[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
EXHIBIT 10.17
PRODUCTION AND MANUFACTURING AGREEMENT
This Production and Manufacturing Agreement (the "Agreement") is made
and entered into this 9th day of September 2002 (the "Effective Date") by and
between (i) ChemSyn Laboratories, a department of Eagle-Picher Technologies,
LLC, with its principal place of business at 00000 X. 00xx Xxxxxxx, Xxxxxx,
Xxxxxx 00000-0000 ("CSL "), and (ii) GTx, Inc., a Tennessee corporation with its
principal place of business at 0 Xxxxx Xxxxxx Xxxxxx, 0xx Xxxxx, Xxxxxxx,
Xxxxxxxxx 00000 ("GTx"), who, intending to be legally bound, hereby agree as
follows:
WHEREAS, GTx has developed and owns the entire right, title and
interest in and to [ * ] and [ * ] and pharmaceutical compositions comprising
[ * ], [ * ] and other related pharmaceutical compositions (collectively the
"Product") and desires to produce and manufacture the Product for preclinical
studies and clinical trials and, if later approved by the requisite governmental
authorities, for commercial sale;
WHEREAS, CSL is currently working with GTx under a contract dated March
9, 2001 (the "2001 Contract") to produce small quantities of [ * ] (the "[ * ]
Product") (previously estimated to be [ * ] per batch) to develop a
manufacturing process for the [ * ] Product and to manufacture the [ * ] Product
for clinical and preclinical studies;
WHEREAS, CSL and GTx desire to enter into this Agreement to replace the
2001 Contract and to form the framework for additional work to be performed by
CSL for GTx from time to time.
NOW, THEREFORE, for and in consideration of the terms and provisions
set forth herein, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, CSL and GTx agree as follows:
1. SERVICE
1.1 THE SERVICE. Schedule 1 sets forth a description and price for
additional Services to be performed by CSL in accordance with the terms hereof.
Any future Services pertaining to [ * ], [ * ] or other related compounds shall
be performed by CSL under the terms of this Agreement by CSL and GTx executing
an Addendum hereto identifying the additional Service to be performed, the
price, time period, and other terms specific to the particular Service. Upon
execution of the Addendum by the parties, the Addendum shall be considered an
additional Schedule to his Agreement and a part hereof.
1.2 THE PROCESS. Operating under the 2001 Contract, CSL has
synthesized [ * ] of material through [ * ] of a [ * ] process to manufacture
the [ * ] Product. Current batch records documenting the manufacturing process
("Batch Records") through [ * ] for the manufacture of
1.
[ * ] Product have been prepared by CSL and reviewed by GTx. CSL has used
portions of this material to synthesize [ * ], under cGMP conditions, and to
synthesize [ * ]. The remainder of the material will be stored by CSL and
utilized in accordance with the agreement of GTX and CSL. Any additional Product
to be manufactured in the future by CSL will be manufactured under cGMP or
non-cGMP conditions, as specified in an Addendum to this Agreement.
CSL agrees that it will utilize the best available current technology known to
it to synthesize [ * ], [ * ] and other compounds the parties may hereinafter
agree upon, utilizing the most current Batch Records then available for a
particular process. CSL also agrees that it will consult with GTx at all
reasonable times during the manufacturing process to ensure that the desired
Product is being manufactured in accordance with the current specifications then
approved for the Product by the parties. For any Product being manufactured by
CSL in accordance with then applicable Batch Records, GTx shall have the right
to approve the master Batch Records for such Product, any planned deviations
from the Batch Records (and GTx should be consulted as soon as possible
regarding any emergency deviation from the Batch Records), as well as the final
Batch records for the Product.
1.3 RECORD MAINTENANCE; BATCH RECORDS. For the term specified, CSL
shall retain, by company Standard Operating Procedures (SOP), files, records,
manufacturing logs, forms, laboratory data books and notebooks for any and all
data, process information and results, for each of the Services performed under
this Agreement; copies of all such records which are reasonably requested by GTx
in writing shall be provided by ChemSyn's Standard Operating Procedures at GTx's
expense. CSL will develop, document, and maintain current Batch Records for each
step of the production process for each desired cGMP Product produced as a part
of the Services hereunder, in accordance with good manufacturing practices and
procedures and applicable FDA and other governmental agency requirements. CSL
agrees to provide GTx with a copy of all Batch Records along with CSL's quality
assurance review statement. CSL also shall provide GTx, at GTx's expense, with
all information GTx may reasonably request in order to obtain or comply with any
necessary regulatory approvals, permits, licenses, clearances and notifications
for manufacture, shipment, sale or use of the Product. All CSL records
pertaining to any GTx Product shall be maintained by CSL in accordance with
applicable regulations.
