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Exhibit 10.14
COOPERATIVE DEVELOPMENT AGREEMENT
THIS
AGREEMENT, entered into as of the 8th day of November, 2002, by
and
between ALTUS BIOLOGICS INC., a corporation organized and existing
under the
laws of the State of Delaware and having its principal place of
business at 625
Putnam Avenue, Cambridge, MA 02139 (hereinafter called "ALTUS"),
and AMANO
ENZYME INC., a corporation organized and existing under the laws of
Japan and
having its principal place of business at 1-2-7, Nishiki, Naka-ku,
Nagoya, Japan
(hereinafter called "AMANO"),
WITNESSETH:
WHEREAS, ALTUS, through research and development for a long time,
acquires and
possesses certain valuable technologies pertaining to certain
pharmaceutical
products known as TheraCLEC(TM) Total and a method for
manufacturing such
products and continues to develop scientific techniques pertaining
to the
products, and owns and controls certain patent rights and trademark
rights in
the products, and
WHEREAS, AMANO has, over the years, demonstrated its expertise in
development,
manufacturing and worldwide marketing of many kind of enzymes for
the commercial
markets especially in food industry and pharmaceutical industry,
and has thereby
established a reputation of high regard in such markets, which
reputation is
believed by ALTUS to be of great value to the possible success of
the joint
development contemplated hereunder, and
WHEREAS, AMANO desires to undertake manufacture of enzyme materials
to be used
in the products of ALTUS,
WHEREAS, ALTUS and AMANO are willing to enter into a cooperative
development of
certain enzyme materials, which are fit for TheraCLEC(TM) Total,
and entire
specifications of which are instructed by ALTUS, and
WHEREAS, ALTUS and AMANO propose to decide at the end of Phase II
of the U.S.
clinical trial process whether they will enter into a further
manufacturing
agreement.
NOW, THEREFORE, ALTUS and AMANO agree as follows:
ARTICLE 1. DEFINITIONS
1. The
term "Products" shall mean the pharmaceutical products known as
TheraCLEC(TM) Total, in a certain preparation form or forms
intended for
therapeutic use in humans specified, developed, manufactured,
labeled and
packaged
and sold by or on behalf of ALTUS.
2. The
term "Materials" shall mean enzymes used as active ingredients in
the
Products,
which are made up of selected [***********] and [******]
prepared
by AMANO in accordance with Specifications developed and
submitted
by ALTUS for use in manufacturing Products.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
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3. The
term "Amano Enzymes" shall mean enzymes including but not limited
to
[**************] and [********], which are discovered,
invented,
developed,
produced, sold or otherwise disposed by Amano with its sole
technologies and which are basis of Materials to be develop
hereunder.
4. The
term "Technical Information" shall mean all of the information
and
knowledge
now possessed by ALTUS or AMANO and those acquired by ALTUS or
AMANO
during the life of this Agreement, which relate to
manufacturing
process of
Materials -or relate to Products.
5. The
term "ALTUS's Development" shall mean any and all works of
research
and
development made by ALTUS with respect to Materials and Products to
be
developed
hereunder.
6. The
term "AMANO's Development" shall mean any and all works of
research
and
development made by AMANO with respect to Materials to be
developed
hereunder.
7. The
term "Joint Development" shall mean any and all technical works
of
research
and development jointly made by ALTUS and AMANO with respect to
Materials
to be developed hereunder.
8. The
term "Development" shall mean ALTUS's Development, AMANO's
Development
and/or
Joint Development.
9. The
term "ALTUS's Technologies" shall mean any and all technologies
now
possessed
by ALTUS and those acquired by ALTUS during the life of this
Agreement.
10. The term
"AMANO's Technologies" shall mean any and all technologies now
possessed
by AMANO and those acquired by AMANO during the life of this
Agreement.
11. The term
"Joint Technologies" shall mean any and all technologies
jointly
developed
by ALTUS and AMANO as the results of working together during
the
life of
this Agreement, which relate to manufacturing process of
Materials.
12. The term
"Patents" shall mean those patents and patent applications
which
either
party owns or controls or which either party may obtain or both
the
parties
may jointly obtain hereunder, the application date of which is
on
or before
the date of this Agreement or during the life of this
Agreement,
and all of
which are useful for or relating to Materials and/or Products.
13. The term
"Specifications" shall mean the written specifications
established for the characteristics, quality and quality control
testing
procedures
for each of Materials as developed by ALTUS, and as amended or
supplemented from time to time.
