CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
EXHIBIT 10.9
CLINICAL SUPPLY AGREEMENT
Drug Abuse Sciences, ("DAS"), a corporation incorporated under
the laws of the State of California, with offices located at 0000 X'Xxxxx Xxxxx,
Xxxxx X, Xxxxx Xxxx, Xxxxxxxxxx, 00000 and SP Pharmaceuticals, L.L.C., a New
Mexico limited liability company ("SP"), located at 0000 Xxxxxxx Xxxx Xxxx,
X.X., Xxxxxxxxxxx, Xxx Xxxxxx 00000 agree:
1. RECITALS. SP proposes to manufacture the Product for DAS
for use in clinical trials in accordance with the terms of this Agreement.
2. THE WORK. SP will manufacture and supply DAS with the
Product pursuant to DAS Purchase Orders in accordance with the Specifications,
CGMPs and other terms described in the Statement of Work pursuant to the terms
of this Agreement and all appendices, exhibits and other attachments, subject to
DAS' right to have a third party perform the work specified in section 5.2 of
this Agreement. Subject to Section 3.3 below, any amendments to the Statement of
Work must be mutually agreed to by the Parties in writing and must be attached
to the Statement of Work, whereupon such amendment will become part of this
Agreement. Upon mutual agreement of the parties, DAS may add additional products
to this Agreement to be finished by SP, and the Parties will amend this
Agreement to cover such additional products. Any additional products added to
this Agreement will require their own statements of work, and a statement of
work for the related work. SP will have a right of first refusal to manufacture
each lot of clinical supply of Product required by DAS on the same terms and
conditions as may be offered by DAS to a third party.
2.1 SUPPLIED MATERIALS. SP will order the Supplied
Materials from vendors mutually agreed upon by the parties. SP agrees to inspect
the Supplied Materials and agrees to use all diligent efforts to replace
non-conforming Supplied Materials on a timely basis. All materials and products,
including Supplied Materials, paid for or provided by DAS pursuant to this
Agreement shall be and remain the property of DAS.
2.2 ACTIVE INGREDIENT AND [****]. DAS shall
furnish to SP [********] in these quantities as are reasonably necessary to
enable SP to manufacture the desired quantities of Product in accordance with
the Statement of Work. All shipments of Active Ingredient shall be
accompanied by a certificate of analysis from the bulk supplier of the Active
Ingredient, confirming the quantity and purity of such Active Ingredient. SP
shall verify the labeled quantity of Active Ingredient against the xxxx of
lading and shall perform release testing to confirm that the Active
Ingredient conforms with specifications defined in Appendix B. If SP fails to
properly carry out the above-referenced inspection and analysis obligations,
or its storage and handling obligations, SP shall be responsible for the
non-conformance or other failure of the Active Ingredient. SP will inform DAS
of any discrepancies in quantity and identity of the Active Ingredient or
failure of the Active Ingredient to conform to the bulk supplier's
certificate of analysis in any respect as soon as reasonably practical after
receipt of the Active Ingredient. SP shall also inform DAS of any damage to
the Active Ingredient received that is visually obvious (e.g., damaged or
punctured containers) within twenty (20) days of SP's receipt of the Active
Ingredient. Active Ingredient that is rejected in accordance with the
foregoing or SP's standard operating procedures will be returned
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
to the bulk supplier at DAS' expense and direction and DAS will be
responsible for arranging replacement Active Ingredient on a timely basis to
allow SP to produce the Product.
2.3 PACKAGING REQUIREMENTS. SP shall furnish all
labor, packaging materials, and packaging supplier necessary to package the
Product in sealed vials in accordance with the Statement of Work and at the
prices set forth in with the Pricing Appendix. SP guarantees that is packaging
procedures shall comply with all relevant laws, rules and regulations of the FDA
and the Foreign Authorities.
2.4 RECORDS. SP will maintain and provide to DAS
adequate documentation with respect to the manufacture of Product to properly
document and support all of DAS' filings as they relate to Product production
with the FDA. Further, during the Hold Period, SP shall maintain records and
samples relating to such Product batches sufficient to substantiate and verify
its duties and obligations hereunder, including but not limited to, records of
Active Ingredient used, Product manufactured, work in progress, Product
analyses, quality control tests and the like. During the Hold Period, SP shall
not destroy any records relating to regulatory compliance or quality assurance
without giving DAS notice and an opportunity to take possession of or copy such
records as DAS may reasonably require. After the Hold Period, SP will transfer
all such records to DAS or at DAS' request destroy such records in accordance
with SP's standard operating procedures then in effect (but which shall be at
least as protective as the SP Standard Operating Procedure attached hereto as
Appendix D). DAS will reimburse SP for reasonable out-of-pocket costs incurred
for such transfer.
3. QUALITY CONTROL.
3.1 SPECIFICATIONS. SP shall not implement any
changes relevant to the Product which are not in compliance with the
Specifications without obtaining DAS' prior written approval.
3.2 SP LABORATORY SERVICES. SP will test the Active
Ingredient, [****] and finished Product in accordance with the Statement of
Work attached as Appendix B. SP will provide required xxxxxxx and supervision,
training, procedures, qualifications, reagents, analysis, investigating, data
collection and reporting with respects the Product, and DAS will provide all
validated analytical methodologies and standards, including method transfer
protocols needed for the testing of Active Ingredient, [****] and finished
Product.
3.3 MODIFICATIONS. DAS will inform SP in writing of
any modifications to the Specifications or Statement of Work as soon as
reasonably practicable. SP will inform DAS of the amount of reasonable
additional costs, if any, SP would incur due to the modification. If DAS elects
to adopt the modification, DAS will (i) at DAS' election either directly
purchase required additional equipment or materials which are approved by SP, or
reimburse SP for required direct capital expenditures, and (ii) pay SP for any
increased services or materials which are necessary to implement the
modification to the Specifications or Statement of Work at SP's then current
pricing rates for such services and materials. SP will provide DAS a detailed
and itemized written explanation of capital expenditures and additional charges
for services and materials incurred due to the modification. If the parties
agree that SP is
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
technically unable to comply with a proposed modification or if DAS is unwilling
to pay SP's costs for direct capital expenditures in advance, DAS shall have the
option to withdraw the proposed modification or negotiate a payment plan
acceptable to SP. When a cost-saving modification is recommended by DAS and
implemented by SP, SP will decrease its charges to DAS by an amount equal to the
reduction in price resulting from the decreased services or materials afforded
by the modification. SP and DAS will revise the Pricing Appendix, Statement of
Work, Specifications and related schedules to account for any modifications
agreed to and implemented by the parties pursuant to this paragraph. SP is not
required to accept any modification which in SP's reasonable belief would create
a compliance risk for any regulatory requirement.
3.4 ACCESS TO SP FACILITIES BY DAS. Upon reasonable
notice and at a time mutually agreeable to the parties, or immediately in the
event of a bona fide emergency, SP shall permit DAS representatives to enter
SP's plant during regular business hours for the purpose of making quality
control inspections of the facilities used in production of Product for DAS, for
taking inventories of Active Ingredient and Product, and for examining and
copying any relevant records (described in Section 2.04) during normal business
hours. DAS may observe and inspect all activities and records associated with
manufacturing, quality control, storage, and waste disposal. [********]. Any DAS
Representatives shall be advised of the confidentiality obligations under this
Agreement and shall follow such security, safety and facility access procedures
as are reasonably designated by SP.
3.5 SAFETY. SP shall have sole responsibility for
adopting and enforcing safety procedures for the handling and production of the
Product by SP and handling and disposal of waste relating thereto that comply in
all material respects with all federal, New Mexico state, regulatory and
Albuquerque local environmental and occupational safety and health requirements
based on material safety data sheets or other raw material, Active Ingredient,
or finished Product data. Such responsibilities shall include the proper
disposal of waste in an appropriate manner consistent with the nature of the
waste and at a permitted waste disposal facility. Such responsibilities shall
terminate as to Product upon delivery thereof to DAS. DAS shall, at SP's
reasonable request, advise and consult with SP concerning such safety
procedures. Subject to the foregoing, DAS acknowledges and agrees that it is
responsible for providing the material safety data sheets, toxicology, safe
handling and disposal requirements for Active Ingredient, [****], Product, and
other raw materials provided by DAS.
