Document:

Exhibit
10.32

 

AGREEMENT RELATING TO ADDITIONAL TRADEMARK

This Agreement Relating to Additional Trademark (this “Agreement”) is
made as of July ___, 2005 (the “Effective Date”) by and between Elan
Pharmaceuticals, Inc. (“EPI”) and Acorda Therapeutics, Inc. (“Acorda”).  Capitalized terms not otherwise defined herein
shall have the meanings ascribed to them in that certain Asset Purchase
Agreement by and between EPI and Acorda dated as of July 21, 2004 (the “Asset
Purchase Agreement”).

 

RECITALS

 

        A.        Acorda desires to utilize the trademark “Zanaflex Capsules”
(the “Mark”) in connection with Zanaflex Capsules; and

        B.         The parties desire set forth rights and obligations relating
to the Mark as set forth herein.

                NOW, THEREFORE, in
consideration of the mutual covenants and agreements set forth herein and for
good and valuable consideration, the receipt and adequacy of which are hereby
acknowledged, the parties hereby agree as follows:

 

1.             Rights to Mark.  The parties hereby agree that, subject to the
rights granted to Acorda by making and deeming the Mark a “Product Trademark”
under the Asset Purchase Agreement and Trademark License Agreement as set forth
in the following paragraph, all right, title and interest in and to the Mark
and all goodwill associated therewith shall be owned exclusively by EPI, and
each party will execute and deliver any and all instruments and documents and
perform any and all acts necessary to vest such right, title and interest in
EPI.

The Mark shall be and shall be deemed to be a Product
Trademark for all purposes under the Asset Purchase Agreement, the Elan
Disclosure Schedule and the Trademark License Agreement, and shall be subject
to all of the rights and obligations of the parties relating to the Product
Trademarks contained in such documents; provided that, notwithstanding the
foregoing or anything to the contrary contained in such documents, none of the
representations and warranties of EPI contained in Article VI of the Asset
Purchase Agreement shall apply to the Mark.

Acorda hereby represents and warrants to EPI that any
use by Acorda of the Mark will comply with all applicable Laws.  Acorda agrees that for purposes of its
indemnification obligations relating to Assumed Liabilities contained within
Section 11.02(b)(iv) of the Asset Purchase Agreement, the use by Acorda or its
Affiliates of the Mark in connection with the Products shall be deemed to be
included within the operation of the Business by Acorda or its Affiliates after
the Closing.

2.             Registration of Mark. As soon as is practicable
after the Effective Date, EPI shall use commercially reasonable efforts to
apply for and to obtain registration of the Mark in its name with the United
States Patent and Trademark Office (the “PTO”), using trademark 

 

 

Certain portions of this Exhibit have been omitted
pursuant to a request for confidentiality. 
Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately
filed with the Commission.   

 

 

counsel engaged by EPI.  Acorda will reimburse EPI for the fees of such
counsel (including but not limited to fees incurred in performing customary
searches for conflicting trademarks), filing fees and other fees incident to
such application and registration activities; provided that in no event shall
such fees to be reimbursed by Acorda in the aggregate exceed $2,500 (the “Cap”).
Acorda hereby represents and warrants to EPI that it knows of no trademarks
currently in use anywhere in the world that would conflict with EPI’s ownership
or goodwill in the Mark, or that would reasonably be expected to adversely
affect EPI’s ability to obtain registration of the Mark with the PTO.  EPI shall notify Acorda within two (2)
business days upon registration or rejection of the Mark by the PTO.

3.             Conflicts.  Except as amended by this Agreement, each of
the Asset Purchase Agreement, the Elan Disclosure Schedule and the Trademark
License Agreement shall continue in full force and effect.  In the event of any conflict between the terms
of the Agreement and the terms of any of the Asset Purchase Agreement, the Elan
Disclosure Schedule and the Trademark License Agreement, the terms of this
Agreement shall govern and control.

4.             Further Assurances.  The parties agree to execute such further
instruments, agreements and documents and to take such further actions as may
reasonably be necessary to carry out the intent of this Agreement.

5.             Counterparts.  This Agreement may be executed in any number
of counterparts, each which shall be deemed an original, and all of which
together shall constitute one instrument.

6.             Severability.  If one or more provisions of this Agreement
are held to be unenforceable under applicable law, such provision(s) shall be
excluded from this Agreement, and the balance of this Amendment shall be
interpreted as if such provision(s) were so excluded.

7.             Entire Agreement.  This Agreement, together with the documents
referenced herein, constitute the full and entire understanding and agreement
among the parties with regard to the subjects hereof and thereof.

8.             Governing Law.  This Agreement shall be governed by and
construed under the laws of the State of New York, without giving effect to
conflict of law principles.

[REMAINDER OF THIS PAGE
INTENTIONALLY LEFT BLANK]

 

2

 

IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first above written.

 

	
   

  	
  ELAN PHARMACEUTICALS, INC.

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/Joe Boudreau

  
	
   

  	
  Name:

  	
  Joe Boudreau

  
	
   

  	
  Title:

  	
  SVP

  
	
   

  	
   

  	
   

  
	
   

  	
  ACORDA THERAPEUTICS, INC.

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/Ron Cohen

  
	
   

  	
  Name:

  	
  Ron Cohen

  
	
   

  	
  Title:

  	
  President & CEO

  

 

3Exhibit
10.38

 

Certain portions of this Exhibit have been omitted pursuant to a
request for confidentiality. Such omitted portions, which are marked with
brackets [   ] and an asterisk*, have
been separately filed with the Commission.