1.4 TESTING. CSL will perform in-process testing for quality,
quantity and yield in accordance with its planned manufacturing process for the
production of each Product it is producing for GTx, including [ * ] and [ * ],
and all such in-process testing for Product manufactured under cGMP conditions
shall be done in accordance with then applicable regulations. Solvents and
reagents used in the manufacturing process will require only an identification
test by CSL and an accompanying Certification of Analysis. All test results of
the Product will be shared with GTx. No other tests by CSL are contemplated
under this Agreement, and any additional testing by CSL will be done only with
both parties prior written approval at an agreed upon price.
1.5 TIMING. The Services to be performed hereunder are expected to
take approximately the time period set forth in Schedule 1 hereof for each such
Service. In the event a particular Service will exceed the estimated time
period, CSL will consult with GTx to determine the appropriate additional time
necessary to complete the Service. If additional manufacturing or process
development time is required by CSL to complete the Service, no additional fee
shall be
2.
payable to CSL for additional work unless this Agreement shall be amended in
writing by both parties.
1.6 INFORMATION. CSL will provide GTx with verbal weekly updates
on the progress it is making under this Agreement, and written project updates
monthly if requested by GTx. CSL also will provide to GTx copies of all test
results, laboratory records, Batch Records, and other information pertaining to
the Services it is performing for GTx under this Agreement.
1.7 INSPECTIONS. GTx or its designated agent may inspect CSL's
production and testing facilities at Lenexa, Kansas, examine samples of the
material and/or Product, as the case may be, review the records under Section
1.3 and review any other records applicable to any GTX Product including all
test results, equipment, maintenance and calibration records, raw material and
finished product storage area records, shipping records and all applicable SOP's
developed and utilized by CSL for its development, manufacturing and/or testing
processes and procedures. The inspections are limited to two (2) days per
calendar year. If GTx requests additional time, then CSL shall be compensated by
an amount to be agreed upon in a mutually agreed upon Addendum.
1.8 GOVERNMENT COMMUNICATION. CSL will promptly provide to GTx
copies of all documents in its possession concerning communications to or from
the FDA or prepared by the FDA, or to or from or prepared by any other
governmental agency, which bear in any respect on compliance by CSL with FDA and
other relevant governmental agency requirements pertaining to the development or
manufacture of any Product under this Agreement.
2. PAYMENT AND DELIVERY
2.1 AMOUNT. The Project Fee for this Service is outlined in the
workscope found in Schedule 1. The fees for subsequent projects shall be
determined by GTx and CSL on a project by project basis, and will be attached to
this Agreement an Addendum hereto. Applicable state sales taxes will be assessed
on all shipments and/or services unless proof of exemption for the destination
state(s) can be provided.
2.2 STORAGE FEE. Finished product (Active Pharmaceutical
Ingredient) stored by CSL for GTx for [ * ] will be subject to a storage fee.
The [ * ] storage fee for the stored finished product will be the [ * ]: (i) an
amount equal to [ * ] of the contract pertaining to the stored finished product,
or (ii) [ * ] per lot. For purposes hereof, a "lot" shall mean for each Service,
the amount of finished product to be manufactured by CSL for GTx as specified
for the Service. The storage fee will activate [ * ] after the completion of the
project. In the event any finished product, which is being stored by CSL, is
specified in writing by the Parties for use as an ingredient in another Product,
the storage fee for such finished product shall be waived.
2.3 FIXED FEE PAYMENT. Upon execution of this Agreement, GTx will
pay as an Initial Deposit [ * ] of the aggregate Project Fee for the initial
project. GTx will pay to CSL [ * ] of the agreed upon amount for each additional
Service upon execution of the Addendum adding each Service to this Agreement.
Another [ * ] of the Project Fee for each such Service will be considered earned
by CSL and due and payable to it upon completion of each such Service.
Completion of Service will be defined as when CSL has Product packaged, batch
records
3.
reviewed and the Product is ready for shipment or is waiting for independent
laboratory results to complete the certificate of analysis. A final payment of
[ * ] of the Project Fee for each Service shall be due and payable to CSL upon
CSL's completion of the Service and delivery of copies of any applicable Batch
Records to GTx in accordance with this Agreement. All payments are to be made by
GTx within [ * ] of CSL's issuance of its invoice.
2.4 TIME AND MATERIAL PAYMENT. If CSL is to perform services based
on a Time and Material fee schedule, GTx will pay an Initial Deposit of [ * ] of
each additional Service which is based on a Time and Material Addendum executed
by both parties. GTx shall reimburse CSL for all related project costs including
direct labor at specified hourly rates, direct material, direct suppliers and
waste disposal, as well as all other reasonable out-of pocket costs incurred by
CSL with unaffiliated third parties in the performance of each such additional
Service thirty days after issuance by CSL of an itemized invoice of such costs.
