Exhibit 10.1
DRUG PRODUCT PRODUCTION AND CLINICAL SUPPLY AGREEMENT
THIS AGREEMENT is made and entered into effective as of the 15th day of
August, 2006 (the "Effective Date") by and between:
ALTUS PHARMACEUTICALS, INC., a Delaware corporation, with its principal offices
located at ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (hereinafter referred to as
"Altus"); and
▇▇▇▇▇▇ TECHNOLOGIES, INC., a Delaware corporation, with a place of business
located at ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (hereinafter referred to as
"▇▇▇▇▇▇").
Altus and ▇▇▇▇▇▇ may be referred to herein individually as a "Party", and
collectively as the "Parties".
WHEREAS, Altus has formulations and/or know-how related to Drug Product, as
defined below; and
WHEREAS, Altus wishes to have ▇▇▇▇▇▇ implement certain upgrades and
modifications to its manufacturing facility and Produce Drug Product, and ▇▇▇▇▇▇
wishes to implement such upgrades and modifications and Produce Drug Product for
Altus.
NOW, THEREFORE, in consideration of the premises and the undertakings,
terms, conditions and covenants set forth below, the Parties hereto agree as
follows:
ARTICLE 1
DEFINITIONS.
1.1 AFFILIATE of a Party shall mean any entity that controls or is controlled
by such Party, or is under common control with such Party. For purposes of
this definition, an entity shall be deemed to control another entity if it
owns or controls, directly or indirectly, at least 50% of the voting equity
of such other entity (or other comparable interest for an entity other than
a corporation), or otherwise has the actual ability to direct and control
the management and business affairs of such other entity.
1.2 ANALYTICAL TESTS shall have the meaning provided in Section 3.5.
1.3 BATCH shall mean the quantity of a Drug Product that (a) is produced
according to a single manufacturing order during a single manufacturing
run, and (b) is intended to have uniform character and quality within
specified limits.
1.4 BULK DRUG SUBSTANCE shall mean the human growth hormone compound that is an
active ingredient in the Altus product known as ALTU-238 (as more fully
described in the Project Plan) to be supplied by Altus for use in
Production of Drug Product.
1.5 CGMP shall mean current Good Manufacturing Practices as defined in the Code
of Federal Regulations, 21 CFR Parts 210-211 and/or the laws and
regulations of other applicable countries or jurisdictions.
1.6 CANCELLATION FEES shall mean the fees payable by Altus under Section 6.3 in
the event that Altus cancels the Production of any Batch of Drug Product
set forth in the Project Plan, except in the event of a default by ▇▇▇▇▇▇.
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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1.7 COMPONENTS shall mean all components and materials used by ▇▇▇▇▇▇ in
Production of Drug Product under this Agreement, including, without
limitation, Bulk Drug Substance. Components are listed in the Project Plan,
such Components identified as Components supplied by Altus ("Altus Supplied
Components") and Components supplied by ▇▇▇▇▇▇ ("▇▇▇▇▇▇ Supplied
Components").
1.8 CONFIDENTIAL INFORMATION shall mean all information and data provided by
one Party to the other Party under this Agreement, but excluding any
specific portion of such information or data that the receiving Party can
demonstrate:
(I) is disclosed to the recipient by a third person who has the
right to make such disclosure;
(II) is or becomes part of the public domain through no fault of
the recipient; or
(III) the recipient can reasonably establish is independently
developed by recipient without use of the information
disclosed by the disclosing Party.
1.9 DRUG PRODUCT shall mean Altus' proprietary product known as ALTU-238,
containing Bulk Drug Substance, in finished dosage form packaged and
labeled for clinical use only, which is to be Produced by ▇▇▇▇▇▇ under this
Agreement.
1.10 EQUIPMENT shall have the meaning provided in Section 3.3.
1.11 FACILITY shall mean Althea's existing manufacturing facility located in San
Diego, California.
1.12 FDA shall mean the United States Food and Drug Administration or any
successor entity thereto.
1.13 FD&C ACT shall mean the United States Federal Food, Drug and Cosmetic Act,
as may be amended from time to time.
1.14 IND shall mean an Investigational New Drug Application, as defined in the
United States Code of Federal Regulations (21 CFR).
1.15 LABELING shall mean all labels and other written, printed, or graphic
matter upon: (i) Drug Product or any container, carton, or wrapper utilized
with Drug Product or (ii) any written material accompanying Drug Product.
1.16 MASTER BATCH RECORD (MBR) shall mean the formal set of instructions for
Production of Drug Product. The MBR shall be developed and maintained by
the Parties in accordance with Section 4.3.
1.17 PROCESS shall mean Altus' proprietary manufacturing process for the
manufacture of Drug Product using the Components.
1.18 PRODUCTION OR PRODUCE shall mean the manufacturing, formulation, filling,
packaging, inspection, labeling, and testing of Drug Product by ▇▇▇▇▇▇
using the Process.
1.19 PRODUCT REQUIREMENTS shall have the meaning provided in Section 8.1.
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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1.20 PRODUCT SPECIFICATIONS shall mean a listing of the analytical testing and
corresponding Specifications, to be performed on the Bulk Drug Substance
and Drug Product in connection with the stability program.
1.21 PROJECT PLAN shall mean the attached Schedule 1 documenting the parameters
for Production of Drug Product, including a statement of work defining the
scope and assumptions of the project, an agreed-upon timeline based upon
the project's scope and assumptions, the Specifications to be adhered to in
Producing the Drug Product, a description of Bulk Drug Product and other
Altus property to be used in the project, a Quality Management Agreement,
an agreed upon price quote, packaging and delivery instructions, and sample
certificates of analysis. The Parties acknowledge that as of the Effective
Date Schedule 1 is a work in process, and each Party agrees to use
commercially reasonable and good faith efforts to develop and mutually
agree upon completed versions of such Schedule as promptly as practicable
following the Effective Date, and upon such agreement the complete Schedule
1 shall be attached as part of this Agreement.
1.22 PURCHASE PRICE shall mean the amount to be paid by Altus per Batch of Drug
Product delivered by ▇▇▇▇▇▇ conforming to the Specifications, as specified
in Article 5.
1.23 QUALITY MANAGEMENT AGREEMENT shall mean an agreement executed between the
Parties as provided in Section 7.3, which shall govern quality issues
related to Production by ▇▇▇▇▇▇ of Drug Product.
1.24 REGULATORY AUTHORITY shall mean those agencies or authorities responsible
for regulation of Drug Product in the United States and overseas. ▇▇▇▇▇▇
shall have no obligation to Produce Drug Product in compliance with the
requirements of a Regulatory Authority not specified in the applicable
Project Plan.
1.25 RELEASED EXECUTED BATCH RECORD shall mean the completed batch record and
associate deviation reports, investigation reports, and certificates of
analysis created for each Batch of Drug Product.
1.26 SPECIFICATIONS shall mean the complete specifications for the Production of
Drug Product, including as to primary and secondary packaging, and to the
extent that ▇▇▇▇▇▇ is required to test the Bulk Drug Substance, for the
Bulk Drug Substance, which shall be set forth in Product Specifications and
the Master Batch Record for Drug Product.
1.27 TERM shall have the meaning provided in Section 6.1.
ARTICLE 2
STEERING COMMITTEE
Promptly after the Effective Date, the Parties will form a Steering
Committee (composed of two representatives from each Party) that will
oversee and manage the activities of the Parties contemplated by this
Agreement. Such Steering Committee will seek to operate by consensus. The
initial members of the Steering Committee shall be [***] and [***] for
Altus and [***] and [***] for ▇▇▇▇▇▇. The Steering Committee shall meet
within 30 days to establish an overall governance for the collaboration,
including appointing any subcommittees as needed. The Steering Committee
will be responsible for managing any such subcommittees created by the
Steering Committee, and shall have the ultimate decision-making authority
as to any matter delegated to a subcommittee. A Party may
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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change its members of the Steering Committee at its discretion. The
Steering Committee shall meet by telephone, or as otherwise agreed by the
Parties, as often as needed to facilitate the efficient conduct of the
activities contemplated by this Agreement, and each Party shall be
responsible for the costs of its representatives in participating in
Steering Committee meetings. For clarity, the Steering Committee (and any
subcommittee) will not have any right or authority to amend or modify in
any way the terms of this Agreement.
ARTICLE 3
FACILITY MODIFICATIONS; TECHNOLOGY TRANSFER
3.1 FACILITY MODIFICATIONS: For ▇▇▇▇▇▇ to be able to provide to Altus the Drug
Product in the timeframes contemplated by the Parties, ▇▇▇▇▇▇ shall perform
the specific modifications and upgrades to the Facility, as set forth in
Schedule 1 to this Agreement. Such upgrades and modifications to the
Facility shall be completed by ▇▇▇▇▇▇ in accordance with the timeline set
forth in Schedule 1 hereto. Notwithstanding the foregoing, Altus
acknowledges that Althea's ability to perform such Facility upgrades and
modifications will depend upon Altus timely providing to ▇▇▇▇▇▇ finalized
CAD drawings and equipment utility requirements for the Facility, and
timely delivery of skids, and Altus agrees that ▇▇▇▇▇▇ will not be
responsible for delays in completion of such modifications and upgrades
caused by Altus' delay or failure to provide such CAD drawings and
equipment utility requirements, by delay in delivery of skids, or by other
causes to the extent beyond Althea's reasonable control and provided that
▇▇▇▇▇▇ uses diligent, commercially reasonable efforts to avoid any such
delays despite such causes.
3.2 FACILITIES RESERVATION: ▇▇▇▇▇▇ shall reserve such equipment, space and
resources in the Facility (after the above modifications described in
Section 3.1 are completed) as needed to Produce and supply to Altus [***]
Batches of Drug Product as contemplated by this Agreement (and to
accomplish all related tasks as set forth in this Agreement) according to a
schedule mutually agreed by the Parties in good faith. It is anticipated
that such reservation would begin consistent with Schedule 1, and provided
further that if additional Facility time is required for ▇▇▇▇▇▇ to complete
Production of the [***] Batches, the Parties shall mutually agree in good
faith to a modified schedule to accomplish such Production as soon as
practicable.