14. The term
"Good Manufacturing Practices" shall mean good manufacturing
practices
as defined in applicable laws, regulations and guidelines.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
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ARTICLE 2. PURPOSES
ALTUS and AMANO shall together and individually make Development
toward the goal
of successfully manufacturing Materials to be used in Products.
ALTUS and AMANO
shall exert [************] to successfully complete Development
under the terms
and conditions of this Agreement.
ARTICLE 3. RESPECTIVE CHARGES OF DEVELOPMENT
1. ALTUS
shall take charge of clinical development in the nature and
characteristic of Materials used for the preparation of Products,
and
chemical
reaction and effect against malabsorption resulting from
pancreatic
insufficiency including cystic fibrosis, and carry out such
development at ALTUS's laboratory and AMANO's facility during the
life of
this
Agreement. In the course of ALTUS's Development, ALTUS shall:
1)
develop
and establish ALTUS's Technologies utilized in Materials as
bulk drug active for Products,
2)
develop
and establish the standard of Specifications of Materials to
be manufactured by AMANO and prototype manufacturing processes
therefor,
3)
transfer
to AMANO Specifications to be employed by AMANO and give
AMANO a technical guidance in the manufacture of Materials,
particularly TheraCLEC [******] and [**************] and
[********],
4)
inspect
and approve AMANO's Development,
5)
prepare
and realize an Investigational New Drug application ("IND")
to the Food and Drug Administration ("FDA") for Materials
and/or
Products,
6)
provide
assistance to AMANO in establishing Good Manufacturing
Practices, and
7)
perfect
the regulatory process and retain records pertaining to
development of the Materials and Products.
2. AMANO
shall take charge of development in the manufacture of Materials
and
carry out
such development at AMANO's laboratory during the life of this
Agreement.
In the course of AMANO's Development, AMANO shall:
1)
arrange
production facility located in Japan for Materials, which
meets requirement of Good Manufacturing Practices,
2)
establish
AMANO's Technologies of [*********************] and
[*************************] for Materials,
3)
establish
AMANO's Technologies of the [*******] and
[****************] for materials,
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
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4)
develop
technologies manufacturing TheraCLEC [******] and
[*************] and [********] under AMANO's Technologies in
accordance
with ALTUS's Technologies disclosed to AMANO,
5)
develop
AMANO's Technologies of manufacturing Materials in
accordance with Specifications and guidance given by ALTUS, and
6)
support
the regulatory process and retain records pertaining to
development of the Materials.
3. ALTUS
and AMANO shall jointly develop and establish a standard
manufacturing management protocol for Materials on the basis of
quality
control
procedures originally developed by Altus, that may need to be
modified
to fulfill requirements for an FDA regulated product or other
product.
ARTICLE 4. EXCHANGE OF TECHNICAL INFORMATION
Forthwith after the execution of this Agreement, both parties.
shall disclose to
the other party Technical Information owned and possessed in the
respective
field of which either party takes charge hereunder from time to
time during the
life of this Agreement. All Technical Information that was
exchanged between or
developed jointly by the parties
[**********************************] shall be
deemed to be information exchanged between or developed jointly by
the parties
pursuant to this Article 4. All intellectual property provisions in
this
Agreement shall be effective as of the earliest date that the
parties began
working together.
ARTICLE 5. SUPPLY OF MATERIALS
1. ALTUS
shall provide AMANO with forecasts setting out the amounts of
Materials
it expects it will require for each month during the [********]
period
from the time of preparation of the relevant forecast. The
forecasts
shall be updated [********]. ALTUS shall prepare a separate
forecast
for the [**********] required for any [*********************].
Upon
ALTUS's request, AMANO shall supply ALTUS with reasonable
quantities
of
Materials manufactured by AMANO in accordance with
Specifications,
regardless
of fully finished or not, be necessary for ALTUS's Development.
2. If
ALTUS places an order for Materials with AMANO for the purpose
of
ALTUS's
Development pursuant to this Agreement that does not exceed the
amount of
Materials set forth in the most recent forecast for the
relevant
month,
AMANO shall [**************************************; provided,
however,
if ALTUS places an order for Materials in excess of the volume
specified
in the applicable forecast, supply by AMANO of such excess
Materials
shall be subject to [***********************************] and
to
[************************************************]. Supply of
Materials
by AMANO
hereunder may be conducted through AMANO's subsidiary, Amano
Enzyme USA
Co., Ltd. based in U. S. A.