Upon completion of work covered by the Initial Deposit, CSL will commence
monthly invoicing for the balance of the work preformed under the Time and
Materials Addendum. CSL will invoice every thirty days for work completed during
that period. All payments are to be made by GTx within [ * ] of CSL's issuance
of its invoice.
2.5 DELIVERY. Unless otherwise stated in this Agreement, all goods
are sold F.C.A. shipping point.
3. CHANGES AND DESIGNATED REPRESENTATIVES
3.1 CHANGE ORDERS. Any changes or modifications to this Agreement
requiring the payment by GTx of additional fees or costs shall require the prior
written approval of GTx. Any modification to the Project Fee on account of a
change order will be paid in accordance with Section 2.3 or 2.4, whichever is
applicable.
3.2 DESIGNATED REPRESENTATIVE. Any material change in the Services
to be provided by CSL shall be confirmed in writing by the parties' authorized
representative(s) designated to be anyone of the following persons:
GTX
NAME TITLE:
Xxxx Xxxxxxx President, COO
Xxxx Xxxxxxxxx CFO
Xxxxx Xxxxxxx Director, ARTA Program
CSL
Xx. Xxxx Xxxxxx Regional Accounts Manager
Xxxxx X. Xxxxxx Sales and Marketing Manager
4.
4. INTELLECTUAL PROPERTY
4.1 CSL will acquire no rights of any kind with respect to the
material or ingredients for any Product or any of the finished Product. GTx
shall own the entire right, title and interest in and to the material,
ingredients and the Products.
4.2 CSL will not sell or use the material, ingredients or Products
for any purpose other than as provided herein without first receiving prior or
written approval from GTx.
4.3 All intellectual property, information, discoveries,
formulation, compounds, compositions, processes, Batch Records, test results,
formulae, specifications, methods, techniques, or improvements, whether or not
patentable ("Service Inventions") arising from the performance of the Services
shall promptly be made known to GTx in writing, and GTx shall have sole and
exclusive rights to all such Service Inventions, which shall be the sole
property of GTx. CSL shall assign and will assign Service Inventions to GTx, at
no cost to GTx, and execute any and all documents and do any and all things
reasonably requested by GTx to vest and perfect GTx's interest in the Service
Inventions. CSL further agrees to provide reasonable assistance to GTx, at GTx's
expense, in making application for, obtaining, and from time to time, enforcing
and defending GTx rights that may be required resulting from the Services
performed, or to be performed, hereunder.
4.4 CSL shall not use the name of GTx in any advertising or sales
promotional material or in any other way without the prior written consent of
GTx, except where required to do so in compliance with an official government or
government agency request for information.
5. PROPRIETARY INFORMATION
5.1 "Proprietary Information" shall include, but shall not be
limited to, information pertaining to compounds, formulations, products, data,
know-how, business strategy, ideas, and concepts and shall be (i) written or
documentary technical and business information of any kind relating to the
subject matter hereof and identified by the disclosing Party with a conspicuous
legend appearing on such written or documentary information that it contain
proprietary information of the disclosing Party; (ii) orally or visually
disclosed technical and business information relating to the subject, matter
hereof which is identified at the time of disclosure as confidential and which
GTx or CSL reduces to writing, with the proprietary information specifically
identified, bearing the legend described in subsection (i) above and delivers
such writing to the receiving Party no later than thirty (30) days after such
oral or visual disclosure; and (iii) models, tools or other hardware disclosed
and identified and confirmed in writing, as described in subsection (ii) above.
5.2 CSL acknowledges and agrees that GTx will be disclosing
Proprietary Information to CSL, (the "GTx Proprietary Information"). CSL agrees
that it shall hold the GTx Proprietary Information in strict confidence, shall
not disclose it to others or use it in any way, commercially or otherwise,
except for purposes of performing its obligations under this Agreement. CSL
further agrees to take all action necessary to protect the confidentiality of
GTx including, without limitation, (a) implementing and enforcing operating
procedures to minimize
5.
the possibility of unauthorized use or copying of GTx Proprietary Information,
and (b) obligating each of its subcontractors, by written agreement, to protect
GTx's Proprietary Information.
5.3 GTx acknowledges and agrees that CSL will be disclosing
Proprietary Information to GTX, (the "CSL Proprietary Information"). GTx agrees
that it shall hold the CSL Proprietary Information in strict confidence, shall
not disclose it to others or use it in any way, commercially or otherwise,
except for purposes of performing its obligations under this Agreement. GTx
further agrees to take all action necessary to protect the confidentiality of
CSL including, without limitation, (a) implementing and enforcing operating
procedures to minimize the possibility of unauthorized use or copying of CSL
Proprietary Information, and (b) obligating each of its subcontractors, by
written agreement, to protect CSL's Proprietary Information.
