|
|
|
|
Legal Resources
Business Contracts
MCLE Courses
Projects
Friends
|
Sample Business ContractsHome: Sample Business Contracts:
EXECUTION COPY
COLLABORATION AGREEMENT
BY AND BETWEEN
AMGEN INC.
AND
VIACELL, INC.
DECEMBER 23, 2003
<PAGE>
TABLE OF CONTENTS
ARTICLE 1, DEFINITIONS .................................................. 2
1.1 "AFFILIATE" ................................................... 2
1.2 "AMGEN KNOW-HOW" .............................................. 2
1.3 "AMGEN PATENT RIGHTS" ......................................... 2
1.4 "AMGEN TECHNOLOGY" ............................................ 2
1.5 "AMGEN TRADEMARKS" ............................................ 2
1.6 "CALENDAR QUARTER" ............................................ 2
1.7 "CALENDAR YEAR" ............................................... 3
1.8 "CELL THERAPY PRODUCT(S)" ..................................... 3
1.9 "CHANGE OF CONTROL" ........................................... 3
1.10 "CLINICAL TRIAL" .............................................. 3
1.11 "CMC" ......................................................... 3
1.12 "COLLABORATION PRODUCT(S)" .................................... 3
1.13 "COMMERCIAL EXPENDITURES" ..................................... 3
1.14 "COMMERCIAL PLAN" ............................................. 3
1.15 "COMMERCIALIZE" OR "COMMERCIALIZATION" ........................ 3
1.16 "COMMERCIALLY REASONABLE EFFORTS" ............................. 3
1.17 "CONFIDENTIAL INFORMATION" .................................... 4
1.18 "CONTRIBUTED PRODUCT" ......................................... 4
1.19 "CONTROL" OR "CONTROLLED" ..................................... 4
1.20 "COVERED ENTITY" .............................................. 4
1.21 "DERIVATIVE" .................................................. 5
1.22 "DETAIL" OR "DETAILING" ....................................... 5
1.23 "DEVELOPMENT" OR "DEVELOP" .................................... 6
1.24 "DEVELOPMENT PLAN" ............................................ 6
1.25 "DIRECT DEVELOPMENT COST" ..................................... 6
1.26 "DOLLAR" OR "$" ............................................... 6
1.27 "DRUG APPROVAL APPLICATION" ................................... 6
1.28 ""FDA" ........................................................ 6
1.29 "FIRST COMMERCIAL SALE" ....................................... 6
1.30 "FLT3-L" ...................................................... 7
1.31 "FORCE MAJEURE" ............................................... 7
1.32 "GAAP" ........................................................ 7
1.33 "IND" ......................................................... 7
1.34 "INFORMATION" ................................................. 7
1.35 ""JOINT KNOW-HOW" ............................................. 7
1.36 "JOINT PATENT RIGHTS" ......................................... 7
1.37 "LOSSES" ...................................................... 7
1.38 "MAJOR MARKET COUNTRY" ........................................ 7
1.39 "MANUFACTURING PLAN" .......................................... 7
1.40 "MANUFACTURING TRANSITION" .................................... 8
1.41 "MATERIALS" ................................................... 8
1.42 "NET SALES" ................................................... 8
1.43 "OPERATING PROFIT OR LOSS" .................................... 8
<PAGE>
1.44 "PATENT RIGHTS" ............................................... 8
1.45 "PIVOTAL TRIAL(S)" ............................................ 8
1.46 "POST-APPROVAL CLINICAL STUDIES" .............................. 8
1.47 "POST MARKETING APPROVAL STUDIES" ............................. 9
1.48 "PROCESS DEVELOPMENT/MANUFACTURING PLAN" ...................... 9
1.49 "PRODUCT LABELING" ............................................ 9
1.50 "PRODUCT TRADEMARK" ........................................... 9
1.51 "PROGRAM PLAN" ................................................ 9
1.52 "PROMOTE" OR "PROMOTION" OR "PROMOTING" OR "PROMOTIONAL" ...... 9
1.53 "PROMOTIONAL MATERIALS" ....................................... 9
1.54 "RECALL" OR "RECALLING" ....................................... 10
1.55 "REGULATORY APPROVAL" ......................................... 10
1.56 "REGULATORY AUTHORITY" ........................................ 10
1.57 "REGULATORY FILINGS" .......................................... 10
1.58 "REGULATORY PLAN": ............................................ 10
1.59 "REPRESENTATIVES" ............................................. 10
1.60 "SCF" ......................................................... 10
1.61 "TERRITORY" ................................................... 10
1.62 "THIRD PARTY" ................................................. 11
1.63 "TRANSITION DATE" ............................................. 11
1.64 "UNOPTIONED CELL THERAPY PRODUCT(S)" .......................... 11
1.65 "VIACELL KNOW-HOW" ............................................ 11
1.66 "VIACELL PATENT RIGHTS" ....................................... 11
1.67 "VIACELL TECHNOLOGY" .......................................... 11
1.68 "VIACELL TRADEMARKS" .......................................... 11
ARTICLE 2, COLLABORATION ACTIVITIES AND GOVERNANCE ...................... 11
2.1 DEVELOPMENT PRIOR TO OPTION EXERCISE .......................... 11
2.2 JOINT STEERING COMMITTEE ...................................... 11
2.3 JSC RESPONSIBILITIES .......................................... 11
2.4 JSC MEETING PREPARATION ....................................... 13
2.5 DECISION MAKING; ADMINISTRATIVE MATTERS ....................... 13
2.6 SCIENTIFIC ADVISORY BOARD ..................................... 15
ARTICLE 3, DEVELOPMENT .................................................. 15
3.1 VIACELL RESPONSIBILITIES ...................................... 15
3.2 AMGEN RESPONSIBILITIES ........................................ 15
3.3 ADDITIONAL AMGEN ASSISTANCE ................................... 16
3.4 DEVELOPMENT OBLIGATIONS ....................................... 16
3.5 INFORMATION AND DATA .......................................... 17
3.6 AUDIT ......................................................... 17
ARTICLE 4, AMGEN OPTION ................................................. 17
4.1 VIACELL REPORTING OBLIGATIONS ................................. 17
4.2 OPTION GRANT .................................................. 18
4.3 OPTION EXERCISE ............................................... 18
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
4.4 PAYMENT OF DEVELOPMENT COSTS .................................. 18
4.5 TRANSITION OF RESPONSIBILITIES ................................ 18
4.6 TRANSFERABILITY ............................................... 19
4.7 OPT-OUT ....................................................... 20
ARTICLE 5, REGULATORY ................................................... 20
5.1 REGULATORY PLAN ............................................... 20
5.2 REGULATORY LEAD ............................................... 20
5.3 RESPONSIBILITIES AND RIGHTS OF REGULATORY LEAS ................ 20
5.4 RIGHT TO CROSS-REFERENCE IND AND EQUIVALENT FOREIGN FILINGS ... 21
5.5 DRUG APPROVAL APPLICATIONS .................................... 21
5.6 TRANSFER OF REGULATORY FILINGS AND REGULATORY APPROVALS ....... 21
5.7 ADVERSE EVENT REPORTING; CUSTOMER COMPLAINTS .................. 21
5.8 COMMUNICATIONS ................................................ 22
5.9 APPLICATIONS FOR REGULATORY EXCLUSIVITY ....................... 23
5.10 RECALLS ....................................................... 23
5.11 MANUFACTURING ................................................. 24
5.12 COMPLIANCE WITH LAWS AND REGULATIONS .......................... 24
ARTICLE 6, COMMERCIALIZATION ............................................ 24
6.1 COMMERCIAL PLAN ............................................... 24
6.2 RESPONSIBILITIES AND RIGHTS OF AMGEN .......................... 24
6.3 MEDICAL AND OTHER INQUIRIES ................................... 25
6.4 PROMOTIONAL MATERIALS ......................................... 25
ARTICLE 7, MANUFACTURE AND SUPPLY ....................................... 26
7.1 MANUFACTURING PLAN ............................................ 26
7.2 RESPONSIBILITIES AND RIGHTS OF VIACELL ........................ 27
7.3 MANUFACTURE OF CONTRIBUTED PRODUCTS ........................... 30
7.4 LIMITATION ON APPLICATION OF SUPPLY TERMS ..................... 32
ARTICLE 8, COLLABORATION CONSIDERATION .................................. 32
8.1 LICENSE FEE ................................................... 32
8.2 MILESTONE PAYMENTS ............................................ 32
8.3 RELATED AGREEMENTS ............................................ 32
ARTICLE 9, PROGRAM PLAN; OPERATING PROFIT OR LOSS ....................... 32
9.1 OPERATING PROFIT OR LOSS SHARING .............................. 32
9.2 ACCOUNTING AND REPORTING OF COLLABORATION PROFITS AND LOSSES .. 32
ARTICLE 10, INTELLECTUAL PROPERTY ....................................... 33
10.1 TECHNOLOGY OWNERSHIP .......................................... 33
10.2 CONTRIBUTED PRODUCT LICENSES; SUBLICENSE RIGHTS ............... 34
10.3 COLLABORATION PRODUCT LICENSE; SUBLICENSE RIGHTS .............. 34
10.4 PASS THROUGH RESTRICTIONS ..................................... 35
10.5 TRADEMARK LICENSE ............................................. 35
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
3
<PAGE>
10.6 PROSECUTION ................................................... 36
10.7 INFRINGEMENT OF PATENT RIGHTS AND PRODUCT TRADEMARKS .......... 38
10.8 INFRINGEMENT OF THIRD PARTY RIGHTS ............................ 39
10.9 COOPERATION ................................................... 39
10.10 TECHNICAL ASSISTANCE .......................................... 40
10.11 EMPLOYEE OBLIGATIONS .......................................... 40
10.12 PATENT MARKING ................................................ 40
10.13 THIRD PARTY RESEARCH AGREEMENTS ............................... 41
10.14 NO IMPLIED LICENSES ........................................... 41
ARTICLE 11, PAYMENTS; RECORDS; AUDIT .................................... 41
11.1 PAYMENTS ...................................................... 41
11.2 TAXES ......................................................... 42
11.3 RECORDS; AUDIT ................................................ 42
ARTICLE 12, PUBLICATIONS ................................................ 43
12.1 PROCEDURE ..................................................... 43
12.2 CREDIT ........................................................ 43
ARTICLE 13, CONFIDENTIALITY ............................................. 44
13.1 TREATMENT OF CONFIDENTIAL INFORMATION ......................... 44
13.2 AUTHORIZED DISCLOSURE ......................................... 44
13.3 TRANSFER OF MATERIALS ......................................... 45
13.4 PUBLICITY; TERMS OF AGREEMENT ................................. 45
ARTICLE 14, REPRESENTATIONS, WARRANTIES AND COVENANTS ................... 46
14.1 MUTUAL REPRESENTATIONS AND WARRANTIES ......................... 46
14.2 MUTUAL COVENANTS .............................................. 46
14.3 ADDITIONAL REPRESENTATIONS, WARRANTIES AND COVENANTS OF VIACELL 47
14.4 ADDITIONAL REPRESENTATIONS, WARRANTIES AND COVENANTS OF AMGEN . 48
14.5 DISCLAIMERS ................................................... 48
ARTICLE 15, INDEMNIFICATION ............................................. 48
15.1 INDEMNIFICATION BY AMGEN ...................................... 48
15.2 INDEMNIFICATION BY VIACELL .................................... 49
15.3 JOINT LIABILITY ............................................... 49
15.4 INSURANCE ..................................................... 50
15.5 LIMITATION OF LIABILITY ....................................... 50
ARTICLE 16, TERM AND TERMINATION ........................................ 51
16.1 TERM .......................................................... 51
16.2 TERMINATION FOR DILIGENCE FAILURE ............................. 51
16.3 MUTUAL CONSENT ................................................ 51
16.4 TERMINATION FOR DEFAULT ....................................... 51
16.5 BANKRUPTCY .................................................... 52
16.6 EFFECTS OF TERMINATION ........................................ 52
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
4
<PAGE>
16.7 TRANSITION .................................................... 53
16.8 ACCRUED RIGHTS ................................................ 53
ARTICLE 17, DISPUTE RESOLUTION .......................................... 53
17.1 DISPUTES ...................................................... 53
17.2 GOVERNING LAW; JUDICIAL RESOLUTION ............................ 54
ARTICLE 18, GENERAL ..................................................... 54
18.1 FORCE MAJEURE ................................................. 54
18.2 NOTICES ....................................................... 54
18.3 MAINTENANCE OF RECORDS ........................................ 55
18.4 NO STRICT CONSTRUCTION ........................................ 55
18.5 PERFORMANCE BY AFFILIATES ..................................... 55
18.6 SUBCONTRACTING ................................................ 56
18.7 ASSIGNMENT .................................................... 56
18.8 COUNTERPARTS .................................................. 56
18.9 SEVERABILITY .................................................. 56
18.10 HEADINGS ...................................................... 57
18.11 FURTHER ACTIONS ............................................... 57
18.12 INDEPENDENT CONTRACTORS ....................................... 57
18.13 NO BENEFIT OF THIRD PARTIES ................................... 57
18.14 USE OF NAMES, LOGOS OR SYMBOLS ................................ 57
18.15 NO WAIVER ..................................................... 57
18.16 OFFSET ........................................................ 57
18.17 EXPORT REQUIREMENTS ........................................... 58
18.18 ENTIRE AGREEMENT; AMENDMENT ................................... 58
18.19 EXHIBITS AND SCHEDULES ........................................ 58
EXHIBIT A, AMGEN PATENT RIGHTS AS OF THE EFFECTIVE DATE.................. A-1
EXHIBIT B, ALLOWABLE COLLABORATION EXPENDITURES TO THE
OPERATING PROFIT AND LOSS ACCOUNT............................. B-1
EXHIBIT C, COVERED ENTITIES.............................................. C-1
EXHIBIT D, ADDITIONAL CONTRIBUTED PRODUCTS............................... D-1
EXHIBIT E, FLT3 LIGAND AMINO ACID SEQUENCE............................... E-1
EXHIBIT F, SCF AMINO ACID SEQUENCE....................................... F-1
EXHIBIT G, VIACELL PATENT RIGHTS......................................... G-1
EXHIBIT H, VIACELL TRADEMARKS............................................ H-1
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
5
<PAGE>
COLLABORATION AGREEMENT
THIS COLLABORATION AGREEMENT (the "Agreement") is made effective as of
December 23, 2003 (the "Effective Date") by and between AMGEN INC., a Delaware
corporation having its principal place of business at One Amgen Center Drive,
Thousand Oaks, California 91320-1799 ("Amgen"), and VIACELL, INC., a Delaware
corporation having its principal place of business at 131 Clarendon Street,
Boston, Massachusetts 02116 ("ViaCell"). Amgen and ViaCell are sometimes
referred to herein individually as a "Party" and collectively as the "Parties".
