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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.
2
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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.
5
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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.
6
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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