3.3 EQUIPMENT VALIDATION: ▇▇▇▇▇▇ shall conduct the manufacturing equipment
acceptance and preliminary validation processes (IQ, OQ, PQ and Cleaning
Validation), all as provided in the Project Plan. Such work shall commence
as promptly as practicable following the completion of the installation of
the Equipment (as below). Altus shall provide to ▇▇▇▇▇▇ (on loan) the
equipment specified in Schedule 2 hereto (the "Equipment") for
crystallization and formulation of Drug Product and shall provide support
to ▇▇▇▇▇▇ for validation of the Equipment. The Equipment shall remain the
property of Altus and shall be returned to Altus at the end of this
Agreement or upon early termination of this Agreement. Following written
notice by Altus to ▇▇▇▇▇▇ that the Equipment is subject to a third party
lien or other encumbrance resulting from a financing arrangement, ▇▇▇▇▇▇
agrees to provide such third party with access to the Equipment as
necessary for such third party to exercise its rights under such financing
arrangement. Altus shall be responsible for insuring the equipment against
loss or damage. ▇▇▇▇▇▇ shall use commercially reasonable efforts to
maintain the Equipment in good working order and to avoid damage or harm to
the Equipment. If Altus or a third party is required to visit the Facility
to perform service, repair or maintenance of the Equipment, or if such
service, repair or maintenance requires the purchase of spare parts, Altus
shall be responsible for the cost thereof (which shall be in addition to
the payment amounts set forth in this Agreement),
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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except to the extent that Althea's negligence or willful misconduct or
other failure to comply with its obligations under this Agreement result in
the need for such service, repair, maintenance or parts, in which case
▇▇▇▇▇▇ shall bear full responsibility for all such costs and expenses.
3.4 PRODUCTION PROCESS TECHNOLOGY TRANSFER: Altus shall transfer all
manufacturing know-how and processes controlled by Altus comprising the
Process as necessary for ▇▇▇▇▇▇ to manufacture the Drug Product using the
Process, and ▇▇▇▇▇▇ shall incorporate such technology into the applicable
resources in the Facility and shall conduct one [***] buffer run, all as
provided in the Project Plan. ▇▇▇▇▇▇ also shall conduct additional buffer
runs as requested by Altus in writing.
3.5 ANALYTICAL METHODS TECHNOLOGY TRANSFER: Altus shall transfer all analytical
test methods and know-how controlled by Altus as necessary for ▇▇▇▇▇▇ to
conduct the validation, QC/QA, and product release of the Drug Product as
contemplated in the Project Plan (the "Analytical Tests").
3.6 VALIDATION RUNS: Promptly after completion of the Equipment validation as
provided in Section 3.3 above, ▇▇▇▇▇▇ shall conduct validation runs of the
Equipment and separately of the fill process (which uses ▇▇▇▇▇▇ equipment),
in accordance with the jointly agreed upon protocols for such validation
runs. Each such validation run shall use appropriate [***]. Altus shall
determine whether each such validation Batch manufactured by ▇▇▇▇▇▇ and
delivered to Altus has met the success criteria for the validation run,
which criteria shall be as established by Altus in agreement with ▇▇▇▇▇▇,
such agreement not to be unreasonably withheld. If a particular validation
run conducted by ▇▇▇▇▇▇ fails to meet such criteria, an appropriate
representative from each Party shall meet and discuss and seek to determine
the causes of such validation run having failed to meet such criteria, and
▇▇▇▇▇▇ shall use best efforts to rectify any such problems as soon as
practicable. ▇▇▇▇▇▇ shall recommence conducting the applicable validation
run, and shall conduct such validation runs (on each of the Equipment and
the fill process, until three (3) consecutive validation runs for each the
particular manufacturing steps (i.e., using the Equipment or using fill
equipment) have met the applicable criteria.
ARTICLE 4
PRODUCTION OF DRUG PRODUCT.
4.1 DRUG PRODUCT MANUFACTURING: After completion of the validation runs as
provided in Section 3.6, ▇▇▇▇▇▇ shall Produce the Drug Product in the
Facility using the Equipment, and such other equipment and resources of
▇▇▇▇▇▇ as are needed to complete such Production. The Drug Product shall be
manufactured in accordance with cGMP, the Master Batch Record and all other
applicable laws and regulations and shall conform with the Specifications.
The Drug Product will be manufactured in [***] Batches: [***] Batches at
[***] per run and [***] Batch of [***] (but provided that Altus may elect
to convert one of the [***] Batches into a [***] [***] Batch, on written
notice and subject to payment of additional Purchase Price as provide in
Section 5.5). It is agreed that the first Batch will be conducted and
completed consistent with the applicable timeline in Schedule 1 (subject to
Section 3.1 above), with the commencement and delivery of such Batch to
occur on the schedule set forth in Schedule 1 hereto. For the remaining
Batches, which are expected to be conducted and completed in 2007, Altus
will provide one month's notice to ▇▇▇▇▇▇ to schedule the manufacturing
run(s), and ▇▇▇▇▇▇ shall commence the manufacturing run within one month of
such notice. In addition, Altus may request that ▇▇▇▇▇▇ Produce one or more
additional Batches of Drug Product in 2007 (at [***] and/or [***] per run,
as specified by Altus) upon the same advance notice as applicable to the
first [***] Batches to be Produced in 2007, except that if, at the time of
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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Altus' request, the skids have been removed from the Facility, then six
weeks' advance notice will be required. ▇▇▇▇▇▇ shall complete the
manufacturing and QA/QC and delivery of the final, completed Drug Product
in a particular Batch within [***] days of commencing the manufacturing run
for such Batch. For each Batch that is Produced, the delivered Drug Product
shall comprise at least an aggregate of [***] pre-filled syringes (for a
[***] Batch), or [***] pre-filled syringes (for a [***] Batch), meeting the
Specifications and other obligations of this Agreement. Altus shall have
the right to inspect each Batch delivered to determine if it meets the
Specifications and otherwise is conforming, and may reject any Batch that
fails to meet the Specifications or otherwise is defective. ▇▇▇▇▇▇ shall
manufacture and deliver to Altus as soon as possible a new complete Batch
meeting the Specifications if Altus properly rejects a Batch.
4.2 STABILITY STUDIES: ▇▇▇▇▇▇ shall conduct stability studies on the Drug
Product, in accordance with the study protocols as provided in Schedule 5
hereto. The Parties acknowledge that as of the Effective Date such Schedule
is a work in process; each Party agrees to use commercially reasonable and
good faith efforts to develop and mutually agree upon the completed version
of such Schedule as promptly as practicable following the Effective Date,
and upon such agreement such completed Schedule shall be attached as part
of this Agreement.
4.3 DOCUMENTATION: The Master Batch Record shall be prepared, discussed,
reviewed and approved by ▇▇▇▇▇▇ and Altus jointly prior to commencement of
Production. ▇▇▇▇▇▇ shall not make any change to the Master Batch Record
without Altus' prior written consent. Each Batch of Drug Product shall be
Produced by using a copy of the Master Batch Record, and such copy shall be
assigned a unique batch number applicable to such Batch of Drug Product.
Such copy of the Master Batch Record for a particular Batch shall record
all applicable information relating to the Production of the Drug Product
in such Batch in the form specified by the Master Batch Record, including
any deviation from the manufacturing process specified in the Master Batch
Record and the results of all quality control and quality assurance testing
performed in such Production. ▇▇▇▇▇▇ shall ensure that all information
required by the Master Batch Record relating to the Production of a Batch
shall be completely and accurately recorded and documented in the copy of
the Master Batch Record applicable to such Batch. The final, complete
Master Batch Record for a particular completed Batch shall be the Released
Executed Batch Record. Upon delivery of a completed Batch, ▇▇▇▇▇▇ shall
provide to Altus the Released Executed Batch Record for such Batch and any
additional required documentation to support Production in a form
reasonably suitable for Altus' submission to the FDA.
4.4 COMPONENT SUPPLY: ▇▇▇▇▇▇ shall be responsible for procuring, testing and
releasing on a timely basis all Components (including BD syringes, except
as otherwise provided below) needed to Produce and deliver the Drug
Product, except that Altus shall supply to ▇▇▇▇▇▇, at Altus' cost, the
Altus Supplied Components. Except as may specifically be set forth in the
Project Plan, on receipt of the Altus Supplied Components as set forth
above, Althea's sole obligation with respect to evaluation of the Altus
Supplied Components shall be to review the accompanying certificate(s) of
analysis (if any) to confirm that the Altus Supplied Components conform
with the Specifications. [***]▇▇▇▇▇▇ [***] in order to [***] of the batches
of Drug Product, the Parties will[***] [***] [***] As promptly as
practicable after the Effective Date, ▇▇▇▇▇▇ will inform Altus of the
quantity of BD syringes that ▇▇▇▇▇▇ anticipates it will need. In addition,
▇▇▇▇▇▇ will as promptly as practicable provide an approved vendor list for
its purchase of all needed ▇▇▇▇▇▇ Supplied Components, [***] that relate to
▇▇▇▇▇▇ Supplied Components for Altus' review. If Altus determines that
additional audits of vendors of ▇▇▇▇▇▇ Supplied Components need to be
conducted, such needed vendor audits will be conducted by the Parties
[***].
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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4.5 COMPONENT DELIVERY DELAYS: ▇▇▇▇▇▇ shall have no responsibility for delays
in delivery of Drug Product caused by delays in receipt of Altus Supplied
Components. If ▇▇▇▇▇▇ receives the Altus Supplied Components from Altus
with less time than requested in the applicable Project Plan prior to the
scheduled date of Production of a particular Batch of Drug Product, and as
a result ▇▇▇▇▇▇ does not have sufficient time to Produce such Drug Product
by the scheduled date as reasonably determined by ▇▇▇▇▇▇, then ▇▇▇▇▇▇ and
Altus shall discuss and agree on a rescheduled date for commencement and
completion of Production of such Batch of Drug Product and on a reasonable
rescheduling fee to be paid by Altus to compensate ▇▇▇▇▇▇ for the delay.
4.6 IMPORTER OF RECORD: In the event any material or equipment to be supplied
by Altus, including without limitation Altus Supplied Components, is
imported into the United States for delivery to ▇▇▇▇▇▇ ("Imported Goods"),
Altus shall be the "Importer of Record" of such Imported Goods. As the
Importer of Record, Altus shall be responsible for all aspects of the
Imported Goods including, without limitation (a) customs and other
regulatory clearance of Imported Goods, (b) payment of all tariffs, duties,
customs, fees, expenses and charges payable in connection with the
importation and delivery of the Imported Goods, and (c) keeping all
records, documents, correspondence and tracking information required by
applicable laws, rules and regulations arising out of or in connection with
the importation or delivery of the Imported Goods.
