
of directors, in the case of a corporation, or fifty percent (50%) or more of
the equity interests in the case of any other type of legal entity, status as a
general partner in any partnership, or any other arrangement whereby a Party
controls or has the right to control the Board of Directors or equivalent
governing body of a corporation or other entity.
1.2 "CELL SEPARATION KIT" means a product consisting of CliniMACS [**],
CliniMACS [**], CliniMACS [**], CliniMACS [**], and CliniMACS [**], which is
sufficient to deplete [**] and includes cGMP Cell Separation Kit.
1.3 "CGMP" means the current safety and performance specifications, guidelines,
and regulations with which MILTENYI's CliniMACS [**], CliniMACS [**] and
CliniMACS [**] currently comply. These specifications, guidelines and
regulations consist of the 1977 FDA document Points to Consider in the
Manufacture and Testing of Monoclonal Antibodies Products for Human Use, the ICH
harmonized tripartite guideline Q5A: Viral Safety Evaluation of Biotechnology
Products Derived from Cell Lines of Human or Animal Origin, and the ISO standard
10993-1:1997 (E) Biological evaluation of medical devices - Part 1: Evaluation
and testing. Additionally, the manufacture, testing and release of the CliniMACS
[**], ClinicMACS [**] and CliniMACS [**] are conducted under an ISO 13485
certified quality system and the manufacture, testing and release of CliniMACS
[**] and CliniMACS [**] will also be conducted under the same quality system as
the CliniMACS [**], CliniMACS [**] and CliniMACS [**].
1.4 "CGMP CELL SEPARATION KIT" means the Cell Separation Kit manufactured
pursuant to cGMP.
1.5 "CLINICAL STUDIES" means the clinical trials utilizing the Cell Separation
Kit.
1.6 "CLINIMACS BUFFERS" means the buffers developed by MILTENYI for use in the
CliniMACS System.
1.7 "CLINIMACS REAGENT" means MILTENYI's proprietary colloidal magnetic particle
system utilizing a monoclonal antibody developed by MILTENYI for use in the
CliniMACS system and to deplete certain cells in a mixture.
1.8 "CLINIMACS [**]" means the CliniMACS Reagent where the monoclonal antibody
is an antibody to a [**] cell surface marker.
1.9 "CLINIMACS [**]" means the CliniMACS Reagent where the monoclonal antibody
is an antibody to a [**] cell surface marker.
1.10 "CLINIMACS [**]" means the CliniMACS Reagent where the monoclonal antibody
is an antibody to a [**] cell surface marker.
1.11 "CLINIMACS [**]" means the CliniMACS Reagent where the monoclonal antibody
is an antibody to a [**] cell surface marker.
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1.12 "CLINIMACS [**]" means the CliniMACS Reagent where the monoclonal antibody
is an antibody to a [**] cell surface marker.
1.13 "CLINIMACS SYSTEM" means that the system developed by MILTENYI for
conducting cell separation by use of CliniMACS Reagents, CliniMACS Tubing Sets
and the Instrument.
1.14 "CLINIMACS TUBING SETS" means the tubing and related disposable equipment
development by MILTENYI for use with the CliniMACS Instrument.
1.15 "CONFIDENTIAL INFORMATION" means all tangible embodiments of Technology and
all information (including but not limited to information about any element of
Technology) which is disclosed by one Party to the other hereunder except to the
extent that such information (i) as of the date of disclosure is demonstrably
known to the Party received such disclosure or its Affiliates, as shown by
written documentation, other than by virtue of a prior confidential disclosure
to such Party or its Affiliates; (ii) as of the date of disclosure is in, or
subsequently enters, the public domain, through no fault or omission of the
Party receiving such disclosure; or (iii) as of the date of disclosure or
thereafter is obtained from a Third Party free from any obligation of
confidentiality to the disclosing Party.
1.16 "DEVELOPMENT AGREEMENT" means the Development Agreement entered into
between MILTENYI and VIACELL effective January 24, 2005.
1.17 "EFFECTIVE DATE" means the date set forth in the first paragraph above.
1.18 "FACILITY AUDITS" shall have the meaning set forth in Section 6.2.
1.19 "INSTRUMENT" means the CliniMACS(R) instrument developed by MILTENYI for
conducting the separation of cells labeled with CliniMACS Reagent from other
cells, and consisting primarily of a magnetized column through which such cells
pass and certain related equipment or another instrument the Parties may decide
to develop at a later time.
1.20 "JOINT PATENT RIGHTS" means Patent Rights with respect to Joint Technology.
1.21 "JOINT TECHNOLOGY" has the meaning set forth in Section 8.1.2.
1.22 "MASTER FILE" means a Device Master file filed by MILTENYI with the FDA.
1.23 "MILTENYI CATALOG ITEMS" means products which MILTENYI lists in its current
product catalog and specifically excludes products customized for VIACELL or
others.
1.24 "MILTENYI TECHNOLOGY" means Technology owned or controlled by MILTENYI or
its Affiliates, that is useful in the Collaboration, and that was conceived or
developed without contribution by VIACELL, and independently of the VIACELL
Technology or Joint Technology.
1.25 "OPERATING COMMITTEE" means the committee of MILTENYI and VIACELL
representatives established pursuant to Section 2.1 hereof.
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1.26 "PARTIES" means MILTENYI and VIACELL.
1.27 "PARTY" means MILTENYI or VIACELL, as appropriate.
1.28 "PATENT RIGHTS" means the rights and interests in and to issued patents and
pending patent applications (which for purposes of this Agreement shall be
deemed to include certificates of invention and applications for certificates of
invention and priority rights) in any country, including all provisional
applications, substitutions, continuations, continuations-in-part, divisions,
and renewals, all letters patent granted thereon, and all reissues,
reexamination and extensions thereof, whether owned or licensed in by a Party
with the right to sublicense. As used herein, "VIACELL Patent rights" means
Patent Rights with respect to VIACELL Technology and "MILTENYI Patent Rights"
means Patent Rights with respect to MILTENYI Technology.
1.29 "REGULATORY AUTHORITY INSPECTION" shall have the meaning set forth in
Section 6.3.
1.30 "SPECIFICATIONS" are the criteria by which the Cell Separation Kit is
released and accepted, including the configuration of the packaging that
comprises the Cell Separation Kit. The criteria will be agreed to the Operating
Committee. Such criteria may be modified by the Parties from time to time as
agreed to by the Operating Committee until MILTENYI begins any part of the
production process for product falling within the scope of Section 3.2 of the
Supply Agreement ("Second Product shipment"), however, the Parties recognize
that VIACELL may be required to pay additional fee for any modifications to
criteria.
1.31 "TECHNOLOGY" means and includes all inventions, discoveries, improvements,
trade secrets and proprietary methods and materials, whether or not patentable,
including but not limited to, samples of, methods of production or use of, and
structural and functional information pertaining to, chemical compounds,
proteins or other biological substances; other data; formulations; techniques;
and know-how; including any negative results. "Technology" of a Party includes
Technology owned or controlled by a Party or licenses to that Party.
1.32 "TERM" means the term of this Agreement as set forth in Article 10.
1.33 "THIRD PARTY" means any person or entity other than MILTENYI and VIACELL
and their respective Affiliates.
1.34 "TUBING SETS" means the tubing and related disposable equipment developed
by MILTENYI for use with the CliniMACS Instrument.