RECITALS
WHEREAS, Amgen is a biopharmaceutical company with experience in the
research, development, manufacture, and commercialization of biotechnology and
pharmaceutical products for the treatment of human diseases;
WHEREAS, ViaCell is a development stage cellular medicine company that has
expertise and technology relating to the use of stem cells in the production of
cell therapy products;
WHEREAS, Amgen has developed certain technology and know-how that relates
to human proteins known as SCF and Flt3-L, which may be useful in the production
of ViaCell's cell therapy products;
WHEREAS, ViaCell has technology, know-how, experience and expertise in the
research and development of ex vivo cell culture and cell therapy products that
may be improved or made possible by the use of SCF and Flt3-L;
WHEREAS, ViaCell now wishes to obtain supplies of and a license under
Amgen's intellectual property rights in SCF and Flt3-L for use in ViaCell's
research and development activities relating to cell therapy products and
services;
WHEREAS, the parties may wish to collaborate in the future with respect to
late stage clinical trials and commercialization of ViaCell's cell therapy
products on the terms and conditions set forth herein;
WHEREAS, concurrently with the execution of this Agreement the Parties are
entering into a Securities Purchase Agreement whereby Amgen is making an equity
investment in ViaCell;
NOW THEREFORE, based on the foregoing premises and the mutual covenants
and obligations set forth below, the Parties agree as follows:
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
1
<PAGE>
ARTICLE 1
DEFINITIONS
Capitalized terms used but not otherwise defined in this Agreement
(including in Exhibit B attached hereto) have the meanings set forth below:
1.1 "AFFILIATE" shall mean, except as provided below, an individual, a
partnership, a joint venture, a corporation, a trust, an estate, an
unincorporated organization, a government or any department or agency thereof,
or any other entity or any combination of the aforementioned entities that,
directly or indirectly through one or more intermediaries, controls, is
controlled by or is under common control with a Party. For purposes of this
definition, "control" shall mean the possession, direct or indirect, of the
power to cause the direction of the management and policies of a Party, whether
through ownership of more than fifty percent (50%) of the voting securities of
such Party, by contract or otherwise.
1.2 "AMGEN KNOW-HOW" shall mean all Information and Material Controlled by
Amgen on or following the Effective Date necessary to Develop, manufacture or
Commercialize Cell Therapy Products, Collaboration Products or Unoptioned Cell
Therapy Products, including but not limited to the following information: (1)
information disclosed in an IND for SCF and/or Flt3-L as of the Effective Date;
(2) information disclosed as of the Effective Date in any IND supplements for
SCF and/or Flt3-L; (3) all Amgen-sponsored collaborator data and results
(subject to any contractual confidentiality obligations of Amgen to Third
Parties regarding such results) that Amgen elects to and does provide to
ViaCell; (4) any regulatory data that Amgen elects to and does provide to
ViaCell; (5) sequence information or other technical information and trade
secrets relating to any Amgen Materials and information regarding their
structure, function and activity that Amgen elects to and does provide to
ViaCell; and (6) such other information that Amgen elects to and does disclose
to ViaCell, in each case that Amgen expressly designates in writing as
"confidential" or "proprietary" or that it otherwise designates as Amgen
Know-How under this Agreement; provided however, that Amgen Know-How shall
exclude Joint Know-How.
1.3 "AMGEN PATENT RIGHTS" shall mean Amgen's rights in those Patent Rights
Controlled by Amgen on or following the Effective Date necessary to make or use
each Contributed Product including without limitation those patents and patent
applications listed in Exhibit A.
1.4 "AMGEN TECHNOLOGY" shall mean all Amgen Patent Rights and Amgen
Know-How.
1.5 "AMGEN TRADEMARKS" shall mean any and all corporate names, service
marks, logos or trademarks and trademark applications (whether or not
registered) together with all good will associated therewith, and any renewals,
extensions or modifications thereto either filed or used by Amgen.
1.6 "CALENDAR QUARTER" shall mean the respective periods of three (3)
consecutive calendar months ending on either March 31, June 30, September 30, or
December 31 for so long as this Agreement is in effect.
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
2
<PAGE>
1.7 "CALENDAR YEAR" shall mean each successive period of twelve (12)
months commencing on January 1 and ending on December 31.
1.8 "CELL THERAPY PRODUCT(S)" shall mean any treatment, whether a product
or a service, that utilizes cells or tissues that are manipulated and/or
expanded ex vivo, prior to use as a therapeutic agent to treat any injury,
disease or other condition, and which includes or is produced using a
Contributed Product, including without limitation, CB001, prior to the earlier
of the exercise of the Option or the expiration of the Option Period with
respect to such treatment. For the avoidance of doubt, once Amgen exercises its
Option with respect to a Cell Therapy Product, such Cell Therapy Product shall
be deemed a Collaboration Product and shall cease to be considered a Cell
Therapy Product. For the avoidance of doubt, once the Option Period expires
with respect to a Cell Therapy Product for an indication such Cell Therapy
Product for that indication shall be deemed an Unoptioned Cell Therapy Product
and shall cease to be considered a Cell Therapy Product.
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
3
<PAGE>
1.9 "CHANGE OF CONTROL" shall mean that ViaCell entered into a transaction
resulting in a transfer of [**] or more of the outstanding shares of ViaCell to
a Covered Entity.
1.10 "CLINICAL TRIAL" shall mean any study to evaluate the safety and/or
the efficacy of a Cell Therapy Product or a Collaboration Product in humans,
including, without limitation a phase 1, phase 2, phase 3, phase 4 or other
clinical trial performed by or on behalf of either party.
1.11 "CMC" shall mean the Chemistry Manufacturing Control section of a
Regulatory Filing.
1.12 "COLLABORATION PRODUCT(S)" shall mean any Cell Therapy Product that
is developed or manufactured using a Contributed Product or any Derivative and
with respect to which Amgen exercised its Option.
1.13 "COMMERCIAL EXPENDITURES" shall have the meaning set forth in Exhibit
B.
1.14 "COMMERCIAL PLAN" shall mean the comprehensive plan and overall
strategy, and any updates thereto, for the Commercialization of Collaboration
Products (in accordance with customary standards for a product of comparable
market potential) including, without limitation, regulatory activities after the
Transition Date, Promotion, Detailing and other pre-launch and post-launch
marketing and sales activities. The Commercial Plan shall include, but not be
limited to, a reasonably detailed description of the schedule of work
activities, responsibility for the work activities and an associated budget.
1.15 "COMMERCIALIZE" OR "COMMERCIALIZATION" shall mean all activities
(including the preparation and filing of Drug Approval Applications) relating to
the Promotion, Detailing, and other pre-launch and post-launch marketing and
sale activities of a Collaboration Product and shall include, without
limitation, Post-Approval Clinical Studies and regulatory affairs related to the
foregoing.
1.16 "COMMERCIALLY REASONABLE EFFORTS" shall mean the level of efforts and
resources required to develop, manufacture or commercialize a Collaboration
Product in a sustained manner consistent with the efforts a similarly situated
biopharmaceutical company would typically devote to a product of similar market
potential, profit potential or strategic value resulting from its own research
efforts, based on conditions then prevailing. Commercially Reasonable Efforts
shall be determined on a country-by-country (each country including its
territories) basis for a particular Collaboration Product, and it is anticipated
that the level of effort will change over time reflecting changes in the status
of the Collaboration Product and the country (including its territories)
involved.
1.17 "CONFIDENTIAL INFORMATION" shall mean, subject to the exceptions set
forth in the following sentence, any all Information received by either Party
("receiving Party") from the other Party ("disclosing Party") pursuant to this
Agreement that the disclosing Party has either marked as confidential or
proprietary, or has identified in writing as confidential or proprietary within
[**] after disclosure to the receiving Party in a non-written form.
"Confidential Information" shall not include any Information which:
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
(A) is publicly disclosed by the disclosing Party, either before or
after it becomes known to the receiving Party;
(B) was known to the receiving Party, without obligation to keep it
confidential, prior to when it was received from the disclosing Party;
(C) is subsequently disclosed to the receiving Party by a Third
Party lawfully in possession thereof without obligation to keep it confidential;
(D) has been publicly disclosed other than by the disclosing Party
and without breach of an obligation of confidentiality with respect thereto; or
(E) has been independently developed by the receiving Party without
the aid, application, reference to or use of Confidential Information, as
demonstrated by competent written proof.
1.18 "CONTRIBUTED PRODUCT" shall mean (a) SCF, (b) Flt3-L and (c) any
cytokine or other Amgen Know-How or Material that Amgen Controls and which Amgen
has, in its sole discretion chosen to make available to ViaCell under this
Agreement, and which ViaCell has expressly accepted for use in connection with
Unoptioned Cell Therapy Products, Cell Therapy Products and/or Collaboration
Products under this Agreement, as listed on Exhibit D, as updated from time to
time by mutual agreement of the Parties.
1.19 "CONTROL" OR "CONTROLLED" shall mean possession of the ability to
grant a license or sublicense as provided for herein under valid and subsisting
intellectual property rights without violating the terms of any agreement or
other arrangement with any Third Party or applicable law.