4.7 MATERIAL SAFETY DATA SHEET: Altus shall provide ▇▇▇▇▇▇ a Material Safety
Data Sheet for Bulk Drug Substance and for Drug Product. ▇▇▇▇▇▇ shall
immediately notify Altus of any unusual health or environmental occurrence
relating to Drug Product, including, but not limited to any claim or
complaint by any employee of ▇▇▇▇▇▇ or any of its Affiliates or third party
that the operations of ▇▇▇▇▇▇ pursuant to this Agreement have resulted in
any adverse health or safety effect on an employee or third party. ▇▇▇▇▇▇
agrees to advise Altus immediately of any safety or toxicity problems of
which it becomes aware regarding the Drug Product.
4.8 VENDOR AND SUPPLIER AUDIT AND CERTIFICATION: Altus shall certify and audit,
as per its standard practice, all vendors and suppliers related to Altus'
purchase of Altus Supplied Components, and shall have the right to approve
Althea's selection of vendors and suppliers for ▇▇▇▇▇▇ Supplied Components.
4.9 DELIVERY TERMS: ▇▇▇▇▇▇ shall ship all finished Drug Product to Altus or to
Altus' designated consignee. All shipments shall be shipped FCA the
Facility, by a common carrier designated by Altus, at Altus' expense;
provided, however, that ▇▇▇▇▇▇ shall be responsible for the loading of the
Drug Product on departure and shall bear risk of loss and all costs of such
loading. Altus shall procure, at its cost, insurance covering damage or
loss of Drug Product during shipping. All shipping instructions of Altus
shall be accompanied by the name and address of the recipient and the
shipping date.
4.10 EXPORTER OF RECORD: Altus shall be the exporter of record for any Product
shipped out of the United States, as Altus remains the owner of the
Product. Altus warrants that all shipments of Product exported from the
United States will be made in compliance with all applicable United States
export laws and regulations and all applicable import laws and regulations
into the country of deportation. Altus shall be responsible for obtaining
and paying for any licenses or other governmental authorization(s)
necessary for the exportation from the United States. Altus shall select
and pay the freight forwarder who shall solely be Altus' agent. Altus and
its freight forwarder shall be solely responsible for preparing and filing
the Shipper's Export Declaration and any other documentation required for
the export.
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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4.11 RETURNS: Drug Product returned by third parties is the responsibility of
Altus, but subject to Section 4.1 with respect to defective Drug Product.
4.12 COMMERCIAL SUPPLY: Commencing on the written request by Altus, the Parties
shall negotiate in good faith the terms of a commercial supply agreement
under which ▇▇▇▇▇▇ shall manufacture and supply to Altus final ALTU-238
product containing Bulk Drug Substance for commercial sale by Altus (the
"Commercial Supply Agreement"), which agreement shall be on commercially
reasonable terms as negotiated in good faith. The Parties shall use good
faith efforts to complete such negotiations and enter into the Commercial
Supply Agreement as soon as practicable after Altus' notice, and in any
event within 45 days of such notice. In the event that, during the term of
this Agreement or within one (1) year after its expiration or termination
(except in the case of termination as a result of Althea's uncured material
breach), Altus has not entered into the Commercial Supply Agreement and
instead Altus enters into an agreement or arrangement under which a third
party is granted the right to manufacture, formulate, fill, package and
label Altus' proprietary product known as ALTU-238 for commercial sale,
then Altus shall, within 10 days after entering into such agreement or
arrangement, notify ▇▇▇▇▇▇ thereof in writing [***] needed to perform the
services under this Agreement. Altus acknowledges that entering into this
Agreement will require substantial investment by ▇▇▇▇▇▇ and will require
that ▇▇▇▇▇▇ forego other potential opportunities, and Altus hereby agrees
that the foregoing fee is reasonable in principle and in amount.
ARTICLE 5
FINANCIAL TERMS
5.1 FACILITY MODIFICATIONS PAYMENT: ▇▇▇▇▇▇ acknowledges receipt of payment from
Altus of $[***] in consideration of ▇▇▇▇▇▇ undertaking and completing the
Facility modifications as contemplated in Section 3.1 above and ▇▇▇▇▇▇
reserving Facility time as provided in Section 3.2 above.
5.2 VALIDATION PAYMENTS: In consideration of the IQ, OQ and PQ validation work
under Section 3.3, Altus shall pay ▇▇▇▇▇▇ the sum of $[***], which shall be
due and payable as follows: (a) $[***] within 30 days of receipt of an
invoice provided after the Effective Date; (b) $[***] within 30 days after
receipt of an invoice from ▇▇▇▇▇▇ provided after the completion of such
validation work, and delivery to Altus of the draft validation report, and
(c) $[***] within 30 days after receipt of an invoice from ▇▇▇▇▇▇ [***]. In
consideration of the Cleaning Validation work under Section 3.3, Altus
shall pay ▇▇▇▇▇▇ the sum of $[***], which shall be due and payable as
follows: (a) $[***] within 30 days of receipt of an invoice provided after
the Effective Date; (b) $[***] within 30 days after receipt of an invoice
from ▇▇▇▇▇▇ provided after the completion of the first two manufacturing
Batches and their respective cleaning validation work, and (c) $[***]
within 30 days after receipt of an invoice from ▇▇▇▇▇▇ provided after
completion of manufacturing Batches and respective cleaning validation work
[***]. ▇▇▇▇▇▇ will replace a failed equipment validation Batch at its cost
if such failure is caused by Althea's failure to conform to the Master
Batch Record or other negligence of ▇▇▇▇▇▇ in performance of the Process.
If failure is not determined to be caused by Althea's failure as described
above then replacement validation runs will be at Altus cost. In
consideration of the 3 media fill validation runs under Section 3.6 (i.e.,
validation runs using the ▇▇▇▇▇▇ fill equipment), Altus shall pay ▇▇▇▇▇▇
the sum of $[***] per fill run including all raw materials, which shall be
due and payable as follows: $[***] within 30 days after of receipt by Altus
of an invoice provided by ▇▇▇▇▇▇ 30 days prior to the scheduled
commencement of each run, and $[***] within 30 days after receipt of an
invoice by Altus [***]. If a fill validation run fails, ▇▇▇▇▇▇ will rerun
at the validation run at its cost (including raw materials).
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
8
5.3 PROCESS TRANSFER PAYMENT: In consideration of the process technology
transfer work under Section 3.4, Altus shall pay ▇▇▇▇▇▇ the sum of $[***],
which shall be due and payable as follows: (a) $[***] within 30 days of
receipt of an invoice provided after the Effective Date; (b) $[***] within
30 days after receipt of an invoice from ▇▇▇▇▇▇ provided after the
completion of the first buffer run after such process technology transfer
work is completed and the delivery to Altus of the draft report, and (c)
$[***] within 30 days after receipt of an invoice from ▇▇▇▇▇▇ provided
after the completion of all such process technology transfer work [***].
Further, Altus shall pay ▇▇▇▇▇▇ $[***] for each additional buffer run at
[***] scale that is requested by Altus for assurance, which shall be due
and payable as follows: (i) $[***] within 30 days after receipt of an
invoice from ▇▇▇▇▇▇ provided after Altus' request for such additional
buffer run; and (ii) $[***] within 30 days after receipt of an invoice from
▇▇▇▇▇▇ provided after the completion of such buffer run [***] by ▇▇▇▇▇▇.
5.4 ANALYTICAL METHODS TRANSFER PAYMENT: In consideration of the analytical
methods transfer work under Section 3.5, Altus shall pay ▇▇▇▇▇▇ the sum of
$[***], which shall be due and payable as follows: (a) $[***] within 30
days after the Effective Date; (b) $[***] within 30 days after receipt of
an invoice from ▇▇▇▇▇▇ provided after the completion of the technical
activity of assay qualification, and (c) $[***] within 30 days after
receipt of an invoice from ▇▇▇▇▇▇ provided after the completion of such
analytical methods transfer work [***] by ▇▇▇▇▇▇.
5.5 TRANSFER PRICES FOR DRUG PRODUCT: In consideration of the Production of a
Batch in accordance with Section 4.1, Altus shall pay ▇▇▇▇▇▇ the sum of
$[***] (whether such Batch results from a [***] or [***] run), which shall
be due and payable as follows: (a) $[***], payable within 30 days after
receipt of an invoice from ▇▇▇▇▇▇ provided after the Effective Date for the
first Batch, and within 30 days of receipt of an invoice from ▇▇▇▇▇▇
provided after Altus ordering each successive Batch thereafter; and (b)
$[***] within 30 days after receipt of an invoice from ▇▇▇▇▇▇ provided
after completion by ▇▇▇▇▇▇ of delivery of such Batch acceptance of such
Batch by Altus (under terms of Section 8.1). Notwithstanding the foregoing,
if Altus elects (as provided in Section 4.1) to convert one of the [***]
Batches to a [***] Batch, then the payment amount for such [***] Batch
shall be a sum of $[***] due and payable as follows: (a) $[***], payable
within 30 days after receipt of an invoice from ▇▇▇▇▇▇ provided after Altus
makes such election; (b) $[***] within 30 days after receipt of an invoice
from ▇▇▇▇▇▇ provided after completion by ▇▇▇▇▇▇ of delivery of such Batch
and acceptance of such Batch by Altus (under terms of Section 8.1).
5.6 STABILITY STUDIES PAYMENT: In consideration of the stability studies work
under Section 4.2 on each Batch (including delivery of the final report to
Altus) as requested by Altus, Altus shall pay ▇▇▇▇▇▇ the sum of $[***],
which shall be due and payable as follows: (a) $[***] within 30 days after
receipt of an invoice from ▇▇▇▇▇▇ provided after initiation of protocol
drafting for such studies; (b) $[***] within 30 days after receipt of an
invoice from ▇▇▇▇▇▇ provided after completion of the last sample point for
the stability study for the second batch; and (c) $[***] within 30 days
after receipt of an invoice from ▇▇▇▇▇▇ [***].
5.7 SUCCESS BONUS PAYMENT: Altus shall pay ▇▇▇▇▇▇ a success bonus payment in
the amount of $[***], within 30 days after receipt of an invoice provided
by ▇▇▇▇▇▇ after successful completion and delivery, in accordance with the
mutually agreed upon timeline in Schedule 1, of the first Batch that meets
the Specifications. Any modifications to such timeline must be agreed upon
in writing by both Parties.