1.35 "VIACELL PRODUCT" means VIACELL's cell therapy product candidate, which is
manufactured using VIACELL Technology and MILTENYI Technology, including
MILTENYI's CliniMACS [**], CliniMACS [**], CliniMACS [**], CliniMACS [**] and
CliniMACS [**].
1.36 "VIACELL TECHNOLOGY" means Technology owned or controlled by VIACELL or its
Affiliates, and that was conceived or developed without contribution by
MILTENYI, and independently of the MILTENYI Technology or Joint Technology.
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2. ADMINISTRATIVE ISSUES
2.1 OPERATING COMMITTEE. The right to make decisions concerning the
administration of the Agreement shall reside in a committee (the "Operating
Committee") consisting of two (2) representatives designated by MILTENYI and two
(2) representatives designated by VIACELL. The Operating Committee shall also
keep the Parties informed as to the progress of the efforts of the Parties
relating to this Agreement. The Operating Committee shall have responsibility
for decisions and tasks specified in Exhibit B. The Operating Committee shall
also discuss any potential strategic collaboration projects the Parties may wish
to participate in together, which may include joint research projects of mutual
interest or application of one another's products, technologies and expertise to
the other's development programs or products.
2.2 OPERATING COMMITTEE DESIGNEES. Each Party shall designate one of its
representatives on the Operating Committee as its "Co-Chair". Each Party shall
have the right at any time to substitute individuals, on a permanent or
temporary basis, for any of its previously designated representatives to the
Operating Committee, including its Co-Chair, by giving written notice thereof to
the other Party.
Initial designees of the Parties to the Operating Committee shall be as follows:
For MILTENYI: [**]
For VIACELL: [**]
2.3 OPERATING COMMITTEE MEETINGS.
2.3.1 SCHEDULE OF MEETINGS. The Operating Committee shall establish a
schedule of times for meetings. It is contemplated that meetings shall occur on
a quarterly basis. Meetings shall take place in Bergisch Gladbach or Teterow,
Germany or another mutually agreed upon location; provided, however, that the
Parties may mutually agree to meet by teleconference or video conference.
2.3.2 QUORUM; VOTING; DECISIONS. At each Operating Committee meeting, both
members designated by each Party shall constitute a quorum. Each Operating
Committee member shall have one vote on all matters before the Operating
Committee. All decisions of the Operating Committee shall be made by majority
vote of all of the members. Whenever any action by the Operating Committee is
called for hereunder during a time period in which the Operating Committee is
not scheduled to meet, the Co-Chairs shall cause the Operating Committee to take
the action in the required time period by calling a special meeting or by action
without a formal meeting by written memorandum signed by the Co-Chairs.
Representatives of each Party or of its Affiliates, in addition to the members
of the Operating Committee, may attend Operating Committee meetings as
non-voting observers at the invitation of either Party with the approval of the
other Party, which shall not be unreasonably withheld. In the event that the
Operating Committee is unable to resolve any matter before it, such matter shall
be resolved as set forth in Section 2.5 here.
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2.3.3 MINUTES. The Operating Committee shall keep accurate minutes of its
deliberations that record all proposed decisions and all actions recommended or
taken.
2.3.4 EXPENSES. MILTENYI and VIACELL shall each bear all expenses of their
respective Operating Committee members related to their participation on the
Operating Committee and attendance at Operating Committee meetings.
2.4 INTERESTS OF THE PARTIES. Notwithstanding any other provisions of this
Agreement, all decisions made and all actions taken by the Operating Committee,
by MILTENYI or by VIACELL with respect to any matter, shall be made or taken in
the best interest of the Parties.
2.5 DISPUTE RESOLUTION. In the event that the Operating Committee shall not be
able to reach a decision or take an action on any matter which is reserved to
the Operating Committee hereunder, such as those decisions and actions specified
in Exhibit A, then the matter in question shall first be referred for resolution
to the Chief Executive Officers of MILTENYI and VIACELL, respectively, and in
the event that said Chief Executive Officers shall be unable to resolve such
matter after reasonable efforts to do so and after the passage of a reasonable
period of time under the relevant circumstances, in any event not to exceed
forty-five (45) days, such matter shall be resolved in accordance with the
otherwise applicable procedures for resolving disputes under this Agreement as
set forth in Article 13 hereof.
3. SUPPLY OF CELL SEPARATION KIT
3.1 FIRST PRODUCT SHIPMENT. Following VIACELL's acceptance of the Cell
Separation Kits pursuant to the Development Agreement, MILTENYI shall deliver to
VIACELL [**] which meet specifications mutually agreed to by MILTENYI and
VIACELL. Within fifteen (15) days of delivery of the [**] referred to in this
Section 3.1, VIACELL shall pay MILTENYI (in cash sent by wire transfer) [**]),
MILTENYI will endeavor to deliver the product to VIACELL during the fourth
quarter of 2005 on a date specified by VIACELL in writing at least thirty (30)
days prior to the desired delivery date.
3.2 SECOND PRODUCT SHIPMENT. Approximately eighteen (18) months after the
Effective Date of this Agreement, MILTENYI shall deliver to VIACELL [**] which
meet the Specifications on a date specified by VIACELL in writing at least
thirty (30) days prior to the desired delivery date, provided that such delivery
date specified by VIACELL shall be no later than June 30, 2006. Within fifteen
(15) days of delivery of the [**] referred to in this Section 3.2, VIACELL shall
pay MILTENYI (in cash sent by wire transfer) [**].
3.3 SUPPLY OF ADDITIONAL CGMP CELL SEPARATION KITS FOR CLINICAL TRIALS. VIACELL
agrees to purchase additional CGMP Cell Separation Kit from MILTENYI for use in
VIACELL's Clinical Studies of the VIACELL Product.
3.3.1 ORDERING; DELIVERY. VIACELL will provide to MILTENYI, at least
thirty(30) days prior to the beginning of each calendar quarter a twelve (12)
month rolling forecast of VIACELL's requirements for cGMP Cell Separation Kits
for Clinical Trials. The first six months contained in such twelve (12) month
rolling forecast shall constitute a firm order of cGMP Cell Separation Kits
("Order") and VIACELL shall initiate purchase orders in accordance with the
rolling forecast pursuant to this Section 3.3.1. The Order shall be delivered
during the
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month specified in the purchase order. These delivery terms assume [**]. The
Parties agree to revise the timing of such deliveries, if appropriate, once the
stability of the cGMP Cell Separation Kit has been determined. The minimum Order
shall be for [**] Cell Separation Kits and the minimum shipment shall be [**]
Cell Separation Kits.
3.3.2 PAYMENT. Within fifteen (15) days of delivery of each shipment of
cGMP Cell Separation Kits referred to in this Section 3.3, VIACELL shall pay
MILTENYI (in cash sent by wire transfer) at [**] per cGMP Cell Separation Kit.
3.3.3 FAILURE TO ORDER PRODUCT. If VIACELL fails to order [**] Cell
Separation Kits pursuant to Section 3.3.1 within twelve (12) months following
submission to the FDA of the Master Files for the CliniMACS [**] and the
CliniMACS [**], VIACELL shall pay MILTENYI (in cash sent by wire transfer) [**]
within ten (10) days of notification by MILTENYI of VIACELL's failure to order
sufficient cGMP Cell Separation Kits pursuant to this Section 3.3.3.