4. NON-CONFORMING PRODUCT. Upon receiving a written request
from DAS, SP will rework or, if necessary, remanufacture a new Product lot to
replace any Non-conforming Product lot. If SP agrees that the Product in
question is Non-conforming Product as a result of an error or omission by SP, it
shall promptly pay to DAS the Reimbursement Amount. At DAS' option, (i) SP shall
be relieved of any obligation to deliver any substitute Product with respect to
the Non-conforming Product lot, or (ii) SP shall use best efforts to replace the
Non-conforming Product with substitute Product that conforms with the
Specifications and any other requirements of this Agreement as soon as
reasonably possible, in which case DAS shall pay SP for the substitute Product
in accordance with the Pricing Appendix and this Agreement. SP shall dispose of
any Non-conforming Product which is the result of an error or omission of SP at
its own expense. DAS shall pay for disposal of all Non-conforming
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
Product which is not due to the error or omission of SP, and which occurs after
the Product is surrendered by SP for shipping to DAS or its representatives.
4.1 If SP does not agree that the Product is
Non-conforming Product as a result of an error or omission by SP, the parties
shall timely consult with each other and attempt to resolve the discrepancies.
If the parties cannot resolve the discrepancies in a timely manner, they shall
promptly nominate an independent, reputable laboratory, which shall carry out
appropriate analyses with respect to such Product to determine if it conforms to
the Specifications. If the results conclude that the Product conformed to the
Specifications, DAS will be responsible for all amounts owed to the laboratory
and shall not be entitled to the Reimbursement Amount. If the results conclude
that the Product did not conform to the Specifications, as a result of an error
or omission by SP, SP shall be responsible for all amounts owed to Laboratory
and shall promptly pay DAS the Reimbursement Amount.
5. PRICING AND PAYMENT TERMS.
5.1 PAYMENT. Subject to the terms of this Agreement,
DAS will pay SP for the Product, SP miscellaneous charges, and for any services
rendered by SP in accordance with the pricing terms described in the Pricing
Appendix, provided that such SP services (including the manufacture of Product)
have been rendered pursuant to a DAS Purchase Order and in accordance with the
Statement of Work. [********] and (ii) [********] without the requirement of a
Purchase Order. The amount to be paid to SP by DAS under this Agreement does not
include the cost of materials provided by DAS to SP. In the event DAS and SP
have not executed a development agreement prior to the execution of this
clinical supply agreement, DAS will pay SP [********] in accordance with the
terms set forth in the Pricing Appendix.
5.2 OUTSOURCE WORK. DAS will have the right to
have a third party perform the work for the [********] (item 4 in the Pricing
Appendix), [********] (item 10 in the Pricing Appendix) and [********] (item
11 in the Pricing Appendix) (collectively referred to as the "Outsource
Work"). If a third party does perform the Outsource Work for DAS as set forth
above, DAS will have no obligation to pay SP for items 4, 10 and 11 in the
Pricing Appendix. If DAS decides to have SP perform the Outsource Work
instead of a third party, DAS will pay SP for the Outsource Work in
accordance with the prices and terms set forth in the Pricing Appendix. SP
will not be responsible for any delays in testing or manufacturing the
clinical supplies which are due to delays of the third party performing the
Outsource Work.
6. PURCHASE ORDERS. Purchase Orders shall be written and shall
specify the quantity of Product ordered, the location to which the Product is to
be delivered and the requested delivery date. [********], as necessary, to the
attention of Xxxxx Xxxx, Pricing Analyst, [********] confirmed by SP. SP will
use its best efforts to deliver Product in accordance with the delivery schedule
listed in the Statement of Work. However, the parties recognize that
installation, validation, and operation of the equipment used to manufacture the
Product may affect the delivery dates.
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
6.1 SHIPMENT. SP will ship the Product and an
applicable certificate of analysis at DAS' expense pursuant to a DAS Purchase
Order. Delivery of the Product will be F.O.B. SP's shipping docks in
Albuquerque.
6.2 TITLE. Title to all Active Ingredient,
[********], all work in process to produce the Product, and all completed
Product, shall at all times remain in DAS. However, SP shall assume liability
for any loss or damage relating to the foregoing while SP has custody over
the same. If any Active Ingredient, work in process or Product is destroyed,
damaged or lost while in SP's custody or control, SP shall reimburse DAS for
DAS' out-of-pocket costs for items provided by DAS for the manufacture of the
Product, provided that reimbursement for Active Ingredient and [********] per
lot produced under this Agreement. SP shall keep DAS' title to all Active
Ingredient, work in process to produce Product, and finished Product while in
SP's custody free and clear of all liens and encumbrances. SP shall pay all
costs associated with securing the release of any such liens and encumbrances.
7. TAXES AND FEES. DAS will be liable for and pay to SP any
sales, use, gross receipts or other taxes, licenses, or fees (excluding tax
based on net income and franchise taxes) required to be paid by SP to the State
of New Mexico or any other state or tax jurisdiction as a result of purchasing
materials, rendering services, transferring property, or taking any other action
necessary to fulfill the terms of this Agreement.
8. COMPLIANCE WITH APPLICABLE LAWS. SP and DAS will each
comply with all applicable state, United States and Foreign Authorities
regulations, including without limitation all applicable FDA laws and
regulations and all Environmental Protection Agency laws and regulations, and
will provide such information and documentation to each other as is necessary
for such compliance.
9. NATURE OF RELATIONSHIP. The relationship between the
parties shall be governed by the terms of this Agreement and shall not extend to
other activities, transactions or contracts. Neither party to this Agreement is
in any way the legal representative or agent of, nor has any authority to assume
or create any obligation on behalf of, the other party. Under no circumstances
shall the employees, agents or representatives of one party be considered
employees, agents or representatives of any other. Each party shall perform
under this Agreement as an independent contractor and nothing herein shall be
construed to be inconsistent with that relationship or status. This Agreement
shall not constitute, create, or in any way be interpreted as a joint venture,
partnership, or formal business organization of any kind. Storage of the
finished Product by SP will not create or constitute an agency relationship
between the parties.
10. PRODUCT DEVELOPMENT. DAS and SP will negotiate in good
faith toward the execution of a mutually acceptable supply agreement by
[********], pursuant to which [********] the supply of quantities of Product
during the Initial Supply Period for the United States and Foreign Authorities.
DAS and SP agree to negotiate in good faith during the term of this Agreement
towards the execution of a mutually acceptable Supply Agreement for the period
following the Initial Supply Period, taking into account such factors as (but
not limited to) capacity, delivery location, environmental constraints, price
and quality issues and the like. If
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
the parties cannot reach agreement on such a Supply Agreement, then DAS shall be
free to enter into a definitive agreement with a third party.
11. CONFIDENTIALITY.
11.1 DISCLOSURE AND USE OF CONFIDENTIAL INFORMATION.
Each Receiving Party will maintain in confidence all Confidential Information
disclosed pursuant to this Agreement and will not use any Confidential
Information except as permitted by this Agreement, or disclose the same to
anyone other than its Representatives who need to know such Confidential
Information in connection with the Receiving Party's activities under this
Agreement. SP acknowledges and agrees that all information relating to the
Product, the SRI Process and the Process Improvements shall be deemed to be the
Confidential Information of DAS.