5.8 LATE PAYMENTS: Late payments shall accrue interest from the due date at the
rate of 1.0% per month; provided, however, that in no event shall such rate
exceed the maximum legal annual interest
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
9
rate. Notwithstanding the foregoing, if Altus disputes in good faith that a
particular payment hereunder is due, Altus shall provide prompt written
notice thereof to ▇▇▇▇▇▇, and the Parties shall promptly discuss such
dispute in good faith and use all reasonable efforts to resolve such
dispute as promptly as practicable. No interest shall accrue hereunder on
amounts that are subject to good faith dispute between the Parties for so
long as such dispute continues. The payment of interest hereunder shall not
limit ▇▇▇▇▇▇ from exercising any other rights it may have as a consequence
of the lateness of any payment.
5.9 MANNER AND PLACE OF PAYMENT: All payments by Altus, as specified above,
shall be subject to ▇▇▇▇▇▇ delivering to Altus by electronic mail an
invoice in the amount owed in accordance with the above provisions, and the
payment shall be made within the applicable number of calendar days (as
specified in the particular payment provision) after the date Altus
receives the applicable invoice. All such electronic mail invoices shall be
sent to the following e-mail address (or such other e-mail address as Altus
may specify in writing to ▇▇▇▇▇▇): [***]. All payments under this Article 5
shall be made by check or wire transfer in immediately available funds to
the following account:
▇▇▇▇▇▇ Technologies, Inc.
▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇ ▇▇▇▇▇ ▇▇ ▇▇▇▇▇-▇▇▇▇
Ph. 858-882-0123
Comerica Bank
▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇▇ ▇▇ ▇▇▇▇▇
SWIFT#: [***]
TRANSIT#: [***]
ACCOUNT#: [***]
5.10 REMAINING COMPONENTS: Within 30 days of completion of the final quality
control release and final invoice and of delivery of the final completed
Batch, Altus will instruct ▇▇▇▇▇▇ as to whether to return or dispose of all
of the remaining Components provided by Altus. If ▇▇▇▇▇▇ does not receive
notice from ▇▇▇▇▇, ▇▇▇▇▇▇ will have the right to use or dispose of any such
remaining Components.
5.11 DEFAULT IN PAYMENT OBLIGATIONS: In addition to all other remedies available
to ▇▇▇▇▇▇ in the event of a Altus default, if Altus fails to make payments
as required hereunder, ▇▇▇▇▇▇ may take appropriate measures to assure
prompt and full payment, including refuse to Produce any Drug Product until
Altus' account is paid in full, modify the foregoing terms of payment,
place the account on a letter of credit basis, require full or partial
payment in advance, suspend deliveries of Drug Product until Altus provides
assurance of performance reasonably satisfactory to ▇▇▇▇▇▇, and/or take
other reasonable means as ▇▇▇▇▇▇ may determine.
5.12 FORMAT OF REPORTS: For any payment obligation of Altus under this Article 5
that is contingent upon Altus' acceptance of a draft or final report
delivered by ▇▇▇▇▇▇, the parties shall mutually agree in advance on the
format of such report, and Altus shall not unreasonably withhold or delay
its acceptance of any such report delivered by ▇▇▇▇▇▇ that conforms to the
agreed-upon format.
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
10
ARTICLE 6
TERM AND TERMINATION.
6.1 TERM: This Agreement shall commence on the date first above written and
will continue until the Production and delivery of all [***] Batches, as
described in the Project Plan, has been completed in accordance with this
Agreement, unless sooner terminated pursuant to Section 6.2 herein (the
"Term").
6.2 TERMINATION: This Agreement may be terminated at any time upon the
occurrence of any of the following events:
6.2.1 TERMINATION FOR BREACH: A Party may terminate this Agreement upon the
material breach of any provision of this Agreement by the other Party
if such breach is not cured by the breaching Party within 30 calendar
days (or such additional time reasonably necessary to cure such
default provided the breaching Party has commenced a cure within the
30-day period and is diligently pursuing completion of such cure)
after receipt by the breaching Party of written notice of such breach.
At the option of the non-breaching Party, such termination may be with
respect to the entire Agreement, or only with respect to the Batch of
Drug Product that is subject to the breach.
6.2.2 TERMINATION FOR FINANCIAL MATTERS: This Agreement may be terminated
immediately by a Party by giving the other Party written notice
thereof in the event such other Party makes a general assignment for
the benefit of its creditors, or proceedings of a case are commenced
in any court of competent jurisdiction by or against such Party
seeking (a) such Party's reorganization, liquidation, dissolution,
arrangement or winding up, or the composition or readjustment of its
debts, (b) the appointment of a receiver or trustee for or over such
Party's property, or (c) similar relief in respect of such Party under
any law relating to bankruptcy, insolvency, reorganization, winding up
or composition or adjustment of debt, and such proceedings shall
continue undismissed, or an order with respect to the foregoing shall
be entered and continue unstated, for a period of more than 60 days.
6.3 PAYMENT ON TERMINATION: In the event of cancellation by Altus of the
Production of any Batch set forth in a Project Plan or of the early
termination of this Agreement, Altus shall make the following payments to
▇▇▇▇▇▇: (a) [***] ▇▇▇▇▇▇ for the [***] by ▇▇▇▇▇▇ for [***] and not already
[***], and for which such [***] ▇▇▇▇▇▇ [***] Altus on such [***]; (b) [***]
▇▇▇▇▇▇ for the [***]▇▇▇▇▇▇ for [***] Altus [***] ▇▇▇▇▇▇ not to [***] under
subsection (a) above; (c) reimburse ▇▇▇▇▇▇ for the actual out-of-pocket
amounts incurred (up to ceasing Production) for all Batch work-in-process
commenced by ▇▇▇▇▇▇ on Drug Product being manufactured, but after deducting
the actual amounts already paid by Altus (as to such work-in-progress)
under Section 5.5; and (d) complete payment for all finished Drug Product
delivered by ▇▇▇▇▇▇ and meeting the Specifications. Following expiration or
termination, ▇▇▇▇▇▇ shall ship to Altus all remaining Components and any
other materials supplied by Altus, at Altus' cost and per Altus'
instructions. Altus shall make payment for all expenses described in
Section 6.3 within 30 days of the invoice date, provided that ▇▇▇▇▇▇
provides Altus with all appropriate documentation and back-up for such
invoices.
6.4 SURVIVAL: Termination, expiration, cancellation or abandonment of this
Agreement through any means or for any reason, except as set forth in
Section 15.1, shall be without prejudice to the rights and remedies of
either Party with respect to any antecedent breach of any of the provisions
of this
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
11
Agreement. The provisions of Sections 4.12, 5, 6, 12, 13, 14, 15, 16, 17
and 18 hereof shall survive expiration or termination of this Agreement.
ARTICLE 7
CERTIFICATES OF ANALYSIS AND MANUFACTURING COMPLIANCE.
7.1 CERTIFICATES OF ANALYSIS: At Althea's cost and expense, ▇▇▇▇▇▇ shall test,
or cause to be tested by third parties, in accordance with the
Specifications each Batch of Drug Product that is Produced pursuant to this
Agreement, such testing to be completed before delivery of the Batch to
Altus or its designee. All results of such testing shall be recorded in a
certificate of analysis in a form approved by Altus or its designee (each,
a "Certificate of Analysis"). ▇▇▇▇▇▇ shall deliver to Altus or its
designee, prior to each completed Batch being delivered, the completed
Certificate of Analysis for such Batch, which shall set forth the items
tested and the test results. ▇▇▇▇▇▇ shall also indicate on the final page
of the Executed Release Batch Record for each Batch delivered that all
batch Production and control records have been reviewed and approved by the
appropriate quality control unit. ▇▇▇▇▇▇ shall send, or cause to be sent,
to Altus or its designee such Certificate of Analysis and Executed Release
Batch Record for each Batch prior to the shipment of the Batch of Drug
Product. Altus or its designee shall have the right to test, or cause to be
tested, for final release, each Batch of Drug Product as meeting the
Specifications and other requirements of this Agreement. As required by the
FDA (see Section 7.2 below), Altus (or its designee, as applicable) assumes
full responsibility for final release of each Batch of Drug Product.
7.2 MANUFACTURING COMPLIANCE: ▇▇▇▇▇▇ shall advise Altus immediately if an
authorized agent of any regulatory body visits Althea's manufacturing
facility and makes an inquiry regarding Althea's Production of Drug Product
for Altus. Manufacturing deviations and investigations which occur during
Production of Drug Product and which do not cause the Production to be
non-compliant with cGMP, shall not be deemed to cause such Drug Product to
be non-conforming.
7.3 QUALITY AGREEMENT: The responsibilities of the quality units of each Party
related to the Production of all Drug Product shall be described in a
quality agreement between the Parties, substantially in accordance with
industry standards (the "Quality Agreement"). The Parties agree to
negotiate and execute the Quality Agreement within ninety (90) days
following the Effective Date (or such other period of time as may be
mutually agreed by the Parties). Such responsibilities shall include: (i)
the specific content of the Certificate of Analysis, including without
limitation the certificate of conformance, (ii) the nature of the Batch
record review process, including notification of deviations associated with
the Process or Specifications, (iii) a table of key contacts associated
with the manufacturing, regulatory, quality control and quality assurance
functions; and (iv) maintenance of distribution records that contain all of
the appropriate information as specified in cGMP; and (v) other appropriate
quality matters, such responsibility for maintaining reserve samples
pursuant to cGMP.
7.4 CUSTOMER COMPLAINTS: Altus, as required by cGMP, shall maintain complaint
files. All specific Altus Drug Product-related complaints received by
▇▇▇▇▇▇ shall be forwarded to Altus. Altus shall be responsible for the
review of the complaint to determine the need for an investigation or the
need to report to the FDA as required by cGMP. Altus shall send to ▇▇▇▇▇▇
all Drug Product performance or manufacturing-related complaints which
require investigation. ▇▇▇▇▇▇ shall conduct an investigation for each Drug
Product performance or manufacturing-related complaint and shall report
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
12
findings and follow-up of each investigation to Altus. Altus shall make
these complaint files available to ▇▇▇▇▇▇ in the event they are required
during an FDA inspection.