3.3.4 MINIMUM ANNUAL CLINICAL SUPPLY. During clinical development, VIACELL
shall purchase a minimum of [**] cGMP Cell Separation Kits for [**] in each
calendar year, pro-rated for any partial year starting on January, 1, 2007. In
the event VIACELL purchases less than this minimum amount, VIACELL shall pay to
MILTENYI in cash the difference between [**] and the amount VIACELL purchased
during the relevant calendar year.
3.4 COMMERCIAL SUPPLY. VIACELL agrees to purchase additional cGMP Cell
Separation Kits from MILTENYI to manufacture VIACELL Products sold commercially.
3.4.1 ORDERING; DELIVERY. Following receipt of marketing approval of a
VIACELL Product, VIACELL will provide to MILTENYI, at least thirty (30) days
prior to the beginning of each calendar quarter a twelve (12) month rolling
forecast of VIACELL's requirements for cGMP Cell Separation Kits for Commercial
Supply. The first six months contained in such twelve (12) month rolling
forecast shall constitute a firm order of cGMP Cell Separation Kits ("Commercial
Supply Order") and VIACELL shall initiate purchase orders in accordance with the
rolling forecast pursuant to this Section 3.4.1. The Cell Separation Kits shall
be delivered in the amount and during the month in which the appropriate
purchase order specifies. These delivery terms assume [**]. The Parties agree to
revise the timing of such deliveries, if appropriate, once the [**] has been
determined. The minimum Commercial Supply Order shall be for [**] Cell
Separation Kits and the minimum shipment shall be [**] Cell Separation Kits.
3.4.2 PAYMENT. Within fifteen (15) days of delivery of each shipment of
cGMP Cell Separation Kit ordered pursuant Section 3.4, VIACELL shall pay
MILTENYI (in cash sent by wire transfer) [**] per Cell Separation Kit. The
Parties agree they will renegotiate the price per unit if VIACELL orders
quantities greater than [**] Cell Separation Kits per year.
3.4.3 MINIMUM ANNUAL PURCHASE COMMERCIAL SUPPLY. VIACELL shall purchase a
minimum of [**] of cGMP Cell Separation Kits each calendar year. In the event
VIACELL purchases less than this minimum amount, VIACELL shall pay to MILTENYI
in cash the difference between [**] and the amount VIACELL purchased during the
relevant calendar year.
3.5 INCREASES IN PRICE PER UNIT. [**].
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3.6 DELIVERY; RISK OF LOSS. Delivery of Cell Separation Kits and cGMP Cell
Separation Kits shall be FCA Bergisch Gladbach or Teterow, Germany. "FCA" shall
be construed in accordance with INCOTERMS 2000 of the International Chamber of
Commerce. At VIACELL's requires and cost, MILTENYI shall arrange shipping to
specified VIACELL locations.
3.7 ACCEPTANCE AND REJECTION. VIACELL shall have the right to test at its
expense, using testing procedures agreed upon by the Parties and set forth in
the Specifications for the Cell Separation Kit to confirm that such shipment
meets the applicable Specifications. If VIACELL rejects in whole or in part any
nonconforming shipment of Cell Separation Kits, VIACELL shall provide MILTENYI
written notice of such rejection no later than [**] days after receipt of such
shipment of Cell Separation Kits. If VIACELL fails to provide MILTENYI with such
notice of rejection within such [**] day inspection period, VIACELL shall be
deemed to have accepted the applicable shipment of Cell Separation Kits.
3.7.1 If MILTENYI agrees with VIACELL's determination that a shipment of
Cell Separation Kits does not comply with applicable Specifications, then
MILTENY shall, [**].
3.7.2 If MILTENYI disagrees with VIACELL's determination that the rejected
shipment did not meet the applicable Specifications, a sample of the rejected
shipment shall be provided by VIACELL to MILTENYI. [**].
(a) If the shipment of Cell Separation Kits failed to meet the
applicable Specifications, then MILTENY shall, [**] use
reasonable efforts to replace the nonconforming Cell
Separation Kits with Cell Separation Kits meeting the
applicable Specifications at no additional cost to VIACELL and
MILTENYL shall bear all costs of the testing pursuant to
Section 3.7.2.
(b) If the [**] the Cell Separation Kit does not meet the
applicable specifications, and [**]. At such time, the Parties
will discuss in good faith potential solutions to the supply
problem.
(c) If [**] the rejected shipment of Cell Separation Kits met the
applicable specifications, then VIACELL shall accept such
shipment (including all costs of shipping and insurance) and
VIACELL shall bear all costs of the testing pursuant to
Section 3.7.2.
3.7.3 Shipments of Cell Separation Kits not meeting the applicable
specifications may, at MILTENYI's option and expense, be returned to MILTENYI or
destroyed by VIACELL. If MILTENYI has acknowledged in writing that it is unable
to produce conforming Cell Separation Kits, any sums actually paid therefore
will be refunded.
3.7.4 The remedy of replacement or refund is available only if such
nonconformance was not caused by VIACELL's misuse, unauthorized modifications,
neglect, improper testing or improper storage, including without limitation
storage at inappropriate temperatures, of such shipment of Cell Separation Kits,
including, but not limited to, any nonconformance due to or the results of the
shipping of the Cell Separation Kits.
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3.8 LIMITATION ON USE OF CELL SEPARATION KITS. VIACELL and its Affiliates may
only use the Cell Separation Kits and cGMP Cell Separation Kits supplied by
MILTENYI for internal research use and to manufacture cellular products for
cellular therapy. The Cell Separation Kits shall not be sold or otherwise
provided to any Third Party by VIACELL or its Affiliates.
3.9 [**]
3.10 EXCLUSIVITY. During the Term of this Agreement, MILTENYI shall be the
exclusive supplier to VIACELL and its Affiliates of Cell Separation Kits,
components of Cell Separation Kits and devices for immunomagnetic separation and
non-reagent disposables for those devices.
3.10.1 FAILURE TO SUPPLY. [**].
3.11 MILTENYI RIGHTS. MILTENYI and its Affiliates shall have the right to
manufacture, use, sell, offer for sale, sell and import Cell Separation Kits
that are not certified as cGMP Cell Separation Kits. MILTENYI shall also have
the right to manufacture, use, sell offer for sale, sell and import each of the
components of the Cell Separation Kit, whether they are cGMP or non-cGMP.
MILTENYI shall further have the right to manufacture, use, sell, offer for sale
and import cGMP Cell Separation Kits that are certified as cGMP Cell Separation
Kits except that MILTENYI may not sell cGMP Cell Separation Kits for expansion
of hematopoietic stem cells to a competitor of VIACELL without the prior written
permission of VIACELL. In the event VIACELL, abandons its efforts to develop and
commercialize a product made using the cGMP Cell Separation Kit, MILTENYI and
its Affiliates shall have the right to manufacture, sell, offer for sale, use
and sell cGMP Cell Separation Kit, including the right to use cGMP Cell
Separation Kit to manufacture cellular products for cellular therapy.
4. COMMERCIALIZATION OF PRODUCTS
4.1 COMMERCIALIZATION OF PRODUCT. VIACELL shall use commercially reasonable
efforts to commercialize products made using the Cell Separation Kits.