 

Fampridine
Tablets (10mg, 15mg, 20mg, 25mg)

Technical Transfer Program Proposal for 

Commercial Registration

 

 

For

 

Acorda
Therapeutics

 

 

Proposal
No. ELN-FQ-0001-1002-R4

 

Dated:  February 26, 2003

 

 

Confidential

 

 

TABLE OF
CONTENTS

 

	
  1.0

  	
  Project Scope

  
	
   

  	
   

  
	
  2.0

  	
  Environmental, Health and Safety

  
	
   

  	
   

  
	
  3.0

  	
  Analytical Development

  
	
   

  	
   

  
	
   

  	
  3.1

  	
  Cleaning
  Residuals Assay (Method Development and Validation)

  
	
   

  	
   

  	
   

  
	
   

  	
  3.2

  	
  Drug
  Substance Potency and Related Substance Assay (Method Transfer)

  
	
   

  	
   

  	
   

  
	
   

  	
  3.3

  	
  Drug
  Substance – Particle Size (Method Transfer)

  
	
   

  	
   

  	
   

  
	
   

  	
  3.4

  	
  Drug
  Substance – Residual Solvent Assay (Method Verification)

  
	
   

  	
   

  	
   

  
	
   

  	
  3.5

  	
  Drug
  Substance – Moisture by KF (Verification)

  
	
   

  	
   

  	
   

  
	
   

  	
  3.6

  	
  Drug
  Product Potency & Related Substance Assay, Two Methods (Method Transfer)

  
	
   

  	
   

  	
   

  
	
   

  	
  3.7

  	
  Dissolution Assay
  (Method Validation)

  
	
   

  	
   

  	
   

  
	
   

  	
  3.8

  	
  Drug
  Product – Moisture by KF (Verification)

  
	
   

  	
   

  	
   

  
	
   

  	
  3.9

  	
  Release Testing
  of the Drug Substance, per Lot

  
	
   

  	
   

  	
   

  
	
  4.0

  	
  Feasibility Manufacturing

  
	
   

  	
   

  
	
  5.0

  	
  Registration Manufacturing

  
	
   

  	
   

  
	
  6.0

  	
  Stability - Registration

  
	
   

  	
   

  
	
  7.0

  	
  Project Management

  
	
   

  	
   

  
	
  8.0

  	
  Assumptions, Terms and Conditions

  
	
   

  	
   

  
	
  Appendix A: Budget Summary

  
	
   

  
	
  Appendix B:
  High Level Timeline

  

 

2

 

Patheon Proposal #
ELN-FQ-0001-1002-R4

29-Feb-03

 

1.0          Project Scope

 

Patheon Inc. (“Patheon”) will perform manufacturing and analytical
services in order to manufacture Fampridine Tablets (10mg, 15mg, 20mg, 25mg)
for Acorda Therapeutics (“Client”). 
Analytical methods will be assessed to support the manufacturing
program.

 

The Budget Summary for this proposal is presented in Appendix A.

 

Patheon will commence the activities described in this proposal
following the execution of the Contract by both parties.

 

Reference standards for Fampridine and impurities and tablet samples
will be provided by the Client.  Source
technical documents (e.g., current Elan methods, validation reports, and master
batch records, etc) and an HPLC column for initiation of method familiarization
activities will be provided by the Client. 
Patheon will be responsible for the generation of documentation and
protocols required to support methods familiarization, methods transfer,
manufacturing studies, and process transfer activities to be performed as part
of this proposal.  The Client will review
and approve all protocols generated by Patheon prior to execution of studies
with the exception of the Clean Residuals Assay method.  Patheon will provide final reports at key
stages in the project, as indicated in this proposal.  The Client will review and approve final reports.

 

2.0          Environmental,
Health and Safety

 

Prior to the commencement of analytical method development, formulation
development and manufacturing activities, a thorough review by Patheon of the
Environmental, Health and Safety (EH&S) requirements for Fampridine will be
completed.  The fee assumes the EH&S
review will determine that Fampridine can be safely handled at Patheon.  A summary report for this evaluation will be
provided to the Client.

 

3.0          Analytical
Development

 

Patheon will perform the required method familiarization, method
transfer, method development and/or method validation work required to support
the manufacture of Fampridine Tablets. 
Patheon is responsible for preparing all protocols.  The Client will review and approve all
protocols prior to execution of the work. Upon completion of individual
studies, Patheon will prepare final reports to document results of all studies
with the exception of the Clean Residuals Assay method.  The Client will review and approve all
reports before moving forward with activities that rely on results of the
activities that are the subject of a report.