3. The
parties hereto shall make a supply contract or contracts in
accordance
with the
terms of this Agreement, on a bona fide basis, from case to
case
relating
to the supply of Materials as provided hereinabove. The supply
contract
shall definitely provide terms
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
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and
conditions including but not limited to kind of Materials,
quantities,
Specifications, time of shipment, trade terms, price, payment and
etc.
4. AMANO
shall not supply [**************] other than to ALTUS without
prior
written
consent from ALTUS except as otherwise provided in Article
12.3,
provided
that nothing herein contains any restriction of supplying other
party than
ALTUS with any of Amano Enzymes or materials manufactured
[***************************************] and/or other technologies
of any
third
party.
5. Being
understood that evaluate, use or application of Materials and
Specifications for medical products are decided by ALTUS at its
sole
discretion, AMANO shall incur no liability on Materials
supplied
hereunder,
whatsoever for (a) all or any consequential or indirect losses
or damages
or loss of profit suffered or incurred by ALTUS or any third
party
howsoever caused; or (b) all or any actions, proceedings, demands
or
claims
made against ALTUS or any third party by any person whatsoever,
provided
AMANO prepares the Materials in accordance with the
Specifications and Good Manufacturing Practices. ALTUS shall
indemnify and
hold AMANO
harmless from all cost, expense and liability arising out of or
related to
injury to persons or property resulting from ALTUS's use of
Materials,
provided AMANO prepares the Materials in accordance with the
Specifications and Good Manufacturing Practices. ALTUS halt obtain
and
maintain,
at its own expense, during the life of this Agreement and
thereafter, sufficient insurance covering product liability,
tort
liability
and other liability relating to Materials and Products written
by an
insurer satisfactory to AMANO and in which insurance AMANO shall
be
named as
additional insured.
ARTICLE 6. JOINT DEVELOPMENT COMMITTEE
1. ALTUS
and AMANO shall, within [**********] after the execution of
this
Agreement,
establish a Joint Development Committee ("JDC") to (a)
elaborate
and confirm the plan of Development contemplated herein; (b)
give each
other the progress condition of Development at the time of the
meeting;
(c) oversee the compliance of the facility with Good
Manufacturing Practices and the transfer of the prototype process
of
manufacturing Materials from ALTUS to AMANO; (d) coordinate
Development to
the
manufacturing process of Materials; and (e) to exercise
decision
making
authority, and, further, shall make the plan and schedule of
Development within [**********] after the first meeting of JDC.
2. The JDC
shall be comprised of [*****] ALTUS representatives and [*****]
AMANO
representatives, who will initially be the business and
technical
mangers.
Each party may replace its JDC representative at any time,
after
discussion
with the other party, with subsequent written notice to the
other
party.
3.
Decisions of the JDC shall be made by consensus approval. In the
event the
parties
are unable to agree on any issue, the dispute will be referred
to
the
President or a person designated by the President of each party,
who
shall
promptly meet in person or by means of telephone or video
conference
and
endeavor to resolve the dispute in a timely manner.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
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In the
event such individuals are unable to resolve the dispute, it
shall
be settled
by [***************], or as otherwise agreed.
4. On and
after the execution of this Agreement, the JDC shall meet at
least
quarterly
at regular intervals, or more often as agreed by the parties,
in
person at
such locations as the parties agree, or by means of telephone
or
video
conference. With the consent of the parties, other
representatives
of each
party may attend JDC meetings as nonvoting observers.
5. Each
party shall each bear the expenses of their respective JDC
members
related to
their participation on the JDC and attendance at JDC meetings.
ARTICLE 7. EXPENSES
1. Each party hereto shall
[*************************], including but not
limited
to, the [**************] in its laboratory
[***********************] for Development from time to time, and
such
party
[***********************************************].
2. During
ALTUS's stay in Japan for Development, ALTUS may,
[***************], use all equipment in AMANO's laboratory, which
are
necessary
for Development, and, during AMANO's stay in U.S.A. for
Development, AMANO may, [****************], use all equipment in
ALTUS's
laboratory, which are necessary for Development.
3. Each
party hereto [**********************], including but not limited
to,
[*********
*************] from U.S.A. to Japan and back,
[**************************************************], which would
be
incurred
on ALTUS or AMANO under this Agreement.
ARTICLE 8. PATENTS AND ETC.
