Exhibit 4.50


 


 


MANUFACTURING AND SUPPLY


 


MASTER AGREEMENT


 


BETWEEN


 


PFIZER CANADA INC. (“PFIZER”)


 


AND


 


DRAXIS PHARMA,


 


A DIVISION OF DRAXIS SPECIALTY PHARMACEUTICALS
INC.


 


(an amalgamation of DRAXIS Pharma Inc. and
DRAXIMAGE Inc.)


 


(“COMPANY”)


 


DATED AS OF January 1, 2005


 

















 


Table Of Contents


 


	
   

  	
  Page

  
	
   

  	
   

  
	
  Section 1.
  Definitions

  	
  4

  
	
   

  	
   

  
	
  Section 2.
  Start-Up Activities

  	
  10

  
	
   

  	
   

  
	
  2.1.

  	
  Start-Up
  Activities

  	
  10

  
	
  2.2

  	
  Purchase
  and Installation of Equipment, Dedicated Change Parts and Tooling

  	
  11

  
	
   

  	
   

  	
   

  
	
  Section 3
  Supply Requirements; Orders; Shipment And Delivery Terms; Reports;
  Alternative Supply

  	
  11

  
	
   

  	
   

  	
   

  
	
  3.1.

  	
  Agreement
  to Supply under Addendum

  	
  11

  
	
  3.2.

  	
  Use of
  Facility, Equipment, Molds and Tooling

  	
  11

  
	
  3.4

  	
  Forecasts

  	
  12

  
	
  3.5

  	
  Firm
  Orders; Changes to Firm Orders

  	
  12

  
	
  3.6

  	
  Shipment Reports

  	
  12

  
	
  3.7

  	
  Shipping
  Instructions/Risk of Loss

  	
  12

  
	
  3.8

  	
  Standard
  Forms

  	
  13

  
	
  3.9

  	
  Procurement
  and Approval of Raw Materials and Ingredients

  	
  13

  
	
  3.10

  	
  No Third
  Party Conflicts

  	
  14

  
	
  3.11

  	
  Product
  Samples

  	
  14

  
	
  3.12

  	
  Alternative
  Supply

  	
  15

  
	
   

  	
   

  	
   

  
	
  Section 4.
  Price; Payment; Price Adjustments; Taxes

  	
  16

  
	
   

  	
   

  	
   

  
	
  4.1

  	
  Purchase
  Price

  	
  16

  
	
  4.2

  	
  Changes
  in Price

  	
  16

  
	
  4.3

  	
  Cost
  Improvement

  	
  16

  
	
  4.5

  	
  Taxes

  	
  16

  
	
  4.6

  	
  Provision
  of Similar Products

  	
  16

  
	
   

  	
   

  	
   

  
	
  Section 5.
  Manufacturing Standards And Quality Assurance

  	
  16

  
	
   

  	
   

  	
   

  
	
  5.1

  	
  Manufacturing
  Standards

  	
  16

  
	
  5.2

  	
  Modifications
  in Specifications

  	
  17

  
	
  5.3

  	
  Pest
  Control

  	
  17

  
	
  5.4

  	
  Storage
  and Handling

  	
  17

  
	
  5.5

  	
  Maintenance
  of Facility, Equipment and Molds

  	
  18

  
	
  5.6

  	
  Legal and
  Regulatory Filings and Requests

  	
  18

  
	
  5.7.

  	
  Analysis
  of Materials

  	
  19

  
	
  5.8.

  	
  Quality
  Tests and Checks

  	
  19

  
	
  5.9.

  	
  Non-conforming
  Materials

  	
  19

  
	
  5.10.

  	
  Non-complying
  Product

  	
  20

  
	
  5.11.

  	
  Responsibility
  for Rejected and Non-Complying Product

  	
  20

  
	
  5.12.

  	
  Disposal
  of Rejected and Non-Complying Product and Materials

  	
  20

  



 

















 


	
  5.13.

  	
  Maintenance
  and Retention of Records

  	
  20

  
	
  5.14.

  	
  Quantitative
  Defects; Rejection of Product; Replacement of Rejected Shipments

  	
  21

  
	
  5.15.

  	
  Customer
  Complaints and Inquiries

  	
  22

  
	
  5.16.

  	
  Government
  Inspections, Seizures and Recalls

  	
  23

  
	
  5.17.

  	
  Quality
  Agreement

  	
  24

  
	
  5.18

  	
  Facility Inspections and Audits

  	
  24

  
	
  5.19

  	
  Audit of
  Financial Books and Inspections

  	
  24

  
	
  5.20.

  	
  Diversion
  Issues

  	
  25

  
	
  5.21

  	
  Waste Disposal

  	
  25

  
	
  5.23

  	
  Segregation of Restricted Compounds

  	
  25

  
	
  5.24

  	
  Survival

  	
  25

  
	
   

  	
   

  	
   

  
	
  Section 6.
  Representations; Warranties And Covenants

  	
  26

  
	
   

  	
   

  	
   

  
	
  6.1

  	
  Representations,
  Warranties and Covenants of COMPANY

  	
  26

  
	
  6.2

  	
  Representations,
  Warranties and Covenants of PFIZER

  	
  28

  
	
  6.3.

  	
  Notice of
  Material Events

  	
  29

  
	
  6.4.

  	
  Survival

  	
  29

  
	
   

  	
   

  	
   

  
	
  Section 7.
  Environmental Representations, Warranties And Covenants

  	
  29

  
	
   

  	
   

  	
   

  
	
  7.1.

  	
  Compliance
  with Environmental Laws

  	
  29

  
	
  7.2.

  	
  Permits,
  Licenses and Authorization

  	
  29

  
	
  7.3.

  	
  Hazardous
  Materials and Waste

  	
  30

  
	
  7.4.

  	
  Generation
  of Hazardous Wastes

  	
  30

  
	
  7.5.

  	
  Diversion
  Issues

  	
  30

  
	
  7.6.

  	
  Health
  and Safety Procedure

  	
  30

  
	
  7.7.

  	
  Training

  	
  30

  
	
  7.8

  	
  Environmental
  and Health and Safety Reviews

  	
  31

  
	
  7.9

  	
  Prompt
  notice to PFIZER of Material Environmental or Health and Safety adverse
  impacts upon COMPANY’S ability to perform

  	
  32

  
	
  7.10.

  	
  Survival

  	
  32

  
	
   

  	
   

  	
   

  
	
  Section 8
  Ownership; Trademarks; Proprietary

  	
  32

  
	
   

  	
   

  	
   

  
	
  8.1.

  	
  PFIZER’s
  Ownership of Intellectual Property; PFIZER Technology and Information

  	
  32

  
	
  8.2.

  	
  Ownership
  of Other Property

  	
  33

  
	
  8.3.

  	
  Limited
  Right to Use

  	
  33

  
	
  8.4.

  	
  Survival

  	
  34

  
	
   

  	
   

  	
   

  
	
  Section 9.
  Indemnification

  	
  34

  
	
   

  	
   

  	
   

  
	
  9.1.

  	
  Indemnification
  of PFIZER

  	
  34

  
	
  9.2.

  	
  Indemnification
  of COMPANY

  	
  34

  
	
  9.3.

  	
  Assertion
  of Claim

  	
  35

  
	
  9.5

  	
  Limitation
  on Liability

  	
  35

  
	
  9.4.

  	
  Survival

  	
  35

  
	
   

  	
   

  	
   

  
	
  Section 10.
  Insurance

  	
  35

  
	
   

  	
   

  	
   

  
	
  10.1.

  	
  Coverage

  	
  35

  



 

















 


	
  10.3.

  	
  Certificates
  of Insurance; Maintenance of Coverage

  	
  36

  
	
   

  	
   

  	
   

  
	
  Section 11.
  Pfizer Supply Of Materials(Raw Materials, API Or Packaging)

  	
  37

  
	
   

  	
   

  	
   

  
	
  11.1

  	
  Supply of
  Raw Materials

  	
  37

  
	
  11.2

  	
  Testing

  	
  37

  
	
  11.3

  	
  Title and
  Risk of Loss

  	
  37

  
	
  11.4

  	
  Reimbursement
  for Loss of Raw Materials

  	
  38

  
	
   

  	
   

  	
   

  
	
  Section 12.
  Confidential Information

  	
  38

  
	
   

  	
   

  	
   

  
	
  12.1

  	
  Confidential
  Information

  	
  38

  
	
   

  	
   

  	
   

  
	
  Section 13.
  Term; Termination

  	
  40

  
	
   

  	
   

  	
   

  
	
  13.1

  	
  Commencement
  and Termination of the Agreement

  	
  40

  
	
  13.2

  	
  Initial
  Term; Term of an Addendum

  	
  40

  
	
  13.3

  	
  Termination
  by PFIZER

  	
  40

  
	
  13.4

  	
  Termination
  by COMPANY

  	
  41

  
	
  13.5

  	
  Effect of
  Termination

  	
  41

  
	
  13.6

  	
  Unused
  Materials

  	
  42

  
	
  13.7

  	
  Return of
  Materials, etc. Supplied by PFIZER

  	
  42

  
	
   

  	
   

  	
   

  
	
  Section 14. Force Majeure

  	
  43

  
	
   

  	
   

  	
   

  
	
  14.1

  	
  Force Majeure

  	
  43

  
	
   

  	
   

  	
   

  
	
  Section 15. Exclusivity

  	
  43

  
	
   

  	
   

  	
   

  
	
  15.1

  	
  Manufacture
  of Competing Product

  	
  43

  
	
   

  	
   

  	
   

  
	
  Section 16.
  Miscellaneous

  	
  44

  
	
   

  	
   

  	
   

  
	
  16.1

  	
  Relationship
  of the Parties

  	
  44

  
	
  16.2

  	
  Successors
  and Assigns; Subcontracting

  	
  44

  
	
  16.3

  	
  Notice

  	
  44

  
	
  16.4

  	
  Entire
  Agreement

  	
  45

  
	
  16.5

  	
  Severability

  	
  45

  
	
  16.6

  	
  Waiver

  	
  46

  
	
  16.7

  	
  Headings

  	
  46

  
	
  16.8

  	
  Counterparts

  	
  46

  
	
  16.9

  	
  Governing
  Law

  	
  46

  
	
  Schedule B
    Form of
  Addendum

  	
  49

  
	
  Schedule B-1   Addendum

  	
  51

  
	
  Schedule C   PFIZER Owned Equipment, Dedicated Change
  Parts and/or Tooling

  	
  54

  
	
  Schedule D   Approved Carriers

  	
  55

  
	
  Schedule E
    Raw
  Materials to be supplied by PFIZER

  	
  56

  
	
  Attachment
  A   Canada Product / Price List

  	
  57

  
	
  Attachment
  B   Draft Quality Agreement

  	
  60

  



 

















 


MANUFACTURING AND SUPPLY MASTER AGREEMENT


 


MANUFACTURING AND SUPPLY
MASTER AGREEMENT dated as of January 1, 2005 (“Effective Date”), by PFIZER
CANADA INC., a Canadian corporation having its principal office located at
17,300 Trans Canada Highway, Kirkland, Quebec, H9J 2M5 (hereinafter “PFIZER”)
and DRAXIS PHARMA, a division of DRAXIS Specialty Pharmaceuticals Inc. (an
amalgamation of DRAXIS Pharma Inc. and DRAXIMAGE Inc.), a Canadian corporation having its principal manufacturing facilities at 16751
Trans Canada Highway, Kirkland, Quebec, H9H 4J4 (hereinafter “COMPANY”).


 


WITNESSETH:


 


WHEREAS,
PFIZER desires to have COMPANY manufacture and supply PFIZER with product(s) as
defined in Section 1 Definitions below;


 


WHEREAS,
COMPANY desires to manufacture and supply PFIZER with such Product(s); and


 


WHEREAS,
the parties are willing to carry out the foregoing pursuant to the terms and
conditions set forth in this Agreement;


 


NOW,
THEREFORE, in consideration of these premises and the covenants, agreements,
representations and warranties herein contained, and for other good and
valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the parties hereby agree as follows:


 


SECTION 1.