11.2 USE BY REPRESENTATIVES. Each party will use its
best efforts to ensure that its Representatives do not disclose or make any
unauthorized use of any Confidential Information. Each party will notify the
other promptly upon discovery of any unauthorized use or disclosure of the
other's Confidential Information. Each Receiving Party shall direct its
Representatives to handle all Confidential Information in a manner consistent
with the terms of this Agreement and to take all precautions and measures that
are reasonably necessary to prevent any improper use of the Confidential
Information. At Disclosing Party's request, Receiving Party shall cause its
Representatives to execute written confidentiality agreements, in form
satisfactory to both Disclosing Party and Receiving Party, requiring such
Representatives to handle all Confidential Information in a manner consistent
with the terms of this Agreement.
11.3 LIMITATION ON CONFIDENTIALITY.
A. The obligation of confidentiality imposed by this
Section 11 will not apply to the extent that (i) the Receiving Party is required
to disclose information by applicable law, regulation or order of a governmental
agency or a court of competent jurisdiction, subject to the conditions of
Section 11.04; (ii) the Receiving Party can demonstrate that the disclosed
information was at the time of disclosure already in the public domain, other
than as a result of actions or failure to act of the Receiving Party or its
Representatives in violation of this Agreement; (iii) the disclosed information
was rightfully known by the Receiving Party (as shown by its written records)
prior to the date of disclosure to the Receiving Party in connection with the
transactions contemplated by this Agreement; or (iv) the disclosed information
was received by the Receiving Party on an unrestricted basis from a source which
is not under duty of confidentiality to the Disclosing Party.
B. All Confidential Information developed by SP
pursuant to this Agreement, excluding Elements of the Process which are
generally known or have been used by SP prior to development of the Process
shall be deemed to be Confidential Information of DAS disclosed by DAS to SP and
exception (iii) above will not be applicable thereto.
C. Notwithstanding any limitations imposed by Section
11 of this Agreement, SP will have the full right to use and disclose such
portions of the Confidential Information, including Confidential Information
owned by DAS which relates to the Process
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
Improvements, as are necessary to allow SP to fully exploit its licenses
described in Section 12.3 of this Agreement.
11.4 DISCLOSURE OF CONFIDENTIAL INFORMATION. If the
Receiving Party must make disclosure of any Confidential Information as a result
of the issuance of a court order or other government process, the Receiving
Party will promptly, but in no event more than forty-eight hours after learning
of such court order or other government process, notify, by personal delivery or
facsimile, the Disclosing Party of the same. At the Disclosing Party's expense,
the Receiving Party will (a) take all reasonably necessary steps requested by
the Disclosing Party to defend against the enforcement of such court order or
other government process, and (b) permit the Disclosing Party to intervene and
participate with counsel of its choice in any proceeding relating to the
enforcement thereof.
11.5 IRREPARABLE HARM. Each party acknowledges that
its breach of these Confidentiality provisions would cause irreparable injury to
the other party for which monetary damages are not an adequate remedy.
Accordingly, a party will be entitled to injunctive relief and other equitable
remedies in the event of such a breach by the other.
11.6 RETURN AND RETENTION. The Receiving Party shall,
upon the written request of the Disclosing Party, promptly return to the
Disclosing Party all Confidential Information (including notes, writings and
other material developed therefrom) and all copies thereof and retain none for
its files, except that SP may retain original documents generated by SP and
except to the extent SP is required by law to retain such Confidential
Information. The return or retention of such information shall not relieve the
Receiving Party of its continuing obligation of confidentiality hereunder. All
original documents prepared by SP in support of development of the Product, the
development work and the manufacturing process will be maintained by SP during
the Hold Period. SP will provide DAS with reasonable written notice not less
than 60 days prior to the proposed destruction of such documents and will
provide DAS with reasonable opportunity to have such items shipped to DAS at
DAS' expense prior to destruction. At a time mutually agreeable to the parties
or within 3 business days if in connection with a regulatory filing, DAS will
have access to original documents relating to the Product, the development work
and the manufacturing process during ordinary SP business hours, and may use
copies of the original documents for any purpose, including, without limitation,
submission to the FDA or other regulatory agencies in connection with an
application for governmental approval.
11.7 PUBLIC ANNOUNCEMENT. The parties agree that no
press release, public announcement or publication regarding this Agreement or
the relationship of the parties, (except to the extent that it may be legally
required), shall be made unless mutually agreed to prior to the release or
dissemination of any such press release, public announcement or publication.
12. PATENTS AND INTELLECTUAL PROPERTY RIGHTS.
12.1 OWNERSHIP OF INTELLECTUAL PROPERTY. The
parties expect that the Product will be manufactured using a process
developed by SP which is based upon a process developed by [****]. The
parties expect that the process to
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
be developed by SP will, among other things, provide for the manufacture of
Product in large quantities and allow the Product to be (i) [********], and
(ii) [********]. SP expects to improve upon the SRI Process by developing new
technologies and by using certain processes and information that SP
developed, used or had access to prior to development of the Product. DAS and
SP intend and agree that the Product, Process, and Process Improvements shall
be solely and exclusively owned by DAS. SP will own improvements to the SP
Intellectual Property which are developed by SP while performing the
development work for DAS and which do not rely on or incorporate the
proprietary rights (whether or not confidential) of DAS or its suppliers.
12.2 SP ASSIGNMENT. SP hereby assigns and agrees to
assign to DAS all of SP's ownership rights in and to the Product, Process and
any and all Process Improvements, which assignment includes all related
intellectual property rights. SP will execute such documents and provide such
assistance as may be deemed necessary by DAS to apply for, defend or enforce any
United States or foreign letters patent which are the result of any Process
Improvements developed, in whole or in part, by SP.
12.3 DAS LICENSES TO SP.
A. DAS hereby grants to SP a non-exclusive, royalty
free license to use the Product, Process, SRI Process, and Process Improvements
for the purpose of producing, developing or manufacturing the Product for DAS.
B. Subject to the limitations set forth below, DAS
hereby grants to SP a perpetual, non-exclusive, royalty-free license to use
any Process Improvements for any purpose, including without limitation in the
development or manufacture of products for third parties, except that (a) SP
will have no license or right to use in any respect (and shall not permit
others to use) the Process Improvements in the development, production or
manufacture of products, processes or compounds with the [********]. DAS will
not have any claim or cause of action against any third party based on SP's
use of the Process Improvements for such third party solely in the
development, production or manufacture of a product or processes which is
outside the Field. The SP License may only be revoked if SP (i) exceeds the
scope of the SP License or (ii) violates the non-competition provisions of
Section 22 of this Agreement; [********].
C. SP hereby grants to DAS an irrevocable, perpetual,
non-exclusive, royalty-free license to use for any purpose any Elements of the
Process that are owned by SP and which are directly incorporated into the
Process.
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
13. INSURANCE. SP and DAS shall each, throughout the term
of this Agreement, obtain and maintain at its own cost and expense from a
qualified insurance company, [****], including [****] insurance designating
each other as an [****]. Such policies shall provide protection against any
and all claims, demands and causes of action arising out of any defects or
failure to perform, alleged or otherwise, of the Product or any material used
in connection therewith or any use thereof. The amount of coverage shall be a
minimum of [********] combined single limit coverage, for each occurrence for
bodily injury and/or for property damage. SP and DAS each agree to furnish
within [********] after execution of this Agreement proof that such insurance
is in effect.
14. REGULATORY MATTERS.
14.1 COMPLIANCE. SP shall be responsible for
compliance of the manufacturing, quality control, testing, packaging procedures,
and any of its other pertinent obligations hereunder, with FDA standards,
including those pertaining to CGMPs, provided that, as set forth in the
Statement of Work, DAS shall provide and be responsible for compliance of the
(I) testing methods and procedures for the Active Ingredient and [****]
provided by DAS, (II) label copy for use in or with the Product, (III) conduct
and implementation of the clinical trials, (IV) Product distribution, and (V)
any other DAS' obligations hereunder in accordance with FDA standards. Each
party will provide all reasonable assistance and cooperation to the other if
necessary to respond to FDA audits, inspections, inquiries or requests
concerning the Product. However, DAS shall reimburse SP for any costs incurred
in connection with SP's efforts to comply with regulatory requests that are
outside of the normal course of SP's business in accordance with the terms of a
pricing protocol to be mutually agreed upon by DAS and SP ("Pricing Protocol").