5.4 CSL shall not disclose, without the prior written consent of
GTx, any GTx Proprietary Information, and any files, documents, records, data,
results, experiments, formulations, manufacturing logs, specifications,
compounds, compositions, and Batch Records arising from the Services to any
third party without the prior written consent of GTx, except to the Food and
Drug Administration upon inspection. If, during an inspection of CSL by the Food
and Drug Administration (FDA), any work owned by GTx is examined, GTx must be
notified in writing of the extent and nature of the review. GTx will be notified
verbally when an FDA inspection of CSL is scheduled which might include a review
of GTx intellectual property. Directed FDA inspections for GTx's Products are
not included in the scope of work and pricing in the current Agreement. A
separate addendum will be necessary for FDA inspections, should inspections be
required. Any correspondence with the FDA outside the scope of an inspection
where CSL discloses GTx Proprietary Information requires written approval by
GTx.
5.5 All obligations of confidentiality and non-disclosure set
forth herein will survive, without limitation, the expiration, or early
termination, for any reason of this Agreement.
6. TERMINATION
6.1 TERM. The term of this Agreement shall commence upon the
Effective Date hereof and shall remain in effect until the completion of each of
the Services unless otherwise terminated in accordance with this Section.
6.2 TERMINATION BY GTX. In the event that GTx demonstrates that:
1) the material or any Product is not safe or is toxic in animal or human
experiments; and/or 2) the process work indicates that GTx's proposed Product is
not feasible, GTx shall promptly inform CSL of such determination and GTx may
immediately and unilaterally terminate the particular Service being provided by
CSL pursuant to this Agreement.
6.3 RENEWAL. This general terms of this Agreement will remain in
effect for a term of five years, after which, both Parties can agree to renew or
modify this Agreement.
6.4 TERMINATION FOR BREACH. This Agreement may be terminated by
either party in the event that the other party has not performed any material
obligation or has otherwise breached any material term of this Agreement upon
the expiration of [ * ] (or any longer cure period authorized by the
non-breaching party with respect to any individual breach) after receipt
6.
of written notice thereof if the breach or nonperformance is capable of cure and
has not then been cured.
6.5 EFFECT OF TERMINATION. Upon termination of any Service or
termination of this Agreement, CSL shall immediately return to GTx at GTx's
expense, all or any part of the material and any Product made as of the date of
such Termination. CSL shall be entitled to reimbursement for all direct and
indirect costs incurred or irrevocably obligated as of the date of such
termination. In addition, CSL shall be entitled to [ * ] of the remaining amount
of the contract price pertaining to any terminated Service which is unpaid at
the time of termination, as set forth in Schedule 1 and each Addendum defining
the then current Services. If the amount that GTx has previously paid to CSL
exceeds the amount that is actually owed to it, CSL shall reimburse the balance
to GTx within thirty (30) days of receipt of notice of termination. All
materials provided by GTx unused at the effective date of termination shall be
returned to GTx unless otherwise agreed to in writing.
7. NOTICE
7.1 All notices shall be in writing and shall be deemed to be
delivered two (2) days after being deposited with a recognized international
express courier service, or when sent by facsimile transmission promptly
confirmed by return transmission. All notices shall be directed to CSL or GTx at
the respective addresses first set forth above or to such other address as
either party may, from time to time, designate by notice to the other party.
8. REGULATORY MATTERS
8.1 APPROVALS. CSL shall obtain all regulatory approvals, permits,
licenses, clearances and notifications which it is required to have for the
manufacture, shipment, sale or use of any product prior to any such manufacture,
sale or use or shall ensure that such required approvals, permits, licenses,
clearances and notifications are otherwise obtained. CSL shall provide GTx with
all information that it may reasonably request in order to obtain or comply with
any necessary regulatory approvals, permits, licenses, clearances and
notifications for manufacture, shipment, sale or use of any product.
9. GENERAL PROVISIONS
9.1 WARRANTY. CSL warrants that it has the right to enter into the
Agreement including these terms and conditions; that the execution of the
Agreement and the terms and conditions and the performance by CSL of its
obligations hereunder will not result in any breach or violation or default
under any other agreement; that the execution, delivery and performance of the
Agreement and the terms and conditions have been duly authorized; and that the
Agreement and the terms and conditions constitute an agreement that is the
legal, valid and binding obligation of CSL, enforceable against it in accordance
with its terms.
CSL warrants that it has the appropriate registrations, licenses and
any other governmental authorizations to carry out its obligations under the
Agreement and the terms and conditions.
7.
CSL warrants that it will perform all services and work under the
Agreement and the terms and conditions in accordance with the Regulatory
Requirements specified herein, and that it shall follow in all respects the
terms and provisions of, and shall at all times meet the standards of quality
specified in the Agreement and the terms and conditions.