1. Subject
to Article 8(4) below, Patents and/or other industrial property
rights,
inventions, discoveries, know-how and other technologies
(collectively, "Intellectual Property Rights") solely developed,
acquired
or owned
by either party during the life of this Agreement
[*************************************************************
*********************] Patents and/or other industrial property
rights,
inventions, discoveries, know-how and other technologies in any
country
without a
prior written consent of such party.
2. Each
party [*****************************************] of Patents
and/or
other
Intellectual Property Rights concerning all discoveries,
inventions
and/or
other technologies acquired by such party in the course of or
as
the result
of Development. The [***************] of such Intellectual
Property
Rights [******************] shall be ALTUS or AMANO and
[*********************************************] for such Patents
and/or
other
Industrial Property Rights [***************************].
3. Each
party [****************] for its own Intellectual Property
Rights
[***********************].
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
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4. All
Intellectual Property Rights which constitute Joint Technologies
shall
be the
joint property of both parties. As to Joint Technologies
resulted
from Joint
Development, Intellectual Property Rights for such Joint
Technologies shall be applied and registered, in Japan and in any
overseas
countries,
in both the names of ALTUS and AMANO as to the co-owners and
the
parties shall share the costs incurred in connection with such
registrations; provided, however, that either party may refuse to
apply
for
co-registration of Intellectual Property Right in case such party
has,
a
sufficient reason not to apply or a thought to hold Joint
Technologies
as trade
secrets; and that where one party refuses or fails to apply for
co-registration of such Intellectual Property Rights within 90 days
of a
request
for such co-registration by the other party without such a
reason
or a
thought, then the other party shall be free at their own expense
to
file an
application for registration of the Intellectual Property
Rights
as sole
registrant and thereafter utilize such Intellectual Property
Rights
without any requirement to pay a royalty.
5. Either
party may not assign, transfer, sell or otherwise dispose of
its
Intellectual Property Rights and know-how acquired in Joint
Development to
any third
party without a prior written consent of the other party. In
case
either party desires to dispose such technologies, the other
party
[***********************************************] as negotiated
between
the
parties in good faith.
6. Subject
to the terms of this agreement, the parties [*****************]
any
Intellectual Property Rights they own in accordance with Articles
8(1)
and (4)
above, in any manner they deem fit, and
[***********************************************], provided that,
if
either party
desire to have a third party utilize any Joint Technologies,
such
either party shall obtain a prior written consent of the other
party.
ARTICLE 9. PLAN, SCHEDULE AND REPORTS OF DEVELOPMENT
1. Both
the parties apply due diligence to Development in accordance with
the
plan and
schedule of Development which should be prepared and amended
from
time to
time during the life of this Agreement by mutual consultation.
Provided,
however, that; (a) in the event that Development of either
party
should be
delayed by the force majeure or other reasonable causes to such
party, the
other party shall agree to the extension [*****************]
in the
plan and schedule of Development and continue Development
during
such
extended period; (b) in case any alteration of a part of whole of
the
plan and
schedule of Development is required by any reason, either of
the
parties
having or knowing such reason shall notify the other party to
that
effect in
advance.
2. ALTUS
and AMANO shall provide the other party with the written report
on
the
results of Development [******************] reasonably requested
by
the other
party.
ARTICLE 10. NDA APPLICATION
1. ALTUS
shall use best efforts to research, develop and conduct such
research,
development and preclinical and human clinical trials as
necessary
or desirable to obtain all regulatory approvals to manufacture
and
market, and to obtain necessary approval to
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION
REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT.
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market,
commence marketing and market Products in U. S. A. and any
other
countries
in the world as ALTUS determines are commercially feasible.
2. Within
[**************] following the end of each [**********] period
during the
life of this Agreement, ALTUS shall prepare and deliver to
AMANO a
written report which shall describe, in reasonably sufficient
detail,
(a) the research performed to date employing Materials; (b) the
progress
of the development, and testing of Materials and Products in
all
studies
including clinical trials; and (c) the status of obtaining the
necessary
approvals to market Products. In addition, ALTUS shall provide
AMANO with
a minimum of [**********] advance written notice of the
contemplated filing of an NDA application, written notice of
other
significant regulatory filings and submissions in a timely fashion,
and
written
notice of all approvals obtained after obtaining such
approvals.
ARTICLE 11. COMMERCIALIZATION
1. In case
that Development of Materials and products contemplated
hereunder
has been
completed and Products may be manufactured and sold on a
commercial
basis, [***************************] manufacture and sold
Products
by using all results from ALTUS's Deve