DEFINITIONS.


 


As
used in this Agreement, the following defined terms shall have the meanings set
forth below.


 


“Active
Pharmaceutical Ingredients” or “API” shall mean the bulk active drug
substances.


 


“Addendum” shall mean a document in the form of Schedule “B”
to this Agreement which incorporates this Agreement by reference and is
executed by the parties. In the event of a discrepancy between the terms of an
Addendum and the terms of this Agreement, the terms of the executed Addendum
shall govern.


 


“Affiliate”
shall mean, with respect to any Person, any individual, corporation or other
business entity that either directly or indirectly, controls such Person, is
controlled by such Person, or is under common control by a Parent Company with
such Person. For purposes of this definition, the term “control” means the possession
of the power to direct or cause the direction of the management and policies of
such Person, whether through the ownership of voting securities, by contract or
otherwise.


 


4

















 


“Agreement”
shall mean or refer to either this Manufacturing and Supply Master Agreement
and all attachments hereto or be read as referring to an Addendum as either may be
amended, supplemented or otherwise modified from time to time, whichever is
appropriate given the context, with the expectation that upon incorporating the
terms of this Manufacturing and Supply Agreement into an Addendum that the term
“Agreement” when used herein will most often refer to an Addendum.


 


“Annual
Product Review” shall mean the APR prepared by the COMPANY for each Product. Each
APR shall include, but shall not necessarily be limited to, the following
information: (i) stability data, (ii) the total number of Product
batches formulated during the APR period, including related analytical data for
all Product batches which passed or failed quality or other testing during the
APR period, (iii) an investigation summary in respect of each Product
batch failure, and (iv) a summary of any significant Product processing,
packaging or analytical changes. A copy of the final APR for each Product must
be forwarded by the COMPANY to PFIZER within five (5) Business Days of
completion.


 


“Business
Day” shall mean any day other than Saturday, Sunday or any day on which banks
located in Canada are authorized or obligated to be closed.


 


“cGMP”
shall mean all applicable standards and Laws relating to manufacturing
practices for Products (including ingredients, testing, storage, handling,
intermediates, bulk and finished products) promulgated by any Governmental
Authority having jurisdiction in the form of laws, regulations,
guidelines, advisory opinions and compliance policy guides and current
interpretations of the authority agency (as applicable to pharmaceutical
products and ingredients), as the same may be updated, supplemented or
amended from time to time.


 


“Claim
or Proceeding” shall mean any claim, action, suit, proceeding or arbitration
including any Governmental Authority action, notification, investigation or
audit.


 


“Commercial
Launch Date” shall have the meaning set forth in Section 3.3.


 


 “COMPANY Indemnified Party” shall have the
meaning set forth in Section 9.2.


 


“Confidential
Information” shall have the meaning set forth in Section 12.1.


 


“Effective
Date” means the date first appearing in this Agreement.


 


“Environmental
Law” means any applicable statute, ordinance, rule, regulation code, order,
judgment, decree or injunction relating to the protection of the environment,
occupational safety and health, or the exposure to, or the use, storage,
recycling, treatment, generation, labeling, protection, release or disposal of
Hazardous Materials.


 


5

















 


“Environmental
Losses” shall mean any and all fines, penalties, costs, liabilities, damages or
losses incurred by PFIZER or an Affiliate of PFIZER, or for which PFIZER or an
Affiliate of PFIZER is liable or obligated pursuant to any Environmental Law
and (i) arising out of the COMPANY’s operation or ownership of the
Facilities of COMPANY, the facilities of any Affiliate of COMPANY, or the
facilities of any subcontractor of COMPANY or such subcontractor’s Affiliates;
or (ii) relating to, arising from, or in any way connected with, the
testing, manufacture, packaging, generation, processing, storage,
transportation during processing or outside testing, distribution, treatment,
disposal or other handling of Product(s) or Product Materials used in the
manufacture, packaging, handling or storage of Product(s), or associated
by-products, Raw Materials, intermediates, Wastes, Releases or returned
Product(s), by COMPANY, Affiliates of COMPANY, or subcontractors of COMPANY or
such subcontractor’s Affiliates, or their respective officers, directors,
employees, agents or contractors all of which is related to or arising from any
of the services to be provided pursuant to this Agreement.


 


“Environmental
Release” shall mean any release, spill, emission, leaking, pumping, injection,
deposit, disposal, discharge, dispersal, leaching or migration into the
environment, including the movement of Hazardous Materials through the ambient
air, soil, subsurface water, groundwater, wetlands, lands or subsurface strata
from COMPANY’s Facilities, the facilities of Affiliates of COMPANY, or the
facilities of the Subcontractors of COMPANY.


 


“Estimated
Start-Up Costs” shall have the meaning set forth in Section 2.1(a).


 


“Facility”
shall mean COMPANY’s manufacturing facility located at 16751 Trans-Canada
Highway, Kirkland, Quebec H9H 4J4 and, subject to PFIZER’s prior written
approval, such other facilities used by COMPANY in the manufacture, packaging
and storage of (a) Product(s) or (b) Product Materials utilized in
the manufacture of Product(s) hereunder.


 


“FDA”
shall mean the United States Food and Drug Administration or any successor
agency.


 


“FDA
Act” shall mean the Food, Drug and Cosmetic Act, as amended.


 


“Firm
Order Period” shall have the meaning set forth in Section 3.5.


 


“Food
and Drugs Act” shall mean the Canadian Food and Drugs Act, as amended.


 


 “Governmental Authority” shall mean any duly
authorized court, tribunal, arbitrator, agency, commission, official or other
instrumentality of any federal, state, province, county, city or other
political subdivision, domestic or foreign.


 


“Hazardous
Material” means any substance, matter, pollutant or contaminant as defined or
regulated under applicable Environmental Laws, including, without limitation,
toxic, flammable, or explosive materials; asbestos-containing materials,
polychlorinated 


 


6

















 


biphenyls, or lead-containing materials; and, carcinogenic, mutagenic,
or teratogenic materials.


 


“Hazardous Waste” shall mean waste arising from the
COMPANY’s manufacturing, handling or storage of the Product(s) or which is
otherwise generated by COMPANY, Affiliates of COMPANY or Subcontractors of
COMPANY through the implementation of this Agreement, that is defined in, or
which would be determined to be hazardous waste under, any Environmental Laws.


 


“Health Canada” shall mean the Canadian regulatory
body or any successor agency.


 


“Indemnified
Party” shall have the meaning set forth in Section 9.3.


 


“Indemnifying
Party” shall have the meaning set forth in Section 9.3.


 


 “Initial Term” shall have the meaning set
forth in Section 13.1.


 


“Intellectual
Property” shall mean (a) any processes, trade secrets, inventions,
industrial models, designs, methodologies, drawings, formulae, procedures,
techniques, clinical data or technical or other information or data,
manufacturing, engineering and technical drawings necessary or useful in the
registration, packaging, manufacture, use or sale of the Product(s), and (b) registered
trade marks, trade mark applications, unregistered marks, trade dress,
copyrights, know-how, patents, patent applications, and any and all
provisionals, divisions, continuations, continuations in part, extensions,
substitutions, renewals, registrations, revalidations, reissues or additions,
including supplementary certificates of protection, of or to any of the
aforesaid patents and patent applications, and all foreign counterparts of any,
or to any, of the aforesaid patents and patent applications, or any future
patents or patent applications covering the Product(s) or any components
thereof or improvements thereof.


 


“Laws”
shall mean any law, statute, rule, regulation, guideline (including cGMP),
ordinance or other pronouncements of any Governmental or Regulatory Authority
having the effect of law in Canada, any applicable foreign country or
territory, or any domestic or foreign state, province, county, city or other
political subdivision, including any applicable Environmental Laws. The laws of Canada shall always be deemed the
applicable law even if the PFIZER Affiliate executing an Addendum is not a
Canadian company and/or there is no expectation that Product(s) will be sold in
Canada except where to do so would contradict laws of the jurisdiction in which
Product(s) will be sold.


 


“Losses”
shall mean any and all damages, fines, fees, settlements, payments,
obligations, penalties, deficiencies, losses, costs and expenses (including
Environmental Losses, interest, court costs, reasonable fees of attorneys,
accountants and other experts and other reasonable expenses of litigation or
other proceedings or of any claim, default or assessment).


 


7

















 


“Packaging
Materials” shall mean the packaging components used to package the Product(s)
including the Product(s) labeling.


 


“Person”
shall mean any natural person, entity, corporation, general or, limited
partnership, proprietorship, other business organization, trust, union,
association or Governmental Authority.


 


“PFIZER
Equipment” shall mean the equipment, dedicated change parts, tooling, molds and
operating supplies or other proprietary materials owned by PFIZER and provided
by PFIZER to COMPANY for the manufacturing, processing, packaging, labeling,
testing, handling or storing of the Products as set out in Schedule “C” as
may be updated from time to time.


 


“PFIZER
Indemnified Party” shall have the meaning set forth in Section 9.1.


 


“Price”
shall mean the price to be charged by COMPANY for Product(s) manufactured and
supplied hereunder as delivered to PFIZER attached as Attachment “A”, which
price shall include all of the costs associated with the manufacture,
packaging, handling or storing of the Products including, but not limiting the
generality of the foregoing, all of the following costs:  (i) materials; (ii) manufacturing; (iii) labour;
(iv) ***; (v) ***; (vi) ***; (vii) ***; (viii) ***; (ix) ***;
(x) ***; (xi) ***; (xii) ***; (xiii) ***; and (xiv) Taxes (excluding GST on the
Finished Product(s)) and which Price is fully described in Section 4.1 and
more specifically in Attachment “A” or the Addendum for such Product(s).


 


“Product
Materials” shall mean Raw Materials and Packaging Materials .


 


“Product(s)”
shall mean the finished product(s) as more fully described in the
Specifications contained in Attachment “A” or the Addendum for such product(s)
as the same may be varied by the mutual written agreement of the parties from
time to time.


 


 “Purchase Order” shall mean a written or
electronic form submitted by PFIZER in accordance with the terms of this
Agreement to COMPANY authorizing the manufacture of Product(s).


 


 “Quality Agreement” shall mean those
supplemental quality provisions set forth in the Quality Agreement among
COMPANY and PFIZER relating to the Product(s) attached hereto as Attachment B,
as the same may be amended or modified from time to time.


 


“Quantitative
Defects” shall mean defects in a shipment of Product(s) resulting from PFIZER’s
receipt of less than the invoiced amount of Product(s) for such shipment.


 


“Raw
Materials” shall mean active pharmaceutical ingredient(s) (API(s)) and other
ingredients and excipients used in the manufacture of the Products.


 


8

















 


“Recall”
shall mean a “recall”, “correction” or “market withdrawal” and shall include
any post-sale warning or mailing of information.


 


“Regulatory
Approvals” shall mean any registrations, licenses, authorizations, permits or
approvals (as well as applications with respect to any of the foregoing) issued
by any Governmental Authority in each case required in connection with the
packaging, manufacture, use, distribution, transportation (including export or import)
or sale of the Product(s).


 


“Significant
Material Cost Change(s)” shall mean a change of plus or minus *** or more in
the aggregate cost of all Product Materials..


 


 “Specifications” shall mean the PFIZER
provided specifications for the manufacture, processing, packaging, labeling,
testing and testing procedures, shipping, storage and supply of the Product(s),
including all formulae, know-how, Raw Materials requirements, analytical
procedures and standards of quality control, quality assurance and sanitation,
as referenced currently existing manufacturing and packaging instructions and
guidelines as well as any generally and properly understood practices required
by PFIZER (as disclosed in writing by PFIZER from time to time to COMPANY,) or
as specifically set out in the Addendum for such Product(s), and as such
Specifications may be amended, supplemented or otherwise modified by the
parties in accordance with Section 5.2 hereof. Where possible, parties
shall refer to code or identifiable item number to address Specifications.