5. LICENSES
5.1 LICENSE TO VIACELL. MILTENYI shall permit VIACELL to cross-reference
MILTENYI's Master Files for the CliniMACS Reagents utilized in the Cell
Separation Kit to complete regulatory filings with the FDA required for Clinical
Trials or FDA product approval in the United States. However, the license
provided in this Section 5.1 does not provide the right to VIACELL to view or
copy MILTENYI's Master files or excerpts of the Master Files.
6. SERVICES AND AUDITS
6.1 TECHNICAL SERVICES ASSISTANCE. except as provided for in the Development
Agreement, upon reasonable request by VIACELL, and in consideration of payment
by VIACELL at mutually agreed upon rates, plus out of pocket expenses, MILTENYI
shall make its regulatory, technical, QA and QC personnel available (at their
usual place of employment or by telephone) to provide reasonable levels of
technical assistance to VIACELL in connection with the development and
manufacture of Cell Separation Kits and regulatory, QA and QC issues relating to
the Cell Separation Kits.
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6.2 FACILITY AUDITS. Upon not less than thirty (30) days prior written notice to
MILTENYI, and no more than once every 12 months, VIACELL shall be entitled to
have its representatives, acting reasonably, audit MILTENYI's production of the
Cell Separation Kits for compliance with cGMP; provided, however, that such
representatives, if not employees of VIACELL, shall have first signed a
confidentiality agreement with MILTENYI. VIACELL and its representatives shall
comply with all applicable health, safety, environmental and security laws and
with MILTENYI's policies and procedures with present at MILTENYI's facilities.
6.2.1 COSTS OF FACILITY AUDITS. VIACELL shall pay to MILTENYI for the time
spent by MILTENYI personnel in connection with all Facility Audits, at a
mutually agreed upon rate and VIACELL shall bear all costs and expenses of all
Facility Audits, including costs and expenses relating to any corrective action
requested by VIACELL [**].
6.3 REGULATORY AUTHORITY INSPECTION. MILTENYI will permit inspections of
MILTENYI's facilities by regulatory bodies of all jurisdictions (such as the FDA
and equivalent European regulatory authorities) ("Regulatory Authority
Inspection") and will respond to any notices or requests for information by
regulatory authorities, for any import or export license, registration or
pending registration for manufacturing of Cell Separation Kits during the term
of this Agreement.
6.3.1 VIACELL REPRESENTATIVE. VIACELL shall be entitled to have two
representatives attend any audit conducted pursuant to Section 6.3; provided,
however, that such representatives, if not employees of VIACELL, shall have
first signed a confidentiality agreement with MILTENYI. VIACELL's
representatives shall comply with all applicable health, safety, environmental
and security laws and with MILTENYI's policies and procedures with present at
MILTENYI's facilities.
6.3.2 COSTS OF REGULATORY AUTHORITY INSPECTIONS. VIACELL shall pay to
MILTENYI for the time spent by MILTENYI personnel in connection with all
Regulatory Authority Inspections, at a mutually agreed upon rate and VIACELL
shall bear all costs and expenses of all Regulatory Authority Inspections,
including costs and expenses relating to any corrective actions and responses to
notices and requests for information by regulatory authorities.
6.3.3 NOTICE. The Parties shall give prompt notice to each other upon
notice by a regulatory authority that MILTENYI's facilities will undergo a
regulatory Authority Inspection.
7. TREATMENT OF CONFIDENTIAL INFORMATION
7.1 CONFIDENTIALITY/RESTRICTIONS ON TRANSFER.
7.1.1 CONFIDENTIAL INFORMATION. MILTENYI and VIACELL each recognize that
the other Party's Confidential Information constitutes highly valuable and
proprietary confidential information. MILTENYI and VIACELL each agree that
during the Term of this Agreement and the term of the License and Supply
Agreement and for five (5) years after the latter to terminate of those
agreements, it will keep confidential, and will cause its employees, consultants
and Affiliates to keep confidential, and shall not transfer to any third Party,
Confidential Information of the other Party that is disclosed or transferred to
it, or to any of its employees, consultants and Affiliates, pursuant to or in
connection with this Agreement, without the prior written consents of
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the other Party and except to the extent that disclosure, or transfer, is
required in accordance with the performance of this Agreement. Neither VIACELL,
nor MILTENYI, nor any of their respective employees, consultants and Affiliates
shall use Confidential Information of the other Party for any purpose whatsoever
except as expressly permitted in this Agreement. Notwithstanding anything
contained herein to the contrary, the Parties agree that with respect to
production technology, QA, QC and regulatory information, such information shall
remain confidential without limit unless such information becomes part of the
public domain through no fault of the recipient of such information.
7.1.2 NON-DISCLOSURE. Each Party shall take such action, and shall cause
its Affiliates and licensees and sublicensees to take such action, to preserve
the confidentiality of each other's Confidential Information as it would
customarily take to preserve the confidentiality of its own Confidential
Information, and in no event, less than reasonable care. Each Party, upon the
other's request, will return all the Confidential information disclosed or
transferred to it by the other Party pursuant to this Agreement, including all
copies and extracts of documents and all manifestations in whatever form, within
sixty (60) days of the request following the termination of this Agreement;
provided that a Party may retain Confidential Information of the other Party
relating to any license or right to use Technology which survives such
termination and one copy of all other Confidential Information may be retained
in inactive archives solely for the purpose of establishing the contents
thereof.
7.1.3 DISCLOSURE REQUIRED BY LAW. If a Party is requested or required by
subpoena, court order, or similar process to disclose any Confidential
Information of the other Party, the Parties agree that the Party required or
requested to make the disclosure will provide the other Party with prompt notice
of such request(s) so that the Party whose Confidential Information is required
or requested to be disclosed may seek an appropriate protective order and/or
waive the other Party's compliance with the provisions of Section 7.1.
7.1.4 EMPLOYEES AND CONSULTANTS. MILTENYI and VIACELL each represent that
all of its employees and the employees of its Affiliates, and any consultants to
such Party or its Affiliates, participating in the Collaboration's activities
who shall have access to Confidential Information of the other Party are bound
by written obligations to maintain such information in confidence and not to use
such information except as expressly permitted herein. Each Party agrees to
enforce confidentiality obligations to which its employees and consultants (and
those of its Affiliates) are obligated.
7.2 PUBLICITY. Neither Party may publicly disclose the existence or terms of
this Agreement without prior written consent of the other Party; provided,
however, that either Party may make such a disclosure to the extent required by
law. Such disclosure hall be on a reasonable notice to the other Party and after
taking all reasonable steps to maintain confidentiality. The Parties, upon the
execution of this Agreement, will jointly prepare a press release and will
jointly decide about an appropriate time for publishing such press release. The
Parties agree that there will be no press release related to this Agreement of
the Development Agreement that is not authorized by all Parties. Once any
written statement is approved for disclosure by the other Party, either Party
may make subsequent public disclosure of the contents of such statement without
the further approval of the other Party.
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7.3 LIMITATION ON DISCLOSURES. Notwithstanding any provision in this Agreement,
neither Party shall be obligated hereunder to disclose to the other Party any
information which it is prohibited from disclosing by law or under any agreement
with a Third Party.
7.4 THIS AGREEMENT. The Parties agree that the material terms of this Agreement
shall be considered Confidential Information of each of the Parties. The Parties
will consult with one another and agree on the provisions of the Agreement to be
redacted in any filings made by any Party with the Securities and Exchange
Commission or as other wise required by law or regulation. Notwithstanding the
foregoing, each Party shall have the right to disclose in confidence the
material terms of this Agreement to parties retained by such Party to perform
legal, accounting or similar services and who have a need to know such terms in
order to provide such services and to other parties upon the prior written
approval of the Parties to this Agreement.
