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COOPERATIVE DEVELOPMENT AGREEMENT

Development Agreement

COOPERATIVE DEVELOPMENT AGREEMENT | Document Parties: ALTUS PHARMACEUTICALS INC. | ALTUS BIOLOGICS INC. | AMANO ENZYME INC. You are currently viewing:
This Development Agreement involves

ALTUS PHARMACEUTICALS INC. | ALTUS BIOLOGICS INC. | AMANO ENZYME INC.

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Title: COOPERATIVE DEVELOPMENT AGREEMENT
Governing Law: Delaware     Date: 1/23/2006
Industry: Biotechnology and Drugs     Sector: Healthcare

COOPERATIVE DEVELOPMENT AGREEMENT, Parties: altus pharmaceuticals inc. , altus biologics inc. , amano enzyme inc.
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<PAGE>
                                                                   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.

                                       1
<PAGE>

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
<PAGE>

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.

                                       3
<PAGE>

      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.

                                       4
<PAGE>

      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
<PAGE>

      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
<PAGE>


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.

                                       7
<PAGE>

      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


 
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