 


“Start-Up
Activities” shall have the meaning set forth in Section 2.1(a).


 


“Subcontractors”
shall mean those facilities required to conduct services directly linked to the
manufacture, packaging, supply and testing of the Product(s). COMPANY engaged
Subcontractors shall be approved by PFIZER in advance and shall be licensed,
audited, fully insured and compliant with regulations as specified in a written
contract between COMPANY and Subcontractor.


 


“Term”
shall have the meaning set forth in Section 13.2.


 


“Territory”
shall mean Canada and those countries set forth in each Addendum, in accordance
with Schedule “B”, including those countries identified in Schedule “B-1”.


 


“Waste”
shall mean all wastes which arise from COMPANY’s manufacture, handling or
storage of Product(s) hereunder, or which is otherwise produced by COMPANY,
Affiliate of COMPANY or Subcontractor of COMPANY through the implementation of
this Agreement, including Hazardous Materials and Hazardous Waste.


 


“$”
shall mean Canadian dollars unless expressly stated otherwise.


 


The
definitions in this Section 1 shall apply equally to both the singular and
plural forms of the terms defined. As used in this Agreement, (i) the
words “include”, “includes” and “including” shall be deemed to be followed by
the phrase “without 


 


9

















 


limitation”; (ii) the words “hereof”, “herein”, “hereby” and
derivatives or similar words refer to this entire Agreement; (iii) all
references to Attachments shall be deemed references to Sections of this
Agreement and Attachments to this Agreement unless the context shall otherwise
require; and (iv) whenever this Agreement refers to a number of days, such
number shall refer to calendar days unless otherwise specified.


 


SECTION 2.

START-UP ACTIVITIES


 


2.1.          Start-Up
Activities


 


(a)           COMPANY
hereby agrees that (i) by the applicable manufacturing commencement date
set forth in an Addendum, it shall have complied with and completed to the full
satisfaction of PFIZER all scale-up commercialization and manufacturing
start-up activities with respect to new Product(s), including manufacturing
trials, stability testing, validation protocols, validation, writing of
validation reports and Raw Material and finished Products testing, in
accordance with the applicable Addendum, (ii) it shall be responsible for
managing the execution of the manufacturing trials and obtaining Raw Materials,
Packaging Materials and inventory for such trials and providing technical,
quality and operational resources, and (iii) it shall perform all
other activities, preparations, supervision and/or training as is or becomes
necessary to enable COMPANY to commence the manufacturing, packaging, labeling
and shipment of Product(s) to PFIZER hereunder all in accordance with the
provisions set out in an Addendum in accordance with Schedule “B” attached
hereto. The activities described in clauses (i), (ii) and (iii) of
this Section 2.1(a) are collectively referred to herein as the “Start-Up
Activities”. Unless otherwise provided in an Addendum, COMPANY shall pay for
the costs associated with such Start-Up Activities. If under an Addendum,
PFIZER is to pay for all or some portion of the cost associated with Start-Up
Activities, then PFIZER’s obligation with respect to the cost of such Start-Up
Activities shall be no more than the estimated start-up costs identified on the
applicable Addendum (“Estimated Start-Up Costs”).


 


(b)           COMPANY
shall permit a reasonable number of PFIZER employees to observe and review the
Start-Up Activities at the Facility during normal business hours and on
reasonable prior written notice. COMPANY shall permit a reasonable number of
PFIZER employees to provide technical assistance and direction at the Facility
in connection with the Start-Up Activities provided, however, that such
assistance and direction shall not reduce or alter COMPANY’s obligations
hereunder. The validation reports produced hereunder shall be deemed
Confidential Information of PFIZER hereunder and shall not be disclosed by
either party (or by any subcontractor of either party) to any third party,
except as permitted under Section 12.


 


(c)           COMPANY
agrees to provide all final documentation related to Start-Up Activities to
PFIZER for prior approval.


 


10

















 


2.2           Purchase
and Installation of Equipment, Dedicated Change Parts and Tooling


 


COMPANY
shall be responsible for (i) purchasing, installing and validating at its
Facility all equipment, dedicated change parts and tooling (ii) modifications
to existing equipment, dedicated change parts and/or tooling which are
necessary for the manufacture, packaging, labeling and shipment of Product(s)
hereunder and (iii) maintenance of all such equipment, dedicated change
parts and tooling, and all costs and expenses associated therewith in
accordance with the assets set out on Schedule “C”. The installation and
maintenance of the foregoing equipment, dedicated change parts and tooling by
COMPANY shall be done in accordance with all Laws. If pursuant to an Addendum,
PFIZER has agreed to pay for or reimburse any cost associated with equipment,
dedicated changes parts or tooling, then at the request of PFIZER, COMPANY
shall return to PFIZER all equipment, molds, dedicated change parts, tooling and
operating supplies (which shall be considered to be PFIZER Equipment) relating
to any Product(s) that were provided or paid for by PFIZER. If COMPANY must
purchase equipment and PFIZER has agreed to pay for such equipment as an
amortized portion of the Price and an Addendum is terminated prior to COMPANY’s
recovery of agreed upon equipment costs, PFIZER shall meet with COMPANY to
discuss a reimbursement schedule of the equipment cost.


 


SECTION 3
 SUPPLY REQUIREMENTS; ORDERS; SHIPMENT
AND DELIVERY TERMS; 

REPORTS; ALTERNATIVE SUPPLY.


 


3.1.          Agreement
to Supply.


 


The terms of this
Agreement shall be incorporated by reference into each Addendum that may be
signed by the parties to govern the supply and manufacture to PFIZER (and/or
its Affiliates or designees), of such quantities of Product(s) for the
Territory (or part thereof) as shall be more fully specified in each
Addendum. In the event of a conflict between the terms of any Addendum, and the
terms of this Agreement, the terms of the executed Addendum shall prevail. The
execution by the parties of this Agreement does not obligate them to enter into
any Addendum. Each Addendum, when executed, constitutes a separate and distinct
agreement from this Agreement and from any other Addendum executed by the parties.
An Affiliate of PFIZER may execute an Addendum with the COMPANY as a
separate agreement and, in such circumstances, all references in this Agreement
to PFIZER shall be deemed to be to the relevant Affiliate of PFIZER which shall
be entitled to enforce the agreement constituted by the Addendum in its own
name and shall be solely liable to COMPANY for any obligations and liabilities
undertaken hereunder.


 


3.2.          Use
of Facility, Equipment, Molds and Tooling.


 


All manufacturing,
packaging and storage activities shall be carried out by COMPANY, at its
Facility utilizing equipment, molds and tooling in the manner set forth in the
Specifications.


 


11

















 


3.3.          Current
Production Guidelines; Capacity.


 


Subject to the terms
hereof, COMPANY shall devote adequate manufacturing capacity to be capable of
producing, and supplying PFIZER (and/or its Affiliates or designees), the
quantity of Product(s) in accordance with the forecasts plus twenty-five
percent (25%) of such forecast set out in the following provisions of this
Agreement. In addition, for new Products, it is understood and agreed by
COMPANY that it is a material term of this Agreement that COMPANY complete all
necessary packaging, manufacturing and supply arrangements on a schedule which
will enable PFIZER to commence shipping the amount of new Product(s) set forth
in the forecast to its retail customers for the commercial roll out of the new
Product(s) on or before the date set forth in an Addendum for such commercial
launch (“Commercial Launch Date”).


 


COMPANY agrees to adjust
capacity as commercially reasonably necessary in the event PFIZER’s forecasts
increase significantly, and the parties agree to work together to continuously
monitor future requirements and the production capabilities of COMPANY to
assure one hundred percent (100%) timely manufacture and delivery of Product(s)
to PFIZER, on the specified date as set out on the purchase order, is achieved.


 


3.4           Forecasts.


 


***


 


3.5           Firm
Orders; Changes to Firm Orders.


 


a)             ***


 


(b)           ***


 


3.6           Reports.


 


(a)           Monthly
Usage Reports: COMPANY shall provide a written report from COMPANY’s SAP
inventory system on a monthly basis to PFIZER detailing actual consumption of
PFIZER supplied Raw Materials and Packaging Materials and a detailed quarterly
reconciliation.


 


(b)           Shipment:  On the date of each shipment of Product(s),
COMPANY shall submit to PFIZER, via email a report to Supply Chain and the
Distribution Centre detailing such information as required in an Addendum in
accordance with Schedule “B” for all Product(s) and more specifically for
Polymyxin.


 


3.7           Shipping
Instructions/Risk of Loss and Shelf Life.


 


(a)         COMPANY
shall ship Product(s) ordered by PFIZER pursuant to Section 3.5, and any
Product(s) samples requested by PFIZER pursuant to Section 3.11 hereof, in
each case, in accordance with this Section 3.7. COMPANY shall include
certificates of compliance and/or certificates of analysis with all shipments
of Product(s). The Price 


 


12

















 


reflects shipping terms of FOB the Facility (COMPANY’s
loading dock) to PFIZER’s designated carrier.


 


(b)           Upon loading Product(s)
COMPANY shall ensure that PFIZER’s designated carrier confirms the count and
signs off on the amount of Product(s) being loaded onto the carrier.


 


(c)           Risk of loss and damage
to the Product(s) shall pass to PFIZER when the Product(s) is delivered to a
PFIZER facility or a PFIZER designated carrier FOB. COMPANY shall coordinate
with PFIZER for the shipment of the Product(s) with a carrier from COMPANY’s
Facility to PFIZER’s designated facilities in accordance with shipment
instructions provided by PFIZER in the Addendum. COMPANY will schedule freight
pick up, load the carrier’s trailer and complete documentation all in
accordance with PFIZER’s requirements. See Schedule “D” for approved
carriers.


 


(d)           Unless otherwise
specified in writing, COMPANY agrees to deliver Products to PFIZER within ***
of date of manufacture. PFIZER reserves the right not to accept any Product with
less than a remaining shelf life of *** for Products with a minimum of ***
shelf life and *** for Products with a minimum of *** shelf life.


 


(e)           Notwithstanding the generality of the
foregoing, the above requirement for delivery within *** of the date of
manufacture shall not apply (i) to those Products for which the COMPANY
only provides packaging services to PFIZER (ie at the date of this Agreement
the bulk *** which is used for the ***); (ii) for those Products which are
the object of Validation/Stability batches; or (iii) those Products which
are subject to an investigation report which ultimately confirms the viability
of the Product.


 


3.8           Standard
Forms.


 


In ordering and
delivering the Product(s), PFIZER and COMPANY may employ their standard
forms, but nothing in those forms shall be construed to modify, amend or
supplement the terms of this Agreement and any Addendum and, in the case of any
conflict herewith, this Agreement and any Addendum shall prevail.