8. INTELLECTUAL PROPERTY RIGHTS
8.1 OWNERSHIP.
8.1.1 MILTENYI INTELLECTUAL PROPERTY RIGHTS. Except as otherwise provided
herein, MILTENYI shall have sole and exclusive ownership of all right, title and
interest on a worldwide basis in and to any and all MILTENYI Technology with
full rights to license and sublicense. Without limiting the foregoing, except as
otherwise provided herein, MILTENYI shall be the sole owner of all Patent
Rights, all trade secret rights, all know-how and any other intellectual
property rights in the MILTENYI Technology including the sole and exclusive
right to exclude others from making, using, selling, offering for sale or
importing the MILTENYI Technology or any products derived from any MILTENYI
Technology.
8.1.2 VIACELL INTELLECTUAL PROPERTY RIGHTS. VIACELL shall have sole and
exclusive ownership of all right, title and interest on a worldwide basis in and
to any and all VIACELL Technology with full rights to license or sublicense,
except as provided for in Sections 3.11. Without limiting the foregoing, VIACELL
shall be the sole owner of all Patent Rights, all trade secret rights, all
know-how and any other intellectual property rights in the VIACELL Technology,
including the sole and exclusive right to exclude others from making, using,
selling, offering for sale or importing the VIACELL Technology or any products
derived from any VIACELL Technology.
8.1.3 JOINT TECHNOLOGY. MILTENYI and VIACELL shall each own an undivided
interest in all Joint Technology, which is defined for purposes of this
Agreement as Technology (i) jointly invented, discovered, acquired, or developed
by or on behalf of both VIACELL (and/or any party performing sponsored research
for VIACELL) and MILTENYI (and/or any party performing sponsored research for
MILTENYI) or (ii) invented, discovered or developed by one Party (or during any
research sponsored by such Party) with the use of the Technology of the other
Party.
8.2 INVENTORSHIP. In case of a dispute between MILTENYI or VIACELL over
inventorship, the Chief Executive Officers of the Parties or their designees(s),
shall make the determination of the inventor(s) by application of the standards
contained in United States patent law. The Chief
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Executive Officers of the Parties or their designees(s), shall make the
determination of the inventor(s) by application of the standards contained in
United States patent law. The Chief Executive Officers of the Parties or their
designee(s), shall also, in the case of a dispute, make the determination as to
whether an invention is Joint Technology. All such determinations shall be
treated as Joint Decisions hereunder. If the Chief Executive Officers of the
Parties or their designee(s) cannot resolve the dispute, it shall be resolved by
independent patent counsel, not otherwise engaged by either Parties, selected by
the Chief Executive Officers of the Parties or their designee(s). Expenses of
such independent patent counsel shall be shared equally by the Parties.
9. FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS
9.1 FILING OF PATENTS. Each Party will be responsible for the filing and
prosecution, in such countries as the responsible Party shall select, of patents
on Technology solely owned or solely invented by such Party and on Joint
Technology which principally relates to its own Technology and which is
developed during the Development Program, provided that the other Party will
have the opportunity to provide substantive review and comment on any such
prosecution solely as it relates to claims in the scope of the Development
Program. Portions of any documents relating to any such prosecution not within
the scope of the Development Program may be redacted by a Party prior to
provision to the other Party. Except as set forth above, responsibility for
filing and prosecution of patents on Joint Technology not principally related to
either VIACELL Technology alone or MILTENYI Technology alone will be determined
by the Chief Executive Officers of the Parties or their designee(s) on a
case-by-case basis and handled by mutually acceptable patent counsel charged
with the duty to act in the best interests of the Development Program.
9.2 EXPENSES. MILTENYI shall bear the cost for the filing, prosecution and
maintenance of MILTENYI Patent Rights. VIACELL shall bear the cost for the
filing, prosecution and maintenance of VIACELL Patent Rights. The Parties shall
share equally the cost for the filing, prosecution and maintenance of Joint
Patent Rights, and in the event either Party uses any in- house patent counsel,
expenses shall be shared in such instance based on reasonable rates as agreed in
advance by the Chief Executive Officers of their designee(s).
9.3 LEGAL ACTION.
9.3.1 ACTUAL OR THREATENED INFRINGEMENT. Subject to any obligation to a
Third Party licensor of Technology or Patents rights to a Party with respect to
the subject matter hereof.
(a) In the event either Party becomes aware of any possible
infringement or unauthorized possession, knowledge or use of
any intellectual property which is the subject matter of this
Agreement (collectively, an "Infringement"), that Party shall
promptly notify the other Party and provide it with full
details. Upon a determination by either Party that such
Infringement involves the manufacture, use, sale, offer for
sale, or import of Cell Separation Kits by a Third Party, such
Party may give notice of such determination to the other Party
hereto (an "Infringement Notice"). If such infringement
relates solely to the infringement of MILTENYI patent rights,
then MILTENYI shall have the option, but not the obligation,
to prosecute or prevent the Infringement of Patent Rights
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relating to Cell Separation Kits or the manufacture or use
thereof. If such infringement relates solely to the
infringement of VIACELL patent rights, then VIACELL shall have
the option, but not the obligation, to prosecute or prevent
the Infringement of Patent Rights relating to Cell Separation
Kits or the manufacture, use, offer for sale or import
thereof. If either Party determines that it is necessary or
desirable for the other to join any such suit, action or
proceeding, the second Party shall execute all papers and
perform such other acts as may be reasonably required in the
circumstances. In the event of an Infringement of a Joint
Patent Right, or in the event such infringement does not
relate solely to MILTENYI patent rights to VIACELL patent
rights, the Operating Committee shall determine whether and
how to prosecute or prevent the Infringement. If the Operating
Committee is unable to determine whether and how to commence
an action for infringement of a joint Patent Right, either
Party shall have the right to prosecute such patent
infringement action. The Party bringing any action under this
Section 9.3.1(a) shall do so at its own expense and shall
retain all amounts received as a result of such action.
(b) In any action under this Section 9.3.1, the Parties shall
fully cooperate with and assist each other.
(c) In the event that the scope of an action under Section 9.3.1.
goes beyond the scope of the cGMP Cell Separation Kits and an
award of damages or royalties is granted for infringing
activity, such award shall be retained by the owner of the
Patent Right in question.
