EX-10.2 SUPPPLY AGREEMENT DATED JANUARY 24, 2005

 

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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 Friedrich-Ebert-Str. 68, D-51429 Bergisch Gladbach, Germany

("MILTENYI") and ViaCell, Inc., having an address of 245 First Street, Fifteenth

Floor, Cambridge, MA 02142-1292 USA ("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.

 

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"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