 


3.9           Procurement
and Approval of Product Materials.


 


Subject to Section 3.5,
COMPANY shall order sufficient quantities of all Product Materials to enable
COMPANY to manufacture, and to deliver, the Product(s) in accordance with
PFIZER’s delivery requirements, as communicated pursuant to Section 3.5
All Product Materials used in the manufacture of the Product(s) and the
supplier(s) thereof must be approved in advance in writing by PFIZER which
shall not be unreasonably withheld or delayed. COMPANY may not substitute
or otherwise replace any ingredient, Raw Material, Packaging Material and/or
any supplier thereof without the prior written consent of PFIZER. COMPANY
agrees to provide PFIZER, on a timely basis, all information that PFIZER may reasonably
request in order to comply with internal PFIZER procedures regarding approval
of a change in Product Material and/or 


 


13

















 


any supplier thereof. In
the event PFIZER designates certain suppliers, COMPANY shall obtain materials
from such suppliers. The costs of (a) such Product Materials and (b) the
management and procurement of such Product Materials shall be included in the
Price in accordance with the terms of Section 4.1 hereof. PFIZER may choose
to, at its own expense, or for a cost, supply COMPANY with sufficient
quantities of Product Materials as described in Schedule “E” attached
hereto as may be amended from time to time, needed for the manufacture of
the Product(s) specified in the forecasts and Purchase Orders in order to meet
PFIZER’s requirements for commercial and/or developmental quantities of
Product(s) in finished dosage form. At PFIZER’s election, the Raw Materials may be
delivered directly from PFIZER’s vendor to COMPANY at the vendor’s or PFIZER’s
expense. PFIZER or its vendor shall supply COMPANY with a copy of the
Certificate of Analysis for the Raw Materials no later than the date of
delivery of the Raw Materials to COMPANY. At PFIZER’s option, PFIZER may elect
to supply COMPANY with any, Raw Materials and/or Packaging Materials for the
Product(s). In the event PFIZER elects to do so, PFIZER shall notify COMPANY
and COMPANY shall decrease the Price to reflect the reduction in the cost of
the Product(s) associated with such Raw Materials and/or Packaging Materials. In
addition, such PFIZER supplied Raw Materials and/or Packaging Materials shall
be the sole property of PFIZER and shall be appropriately handled and stored by
COMPANY at no additional cost. PFIZER supplied Raw Materials and/or Packaging
Materials shall be held in accordance with PFIZER Specifications as set out in
the Quality Agreement. Where PFIZER charges COMPANY for the provision of Raw
Materials and/or Packaging Materials, the cost of such Product Materials shall
be included in the Price of the Products in accordance with the terms of Section 4
hereof.


 


3.10         No
Third Party Conflicts.


 


COMPANY hereby agrees
that it shall use commercially reasonable efforts to meet the requirements set
forth by PFIZER in its forecasts for the supply of Product(s) hereunder. COMPANY
further agrees that it shall not manufacture, package or process Product(s) for
itself or for a third party where to do so will, as a consequence, either
knowingly delay delivery of PFIZER’s requirements of Product(s) (including any
increases in PFIZER’s delivery requirements thereof pursuant to the terms of Section 3.5)
or violate COMPANY’S obligations pursuant to Section 15 hereof.


 


3.11         Product
Samples.


 


COMPANY shall provide
PFIZER (or any such other Person as PFIZER shall designate in writing) with
representative lot samples of each production batch of Product(s) promptly upon
request. PFIZER shall be entitled to review, upon reasonable prior written
notice, all manufacturing records relating to such samples including all
analytical procedures and cleaning validation relating to the equipment used in
connection with the manufacture of the samples. Such Product(s) samples shall
be shipped to PFIZER (or such other Person as PFIZER shall designate in
writing) in accordance with the provisions set forth in Section 3.6 hereof,
or as otherwise instructed 


 


14

















 


by PFIZER. PFIZER shall
pay for such samples at the Price, when invoiced, in accordance with Section 4.4
hereof.


 


3.12         Alternative
Supply.


 


COMPANY
shall supply PFIZER Product(s) in the Territory in accordance with the terms of
this Agreement and any Addendum. Nothing in this Agreement or any Addendum
shall prevent PFIZER or any of its Affiliates from manufacturing Product(s), or
having Product(s) manufactured, in amounts in addition to the orders for
Product(s) placed with COMPANY in accordance with this Agreement.


 


a)             In the
event that at any time during the Initial or Extended Term (i) COMPANY is, or
anticipates it shall be, unable or unwilling at any time to fill the total
monthly volume of any Product(s) set forth in PFIZER’s forecasts, as a result
of an event of Force Majeure, or for any other reason, or (ii) any
Product(s) does not meet or comply with the Specifications as a result of
COMPANY’s negligence or willful misconduct for a period of at least one (1) month
and COMPANY is not able to remedy such noncompliance within an additional one (1) month
period, PFIZER may, in addition to any other rights or remedies hereunder and
at its option, either purchase from a third party or manufacture and/or package
for itself quantities of such Product(s) sufficient to replace any quantities
of Product(s) which COMPANY is unable or unwilling to supply. COMPANY shall
provide commercially reasonable assistance to PFIZER in arranging for such
alternative suppliers and PFIZER agrees to consider alternative suppliers
proposed by COMPANY. COMPANY shall cooperate with, and supply know-how and
reasonable technical assistance, including technical personnel, at COMPANY’s
reasonable expense, to PFIZER and the alternative supplier and shall assist in
the transfer of know-how to such supplier or PFIZER, and PFIZER shall have
complete access to the know-how. COMPANY shall provide to PFIZER or its
designee (at PFIZER’s option), at COMPANY’s cost, all Packaging Materials, Raw
Materials, and PFIZER Equipment, provided or purchased by PFIZER and in the
possession of COMPANY. PFIZER shall require any such alternative supplier with
access to the know-how to enter into a confidentiality agreement with respect
to such know-how.


 


b)            In
the event that PFIZER shall incur any Losses (including any increase in price
required to be paid by PFIZER to an alternative supplier over the then
applicable price for the relevant Product(s) hereunder) as a result of any failure
of COMPANY to supply Product(s) hereunder in accordance with the terms of this
Agreement and any Addendum, in addition to any other remedies available to
PFIZER, such Losses may be offset by PFIZER against future payments to
COMPANY hereunder except in the case where PFIZER is directly responsible for
such delay or failure to supply Product Material.


 


15

















 


SECTION 4.
 PRICE; PAYMENT; PRICE ADJUSTMENTS; TAXES


 


4.1           Purchase
Price.


 


***


 


4.2           Changes
in Price


 


***


 


(i)            ***


 


(ii)           ***


 


4.3           Cost
Improvements.


 


***


 


4.4           Price
Adjustment Due to Significant Material Cost Change.


 


***


 


4.5           Invoices.


 


***


 


4.6           Taxes.


 


***


 


4.7           Provision
of Similar Products.


 


***


 


SECTION 5.

MANUFACTURING STANDARDS AND QUALITY ASSURANCE.


 


5.1           Manufacturing
Standards.


 


a)             COMPANY
shall manufacture, and supply, the Product(s) (including disposing of all Waste
and other materials) strictly in accordance with the Specifications, applicable
Laws, the Quality Agreement and such quality assurance, trademark usage and
other requirements as may be instructed by PFIZER.


 


b)            COMPANY
agrees to work with PFIZER to attain and agree upon performance metrics in the
area of quality and service for all Facilities. (i) Delivery Metrics = ***
of the quantity orders on the specified dates set out on the Purchase Order. (ii) Quality
Performance = number of recalls; number of rejected batches; number of
deviations (need to determine if failure is due to a COMPANY issue or a PFIZER
issue).


 


16

















 


5.2           Modifications
in Specifications.


 


(a)           COMPANY
will not make any changes to its process, Raw Materials, supply sources,
manufacturing locations or Facilities (where to do so would impact the
Product(s)) for PFIZER without prior written consent of PFIZER which shall not
be unreasonably withheld or delayed. This includes any changes made that may need
notification to regulatory authorities by PFIZER. Any proposed changes that
could fall into the categories above, will be discussed with PFIZER.


 


(b)           In
the event that the Specifications are proposed to be modified, the party
seeking to make such modification shall provide written notice to the other
party to this Agreement or any Addendum as far in advance as is practicable prior
to the proposed effectiveness of such modification, and the parties shall
jointly agree on whether and when to implement such modification. To the extent
that such modification results in an increase or decrease in the cost of
manufacturing and/or packaging the Product(s), the parties shall jointly
examine and mutually agree upon the consequences thereof and shall make
appropriate adjustments to the Price therefore. Each party shall promptly
notify the other of the date of implementation of any such modification and
such other party shall use reasonable efforts to promptly acknowledge receipt
of such notice and promptly provide a response.


 


5.3           Pest
Control.


 


Product(s) will be
manufactured in facilities with insect and rodent pest controls adequate to assure
no contamination of Product(s). COMPANY’s pest control program will be detailed
in a written procedure. Specifically, the pest control procedures will
include:  Appropriate installation and
use of insectocutors and rodent traps applied in zones of defense against
invasion for the Facility. At least monthly thorough cleaning of the facility,
prohibition of food and drink in production areas, protection of Product(s)
from the environment, storage of Product Materials and finished products no
closer than twelve (12) inches from any outside walls, monitoring of flying and
crawling pests, and logs detailing findings and actions taken. The logs will be
made available to PFIZER upon request. All windows in the production buildings,
including office windows, must have screens or be permanently bolted closed.


 


Each of these items will be included in written
operating procedures, which have been signed by the senior manager of the
facilities involved. Any contamination of Product(s) from flying and crawling
insects, rodents or other pests is unacceptable for pharmaceutical, animal
health or consumer healthcare products. Failure to comply with these
requirements will be considered a material breach of the Agreement.


 


5.4           Storage
and Handling.


 


COMPANY shall store all
Product Materials and finished product(s) in a clean, dry area, free from
insects and rodents, in a manner to prevent entry of foreign materials. 


 


17

















 


Storage and handling of
all Product Materials and finished product(s) shall be strictly in accordance
with the provisions of all applicable Laws, the Quality Agreement, the
Specifications and any written instructions issued by PFIZER. Raw Materials
utilized in connection with the manufacture of the Product(s) shall be used by
COMPANY on a first in, first out basis and shall not be used by COMPANY beyond
the expiration date or the retest date, whichever date is the earlier to occur,
as required under applicable Laws, the terms of the Quality Agreement or as designated
or approved by PFIZER. COMPANY agrees to provide storage up to one month after
PFIZER release of the Product(s). COMPANY shall notify PFIZER of its need to
use a third party warehouse for any Product(s) or materials, and any such
storage at such third party warehouse shall be subject to prior written
approval by PFIZER, and shall be at the cost of the party requesting to use
such third party warehouse. PFIZER shall have the right to audit any such third
party warehouse upon reasonable prior written notice and during normal business
hours. Where PFIZER requests COMPANY to store Product(s) for more than one (1) month
after a Product is released to PFIZER, from COMPANY, COMPANY may charge
PFIZER a reasonable amount per month for additional storage services.


 


5.5           Maintenance
of Facility, Equipment and Molds.


 


At COMPANY’s cost and
expense, COMPANY shall maintain all equipment, tooling and molds utilized in
the manufacture, packaging and supply of Product(s) hereunder in good operating
condition and shall maintain its Facility and such equipment, tooling and molds
in accordance with, or in a manner that shall meet the requirements of (i) all
applicable Laws and (ii) all requirements set forth in the Specifications
and the Quality Agreement. In the event that COMPANY fails to, or anticipates
it will fail to, meet any of the foregoing requirements relating to the
maintenance of its Facility or any equipment, tooling or molds utilized in
connection herewith, or in the event that COMPANY receives any notice from any
Governmental Authority relating to its maintenance of, or failure to maintain,
its Facility or any equipment, tooling or molds utilized in connection
herewith, for PFIZER Product(s), COMPANY, as the case may be, shall
promptly contact PFIZER (or such other department or person as PFIZER may direct),
provide copies of such notice to PFIZER and, if such notice relates
specifically to the Product(s), the parties will work together in good faith to
address the problem.


 


5.6           Legal
and Regulatory Filings and Requests.


 


COMPANY and PFIZER shall
cooperate and be diligent in responding to all requests for information from,
and in making all legally required filings with, Governmental Authorities
having jurisdiction to make such requests or require such filings. COMPANY
shall (a) obtain and comply with all licenses, consents and permits, and (b) comply
with all applicable Laws, which may from time to time be required by
Governmental Authorities with respect to its manufacturing and packaging
processes, the Facility or otherwise to permit the performance of its
obligations hereunder.


 


18

















 


5.7.          Analysis
of Materials.


 


Prior to use in
production, COMPANY shall have shipments of Raw Materials analyzed for such
matters as PFIZER may require in accordance with the Specifications,
Quality Agreement, applicable Addenda and standard operating procedures, and
COMPANY shall ensure that all materials conform to the Specifications. COMPANY
may conduct such analyses internally or by an outside laboratory retained
by COMPANY and approved by PFIZER. For purposes of this Agreement, such tests
shall be considered routine and shall be included in the Price of the
Product(s). All test results are to be documented in accordance with cGMP and
available for inspection at PFIZER’s request.