 

3

 

3.1          Cleaning Residuals Assay (Method
Development and Validation)

 

Patheon will develop and validate the test methods required for testing
cleaning residuals and swab samples in order to support the manufacturing
program.  Analytical protocols and report
will be prepared by Patheon.  The
development and validation will challenge the following parameters:

 

•                  System
Suitability

•                  Linearity

•                  LOD

•                  LOQ

•                  Recovery
/ Accuracy

•                  Repeatability

•                  Intermediate
Precision

•                  Robustness

•                  Specificity

•                  Stability

 

3.2          Drug Substance Potency and Related
Substance Assay (Method Transfer)

 

Patheon will transfer the test method required for drug substance
testing in order to support the manufacturing program. The Client will supply
Patheon in advance with the relevant Validation data to allow Patheon to set
acceptance criteria for the protocol. Method Transfer protocols will be
prepared by Patheon and submitted to the Client for approval prior to execution.  A final report documenting the methods
transfer results will be prepared by Patheon and submitted to the Client for
approval prior to use of the method for release testing. The method transfer
will challenge the following parameters:

 

•                  System
Suitability

•                  LOD
and LOQ

•                  Specificity

•                  Repeatability

•                  Reproducibility

•                  Robustness

 

3.3          Drug Substance – Particle Size (Method
Transfer)

 

Patheon will transfer the test method required for drug substance
particle size testing in order to support the manufacturing program. The Client
will supply Patheon in advance with the relevant Validation data to allow
Patheon to set acceptance criteria for the protocol. Method Transfer protocols
will be prepared by Patheon and submitted to the Client for approval prior to execution.   A final report documenting the methods
transfer results will be prepared by Patheon and submitted to the Client for
approval prior to use of the method for release testing. The method transfer
will challenge the following parameters:

 

•                  Reproducibility

•                  Robustness

•                  Repeatability

 

4

 

3.4          Drug Substance – Residual Solvent Assay
(Method Verification)

 

Patheon will verify the test method required for drug substance
residual solvent testing in order to support the manufacturing program.
Analytical protocols will be prepared by Patheon and submitted to the Client
for approval prior to execution.  A final
report documenting the method verification results will be prepared by Patheon
and submitted to the Client for approval prior to use of the method for release
testing. The method verification will evaluate the following parameters:

 

•                 System
Suitability

•                 LOD
and LOQ

•                 Specificity

•                 Repeatability

•                 Reproducibility

 

3.5          Drug Substance – Moisture by KF (Verification)

 

Patheon will verify the test method (up to 6 samples) required for drug
substance moisture testing to ensure the method is precise and accurate in
order to support the manufacturing program. Analytical protocols will be
prepared by Patheon and submitted to the Client for approval prior to
execution. A final report documenting the method verification results will be
prepared by Patheon and submitted to the Client for approval prior to use of
the method for release testing.

 

3.6                               Drug Product Potency & Related
Substance Assay, Two Methods (Method Transfer)

 

Patheon will perform method familiarization for the methods in advance
of methods transfer.  A report
documenting the method familiarization results will be prepared by Patheon and
submitted to the Client for approval prior to commencement of method transfer
studies.  The client will supply Patheon
with the relevant validation data to allow Patheon to set acceptance criteria
for the protocol

 

Patheon will transfer the test methods required for drug product
potency and related substances testing in order to support the manufacturing
program.  It is noted that in addition to
testing the coated finished product using Methods 1 and Method 2, a separate
HPLC method will be used for the following:

 

•                  content
uniformity testing,

•                  assay
of the uncoated tablets

•                  blend
homogeneity testing.

•                  Unit
dose testing

 

Method Transfer protocols will be prepared by Patheon and submitted to
the Client for approval prior to execution. Final reports documenting the method
transfer results will be prepared by

 

5

 

Patheon and submitted to the Client for approval prior to use of the
methods for testing.  The transfer will
challenge the following parameters:

 

•                  System
Suitability

•                  LOD
and LOQ

•                  Specificity

•                  Repeatability

•                  Reproducibility

•                  Robustness

 

3.7          Dissolution Assay (Method Validation)

 

Patheon will perform full validation of the method required for testing
dissolution of the drug product in order to support the manufacturing
program.  Analytical protocols will be
prepared by Patheon and submitted to the Client for approval prior to
execution.  A final report documenting
the method validation results will be prepared by Patheon and submitted to the
Client for approval prior to use of the method for release testing. The
validation will be performed according to ICH guideline requirements typically:

 

•                  System
Suitability

•                  Linearity
& Range

•                  Accuracy

•                  Precision
(Reproducibility)

•                  Robustness
of dissolution parameters & HPLC Methodology

•                  Specificity

•                  Solution
Stability

 

3.8          Drug Product – Moisture by KF
(Verification)

 

Patheon will verify the test method (up to 6 samples) required for drug
product moisture testing to ensure that the method is   precise and accurate in order to support the
manufacturing program. Analytical protocols will be prepared by Patheon and
submitted to the Client for approval prior to execution. A final report
documenting the method verification results will be prepared by Patheon and
submitted to the Client for approval prior to use of the method for release
testing.

 

3.9          Release Testing of the Drug Substance,
per Lot

 

Patheon will test drug substance for receiving and releasing for
manufacture as per Client’s CoA or as specified by Client instruction.

 

Note:

Release testing of the excipients and drug product has been included as
“Analytical Support” under each section of the manufacturing.

 

6

 

4.0          Feasibility
Manufacturing

 

Patheon will manufacture up to three feasibility batches of Fampridine
Tablets at the 10mg strength.  These
batches will be approximately 50 kilograms each and will not be manufactured
back-to-back.  A protocol to evaluate
blend times, tablet press parameters and coating parameters will be prepared by
Patheon and submitted to the Client for approval prior to execution of the
feasibility study.  The protocol will
specify a detailed sampling plan and acceptance criteria.