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission. 2
<PAGE>
1.20 "COVERED ENTITY" shall mean a company that (i) Amgen can reasonably
demonstrate is or was involved, within the previous [**] including, without
limitation, those listed on Exhibit C, (ii) has a Market Capitalization of less
than $[**] or (iii) has a Market Capitalization of more than $[**] and [**]. For
purposes of this definition, "Market Capitalization" of a company shall mean (A)
if the company's common equity is publicly traded, the value of the outstanding
common equity based on (1) if the common equity is listed or admitted to trade
on a national securities exchange, the [**] closing price of the company's
common equity on the principal national securities exchange on which it is so
listed or admitted to trade [**], as published in the Wall Street Journal; (2)
if the common equity is not listed or admitted to trade on a national securities
exchange, the average of the closing price for the company's common equity [**],
as furnished by the National Association of Securities Dealers, Inc. ("NASD")
through the NASDAQ National Market Reporting System or a similar organization if
the NASD is no longer reporting such information; or (3) if the company's common
equity is not listed or admitted to trade on a national securities exchange and
is not reported on the National Market Reporting System, [**], as furnished by
the NASD or a similar organization; or (B) if the company's common equity is not
publicly traded and the NASD or a similar organization does not furnish the mean
between the bid and asked prices for the company's common equity, the fair
market value of the company's outstanding common equity [**].
1.21 "DERIVATIVE" shall mean any modification of a Contributed Product,
wherein the modification is covered by one or more Patent Rights Controlled by
or licensed to Amgen.
1.22 "DETAIL" OR "DETAILING" shall mean, with respect to a Collaboration
Product, an interactive face-to-face visit by a Party's sales representative
with a physician, designated by the Commercial Lead as a member of the target
call audience, at his or her office, at hospitals or at other locations
(excluding exhibits, displays and other forms of communication not involving
face-to-face contact by such sales representative), during which indicated uses,
safety, effectiveness, contraindications, side effects, warnings and/or other
relevant characteristics of a Collaboration Product as approved by a Regulatory
Authority are described in a fair and balanced manner consistent with the FD&C
Act (or equivalent laws in the Territory), as applicable, including, but not
limited to, the regulations at 21 CFR Part 202 and using, as necessary or
desirable, the Product Labeling (as defined herein) or the Promotional Materials
(as defined herein), in an effort to increase physician prescribing preferences
of such Collaboration Product for its approved indicated uses.
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
1.23 "DEVELOPMENT" OR "DEVELOP" shall mean all clinical development
activities undertaken to obtain Regulatory Approval for a Cell Therapy Product
or Collaboration Product in an indication in the Territory. For the avoidance of
doubt, these activities shall include clinical studies and clinical drug
development activities, including among other things: test method development
and stability testing, toxicology, formulation, process development, statistical
analysis and report writing, product approval and registration, and regulatory
affairs related to the foregoing. When used as a verb, "Develop" means to engage
in Development.
1.24 "DEVELOPMENT PLAN" shall mean the comprehensive plan, overall
strategy and timelines, and any updates thereto, for the Development of Cell
Therapy Products and Collaboration Products (in accordance with customary
standards for a product of comparable market potential) including, without
limitation, the research, preclinical research, clinical studies, development/
manufacturing, clinical and regulatory activities required to obtain Regulatory
Approval(s) in the Territory. The Development Plan shall include, but not be
limited to, a reasonably detailed description of the schedule of work
activities, responsibility for the work activities and an associated budget.
1.25 "DIRECT DEVELOPMENT COST" shall mean (i) actual Third Party charges
and fees paid by ViaCell for the performance of clinical development of Cell
Therapy Products, which become Collaboration Products upon Amgen exercising its
Option, (ii) ViaCell's labor cost directly related to clinical development of
Cell Therapy Products, which become Collaboration Products upon Amgen exercising
its Option, and (iii) ViaCell's labor cost and actual Third Party charges and
fees paid by ViaCell for the manufacture of Cell Therapy Products, which become
Collaboration Products upon Amgen exercising its Option [**]. All ViaCell labor
costs included under "Direct Development Cost" shall be charged at [**].
1.26 "DOLLAR" OR "$" shall mean a United States dollar.
1.27 "DRUG APPROVAL APPLICATION" shall mean an application for Regulatory
Approval required before commercial sale or use of a Collaboration Product as a
drug or to treat a particular indication in a regulatory jurisdiction, including
without limitation: (a) (i) a Biologics License Application (BLA) pursuant to 21
C.F.R. 601.2, submitted to the FDA or any successor application or procedure and
(ii) any counterpart of a U.S. BLA in another country in the Territory; and (b)
all supplements and amendments, including supplemental Biologics License
Applications (and any foreign counterparts) that may be filed (e.g., to expand
the label) with respect to the foregoing.
1.28 "FDA" shall mean the United States Food and Drug Administration, or
any successor thereto.
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
1.29 "FIRST COMMERCIAL SALE" shall mean the initial transfer by a Party of
a Collaboration Product to a Third Party for any indication in exchange for cash
or some other consideration to which value can be assigned, following Regulatory
Approval to market such Collaboration Product.
1.30 "FLT3-L" shall mean shall mean Amgen's Flt3 Ligand, a hematopoietic
growth factor, having the amino acid sequence which is set forth in Exhibit E.
1.31 "FORCE MAJEURE" shall mean any occurrence beyond the reasonable
control of a Party that prevents or substantially interferes with the
performance by the Party of any of its obligations hereunder, if such occurs by
reason of any act of God, flood, fire, explosion, earthquake, breakdown of
plant, shortage of critical equipment, loss or unavailability of manufacturing
facilities or material, strike, lockout, labor dispute, casualty or accident, or
war, revolution, civil commotion, acts of public enemies, blockage or embargo,
or any injunction, law, order, proclamation, regulation, ordinance, demand or
requirement of any government or of any subdivision, authority or representative
of any such government, inability to procure or use materials, labor, equipment,
transportation or energy sufficient to meet manufacturing needs without the
necessity of allocation, or any other cause whatsoever, whether similar or
dissimilar to those above enumerated, beyond the reasonable control of such
Party, if and only if the Party affected shall have used reasonable efforts to
avoid such occurrence and to remedy it promptly if it shall have occurred.
1.32 "GAAP" shall mean United States generally accepted accounting
principles.
1.33 "IND" shall mean an Investigational New Drug application.
1.34 "INFORMATION" shall mean all tangible and intangible techniques,
technology, practices, trade secrets, inventions (whether patentable or not),
methods, knowledge, know-how, conclusions, skill, experience, test data and
results (including pharmacological, toxicological and clinical test data and
results), analytical and quality control data, results or descriptions, software
and algorithms.
1.35 "JOINT KNOW-HOW" shall mean Information and Materials characterized,
conceived, developed, derived, generated or identified jointly by employees of
or consultants to ViaCell and employees of or consultants to Amgen from the
Effective Date through the Term in the course of performing obligations or
exercising rights under this Agreement.
1.36 "JOINT PATENT RIGHTS" shall mean all Patent Rights that claim or
disclose Joint Know-How.
1.37 "LOSSES" shall mean liabilities, costs, fees, expenses and/or losses,
including without limitation reasonable legal costs, expenses and attorneys'
fees for outside counsel.
1.38 "MAJOR MARKET COUNTRY" shall mean the United States, United Kingdom,
Italy, Germany, France or Japan.
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
1.39 "MANUFACTURING PLAN" shall mean the comprehensive plan, overall
strategy and timelines, and any updates thereto, for the manufacture of Cell
Therapy Products and Collaboration Products. The Manufacturing Plan shall
include, but not be limited to, a reasonably detailed description of the
schedule of work activities, responsibility for the work activities and an
associated budget.
1.40 "MANUFACTURING TRANSITION" shall mean the process and change in the
rights and responsibilities of the Parties described in Section 7.2(g) of this
Agreement.
1.41 "MATERIALS" shall mean biological materials including, but not
limited to, Contributed Products, screens, animal models, cell lines, cells,
nucleic acids, receptors, cytokines, proteins, reagents and other molecules.
1.42 "NET SALES" shall mean all revenues recognized in accordance with
GAAP from the sale or other disposition of Collaboration Products by Amgen,
ViaCell or their respective Affiliates to a Third Party after deducting returns
and allowances (actually paid or allowed) including, [**]. Amounts received by a
Party or its Affiliates for the sale of Collaboration Products to such Party or
its Affiliates for resale shall not be included in the computation of Net Sales
hereunder.
1.43 "OPERATING PROFIT OR LOSS" shall mean, for any period, the total Net
Sales of Collaboration Products less the sum of Allowed Expenditures.
<PAGE>
1.44 "PATENT RIGHTS" shall mean (i) a pending application for a patent,
including without limitation any provisional, converted provisional, continued
prosecution application, continuation, divisional or continuation-in-part
thereof; or (ii) an issued, unexpired patent (with the term "patent" being
deemed to encompass, without limitation, an inventor's certificate) which has
not been held invalid or unenforceable by a court of competent jurisdiction from
which no appeal can be taken or has been taken within the required time period,
including without limitation any substitution, extension, registration,
confirmation, reissue, re-examination, renewal or any like filing thereof.
1.45 "PIVOTAL TRIAL(S)" shall mean those clinical trials on sufficient
numbers of patients that, if the defined end-points are met, are designed (and
agreed to by the FDA, or other Regulatory Authorities in the Territory) based
upon existing data in the same patient population as of the start of the trial
to definitively establish that a drug is safe and efficacious for its intended
use, and to define warnings, precautions and adverse reactions that are
associated with the drug in the dosage range to be prescribed, and which provide
pivotal data supporting Regulatory Approval of such drug or label expansion of
such drug and that satisfy the requirements of 21 CFR 321.21(c), or its
successor regulation, or an equivalent foreign clinical trial.
1.46 "POST-APPROVAL CLINICAL STUDIES" shall mean those clinical studies,
after Regulatory Approval of a Collaboration Product, approved by the JSC
including, but not limited to, Post Marketing Approval Studies, pharmacoeconomic
studies, pharmacoepidemiology studies, and investigator sponsored clinical
studies and, to the extent requested or modified from time to time, safety
surveillance studies.
1.47 "POST MARKETING APPROVAL STUDIES" shall mean those clinical trials,
including safety surveillance studies, conducted under an IND which are agreed
upon by the Commercial Lead and a Regulatory Authority as a condition of
approval or maintenance of approval of a Drug Approval Application for a
Collaboration Product, as the case may be, other than patient registries of
other than a passive, non-interventional nature.
1.48 "PROCESS DEVELOPMENT/MANUFACTURING PLAN" shall mean the comprehensive
plan and overall strategy, and any updates thereto, for process
development/manufacturing scale-up, manufacture, formulation, filling and/or
shipping of selected Collaboration Products (in accordance with customary
standards for a product of comparable market potential). The Process
Development/Manufacturing Plan shall include, but not be limited to, (i) a
reasonably detailed description of the schedule of work activities,
responsibility for the work activities and an associated budget of Collaboration
Products prior to completion of any Pivotal Trial therewith and (ii) a
reasonably detailed description of the schedule of work activities,
responsibility for the work activities and an associated budget of Collaboration
Products upon or after completion of any Pivotal Trial therewith.
1.49 "PRODUCT LABELING" shall mean (a) the Regulatory Authority-approved
full prescribing information of a Collaboration Product, including any required
patient information
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
and (b) all labels and other written, printed or graphic matter upon any
container, wrapper or any package insert or outsert utilized with or for a
Collaboration Product.
1.50 "PRODUCT TRADEMARK" shall mean any trademarks and trade names (and
trademark applications (whether or not registered) together with all goodwill
associated therewith, and any renewals, extensions or modifications thereto in
the Territory), trade dress and packaging, in each case, which are applied to or
used with Collaboration Products or any Promotional Materials. "Product
Trademark" shall not include the marks AMGEN or VIACELL.
1.51 "PROGRAM PLAN" shall mean the comprehensive plan and overall
strategy, and any updates thereto, for the Development and manufacture of Cell
Therapy Products and the Commercialization of Collaboration Products. The
Program Plan shall be comprised of the Development Plan, Manufacturing Plan,
Regulatory Plan, Commercial Plan and other allowable activities (and Other
Allowed Expenditures) and an associated budget for the foregoing.
1.52 "PROMOTE" OR "PROMOTION" OR "PROMOTING" OR "PROMOTIONAL" shall mean,
with respect to a Collaboration Product, those activities and obligations other
than Detailing undertaken by a Party to encourage sales of such Collaboration
Product including, but not limited to, journal advertising, direct mail
programs, direct-to-consumer advertising, education, convention exhibits, and
other forms of advertising, promotion and any other communication specified in
any Commercial Plan.