DAS employees present at the SP facility shall at all times adhere to safety
regulations, CGMPs and work schedule generally applicable to SP's own employees,
provided that such DAS employees are notified of the same.
14.2 SAFETY MATTERS. DAS shall give SP prompt notice
of any information it receives regarding the safety of the Active Ingredient,
[****] or Product, including any confirmed or unconfirmed information on
serious adverse events associated with the use of the Product that in the
reasonable judgment of DAS are related to the manufacture of the Product by SP
or are necessary to satisfy SP's obligations to the FDA with respect to the
manufacture of the Product by SP. SP shall give DAS prompt notice of any
information it receives regarding the safety of the Product, including any
confirmed or unconfirmed information on adverse, serious or unexpected events
associated with the use of the Product. For serious, unexpected events, notice
must be given by telephone to DAS immediately after receipt of the information
and followed by written notice not more than one business day thereafter. All
responsibility and cost for filing any reports with the FDA concerning such
reactions (including Drug Experience Reports) caused by Product manufactured for
DAS shall be DAS' responsibility and the cost borne by DAS. With respect to
problems relating to SP's production of the Product, SP will provide all
reasonable assistance to DAS in responding to any complaints or inquiries
regarding the Product, including reviews and testing of retained samples,
Product, and batch records relating to a complaint. SP will promptly inform DAS
of any environmental non-compliance or regulatory issues that could jeopardize
SP's ability to manufacture and package the Product hereunder. DAS will
reimburse SP for the cost of SP's investigation into
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
the Product complaint or inquiry where the cause of such complaint or inquiry is
not due to an act or omission of SP.
14.3 COOPERATION. SP will maintain and, upon
reasonable notice, provide to DAS such documentation, data, and other
information as DAS may require for submission to the FDA. SP shall also make
available its cooperation and consultation if reasonably requested by DAS or
required by the FDA for development of additional data, performance of studies
concerning the Product, or consulting with DAS in addressing any issues raised
by FDA concerning manufacture and quality control of the Product, and DAS shall
pay SP in accordance with the Pricing Protocol. SP shall also provide, if
required by the FDA, information concerning its production processes and quality
control procedures with respect to the Product.
14.4 INSPECTION. SP shall promptly notify DAS of any
announced or unannounced FDA or Foreign Authority inspection relating to
production of the Product. SP shall permit a DAS representative to accompany the
FDA or Foreign Authority representative during any inspection relating to the
production of the Product, provided that DAS' representative shall only
participate as an observer and be present only during those portions of the
inspection that relate to the Product. SP shall immediately provide to DAS
copies of any resulting document of action (FDA Form 483 inspectional
observation report, regulatory letters, etc.) resulting from these audits.
Should either SP or DAS receive any such document of action, it shall
immediately notify the other and shall provide to the other an opportunity to
the extent feasible under the circumstances to provide input to any response to
any such document of action.
15. INDEMNIFICATION.
A. DAS will indemnify and hold harmless the
Indemnified SP Parties against any and all losses, liabilities, damages, and
costs (including attorneys' fees and expenses) incurred as a result of any third
party claim, arising out of (i) any failure by DAS to comply with any applicable
governmental regulation (including, without limitation, any applicable
environmental laws), (ii) the breach of any representation, warranty, or
covenant of DAS contained in this Agreement, (iii) a claim that use of the
Process or a process, Active Ingredient or material as provided by DAS infringes
a valid patent or trademark of such third party, to the extent that such claim
arises out of use of such process, Active Ingredient or material as provided by
DAS, (iv) the use by SP of any raw or component material(s) supplied by DAS to
SP or by a third party on DAS' behalf, (v) the promotion, marketing,
distribution and sale, whether directly or through distributors, of the Product,
(vi) any product recall which is not due to an error or omission of SP, or (vii)
personal injury, product liability or property damage relating to or arising
from the Product supplied or the manufacturing process; PROVIDED, HOWEVER, THAT
IN NO EVENT SHALL DAS INDEMNIFY OR HOLD HARMLESS ANY OF THE INDEMNIFIED SP
PARTIES IN THE EVENT SP OR ANY THIRD PARTY IS IN ANY WAY RESPONSIBLE BY GROSS
NEGLIGENCE OR WILLFUL ACT FOR SUCH LOSSES, LIABILITIES, DAMAGES, COSTS AND
EXPENSES.
B. SP will indemnify and hold harmless the
Indemnified DAS Parties against any and all losses, liabilities, damages, and
costs (including attorneys' fees and expenses)
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
incurred as a result of any third party claim, commenced or threatened, arising
out of, based upon, or in connection with (i) any breach of any representation,
warranty, covenant or agreement of SP contained in this Agreement, (ii) any
failure by SP to comply with any state, United States, FDA or Foreign
Authorities regulations (including, without limitation, any applicable
environmental laws), or (iii) any product recalls [********] produced
hereunder), personal injury, product liability or property damage relating to or
arising from any Product supplied or manufacturing Process developed by SP under
this Agreement, BUT ONLY TO THE EXTENT SUCH FAILURE, RECALLS OR WITHDRAWALS,
PERSONAL INJURY, PRODUCT LIABILITY OR PROPERTY DAMAGE REFERRED TO WITHIN (ii)
AND (iii) OF THIS PARAGRAPH IS ATTRIBUTABLE TO SP'S BREACH OF THIS AGREEMENT,
OR SP'S FAILURE TO MANUFACTURE ANY PRODUCT IN CONFORMANCE WITH THE
SPECIFICATIONS; PROVIDED FURTHER THAT SP WILL NOT INDEMNIFY AND HOLD HARMLESS
INDEMNIFIED DAS PARTIES FOR (I) EXPENSES INCURRED IN DEFENDING AGAINST ANY
LITIGATION, CLAIM, OR ANY AND ALL AMOUNTS REASONABLY PAID IN SETTLEMENT OF ANY
CLAIM OR LITIGATION ARISING OUT OF DAS' GROSS NEGLIGENCE INCLUDING, WITHOUT
LIMITATION, DAS' GROSS NEGLIGENCE IN PRODUCT DEVELOPMENT, PRODUCT DESIGN,
PRODUCT SUPPLY, OR INSTRUCTIONS FOR PRODUCT USE OR (II) THE PORTION OF ANY LOSS
OF ACTIVE INGREDIENT OR [****] PROVIDED BY DAS WHICH IS IN EXCESS OF
[********], OR (III) ANY LOSS, LIABILITY OR EXPENSE ARISING FROM DAS' OR ANY
THIRD PARTY'S MODIFICATION OR GROSS NEGLIGENCE OR UNINTENDED USE OF ANY
MANUFACTURING PROCESS DEVELOPED OR IMPROVED BY SP PURSUANT TO THIS AGREEMENT,
INCLUDING WITHOUT LIMITATION THE PROCESS AND ANY IMPROVEMENTS THERETO, ONLY TO
THE EXTENT SUCH LIABILITY WAS CAUSED BY SUCH MODIFICATION OR GROSS NEGLIGENCE OR
UNINTENDED USE AS SET FORTH ABOVE.
X. XXX and SP will cooperate with each other with
respect to resolving any claim or liability with respect to which
indemnification may be sought under this Agreement, including, without
limitation, by making commercially reasonable efforts to mitigate or resolve any
such claim or liability.
D. The foregoing indemnity obligations are
conditioned upon the following: (i) the Indemnified Party will promptly notify
the Indemnifying Party in writing of the claim; (ii) the Indemnified Party will
fully cooperate with the Indemnifying Party in the defense of any such claim;
and (iii) the Indemnified Party will provide the Indemnifying Party sole control
over defense and settlement of any such claim.
E. Upon request, each party will (i) provide such
records and information reasonably relevant to the claim, (ii) make employees
available on a mutually convenient basis to provide additional information, and
(iii) explain any material provided under this Agreement.