 

All excipients will undergo complete analytical release testing in
compliance with USP/NF (if the Client requires additional testing on the
excipients, this will be addressed and costed separately as an amendment to
this proposal).  Patheon will prepare a
master batch record(s), which will be provided to the Client for approval prior
to manufacturing and specifies manufacturing procedures and acceptance
criteria.

 

The feasibility batches will not be GMP batches and will not undergo a
full QA review; the batches will be bulk packaged. A report documenting the
results of the feasibility studies will be prepared by Patheon and submitted to
the Client for approval prior to proceeding to the registration batch
production phase of this proposal.

 

Feasibility Manufacturing Process Train (50 kilograms):

 

•                  325L
Gallay

•                  Beta
Press

•                  Vector
Lab Coater

•                  Comil

 

The following in-process and finished product testing is based upon the
described tests.  

 

Blend Analysis

 

•                  Blend
Homogeneity / uniformity of dosage (total of 10 samples)

•                  Composite
sample Assay

•                  Flow
Properties

•                  Bulk
and Tap Densities (Including one sieve analysis)

 

Coated Tablet
Analysis:

 

•                  Appearance

•                  Weight
Variation

•                  Potency
& Related Substances

•                  Identification

•                  Dissolution
Profile

•                  Physical
Parameters (hardness and friability)

•                  Moisture
(KF)

 

7

 

Uncoated Tablet Analysis:

 

•                  Content
Uniformity (As per USP)

•                  Physical
Parameters (Note Weight thickness and hardness will be evaluated as part of
in-process monitoring these are performed as part of the process) – hardness
and friability

•                  Appearance

•                  Moisture
(KF)

 

5.0                               Registration Manufacturing

 

Patheon will manufacture twelve registration batches of Fampridine
Tablets (three of each tablet strength) that are colored and debossed
tablets.  These batches will be
approximately 50 kilograms each and may be manufactured back-to-back.
Processing parameters will be based on recommendations from the feasibility
study.  All excipients will undergo
complete analytical release testing in compliance with USP/NF (if the Client
requires addition testing on the excipients, this will be addressed and costed
separately as an amendment to this proposal). 
Patheon will prepare a protocol and provide the protocol to the Client
for approval prior to execution of the registration batch production work.  The protocol will specify a detailed sampling
plan and acceptance criteria. Patheon will prepare master batch records, which
will be provided to the Client for approval prior to manufacturing; the batch
records will specify manufacturing procedures and acceptance criteria.

 

The registration batches will be manufactured in accordance with cGMPs
and will undergo a full QA review by Patheon. 
The batches will be packaged as follows by Patheon (packaging
configuration split to be determined by Client):

 

	
  10mg Tablets

  	
   

  	
  HDPE Bottles of 14’s and 60’s

  
	
  15mg Tablets

  	
   

  	
  HDPE Bottles of 14’s and 60’s

  
	
  20mg Tablets

  	
   

  	
  HDPE Bottles of 14’s, 60’s and 180’s

  
	
  25mg Tablets

  	
   

  	
  HDPE Bottles of 14’s, 60’s and 180’s

  

 

(all packaging configurations will include desiccant, filler and
induction seal)

 

Registration Manufacturing Process Train (50 kilograms):

 

•                  325L
Gallay

•                  Beta
Press

•                  Vector
Lab Coater

•                  Comil

 

8

 

The following in-process and finished product testing will be
conducted.

 

Blend Analysis:

 

•                  Blend
Homogeneity/uniformity of dosage (total of 10 samples)

•                  Composite
sample assay, appearance, and ID

•                  Flow
Properties

•                  Bulk
and Tap Densities (Including one sieve analysis)

 

Coated Tablet Analysis:

 

•                  Appearance

•                  Potency
& Related Substances

•                  Identification

•                  Dissolution
Profile

•                  Physical
Parameters (hardness and friability)

•                  Moisture
(KF)

•                  Uniformity
of dosage

 

Uncoated Tablet Analysis:

 

•                  Weight
Variation

•                  Physical
Parameters (hardness,  and friability)

•                  Appearance
ID

•                  Moisture
(KF)

•                  Assay

 

Patheon will provide copies of executed batch records to the Client
with the associated completed sampling protocol and summary of results.  The Client will review the batch records
prior to initiation of registration stability studies by Patheon.

 

6.0          Stability
- Registration

 

For quoting purposes a non-matrix approach has been suggested to
monitor the 30 lots (12 Registration batches, two packaging formats for the 10
and 15mg strengths, and three packaging formats for 20 and 25mg strengths of
Fampridine Tablets) as per ICH guidelines.

 

Additional samples will be stored as contingency samples if required to
generate data for long-term stability of the product.

 

The following storage conditions and test-points are suggested for
testing:

 

•                                          1,
2, 3 and 6 months for 40°C ±
2°C
/ 75% ± 5% RH

•                                          1,
2, 3, 6, 9, and 12 months for 30°C ±
2°C
/ 60% ± 5% RH*

•                                          3,
6, 9, 12, 18, 24 and 36 months for 25°C ±
2°C
/ 60% ± 5% RH

•                                          Contingency
samples at 5°C, Ambient RH*

 

(* Tested only if required due to significant changes in the next level
condition)

 

9

 

The analytical data used for the release of each lot manufactured at
Patheon will be considered as initial (T=0) data if samples are placed on
stability within 30 days of batch release.