9.3 DISCLAIMER. CSL HEREBY MAKES NO OTHER WARRANTIES UNDER THIS
AGREEMENT, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED
WARRANTY; OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
9.4 If, as a result of CSL's negligence any of the materials
and/or Products manufactured by CSL for GTx does not conform to the applicable
specifications, GTx shall give CSL written notice of the nonconformity. CSL
shall promptly rework or replace the nonconforming shipment, without charge,
with a like amount that satisfies the applicable specifications within a period
of time to be mutually agreed to by both parties. In the event that CSL is
unable to produce a replacement amount of materials and/or Products that
satisfies the applicable specifications within a reasonable time after receipt
of the notice of nonconformity, GTx shall have no obligation to CSL for payment
for the nonconforming shipment, and if payment has already been made, GTx shall
be entitled to an immediate refund of the price of the nonconforming material
and/or Product.
9.5 CERTIFICATION OF ANALYSIS. Promptly on the date of each CSL
shipment of any Product actually delivered to GTx or GTx designee and promptly
on the date of each CSL shipment of Product, CSL shall furnish GTx with a
certificate of analysis, in the form specified by GTx and signed by a CSL
representative reasonably acceptable to GTx, which certifies the actual content
of those components of the Product, which are identified in the applicable
specifications. Notwithstanding the foregoing, GTx shall have the right to
designate an independent laboratory to provide the certificate of analysis, in
which case it shall so notify CSL in writing. No shipment of Product (except to
the independent lab designated by GTx and except for developmental batches of
Product provided to GTx or its designee) shall be made by CSL until it shall
have received the appropriate certificate of analysis from the independent
laboratory.
9.6 STOP WORK ORDERS. Stop work orders may be issued in writing by
GTx for any Service under this Agreement for an effective period [ * ] but only
if received in writing by CSL. GTx's stop work orders [ * ] shall constitute a
termination and be subject to the terms set forth in Section 6.2 unless
extensions of the [ * ] stop work period are agreed to in writing by CSL. GTx
will be responsible for reasonable costs that were incurred due to stoppage of
the Service prior to completion. CSL will provide a detailed written list of
such costs to which both parties must agree.
9.7 LICENSES AND PERMITS (INTER-AND INTRASTATE SHIPMENTS). Persons
intending to use any goods involving humans in clinical investigations must
obtain an approved status for such use from the U.S. Food and Drug
Administration. The responsibility to obtain appropriate
8.
permits/licenses is that of GTx. Proof of permit/license may be requested at the
discretion of the CSL.
9.8 SEVERABILITY. If any provision of this Agreement shall be held
to be invalid, illegal or unenforceable for any reason, the validity, legality
and enforceability of the remaining provisions shall not in any way be affected
or impaired thereby.
9.9 RELATIONSHIP OF THE PARTIES. For purposes of this Agreement,
CSL and GTx will be and shall act as independent contractors, and neither party
is authorized to act as an agent or partner of, or joint venturer with, the
other party for any purpose. Neither party by virtue of this Agreement shall
have any right, power, or authority to act or create any obligation, express or
implied, on behalf of the other party.
9.10 FORCE MAJEURE. Neither party shall be liable for any damages
or penalty for any delay in performance of, or failure to perform, any
obligation hereunder or for failure to give the other party prior notice thereof
when such delay or failure is due to the elements, acts of God, delays in
transportation, strikes or labor disputes, delays in delivery by vendors or
other causes beyond that party's reasonable control.
9.11 NO WAIVERS. No express or implied waiver by either party of
any event of default hereunder shall in any way be or be construed as a waiver
of any future or subsequent event of default.
9.12 SURVIVAL. The respective rights and obligations of the parties
under Article 4, 5 and 8 shall survive the termination of this Agreement.
9.13 ENTIRE AGREEMENT. The parties acknowledge that this Agreement
sets forth the complete, exclusive and integrated understanding of the parties
which supersedes all proposals or prior agreements, oral or written, and all
other prior communications between the parties relating to the subject matter of
this Agreement.
9.14 ASSIGNMENT. Neither this Agreement nor any rights granted
hereby may be assigned by CSL without GTx's prior written consent. Any
assignment of this Agreement by GTx shall require that it notify CSL in writing
of any assignment.
9.15 GOVERNING LAW. This Agreement, and any and all tort claims
that may arise in connection with any product and any related services, will be
governed by the substantive laws of the State of Missouri.
9.16 INDEMNIFICATION/LIMITATION OF LIABILITY. Seller's liability
for damages whether based on seller's negligence, breach of contract, warranty
or otherwise, shall not exceed [ * ]. Seller shall not indemnify buyer or
otherwise be liable in contract or in tort for special, indirect, incidental, or
consequential damages such as, but not limited to, loss of profits or revenue.