16. WARRANTIES.
16.1 SP'S WARRANTIES. SP hereby represents and
warrants as follows:
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
(a) The Product shall conform in all respects to the
Specifications and shall be manufactured and packaged in compliance with
CGMPs and other quality assurance procedures and processes in accordance with
FDA or other applicable regulatory standards;
(b) SP shall fully comply in all material respects with
any law, regulation, ordinance, order, injunction, decree or requirement
applicable to the manufacture of the Product or the handling and disposal of
the waste;
(c) SP shall maintain in effect all required federal, FDA,
Foreign Authorities, New Mexico state, and local governmental permits,
licenses, orders, applications and approvals regarding the manufacturing of
the Product, and SP shall manufacture Product in accordance with all such
permits, licenses, orders, applications and approvals;
(d) The Supplied Materials shall (i) not be adulterated or
misbranded within the meaning of the FFDCA or within the meaning of any
applicable state or municipal law in which the definitions of adulteration
and misbranding are substantially the same as those contained in the FFDCA,
and (ii) not be articles that may not, under the FFDCA or any other
applicable law, statute or regulation, be introduced into interstate
commerce; and
(e) The Product, at the time of delivery to DAS, shall
have a minimum shelf life of thirty (30) days as determined by validated
stability information (i.e., Product performance/potency/efficacy shall
continue to conform to the Specifications during the 30 day period).
(f) To the best of SP's knowledge (without requiring SP to
conduct a patent search), the Process Improvements will not infringe any
intellectual property or proprietary rights of any third party.
16.2 DAS' WARRANTIES. DAS hereby represents and warrants as
follows:
(a) DAS shall comply in all material respects with any
law, regulation, ordinance, order, injunction, decree or requirement
applicable to the clinical testing, distribution and labeling of the Product;
(b) DAS shall maintain in effect all material required
federal, Foreign Authorities, New Mexico state, and local governmental
permits, licenses, orders, applications and approvals regarding the clinical
testing, distribution and labeling of the Product, and DAS shall conduct
clinical trials and market the Product in accordance with all such permits,
licenses, orders, applications and approvals; and
(c) Following delivery of Product to DAS by SP, such
Product thereafter shall (i) not be adulterated or misbranded within the
meaning of the FFDCA or any Foreign Authorities within the meaning of any
applicable state or municipal law in which the definitions of adulteration
and misbranding are substantially the same as those contained in the FFDCA or
Foreign Authorities, and (ii) not be articles that may not, under the FFDCA
or any other applicable law, statute or regulation, be introduced into
interstate commerce; and
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
(d) All material safety data sheets and other raw
material, Active Ingredient, finished Product or other data supplied by DAS
to SP are accurate to the best of DAS' knowledge.
(e) SP's use of the SRI Process to produce the Product
will not infringe any intellectual property or proprietary rights of SRI.
16.3 WARRANTY DISCLAIMER. EXCEPT AS OTHERWISE EXPRESSLY SET
FORTH IN THIS AGREEMENT, SP AND DAS MAKE NO REPRESENTATIONS AND EXTEND NO
WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY EXPRESS OR
IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE
17. APPENDICES, AMENDMENTS AND CONFLICTS. The terms of the
appendices, exhibits, schedules and other attachments to this Agreement may
be amended from time to time upon the written consent of an authorized
representative of both SP and DAS. In cases where there is of a conflict
between the terms of this Agreement and the terms of an appendix, exhibit,
schedule or other attachment, the terms of this Agreement will control.
18. GOVERNING LAW. If SP should bring any suit, action or proceeding
arising out of or relating to this Agreement against DAS, this Agreement
shall be governed by and construed in accordance with the laws of the State
of California. If DAS should bring any suit, action, or proceeding arising
out of this Agreement against SP, this Agreement shall be governed by and
construed in accordance with the laws of the State of New Mexico.
19. SEVERABILITY. The invalidity or unenforceability of any term or
provision of this Agreement shall not affect the validity or enforceability
of any other term or provision hereof.
20. SURVIVAL. The obligations in Sections 2.4, 6.2, 9, 11, 12, 14,
15, 16, 17, 18, 19, 20, 21.4, 22 and 23 shall survive the expiration or
termination of this Agreement for any reason whatsoever.
21. TERM AND TERMINATION.
21.1 TERM. Subject to the termination provisions below, the
initial term of this Agreement shall commerce on the date this Agreement is
signed by authorized representatives of both parties and shall continue until
February 1, 2001 unless otherwise terminated as provided below. The parties
may agree to extend this Agreement for additional successive one year periods
until the Development Work is completed and SP will update pricing to account
for pricing increases or decreases at such renewals.
21.2 TERMINATION FOR CONVENIENCE. DAS shall have the right to
terminate this Agreement for convenience on [********] to SP if DAS
reasonably determines that the Product is not commercially or technically
viable.
21.3 TERMINATION FOR CAUSE. In addition, each party shall have
the right to terminate this Agreement:
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
(a) by giving the other party written notice thereof if
the other party fails to perform or violates any material provision of this
Agreement in any material respect, and such failure continues uncured for a
period of [********] after the date the notifying party gives written notice
to the defaulting party with respect thereto; or
(b) immediately if the other party is declared insolvent
or bankrupt by a court of competent jurisdiction, or a voluntary petition of
bankruptcy is filed in any court of competent jurisdiction by the other party
makes or executes any assignment for the benefit of creditors.
21.4 EFFECT OF TERMINATION.
(a) Upon termination of this Agreement for any reason
(whether due to breach of either party or otherwise), SP shall furnish to DAS
a complete inventory of all stock on hand of the Active Ingredient, Polymers,
work in progress for the manufacture of the Product and finished Product.
Unless otherwise agreed to between the parties, all stock on hand as of the
effective date of termination of this Agreement shall be dealt with promptly
as follows:
(i) Product manufactured and packaged pursuant to
this Agreement shall be delivered by SP to DAS, whereupon DAS shall pay SP
therefor in accordance with the terms hereof;
(ii) Work in progress commenced by SP shall be
completed by SP and delivered to DAS, whereupon DAS shall pay SP therefor in
accordance with the terms hereof; and
(iii) [********] not necessary to complete (b) above
shall be disposed of by SP or provided to DAS at DAS' option. At DAS' option,
SP will at its expense tender for delivery to DAS any raw materials paid for
by DAS under this Agreement, whereupon DAS shall be responsible for the costs
of shipping and related insurance.
(b) Upon termination of this Agreement, SP shall at DAS'
request and at DAS' cost, assist DAS in all ways reasonably requested by DAS
to transfer the manufacture of Product to DAS or its designated agents
including, but not limited to, the transfer of any information concerning
SP's processes, quality control procedures and testing, the education and
training of DAS personnel or other designated third parties, and any other
act necessary for DAS to have equivalent capabilities to manufacture Product.
SP shall designate a senior level manager as liaison who shall be responsible
for facilitating and coordinating the transfer of such information. DAS and
SP shall negotiate in good faith the reasonable cost and the reasonable
period of time for which SP shall provide such assistance.
22. NON-COMPETITION AGREEMENT.
A. SP [********], (i) [********], or (ii) [********] [********]
[********], subject to the extended non-competition period in Section 22.B.
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
B. If DAS and SP execute a mutually acceptable supply agreement
for the supply of Product for the Initial Supply Period or any period
thereafter, then the [********] shall be extended and continue uninterrupted
for an additional period ending [********] after:
(i) [********]; or
(ii) the end of any year following the first year
after FDA approval of the Product in which DAS' orders for Product from SP
[********]; provided, however, that if SP is not the exclusive supplier of
Product to DAS in any such year (following the first year after FDA approval
of the Product) where DAS orders for Product from [********], then the
[********] will only continue for a period of [********] after the end of any
such year [********].
C. The Non-Competition Restriction imposed upon SP will
immediately terminate if DAS substantially ceases its activities in the Field.