7.5 INSPECTIONS AND PRODUCTION OVERSIGHT: Altus or its designee, upon prior
written notice and during normal business hours, shall have the right to
inspect, as reasonably needed and for not more than two (2) days, the
▇▇▇▇▇▇ Master Batch Records for each Batch, all other relevant documents
relating to Production, and the portions of Althea's facility used for
Production of Drug Product, and ▇▇▇▇▇▇ shall provide full cooperation and
assistance in such audit. If Altus or its designee chooses to audit ▇▇▇▇▇▇
more than one time in a calendar year or for more than two (2) days, and
Altus does not have a reasonable reason for conducting such additional
audit or additional day(s) of audit, ▇▇▇▇▇▇ may require that Altus or its
designee reimburse ▇▇▇▇▇▇ for Althea's reasonable expenses incurred in
hosting such additional audit or such additional day(s) of auditing. All
audited data will be treated as Confidential Information of ▇▇▇▇▇▇, and
neither Altus nor its designee shall be permitted to remove or copy data
without Althea's prior consent, such consent not to be unreasonably
withheld. In addition, ▇▇▇▇▇▇ shall permit any regulatory agency to
inspect, as reasonably requested or needed, that portion of the Facility
where Drug Product is manufactured or stored and to review all ▇▇▇▇▇▇
documents relating to Drug Product Production or storage as is reasonably
necessary for the purpose of assessing Althea's compliance with the
Process, cGMP, the Specifications, all other applicable law and regulatory
standards, and applicable chemical manufacturing controls. In addition,
Altus or its designee shall have the right to have an employee or agent
present at the Facility during the preparation for or conduct of any
Production run for a Batch of Drug Product, and such employee or agent
shall be free to inspect and oversee all aspects of such preparation or
Production run and to comment to ▇▇▇▇▇▇ thereupon. ▇▇▇▇▇▇ shall provide
such employee or agent of Altus or its designee suitable office space
equipped with a phone line and high-speed internet connection and other
standard office equipment and supplies as needed, for use by such employee
or agent in conducting the inspection and oversight activities during such
Production run. ▇▇▇▇▇▇ shall have the right to require that Altus or its
designee first execute a commercially reasonable and typical confidential
disclosure agreement.
7.6 REGULATORY COMPLIANCE: Prior to commencing production of Drug Product,
▇▇▇▇▇▇ shall: (a) ensure that the Facility meets all requirements of cGMP
and all other applicable laws and regulations; and (b) obtain (and
thereafter during the term of the Agreement maintain) for the Facility, at
its sole cost, all permits, licenses and approvals (including facilities
licenses) needed for ▇▇▇▇▇▇ to be able to Produce and supply the Drug
Product. ▇▇▇▇▇▇ shall use commercially reasonable efforts to resolve as
soon as possible any issues affecting Drug Product that arise in its
seeking or maintaining any such facilities licenses, or other needed
permits and approvals, including completely addressing and rectifying any
deviations or other issues affecting Drug Product raised in any Warning
Letter from the FDA or any similar warning or objection by a regulatory
authority, subject to the provisions of Section 11.2 hereof. Except as set
forth above in this Section 7.6, Altus shall be solely responsible for
compliance with applicable laws and regulations with respect to the use and
distribution of Drug Product, including, without limitation, all contact
with the FDA regarding the foregoing. ▇▇▇▇▇▇ shall reasonably cooperate
with and assist Altus in all regulatory filings and interactions as Altus
may make with regards to the Drug Product, including providing any
information in Althea's control needed for such applications, filings or
activities and any additional support relating to Drug Product as
reasonably requested by Altus.
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
13
ARTICLE 8
ACCEPTANCE OF DRUG PRODUCT.
8.1 NON-CONFORMING DRUG PRODUCT: Within 30 calendar days after receipt by Altus
of a particular Batch, or 15 calendar days after receipt by Altus of the
Released Executed Batch Record for a delivered Batch, whichever is later,
Altus shall use reasonable efforts to determine whether Drug Product in the
Batch conforms to the Specifications, the Master Batch Record, the Process,
and the Project Plan (collectively the "Product Requirements").
8.1.1 If Altus determines that the particular Batch of Drug Product
conforms to the Product Requirements, Altus shall give ▇▇▇▇▇▇ written
notice of such determination and Altus shall be deemed to have
accepted the Drug Product and waived its right to revoke acceptance
[***]
8.1.2 If Altus does not give notice that a particular Batch fails to
conform to the Product Requirements within the time frame specified
above, then Altus shall be deemed to have accepted the Drug Product
and waived its right to revoke acceptance [***].
8.1.3 If Altus believes any Batch of Drug Product does not conform to the
Product Requirements and that such failure to conform was caused by
either (i) Althea's failure to conform to the Master Batch Record or
other negligence of ▇▇▇▇▇▇ in the performance of the Process, or (ii)
[***] of such Drug Product (either case, an "▇▇▇▇▇▇ Fault"), then
Altus shall notify ▇▇▇▇▇▇ by telephone, including a detailed
explanation of the non-conformity and the basis for Altus' belief that
it was caused by an ▇▇▇▇▇▇ Fault, and shall confirm such notice in
writing via facsimile, email or overnight delivery to ▇▇▇▇▇▇. [***]
Upon receipt of such notice, ▇▇▇▇▇▇ will investigate such alleged
non-conformity using good faith commercially reasonable efforts. If
▇▇▇▇▇▇ determines that such Drug Product is non-conforming as a result
of an ▇▇▇▇▇▇ Fault, ▇▇▇▇▇▇ shall notify Altus of such determination
promptly and the Parties shall proceed under Section 8.2. If ▇▇▇▇▇▇
disagrees with Altus' determination that the Batch of Drug Product is
non-conforming as a result of ▇▇▇▇▇▇ Fault, ▇▇▇▇▇▇ shall so notify
Altus by telephone, no later than 30 days after the notice from Altus,
and shall confirm such notice in writing by facsimile, email or
overnight delivery, and the Parties shall proceed under Section 8.1.4.
8.1.4 For any dispute by the Parties as to whether a particular Batch of
Drug Product is conforming or non-conforming with the Product
Requirements, and/or whether such non-conformity resulted from ▇▇▇▇▇▇
Fault, samples of the Batch of Drug Product, and the relevant Batch
records and other related documentation, will be submitted to a
mutually acceptable laboratory or consultant for resolution, whose
determination of conformity or non-conformity, and the cause thereof
if non-conforming, shall be binding upon the Parties (absent fraud or
gross negligence). Altus shall bear the costs of such laboratory or
consultant, except as set forth in Section 8.2.
8.2 REMEDIES FOR NON-CONFORMING PRODUCT: [redactions in this section TBD] With
respect to any Batch that ▇▇▇▇▇▇ agrees is non-conforming, or that the
laboratory or consultant determines is non-conforming (as provided in
Section 8.1.4), due to an ▇▇▇▇▇▇ Fault, ▇▇▇▇▇▇ shall Produce at its cost
and as soon as possible a replacement Batch of Drug Product (in the amount
of the Batch that was non-conforming (that is, [***] or [***], as
applicable), with ▇▇▇▇▇▇ paying for all materials required
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
14
to Produce such replacement Batch including needed amounts of the Altus
Supplied Components [***] Altus shall have the same rights as above to
inspect and accept (or reject, if applicable) such replacement Batch. With
respect to a Batch that is non-conforming to the Product Requirements but
where such non-conformity is not due to an ▇▇▇▇▇▇ Fault, ▇▇▇▇▇▇ shall if
requested by Altus manufacture a replacement Batch of Drug Product, [***]
as provided in Section 5.6, as soon as practicable.
8.3 NON-CONFORMING BULK DRUG SUBSTANCE: Notwithstanding the foregoing, if a
Batch of Drug Product is rejected by Altus, and such Batch's failure to
meet the Product Requirements is due to the Bulk Drug Substance in such
Batch being non-conforming with applicable specifications at the time of
delivery by Altus of such Bulk Drug Substance to ▇▇▇▇▇▇, then Altus shall
not be permitted to reject such Batch (for purposes of payment), but ▇▇▇▇▇▇
shall use reasonable efforts to Produce a conforming replacement Batch on a
reasonable schedule agreed to by the Parties (with Altus supplying at its
cost the amounts of Altus Supplied Components for such Products, and Altus
paying all amounts under Section 5.6 for such replacement Batch).
ARTICLE 9
DRUG PRODUCT RECALLS.
9.1 DRUG PRODUCT RECALLS: In the event Altus shall be required to recall any
Drug Product because such Drug Product may violate local, state or federal
laws or regulations, the laws or regulations of any applicable foreign
government or agency or the Product Specifications, or in the event that
Altus elects to institute a voluntary recall, Altus shall be responsible
for coordinating such recall. Altus promptly shall notify ▇▇▇▇▇▇ if any
Drug Product is the subject of a recall and provide ▇▇▇▇▇▇ with a copy of
all documents relating to such recall. ▇▇▇▇▇▇ shall cooperate with Altus
and provide Altus all reasonable assistance in connection with any recall,
at Altus' expense. Altus shall be responsible for all of the costs and
expenses of such recall, including Althea's actual out-of-pocket costs in
providing assistance; except as otherwise provided in the following. [***]
▇▇▇▇▇▇ that[***] ▇▇▇▇▇▇ (but [***], ▇▇▇▇▇▇ [***] Altus, [***] that was the
[***] [***]
ARTICLE 10
FORCE MAJEURE; FAILURE TO SUPPLY.
10.1 FORCE MAJEURE EVENTS: Failure of either Party to perform under this
Agreement (except the obligation to make payments) shall not subject such
Party to any liability to the other if such failure is caused by acts of
God, acts of terrorism, fire, explosion, flood, drought, war, riot,
sabotage, embargo, strikes or other labor trouble, compliance with any
order or regulation of any government entity, or by any cause beyond the
reasonable control of the affected Party, whether or not foreseeable,
provided that written notice of such event is promptly given to the other
Party.
10.2 FAILURE TO SUPPLY: If ▇▇▇▇▇▇ fails to supply all or any material part of
Drug Product ordered by Altus on a timely basis, in accordance with the
schedule agreed to by the Parties or in the Project Plan, ▇▇▇▇▇▇ shall use
commercially reasonable efforts to supply such amounts of undelivered Drug
Product as soon as possible. Altus may require ▇▇▇▇▇▇ to initiate
Production of a new Batch of Drug Product in order to supply the
undelivered Drug Product at date specified by Altus, and Altus shall have
the right to have an Altus employee or representative present in the
preparation for and conduct of the Production of the Batch as needed to
deliver such Drug Product to Altus. The provisions of
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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this Section 10.2 shall be without prejudice to Altus' rights under Section
6.2 and remedies provided for thereunder.
ARTICLE 11
CHANGES IN PRODUCTION.
11.1 CHANGES TO MASTER BATCH RECORDS AND PRODUCT SPECIFICATIONS: ▇▇▇▇▇▇ agrees
to inform Altus within 15 days of the result of any regulatory development
or changes that ▇▇▇▇▇▇ believes may materially affect the Production of
Drug Product. ▇▇▇▇▇▇ shall not make any changes to the Master Batch Record
or the Specifications or Product Specifications without the prior written
consent of Altus.