Buyer assumes all risk and liability resulting from use of the products
delivered hereunder whether used singly or in combination with other products.
9.17 Contract for Commercial Supplies. The parties acknowledge that
this Agreement is for the manufacture and production of developmental material
and services. If the manufacture
9.
of commercial quantities of product is required, the parties will negotiate in
good faith a commercial manufacturing agreement.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed this 9th day of September, 2002.
CHEMSYN LABORATORIES GTX, INC.
A DEPARTMENT OF
EAGLE-PICHER LABORATORIES, LLC
By: /s/ Xxxxxxx X. Xxxxxx By: /s/ Xxxxx X. Xxxxxxxx
-------------------------------------------- ---------------------
Title: CFO, Eagle Picher Tech, LLC Title: General Counsel
----------------------------------------- ---------------
Date: 9-6-02 Date: Sept. 9, 2002
------------------------------------------ -------------
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
10.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
SCHEDULE 1
PROJECT WORKSCOPE
RE: Please refer to CSL Inquiry No. 807836c
ChemSyn Laboratories (CSL) is pleased to submit this Project Workscope in
response to your recent request.
I. Proposed Scope of Work:
Utilizing the current technology available, begin a synthesis of a
variety of compounds and intermediates. [ * ] of the synthesis will
begin with [ * ] of [ * ] to prepare intermediate [ * ]. All of the
product will be carried forward to [ * ] to prepare intermediate [ * ].
Again, all of the product will be carried forward to [ * ] to prepare
intermediate [ * ].
At this point the product will be [ * ]. [ * ] will be delivered to GTx
Inc. ([ * ]). The [ * ] ([ * ]) will be converted to the [ * ] of [ * ]
([ * ]). The [ * ] ([ * ]) will be used to synthesize the [ * ]
([ * ]). Synthesis of the [ * ] compound ([ * ]) requires process
development. [ * ] is assumed to be similar to [ * ] in terms of time
and materials. GTx Inc. will be contacted to verify the quantity of
[ * ] compound for each of the [ * ] parts. Note, [ * ] of [ * ]
product yields approximately [ * ] of final product.
Phase I Process Development Costs
Perform two lab experiments [ * ]. These experiments allow the chemist
to gain an understanding of the chemistry before the large batch is
committed to the procedure. The first experiment will duplicate the
best technology to date and identify any scale up issues with the small
scale experimental procedure. The issues that are identified in the
first experiment will cause changes to be tried in the second
experiment before performing the large scale work.
Budget [ * ], [ * ]
Timing [ * ]
11.
Inquiry No.: 807836c
Page 2
Phase II [ * ]
[ * ]
- Perform [ * ] of synthetic scheme starting from [ * ] of [ * ].
- The yield is expected to be approximately [ * ] of the [ * ].
Budget Synthesis [ * ], $[ * ]
Project Management [ * ], $[ * ]
------
Total $[ * ]
Timing [ * ]
[ * ] ([ * ] intermediate, yield approx. [ * ])
Budget Synthesis [ * ], $[ * ]
In-Process HPLC, [ * ] $[ * ]
Project Management [ * ], $[ * ]
------
Total $[ * ]
Timing [ * ] after completion of any development work required.
[ * ] ([ * ], yield approx. [ * ])
Assumption is that the technology for [ * ] will work for this
[ * ].
Budget Synthesis [ * ], $[ * ]
In-Process HPLC, [ * ] $[ * ]
Project Management [ * ], $[ * ]
------
Total $[ * ]
Timing [ * ] after completion of any development work required.
II. Project Costs and Billing
Process Development [ * ] $[ * ]
Synthesis [ * ] $[ * ]
Perform [ * ] $[ * ]
Perform [ * ] $[ * ]
Labor Total $[ * ]
Materials Estimate (cost [ * ] fee) $[ * ]
-----------------------------
Total $[ * ]
GTx shall reimburse CSL for all related project costs (estimated above)
including direct labor, direct material, direct suppliers and waste disposal, as
well as all other reasonable out-of pocket costs incurred by CSL with
unaffiliated third parties in the performance of the project thirty days after
issuance by CSL of an itemized invoice of such costs. CSL will invoice every
thirty days for work completed during that period. WE ASK THAT GTX REMIT TO CSL
THE [ * ] OF CONTRACT AMOUNT ([ * ]) AT THE COMMENCEMENT OF THE PROJECT.