23. DEFINITIONS.
23.1 "ACTIVE INGREDIENT" means [********].
23.2 "CGMPs" means the Current Good Manufacturing Practices as
established by the FDA with regard to the manufacture of finished
pharmaceuticals as set forth in 21 CFR 211.
23.3 "CONFIDENTIAL INFORMATION" means, collectively, all
information disclosed pursuant to this Agreement and designated in writing as
"confidential" by the Disclosing Party, which includes but is not limited to:
(i) all information relating to the Product, Active Ingredient, raw
materials, licenses, patents, patent applications, technology, processes and
business plans of the Disclosing Party, (ii) all notes, analyses, studies or
other documents prepared by the Receiving Party which contain or are based on
such information or material relating to the information disclosed by the
Disclosing Party, and (iii) all information obtained by the Receiving Party
upon visiting the Disclosing Party's facilities or reviewing products, plans,
processes, formulations, operations, facilities, equipment or other assets of
the Disclosing Party, whether or not such information or process is the
property of the Disclosing Party.
23.4 "DAS LICENSE" means the license from SP to DAS as defined
and limited in Section 12.3.C.
23.5 "DISCLOSING PARTY" means a party to this Agreement which
discloses Confidential Information to the other party.
23.6 "ELEMENTS" means each of those steps, procedures,
processes or directives involved in producing the Product.
23.7 "FDA" means the United States Food and Drug Administration.
23.8 "FFDCA" means the Federal Food, Drug, and Cosmetic Act.
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
23.9 "FIELD" means the development, production or manufacture
of products, processes or compounds with the primary indication directed to
the treatment of drug, alcohol, or other substance abuse addiction which
involve slow release properties.
23.10 "FOREIGN AUTHORITIES" means those foreign countries
listed on the attached Appendix C and the governments and regulating
authorities of such foreign countries.
23.11 "HOLD PERIOD" means the period of time defined in SP's
Standard Operating Procedures for "Retention and Control of QA Records"
during which time SP will retain records and samples relating to Product
batches and which will not be for a period which is less than five years
following the manufacture date of any particular Product batches or such
longer period as may be required by the FDA.
23.12 "INDEMNIFIED DAS PARTIES" means DAS, its affiliates, any
present or future parent or subsidiary of them, and their respective
officers, members, managers, employees, counsel, agents, investment bankers,
accountants, and affiliates which may be entitled to indemnification pursuant
to the terms of this Agreement.
23.13 "INDEMNIFIED SP PARTIES" means SP, its affiliates, any
present or future parent or subsidiary of them, and their respective
officers, members, managers, employees, counsel, agents, investment bankers,
accountants, and affiliates which may be entitled to indemnification pursuant
to the terms of this Agreement.
23.14 "INDEMNIFIED PARTY" means any party seeking
indemnification under this Agreement.
23.15 "INDEMNIFYING PARTY" means any party which will be
indemnifying the Indemnified Party pursuant to this Agreement.
23.16 "INITIAL SUPPLY PERIOD" means the first two years
following FDA approval of the Product.
23.17 "NON-CONFORMING PRODUCT" means any Product which does not
meet the Specifications.
23.18 [********]
23.19 "PRICING APPENDIX" means Appendix A and includes the
pricing terms for the work to be performed by SP pursuant to this Agreement,
as amended from time to time by the parties.
23.20 "PROCESS" refers to each Element involved in producing
the Product, as well as all of those Elements taken together, but does not
include any Element of the Process developed, used or available to SP prior
to commencement of the Product development, including without limitation SP's
[********] in time release or other products prior to commencement of the
Product development.
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
23.21 "PROCESS IMPROVEMENTS" means any improvements to the
[********] developed by SP, including without limitation new technologies
developed by SP during the Product development and any improvements to
processes or information developed, used or available to SP prior to
development of the Product, but does not include the SRI Process.
23.22 "PRODUCT" means [********].
23.23 "PURCHASE ORDER" means a written order for Product from
DAS.
23.24 "RECEIVING PARTY" means a party to this Agreement which
receives Confidential Information from the other party to this Agreement.
23.25 "REIMBURSEMENT AMOUNT" means the sum of (i) any costs
reasonably expended by DAS in order to identify defects in Non-conforming
Product (e.g., testing), subject to a maximum amount equal to [********] for
the Non-conforming Product lot; (ii) all fees paid to SP for the
Non-conforming Product lot that cannot be shipped due to the defect; (iii)
the replacement cost of Active Ingredient that cannot be shipped due to the
Non-conforming Product lot, provided that SP's liability for such cost shall
not exceed [********] for each Non-conforming Product lot; and (iv) the
transportation charges paid by DAS for the Non-conforming Product lot.
23.26 "REPRESENTATIVES" means the officers, directors, members,
managers, representatives, agents or employees of one of the parties to this
Agreement.
23.27 "SPECIFICATIONS" means the Product specifications
described in the Statement of Work attached as Appendix B and mutually agreed
to by the parties.
23.28 "SP LICENSE" means the license from DAS to SP as defined
and limited in Section 12.03.B.
23.29 "SP INTELLECTUAL PROPERTY" means any patent, know-how, or
trade secret which SP can demonstrate was in existence and owned by SP prior
to the beginning of any development work for DAS.
23.30 "STATEMENT OF WORK" means the Statement of Work attached
to this Agreement as Appendix B.
23.31 "SUPPLIED MATERIALS" means all materials necessary to
manufacture the Product which are to be supplied by SP, but not including
[********] and any other materials to be supplied by DAS.
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
DAS
By: /s/ Philippe Pouletty 11/24/99
--------------------------------------- -------------------------------
Date:
Title: Chairman
SP PHARMACEUTICALS, L.L.C.,
A New Mexico limited liability company
By: /s/ X. Xxxxx 11/24/99
--------------------------------------- -------------------------------
Its: Operating Manager Date:
------------------------------
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
DRUG ABUSE SCIENCES
PRICING APPENDIX
ESTIMATED CLINICAL SUPPLY COSTS
AND TIME LINES
The prices listed below are an estimate only based upon SP's knowledge of the
current process. Because the process is in development, SP cannot predict the
final outcome of the development process. Thus these prices are expected to
change.
ITEMIZED COSTS AND ESTIMATED TIME FRAMES:
1. JUNE 1, 1999-DECEMBER 1999
a) [********]
b) [********]
c) [********]
d) [********]
e) [********]
2. DECEMBER 1, 1999 - MARCH 1, 2000
a) [********]
b) [********]
c) [********]
d) [********]
e) [********]
3. SCALE-UP:
------------------------------------------------------------ ---------------------------------------------------------
Known Activity Expected Cost
------------------------------------------------------------ ---------------------------------------------------------
[********] Costs negotiated and paid for between [******] and DAS
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
Estimate based upon knowledge of process ,to date.
Expect to xxxx on a time, travel, per diem and material
basis at [********] per hour depending on level of
person used.