1.53 "PROMOTIONAL MATERIALS" shall mean all sales representative training
materials and all written, printed, graphic, electronic, audio or video matter
including, but not limited to, journal advertisements, sales visual aids, direct
mail, direct-to-consumer advertising, Internet postings, broadcast
advertisements, and sales reminder aids (e.g., scratch pads, pens and other such
items) intended for use or used by a Party in connection with any Promotion (as
defined herein) or Detailing of a Collaboration Product, except Product
Labeling.
1.54 "RECALL" OR "RECALLING" shall mean an event, incident or circumstance
which may result in the need for a "recall" or "market withdrawal" (as such
terms are defined in U.S. regulations in 21 CFR 7.3 or other similar national,
state or local law or regulations) or field alert or field correction of a
Collaboration Product or any lots thereof.
1.55 "REGULATORY APPROVAL" shall mean any approvals (including
supplements, amendments, pre- and post-approvals and price approvals), licenses,
registrations or authorizations (including designations of a Collaboration
Product as an "Orphan Product" under the Orphan Drug Act), howsoever called, of
any Regulatory Authority, which are necessary for the distribution, importation,
exportation, manufacture, production, use, storage, transport or clinical
testing and/or sale of a Cell Therapy Product or Collaboration Product in a
regulatory jurisdiction. Regulatory Approval shall not include any site license
for an Amgen manufacturing facility.
1.56 "REGULATORY AUTHORITY" shall mean the FDA or any counterpart of the
FDA outside the United States, or other national, supra-national, regional,
state or local regulatory agency, department, bureau, commission, council or
other governmental entity with authority
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
over the distribution, importation, exportation, manufacture, production, use,
storage, transport or clinical testing and/or sale of a Cell Therapy Product or
Collaboration Product.
1.57 "REGULATORY FILINGS" shall mean, collectively, INDs, BLAs,
establishment license applications (ELAs) and drug master files (DMFs),
applications for designation of a Collaboration Product as an "Orphan
Product(s)" under the Orphan Drug Act or any other similar filings (including
any foreign equivalents and further including any related correspondence and
discussions), and all data contained therein, as may be required by the FDA or
equivalent foreign Regulatory Authorities for the Development, manufacture or
Commercialization of a Cell Therapy Product or Collaboration Product.
1.58 "REGULATORY PLAN" shall mean the comprehensive plan or plans and
overall strategy, and any updates thereto, for preparing and filing any and all
Regulatory Filings regarding Cell Therapy Products or Collaboration Products (in
accordance with customary standards for a product of comparable market
potential) and for communications with Regulatory Authorities, including all
interactions with respect to such Regulatory Filings. The Regulatory Plan shall
include, but not be limited to, a reasonably detailed description of the
schedule of the work activities, responsibility for the work activities and an
associated budget.
1.59 "REPRESENTATIVES" of a party shall mean all directors, officers,
employees, agents and advisors (including, without limitation, attorneys,
accountants, investment bankers and financial advisors) of such party and the
Affiliates of such party.
1.60 "SCF" shall mean Amgen's Stem Cell Factor, an early-acting
hematopoietic growth factor, having the amino acid sequence which is set forth
in Exhibit F plus or minus a methionine at position -1.
1.61 "TERRITORY" shall mean the world.
1.62 "THIRD PARTY" shall mean any individual, partnership, joint venture,
corporation, trust, estate, unincorporated organization, government or any
department or agency thereof, or any other entity other than Amgen or ViaCell or
an Affiliate of either of them.
1.63 "TRANSITION DATE" shall mean, with respect to a Collaboration
Product, the date that is [**] regarding such Collaboration Product.
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
1.64 "UNOPTIONED CELL THERAPY PRODUCT(S)" shall mean any Cell Therapy
Product for an indication for which the Option Period has expired.
1.65 "VIACELL KNOW-HOW" shall mean all Information and Materials
Controlled by ViaCell on or following the Effective Date necessary to Develop,
manufacture or Commercialize Collaboration Products. "ViaCell Know-How" shall
not include Joint Know-How.
1.66 "VIACELL PATENT RIGHTS" shall mean ViaCell's rights on or following
the Effective Date in all Patent Rights in force throughout the Territory having
at least one valid and enforceable claim covering the composition, manufacture
or use of Cell Therapy Products and/or Collaboration Products, including without
limitation those patents and patent applications listed in Exhibit G. "ViaCell
Patent Rights" shall not include Joint Patent Rights.
1.67 "VIACELL TECHNOLOGY" shall mean all ViaCell Patent Rights and ViaCell
Know-How.
1.68 "VIACELL TRADEMARKS" shall mean any and all corporate names, service
marks, logos or trademarks and trademark applications (whether or not
registered) together with all good will associated therewith, and any renewals,
extensions or modifications thereto either filed or used by ViaCell and listed
on Exhibit H, as updated from time to time by ViaCell.
ARTICLE 2
COLLABORATION ACTIVITIES AND GOVERNANCE
2.1 DEVELOPMENT PRIOR TO OPTION EXERCISE. ViaCell shall engage in research
and development activities with the goal of developing Cell Therapy Products.
Such research and development may, consistent with the terms of the licenses set
forth in this Agreement, include the use of the Contributed Products.
2.2 JOINT STEERING COMMITTEE. As soon as practicable following the
Effective Date, the Parties shall establish a Joint Steering Committee (the
"JSC") comprised of [**] officers or managers from each of ViaCell and Amgen.
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
2.3 JSC RESPONSIBILITIES. The JSC shall be responsible for overseeing and
managing the collaboration with respect to Cell Therapy Products and
Collaboration Products, including, without limitation the following functions:
(A) The JSC shall meet at least twice per Calendar Year. Such
meetings shall alternate between Amgen and ViaCell locations and be held at such
times as are agreed upon by the JSC. At least one JSC meeting per year shall be
conducted in person, whereas other JSC meetings may be held in person or by
video conference or teleconference. The first meeting shall be held at Amgen's
facilities within [**] of the Effective Date, and the agenda for such meeting
shall include a review of a program plan for 2004 including a budget for Direct
Development Costs for CB001 and any other Cell Therapy Products. If a Party's
representative is unable to attend a meeting, such Party may designate an
alternate representative to attend such meeting. In addition, each Party may, at
its discretion (and with the consent of the other Party, not to be unreasonably
withheld), invite additional employees, consultants or scientific advisors to
attend any JSC meetings.
(B) The JSC shall review and discuss the progress of ViaCell's
Development and manufacturing of Cell Therapy Products and, if applicable,
Amgen's Development and Commercialization and ViaCell's manufacturing of
Collaboration Products, including review of plans, budgets, clinical trial
designs, data, results and other information in appropriate detail to enable the
JSC members to meaningfully monitor the progress of the Development,
manufacturing and Commercialization efforts of the Parties and to provide advice
and feedback relating thereto.
(C) The JSC shall consider the applicability and usefulness of any
Materials that a Third Party or Amgen may (in its sole discretion) choose to
make available to ViaCell for use in producing or using the Cell Therapy
Products and/or the Collaboration Products.
(D) Each year at the first JSC Meeting after the beginning of
ViaCell's fiscal year the JSC shall review an annual budget for projected Direct
Development Costs for each Cell Therapy Product for the following year prepared
by ViaCell in conjunction with ViaCell's annual budget process. At the first JSC
meeting after the end of ViaCell's fiscal year, the JSC shall review and
reconcile the actual Direct Development Costs for each Cell Therapy Product to
the budget previously reviewed. Upon approval by the JSC of the budget and the
reconciliation, such approvals shall be noted in the minutes of the JSC meeting.
[**].
(E) For Collaboration Products, each Party shall submit to the JSC
for review prior to the end of [**] its [**] plans and budgets in draft form
covering activities for which it is responsible. [**].
(F) The JSC shall perform such other functions as appropriate to
further the purposes of the collaboration pursuant to the terms and conditions
of this Agreement.
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
The JSC shall not have the authority to require Amgen or ViaCell to
undertake or modify any activities for which such Party is responsible under
this Agreement. Further, notwithstanding the above responsibilities of the JSC,
nothing in this Section 2.3 shall erode or detract from each Party's rights and
responsibilities for Developing, manufacturing and Commercializing Cell Therapy
Products and Collaboration Products pursuant to the Program Plan and as
described in this Agreement.
2.4 JSC MEETING PREPARATION.
(A) At least [**] prior to each regularly scheduled JSC meeting,
ViaCell shall provide to Amgen a report summarizing the progress of ViaCell's
research and Development efforts relating to Cell Therapy Products and its
manufacturing efforts related to Cell Therapy or Collaboration Products. After
each Transition Date and for so long as Amgen has primary responsibility for the
Development and Commercialization of a Collaboration Product(s), Amgen shall
provide to ViaCell a report summarizing the progress of Amgen's Development and
Commercialization efforts relating to Collaboration Products at least [**] prior
to each regularly scheduled JSC meeting.
(B) ViaCell may provide to Amgen, and Amgen may consider, a request
for information relating to [**] Controlled by Amgen, which ViaCell believes may
have potential utility in Cell Therapy Products.
(C) At least once per Calendar Year, Amgen shall provide to ViaCell
a summary report [**] and which Amgen believes may have potential utility in
Cell Therapy Products, and which Amgen (in its sole discretion) desires to make
available to ViaCell for use in the research and development of Cell Therapy
Products (if any). Amgen may elect to include in its summary report information
[**] that was the subject of a request for information under Section 2.4(b).
(D) All reports, requests for information and other material
provided pursuant to Section 2.4 of this Agreement shall be provided in writing
to each member of the JSC.
2.5 DECISION MAKING; ADMINISTRATIVE MATTERS.
(A) Decision Making. All decisions of the JSC shall be made by the
[**] of ViaCell and Amgen, with the representatives of each Party who are
members of the JSC collectively having one vote in any matter requiring the
approval of the JSC.
(B) Dispute Resolution. If the JSC is unable to reach [**] agreement
on any issue within a period of [**] after receiving written notification from a
Party of a dispute regarding such issue under this Agreement, then the final
decision-making authority for any such matter shall be determined, depending
upon the subject matter of the unresolved issue, as follows:
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
(I) Development decisions: Subject to the obligations set forth in
Section 5.7(a) to meet and cooperate with respect to Severe Adverse Events,
ViaCell shall have final decision-making authority with respect to Development
activities relating to all Cell Therapy Products, after reasonably considering
in good faith any concerns raised or comments promptly provided by Amgen.
Subject to the obligations set forth in Section 5.7(a) to meet and cooperate
with respect to Severe Adverse Events, Amgen shall have final decision-making
authority with respect to Development activities relating to all Collaboration
Products, after reasonably considering in good faith any concerns raised or
comments promptly provided by ViaCell.
(II) Manufacturing decisions: Except for decisions relating to the
manufacture of Contributed Products, ViaCell shall have final decision-making
authority with respect to process development and manufacturing activities,
after reasonably considering in good faith any concerns raised or comments
promptly provided by Amgen. Subject to the provisions of Section 7.3 of this
Agreement, neither ViaCell nor the JSC shall have any authority relating to the
manufacture of Contributed Products, which shall be solely within the authority
and discretion of Amgen. The provisions of this Section 2.5(b)(ii) shall be
subject to Section 7.2(g), and upon and after a Manufacturing Transition, Amgen
shall have final decision-making authority with respect to process development
and manufacturing activities.
(III) Regulatory decisions: ViaCell shall have final decision-making
authority with respect to all activities relating to obtaining Regulatory
Approvals for all Cell Therapy Products, after reasonably considering in good
faith any concerns raised or comments promptly provided by Amgen. Amgen shall
have final decision-making authority with respect to all activities relating to
obtaining Regulatory Approvals for all Collaboration Products, after reasonably
considering in good faith any concerns raised or comments promptly provided by
ViaCell.
(IV) Commercialization decisions: Amgen shall have final
decision-making authority with respect to Commercialization activities relating
to all Collaboration Products, after reasonably considering in good faith any
concerns raised or comments promptly provided by ViaCell. For the avoidance of
doubt, neither Party shall have any rights to commercialize Cell Therapy
Products and ViaCell reserves for itself all rights to commercialize all
Unoptioned Cell Therapy Products.