 

Cost efficiencies for analytical testing have been built into the
stability program based upon the number of samples pulled in a given
month.  The fee for this stability
program assumes that all lots will be placed on stability at the same
time.  If these lots are not placed on
stability at the same time, the fee will be adjusted accordingly through an
Amendment to Proposal. The number of Pulls and costing is based on the
assumption that no testing is required at 30°C/60%RH.

 

	
  Pullpoint Month

  	
   

  	
  1

  	
   

  	
  2

  	
   

  	
  3

  	
   

  	
  6

  	
   

  	
  9

  	
   

  	
  12

  	
   

  	
  18

  	
   

  	
  24

  	
   

  	
  36

  
	
  Number of Samples Pulled

  	
   

  	
  30

  	
   

  	
  30

  	
   

  	
  60

  	
   

  	
  60

  	
   

  	
  30

  	
   

  	
  30

  	
   

  	
  30

  	
   

  	
  30

  	
   

  	
  30

  

 

Therefore, the stability sample breakdown is:

 

•                  0
Single Sample Pullpoints (0 Samples)

•                  0
Double Sample Pullpoints (0 Samples)

•                  0
More Than Two Sample Pullpoints (0 Samples)

•                  0
More Than Five Sample Pullpoints (330 Samples)

•                  9
More Than Ten Sample Pullpoints (330 Samples)

 

The following standard tests are usually performed as part of the
Stability Program:

 

•                  Potency
&Related Substances

•                  Dissolution
Profile

•                  Physical
Appearance

•                  Moisture

•                  Hardness

•                  Friability

 

This estimate is based on a full ICH program.  Patheon will prepare the ICH stability
protocol.  The protocol will be approved
by the Client prior to initiation of the stability studies.  Patheon will provide results to the Client
for each test interval that has been reviewed by Patheon quality
assurance.  Patheon will prepare a report
at the 3 and 6 month test stations and will prepare reports at every subsequent
6 month test station thereafter (or at each 12 month test interval, as
appropriate, based upon the protocol).

 

There is the possibility to reduce the fees for this work based on the
mutual agreement between Patheon and the Client to matrix the testing design.  The final cost is to be determined.

 

7.0          Project
Management

 

Patheon will provide project management support to monitor the progress
of the project against established timelines and will update the Client of
changes in events. The project manager will coordinate regular biweekly
teleconference meetings and quarterly face-to-face meetings.  The fee for project management is
incorporated in the breakdown of each activity.

 

10

 

8.0          Assumptions,
Terms and Conditions

 

1.             Development
Activities:  Patheon
shall undertake and perform the product development work described in this
Proposal (the “Development Activities”) which when accepted by CLIENT shall
become a contract binding on Patheon and CLIENT (the “Contract”).  Notwithstanding the foregoing, CLIENT and
Patheon acknowledge that certain changes are contemplated in the scope of the
Development Activities the details and costs of which will be negotiated at a
later date. No changes, deletions or additions to the Development Activities
will be considered valid without prior written agreement between CLIENT and
Patheon.  Patheon shall notify Client, in
advance of incurring any costs, when additional development activities by
Patheon, beyond the Development Activities set forth in this Proposal, become
necessary due to unforeseen events. 
Patheon shall not perform any additional development activities without
CLIENT approval of such related costs.

 

It is assumed that, based on the information available to Patheon at
this time, Patheon can safely perform the Development Activities at its Toronto
Region Operations facility.  If it is
determined by Patheon’s Environmental Health and Safety personnel that any of
the active ingredients are a Category III or Category IV compound, an
occupational exposure level, then an air sampling method will be required at
CLIENT’s expense prior to commercialization. 
Patheon reserves the right, in its sole and absolute discretion, to
conduct an air sampling method on Category I and II compounds, at such price
and upon such terms as may be mutually agreed to between the parties prior to
commercialization.

 

1.1           “Intellectual Property”: includes, without limitation,
rights in patents, patent applications, trade-marks, trade-mark applications,
trade-names, confidential information, trade secrets, inventions, copyrights,
industrial designs.

 

1.2           Grant of Non-Exclusive License to Patheon:  The CLIENT hereby grants to Patheon, for
the term of the Contract, a royalty-free, non-exclusive license to use Client’s
Intellectual Property for the performance of the Development Activities.  The nonexclusive license granted herein shall
be limited to Intellectual Property of the CLIENT that is necessary for the performance
of the Development Activities and Patheon shall not use such Intellectual
Property for any other purpose than performance of the Development
Activities.  The non-exclusive license
shall not include any right not expressly stated hereunder.  CLIENT represents and warrants that as of the
date of the Contract to the best of its knowledge, without conducting any
inquiry, that the Development Activities performed by Patheon will not, to the
best of CLIENT’s belief, infringe any Intellectual Property held by any third
party.

 

2.             Supply
of Products:

 

(a)           CLIENT shall supply Patheon with
sufficient bulk quantities of the active ingredients and certain excipients for
Patheon’s use in conducting the Development Activities under this
Proposal.  Such ingredients and excipients
shall by supplied by CLIENT at its expense.

 

11

 

Certain portions of this Exhibit have been omitted pursuant to a
request for confidentiality. Such omitted portions, which are marked with
brackets [   ] and an asterisk*, have been
separately filed with the Commission.