 


5.8.          Quality
Tests and Checks.


 


COMPANY
shall perform all bulk holding stability; manufacturing trials; validation
(including, but not limited to, method, process and equipment cleaning
validation); Raw Material testing; in-process and bulk finished product tests
or checks required to assure the quality of the Product(s); and any tests or
checks required by the Specifications, the Quality Agreement, applicable
Addendums or applicable Laws or as reasonably requested by PFIZER. For purposes
of this Agreement, such tests and/or checks shall be performed by COMPANY ***. All
tests and test results shall be performed, documented *** by COMPANY in
accordance with the Specifications, the Quality Agreement, PFIZER’s instructions
and applicable Laws within *** of the date of manufacture of the Product(s). If
COMPANY is unable to conduct finished Product(s) release testing in accordance
with agreed upon protocols and in a timely manner, COMPANY shall promptly have
the finished Product(s) release testing conducted by a third party determined
by COMPANY and agreed to by PFIZER *** for the time COMPANY is unable to perform the
Product(s) release testing. All validation protocols and reports are subject to
the prior approval of PFIZER. All technical documentation not presented in
English shall be translated into English within one Business Day ***. COMPANY
shall review all production records and disposition of each batch of Product(s).
If during testing or batch record review, the Product(s) is found not to be in
accordance with the Specifications or applicable Law, COMPANY shall investigate
the production of the Product(s) in a manner specified in writing by PFIZER. COMPANY
will audit each supplier providing Raw Materials in the manufacture of the
Product(s) according to procedures and requirements to be mutually agreed upon
by the parties. PFIZER and COMPANY have entered or shall enter into a Quality
Agreement, which further details of the quality assurance obligations and responsibilities
of the parties with respect to the Product(s).


 


5.9.          Non-conforming
Product Materials.


 


If COMPANY uses any
non-conforming Product Materials, or if the Product(s) are not produced in
accordance with Specifications, COMPANY shall be responsible for all losses
suffered or incurred by PFIZER as a result of such use or non-conformance,
including any expenses incurred by COMPANY or PFIZER arising out of any Recall
of any affected Product(s) or other reasonably necessary corrective measures
taken with 


 


19

















 


respect thereto. COMPANY
shall be responsible for pursuing all resolutions with the applicable supplier
of non-complying Raw Materials and shall keep PFIZER advised of such
resolution.


 


5.10.        Non-complying
Product(s).


 


COMPANY shall release no
Product(s) for shipment unless such Product(s) strictly comply with the
Specifications; any quality assurance requirements which have been notified in
writing by PFIZER, to the COMPANY; the Quality Agreement; and any other
applicable provisions of any Addendum and all applicable Laws.


 


5.11.        Responsibility
for Rejected and Non-Complying Product(s).


 


Product(s) which are
rejected or non-compliant pursuant to Section 5.10 or 5.14(b) hereof
shall be quarantined and shall be properly tagged and isolated and shall not be
released without the prior written approval of PFIZER. COMPANY will promptly
submit to PFIZER a joint report on the non-complying and/or rejected
Product(s), including the investigation and testing done and the recommended
disposition. PFIZER shall review such report and notify COMPANY that PFIZER
requests additional data approves the recommended disposition of the Product(s)
or will otherwise direct COMPANY as to how the non-complying and rejected Product(s)
should be disposed.


 


5.12.        Disposal
of Rejected and Non-Complying Product(s) and Product Materials.


 


All Product(s) rejected
pursuant to Section 5.14(b) or for non-compliance pursuant to Section 5.10
and all non-conforming Product Materials not able to be used in the manufacture
of the Product(s) pursuant to Section 5.9 shall be removed (if applicable)
and disposed of by COMPANY, as the case may be, in a manner consistent
with applicable Laws and as approved in advance by PFIZER (such disposal cost to
be at the expense of the party deemed to be responsible therefore pursuant to
the terms of Section 5.9, 5.10, 5.11 or 5.14(b), as the case may be)
and all documentation relating to such disposition shall be made available to
PFIZER upon request. PFIZER, at its discretion, may be present to witness
the destruction of rejected or non-complying materials, Product(s) or
Product(s) in process. All printed materials must be defaced or destroyed on
site. No rejected or non-complying Product Materials, Product(s) or Product(s)
in process shall be sold as salvage or for any other purpose by COMPANY or
designees or agents of COMPANY without the prior written approval of PFIZER. Unless
PFIZER otherwise directs, COMPANY shall replace such rejected Product(s) or
Product Materials.


 


5.13.        Maintenance
and Retention of Records.


 


(a)           COMPANY
shall maintain detailed records with respect to Product Materials usage and
finished Product(s) production, which records shall include production code
dates, and COMPANY shall maintain detailed records with respect to shipping
information relating to the Product(s), so that Product(s) can be easily traced
in case of a Recall or rejection of Product(s) or materials. Such records shall
be maintained 


 


20

















 


for at least one (1) year
beyond the expiration date of the finished product lot, or as otherwise
required by applicable law and in accordance with Section II of the
Quality Agreement and any other reasonable instructions issued by PFIZER with
respect thereto. Such records shall be sufficient such that COMPANY shall under
normal circumstances be capable of responding to inquiries by PFIZER within one
(1) Business Day of notification and shall be able to provide the
production code date and the location of the Product(s) in question.


 


(b)           COMPANY
shall provide to PFIZER an Annual Product Review, as defined herein and in
accordance with the Quality Agreement, including production records, control
charts, trend analysis, consumer complaints, deviations and reworks, and any
other information PFIZER may reasonably request for purposes of preparing
an annual report as required by cGMP with respect to the Product(s).


 


(c)           COMPANY
shall provide to PFIZER on a monthly basis, or such other frequency as the
parties may mutually agree, production data, including delivery dates,
quantities delivered, control charts, trend analysis, consumer complaints,
deviations and reworks, and any other information PFIZER may reasonably
request for purposes of preparing performance metrics.


 


5.14.        Quantitative
Defects; Rejection of Product(s); Replacement of Rejected Shipments.


 


(a)           PFIZER
shall notify COMPANY in writing of any claim relating to Quantitative Defects
in shipments of the Product(s) within ninety (90) days following actual receipt
of such shipments by PFIZER. COMPANY shall, at its own expense, provide PFIZER
with any missing quantities of such Product(s) promptly after receipt of notice
from PFIZER, and shall use commercially reasonable efforts to replace missing
quantities not later than thirty (30) days following receipt of notice unless
additional time is required due to extraneous circumstances requiring a longer
lead time for Raw Materials or Packaging Materials. PFIZER shall be obligated
to pay only for actual quantities of Product(s) delivered in the initial
shipment (irrespective of the invoiced amount) in accordance with Section 4
hereof and shall pay for any missing quantities subsequently delivered by
COMPANY to PFIZER within thirty (30) days of the date such invoice relating to
the delivery of such quantities is received by PFIZER.


 


(b)         Within
ninety (90) days following receipt by PFIZER of any shipment of Product(s)
hereunder, PFIZER shall have the right to give COMPANY notice of rejection of
any part of such shipment of Product(s) that fail to meet Specifications;
provided, however, that there shall be no time restrictions applicable to
PFIZER’s provision of notice of rejection of any shipments of Product(s) where
any of the following have occurred or are present:


 


(i)            latent
defects in the shipped Product(s);


 


(ii)           defects
discovered by PFIZER’s customers or the end-users of the Product(s);


 


21

















 


(iii)          breach
by COMPANY of any of its representations, warranties or obligations hereunder.


 


c)             PFIZER
may return any shipments of Product(s) (or portions thereof) rejected
pursuant to this subsection (b) to COMPANY at COMPANY’s expense, and
COMPANY shall replace such rejected Product(s) as soon as practicable at no
additional charge to PFIZER, and in no case later than thirty (30) days
following receipt of PFIZER’s notice of rejection with respect thereto unless
additional time is required due to extraneous circumstances requiring a longer
lead time for Raw Materials or Packaging Materials. In addition to any other
rights or remedies of PFIZER hereunder, PFIZER shall have the right to set off
any refund relating to any such rejection of shipped Product(s) against
invoices otherwise due or that become due to COMPANY. Except in the instances
set forth in clauses (i) and (ii) of this subsection (b),
failure on the part of PFIZER to give timely notice of rejection shall
mean acceptance by it of the shipment to which the notice of rejection would
have otherwise applied.


 


d)            The
provisions of this Section 5.14 shall survive termination or expiration of
this Agreement with respect to shipments of Product(s) manufactured by COMPANY
that are received or sold by PFIZER subsequent to the termination or expiration
of this Agreement; provided, that subsequent to the termination or expiration
of this Agreement, PFIZER, in lieu of having COMPANY replace such rejected
and/or missing quantities of Product(s), may elect in its sole discretion
to have COMPANY reimburse PFIZER for the costs (including any applicable
freight charges) associated with the replacement of such rejected and/or
missing quantities of Product(s) by PFIZER or a third party selected by PFIZER.


 


5.15.        Customer
Complaints and Inquiries.


 


a)             Safety
Related Complaints: COMPANY shall give PFIZER written notice within four (4) Business
Days of initial receipt of any information it receives regarding the safety of
the Product(s), including any confirmed or unconfirmed information on adverse
events possibly associated with the use of the Product(s). COMPANY shall notify
PFIZER of any complaint or investigation relating to the Product(s) promptly
upon receipt by COMPANY; provided, that, all complaints concerning suspected or
actual Product(s) tampering, contamination or mix-up (e.g., wrong ingredients)
shall be delivered to PFIZER within one (1) Business Day of receipt. COMPANY
shall provide all assistance requested by PFIZER in investigating customer
complaints regarding the Product(s) (including testing of the Product(s) in accordance
with PFIZER’s specifications at COMPANY’s expense) that, in PFIZER’s reasonable
opinion, are related to or arise from the manufacturing of such Product(s). PFIZER
shall be responsible for responding to all customers’ complaints relating to
the Product(s) and the record keeping relating thereto. COMPANY and PFIZER
shall also comply with the requirements set forth in the Quality Agreement
relating to the investigation of customer complaints.


 


22

















 


b)            Non-safety
related complaints: COMPANY shall provide all assistance requested by PFIZER in
investigating non-safety related complaints regarding the Product(s). Responses
to non-safety complaints shall be made within two (2) weeks of receipt of
the inquiry. PFIZER shall be responsible for responding to all customers’
non-safety related inquiries and the record keeping relating thereto.


 


c)             Safety
related inquiries: COMPANY shall provide all assistance reasonably requested by
PFIZER in investigating safety related customer inquiries regarding the
Product(s). Acknowledgement of safety related consumer inquiries from COMPANY
is required within 24 hours of notification by PFIZER. Investigation and
response to the safety related inquiry is required within one (1) week of
receipt of the inquiry from COMPANY unless other timing has been mutually
agreed to by PFIZER and COMPANY. Unless otherwise indicated on any Addendum,
PFIZER shall be responsible for responding to all customers’ safety related
inquiries and the record keeping relating thereto.


 


d)            Non-safety
related inquiries: COMPANY shall provide all assistance requested by PFIZER in
investigating non-safety related customer inquiries regarding the Product(s). Responses
to non-safety consumer inquiries shall be made within two (2) weeks of
receipt of the inquiry. PFIZER shall be responsible for responding to all
customers’ non-safety related inquiries and the record keeping relating
thereto.


 


5.16.        Government
Inspections, Seizures and Recalls.


 


a)             If
Health Canada or any other Governmental Authority conducts an inspection at
COMPANY’s Facility, seizes any Product(s) and/or Product Materials, requests a
Recall of any Product(s), or otherwise notifies COMPANY of any violation or
potential violation of any applicable Law, PFIZER shall be notified
immediately, and COMPANY shall take such actions as may be required under
the Specifications or instructed by PFIZER. As applicable, COMPANY shall
promptly send any reports relating to such inspections, Recalls or violations
or potential violations of Law to PFIZER. In the event that any such
Governmental Authority requests, but does not seize, the Product(s) in
connection with any such inspection, COMPANY, as the case may be (i) shall
promptly notify PFIZER of such request, (ii) if possible, shall satisfy
such request only after receiving PFIZER’s approval, (iii) shall follow
any reasonable procedures instructed by PFIZER in responding to such request
and (iv) shall promptly send any samples of the Product(s) requested by
the authority to PFIZER.