A formal costs accounting system is maintained that is approved by or capable of
being approved by Deloitte and Touche, our independent auditors; as well as the
U.S. Government. CSL represents and certifies that it will maintain all fiscal
records for three years from the date of final payment and all costs will be
allocated to this project in accordance with CSL's disclosed accounting
practices. Costs outlined above do not include any applicable taxes. Applicable
state sales taxes will be assessed on all shipments and/or services unless proof
of exemption for the destination state(s) can be provided.
12.
Inquiry No.: 807836c
Page 3
III. Period of Performance
Process Development [ * ] [ * ]
Synthesis [ * ] [ * ]
Synthesis of [ * ] [ * ]
Synthesis of [ * ] [ * ]
*- from the completion of any process development work required and from the
completion of Synthesis [ * ]
IV. Authorization
The project described above may be authorized by returning to CSL a
signed copy of our proposal and your purchase order. This proposal
remains effective until Oct 05, 2002. Please reference Inquiry Number
807836c in all correspondence.
We appreciate your consideration of CSL to support your research endeavors. If
you have questions or require additional information please contact me at (800)
000-0000. Thank you.
Sincerely, Approved by GTx:
/s/ Xxxxx X. Xxxxxx /s/ Xxxxx Xxxxxxx
-----------------
Xxxxx Xxxxxxx, Ph.D.
Xxxxx X. Xxxxxx Director ARTA Research
Sales and Marketing Manager Date Sept. 09,2002
-------------
13
September 19, 2002
GTx, Inc. ("GTx") and ChemSyn Laboratories ("ChemSyn") herby agree to the
following:
1. The attached Addendums 1 and 2 to Schedule 1 to the Production and
Manufacturing Agreement dated September 9, 2002 (the "Contract"),
describing additional Scope of Work to be undertaken by ChemSyn on
behalf of GTx, is hereby approved by the Parties and shall become a
part of the Contract.
2. Except as amended hereby, all other terms and provisions of the
Contract shall remain in full force and effect.
IN WITNESS WHEREOF, the parties have caused their duly authorized
representatives to execute this Agreement as of this 19th day of September,
2002.
GTx, Inc. ChemSyn Laboratories
By: /s/ Xxxxx X. Xxxxxxxx By: /s/ Xxxxxx X. Xxxxxxx
--------------------- ---------------------
Title: General Counsel Title: Business Unit Leader
--------------- --------------------
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Addendum 1
(CHEMSYN LABORATORIES LOGO)
Addendum 1
September 17, 2002
Xx. Xxxxx Xxxxxxx
Director ARTA Research
GTx Inc.
0 Xxxxx Xxxxxx
0xx Xxxxx Xxx Xxxxx
Xxxxxxx, XX 00000
RE: Please refer to CSL Inquiry No. 807941a
Dear Xxxxx:
ChemSyn Laboratories (CSL) is pleased to submit this proposal in response to
your recent request.
I. Proposed Scope of Work:
[ * ] Synthesis ([ * ] Product)
- Perform [ * ] of synthetic scheme starting from [ * ] of [ * ].
- -The yield is expected to be approximately [ * ] of the [ * ].
II. Project Costs and Billing (Fixed Fee)
Budget Synthesis [ * ], $[ * ]
Project Management [ * ], $[ * ]
Materials (cost [ * ] fee) $[ * ]
-------------------------
Total $[ * ]
WE ASK THAT GTX REMIT TO CSL THE [ * ] OF CONTRACT AMOUNT ($[ *]) AT
THE COMMENCEMENT OF THE PROJECT. Payment terms are specified in the
Production and Manufacturing Agreement dated September 9, 2002
III. Deliverable
Approximately [ * ] of [ * ], [ * ] product
IV. Period of Performance
Synthesis [ *] ([ * ] Product) [ * ]
(CHEMSYN LABORATORIES LOGO)
Inquiry No.: 807941a
September 17, 2002
Page 2
V. Authorization
The project described above may be authorized by returning to CSL a
signed copy of our proposal and your purchase order. This proposal
remains effective until October 15, 2002. Terms and conditions are
attached. Please reference Inquiry Number 807941a in all
correspondence.
We appreciate your consideration of CSL to support your research endeavors. If
you have questions or require additional information please contact me at (800)
000-0000. Thank you.
Sincerely, Approved by GTx:
/s/ Xxxxx X. Xxxxxx /s/ Xxxxx Xxxxxxx / X.X. Xxxxxxx 9/18/02
------------------------------------------
Xxxxx Xxxxxxx, Ph.D.
Xxxxx X. Xxxxxx Director ARTA Research
Sales and Marketing Manager Date 9/17/02
-------
2.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Addendum 2
(CHEMSYN LABORATORIES LOGO)
Addendum 2
September 17, 2002
Xx. Xxxxx Xxxxxxx
Director ARTA Research
GTx Inc.