 

(b)           Patheon shall purchase all other
materials required to conduct the Development Activities.  CLIENT shall pay Patheon’s direct cost
thereof plus an additional [**] as a handling charge upon receipt of an invoice
detailing such costs.  Prior to making
any such purchases in excess of [**], Patheon shall obtain CLIENT
approval.  In addition, Patheon shall
obtain prior client approval for each and every purchase of other materials
once the total amount invoiced to CLIENT during performance of the Development
Activities exceeds [**].

 

3.             Payment
for Service:

 

(a)           CLIENT shall pay Patheon for the
services to be provided during the term of this Proposal in such amounts and in
such manner as set forth in this Proposal. 
All amounts quoted are in USD funds and are valid for sixty (60) days
from the date of this Proposal.  All
amounts quoted are subject to review by Patheon of all product specifications,
development reports and, Environmental, Health and Safety assessment.  One review with changes is included in the
fee for final reports.  Any additional
changes shall be invoiced separately at the then prevailing hourly rates.

 

(b)           Project specific items, which include
but are not limited to special equipment, change parts, excipients, laboratory
columns and reagents, tooling etc., obtained by Patheon from third party
suppliers as well as services to be provided by any third party suppliers are
subject to prior CLIENT approval, and will be billed back to CLIENT upon
Patheon’s receipt of invoice from any supplier of Patheon.  The purchase of project specific items and
services are subject to the same prior approval requirements in Section 2 (b)
of the Contract.

 

(c)           Each Patheon invoice shall be due and
payable within thirty (30) days of the date of such invoice.

 

4.             Deposit:  Prior to the commencement
of any Development Activities by Patheon pursuant to this Proposal, Patheon
shall have received from CLIENT a deposit in the amount set out in the Project
Summary.  This deposit amount will be
held by Patheon as a deposit until the Development Activities, as modified from
time to time, are fully completed or until this Contract expires or is
terminated for whatever reason.  The
deposit amount shall be credited towards the final invoice for the
Project.  Patheon may apply this deposit
amount against any accounts overdue in excess of 60 days of the date of the
invoice.  In addition, Patheon may, at
its option, suspend all Development Activities until such time the outstanding
amounts have been paid in full and the original deposit amount has been
replenished.

 

5.             Term
and Termination:  This
Contract will take effect on the date of execution and shall continue until
completion by Patheon of the Development Activities.  Either party may terminate this Contract if
the other party is in material breach of any provisions thereof and the
breaching party fails to remedy any such breach within thirty (30) days of the
notice of such breach by the non-breaching party. Additionally, CLIENT shall have
the right to terminate this Contract immediately for any business reason.

 

In either such case, Patheon shall cease performance of the Development
Activities upon termination and CLIENT shall pay to Patheon:  (i) any fees and expenses due to Patheon for
the

 

12

 

services rendered up to the date of termination; (ii) all actual costs
incurred by Patheon to complete activities associated with the termination and
close of the Project; and (iii) any additional costs incurred by Patheon in
connection with the Project that are required to fulfill applicable regulatory
and contractual requirements.  Any
re-scheduling of the Development Activities requested by CLIENT beyond one
hundred twenty (120) days, notwithstanding a request made pursuant to Section
8.8, shall be deemed to be a termination.

 

All materials and supplies shall be picked up within five (5) business
days of termination otherwise, a $20.00 per square foot per month surcharge
will be assessed for storage.

 

6.             Confidential
Information:  All
proprietary or confidential information of either party that is disclosed or
otherwise made known to the other party as a result of the Development
Activities performed under this Contract shall be considered confidential
property of the disclosing party (the “Confidential Information”).  The Confidential Information shall be used by
the receiving party, its employees and external advisors only for the purpose
of performing the receiving party’s obligations hereunder.  For purposes of this paragraph, Confidential
Information shall not be deemed to include any information that is (i) known to
the receiving party at the time of the disclosure, as evidenced by its written
records prior to disclosure by the disclosing party; (ii) is or becomes
available publicly other than as a result of a breach of this Contract by the
receiving party, (iii) obtained from a third party lawfully in possession of
such information and under no obligation to maintain such information confidential
or (iv) independently developed by the receiving party without use of the
Confidential Information.

 

Each party agrees that it will not reveal, publish or otherwise
disclose the Confidential Information of the other party to any third party
without prior written consent of the disclosing party.  However, disclosure of Confidential
Information may be made if required by law or by any regulatory or governmental
authority to which the receiving party or any of its respective affiliates may
be subject, in each case, on prior written notice to the disclosing party, so
that the disclosing party may determine whether to seek a protective order or
other appropriate remedy.  This
obligation of confidentiality and non-disclosure shall remain in effect for a
period of ten (10) years after the effective date of termination of this
Contract.

 

7.             Inventions,
Etc.:  All data,
information and Intellectual Property generated or derived by Patheon as a
result of Development Activities performed by Patheon under this Contract, to
the extent it is specific to the development, manufacture, use and sale of the
CLIENT’s product the subject of the Development Activities (“CLIENT’s Product”)
shall be and remain the exclusive property of CLIENT.  In addition, any data, information and
Intellectual Property generated or derived by Patheon through the use of
CLIENT’s Intellectual Property that is not a result of the Development
Activities performed by Patheon shall be the exclusive property of CLIENT.  On the other hand, all data information and
Intellectual Property generated or derived by Patheon as a result of
Development Activities performed by Patheon under this Contract, which is not
specific to the development the development, manufacture, use and sale of the
CLIENT’S product and has application beyond the CLIENT’s Product shall be and
remain the exclusive property of Patheon. 
Notwithstanding the foregoing, CLIENT acknowledges that Patheon
possesses certain inventions, processes, know-how, trade secrets, other
intellectual properties and other assets, including but not limited to,
analytical methods, computer technical expertise and

 

13

 

software which have been independently developed by
Patheon (collectively “Patheon Property”). 
CLIENT and Patheon agree that any Patheon Property or improvement
thereto which are used, improved, modified or developed by Patheon under or
during the term of this Contract, is the product of Patheon’s technical
expertise possessed and developed by Patheon prior to or during performance of
this Contract and are the sole and exclusive property of Patheon.