 


b)            Product(s)
Recall. In the event (i) any national government authority or other
regulatory agency issues a request, directive or order that the Product(s) be
recalled, or (ii) a court of competent jurisdiction orders such a recall,
or (iii) PFIZER reasonably determines after consultation with COMPANY that
the Product(s) should be recalled because the Product(s) do not conform to
the Specifications, or (iv) PFIZER reasonably determines that the
Product(s) should be recalled for any reason, the parties shall take all
appropriate corrective actions. In the event that such recall results from the
breach of COMPANY’s express warranty under Section 6 of this Agreement,
COMPANY shall 


 


23

















 


reimburse PFIZER for the Total Cost of the Product(s)
to include any and all materials supplied by PFIZER, and shall be responsible
for all the expense of recalling the Product(s) (i.e., shipping charges,
man-hours spent arranging and coordinating recall). PFIZER shall also include
in recall costs, all costs associated with the distribution of replacement
Product(s).


 


c)             Recall
Administration and Product(s) Returns. PFIZER will be responsible for all
returns and all aspects of any recall except as provided above. Procedures for
handling returns will be covered by communications from PFIZER to COMPANY. PFIZER
will reimburse COMPANY for any and all expenses incurred by COMPANY in
processing and/or disposing of any returns unless such returns are deemed to be
the responsibility of COMPANY in accordance with above.


 


5.17.        Quality
Agreement.


 


The
parties agree to be bound by the Quality Agreement attached hereto as
Attachment B. In the event there is a discrepancy between the terms of the
Quality Agreement and the other terms of this Agreement or any Addendum, the
terms of the Quality Agreement shall govern.


 


5.18.        Facility Inspections and Audits


 


COMPANY shall give access to PFIZER for purposes of
PFIZER auditing its Facilities. PFIZER will provide COMPANY a minimum of thirty
(30) days’ written notice of its intent to audit, however PFIZER shall be
provided immediate access to audit for causes that the parties mutually agree
require immediate attention. COMPANY shall permit a reasonable number of PFIZER’s
employees to observe, review and audit the operations at the Facility related
to the manufacture of the Product(s), including manufacturing and packaging,
quality control and quality assurance (including laboratory areas related
thereto), pack out and shipping, and environmental, health and safety, during
normal business hours. COMPANY agrees to correct any deficiencies identified by
PFIZER in such audits in a mutually agreed upon timeframe.


 


PFIZER
will use reasonable efforts to schedule such audit(s) with COMPANY so as not
to coincide with COMPANY’s own audit(s).


 


5.19.        Audit
of Financial Books and Inspections.


 


PFIZER
and in the case of clause (a), its outside accountants, shall be permitted,
during regular business hours and on reasonable prior written notice, to (a) audit
that portion of the financial books and records (in any media form) of COMPANY
pertaining to the manufacture and supply of the Product(s) under this Agreement
or any Addendum, and (b) physically inspect all Facilities. The outside
accountants shall agree in writing not to disclose any confidential information
they have access to during their audit and 


 


24

















 


shall only disclose to PFIZER such information as is necessary to
comply with this Section 5.19.


 


PFIZER
will use reasonable efforts to schedule such audit(s) with COMPANY so as
not to coincide with COMPANY’s own audit(s).


 


5.20.        Product
Diversion Issues.


 


COMPANY agrees to
immediately notify PFIZER if at any time it believes that any Product(s) has
been lost or stolen, or any Product(s) has been rendered unsaleable.


 


5.21         Waste Disposal.


 


COMPANY shall permit PFIZER’s employees and agents to
audit disposal sites for Waste and Hazardous Materials in accordance with the
audit rights granted by such disposal site, to COMPANY.


 


5.22         Machineability of Packaging Material.


 


Unless
otherwise indicated on an Addendum, PFIZER shall determine and be responsible
for the text (including any logos or other graphics) for the Packaging Material
used in connection with Product(s). COMPANY shall be responsible for ensuring
that all Packaging Materials are accurate and consistent with PFIZER’s
specifications for such text or graphics including, but not limited to, such
matters as placement, size and colors. If PFIZER or its designee provides the
actual Packaging Material for the Product(s), COMPANY shall inspect such
Packaging Material before use to ensure that it is accurate and promptly notify
PFIZER if there are any errors or deficiencies in such provided Packaging Materials.
If COMPANY provides the Packaging Material, then COMPANY shall be responsible
for ensuring that all such Packaging Material conforms to PFIZER’s
specifications therefore. COMPANY shall also be responsible for ensuring that
all Packaging Material runs efficiently on its machinery.


 


5.23         Segregation of Restricted Compounds.


 


COMPANY shall not use any equipment, dedicated change
parts, molds or tooling that are used to manufacture Product(s) to manufacture
products containing any of the following compounds: ***


 


5.24         Survival.


 


The obligations of
COMPANY under Sections 5.11, 5.12, 5.13, 5.14, 5.15, 5.16, 5.17, 5.18, 5.19,
5.20 and 5.21 of this Agreement shall survive the expiration or termination of
this Agreement and any Addendum until one (1) year after the expiration
date of the last batch of Product(s) manufactured hereunder.


 


25

















 


SECTION 6. 
 REPRESENTATIONS; WARRANTIES AND
COVENANTS.


 


6.1           Representations,
Warranties and Covenants of COMPANY.


 


COMPANY hereby
represents, warrants and covenants to PFIZER as follows:


 


(a)           The
Facility and all equipment, tooling and molds utilized in the manufacture and
supply of Product(s) hereunder by COMPANY are, as of the date hereof, and shall
continue during the Term of this Agreement and any Addendum to be maintained,
in good operating condition. The manufacturing and storage operations utilized
in the production of Product(s) hereunder (including the Facility); the
installation, operation and maintenance (and repair or replacement, if any) of
the Facility and the equipment, tooling and molds utilized in connection
herewith; and the procedures and processes (including the installation,
operation and performance qualifications and disposal of all Waste) carried out
by COMPANY hereunder, have been conducted and carried out, as of the date
hereof, and shall continue during the Term of this Agreement and any Addendum
to be conducted and carried out, in material compliance with all applicable
Laws, including cGMP and health and safety laws.


 


(b)           As of the
date hereof (i) COMPANY is, and during the Term of this Agreement and any
Addendum, COMPANY shall continue to be, in material compliance with all
applicable Laws, and (ii) COMPANY holds, and during the Term of this
Agreement and any Addendum shall continue to hold, all licenses, permits and
similar governmental authorizations necessary or required for COMPANY to
conduct its operations and business in the manner currently conducted and as
otherwise contemplated herein.


 


(c)           The Product(s)
furnished by COMPANY to PFIZER under this Agreement or any Addendum:


 


(i)            shall be
of the quality specified in, and shall conform with, the Specifications,
any other quality assurance requirements instructed by PFIZER, the Quality
Agreement, the Addendum and all applicable Laws, and shall be manufactured,
processed, stored and delivered in conformity with the Specifications, other
quality assurance requirements instructed by PFIZER, the Quality Agreement, the
Addendum and all applicable Laws, and shall not contain any material which
material has not been used, handled or stored in accordance with the
Specifications, any other agreed upon quality assurance requirements of PFIZER
or the supplier of such material, the Quality Agreement, the Addendum and all
applicable Laws;


 


(ii)           shall not
contain any material that would cause the Product(s) to be adulterated;


 


26

















 


(iii)          shall
be free from defects in materials and workmanship; and


 


(iv)           shall, at
the time delivered, have a remaining shelf-life consistent with PFIZER’s
requirements as such requirements may evolve over the Term of this
Agreement based upon stability testing and other scientific data and as per
specified in the Addendum.


 


(d)           The
Intellectual Property related to the Product(s), owned or controlled by COMPANY
and its Affiliates includes all rights and licenses necessary for COMPANY to
manufacture and supply the Product(s) in accordance with the Specifications as
of the date hereof and the manufacturing and use of the Intellectual Property
owned or controlled by COMPANY and its Affiliates will not infringe the
intellectual property rights of any third party.


 


(e)           COMPANY is
aware of no patents or any other prior art that invalidates or would invalidate
any of the patents included in the Intellectual Property related to the
Product(s), or prevent the issuance, in any country, of any of the patent
applications included in the Intellectual Property. To COMPANY’s knowledge,
each patent included in the Intellectual Property was validly issued under the
laws of the country that issued it.


 


(f)            As of the
date hereof, neither COMPANY nor its Affiliates have received a written claim
or threat of a claim that the Intellectual Property that is owned or controlled
by COMPANY or any Affiliate of COMPANY infringes any third party’s intellectual
property rights.


 


(g)           COMPANY
has the legal power, authority and right to supply, transfer and grant access
to its know-how pursuant to Section 3.12 hereof.


 


(h)           COMPANY:


 


(i)            is a
corporation duly organized, validly existing and in good standing under the
laws of Canada;


 


(ii)           has the
power and authority to conduct its business as currently being conducted and as
contemplated herein;


 


(iii)          has
the power and authority to make, deliver and perform its obligations under
this Agreement and any Addendum and has taken all necessary action to authorize
the execution, delivery and performance of this Agreement and any Addendum. No
consent of authorization of, filing with or other act by or in respect of, any
Governmental or Regulatory Authority or any other Person is or will be required
in respect of COMPANY in connection with the execution, delivery, performance,
validity or enforceability of this Agreement or any Addendum. These Agreements
have been duly executed and delivered on behalf of COMPANY and the respective
Addenda. This Agreement constitutes the legal, valid 


 


27

















 


and
binding obligations of COMPANY enforceable against COMPANY in accordance with
its terms; and


 


(iv)          the
execution, delivery and performance of this Agreement and any Addendum by
COMPANY will not violate any agreement or instrument to which COMPANY is a
party.


 


6.2           Representations,
Warranties and Covenants of PFIZER.


 


PFIZER hereby
represents, warrants, and covenants to COMPANY as follows:


 


(a)           it is not
subject to any legal, regulatory, contractual, or other restrictions which
might enable another person or entity to claim any rights in or to the
Product(s) or any Information;


 


(b)           it is not
aware of any adverse claim or threat of claim with respect to any of its
Intellectual Property that may be incorporated into the Product(s).


 


(c)           the use by
COMPANY or its Affiliates of the Intellectual Property, owned or controlled by
PFIZER in the performance of COMPANY obligations hereunder, will not infringe
on the Intellectual Property rights of any third party.


 


(d)           PFIZER
warrants to COMPANY that all artwork necessary for the procurement of printed
materials by COMPANY for the packaging of each Product(s) shall comply with all
applicable legal requirements and contains all other information required by
law. PFIZER warrants to COMPANY that all API supplied by PFIZER comply with the
Specifications and all relevant legal requirements. Should a failure to
materially conform with such warranty occur prior to the delivery of any
Product(s), COMPANY shall give PFIZER prompt written notice thereof, and PFIZER
shall correct such non-conformity by replacing the non-conforming artwork or
material and by indemnifying COMPANY for all costs, losses, and expenses
resulting from such non-conformity. COMPANY shall not be liable for delays in
delivery of Product(s) where caused by PFIZER.