11.2 PRODUCT-SPECIFIC CHANGES: If facility, equipment, process or system changes
are required of ▇▇▇▇▇▇ in order to Produce the Drug Product as a result of
requirements set forth by the FDA or any other Regulatory Authority
("Required Regulatory Changes"), and such Required Regulatory Changes apply
primarily to the Production and supply of the Drug Product, then Altus and
▇▇▇▇▇▇ will review such requirements and the necessary changes (including
costs for such changes), and shall (unless Altus elects to terminate the
Agreement) agree in writing to the details of such Required Regulatory
Changes. ▇▇▇▇▇▇ shall implement such agreed changes as soon as practicable,
and Altus shall bear 100% of the reasonable costs of such agreed changes.
11.3 GENERAL CHANGES: If any such Required Regulatory Changes apply generally to
one or more Drug Product as well as to other products manufactured by
▇▇▇▇▇▇ for itself or for third parties, then Altus shall pay a pro rata
amount of the reasonable cost of such Required Regulatory Changes based
upon the proportion of time that such facility is dedicated to the
Production of Drug Product relative to the manufacture of such other
products.
ARTICLE 12
CONFIDENTIALITY.
12.1 CONFIDENTIALITY: It is contemplated that in the course of the performance
of this Agreement each Party may, from time to time, disclose Confidential
Information to the other. Each Party agrees (a) to take all reasonable
steps to prevent disclosure of Confidential Information of the other Party
to third parties, and (b) not to use the Confidential Information of the
other Party except in order to accomplish the purposes of this Agreement.
No provision of this Agreement shall be construed so as to preclude Altus'
disclosure of Confidential Information as may be reasonably necessary to
secure from any governmental agency necessary approvals or licenses or to
obtain patents with respect to the Drug Product. ▇▇▇▇▇▇ understands and
agrees that the Master Batch Records, the Executed Released Batch Records,
and all other information directly relating to the Production and supply of
Drug Product is and shall be the Confidential Information of Altus
(regardless that ▇▇▇▇▇▇ disclosed such information, data and records to
Altus).
12.2 PRIOR CONFIDENTIALITY AGREEMENT: This Agreement, by reference, incorporates
the Confidentiality Agreement signed by Altus and ▇▇▇▇▇▇ on October 4,
2005, and is made a part hereof as though fully set forth herein.
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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12.3 THIRD PARTY DISCLOSURE: ▇▇▇▇▇▇ shall be permitted to disclose Drug Product
information to third party developmental and analytical service providers
in connection with performance of its obligations hereunder provided such
providers shall be subject to confidentiality agreements no less stringent
than the obligations in this Agreement. A Party may disclose Confidential
Information of the other Party to those of its Affiliates, agents and
consultants who need to know such information to accomplish the purposes of
this Agreement (collectively, "Permitted Recipients"); provided such
Permitted Recipients are bound to maintain such Confidential Information in
confidence and not to use such Confidential Information except as necessary
to accomplish such purposes.
12.4 LITIGATION AND GOVERNMENTAL DISCLOSURE: Notwithstanding the above
obligations, a Party may disclose the Confidential Information of the other
Party to the extent such disclosure is reasonably necessary for prosecuting
or defending litigation, complying with applicable governmental laws or
regulations, or as required to comply with court orders, provided that if a
Party is required by law or regulation to make any such disclosure of the
other Party's Confidential Information it will, except where impractical
for necessary disclosures, for example in the event of a medical emergency,
give reasonable advance notice to the other Party of such disclosure
requirement and will use good faith efforts to assist such other Party to
secure a protective order or confidential treatment of such Confidential
Information required to be disclosed.
12.5 LIMITATION OF DISCLOSURE: The Parties agree that, except as otherwise may
be required by applicable laws, regulations, rules or orders, including
without limitation the rules and regulations promulgated by the United
States Securities and Exchange Commission, and except as may be authorized
in Section 12.4, no information concerning this Agreement and the
transactions contemplated herein shall be made public by either Party
without the prior written consent of the other.
12.6 PUBLICITY AND SEC FILINGS. The Parties agree that the public announcement
of the execution of this Agreement shall only be by one or more press
releases mutually agreed to by the Parties. The failure of a Party to
return a draft of a press release with its proposed amendments or
modifications to such press release to the other Party within five (5) days
of such Party's receipt of such press release shall be deemed as such
Party's approval of such press release as received by such Party. Each
Party agrees that it shall cooperate reasonably and in a timely manner with
the other with respect to all disclosures to the Securities and Exchange
Commission and any other governmental or regulatory agencies, including
requests for confidential treatment of Confidential Information of either
Party included in any such disclosure. It is understood that each Party may
disclose this Agreement to the extent required by applicable laws or
regulations, subject to using reasonable efforts to seek confidential
treatment of sensitive economic, business or technical terms in the
Agreement as permitted under law.
12.7 DURATION OF CONFIDENTIALITY: All obligations of confidentiality and non-use
imposed upon the Parties under this Agreement shall expire 10 years after
the expiration or earlier termination of this Agreement; provided, however,
that Confidential Information which constitutes the trade secrets of a
Party shall be kept confidential indefinitely, subject to the limitations
set forth in Sections 12.4 and 12.5.
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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ARTICLE 13
INVENTIONS.
13.1 EXISTING INTELLECTUAL PROPERTY: Except as the Parties may otherwise
expressly agree in writing, each Party shall continue to own its existing
patents, trademarks, copyrights, trade secrets and other intellectual
property, without conferring any interests therein on the other Party.
Without limiting the generality of the preceding sentence, Altus shall
retain all right, title and interest arising under the United States Patent
Act, the United States Trademark Act, the United States Copyright Act and
all other applicable laws, rules and regulations in and to all Drug
Product, Bulk Drug Substance, the Process, the Specifications, Labeling and
trademarks associated therewith, any other Altus technology or know-how
disclosed to ▇▇▇▇▇▇ (collectively, "Altus' Intellectual Property"). Except
as expressly set forth in Section 13.2, ▇▇▇▇▇▇ shall retain all right,
title and interest under the same above noted laws to any of its
manufacturing process technology that existed as of the Effective Date or
is developed after the Effective Date. Neither ▇▇▇▇▇▇ nor any third party
shall acquire any right, title or interest in Altus' Intellectual Property
by virtue of this Agreement or otherwise, except to the extent expressly
provided herein.
13.2 MANUFACTURING IMPROVEMENTS. If ▇▇▇▇▇▇ generates any improvements or other
inventions, information or know-how based on its work under this Agreement
that relate to Bulk Drug Substance or Drug Product, including without
limitation methods relating to the manufacture thereof (collectively, the
"Manufacturing Improvements"), ▇▇▇▇▇▇ shall disclose all such Manufacturing
Improvements to Altus. Altus shall own any such Manufacturing Improvements
that relate to protein crystallization processes and techniques and/or
formulations (the "Assigned Improvements"), and ▇▇▇▇▇▇ shall assign to
Altus the entire right, title and interest in and to such Assigned
Improvements. Altus shall ▇▇▇▇▇ ▇▇▇▇▇▇ the limited, non-exclusive,
non-transferable right for ▇▇▇▇▇▇ to use any such Assigned Improvements in
its manufacturing business, but provided that ▇▇▇▇▇▇ shall not have any
license to use same to make a product that is competitive with any Altus
product, product candidate, or technology or is otherwise a crystalline
protein. ▇▇▇▇▇▇ shall own the entire right, title and interest in and to
any other Manufacturing Improvements (that is, those that are not Assigned
Improvements), and ▇▇▇▇▇▇ hereby grants and agrees to grant to Altus a
non-exclusive, worldwide, royalty-free, fully paid, perpetual, irrevocable,
worldwide license, including the right to sublicense, under any such other
Manufacturing Improvements solely to make, have made, use, sell, have sold,
offer for sale and import Bulk Drug Substance, Drug Product and products
containing Bulk Drug Substance.
13.3 INDIVIDUALLY OWNED INVENTIONS: Except as set forth in Section 13.2, all
Inventions (as defined herein) which are conceived, reduced to practice, or
created by a Party in the course of performing its obligations under this
Agreement shall be solely owned and subject to use and exploitation by the
inventing Party without a duty to account to the other Party. For purposes
of this Agreement, "Invention" shall mean information relating to any
innovation, improvement, development, discovery, computer program, device,
trade secret, method, know-how, process, technique or the like, whether or
not written or otherwise fixed in any form or medium, regardless of the
media on which contained and whether or not patentable or copyrightable.
13.4 JOINTLY OWNED INVENTIONS: Except as set forth in Section 13.2, all
Inventions which are conceived, reduced to practice, or created jointly by
the Parties and/or their respective agents (i.e., employees or agents who
would be or are properly named as co-inventors under the laws of the United
States on any patent application claiming such inventions) in the course of
the performance of this Agreement
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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shall be owned jointly by the Parties. Each Party shall have full rights to
exploit such Inventions for its own commercial purposes without any
obligation to the other. The Parties shall share equally in the cost of
mutually agreed patent filings with respect to all such jointly owned
Inventions. The decision to file for patent coverage on jointly owned
Inventions shall be mutually agreed upon, and the Parties shall select a
mutually acceptable patent counsel to file and prosecute patent
applications based on such joint Inventions.
13.5 DISCLAIMER: Except as otherwise expressly provided herein, nothing
contained in this Agreement shall be construed or interpreted, either
expressly or by implication, estoppel or otherwise, as: (i) a grant,
transfer or other conveyance by either Party to the other of any right,
title, license or other interest of any kind in any of its Inventions or
other intellectual property, (ii) creating an obligation on the part of
either Party to make any such grant, transfer or other conveyance or (iii)
requiring either Party to participate with the other Party in any
cooperative development program or project of any kind or to continue with
any such program or project.
13.6 RIGHTS IN INVENTIONS: The Party owning any Inventions or Manufacturing
Improvements shall have the world wide right to control the drafting,
filing, prosecution and maintenance of patents or other applications or
registrations for intellectual property rights claiming or covering such
Inventions or Manufacturing Improvements, including decisions about the
countries in which to file such patent applications or other applications
or registrations. All costs and fees associated with the patent and other
registration activities described in this Section shall be borne by the
sole owner. Each Party will cooperate with the other Party in the filing
and prosecution of such patent or other applications and registrations.
Such cooperation will include, but not be limited to, furnishing supporting
data and affidavits for the prosecution of patent and other applications
and registrations and completing and signing forms needed for the
prosecution, assignment and maintenance of such applications and
registrations.