 

8.             Errors
and Omissions:  In the event of a
material error by Patheon in the performance of the Development Activities,
CLIENT shall have the option to request Patheon to (1) repeat the service at
Patheon’s own costs provided that CLIENT provides the active ingredient, or (2)
reimburse CLIENT for the price for that particular service, excluding the cost
of the active ingredient.  In any event,
Patheon shall not reimburse the amount of the active ingredient.

 

9.             Indemnification:

 

(a)           CLIENT shall defend, indemnify and
hold harmless Patheon and its affiliates and their respective directors,
officers, employees and agents (together with Patheon, the “Patheon Indemnitees”)
from and against any and all claims, actions, causes of action, damages,
liabilities, expenses including reasonable attorneys’ fees and expenses
(collectively, “Losses”) to and in favour of third parties (other than
affiliates) resulting from, relating to, or arising from: (i) any breach by
CLIENT of any of its obligations under this Contract; and (ii) the Intellectual
Property rights of third parties except to the extent such Losses are: (I)
determined to have resulted from the negligence or willful misconduct of
Patheon; or (2) for which Patheon is obligated to indemnify the CLIENT
Indemnitees pursuant to Section 9(b).

 

(b)           Patheon shall defend, indemnify and
hold harmless CLIENT and its affiliates and their respective directors,
officers, employees and agents (together with CLIENT, the “CLIENT Indemnitees”)
from and against any and all Losses resulting from, relating to, or arising
from any breach by Patheon of any of its obligations under this Contract except
to the extent such Losses are: (i) determined to have resulted from negligence
or willful misconduct of CLIENT; or (ii) for which CLIENT is obligated to
indemnify the Patheon Indemnitees pursuant to Section 9(a).

 

(c)           Under no circumstances whatsoever
shall either party be liable to the other in contract, tort, negligence, or
breach of statutory duty for any otherwise for any indirect or consequential
damages.

 

10.          Indemnification
Procedures:  In the event that
either party seeks indemnification, it shall inform the other party of the claim
as soon as reasonably practicable after it receives notice thereof and, shall
permit the other party, at that party’s cost, to assume direction and control
of the defense of the claim, and shall cooperate as reasonably requested (at
the expense of the other party), in defense of the claim.  Neither party shall settle or otherwise
compromise any claim or suit in any manner that adversely affects that other
party hereunder or imposes obligations on the other party in addition to those
set forth in this Contract, without prior written consent of the other party,
which consent shall not be unreasonably withheld or delayed.

 

14

 

11.          Miscellaneous:  This Contract contains the entire
understanding of the parties with respect to the subject matter herein and
supersedes all previous agreements (oral and written), negotiations and
discussions.  The parties may modify or
amend the provisions hereof only by an instrument in writing duly executed by
both of the parties.  Neither this
Contract, nor any of either party’s rights hereunder, may be assigned or
otherwise transferred by either party without the prior written consent of the
other party.  Any attempt to assign the
rights or obligations under this Contract shall be void. This Contract shall be
deemed to be made in the State of New York and shall be interpreted and
enforced in accordance with the laws of the State of New York, without regard
to conflict of law principles.  The parties
hereby submit to the jurisdiction of the state and federal courts located
within the State of New York.  The
obligation of the parties contained in Sections 6, 7, 8, 9 and 10 shall survive
the expiration or earlier termination of this Contract.

 

Patheon and CLIENT have executed this Contract in duplicate by the duly
authorized officers of each party.

 

	
  Acorda Therapeutics

  	
   

  	
  Patheon Inc.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Mitchell Katz

  	
   

  	
   

  	
  By:

  	
  /s/ Nick A. DiPietro

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  Mitchell Katz, PhD

  	
   

  	
   

  	
  Name:

  	
  Nick A. DiPietro

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Vice President, Clinical Programs

  	
   

  	
   

  	
  Title:

  	
  President & COO

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
  3/28/03

  	
   

  	
   

  	
  Date:

  	
  4/7/03

  	
   

  

 

15

 

Certain portions of this Exhibit have been omitted pursuant to a
request for confidentiality. Such omitted portions, which are marked with
brackets [   ] and an asterisk*, have
been separately filed with the Commission.