0 Xxxxx Xxxxxx
0xx Xxxxx Xxx Xxxxx
Xxxxxxx, XX 00000
RE: Please refer to CSL Inquiry No. 808033a
Dear Xxxxx:
ChemSyn Laboratories (CSL) is pleased to submit this proposal in response to
your recent request.
1. Proposed Scope of Work:
This work is an extension of the Development Batch - Inquiry No.
807836c
Currently, [ * ] of [ * ] intermediate [ * ] ([ * ]) was prepared and
[ * ] shipped to GTx for development work.
This proposal consists of splitting the [ * ] into [ * ], synthesis of
[ * ], synthesis of [ * ], an additional shipment to GTx Inc., and
process development work for [ * ] This proposal does not include final
release testing.
1) [ * ].
[ * ] of [ * ] will be used to synthesis [ * ]. The scope includes
starting from [ * ] of [ * ] and performing [ * ] to synthesis [ * ]
using the best technology available, non-GMP. [ * ] of [ * ] will be
shipped to GTx Inc., the remainder will be used in [ * ]. [ * ] will be
performed under GMP conditions to yield [ * ]. The targeted amount is
[ * ] of [ * ]. [ * ] will require dedicated glassware, estimated to be
[ * ].
2) [ * ].
[ * ] of [ * ] will be used to synthesize [ * ]. Starting with [ * ] of
[ * ] should yield approx [ * ] of [ * ] ([ * ] product) non-GMP. The
scope of Inquiry number 807836c included [ * ] ([ * ] intermediate,
yield approx [ * ]). No additional cost is required for the larger
scale in this proposal. [ * ] will be invoiced under Inquiry number
807836c. This current inquiry includes [ * ] performed under GMP
conditions to yield [ * ]. The targeted amount is [ * ] of [ * ].
Inquiry No.: 808033a
September 17, 2002
Page 2
3) Shipment to GTx
[ * ] of [ * ] will be shipped to GTx [ * ].
4) The remainder [ * ] of [ * ] will be used during Inquiry number
807836c for [ * ] for lab scale development of [ * ].
II. Project Costs and Billing (Fixed Fee)
1) [ * ]
[ * ] ([ * ] intermediate, starting with [ * ] of [ * ])
Budget Synthesis [ * ] $[ * ]
Project Management [ * ] $[ * ]
[ * ] ([ * ] [ * ] GMP, yield target [ * ])
Budget Synthesis [ * ] $[ * ]
In-Process HPLC, [ * ] $[ * ]
Project Management [ * ] $[ * ]
Materials Estimate (cost [ * ] fee) $[ * ]
Dedicated glassware $[ * ]
------------------------
Total $[ * ]
2) [ * ]
[ * ] ([ * ]) Included in Inquiry number 80 7836c
[ * ] ([ * ] [ * ] GMP, yield target [ * ])
Budget Synthesis [ * ] $[ * ]
In-Process HPLC, [ * ] $[ * ]
Project Management [ * ] $[ * ]
Materials Estimate (cost [ * ] fee) $[ * ]
------------------------
Total $[ * ]
3) Shipment of Intermediate Included in Inquiry number 807836c
4) Phase I Process Development Costs Included in Inquiry number 807836c
GRAND TOTAL $[ * ]
WE ASK THAT GTX REMIT TO CSL THE [ * ] OF CONTRACT AMOUNT ($[ * ]) AT THE
COMMENCEMENT OF THE PROJECT. Payment terms are specified in the Production and
Manufacturing Agreement dated September 9, 2002. Applicable state sales taxes
will be assessed on all shipments and/or services unless proof of exemption for
the destination state(s) can be provided.
(CHEMSYN LABORATORIES LOGO)
Inquiry No.: 808033a
September 17, 2002
Page 3
III. Deliverables
1) Approximately [ * ] of [ * ]
2) Approximately [ * ] of [ * ]
3) Shipment of [ * ] Included in Inquiry number 807836c
4) Process Development Report Included in Inquiry number 807836c
IV. Period of Performance
Synthesis of [ * ] [ * ]
Synthesis of [ * ] [ * ]
Synthesis of [ * ] [ * ]
V. Authorization
The project described above may be authorized by returning to CSL a
signed copy of our proposal and your purchase order. This proposal
remains effective until Oct 15, 2002. Please reference Inquiry Number
808033a in all correspondence.
We appreciate your consideration of CSL to support your research endeavors. If
you have questions or require additional information please contact me at (800)
000-0000. Thank you.
Sincerely, Approved by GTx:
/s/ Xxxxx X. Xxxxxx /s/ Xxxxx Xxxxxxx / X.X. Xxxxxxx 9/18/02
-----------------------------------------
Xxxxx Xxxxxxx, Ph.D.
Xxxxx X. Xxxxxx Director ARTA Research
Sales and Marketing Manager Date 9/17/02
--------
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