(V) All other Decisions: The Parties shall attempt to resolve
disputes arising under, or relating to, this Agreement that concern matters not
listed in (i) - (iv) above in accordance with the provisions of Article 17,
below.
For the avoidance of doubt, control of final decision-making authority for any
matter as set forth in Sections 2.5(b)(i)-(iv) shall not relieve the Party with
such final decision-making authority from any of its representations, warranties
and/or covenants as set forth in Article 14 nor shall it enable such Party to
unilaterally modify or amend the terms of this Agreement.
<PAGE>
(C) Administrative Matters. The JSC shall establish its own
procedural rules for its operation, consistent with the terms of this Section
2.5. A chairperson for the JSC shall be appointed from among its members. The
chairperson shall be appointed on an annual basis and will be a ViaCell
representative prior to the Transition Date of the first Collaboration Product
and an Amgen representative after the Transition Date of the first Collaboration
Product. The chairperson shall be responsible for calling meetings of the JSC
and for leading the meetings. A JSC member of the Party hosting a meeting of the
JSC shall serve as secretary of that meeting. Within [**] following each
meeting, the secretary of such meeting shall prepare and distribute to all
members of the JSC the minutes of the meeting. Such minutes shall provide a
reasonably detailed description of the meeting discussions and a list of any
actions, decisions or determinations approved by the JSC. The minutes of each
JSC meeting shall be approved or disapproved, and revised as necessary, at the
next meeting. Final minutes of each meeting shall be distributed to the members
of the JSC by the chairperson.
2.6 SCIENTIFIC ADVISORY BOARD.
(A) During the Term, ViaCell shall arrange for at least one senior
Amgen scientist identified by Amgen, who shall initially be Dr. Glenn Begley,
Senior Director, Basic Research, Hematology (the "MSAB Nominee"), to serve as a
member of ViaCell's Medical Scientific Advisory Board. Amgen, in its sole
discretion, shall have the right to replace such MSAB Nominee at any time upon
written notice to ViaCell.
(B) ViaCell shall retain the right at all times to exclude the MSAB
Nominee from segments of its Medical Scientific Advisory Board meetings that do
not relate to Cell Therapy Products or Collaboration Products. Amgen and the
MSAB Nominee shall retain the right at all times to recuse the MSAB Nominee from
any meeting or segments of a meeting of ViaCell's Scientific Advisory Board.
(C) The Parties understand and acknowledge that the MSAB Nominee is
intended solely to provide ViaCell with strategic technical scientific input,
and is not intended to confer on Amgen, the MSAB Nominee or any employees,
officers or directors of Amgen any duties to ViaCell, including, without
limitation, fiduciary duties or rights. ViaCell further understands that Amgen's
employees, officers and directors owe duties solely to Amgen, its subsidiaries
and Affiliates. Any advice provided by Amgen, its employees, officers and
directors is provided with no warranties of any kind, and ViaCell shall
indemnify, defend and hold Amgen harmless for any claims that may result from
its reliance thereon.
ARTICLE 3
DEVELOPMENT
3.1 VIACELL RESPONSIBILITIES.
(A) ViaCell shall be responsible for preparing and submitting the
Development Plan section of the Program Plan with respect to Cell Therapy
Products to and for approval by the JSC, and shall update the Development Plan
on an annual basis, in time for the annual budget cycle of each of the Parties;
provided however, it is acknowledged and agreed that
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
the Development Plan may need to be modified from time to time between annual
updates, based upon the results of clinical trials and other unanticipated
events. [**].
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
(B) ViaCell shall have responsibility for all aspects of Developing
the Cell Therapy Products in the Territory, including making all strategic and
tactical decisions with respect thereto in accordance with the Development Plan
and establishing the methods and means by which it performs its obligations
under this Agreement (including the management of permitted subcontractors,
pursuant to Section 18.6).
(C) ViaCell hereby covenants that it shall use Commercially
Reasonable Efforts to generate data as soon as practicable from a Phase 1
clinical trial, and, if applicable, from a Phase 2 clinical trial, all in
accordance with the Development Plan approved by the JSC.
3.2 AMGEN RESPONSIBILITIES.
(A) Amgen shall be responsible for preparing and submitting the
Development Plan section of the Program Plan with respect to the Collaboration
Products to and for approval by the JSC, and shall update the Development Plan
on an [**] basis, [**]; provided however, it is acknowledged and agreed that the
Development Plan may need to be modified from time-to-time[**], based upon the
results of clinical trials and other unanticipated events. [**].
(B) Amgen shall have responsibility for all aspects of Developing
the Collaboration Products in the Territory, including making all strategic and
tactical decisions with respect thereto in accordance with the Development Plan
and establishing the methods and means by which it performs its obligations
under this Agreement (including the management of permitted subcontractors,
pursuant to Section 18.6). For the avoidance of doubt, Amgen shall use its
Commercially Reasonable Efforts in relation to creating and amending the
Development Plan in a manner that is reasonable and in exercising
decision-making with respect to the Development of the Collaboration Products.
3.3 ADDITIONAL AMGEN ASSISTANCE. Upon the request of ViaCell, Amgen [**]
to assume certain Development responsibilities in support of ViaCell's carrying
out the activities within the Development Plan. Prior to assuming any such
responsibility, Amgen shall provide to ViaCell, for approval by the JSC and
inclusion within the Development Plan, the estimated budget for carrying out any
such responsibility. Immediately upon execution of such responsibilities, Amgen
may charge its expenses associated therewith to ViaCell in the form of written
invoices to be paid within [**] of receipt.
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
3.4 DEVELOPMENT OBLIGATIONS. Each Party shall be responsible for carrying
out its activities in accordance with the Development Plan. These activities
shall include, without limitation (i) identifying and carrying out all major
Development tasks to be conducted prior to submission of filings for Regulatory
Approval of a Collaboration Product for a particular indication; (ii)
identifying key Development objectives, expected associated resources, risk
factors, timelines, go/no go decision points and relevant decision criteria;
(iii) carrying out all aspects of (e.g., designing studies and protocols and
conducting), and preparing the associated Regulatory Plan for, all clinical
trials necessary to obtain Regulatory Approval for each indication pursued, as
well as establishing new dosage forms, new formulations or other enhancements of
approved Collaboration Products (but excluding Post-Approval Clinical Studies)
including, but not limited to (1) establishing/contracting with clinical sites,
investigators and contract research organizations ("CROs"), (2) enrolling
clinical study patients, (3) organizing investigator meetings, scientific
meetings, advisory panel workshops and regulatory meetings, and (4) analyzing,
summarizing and presenting clinical study results; (iv) performing any other
additional research and pre-clinical research in support of the clinical
development of Collaboration Products; (v) forecasting clinical manufacturing
production requirements; and (vi) Regulatory Authority reporting on study
design, study outcome, other communications and regulatory filings (to the
extent not covered by a Regulatory Plan).
3.5 INFORMATION AND DATA.
(A) ViaCell shall promptly disclose to Amgen all material scientific
or technical information relating to any Collaboration Product that it discovers
in the course of Development activities, promptly after it is learned or its
materiality is appreciated. ViaCell shall maintain a database which contains (i)
all clinical trial data accumulated from clinical trials of all Cell Therapy
Products, (ii) all safety data, and (iii) all adverse reaction information for
all Cell Therapy Products. On an annual basis, ViaCell shall provide Amgen with
written summaries of all pre-clinical and clinical data generated by or on
behalf of ViaCell with respect to Cell Therapy Products, as well as all such
pre-clinical and clinical data in an industry standard computer readable format
requested by Amgen. Amgen shall be entitled to have access, during regular
business hours and upon reasonable advance notice, to such pre-clinical and
clinical data maintained by ViaCell (including all clinical trial databases, in
an industry standard computer readable format requested by Amgen). ViaCell shall
ensure that its preclinical and clinical trials are monitored and audited in
accordance with industry standards.
(B) Amgen shall promptly disclose to ViaCell all material scientific
or technical information relating to any Cell Therapy Product or Collaboration
Product that it discovers in the course of Development activities, promptly
after it is learned or its materiality is appreciated. Amgen shall maintain a
database which contains (i) all clinical trial data accumulated from clinical
trials of all Collaboration Products, (ii) all safety data, and (iii) all
adverse reaction information for all Collaboration Products. On an annual basis,
Amgen shall provide ViaCell with written summaries of all clinical data
generated by Amgen with respect to Collaboration Products, as well as such
clinical data in an industry standard computer readable format requested by
ViaCell. ViaCell shall be entitled to have access, during regular business hours
and upon reasonable advance notice to such clinical data maintained by Amgen
(including all clinical trial databases, in an industry standard computer
readable format requested by
<PAGE>
ViaCell). Amgen shall ensure that its preclinical and clinical trials are
monitored and audited in accordance with industry standards.
3.6 AUDIT. Amgen shall have the right to conduct reasonable quality
assurance audits with respect to all facilities, clinical sites, operations and
laboratories (and any records related thereto) of ViaCell or Third Party
subcontractors, where Development activities are conducted, as is reasonably
necessary solely for the purpose of verifying ViaCell's conformance with
applicable cGMP, cGLP, cGCP and other regulatory requirements. Such audits shall
be conducted upon reasonable notice during reasonable business hours.
ARTICLE 4
AMGEN OPTION
4.1 VIACELL REPORTING OBLIGATIONS. Upon completing the data collection and
analysis resulting from each Clinical Trial for any Cell Therapy Product,
ViaCell shall promptly provide to the JSC a detailed written report describing
the Clinical Trial results and sufficient related information necessary to
evaluate future development options and requirements. The JSC shall promptly
review such report to determine whether the form and substance of the report
meet standards for such reports in the pharmaceutical and biotechnology
industries, and, if applicable, suggest changes or improvements thereto.
Promptly after approval of such report by the JSC, ViaCell shall provide a copy
of the approved report to Amgen. Such report shall include a detailed written
account of the Direct Development Costs approved pursuant to Section 2.3,
incurred up to that date, itemized by product and by indication.
4.2 OPTION GRANT. ViaCell hereby grants to Amgen, and Amgen hereby accepts
a worldwide, exclusive option to select as a Collaboration Product any Cell
Therapy Products that are researched, developed or made using any Contributed
Product (the "Option"). For the avoidance of doubt, upon the exercise of the
Option, Amgen will automatically receive (and ViaCell hereby grants to Amgen) a
worldwide, exclusive license under the ViaCell Technology sufficient to make,
have, made, use, sell, promote, import and export the Collaboration Products,
provided, however, that the rights to make and have made shall be retained by
ViaCell until and unless Amgen exercises its right to assume the rights and
responsibilities of Manufacturing Lead under Section 7.1(f).
<PAGE>
4.3 OPTION EXERCISE. Prior [**] for each Cell Therapy Product [**],
ViaCell shall provide to Amgen a notice of ViaCell's intent to commence such
[**] (which notice shall be provided only after ViaCell has provided to Amgen a
detailed written report in relation to [**], the results of which support the
commencement of the [**], which report has been approved by the JSC in
accordance with Section 4.1 of this Agreement), and Amgen shall have the right
to exercise the Option within [**] of receiving such notice from ViaCell or at
any time prior to receiving such notice from ViaCell (the "Option Period").
Should Amgen choose to exercise an Option, it must do so by providing to ViaCell
a written notice thereof (an "Exercise Notice"). For the avoidance of doubt,
Amgen shall have the right to exercise each Option on a product-by-product and
indication-by-indication basis. If Amgen does not exercise the Option prior to
the expiration of the Option Period with respect to a Cell Therapy Product for
an indication, then that Cell Therapy Product for that indication will be deemed
an Unoptioned Cell Therapy Product and Amgen will no longer have an Option with
respect to that Cell Therapy Product for that indication.
4.4 PAYMENT OF DEVELOPMENT COSTS. Within [**] of the Transition Date,
Amgen shall pay to ViaCell [**] of the Direct Development Costs incurred prior
to the Transition Date for the Collaboration Product and indication for which
Amgen has exercised its Option.