9.3.2 DEFENSE OF CLAIMS. Subject to any obligation to a Third Party
licensor of Technology or Patent Rights to a Party with respect to the subject
matter hereof, in the event that any action, suit or proceeding is brought
against MILTENYI or VIACELL or any affiliate of either Party alleging the
infringement of the intellectual property rights of a third Party by reason of
the discovery, development, manufacture, use, sale, importation or offer for
sale of Cell Separation Kits or use of MILTENYI, VIACELL or Joint Technology in
the discovery, development, manufacture, use sale offer for sale, or importation
of Cell Separation Kits, the Parties will cooperate with each other in the
defense of any such suit, action or proceeding. The Parties will give each other
prompt written notice of the commencement of any such suit, action or proceeding
or claim of infringement. Neither Party shall compromise, litigate, settle or
otherwise dispose of any such suit, action or proceeding which involves the use
of the other's Technology or Patent Rights without the other Party's advice and
prior consent, provided that the Party not defending the suit shall not
unreasonably withhold its consent to any settlement which does not have a
material adverse effect on its business. If the defending Party agrees that the
other Party should institute or join any suit, action or proceeding, and the
Party so joined shall execute all documents and take all other actions,
including giving testimony, which may reasonably be required in the connection
with the prosecution of such suit, action or proceeding. To the extent that the
allegation of infringement is based principally on the use of VIACELL
Technology, or on the manufacture, use, sale, offer for sale or import of the
Cell Separation Kits, and no other MILTENYI products or MILTENYI processes used
to produce other MILTENYI products are accused of infringement, VIACELL shall
have the right to join in any suit, action,
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proceeding pursuant to this Section alleging the infringement of the
intellectual property rights of a Third Party by reason of the discovery,
development, manufacture, use, sale, importation or offer for sale of Cell
Separation Kits or use of VIACELL Technology in the discovery, development,
manufacture, use, sale, offer for sale, or importation of Cell Separation Kits
and the expenses of defense of the suit shall be borne by VIACELL. To the extent
that the allegation of infringement is based principally on the use of MILTENYI
Technology, or on the manufacture, use, sale, offer for sale or import of the
Cell Separation Kits, and no other VIACELL products or VIACELL processes used to
produce other VIACELL products are accused of infringement, MILTENYI shall have
the right to join in any suit, action, proceeding pursuant to this Section
alleging the infringement of the intellectual property rights of a Third Party
by reason of the discovery, development, manufacture, use, sale, importation or
offer for sale of Cell Separation Kits or use of MILTENYI Technology in the
discovery, development, manufacture, use, sale, offer for sale, or importation
of Cell Separation Kits. To the extent that the allegation of infringement is
based principally on the use of Joint Technology, or to the extent that the
allegation of infringement is not based principally on the use of either
MILTENYI Technology or VIACELL Technology, each Party shall have the right to
join in any suit, action, proceeding pursuant to this Section alleging the
infringement of the intellectual property rights of a Third Party by reason of
the discovery, development, manufacture, use, sale, importation or offer for
sale of Cell Separation Kits or use of Joint Technology in the discovery,
development, manufacture, use, sale, offer for sale, or importation of Cell
Separation Kits. The Parties shall bear their own expenses in defense of the
suit. If as a consequence of such action, suit or proceeding by a Third Party
claiming that the discovery, development, manufacture, use, sale, offer for
sale, or importation of Cell Separation Kits. The Parties shall bear their own
expenses in defense of the suit. If as a consequence of such action, suit or
proceeding by a Third Party claiming that the discovery, development,
manufacture, use or sale of a Cell Separation Kit infringes such Third Party's
intellectual property rights, the Parties shall examine and discuss in good
faith the consequences of such prohibition or restriction or other conditions on
this agreement and on possible modifications thereto.
10. TERMINATION AND DISENGAGEMENT
10.1 TERM. This Agreement shall take effect as of the Effective Date and shall
continue until the seventh (7th) anniversary hereof, with the periods of
extension as described herein, unless earlier terminated in accordance with the
provisions of this Article 9 (the "Term"). Upon termination of the initial seven
(7) year Term, the Term shall automatically be extended for successive periods
of one (1) year unless notice of termination is given by either Party to the
other not less than six (6) months prior to the end of the then current Term.
10.2 TERMINATION.
10.2.1 TERMINATION FOR CAUSE. The Agreement may be terminated at any time
by either Party in the following ways:
(a) immediately by a Party if (i) the other Party shall have
dissolved, ceased active business operations or liquidated,
unless such dissolution, cessation or liquidation results from
reorganization, acquisition, merger or similar event, or (ii)
bankruptcy or insolvency proceedings, including any
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proceeding under Title 11 of the United States Code, have been
brought by or against the other Party and, in the event such a
proceeding has been brought against such Party, remains
undismissed for a period of sixty (60) days, or (iii) an
assignment has been made for the benefit of the other Party's
creditors or a receiver of such Party's assets has been
appointed; or
(b) by the non-defaulting Party upon thirty (30) days' written
notice to the defaulting Party (which notice shall specify the
nature of the default), if either Party shall have failed in
the full and timely observance or performance of any of its
covenants or obligations under this Agreement, including,
without limitation, the failure of VIACELL to meet the
obligations set forth in Sections 3.3.3 and 3.4.3.
10.2.2 TERMINATION WITHOUT CAUSE. This Agreement may be terminated upon
six (6) months written notice by VIACELL, provided such notice does not occur
earlier than thirty (30) days months from the Effective Date.
10.3 CONSEQUENCES OF TERMINATION OR EXPIRATION
10.3.1 TECHNOLOGY RIGHTS. Except as otherwise provide in Sections 3.11, in
the event of termination or expiration of this Agreement:
(a) each Party will retain exclusive rights under its own
Technology and Patent Rights, and each Party shall be free to
pursue the development and commercialization of such rights in
any manner that it may choose, subject only to the rights as
set forth below; and
(b) all exclusive and non-exclusive rights granted to either Party
shall immediately terminate.
10.4 SURVIVING PROVISIONS. Termination and expiration of this Agreement for any
reason shall be without prejudice to:
(a) the rights and obligations of the Parties provided in Sections
2.3.4, 3.3.3, 3.8, 3.11, 8.1, 8.2, 10.3, 10.4, 14.1, 14.2,
14.3, 14.4, 14.5, 14.7, 14.8, 14.9, 14.10, 14.11, 14.12 and
Articles 7, 8, 9, 11, 12, 13 and 1 (to the extent terms
defined therein are used in other surviving sections or
articles hereof) all of which shall survive such termination;
(b) any rights of either Party which may have accrued up to the
date of such termination or expiration; and
(c) any other rights or remedies provided at law or equity which
either Party may otherwise have against the other.
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11. REPRESENTATIONS, WARRANTIES AND COVENANTS
11.1 MUTUAL REPRESENTATIONS. MILTENYI and VIACELL each represents and warrants
to the other, as of the Effective Date as follows:
11.1.1 ORGANIZATION. It is a corporation duly organized, validly existing
and in good standing under the laws of the jurisdiction of its incorporation, it
is qualified to do business and is in good standing as a foreign corporation in
each jurisdiction in which the performance of its obligations hereunder requires
such qualification and has all requisite power and authority, corporate or
otherwise, to conduct its business as now being conducted, to own, lease and
operate its properties and to execute, deliver and perform this Agreement.
11.1.2 AUTHORIZATION. The execution, delivery and performance by it of
this Agreement have been duly authorized by all necessary corporate action and
do not and will not (a) require any consent or approval of its stockholders or
(b) violate any provision of any agreement, law, rule, regulation, order, writ,
judgment, injunction, decree, determination or award presently in effect having
applicability to it or any provision of its charter documents.
11.1.3 BINDING AGREEMENT. This Agreement is a legal, valid and binding
obligation of it enforceable against it in accordance with its terms and
conditions.
11.1.4 NO INCONSISTENT OBLIGATION. It is not under any obligation to any
person, or entity, contractual or otherwise, that is conflicting or inconsistent
in any respect with the terms of this Agreement or that would impede the
diligent and complete fulfillment of its obligations hereunder and that it has
all power and authority under all instruments or agreements to which it is a
Party to enter into this Agreement and to perform its obligations hereunder.