 

Appendix A: Budget Summary

 

THE
FOLLOWING COSTS ARE ALL QUOTED IN:                              USD

 

	
  2.0
  ENVIRONMENTAL HEALTH AND SAFETY

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  ACTIVITY

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PRICE

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  EH&S
  Assessment ($3,000 per active)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.0
  ANALYTICAL DEVELOPMENT

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  ACTIVITY SHIFTS

  	
   

  	
  HOURS

  	
   

  	
  PRICE

  	
   

  	
   

  	
   

  	
  HOURS

  	
   

  	
  PRICE

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.1
    Cleaning Residuals Assay (Method Development and Validation)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protocol/benchwork

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Final Report

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  
	
  3.2
    Drug Substance Potency & Related Substances (Method Transfer)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protocol/benchwork

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Final Report

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.3
    Drug Substance - Particle Size (Method Transfer)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protocol/benchwork

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Final Report

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.4   Drug Substance - Residual Solvents
  Assay (Method Verification)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protocol/benchwork

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Final Report

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.5
    Drug Substance - Moisture by KF (MethodVerification)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protocol/benchwork

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Final Report

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.6   Drug Product Potency & Related
  Substances Assay (Method Transfer)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protocol/benchwork

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Final Report

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.7   Dissolution (Validation)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protocol/benchwork

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Final Report

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.8   Drug Product - Moisture by KF (Method
  Verification)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protocol/benchwork

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Final Report

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.9   Full Release testing of the Drug
  Substance (per Lot)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protocol/benchwork

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Final Report

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TOTAL
  (Analytical Development)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4.0 FEASIBILITY MANUFACTURING -
  OPTIMIZATION BATCHES

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  ACTIVITY

  	
   

  	
  SHIFTS

  	
   

  	
  HOURS

  	
   

  	
  PRICE

  	
   

  	
  SHIFTS

  	
   

  	
  HOURS

  	
   

  	
  PRICE

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Certain 
  portions of this Exhibit have been omitted pursuant to a request for
  confidentiality. Such omitted 

  portions, which are marked with brackets
  [     ] and an asterisk*, have been separately filed
  with the 

  Commission.

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Per
  Batch:

  	
  Manufacturing

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Bulk Packaging

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Analytical
  Support

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Project Support

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  TOTAL
  (Three Feasibility Batches)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  

 

16

 

Certain portions of this Exhibit have been omitted pursuant to a
request for confidentiality. Such omitted portions, which are marked with
brackets [   ] and an asterisk*, have
been separately filed with the Commission.

 

	
  5.0 REGISTRATION MANUFACTURING

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  ACTIVITY

  	
   

  	
  SHIFTS

  	
   

  	
  HOURS

  	
   

  	
  PRICE

  	
   

  	
  SHIFTS

  	
   

  	
  HOURS

  	
   

  	
  PRICE

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Per
  Batch:

  	
   

  	
  Manufacturing

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Packaging

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Analytical
  Support

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Project Support

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  First
  Batch

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
  11

  	
  Additional
  Batches Manufactured Back-to-Back from First Batch

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  Cost
  Savings Per Additional Batch:

  	
   

  	
  3.5

  	
   

  	
  Shifts/

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  Cost
  Per Additional Batch:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
  OPTIONAL:
  For 4 Registration Batches Manufacture
  Back-to-Back the Cost will be $249,820

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Bulk Hold Time
  Study (per Strength - one Timepoint)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  TOTAL
  (Registration Manufacturing)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6.0 STABILITY - REGISTRATION

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  ACTIVITY

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  HOURS

  	
   

  	
  PRICE

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Number of Lots

  	
  24

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Total Samples

  	
  264

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  Cost per
  Sample

  	
   

  	
  # of Samples

  	
   

  	
  Subtotal

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Analytical
  Support (1 sample per pullpoint)

  	
   

  	
  $

  	
  [**]

  	
   

  	
  0

  	
   

  	
  $

  	
  0

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Analytical Support
  (2 samples per pullpoint)

  	
   

  	
  $

  	
  [**]

  	
   

  	
  0

  	
   

  	
  $

  	
  0

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Analytical
  Support (2+ samples per pullpoint)

  	
   

  	
  $

  	
  [**]

  	
   

  	
  0

  	
   

  	
  $

  	
  0

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Analytical
  Support (5+ samples per pullpoint)

  	
   

  	
  $

  	
  [**]

  	
   

  	
  0

  	
   

  	
  $

  	
  0

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Analytical
  Support (10+ samples per pullpoint)

  	
   

  	
  $

  	
  [**]

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  TOTAL
  (Stability - Validation)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [**]

  	
   

  	
   

  	
  [**]

  	
   

  
	
  BUDGET TOTAL *

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  USD

  	
   

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Deposit

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  $

  	
  [**]

  	
   

  
																							

 

* The manufacturing cost given in this proposal is based upon the
assumption that the drug substance is classified as a high potency material in
accordance with Patheon’s Categorization System.  If it is determined through Patheon’s
Environmental Health and Safety Review that the drug substance is not
categorized as a high potency material, the manufacturing cost will be revised
through a Change of Scope to reflect handling charges for a low potency
product.

 

17

 

Appendix
B: High Level Timeline

(2 pages)

 

The attached High Level Timeline is presented at this stage as a
projected estimate of the duration and achievable milestones, based upon
Patheon’s experience and history.  The
High Level Timeline should not be taken as part of an agreed legal deliverable
of this proposal.

 

Once the project has been awarded to Patheon and the relevant legal
documentation is in place, a revised Timeline detailing set milestones and
duration of deliverables will be agreed upon between Patheon and the
Client.  The revised Timeline would
likely have a similar duration and would be based upon resources and the
availability of manufacturing time at the initiation of the project.

 

18

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00096-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00096-of-00352.parquet"}]]