------------------------------------------------------------ ---------------------------------------------------------
[********] runs. Price includes [********] ([********] per lot)
- [********]
- [********]
- [********]
- [********]
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
------------------------------------------------------------ ---------------------------------------------------------
Price does NOT include: TBD - Price to be mutually agreed upon at a later date
- [********]
- [********]
- [********]
Drug Abuse Sciences provides SP with:
- [********]
------------------------------------------------------------ ---------------------------------------------------------
Estimated Total [********] to [********]
------------------------------------------------------------ ---------------------------------------------------------
4. PLACEBO LOT MANUFACTURE [********]:
Estimated Time Frame: Manufacture: [********]
Release: [********]
------------------------------------------------------------ ---------------------------------------------------------
Item Expected Cost
------------------------------------------------------------ ---------------------------------------------------------
Placebo lot manufacture: $ [********]
- Manufacture up to [********]
- One lot
Does not include cost for: TBD - Price to be mutually agreed upon at a later date
- [********]
- [********]
- [********]
------------------------------------------------------------ ---------------------------------------------------------
Document preparation: [********]
- [********]
- [********]
- [********]
- [********]
- [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
5. [********]:
Estimated Time Frame: [********]
------------------------------------------------------------ ---------------------------------------------------------
Known Activity Expected Cost
------------------------------------------------------------ ---------------------------------------------------------
[********] [********] per tote
------------------------------------------------------------ ---------------------------------------------------------
Transportation [********] [********] per round trip
------------------------------------------------------------ ---------------------------------------------------------
Process validation. To be contracted out. [********]
------------------------------------------------------------ ---------------------------------------------------------
Regulatory compliance work [********]
------------------------------------------------------------ ---------------------------------------------------------
Estimated Total [********]
------------------------------------------------------------ ---------------------------------------------------------
6. MANUFACTURING EQUIPMENT LEASE OR PURCHASE:
Estimated time frame for completion: [********]
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
------------------------------------------------------------ ---------------------------------------------------------
Equipment Expected Total Cost
------------------------------------------------------------ ---------------------------------------------------------
[********] DAS to provide
------------------------------------------------------------ ---------------------------------------------------------
[********] DAS to provide
------------------------------------------------------------ ---------------------------------------------------------
[********] DAS to provide
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
- [********]
- [********]
[********]
------------------------------------------------------------ ---------------------------------------------------------
[********] Modification to be performed on SP equipment to adapt
to DAS requirements.
No Charge.
------------------------------------------------------------ ---------------------------------------------------------
Miscellaneous Equipment and Accessories [********] (price not expected to exceed)
(hoses, valves, modifications to existing
equipment, etc.)
------------------------------------------------------------ ---------------------------------------------------------
Estimated Total for SP [********]
Plus appropriate
shipping, handling,
installation and
taxes.
------------------------------------------------------------ ---------------------------------------------------------
7. [********]:
------------------------------------------------------------ ---------------------------------------------------------
Test Cost
------------------------------------------------------------ ---------------------------------------------------------
[********] [********] per vendor lot
Certificate of Analysis:
- [********]
- [********]
- [********]
- [********]
- [********]
[********]
[********]
[********]
[********]
[********]
[********]
- [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] Certificate of Analysis Outside Laboratory costs plus [********]
- [********] (to be performed by a contract [********] - Price to be mutually agreed upon at a
laboratory) at a later date.
- [********] (to be performed by a contract
laboratory) SP is waiting for copies of methods from the
- [********] three outside laboratories that [********]. If
- [********] SP is unable to obtain copies of the methods
- [********] SP will need to discuss other options with [********]
------------------------------------------------------------ ---------------------------------------------------------
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
------------------------------------------------------------ ---------------------------------------------------------
- [********]
- [********]
- [********]
------------------------------------------------------------ ---------------------------------------------------------
8. CLINICAL/STABILITY LOTS OF [********]:
Estimated Time Frame: First lot manufacture: [********]
First lot Release: [********]
Second lot Manufacture: [********]
Second lot Release: [********]
Third lot Manufacture: [********]
[********]
------------------------------------------------------------ ---------------------------------------------------------
Item Expected Cost
------------------------------------------------------------ ---------------------------------------------------------
Manufacturing Cost [********]
[********]:
- [********]
- [********]
- [********]
------------------------------------------------------------ ---------------------------------------------------------
Document preparation [********] per formulation
- [********]
- [********]
- [********]
- [********]
- [********]
------------------------------------------------------------ ---------------------------------------------------------
Total for [********] lot [********]
------------------------------------------------------------ ---------------------------------------------------------
Total for [********] lots [********]
------------------------------------------------------------ ---------------------------------------------------------
SP assumes DAS prefers to schedule the lots several weeks apart to allow for
obtaining test data on finished product for one lot prior to manufacturing the
next lot.
9. CLINICAL/STABILITY LOTS OF DILUENT [********]:
Estimated time frame to Manufacture: [********]
Estimated time frame to Release: [********]
------------------------------------------------------------ ---------------------------------------------------------
Item Expected Cost
------------------------------------------------------------ ---------------------------------------------------------
Manufacturing Cost Diluent [********] per lot
Includes the cost of the
- [********]
- [********]
- [********]
------------------------------------------------------------ ---------------------------------------------------------
- [********]
------------------------------------------------------------ ---------------------------------------------------------
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
------------------------------------------------------------ ---------------------------------------------------------
Does not include the cost of:
- [********] See Item 13. Validations
- [********]
- [********]
- [********]
- [********]
------------------------------------------------------------ ---------------------------------------------------------
10. STABILITY STUDY [********] (SCHEDULE ATTACHED) [Outsource Work. DAS has
the right to have a third party perform the work for the Stability
Study for [********]]:
------------------------------------------------------------ ---------------------------------------------------------
Number of Lots on Stability Expected Cost
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
Estimated Total [********]
------------------------------------------------------------ ---------------------------------------------------------
Estimated Time Frame: Each study begins upon lot release and continues through
the [********] test point following ICH guidelines.
11. STABILITY STUDY DILUENT (SCHEDULE ATTACHED) [Outsource Work. DAS has
the right to have a third party perform the work for the Stability
Study for Diluent:
------------------------------------------------------------ ---------------------------------------------------------
Number of Lots on Stability Expected Cost
------------------------------------------------------------ ---------------------------------------------------------
[********] [********] per lot
------------------------------------------------------------ ---------------------------------------------------------
Estimated Time Frame: The study begins upon lot release and continues through
the [********] test point following ICH guidelines.
12. GOVERNMENT SUBMISSION:
Estimated Time Frame: Dependent upon DAS Projected Time Frames.
DAS needs to inform SP of IND requests [********] in advance of date DAS
needs the information.
DAS needs to inform SP of NDA requests [********] in advance of date DAS
needs the information.
------------------------------------------------------------ ---------------------------------------------------------
Submission Type Expected Cost
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
[********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
[********]
------------------------------------------------------------ ---------------------------------------------------------
Estimated Total [********]
------------------------------------------------------------ ---------------------------------------------------------
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
13. VALIDATIONS:
Estimated Start Date: [********].
------------------------------------------------------------ ---------------------------------------------------------
Validations Stage Expected Cost
------------------------------------------------------------ ---------------------------------------------------------
[********] SP does not plan to perform process validation on the
clinical lots
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
[********] Perform additional work on a time and materials basis
at [********].
------------------------------------------------------------ ---------------------------------------------------------
[********] TBD - Price to be mutually agreed upon at a later date
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] TBD - Price to be mutually agreed upon at a later date.
[********]
------------------------------------------------------------ ---------------------------------------------------------
Estimated Total $[********] without terminal sterilization validation
------------------------------------------------------------ ---------------------------------------------------------
SUMMARY OF ESTIMATED CLINICAL COSTS: APPROXIMATE RANGE
-----------------------------------------------------------------------------------------------------------------------------
1. [********] [********] [********]
2. [********] [********]
3. [********] [********]
4. [********] [********]
5. [********] [********]
6. [********] [********]
7. [********] [********]
8. [********] [********]
9. [********] [********]
10. [********] [********]
11. [********] [********]
-----------------------------------------------------------------
ESTIMATED TOTAL [********]* [********]*
[********] [********] [********]
[********] [********] [********]
*Does not include costs outlined in various sections that are yet to be
determined.
PREPAYMENT:
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
A [********] or [********] prepayment of the estimated total (less the costs for
the optional items of [********].
PURCHASE ORDERS:
A purchase order will be issued by DAS prior to the initiation of any work with
the exception of the SP Process Transfer and Scale Up, Experimental lots and
Travel incurred to date, Equipment leased or to be purchased, through December
1, 1999. Verbal authorization to initiate work is acceptable and will be
followed immediately with the issue of a purchase order. The terms of the
contract and this Appendix and any amendments to them will supercede any
conflicts with the Terms and Conditions of the Purchase Order.
PAYMENT METHODS:
1. PER CENT OF COMPLETION: The SP Process Transfer and Scale Up will be invoiced
using a per cent of completion method.