13.7 CONFIDENTIALITY OF INVENTIONS: All Inventions or Manufacturing Improvements
shall be deemed to be the Confidential Information of the Party owning such
Inventions or Manufacturing Improvements. The protection of each Party's
Confidential Information is described in Article 12. It shall be the
responsibility of the Party preparing a patent or other intellectual
property application or registration to obtain the written permission of
the other Party to use or disclose the other Party's Confidential
Information in the application or registration before it is filed and for
other disclosures made during the prosecution thereof, such permission not
to be unreasonably withheld or delayed.
ARTICLE 14
REPRESENTATIONS AND WARRANTIES.
14.1 MUTUAL REPRESENTATIONS: Each Party hereby represents and warrants to the
other Party that (a) the person executing this Agreement is authorized to
execute this Agreement; (b) this Agreement is legal and valid and the
obligations binding upon such Party are enforceable by their terms; and (c)
the execution, delivery and performance of this Agreement does not conflict
with any agreement, instrument or understanding, oral or written, to which
such Party may be bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having jurisdiction
over it.
14.2 ▇▇▇▇▇▇ WARRANTY: ▇▇▇▇▇▇ represents and warrants that Drug Product shall be
Produced in accordance with cGMP, the Specifications and the Master Batch
Record, and that the [***]
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
19
(excluding adulteration or misbranding resulting solely from the Altus
Supplied Components incorporated into the applicable Drug Product being
defective). ▇▇▇▇▇▇ represents and warrants that it has obtained (or will
obtain prior to commencing the Production of Drug Product), and will remain
in compliance with during the term of this Agreement, all permits, licenses
and other authorizations (the "Permits") which are required under federal,
state and local laws, rules and regulations applicable to the Production
only of Drug Product as specified in the Master Batch Record and the
Project Plan; provided, however, that ▇▇▇▇▇▇ shall have no obligation to
obtain Permits relating to the sale, marketing, distribution or use of Bulk
Drug Substance or Drug Product or with respect to the Labeling of Drug
Product. ▇▇▇▇▇▇ makes no representation or warranty with respect to the
sale, marketing, distribution or use of the Bulk Drug Substance or as to
printed materials supplied by Altus or its consignee.
14.3 DISCLAIMER OF WARRANTIES: Except for those warranties set forth in Sections
14.1 and 14.2 of this Agreement, ▇▇▇▇▇▇ makes no warranties, written, oral,
express or implied, with respect to Drug Product or the Production of Drug
Product. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE AND NONINFRINGEMENT HEREBY ARE DISCLAIMED BY ▇▇▇▇▇▇. NO
WARRANTIES OF ▇▇▇▇▇▇ MAY BE CHANGED BY ANY REPRESENTATIVES OF ▇▇▇▇▇▇. Altus
accepts Drug Product subject to the terms of this Section 14.3.
14.4 ALTUS WARRANTIES: Altus warrants that (a) it has the right to give ▇▇▇▇▇▇
any information provided by Altus hereunder, and that ▇▇▇▇▇▇ has the right
to use such information for the Production of Drug Product, and (b) Altus
has no knowledge of any (i) patents or other intellectual rights that would
be infringed by Althea's Production of Drug Product in accordance with the
terms of this Agreement, or (ii) proprietary rights of third parties which
would be violated by Althea's performance hereunder. Altus further warrants
that the Bulk Drug Substance provided to ▇▇▇▇▇▇ hereunder (1) conforms to
the Bulk Drug Substance Specifications and (2) is not adulterated or
misbranded within the meaning of the FD&C Act.
ARTICLE 15
LIMITATION OF LIABILITY AND WAIVER OF SUBROGATION.
15.1 LIMITATION OF LIABILITY: Altus' sole and exclusive remedy for breach of
this Agreement is limited to those remedies set forth in Article 8 and at
Althea's decision, in Althea's sole discretion, to either replace the
non-conforming Drug Product or reimburse Altus for the Purchase Price for
the non-conforming Drug Product. Under no circumstances shall ▇▇▇▇▇▇ be
liable for loss of use or profits or other collateral, special,
consequential or other damages, losses, or expenses, including but not
limited to the cost of cover or the cost of a recall in connection with, or
by reason of the Production and delivery of Drug Product under this
Agreement whether such claims are founded in tort or contract. The
foregoing constitutes the sole and exclusive remedy of Altus and the sole
and exclusive liability of ▇▇▇▇▇▇. All claims by Altus for breach or
default under this Agreement shall be brought within one (1) year after the
cause of action accrued or shall be deemed waived.
15.2 WAIVER OF SUBROGATION: All ▇▇▇▇▇▇ Supplied Components and equipment (other
than the Equipment) used by ▇▇▇▇▇▇ in the Production of Drug Product
(collectively, "▇▇▇▇▇▇ Property") shall at all times remain the property of
▇▇▇▇▇▇ and ▇▇▇▇▇▇ assumes risk of loss for such property until delivery of
Drug Product to a common carrier as specified under Section 4.9. ▇▇▇▇▇▇
hereby waives
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
20
any and all rights of recovery against Altus and its Affiliates, and
against any of their respective directors, officers, employees, agents or
representatives, for any loss or damage to ▇▇▇▇▇▇ Property to the extent
the loss of damage is covered or could be covered by insurance (whether or
not such insurance is described in this Agreement). Altus assumes all risk
of loss for all Altus Supplied Components, all Bulk Drug Substance supplied
by Altus, and all Drug Product (collectively, "Altus Property"). Altus
hereby waives any and all rights of recovery against ▇▇▇▇▇▇ and its
Affiliates, and against any of their respective directors, officers,
employees, agents or representatives, for any loss or damage to the Altus
Property to the extent the loss of damage is covered or could be covered by
insurance (whether or not such insurance is described in this Agreement).
15.3 WAIVER OF CLAIMS: In connection with providing Production Services, ▇▇▇▇▇▇
represents only that it will use reasonable care in providing such
information solely as it relates to development studies, formulation,
primary packaging and manufacturing process development. ▇▇▇▇▇▇ makes no
representation or warranty, and Altus expressly waives all claims against
▇▇▇▇▇▇ and its Affiliates, and any of their respective agents or employees,
arising out of or in connection with any claims relating to the stability,
efficacy, safety, or toxicity of Drug Product developed, formulated,
packaged or manufactured in accordance with the Production Services
provided by ▇▇▇▇▇▇.
ARTICLE 16
INDEMNIFICATION.
16.1 ALTUS INDEMNIFICATION: Altus shall indemnify, defend and hold harmless
▇▇▇▇▇▇ and its Affiliates, and any of their respective directors, officers,
employees, subcontractors and agents (collectively the "Indemnified
Parties") from and against any and all liabilities, obligations, penalties,
claims, judgments, disbursements of any kind and nature, losses, damages,
costs and expenses (including, without limitation, reasonable attorney's
fees) arising out of or in connection with any third party demands,
actions, or suits resulting from property damage or personal injury
(including without limitation death) of third parties (collectively
"Claims") resulting from: (a) Altus' storage, promotion, labeling,
marketing, distribution, use or sale of Bulk Drug Substance or Drug
Product, (b) Altus' negligence or willful misconduct, (c) Altus' breach of
this Agreement, or (d) any claim that the use, sale, Production, marketing
or distribution of Bulk Drug Substance or Drug Product by ▇▇▇▇▇▇ or Altus
violates the patent, trademark, copyright or other proprietary rights of
any third party, except to the extent any of the foregoing (a) through (d)
is caused by the negligence or willful misconduct of the Indemnified
Parties or by the breach by ▇▇▇▇▇▇ of its obligations under this Agreement.
16.2 ▇▇▇▇▇▇ INDEMNIFICATION: ▇▇▇▇▇▇ shall indemnify, defend and hold harmless
Altus and its Affiliates and any of their respective directors, officers,
employees, subcontractors and agents from and against any and all Claims
resulting from any of the Indemnified Parties' (as defined in Section 16.1
above) negligence or willful misconduct or from Althea's breach of any its
obligations under this Agreement.
16.3 INDEMNITEE OBLIGATIONS: A Party (the "Indemnitee") which intends to claim
indemnification under this Article 16 shall promptly notify the other Party
(the "Indemnitor") in writing of any action, claim or other matter in
respect of which the Indemnitee or any of its Affiliates, or any of their
respective directors, officers, employees, subcontractors, or agents,
intend to claim such indemnification; provided, however, that failure to
provide such notice within a reasonable period of time shall not relieve
the Indemnitor of any of its obligations hereunder except to the extent the
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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Indemnitor is prejudiced by such failure. The Indemnitee shall permit, and
shall cause its Affiliates, and their respective directors, officers,
employees, subcontractors and agents to permit, the Indemnitor, at its
discretion, to settle any such action, claim or other matter, and the
Indemnitee agrees to the complete control of such defense or settlement by
the Indemnitor. Notwithstanding the foregoing, the Indemnitor shall not
enter into any settlement that would adversely affect the Indemnitee's
rights hereunder, or impose any obligations on the Indemnitee in addition
to those set forth herein, in order for it to exercise such rights, without
Indemnitee's prior written consent, which shall not be unreasonably
withheld or delayed. No such action, claim or other matter shall be settled
by an Indemnitee without the prior written consent of the Indemnitor, which
shall not be unreasonably withheld or delayed. The Indemnitee, its
Affiliates, and their respective directors, officers, employees,
subcontractors and agents shall fully cooperate with the Indemnitor and its
legal representatives in the investigation and defense of any action, claim
or other matter covered by the indemnification obligations of this Article
16. The Indemnitee shall have the right, but not the obligation, to be
represented in such defense by counsel of its own selection and at its own
expense.
16.4 INJUNCTION: In the event that the Production or sale of a Drug Product is
enjoined due to alleged infringement by either Party of the proprietary
rights of a third party, such injunction shall permit either Party to
terminate this Agreement under the terms of Article 6.
ARTICLE 17
INSURANCE.
17.1 ALTUS INSURANCE: Altus shall procure and maintain, during the Term of this
Agreement and for a period of one (1) year beyond the expiration date of
Drug Product, Commercial General Liability Insurance and Product Liability
and Contractual Liability coverage (the "Altus Insurance"). The Altus
Insurance shall cover amounts not less than [***] combined single limit.