 


(e)           PFIZER:


 


(i)            is a
corporation duly organized, validly existing and in good standing under the
laws of Canada;


 


(ii)           has the
power and authority to conduct its business as currently being conducted and as
contemplated herein;


 


(iii)          has
the power and authority to make, deliver and perform its obligations under
this Agreement and any Addendum and has taken all necessary action to authorize
the execution, delivery and performance of this Agreement and any Addendum. No
consent or authorization of, filing with or other act by or in respect of, any 


 


28

















 


Governmental
or Regulatory Authority or any other Person is or will be required in respect
of PFIZER in connection with the execution, delivery, performance, validity or
enforceability of this Agreement or any Addendum. This Agreement and any
Addendum and the respective Addenda have been duly executed and delivered on
behalf of PFIZER. This Agreement constitutes the legal, valid and binding
obligations of PFIZER enforceable against PFIZER in accordance with its terms;
and


 


(iv)          the
execution, delivery and performance of this Agreement and any Addendum by
PFIZER will not violate any agreement or instrument to which PFIZER is a party.


 


6.3.          Notice
of Material Events.


 


COMPANY hereby agrees to
promptly notify PFIZER of any actual events that have or may be reasonably
expected to have a material adverse effect on any Product(s) or on its ability
to manufacture or supply the Product(s) in accordance with the provisions set
forth herein, including any labour difficulties, strikes, shortages in
materials, plant closings, interruptions in activity and the like.


 


6.4.          Survival.


 


The representations,
warranties and obligations of COMPANY and PFIZER under this Section 6
shall survive termination or expiration of this Agreement and any Addendum
insofar as they are applicable to the requirements for the Product(s) up until
the expiration date of the last batch of Product(s) manufactured hereunder.


 


SECTION 7. 

ENVIRONMENTAL REPRESENTATIONS, WARRANTIES AND COVENANTS.


 


7.1.          Compliance
with Environmental Laws.


 


COMPANY shall perform all
of the services provided herein in compliance with all applicable Environmental
Laws and shall be solely responsible for all Environmental Losses related to
those services.


 


7.2.          Permits,
Licenses and Authorization.


 


COMPANY shall be solely
responsible for obtaining, and shall obtain, all necessary environmental or
other licenses, registrations, certificates, approvals, authorizations or
permits required under Environmental Law and any private permissions, whether
original documents or modifications to existing documents, which are necessary
to perform the services hereunder and shall bear all costs and expenses
associated therewith. COMPANY shall provide copies thereof to PFIZER upon
request by PFIZER and shall operate in compliance therewith. COMPANY shall
provide


 


29

















 


PFIZER with immediate verbal notice, confirmed
in writing within twenty-four (24) hours, in the event of revocation or
modification of such documents, or with regard to any other event or regulatory
action or involvement such as an order or notice, which in materially adversely
impacts COMPANY’s ability to provide services under this Agreement and any
Addendum.


 


7.3.          Hazardous
Materials and Waste.


 


The generation,
collection, storage, handling, transportation, movement, and Release of all
Hazardous Materials and Waste in connection with COMPANY’s, Affiliate of
COMPANY or subcontractor of COMPANY’s provision of services hereunder, as
applicable, shall be the sole responsibility of COMPANY at it sole cost and
expense.


 


7.4.          Generation
of Hazardous Wastes.


 


Without limiting other
legally applicable requirements, COMPANY shall prepare, obtain, execute and
maintain, as the generator of Hazardous Waste, all registrations, notices,
shipping documents and Hazardous Waste manifests required under Environmental
Law and in accordance therewith.


 


7.5.          Environmental
Waste Diversion Issues.


 


COMPANY shall be
responsible for developing and implementing all procedures necessary to prevent
the diversion of Product(s) from the waste stream, including the rendering of
the Product(s) unsaleable.


 


7.6.          Health
and Safety Procedure.


 


COMPANY shall be solely
responsible for implementing and maintaining health and safety procedures for
COMPANY’s testing, manufacturing and handling of the Raw Materials, Hazardous
Materials, Waste and Product(s) as provided herein. Such procedures shall
comply with all applicable Environmental Laws. PFIZER shall have no
responsibility for developing, implementing or overseeing COMPANY’s health and
safety program.


 


7.7.          Training.


 


COMPANY shall educate and train all affected employees
and contractors regarding the potential hazards associated with the generation
and handling of the Hazardous Materials, Waste and the COMPANY’s manufacturing,
analyzing and handling of the Product(s) and the Raw Materials and Packaging
Materials, and on the proper use of engineering controls, process equipment and
appropriate personal protective equipment. PFIZER shall have no responsibility
for educating, training or ensuring knowledge of COMPANY’s employees or
contractors regarding the potential or actual hazards associated with the
COMPANY’s handling of any Hazardous Material or Waste, or on the analyzing,
handling and manufacture of the Product(s), or on the proper


 


30

















 


use of engineering
controls, process equipment and appropriate personal protective equipment.


 


7.8           Environmental
and Health and Safety Reviews.


 


a)             If
PFIZER conducted a pre-contractual review of COMPANY’S environmental and health
and safety management practices, facility(ies), equipment, and operations, and
conditioned its willingness to enter into the underlying Agreement upon COMPANY’s
willingness to modify such, then COMPANY agrees to maintain any such
modifications for the duration of this Agreement. COMPANY agrees that
implementing and maintaining such modifications does not negate its status as
an independent contractor; failure to do so shall be considered a material
breach of this Agreement and any Addendum and grounds for termination upon the
number of days specified for written notice in the Termination provision of the
underlying Agreement and any Addendum.


 


b)            PFIZER
reserves the right to conduct, or cause to be conducted, reviews of COMPANY’S
environmental and health and safety management practices, Facility, and
operations to determine if COMPANY is fulfilling its obligations under this Section 7.
Such reviews may occur only during regular business hours and upon
reasonable prior written notice.


 


c)             PFIZER
shall, as soon as practicable, share its findings from such reviews with
COMPANY. COMPANY shall correct deficiencies identified by PFIZER as soon as
commercially reasonably possible, and at no expense to PFIZER. Deficiencies
which must be corrected, may include non-compliance with applicable Environmental
Laws which pose significant threats to COMPANY’S ability to fulfill its
obligations to PFIZER under this Agreement or any Addendum, or significant
threats to health, safety, and the environment. COMPANY shall maintain such
changes for the duration of the underlying Agreement. Failure to correct such
deficiencies and maintain such corrections for the duration of the underlying
Agreement shall constitute a material breach of this Agreement and grounds for
termination upon 30 days written notice if reasonable steps undertaken to
correct deficiencies have not been instituted.


 


d)            COMPANY
acknowledges that it has no right to rely upon PFIZER’s reviews (or PFIZER’S
election not to perform such reviews) to determine the extent of its
compliance with applicable Environmental Laws. The performance of such a review
does not, in any way, limit (ii) COMPANY’S obligation to indemnify PFIZER
pursuant to Section 9 of this Agreement or any Addendum, PFIZER’S right to
terminate this Agreement pursuant to Section 13 of this Agreement, or to
seek any other remedy pursuant to this Agreement as a result of COMPANY’S
inability to fulfill its contractual obligations to PFIZER.


 


31

















 


7.9           Prompt
notice to PFIZER of Material Environmental or Health and Safety adverse impacts
upon COMPANY’S ability to perform.


 


Notwithstanding
COMPANY’s obligation to provide environmental and health and safety information
to PFIZER upon request, as described in this Section 7 of this Agreement,
COMPANY shall promptly provide notice to PFIZER in writing, within five (5) Business
Days, in the event it discovers or undertakes any of the following:


 


(i)    COMPANY’s Material non-compliance with Environmental
Laws;


 


(ii)   Any environmental condition or operating practice
that indicates, or may reasonably be believed to present a significant
threat to health, safety, or the environment (including but not limited to
major incidents such as significant releases of Hazardous Materials to the
environment);


 


Any environmental
condition or operating practice that indicates or may reasonably be
believed to present a significant threat to COMPANY’S ability to fulfill its
obligations to PFIZER under this Agreement.


 


COMPANY represents
and warrants that it has completely and accurately disclosed to PFIZER all
reasonably relevant environmental and health and safety information, whether or
not specifically requested by PFIZER, during its pre-contract review of COMPANY’s
Facility, operations, and environmental and health and safety program. COMPANY
agrees to respond promptly to a request from PFIZER to provide information
related to environmental and health and safety management at the facility(ies)
where COMPANY is performing under this Agreement or any Addendum. Such requests
for information may include, but are not limited to: requests for copies
of permits, licenses, judicial and administrative orders, consent orders,
reports of inspections conducted by a governmental authority, workplace
chemical monitoring or emissions tests from workplaces and production units
contemplated for or used to fulfill COMPANY’s obligations under this Agreement
or any Addendum.


 


7.10.        Survival.


 


The
representations, warranties and obligations of COMPANY under this Section 7
shall survive termination or expiration of this Agreement or any Addendum
insofar as they are applicable to the requirements for the Product(s) up until
the expiration date of the last batch of each of the Product(s) manufactured
hereunder.


 


SECTION 8

OWNERSHIP; TRADEMARKS; PROPRIETARY.


 


8.1.          PFIZER’s
Ownership of Intellectual Property; PFIZER Technology and Information.


 


(a)           It
is agreed that PFIZER is the sole owner of the Product(s) and owns or has
rights to the Intellectual Property relating thereto except for patents, and
know-how,


 


32

















 


to the extent such
know-how is owned or controlled as of the Effective Date of this Agreement or
any Addendum by COMPANY and/or its respective Affiliates.


 


(b)           If
any creative ideas, proprietary information, developments, inventions, or
improvements or modifications to the Product(s) or the Intellectual Property
associated with the Product(s) (“Improvements”) are developed under this
Agreement or any Addendum by PFIZER or COMPANY, either jointly or severally,
and whether or not patentable, such Improvements shall be the exclusive
property of PFIZER and shall be held in confidence by COMPANY, as the case may be,
for PFIZER’s sole benefit in the development and/or the operation of
manufacturing processes with respect to the Product(s). COMPANY agrees to
promptly disclose such Improvements to PFIZER and to receive the approval of
PFIZER prior to COMPANY’S use of any such Improvements whether relating to the
manufacturing, processing and/or packaging of the Product(s) or use of the
Product(s) developed by it or its Affiliates. Any trademarks, trade names,
brand names, patents, slogans, logos, copyrights, trade dress, know-how and
goodwill associated with the Product(s) shall be the sole and exclusive property
of PFIZER. COMPANY shall not have any right or license to use any such rights
at any time before, during or after the Term of this Agreement or any Addendum,
except as necessary for the manufacturing, processing and supplying of
Product(s) for PFIZER hereunder. Any Intellectual Property or information owned
by PFIZER or provided by PFIZER to COMPANY in connection herewith shall not be
used by COMPANY, or its Affiliates in the manufacture of any products other
than the Product(s), or disclosed or made available to any customers of
COMPANY, or its respective Affiliates, or other third parties without the prior
written approval of PFIZER.


 


8.2.          Ownership
of Other Property.


 


It is agreed that PFIZER
is the sole owner of any and all tools, specifications, blueprints and designs
supplied or paid for by PFIZER, and COMPANY shall not use, transfer, loan or
publicize any of the above except as necessary for its performance under this
Agreement or any Addendum.


 


8.3.          Limited
Right to Use.


 


Nothing set forth in
this Agreement or any Addendum shall be construed to grant to COMPANY any
title, right or interest in or to any trade secret, know-how, trademark, trade
dress, trade name, brand name, copyright, patent or other proprietary
technology owned by or licensed to PFIZER or any of its Affiliates. Any
unauthorized use of said trade secret, know-how, trademarks, trade dress, trade
names, brand names, copyrights, patents or other proprietary technology (unless
otherwise specified herein) shall constitute an infringement thereof and/or
violation of PFIZER’s rights. Use by COMPANY of copyrights, patents or other
proprietary technology owned by or licensed to PFIZER or any of its Affiliates
shall be limited exclusively to its performance of this Agreement or any
Addendum.


 


33

















 


8.4.          Survival.


 


The provisions of
Sections 8.1, 8.2 and 8.3 shall survive the expiration or termination of this
Agreement or any Addendum.


 


SECTION 9. 

INDEMNIFICATION.