4.5 TRANSITION OF RESPONSIBILITIES. After Amgen's exercise of the Option
and prior to the Transition Date, ViaCell will transfer to Amgen the IND and all
other Regulatory Filings for the Collaboration Product for which Amgen exercised
its Option. ViaCell shall also deliver to Amgen a complete copy of the IND and
any other Regulatory Filings for the Collaboration Product for which Amgen has
exercised its Option and any related correspondence with the FDA and any other
Regulatory Authority relating thereto, as well as all related Information and
Materials (including but not limited to data and results of Phase 1, Phase 2
and/or Phase 3 clinical trials, to the extent applicable). On and after the
Transition Date for a Collaboration Product, ViaCell will provide all assistance
and execute all documents reasonably requested to facilitate the transition of
the Development responsibilities, as described in Article III, and the
responsibilities of the Commercial Lead, as described in Article VI, for that
Collaboration Product to Amgen. For the avoidance of doubt, the exercise of the
Option will not affect the rights and responsibilities of the Parties with
respect to Cell Therapy Products and/or indications for which the Option Period
has not expired. [**].
4.6 TRANSFERABILITY. Except as otherwise set forth below or as otherwise
explicitly permitted by this Agreement, neither Party shall have the right to
assign, sublicense or transfer its rights with respect to any Cell Therapy
Product or Collaboration Product.
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
(A) Either Party shall have the right to assign its rights to any
or all Collaboration Products, provided however, that prior to such assignment,
that Party (the "Transferring Party") first provides the other Party (the
"Non-Transferring Party") [**] The Non-Transferring Party's [**] first shall
commence upon the Transferring Party providing a written notice describing in
detail the rights (including rights to any tangible or intangible property) it
desires to assign to a Third Party [**] Upon receipt of a [**] the
Non-Transferring Party shall have a [**] in which to determine whether it
desires to [**] proposing the terms on which [**] (if at all). In the event that
the Transferring Party desires to [**] the parties shall [**] of the definitive
documents required to [**] In the event that (i) the Transferring Party does not
desire to [**] such Assets to the Non-Transferring Party [**] or (ii) the
Parties are unable to [**] of the date on which the Transferring Party indicates
its desire to [**] such Assets to the Non-Transferring Party [**] then the
Transferring Party shall [**] In the event that the Non-Transferring Party does
not [**] then the Transferring Party shall [**] In the event that ViaCell
assigns its rights to any Collaboration Product to any Third Party under this
Section 4.6(a), Amgen shall have the right [**] with respect to such
Collaboration Product, which right is exercisable within [**]
(B) For the avoidance of doubt, ViaCell shall have the right to
assign its rights to any Unoptioned Cell Therapy Product without restriction.
(C) In the event of a Change of Control of ViaCell, [**] for any
and/or all Collaboration Products which right is exercisable within [**] after
the date Amgen became aware that the Change of Control occurred. At any time
after a Change of Control of ViaCell, for each Cell Therapy Product for which
Amgen elects to exercise its Option, [**], which right is exercisable within
[**] of the date of the exercise of the Option with respect to such Cell Therapy
Product.
4.7 OPT-OUT. Each party shall have the right, upon [**] written notice
(an "Opt-Out Notice") to the other Party to opt out of its rights with respect
to any Collaboration Product. [**] after delivering such Opt-Out Notice (the
"Opt-Out Date") to the other Party, the Party so doing shall completely forfeit
all rights under this Agreement with respect to the Collaboration Product(s)
listed in the Opt-Out Notice, and all remaining rights shall immediately vest in
the other Party. The Party opting out shall, however, be responsible for and
obligated with respect to (i) [**] and (ii) providing all assistance and
executing all documents as the other Party may reasonably request to facilitate
or assist in transitioning the roles and responsibilities previously held by the
Party opting out, subject to the terms of Section 7.3 below.
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
ARTICLE 5
REGULATORY
5.1 REGULATORY PLAN(A) ViaCell shall be responsible for preparing and
submitting the Regulatory Plan section of the Program Plan with respect to Cell
Therapy Products to and for approval by the JSC, and shall update the Regulatory
Plan on an [**] basis, [**]; provided however, it is acknowledged and agreed
that the Regulatory Plan may need to be modified from time to time between [**]
updates, based upon the results of clinical trials and other unanticipated
events. [**].
(B) Amgen shall be responsible for preparing and submitting the
Regulatory Plan section of the Program Plan with respect to Collaboration
Products to and for approval by the JSC, and shall update the Regulatory Plan on
an [**] basis, [**]; provided however, it is acknowledged and agreed that the
Regulatory Plan may need to be modified from time to time between [**] updates,
based upon the results of clinical trials and other unanticipated events. [**].
5.2 REGULATORY LEAD. ViaCell shall be responsible for all regulatory
matters for Cell Therapy Products and Amgen shall be responsible for all
regulatory matters for Collaboration Products and each shall be referred to as
the "Regulatory Lead" therefor. Regulatory matters shall include, without
limitation, the filing and support of any Drug Approval Applications and matters
concerning Post-Approval Clinical Studies.
5.3 RESPONSIBILITIES AND RIGHTS OF REGULATORY LEAD. During the time
period for which it is responsible for regulatory matters, the Regulatory Lead
for a product and/or indication shall be the trial sponsor with Regulatory
Authorities. With respect to regulatory matters for which it is responsible, the
Regulatory Lead for a product and/or indication shall have the right to monitor,
review and direct all aspects of regulatory matters relating thereto, including
making all strategic and tactical decisions with respect thereto (in accordance
with the Regulatory Plan) and establishing the methods and means by which it
performs such services, including the management of permitted subcontractors,
pursuant to Section 18.6. The Regulatory Lead shall have responsibility for all
associated official correspondence, communications and Regulatory Filings with
Regulatory Authorities regarding such matters.
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
5.4 RIGHT TO CROSS-REFERENCE IND AND EQUIVALENT FOREIGN FILINGS. ViaCell
shall have the right to cross-reference Amgen's IND and equivalent foreign
filings for Contributed Products solely for the purpose of Development and
Commercialization of Cell Therapy Products, Collaboration Products and
Unoptioned Cell Therapy Products. For the avoidance of doubt, ViaCell shall not
have the right, for any reason or under any circumstance, to access, copy or
review Amgen's INDs or equivalent foreign filings for Contributed Products. In
the event that a Regulatory Authority requests information from ViaCell related
to the manufacture or quality of Contributed Products and ViaCell is required to
supply such information to the Regulatory Authority in order to pursue or
maintain Regulatory Approval for a Cell Therapy Product, Collaboration Product
or Unoptioned Cell Therapy, at ViaCell's request [**], Amgen shall provide the
requested information by either of the following methods, as elected by Amgen
[**]: (i) directly to the Regulatory Authority requesting such information; or
(ii) to ViaCell, in order for ViaCell to respond to the Regulatory Authority's
request in a timely manner.
5.5 DRUG APPROVAL APPLICATIONS. Amgen shall own (be the sponsor and
party of record of) all Drug Approval Applications for Collaboration Products in
the Territory, and ViaCell shall own (be the sponsor and party of record of) all
Drug Approval Applications for Cell Therapy Products in the Territory.
5.6 TRANSFER OF REGULATORY FILINGS AND REGULATORY APPROVALS. If
ownership of a Regulatory Filing or Regulatory Approval in any country cannot be
transferred from the owning Party to the other Party pursuant to the terms of
this Agreement, the owning Party shall grant to the other Party an exclusive
right of access and reference to such Regulatory Filing or Regulatory Approval
in such country in order to enable the other Party to become a sponsor and party
of record of an IND or equivalent foreign filing. If such right of access and
reference is not sufficient to permit the other Party to file a Drug Approval
Application and receive Regulatory Approval or to Develop, manufacture or
Commercialize a Collaboration Product, the owning Party shall provide the other
Party with any and all information necessary for the other Party to carry out
such activities and to receive Regulatory Approval in its own name.
5.7 ADVERSE EVENT REPORTING; CUSTOMER COMPLAINTS.
(A) ViaCell shall maintain a record of all non-medical and medical
product-related complaints and reports of adverse events that it receives with
respect to each Cell Therapy Product, and Amgen shall maintain a record of all
non-medical and medical product-related complaints and reports of adverse events
that it receives with respect to each Collaboration Product. At least [**] per
[**], each Party shall provide to the other with copies of any complaint
(including all adverse events) received by it relating to a Cell Therapy Product
and/or a Collaboration Product. In the event of the occurrence of any serious
adverse event(s) (as defined in ICH Guideline E2A), the Parties shall meet (in
person or via telephone) within [**] of first becoming aware of such occurrence
to discuss steps necessary to address any safety concerns and share any relevant
information regarding such occurrence
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
(B) On an indication-by-indication basis for each Cell Therapy
Product, ViaCell (as the IND sponsor and party of record) shall be responsible
for reporting to Regulatory Authorities any adverse experience and safety issues
for such Cell Therapy Product in compliance with the requirements of all
applicable laws and regulations (including the FD&C Act and the PHS Act, and any
amendments thereto and the regulations promulgated thereunder, and the
equivalent laws, rules and regulations of other countries in the Territory) and
shall promptly thereafter provide Amgen with a copy of such report.
(C) On an indication-by-indication basis for each Collaboration
Product, Amgen shall be responsible (as the IND sponsor and party of record) for
reporting to Regulatory Authorities any adverse experience and safety issues
regarding such Collaboration Product in compliance with the requirements of all
applicable laws and regulations (including the FD&C Act and the PHS Act, and any
amendments thereto and the regulations promulgated thereunder, and the
equivalent laws, rules and regulations of other countries in the Territory) and
shall promptly thereafter provide ViaCell with a copy of such report.
5.8 COMMUNICATIONS.
(A) The Regulatory Lead for a product and/or indication under this
Agreement shall have exclusive responsibility for all correspondence and for any
official communication (except as the other Party may be required by applicable
laws or regulations or a Regulatory Authority to communicate) regarding such
product and/or indication with applicable Regulatory Authorities in the
Territory and the other Party shall have the right to be present (and to
participate at the request of the Regulatory Lead or the Regulatory Authority)
at all face-to-face meetings and scheduled conference calls regarding
significant clinical events or decisions. If one Party is required by applicable
laws or regulations or a Regulatory Authority to disclose information to such
Regulatory Authority having jurisdiction in the Territory, including information
regarding the manufacture of Cell Therapy Products and/or Collaboration
Products, such Party will notify the other Party before communicating with the
Regulatory Authority.
(B) ViaCell (to the extent it is the Manufacturing Lead) will
reasonably cooperate with Amgen to make and provide copies of any direct
communications by ViaCell with the Regulatory Authorities having jurisdiction in
the Territory regarding the manufacture of any Collaboration Product by ViaCell
for supply to Amgen; provided, however, that ViaCell's obligation to provide
Amgen with information relating to the manufacture of the Collaboration
Product(s) is limited to the circumstance where such information is reasonably
required for Amgen to carry out its responsibilities Developing the
Collaboration Product and/or as Regulatory Lead and/or Commercial Lead, or is
required by law, rule, regulation or a Regulatory Authority having jurisdiction
in the Territory, to have access; but Amgen shall only be entitled to use such
information to the extent required by such law, rule, regulation or Regulatory
Authority or to the extent reasonably required to carry out its responsibilities
under this Agreement, including its Development responsibilities and/or its
responsibilities as Regulatory and/or Commercial Lead. For so long as ViaCell is
supplying Amgen with Collaboration Products hereunder, ViaCell shall have the
right to be present at all meetings and to participate in all
<PAGE>
telephone calls with Regulatory Authorities having jurisdiction in the Territory
wherein the CMC contained in any Regulatory Filing is to be discussed.
(C) Each Party shall promptly notify the other Party of and
provide such other Party with a copy of any correspondence or other reports or
complaints submitted to or received from any Regulatory Authority, or other
Third Party claiming that any Promotional Materials are inconsistent with the
Product Labeling or are otherwise in violation of any applicable laws and
regulations (including the FD&C Act and the PHS Act, and any amendments thereto
and the regulations promulgated thereunder, and the equivalent laws, rules and
regulations of other countries in the Territory).
5.9 APPLICATIONS FOR REGULATORY EXCLUSIVITY. The Parties recognize that
exclusivity rights granted or provided for under regulatory laws of the
countries of the Territory may be commercially significant to Collaboration
Products. To the extent permitted by law, as between the Parties, Amgen shall
have the exclusive right to file for, request and maintain any regulatory
exclusivity rights for Collaboration Products in the Territory (including
without limitation regulatory exclusivity rights based upon an orphan drug
designation of a Collaboration Product) and to conduct and prosecute any
proceedings or actions to enforce such regulatory exclusivity rights.