Altus promptly shall deliver a certificate of Altus Insurance to ▇▇▇▇▇▇
evidencing such coverage. If Altus fails to furnish such certificates or if
at any time during the Term of this Agreement ▇▇▇▇▇▇ is notified of the
cancellation or lapse of the Altus Insurance, and Altus fails to rectify
the same within 30 calendar days after notice from ▇▇▇▇▇▇, in addition to
all other remedies available to ▇▇▇▇▇▇ hereunder, ▇▇▇▇▇▇, at its option,
may obtain the Altus Insurance at a reasonable cost and Altus promptly
shall reimburse ▇▇▇▇▇▇ for the cost of the same. Any deductible and/or self
insurance retention shall be the sole responsibility of Altus.
17.2 ▇▇▇▇▇▇ INSURANCE: ▇▇▇▇▇▇ shall procure and maintain, during the Term of
this Agreement and for a period of one (1) year beyond the expiration date
of Drug Product, Commercial General Liability Insurance and Product
Liability and Contractual Liability coverage (the "▇▇▇▇▇▇ Insurance"). The
▇▇▇▇▇▇ Insurance shall cover amounts not less than [***] combined single
limit. ▇▇▇▇▇▇ promptly shall deliver a certificate of ▇▇▇▇▇▇ Insurance to
Altus evidencing such coverage. If ▇▇▇▇▇▇ fails to furnish such
certificates, or if at any time during the Term of this Agreement Altus is
notified of the cancellation or lapse of the ▇▇▇▇▇▇ Insurance, and ▇▇▇▇▇▇
fails to rectify the same within 30 calendar days after notice from Altus,
in addition to all other remedies available to Altus hereunder, Altus, at
its option, may obtain the ▇▇▇▇▇▇ Insurance at reasonable cost, and ▇▇▇▇▇▇
promptly shall reimburse Altus for the cost of the same. Any deductible
and/or self insurance retention shall be the sole responsibility of ▇▇▇▇▇▇.
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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ARTICLE 18
GENERAL PROVISIONS.
18.1 NOTICES: All notices hereunder shall be delivered by facsimile (confirmed
by overnight delivery), or by overnight delivery with a reputable overnight
delivery service, to the following address of the respective Parties:
If to Altus: Altus Pharmaceuticals Inc.
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn: Chief Financial Officer
Telephone: [***]
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
If to ▇▇▇▇▇▇: ▇▇▇▇▇▇ Technologies, Inc.
▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn: Chief Financial Officer
Telephone: [***]
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
For specific inquiries, the following ▇▇▇▇▇▇ responsible individuals may be
contacted directly:
Project Manager [***]
Quality Control and
Quality Assurance Manager [***]
Materials Manager [***]
For specific inquiries, the following Altus responsible individuals may be
contacted directly:
Project Manager [***]
Director, Quality Assurance [***]
Materials Manager [***]
Quality Control Associate Director [***]
Notices shall be effective on the day following the date of transmission if
sent by facsimile, and on the second business day following the date of
delivery to the overnight delivery service if sent by overnight delivery. A
Party may change its address listed above, or any listed responsible
individual, by notice to the other Party given in accordance with this
section.
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
23
18.2 ENTIRE AGREEMENT; AMENDMENT: The Parties hereto acknowledge that this
Agreement sets forth the entire agreement and understanding of the Parties
and supersedes all prior written or oral agreements or understandings with
respect to the subject matter hereof, including the letter of intent
between the Parties dated May 18, 2006, but excluding the Confidentiality
Agreement between the Parties dated October 4, 2005. No modification of any
of the terms of this Agreement, or any amendments thereto, shall be deemed
to be valid unless in writing and signed by an authorized agent or
representative of both Parties hereto. No course of dealing or usage of
trade shall be used to modify the terms and conditions herein.
18.3 WAIVER: None of the provisions of this Agreement shall be considered waived
by any Party hereto unless such waiver is agreed to, in writing, by
authorized agents of both Parties. The failure of a Party to insist upon
strict conformance to any of the terms and conditions hereof, or failure or
delay to exercise any rights provided herein or by law shall not be deemed
a waiver of any rights of any Party hereto.
18.4 OBLIGATIONS TO THIRD PARTIES: Each Party warrants and represents that this
Agreement is not inconsistent with any contractual obligations, expressed
or implied, undertaken with any third party.
18.5 ASSIGNMENT: This Agreement shall be binding upon and inure to the benefit
of the successors or permitted assigns of each of the Parties and may not
be assigned or transferred by either Party without the prior written
consent of the other, which consent will not be unreasonably withheld or
delayed, except that no consent shall be required in the case of an
assignment of this Agreement by a Party to its Affiliate or to its
successor in interest pursuant to a transaction involving the merger,
consolidation or sale of all or substantially all of the assets of the
Party and provided that such successor entity assumes in writing all the
obligations of the assigning Party under this Agreement. No assignment
shall relieve any Party of responsibility for the performance of its
obligations hereunder.
18.6 TAXES: Altus shall pay all national, state, municipal or other sales, use
excise, import, property, value added, or other similar taxes, assessments
or tariffs assessed upon or levied against the sale of Drug Product to
Altus pursuant to this Agreement or the sale or distribution of Drug
Product by Altus (or at Altus' sole expense, defend against the imposition
of such taxes and expenses). ▇▇▇▇▇▇ shall notify Altus of any such taxes
that any governmental authority is seeking to collect from ▇▇▇▇▇▇, and
Altus may assume the defense thereof in Althea's name, if necessary, and
▇▇▇▇▇▇ agrees to fully cooperate in such defense to the extent of the
capacity of ▇▇▇▇▇▇, at Altus' expense. ▇▇▇▇▇▇ shall pay all national,
state, municipal or other taxes on the income resulting from the sale by
▇▇▇▇▇▇ of the Drug Product to Altus under this Agreement, including but not
limited to, gross income, adjusted gross income, supplemental net income,
gross receipts, excess profit taxes, or other similar taxes.
18.7 INDEPENDENT CONTRACTOR: ▇▇▇▇▇▇ shall act as an independent contractor for
Altus in providing the services required hereunder and shall not be
considered an agent of, or joint venturer with, Altus. Unless otherwise
provided herein to the contrary, ▇▇▇▇▇▇ shall furnish all expertise, labor,
supervision, machining and equipment necessary for performance hereunder
and shall obtain and maintain all building and other permits and licenses
required by public authorities.
18.8 GOVERNING LAW: Any action or proceeding seeking to enforce any provision
of, or based on any right arising out of, this Agreement may be brought by
either of the Parties, such action shall be
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
24
subject to the laws of the State of New York, excluding any conflicts of
laws provisions that would require application of other laws.
18.9 ATTORNEY'S FEES: The successful Party in any litigation or other dispute
resolution proceeding to enforce the terms and conditions of this Agreement
shall be entitled to recover from the other Party reasonable attorney's
fees and related costs involved in connection with such litigation or
dispute resolution proceeding.
18.10 SEVERABILITY: In the event that any term or provision of this Agreement
shall violate any applicable statute, ordinance, or rule of law in any
jurisdiction in which it is used, or otherwise be unenforceable, such
provision shall be ineffective to the extent of such violation without
invalidating any other provision hereof.
18.11 HEADINGS, INTERPRETATION: The headings used in this Agreement are for
convenience only and are not part of this Agreement. The term "including"
shall be interpreted to mean "including without limitation" and shall not
limit the generality of any provision preceding the term.
18.12 COUNTERPARTS; FACSIMILE EXECUTION: This Agreement may be executed in one
or more counterparts, each of which shall be deemed to be an original copy
of this Agreement and all of which, when taken together, shall be deemed to
constitute one and the same agreement. Facsimile execution and delivery of
this Agreement, is legal, valid and binding for all purposes.
****************
[remainder of page left blank]
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
25
IN WITNESS WHEREOF, the Parties hereto have each caused this Drug Product
Production and Clinical Supply Agreement to be executed by their duly-authorized
representatives as of the Effective Date above written.
ALTUS PHARMACEUTICALS INC. ▇▇▇▇▇▇ TECHNOLOGIES, INC
By: By:
--------------------------------- ------------------------------------
Name: Name:
------------------------------- ----------------------------------
Title: Title:
------------------------------ ---------------------------------
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
26
SCHEDULE 1
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
%Work
ID Task Name Complete Duration Start Finish [***] [***]
--- ------------ -------- -------- ----- ------ ----- -----
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Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material [▇▇▇▇▇ Chart Information Redacted]
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
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%Work
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Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material [▇▇▇▇▇ Chart Information Redacted]
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
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%Work
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Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material [▇▇▇▇▇ Chart Information Redacted]
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
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Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material [▇▇▇▇▇ Chart Information Redacted]
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
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Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material [▇▇▇▇▇ Chart Information Redacted]
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
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259 [***] [***] [***] [***] [***]
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262 [***] [***] [***] [***] [***]
263 [***] [***] [***] [***] [***]
264 [***] [***] [***] [***] [***]
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material [▇▇▇▇▇ Chart Information Redacted]
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
%Work
ID Task Name Complete Duration Start Finish [***] [***]
--- ------------ -------- -------- ----- ------ ----- -----
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294 [***] [***] [***] [***] [***]
295 [***] [***] [***] [***] [***]
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297 [***] [***] [***] [***] [***]
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300 [***] [***] [***] [***] [***]
301 [***] [***] [***] [***] [***]
302 [***] [***] [***] [***] [***]
303 [***] [***] [***] [***] [***]
304 [***] [***] [***] [***] [***]
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material [▇▇▇▇▇ Chart Information Redacted]
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
▇▇
▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ Material
[***] [***] [***]
[***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***]
▇▇▇▇▇ Chart Information Redacted
Project: ▇▇▇▇▇-▇▇▇ ▇▇▇▇▇ ▇ [▇▇▇▇▇ Chart Information Redacted]
Material
Date: Tue 8/15/06
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
53
SCHEDULE 2
EQUIPMENT
The Equipment owned by Altus to be used in this project includes:
1. [***]
2. [***]
3. [***]
4. [***]
5. [***]
6. API Thawing Cabinet (to be detailed later)
7. Vessel Temperature Controller ([***] chiller/heater) (to be detailed
later)
8. Product Transfer Tank Filling Support Stand (to be detailed later)
9. Product Transfer Tank Autoclave Support Stand to be detailed later
10. Product Transfer Tank Transfer Stand (to be detailed later)
11. Spare Parts (to be detailed later)
12. Storage Crates (to be used WHENEVER equipment is stored -- to be
detailed later)
13. Filter Integrity Tester (to be detailed later)
14. [***] Labeling System MOP3 (to be detailed later)
Other items and details may be included later as addendum to Schedule 2
Final Execution Version
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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
54