Furthermore, except as otherwise provided herein, it is not a party to any
agreement that would directly or indirectly grant rights in the other Party's
Technology to any Third Party.
12. INDEMNIFICATION
12.1 INDEMNIFICATION OF VIACELL BY MILTENYI. MILTENYI shall indemnify, defend
and hold harmless VIACELL, its Affiliates and their respective directors,
officers, employees, and agents and their respective successors, heirs and
assigns (the "VIACELL Indemnitees"), against any liability, damage, loss or
expense (including reasonable attorneys' fees and expenses of litigation)
incurred by or imposed upon the VIACELL Indemnitees, or any one of them, in
connection with any claims, suits, actions, demands or judgments result from a
material breach of this Agreement, gross negligence or willful misconduct on the
part of VIACELL) arising out or based on the breach by MILTENYI of any of its
representations, warranties covenants or obligations contained or incorporated
in this Agreement or willful misconduct, except that MILTENYI shall not
indemnify VIACELL for any liability, damage, loss or expense (including
reasonable attorneys' fees and expenses of litigation) incurred by or imposed
upon the VIACELL Indemnitees, or any one of them, in connection with any claims,
suits, actions, demands or judgments of any Third Party for patent infringement
or for any product liability claims (unless in cases of willful misconduct). IN
NO EVENT WILL MILTENYI BE LIABLE FOR ANY CONSEQUENTIAL, INDIRECT OR EXEMPLARY
DAMAGES SUFFERED BY THE VIACELL INDEMNITEES.
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12.2 INDEMNIFICATION OF MILTENYI BY VIACELL. VIACELL shall indemnify, defend and
hold harmless VIACELL, its Affiliates and their respective directors, officers,
employees, and agents and their respective successors, heirs and assigns (the
"MILTENYI Indemnitees"), against any liability, damage, loss or expense
(including reasonable attorneys' fees and expenses of litigation) incurred by or
imposed upon the MILTENYI Indemnitees, or any one of them, in connection with
any claims, suits, actions, demands or judgments of any Third Party, (except in
cases where such claims, suits, actions, demands or judgments result from
willful misconduct on the part of MILTENYI) arising out of or based on product
liability, patent infringement or the breach by VIACELL of any of its
representations, warranties, covenants or obligations contained or incorporated
in this Agreement. IN NO EVENT WILL MILTENYI BE LIABLE FOR ANY CONSEQUENTIAL,
INDIRECT OR EXEMPLARY DAMAGES SUFFERED BY THE VIACELL INDEMNITEES.
12.3 INDEMNITY PROCEDURE. In the event that a Party is seeking indemnification
under Section 12.1 or 12.2, it shall inform the other Party (the "Indemnifying
Party") of a claim as soon as reasonably practicable after it receives notice of
the claim, shall permit the Indemnifying Party to assume direction and control
of the defense of the claim (including the right to settle the claim solely for
monetary consideration), and, at the Indemnifying Party's expense, shall
cooperate as reasonably requested in the defense of the claim. The Indemnified
Party shall have the right to retain its own counsel, subject to the approval of
any such outside counsel by the Indemnifying Party, with the fees and expenses
to be paid by the Indemnifying Party if representation of such Party by the
counsel retained by Indemnifying Party would be inappropriate due to actual or
potential differing interests between such indemnitee and any other Party
represented by such counsel in such proceedings. The Indemnifying Party may not
settle such action or claim, or otherwise consent to an adverse judgment in such
action or claim, without the express written consent of the Indemnified Party if
such settlement or adverse judgment diminishes the rights or interests of the
Indemnified Party but such written consent shall not be unreasonably withheld.
12.4 INSURANCE. VIACELL agrees to maintain, at its costs and expense, at all
times while this Agreement is in effect and for five (5) years thereafter, an
insurance policy covering the Cell Separation Kits and cGMP Cell Separation
Kits, the use of the Cell Separation Kits and cGMP Cell Separation Kits and the
products made using the Cell Separation Kits and CGMP Cell Separation Kits and
other operations relating to claims regarding the subject matter under this
Agreement in an amount appropriate to the conduct of VIACELL's activities under
this Agreement. However the minimum amount for such policy shall be [**] per
occurrence prior to the start of the first human clinical trials by VIACELL
using Cell Separation Kits.
12.5 LIMITATION OF MILTENYI'S LIABILITY. MILTENYI's liability is limited to
delivering Cell Separation Kits or cGMP Cell Separation Kits meeting the
mutually agreed upon specifications to VIACELL. MILTENYI is in no event liable
for any damage, loss or expense arising out or based on any use of the Cell
Separation Kits or cGMP Cell Separation Kits by VIACELL, unless in cases of
willful misconduct. Any and all claims of VIACELL against MILTENYI for any other
reason than willful misconduct or delivery of Cell Separation Kits or cGMP Cell
Separation Kits not meeting the mutually agreed upon specifications are
excluded. VIACELL is aware that this provision requires the consent of VIACELL's
insurance company providing pharmaceutical liability insurance. VIACELL shall
provide such consent in writing to MILTENYI.
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12.6 FURTHER LIMITATION OF LIABILITY. In any event MILTENYI's liability for any
claim or obligation to VIACELL or to indemnify VIACELL shall be limited to the
amount of payment received by MILTENYI under this Agreement from VIACELL for the
shipment which has caused such claim.
12.7 WARRANTY DISCLAIMER. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS
AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY WITH RESPECT TO ANY TECHNOLOGY,
GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY
DISCLAIMS WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND
NONINFRINGEMENT WITH RESPECT TO ANY AND ALL OF THE FOREGOING.
12.8 LIMITED LIABILITY. NOTWITHSTANDING ANYTHING ELSE IN THIS AGREEMENT OR
OTHERWISE, NEITHER VIACELL NOR MILTENYI WILL BE LIABLE WITH RESPECT TO ANY
SUBJECT MATTER OF THIS AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR (I) ANY INDRECT, INCIDENTAL,
CONSEQUENTIAL OR PUNITIVE DAMAGES OR LOST PROFITS OR (II) COST OF PROCUREMENT OR
SUBSTITUTE GOODS, TECHNOLOGY OR SERVICES.
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13. DISPUTE RESOLUTION
13.1 DISPUTE RESOLUTION.
13.1.1 GENERAL. In no event of any dispute, difference or question arising
between the Parties in connection with this Agreement, the construction thereof,
or the rights, duties or liabilities of either party, and which dispute cannot
be amicably resolved by the good faith efforts of the persons designated under
Section 2.2, then such dispute shall be resolved by binding arbitration as set
forth in Section 13.1.2.
13.1.2 ARBITRATION. Binding arbitration shall be conducted in accordance
with the Arbitration Rules of the Cologne Chamber of Commerce and Industry (IHK
Koln) without recourse to the ordinary courts of law. The arbitration panel
shall be composed of three arbitrators, one of whom shall be chosen by MILTENYI,
one by VIACELL and the third, who shall be chairman of the panel, by the two so
chosen. If both or either of MILTENYI or VIACELL fails to choose an arbitrator
or arbitrators within fourteen (14) days after receiving notice of commencement
of arbitration or if the two arbitrators fail to choose a third arbitrator
within fourteen (14) days after their appointment, the then President of the
Cologne Chamber of Commerce and Industry shall, upon the request of both or
either of the Parties to the arbitration, appoint the arbitrator or arbitrators
required to complete the board or, if he shall decline or fail to do so, such
arbitration or arbitrators shall be appointed by the Cologne Chamber of Commerce
and Industry.