2. MILESTONES: Invoices for items other than the SP Process Transfer and Scale
Up will be sent at the completion of each milestone.
PAYMENT LOCATION: Payment shall be made to SP by electronic transfer of funds
to:
[********]
APPLICATION TO PREPAYMENT: Invoices for items covered under both the Percent of
Completion and Milestone methods will be applied to the prepayment until the
prepayment amount is met. Once the prepayment is met, [********].
INTEREST OF [********] PER MONTH WILL BE CHARGED ON ALL INVOICES PAID LATER
THAN [********] FROM DATE OF INVOICE.
---------------------------------------- ------------------------------- ---------------------------------------------
PERCENT OF COMPLETION EXPECTED COST INVOICE DATE
---------------------------------------- ------------------------------- ---------------------------------------------
SP process transfer and scale up [********] [********]
---------------------------------------- ------------------------------- ---------------------------------------------
---------------------------------------- ------------------------------- ---------------------------------------------
MILESTONE EXPECTED COST MILESTONE COMPLETION (BILLING DATE
---------------------------------------- ------------------------------- ---------------------------------------------
Travel [********]
---------------------------------------- ------------------------------- ---------------------------------------------
Experimental Lots [********] per lot [********]
---------------------------------------- ------------------------------- ---------------------------------------------
[********] [********] per lot [********]
---------------------------------------- ------------------------------- ---------------------------------------------
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
---------------------------------------- ------------------------------- ---------------------------------------------
of the lot, whichever comes first.
[********]
---------------------------------------- ------------------------------- ---------------------------------------------
[********] [********] [********]
---------------------------------------- ------------------------------- ---------------------------------------------
Equipment lease or purchase [********] expected plus [********]
and installation shipping, handling,
installation and taxes
---------------------------------------- ------------------------------- ---------------------------------------------
[********] [********] [********]
[********] TBD
---------------------------------------- ------------------------------- ---------------------------------------------
Manufacture [********] of [********] per lot [********]
Documentation Preparation [********]
---------------------------------------- ------------------------------- ---------------------------------------------
[********] [********] per lot [********]
---------------------------------------- ------------------------------- ---------------------------------------------
[********] [********] per lot [********]
[********] [********]
[********]
[********] [********]
[********] [********]
[********] [********]
[********] [********]
[********] [********]
[********] [********]
[********] [********]
[********] Final report
[********]
---------------------------------------- ------------------------------- ---------------------------------------------
[********] [********] [********]
[********] [********]
---------------------------------------- ------------------------------- ---------------------------------------------
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
---------------------------------------- ------------------------------- ---------------------------------------------
[********]
[********] [********]
[********] [********]
[********] [********]
[********] [********]
[********] [********]
[********] [********]
[********] Final report
[********]
---------------------------------------- ------------------------------- ---------------------------------------------
[********] [********] [********]
---------------------------------------- ------------------------------- ---------------------------------------------
[********] [********] [********]
---------------------------------------- ------------------------------- ---------------------------------------------
[********] [********] [********]
---------------------------------------- ------------------------------- ---------------------------------------------
[********] [********] [********]
---------------------------------------- ------------------------------- ---------------------------------------------
[********] [********] [********]
---------------------------------------- ------------------------------- ---------------------------------------------
[********] [********] [********]
---------------------------------------- ------------------------------- ---------------------------------------------
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
APPENDIX B
"SCOPE OF WORK"
DRUG ABUSE SCIENCES [********]
PRODUCT MANUFACTURE AND TESTING RESPONSIBILITIES AND
REQUIREMENTS
1) DRUG ABUSE SCIENCES will provide:
a) Vendor released [********]
b) [********]
c) Validated analytical methodology and standards (i.e., reference
standards or in-house standards) required to test the materials
provided by DAS for the following. The standards shall be from the
same lot DRUG ABUSE SCIENCES WILL use for its tests.
i) Receiving
ii) In process bulk solution
iii)Finished product testing
2) These budgetary quotes are based upon SP performing the following:
a) Performance of the following Receiving Tests:
[********]
------------------------------------------------------------ ---------------------------------------------------------
TEST SPECIFICATION
------------------------------------------------------------ ---------------------------------------------------------
Appearance [********]
------------------------------------------------------------ ---------------------------------------------------------
Water (Xxxx Xxxxxx) [********]
------------------------------------------------------------ ---------------------------------------------------------
Assay [********]
------------------------------------------------------------ ---------------------------------------------------------
Related Substances Pass
- [********] [********]
- [********] [********]
- [********] [********]
- [********] [********]
- [********] [********]
- [********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
Identification by IR To Be Determined (TBD)
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
[********]
------------------------------------------------------------ ---------------------------------------------------------
TEST SPECIFICATION
------------------------------------------------------------ ---------------------------------------------------------
Identity by [********]
------------------------------------------------------------ ---------------------------------------------------------
Inherent viscosity, [********] Unknown
- [********] [********]
- [********] [********]
- [********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] Unknown
------------------------------------------------------------ ---------------------------------------------------------
[********] to be defined Unknown
------------------------------------------------------------ ---------------------------------------------------------
[********] (Total Concentration) Unknown
------------------------------------------------------------ ---------------------------------------------------------
b) Performance of the following In Process Tests:
------------------------------------------------------------ ---------------------------------------------------------
TEST SPECIFICATION
------------------------------------------------------------ ---------------------------------------------------------
Appearance TBD
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] TBD
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
*NOTE: [********]
c) Performance of the following End Product Analysis after Gama
Sterilization:
------------------------------------------------------------ ---------------------------------------------------------
TEST SPECIFICATION
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] TBD
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
*NOTE: [********].
3) Providing the following components:
a) Vial: [********]
b) Stopper: [********]
c) Seal: [********]
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
d) Standard SP Shippers
4) Raw Materials: SP will furnish and conduct the appropriate inspection,
testing and release of the excipient raw material. For the purpose of
this quote the excipients were quoted as:
(a) [********]
(b) [********]
5) Preparing the Master Batch Record and associated records following the
information provided.
6) Manufacturing the product according to the approved master batch record
as follows:
a) Compound the [********].
b) Prepare and sterilize [********].
c) Fill the [********].
d) [********].
e) [********].
f) [********].
g) [********].
h) [********].
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
APPENDIX C
"SCOPE OF WORK"
DRUG ABUSE SCIENCES [********]
PRODUCT MANUFACTURE AND TESTING RESPONSIBILITIES AND
REQUIREMENTS
1) These budgetary quotes are based upon SP performing the following:
a) Performance of the following Receiving Tests:
------------------------------------------------------------ ---------------------------------------------------------
TEST SPECIFICATION
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
b) Performance of the following In Process Tests:
------------------------------------------------------------ ---------------------------------------------------------
TEST SPECIFICATION
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
*NOTE: Relative Viscosity is not included in pricing due to unknown method.
c) Performance of the following End Product Analysis:
------------------------------------------------------------ ---------------------------------------------------------
TEST SPECIFICATION
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] To Be Determined (TBD)
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
*Note: [********].
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
APPENDIX C
"SCOPE OF WORK"
DRUG ABUSE SCIENCES [********]
d) Performance of the following product specific validations:
------------------------------------------------------------ ---------------------------------------------------------
TEST SPECIFICATION
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
[********] [********]
------------------------------------------------------------ ---------------------------------------------------------
2) Providing the following components:
a) Vial: [********]
b) Stopper: [********]
c) Seal: [********].
d) [********]
3) Raw Materials: [********]:
(a) [********]
(b) [********]
(c) [********]
(d) [********]
4) Gases and Water for Injection (WFI): [********].
5) Preparing the Master Batch Record and associated records following the
information provided.
6) Manufacturing the product according to the approved master batch record
as follows:
a) [********]
b) [********]
c) [********]
d) [********]
e) [********]
f) [********]
g) [********]
h) [********]
i) [********]
j) [********]
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