5.10 RECALLS.
(A) The Parties shall exchange their internal standard operating
procedures, if any, as to product recalls ("SOPs") reasonably promptly after the
Effective Date and thereafter reasonably promptly after such SOPs are approved
or modified. If either Party becomes aware of information about quantities of
Collaboration Product supplied from ViaCell to Amgen, which may not conform to
the specifications for such Collaboration Product, or for which there are
potential adulteration, misbranding and/or other issues regarding safety or
effectiveness, or for which the Collaboration Product itself is alleged or
proven to be the subject of a Recall in any country in the Territory, it shall
promptly so notify the other Party and the Party having the right to control
such a Recall pursuant to Section 5.10(b) may take [**] when the regulatory
timeframes or public safety considerations so require. In all other
circumstances, Recalls can only be made by [**] consent of the JSC and shall be
made by the Party having the first right to control a Recall pursuant to Section
5.10(b). The JSC will meet (in person, by telephone or otherwise) to discuss
such other circumstances and to consider appropriate courses of action, which
courses of action with respect to a Recall shall be consistent with the internal
SOP of the Party having the first right to control such Recall pursuant to
Section 5.10(b), and the other Party shall make available to the Party having
the first right to control such Recall all pertinent records which the Party
having the first right to control such Recall may reasonably request to assist
in effecting any Recall.
<PAGE>
(B) With respect to any clinical studies conducted by ViaCell
under this Agreement, ViaCell shall have the exclusive right to control a Recall
of any Cell Therapy Products in the Territory, and shall conduct such a Recall
at any time at which regulatory timeframes or public safety considerations so
require. Other than with respect to any clinical studies conducted by ViaCell
under this Agreement, Amgen shall have the exclusive right to control any Recall
of the Collaboration Products in the Territory, and shall conduct such a Recall
at any time at which regulatory timeframes or public safety considerations so
require. ViaCell and Amgen shall each maintain complete and accurate records of
any Recall it has the right to control pursuant to this Section 5.10 for such
periods as may be required by legal requirements, but in any event for no less
than [**].
5.11 MANUFACTURING. ViaCell shall bear initial responsibility for
preparing communications to Regulatory Authorities relating to manufacturing
issues for Collaboration Products, subject to review by Amgen, and ViaCell shall
cooperate with Amgen with respect to other Regulatory Authority reporting,
communications and Regulatory Filings regarding the Collaboration Products.
5.12 COMPLIANCE WITH LAWS AND REGULATIONS. To the extent applicable, each
Party agrees to maintain all regulatory and governmental permits, licenses and
approvals and to comply with all laws, rules and regulations that are applicable
to each such Party's activities and the particular stage of Development or
Commercialization of the Collaboration Products including, without limitation,
GLPs, GCPs and GMPs, as such standards are defined in accordance with the
applicable guidance and regulations including the International Conference of
Harmonization (ICH), the U.S. Food, Drug and Cosmetic Act, 21 C.F.R. Section
210, 312, 1271 et seq. and the regulations promulgated thereunder, and any
amendments thereto and the regulations promulgated thereunder, and the
equivalent laws, rules and regulations of other countries in the Territory.
ARTICLE 6
COMMERCIALIZATION
6.1 COMMERCIAL PLAN. Amgen shall be responsible for preparing and
submitting the Commercial Plan section of the Program Plan with respect to
Collaboration Products to and for approval by the JSC, and shall update the
Commercial Plan on an [**] basis, [**]; provided however, it is acknowledged and
agreed that the Commercial Plan may need to be modified from time to time based
upon commercial considerations including unanticipated events. [**].
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
6.2 RESPONSIBILITIES AND RIGHTS OF AMGEN. Amgen shall be the "Commercial
Lead" and be responsible for all aspects of Commercializing Collaboration
Product(s) in the Territory, including making all strategic and tactical
decisions with respect thereto. These activities shall include, without
limitation: (a) Commercial strategies (e.g., strategies for regulatory,
branding, product positioning, pre-launch, market research, launch and
post-launch marketing and promotion, pricing and reimbursement and field sales
force optimization); (b) packaging, labeling and language to be included in the
package insert; (c) forecasting sales and Commercial manufacturing production
requirements; (d) creating and developing Promotional Materials regarding
Collaboration Products which are intended for distribution to medical
professionals, other Third Parties and to the Parties' respective sales forces;
(e) Promotion; (f) Detailing, including setting sales force staffing levels and
Detailing levels; (g) sales and distribution, taking orders and distributing,
contracting, handling of returns, handling all aspects of order processing,
invoicing and collecting, warehousing, documenting inventory and receivables and
collecting prescription tracking, call reporting, handling data regarding sales
to hospitals and other end users and handling all other customer service-related
functions; (h) setting level of sampling; (i) selecting, obtaining and
maintaining generic names and Product Trademarks; (j) licensing or otherwise
acquiring rights to intellectual property from Third Parties; (k) supervising
and training of (and coordinating sales briefing meetings and disseminating
information, including all communications related to marketing and Promotion);
(l) establishing target call lists; (m) carrying out all aspects of conducting
all Post-Approval Clinical Studies; (n) preparing publications and presentations
of data regarding Collaboration Products and (o) establishing material transfer
agreements, clinical trial and other agreements, pursuant to Section 10.13. For
the avoidance of doubt, neither Party shall have any rights to commercialize
Cell Therapy Products and ViaCell reserves for itself all rights to
commercialize all Unoptioned Cell Therapy Products.
6.3 MEDICAL AND OTHER INQUIRIES. Amgen shall have responsibility for all
correspondence and communication with physicians and other health care
professionals and customers in the Territory regarding Collaboration Product
complaints and all adverse drug experience information and all other
correspondence and communication with physicians and other health care
professionals and customers in the Territory relating to Collaboration Products.
Amgen shall keep such records and make such reports as shall be reasonably
necessary to document such communications in compliance with all applicable
regulatory requirements.
6.4 PROMOTIONAL MATERIALS. Amgen shall be responsible for the creation,
preparation, production and reproduction of all Promotional Materials relating
to the Collaboration Products and for filing, as appropriate, such Promotional
Materials with all Regulatory Authorities.
<PAGE>
(A) To the extent permitted by law, regulation or Regulatory
Authorities, each Collaboration Product will be marketed as a joint product of
ViaCell and Amgen and references to ViaCell and ViaCell's logo shall be included
on all Product Labeling in a manner that is substantially similar in terms of
prominence and in all other respects as the references to Amgen and Amgen's logo
included in such Product Labeling and in a manner that complies with the terms
and conditions of this Agreement (including without limitation Section 10.5
hereof). Amgen shall use Commercially Reasonable Efforts in designing and
producing Promotional Materials to promote the Collaboration Products and shall
use Commercially Reasonable Efforts to use ViaCell's name and logo in such
Promotional Materials with reasonably similar prominence as Amgen's name and
logo, and pursuant to the terms of Section 6.4(b), shall consider in good faith
the comments and suggestions of ViaCell in relation to such Promotional
Materials, including with respect to the use of ViaCell's logo.
(B) Prior to the use thereof, Amgen shall provide to ViaCell a
prototype of any Promotional Materials or Product Labeling which contains
ViaCell's corporate name and/or logo, so that ViaCell may review the manner in
which its corporate name and/or logo are used therein. ViaCell shall notify
Amgen within [**] after delivery of such prototype, whether ViaCell approves or
disapproves of the manner of such use and, in the case of disapproval, the
specific reasons therefor and an acceptable alternative. In the event that
ViaCell fails to so notify Amgen within such [**] period, ViaCell shall be
deemed to have approved the manner of such use. In the event that (i) the
Promotional Materials and Product Labeling comply with Section 6.4(a), but
ViaCell disapproves of the manner of such use and (ii) the Parties are unable to
reach agreement regarding the manner of such use before an applicable regulatory
or other legal deadline for submission of Promotional Materials, then Amgen
shall retain the right to print and use, and ViaCell agrees to use, to the
extent applicable, such Promotional Materials and Product Labeling without
ViaCell's corporate name and/or logo. Amgen and ViaCell shall continue efforts
to reach agreement on approving Promotional Materials with ViaCell's corporate
name and/or logo that comply with Section 6.4(a).
(C) Compliance with Laws, Regulations and Guidelines. Each Party
agrees to comply with all applicable laws, rules and regulations (e.g., the FD&C
Act, the PHS Act, the U.S. Foreign Corrupt Practices Act and any amendments
thereto and the regulations promulgated thereunder, and the equivalent laws,
rules and regulations in the Territory) and in all material respects to conform
its practices and procedures with, as applicable, the Pharmaceutical Research
and Manufacturers of America ("PhRMA") Code of Pharmaceutical Marketing
Practices and the American Medical Association ("AMA") Guidelines on Gifts to
Physicians from Industry, as the same may be amended from time to time, and
equivalent guidelines in the Territory with respect to the Commercialization of
Collaboration Products. Each Party shall conduct its business operations and
cause each of its employees, representatives and agents to do nothing which such
Party knows or reasonably should know would jeopardize the good will or
reputation of the other Party or the Cell Therapy Products or Collaboration
Products. Neither Party shall be required to undertake any activity relating to
the Commercialization of Cell Therapy Products or Collaboration Products that it
believes, in good faith, may violate any law or regulations. Each Party shall
promptly notify the other Party of and provide to that other Party a copy of any
correspondence or other reports with respect to the Promoting or Detailing of
Collaboration Products submitted to or received from PhRMA or the AMA or
equivalent organizations in the Territory and Amgen shall be responsible for
responding to such correspondence or other
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
reports. Each Party shall in all material respects conform its practices and
procedures relating to educating the medical community in the U.S. with respect
to Collaboration Products to the Accreditation Council for Continuing Medical
Education ("ACCME") Standards for Commercial Support of Continuing Medical
Education and any applicable FDA regulations or guidelines, as the same may be
amended from time to time, and, as applicable, equivalent guidelines in the
Territory and each Party shall promptly notify the other Party of and provide to
the other Party a copy of any correspondence or other reports submitted to or
received from the ACCME with respect to Collaboration Products and Amgen shall
be responsible for responding to such correspondence or other reports.
ARTICLE 7
MANUFACTURE AND SUPPLY
7.1 MANUFACTURING PLAN. Except as otherwise provided in this Agreement,
ViaCell shall be responsible for preparing and submitting the Manufacturing Plan
section of the Program Plan with respect to Cell Therapy Products and
Collaboration Products to and for approval by the JSC, and shall update the
Manufacturing Plan on an [**] basis, [**]; provided however, it is acknowledged
and agreed that the Manufacturing Plan may need to be modified from time to time
based upon commercial considerations including unanticipated events. [**].
7.2 RESPONSIBILITIES AND RIGHTS OF VIACELL. Subject to Section 7.2(g),
ViaCell shall be the "Manufacturing Lead" and ViaCell shall be responsible for
manufacturing and supplying Cell Therapy Products and Collaboration Products for
Development and Commercialization in the Territory. Except as otherwise provided
in this Agreement, ViaCell shall have responsibility for all aspects of
manufacturing Collaboration Products(s) in the Territory, including making all
strategic and tactical decisions with respect to establishing the methods and
means by which it performs such services and fulfills its regulatory
responsibilities over all steps of the manufacturing process. These activities
include, without limitation, bulk manufacture, finish and fill, labeling and
packaging, lot release and process development work to support quality
assurance, improving manufacturing/cost efficiency and commercial scale-up
manufacturing.
(a) Manufacture of Cell Therapy Products for Development. With
respect to each Cell Therapy Product selected to be advanced to IND-enabling
toxicology studies and/or clinical studies, ViaCell shall use its Commercially
Reasonable Efforts to develop and initiate scale-up of the manufacturing
process, to develop a manufacturing process(es) suitable for commercial
production, and to supply clinical grade, filled and finished, selected Cell
Therapy Products for use in all pre-clinical trials and clinical trials in the
Territory, in quantities and with specifications sufficient to support the
required studies.
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
(b) Manufacture of Collaboration Product(s) for Commercialization.