(a) EXCHANGE OF PROPOSALS. Within ten (10) days of the appointment
of the full arbitration panel, the Parties shall exchange
documents setting forth their final detailed proposals for
resolution of the matter in dispute, together with a brief or
other written memorandum supporting the merits of their final
proposal. The arbitration panel shall promptly convene a
hearing, at which time each Party shall have an agreed upon
time to argue and present witnesses in support of its final
proposal.
(b) GOVERNING LAW. In the event the arbitrators seek the guidance
of the law of any jurisdiction, the laws of Germany shall
govern.
(c) LANGUAGE. The language of the proceedings shall be in English.
(d) NOTIFICATION OF DECISION. The arbitrators shall make their
decision known to both Parties as quickly as possible by
delivering written notice of their decision to both Parties.
The Parties shall agree in writing to comply with the proposal
selected by the arbitration panel within five (5) days of
receipt of notice of such selection. The decision of the
arbitrators shall be final and binding on the Parties, and
specific performance may be ordered by any court of competent
jurisdiction.
(e) COSTS. The Parties shall bear their own costs in preparing for
the arbitration. The costs of the arbitrators shall be equally
divided between the Parties.
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14. MISCELLANEOUS
14.1 NOTICES.
All notices shall be in writing mailed via certified mail, return receipt
requested, courier, or facsimile transmission addressed as follows, or to such
other address as may be designated from time to time.
If to MILTENYI: Miltenyi Biotec GmbH
▇▇▇▇▇▇▇▇▇-▇▇▇▇▇-Str. 68
D-51429 Bergisch Gladbach
Germany
Attn: Stefan Miltenyi
Fax: ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
With a copy to: Miltenyi Biotec GmbH
▇▇▇▇▇▇▇▇▇-▇▇▇▇▇-▇▇▇. ▇▇
▇-▇▇▇▇▇ ▇▇▇▇▇▇▇▇ Gladbach
Germany
Attn: General Counsel
Fax: ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
If to VIACELL: ViaCell, Inc.
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn: ▇▇▇▇ ▇▇▇▇
Fax: ▇▇ ▇▇▇ ▇▇▇ ▇▇▇▇
With a copy to: Ropes & ▇▇▇▇ LLP
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▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
▇▇▇
Attn: ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
Fax: ▇▇ ▇▇▇ ▇▇▇ ▇▇▇▇
Notices shall be deemed given as of the date received. If facsimile
transmission is used, an additional means of notification shall be
used, however, notice shall be deemed to be given as of the date the
facsimile transmission was received.
14.2 GOVERNING LAW AND JURISDICTION. This Agreement shall be governed by and
construed in accordance with the laws of Germany, without regard to the
application of principles of conflicts of law.
14.3 BINDING EFFECT. Except as provided for in Section 14.14, as of the
Effective Date, this Agreement shall be binding upon and inure to the benefit of
the Parties and their respective legal representatives, successors and permitted
assigns.
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14.4 HEADINGS. Section and subsection headings are inserted for convenience of
reference only and do not form a part of this Agreement.
14.5 COUNTERPARTS. This Agreement may be executed simultaneously in two or more
counterparts, each of which shall be deemed an original.
14.6 AMENDMENT; WAIVER. This Agreement may be amended, modified, superseded or
canceled, and any of the terms may be waived, only by a written instrument
executed by each Party or, in the case of waiver, by the Party or Parties
waiving compliance. The delay or failure of any Party at any time or times to
require performance of any provisions shall in no manner affect the rights at a
later time to enforce the same. No waiver by any Party of any condition or of
the breach of any term contained in this Agreement, whether by conduct, or
otherwise, in any one or more instances, shall be deemed to be, or considered
as, a further or continuing waiver of any such condition or of the breach of
such term or any other term of this Agreement.
14.7 NO THIRD PARTY BENEFICIARIES. Except as set forth in Sections 11.1 and
11.2 hereof, no Third Party, including any employee of any Party to this
Agreement, shall have or acquire any rights by reason of this Agreement.
14.8 ASSIGNMENT. Neither this Agreement nor any obligation of a party hereunder
may be assigned by either party without the consent of the other.
14.9 FORCE MAJEURE. Neither MILTENYI nor VIACELL shall be liable for failure of
or delay in performing obligations set forth in this Agreement, and neither
shall be deemed in breach of its obligations, if such failure or delay is due to
natural disasters or any causes beyond the reasonable control of MILTENYI or
VIACELL. In event of such force majeure, the Party affected thereby shall use
reasonable efforts to cure or overcome the same and resume performance of its
obligations hereunder.
14.10 INTERPRETATION. The Parties hereto acknowledge and agree that: (i) each
Party and its counsel reviewed and negotiated the terms and provisions of this
Agreement and have contributed to its revision; (ii) the rule of construction to
the effect that any ambiguities are resolved against the drafting Party shall
not be employed in the interpretation of this Agreement; and (iii) the terms and
provisions of this Agreement shall be construed fairly as to all Parties hereto
and not in a favor of or against any Party, regardless of which Party was
generally responsible for the preparation of this Agreement.
14.11 INTEGRATION; SEVERABILITY. This Agreement is the sole agreement with
respect to the subject matter hereof and supersedes all other agreements and
understandings between the Parties with respect to same. If any provision of
this Agreement is or becomes invalid or is ruled invalid by any court of
competent jurisdiction or is deemed unenforceable, it is the intention of the
Parties that the remainder of the Agreement shall not be affected.
14.12 RELATIONSHIP OF THE PARTIES. Each of the Parties shall be independent
contractors with respect to each other, and the relationship established hereby
shall not constitute a partnership, joint venture, or agency. No Party shall
have the authority to make statements, representations or commitments of any
kind, or take any action, which shall be binding on any other Party, without the
express, prior, written consent of the Party to be so bound.
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14.13 FURTHER ASSURANCES. Each of MILTENYI and VIACELL agrees to duly execute
and deliver, or cause to be duly executed and delivered, such further
instruments and do and cause to be done such further acts and things, including,
without limitation, the filing of such additional assignments, agreements,
documents and instruments, that may be necessary or as the other Party hereby
may at any time and from time to time reasonably request in connection with this
Agreement or to carry out more effectively the provisions and purposes of, or to
better assure and confirm unto such other Party its rights and remedies under,
this Agreement.
14.14 SIMULTANEOUS EXECUTION OF THE AGREEMENT AND THE DEVELOPMENT AGREEMENT. The
Parties agree that they will execute and they will execute this Agreement
simultaneously with the Development Agreement and neither the Agreement nor the
Development Agreement shall become binding on any Party unless the Agreement and
the Development Agreement are executed by all parties to those agreements.
IT WITNESS WHEREOF, the Parties have caused this Agreement to be executed
by their duly authorized representatives.
MILTENYI BIOTEC GMBH
By: /s/ Stefan Miltenyi
_______________________
Name: Stefan Miltenyi
Title: Geschaftsfuhrer
Date:______________________
VIACELL, INC.
By: /s/ ▇▇▇▇ ▇▇▇▇
________________________
Name: ▇▇▇▇ ▇▇▇▇
Title: Chief Executive Officer
Date:_______________________
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EXHIBIT A
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