With respect to each Collaboration Product, ViaCell shall use its Commercially
Reasonable Efforts to supply filled and finished Collaboration Products approved
by each applicable Regulatory Authority for commercial use in the Territory, in
quantities (as reasonably forecast by Amgen) and with specifications consistent
with the Collaboration Product. Amgen shall determine its good faith projected
Collaboration Product supply needs, taking into consideration inventory levels,
and will deliver an annual rolling forecast, updated quarterly.
(c) Standards of Supply. ViaCell will use its Commercially
Reasonable Efforts to manufacture Cell Therapy Products and Collaboration
Products in accordance with current GMP in a manufacturing process and facility
as described in the applicable Regulatory Filings filed with the Regulatory
Authority. ViaCell shall be responsible for the labeling, packaging and lot
release of Collaboration Products it manufactures or has manufactured. ViaCell
shall be responsible for the quality assurance/quality control (QA/QC) of all
Collaboration Products manufactured by or for it and shall provide a
certification that all supplied Collaboration Products shall conform to the
product specifications.
(d) Manufacturing Cost and Budget. [**]. For Commercial
Collaboration Products, [**] shall be estimated and established [**] . Within
[**] following the end of ViaCell's fiscal year, ViaCell shall compare its
actual annual [**] for the prior year calculated using the [**] amount (vials
manufactured multiplied by [**] per vial, excluding any annual adjustment
related to the previous year, but including any interim adjustment charged to
Amgen as described below). ViaCell shall use this annual adjustment to
increase/decrease the [**] for the then-current Calendar Year in order to
recover/refund this difference from/to the Parties. The per unit annual
adjustment to the [**] shall be based upon the forecasted annual requirements
(as included in the rolling forecast to be supplied by the Commercial Lead on a
quarterly basis) for such following year. Until the annual adjustment is
calculated, ViaCell shall estimate the annual adjustment to be included in the
following year's [**] in good faith. If the rolling forecast volume over the
next [**] to be supplied to the Commercial Lead decreases by more than [**]
compared to the previously submitted rolling forecast, [**] for the year will be
recalculated. If, based upon such recalculation, ViaCell determines that [**]
has increased, an interim adjustment shall be made to [**] and such interim
adjustment will apply to all Commercial Collaboration Products supplied for the
remainder of the year on a Collaboration Product-by-Collaboration Product basis.
ViaCell will give Amgen [**] written notice prior to applying the interim
increase in [**]
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
(e) Third Party Licenses.
(I) [**] deems necessary for a license or other rights or to
incur an obligation to make payments to any Third Parties in return for a
license to Third Party Patent Rights and other intellectual property rights
necessary or useful to make or have made Collaboration Product in any country in
the Territory, for subsequent use, sale or other exploitation or transfer of
physical possession of or title in a Collaboration Product in the Territory.
[**] shall have the right to incorporate Third Party payments made to any Third
Party within the [**] as set forth in Exhibit B, provided however that prior to
entering into any such agreement, [**] shall provide to [**] a summary of the
subject matter of the proposed license and the proposed financial terms and
consider in good faith any comments or suggestions [**] may timely provide in
relation thereto. In the event that ViaCell becomes aware of any Third Party
intellectual property rights that ViaCell believes in good faith would be
necessary or useful in connection with the manufacturing or Commercialization of
Collaboration Products, ViaCell shall identify such Third Party intellectual
property rights to Amgen and the parties shall discuss in good faith whether
obtaining a license would be beneficial.
(II) [**] deems necessary for a license or other rights or to
incur an obligation to make payments to any Third Parties in return for a
license to Third Party Patent Rights and other intellectual property rights
necessary or useful to make or have made Cell Therapy Product(s) in any country
in the Territory, for subsequent use, sale or other exploitation or transfer of
physical possession of or title in a Cell Therapy Product in the Territory. [**]
shall have the right to incorporate Third Party payments made to any Third Party
within the [**] as set forth in Exhibit B, provided however that prior to
entering into any such agreement, [**] shall provide to [**] a summary of the
subject matter of the proposed license and the proposed financial terms and
consider in good faith any comments or suggestions [**] may timely provide in
relation thereto. In the event that Amgen becomes aware of any Third Party
intellectual property rights that Amgen believes in good faith would be
necessary or useful in connection with the manufacturing or future
Commercialization of Cell Therapy Products, Amgen shall identify such Third
Party intellectual property rights to ViaCell and the Parties shall discuss in
good faith whether obtaining a license would be beneficial. Notwithstanding the
foregoing, ViaCell may not obtain a license to Third Party Patent Rights to make
or have made a Cell Therapy Product without the prior written consent of Amgen
if the license requires ViaCell to pay, on a product-by-product basis a
percentage-based royalty that exceeds (A) [**] or (B) together with all other
percentage-based royalties owed to Third Parties for licenses to make or have
made such Cell Therapy Products entered into by ViaCell without Amgen's prior
written consent, [**].
(F) Supply Performance. In the event that ViaCell does not
exercise Commercially Reasonable Efforts to perform its duties as Manufacturing
Lead for a Collaboration Product, Amgen [**] upon written notice to ViaCell.
[**], a Manufacturing Transition shall be initiated. For the avoidance of doubt,
ViaCell shall be deemed to have not exercised Commercially Reasonable Efforts
upon the occurrence of any of the following events (except to the extent that
such events are the direct result of Amgen's failure to supply Contributed
Products in accordance with the terms and conditions of this Agreement):
(I) [**];
(II) [**];
(III) [**]; and
(IV) [**];
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
provided however that Amgen may not have the right to effect a Manufacturing
Transition as a result of any of these failures, unless Amgen has given ViaCell
prior written notice of such failure and ViaCell has not cured such failure
within [**]of the receipt of such notice. Amgen's right to assume the rights and
responsibilities of Manufacturing Lead is in addition to and does not relieve
the Parties of any rights or responsibilities under this Agreement.
(G) Manufacturing Transition.
(I) Upon Amgen providing a written notice to ViaCell of
Amgen exercising its rights to assume the rights and obligations of the
Manufacturing Lead pursuant to Section 7.2(f) or 4.6 with respect to a
Collaboration Product (a "Manufacturing Transition Notice"), ViaCell shall
promptly provide to Amgen all information, Materials and ViaCell Know-How as may
be useful or necessary to facilitate Amgen's manufacture of that Collaboration
Product.
(II) Upon delivering a Manufacturing Transition Notice to
ViaCell, the JSC shall no longer have any rights or obligations with respect to
the Collaboration Product that is the subject of such manufacturing Transition
Notice, and Amgen shall have sole decision making authority with respect to all
aspects of such Collaboration Product, including the Development, manufacturing
and Commercialization of such Collaboration Product, without any obligation to
discuss information with or disclose information to ViaCell (other than
information relating to Operating Profit or Loss for such Collaboration Product,
including without limitation the information described in Section 9.2 hereof),
[**].
(III) ViaCell and Amgen shall [**].
7.3 MANUFACTURE OF CONTRIBUTED PRODUCTS. Except as otherwise explicitly
provided below, Amgen will have the sole right and responsibility to manufacture
Contributed Products in accordance with the supply obligations set forth below.
At Amgen's sole discretion, Amgen may decide to transfer manufacturing
responsibility for a Contributed Product to a third party manufacturer,
including but not limited to a contract manufacturer.
(A) Supply Terms.
(I) Subject to Section 7.3(a)(ii) below, Amgen shall supply
Contributed Products to ViaCell and any Sublicensees in reasonable quantities,
as requested by ViaCell or such Sublicensees from time to time.
(II) Amgen shall only be obligated to supply Contributed
Products from readily available inventory on an as-available basis and in the
filled and finished form of Amgen's existing inventory, and Amgen shall not, for
any reason or under any circumstance, be obligated to manufacture Contributed
Products for the purpose of supplying Contributed Products to ViaCell or any
Sublicensees. Prior to the Transition Date, ViaCell shall pay Amgen [**] per
vial of Flt3-L supplied, [**] per vial of SCF supplied, and for any other
Contributed Products, a price to be agreed by the Parties prior to ViaCell
accepting such product as a Contributed Product. After the Transition Date,
ViaCell shall pay Amgen a price equal to [**].
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
(B) cGMP and Specifications. Where required, Contributed Products
supplied by Amgen hereunder shall be manufactured in accordance with current
Good Manufacturing Practices (as defined in the United States Code of Federal
Regulations) and the manufacturing process approved by relevant Regulatory
Authorities, and shall at least conform to the current specifications as of the
Effective Date, a copy of which has been provided to ViaCell. Amgen shall
promptly notify ViaCell of any changes to the specifications of Contributed
Products.
(C) No Transfer of Manufacturing Know-How. Amgen shall have no
obligation for any reason or under any circumstance, to provide ViaCell or any
Third Party with any information or materials regarding Amgen's know-how related
to the manufacturing of Contributed Products. Subject to the foregoing, in the
event that Amgen is unable or unwilling to supply ViaCell's or any Sublicensee's
requirements of Contributed Products in accordance with the terms and conditions
of this Agreement, including as a result of a Force Majeure, Amgen shall grant
to ViaCell a non-exclusive license under the Amgen Patent Rights to make or have
made (under contract with no more than two (2) Third Parties, who shall be
permitted under such contract(s) solely to supply Contributed Products
exclusively to ViaCell and any Sublicensees) and import ViaCell's and any
Sublicensee's requirements of Contributed Products for the sole purpose of
practicing ViaCell's and any Sublicensee's rights under the non-exclusive
license as set forth in Section 10.2.
(D) Demand Forecasts. ViaCell shall provide Amgen a written report
containing a forecasted estimate of the following Calendar Year's requirements
of Contributed Products. The report will include monthly requirements for each
SKU (Stock Keeping Unit) and will be delivered in the prior Calendar Year in
time to meet Amgen's budget timeline. Updates to the forecast shall be provided
in writing to Amgen [**] prior to the beginning of each [**].
(E) Orders. ViaCell and any Sublicensees shall specify by binding
written firm purchase order its or their reasonable requirements of Contributed
Products not later than [**] prior to ViaCell's or such Sublicensees' requested
delivery date. Each binding firm purchase order shall specify the quantity of
vials (or other relevant unit) of Contributed Products and the requested
delivery date. Subject to the terms of Section 7.2(a) above, Amgen shall supply
Contributed Products to ViaCell and any Sublicensees on the requested delivery
date in response to any such written firm purchase order.
(F) Shipment and Delivery. All Contributed Products supplied by
Amgen to ViaCell shall be delivered to ViaCell Ex Works ("EXW") (IncoTerms 2000)
a designated Amgen manufacturing facility. ViaCell shall be responsible for all
delivery logistics, delivery validation, insurance and compliance with laws and
regulations (including but not limited to those applicable to the export of each
EXW delivery from the United States to destinations outside the United States)
and all costs associated with the foregoing. Title to each EXW delivery and risk
of damage or loss shall pass to ViaCell immediately after leaving Amgen's
designated facility.
(G) Release of Licensed Product. Amgen shall be responsible for
the final release of Contributed Product.
[**] Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed with the
Commission.
<PAGE>
(H) Statements and Payments. For Contributed Products shipped
prior to the Transition Date, Amgen shall, on an as-delivered basis, provide
ViaCell with an invoice setting forth the quantities of Contributed Products
delivered to ViaCell and the supply price. Payments shall be due from ViaCell
within [**] following ViaCell's receipt of an invoice. ViaCell shall pay all
applicable excise, sales or other transfer taxes assessed on the supply of
Contributed Products hereunder. Delivery costs shall be paid directly by ViaCell
to its designated carrier. Any sums not paid when due are subject to a service
charge of [**] per month or the maximum rate permitted by law, whichever is
lower. [**].
7.4 LIMITATION ON APPLICATION OF SUPPLY TERMS. The provisions in this
Agreement governing per vial price apply solely in the context of this agreement
and are not meant to be effective independent from the terms contained herein.
ARTICLE 8
COLLABORATION CONSIDERATION
8.1 LICENSE FEE. The parties recognize that, pursuant to the terms and
conditions set forth in the License Agreement by and between ViaCell and Amgen
dated April 9, 2002 and related Warrant Purchase Agreement, ViaCell issued Amgen
a warrant to purchase 560,000 shares |