 


9.1.          Indemnification
of PFIZER.


 


COMPANY shall indemnify,
defend and hold PFIZER, its Affiliates and their respective officers,
directors, employees and agents (each, a “PFIZER Indemnified Party”) harmless
from and against any and all claims, liabilities, lawsuits, or governmental
action, or Losses suffered, incurred or sustained by any PFIZER Indemnified
Party, by reason of any Claim or Proceeding to the extent arising out of or
resulting from (a) any breach of representations, warranties or
obligations of COMPANY under this Agreement (including a breach that results in
a Recall of the Product(s), or non-fulfillment of or failure to perform any
covenant or agreement made by COMPANY in this Agreement or any Addendum; (b) any
injury to any Person or property or death occurring to any employees,
subcontractors, agents of COMPANY, or any individuals on the premises of
COMPANY; (c) any injury to any Person or property or death resulting from
the possession, use or consumption by any Person of any Product(s) or sample
supplied by COMPANY under this Agreement or any Addendum if caused by COMPANY; (d) any
negligent act or omission on the part of COMPANY, Affiliates of COMPANY or
employees or agents of COMPANY, or its respective Affiliates; or (e) infringement
of any third party’s Intellectual Property arising out of the unauthorized
manufacture, use or sale of the Product(s) or samples. Notwithstanding the
foregoing, it is understood and agreed that COMPANY shall not be liable for
Losses to the extent such Losses are caused by any act or omission on the part of
PFIZER or the negligence, recklessness, willful misconduct or breach of any of
the terms of this Agreement by PFIZER or the Pfizer Affiliate that executed the
affected Addendum.


 


9.2.          Indemnification
of COMPANY.


 


PFIZER shall indemnify
and hold COMPANY, its Affiliates and its respective officers, directors,
employees and agents (each, a “COMPANY Indemnified Party”) harmless from and
against any and all claims, liabilities, lawsuits, or governmental action, or
Losses suffered, incurred or sustained by any COMPANY Indemnified Party, by
reason of any Claim or Proceeding to the extent arising out of or resulting
from any breach of PFIZER’s representations, warranties or obligations under
this Agreement or any Addendum, or non-fulfillment of or failure to perform any
covenant or agreement made by PFIZER in this Agreement or any Addendum. Notwithstanding
the foregoing, it is understood and agreed that PFIZER shall not be liable for
Losses to the extent such Losses are caused by any act or omission on the part of
COMPANY or the negligence, recklessness, willful misconduct or breach of any of
the terms of this Agreement by COMPANY, or its respective Affiliates or agents.


 


34

















 


9.3.          Assertion
of Claim.


 


In the event that any
Claim or Proceeding is asserted or imposed against any party hereto, and such
Claim or Proceeding involves a matter which is subject to a claim for
indemnification under this Section 9, then such party (an “Indemnified
Party”) shall promptly give written notice to the other party (the “Indemnifying
Party”) of such claim, Action or Proceeding, and such Indemnifying Party shall
have the right to join in the defense of said claim, Action or Proceeding, at
such Indemnifying Party’s own cost and expense, and if the Indemnifying Party
agrees in writing to be bound by and to promptly pay the full amount of any
final judgment from which no further appeal may be taken and if the
Indemnified Party is reasonably assured of the Indemnifying Party’s ability to
satisfy such agreement, then at the option of the Indemnifying Party, such
Indemnifying Party may take over the defense of such claim, Action or
Proceeding, except that, in such case, the Indemnified Party shall have the
right to approve any attorney or counsel selected by the Indemnifying Party
(which approval shall not be unreasonably delayed or withheld) and to join in
the defense of said claim, Action or Proceeding at its own cost and expense. In
no event shall COMPANY institute, settle or otherwise resolve any claim or
potential claim, Action or Proceeding relating to the Product(s) or any
trademarks, patents or other intellectual property of or licensed to PFIZER
without the prior written consent of PFIZER.


 


9.4           Limitation
on Liability.


 


No party to this
Agreement or any Addendum shall be liable to any other party for any indirect,
special, consequential or punitive damages or lost profits arising out of or
relating to any of its obligations or duties under this Agreement or any
Addendum.


 


9.5.          Survival.


 


The provisions of this Section 9
shall survive termination or expiration of this Agreement or any Addendum.


 


SECTION 10. 

INSURANCE.


 


10.1.        Coverage.


 


COMPANY shall, as of the
date hereof, obtain and keep in force throughout the Term of this Agreement or
any Addendum and for a period of *** from the date of the last delivery of
Product(s) to PFIZER hereunder, policies of insurance from carriers reasonably
acceptable to PFIZER providing coverage as specified herein. COMPANY shall
require its subcontractors, to the extent possible hereunder, to provide
adequate coverage and any deficiencies in the coverage or policy limits of said
subcontractors will be the sole responsibility of COMPANY. The provisions of
this Section 10.1 shall survive the expiration or termination of this
Agreement or any Addendum.


 


35

















 


COMPANY
shall maintain during the Term of this Agreement or any Addendum  or amendment or extension
all insurance normally associated with
conducting business, such as, but not limited to: worker’s compensation
insurance, employer’s liability insurance, if applicable, comprehensive
liability insurance, comprehensive auto insurance, business interruption
insurance and commercial blanket bond insurance.


 


COMPANY
must be in compliance with:


 


(i)    The statutory
limits for all claims under the applicable Federal or Provincial Workers’
Compensation Acts or plan;


 


(ii)   Voluntary
Compensation insurance covering all employees not subject to the applicable
Federal or Provincial Workers’ Compensation Acts or plan;


 


(iii)  Commercial
General Liability Insurance with the following limits and forms/endorsements;


 


Each Occurrence: 
***


Product(s)
and Completed Operations Aggregate:   ***


 


Occurrence form including
premises and operations coverage, products and completed operations, broad form property
damage, coverage for independent contractors, personal injury coverage,
contractual liability limit.


 


(iv)  Comprehensive
Automobile and Truck Liability Insurance if not already covered under COMPANY’s
General Liability Insurance:


 


*** combined single limit for bodily injury and
property damage arising out of all owned, non-owned and hired vehicles. This
must cover all owned and non-owned uninsured and under-insured motorists for
automotive and truck equipment used in the performance of the work under this
Agreement or any Addendum both on and off the worksite, and must include the
loading and unloading of same; and


 


(v)   Umbrella (Excess)
Liability Coverage (follow form) in an amount not less than *** per occurrence
and in the aggregate.


 


COMPANY will reimburse
PFIZER for all costs incurred as a result of defective Product(s) supplied by
COMPANY as a result of COMPANY act, omission or error.


 


10.2         Certificates
of Insurance; Maintenance of Coverage.


 


Where applicable,
COMPANY shall submit a certificate of such insurance (which shall include such
information as set forth in Section 10.2 to PFIZER for its approval as of
the date hereof. If such certificate is not furnished within thirty (30) days,
PFIZER shall notify COMPANY in writing and give the applicable party thirty
(30) days to cure such breach. If such party (or parties, as the case may be)
fails to provide the certificate


 


36

















 


during such thirty (30) day cure period, PFIZER
may, at its option, immediately terminate this Agreement or any Addendum.


 


SECTION 11.
 PFIZER SUPPLY OF MATERIALS (RAW
MATERIALS, API OR PACKAGING)


 


11.1         Supply
of Materials.


 


As per section 3.9
above, PFIZER may choose to, at its own expense, supply COMPANY with
sufficient quantities of Product Materials as described in an Addendum, needed
for the manufacture of the Product(s) specified in the forecasts and Purchase
Orders in order to meet PFIZER’s requirements for commercial and/or
developmental quantities of Product(s) in finished dosage form. At PFIZER’s
election, the Raw Materials may be delivered directly from PFIZER’s vendor
to COMPANY at the vendor’s or PFIZER’s expense. PFIZER or its vendor shall
supply COMPANY with a copy of the certificate of analysis for the Raw Materials
no later than the date of delivery of the Raw Materials to COMPANY.


 


11.2         Testing.


 


COMPANY shall undertake
testing of each shipment of Raw Materials if required by the Addendum. If the
Raw Materials do not meet the Specifications, COMPANY will immediately inform PFIZER
and COMPANY shall be excused from its obligation to supply Product(s) to PFIZER
until Raw Materials meeting the Specifications are delivered to COMPANY. Upon
such delivery, COMPANY shall have sixty (60) days in which to supply Product(s)
to PFIZER. To the extent COMPANY has existing stock of Raw Materials, which
conforms to the approved Specifications, nothing in the forgoing shall relieve
COMPANY of its obligation to supply Product(s) deriving from such conforming
Raw Materials.


 


11.3         Title
and Risk of Loss.


 


(a)           Title
to the Raw Materials supplied by PFIZER shall remain with PFIZER; however ***. COMPANY
shall not use Raw Materials supplied by PFIZER for any purposes other than
those related to the manufacture of the Product(s) for sale pursuant hereto.


 


(b)           The risk
of loss or damage to Raw Materials during the storage thereof by COMPANY shall
be ***. In the event of such loss or damage, ***.


 


(c)           COMPANY
shall not be obligated to but may insure the Raw Materials and the
Product(s) while such are in COMPANY’s possession, and PFIZER shall cooperate
with COMPANY and its insurers in obtaining insurance coverage.


 


37

















 


11.4         Reimbursement
for Loss of Raw Materials.


 


COMPANY agrees to
reimburse PFIZER for its out of pocket costs per batch pro-rated over the
usable portion of the batch if applicable, for any loss of PFIZER supplied (i) Raw
Materials; (ii) API; or (iii) Packaging Materials for each batch that
does not meet Specifications and therefore cannot be released, provided that
the loss of such Raw Materials, API or Packaging Materials was caused by, a)
the failure of COMPANY to comply with the terms and conditions of the Agreement
(including, without limiting the foregoing, the failure to meet the
Specifications); b) the negligence of COMPANY; 
c) willful misconduct on the part of COMPANY; d) failure to
maintain the Facilities or equipment in a state necessary and capable of performing
COMPANY’s obligations under this Agreement; or e) unable to meet minimum
established yields as specified in the Addendum. In addition to this payment,
COMPANY will be responsible for all manufacturing costs incurred during the
manufacture of the failed batch, pro-rated over the usable portion of the batch
if applicable. COMPANY shall not be responsible for the above costs if loss of
Raw Materials, API or Packaging Materials was caused by incorrect
Specifications given to COMPANY by PFIZER or as a result of PFIZER’s delay to
grant consent to changes sought in accordance with Section 5.2.


 


SECTION 12. 

CONFIDENTIAL INFORMATION.


 


12.1         Confidential
Information.


 


(a)           In
performing the obligations under this Agreement or any Addendum, each party
shall come in contact with certain confidential and proprietary information of
the other party (“Confidential Information”). Each party agrees that it will
(and will cause each of its representatives, employees and agents to):


 


(i)            use
such Confidential Information obtained from the other party hereunder only in
connection with the activities to be undertaken by each party as contemplated
hereunder;


 


(ii)           use
its best efforts to restrict disclosure of such Confidential Information within
its own organization to those of its employees having a reasonable need to
know; and


 


(iii)          not
divulge to third parties, without the prior written consent of the other party,
any Confidential Information obtained from the other party hereunder.


 


(b)           The
foregoing confidentiality obligations shall not apply if and to the extent
that:


 


38

















 


(i)            the
Confidential Information is known to the receiving party prior to obtaining the
same from the disclosing party, as demonstrated by the receiving party’s
written records;


 


(ii)           the
Confidential Information is, at the time of disclosure, in the public domain,
or comes into the public domain without any fault of the receiving party or its
Affiliates;


 


(iii)          the
Confidential Information is obtained by the receiving party from a third party
who is not obligated to keep the Information confidential;


 


(iv)          the
Confidential Information is independently developed by the receiving party
and/or by any of its Affiliates, as demonstrated by the receiving party’s
written records; or


 


(v)           the
disclosure of the Confidential Information is required by Law or Governmental
Authority.


 


(c)           Upon
expiration or termination of this Agreement or any Addendum, each party shall
return to the other party, or by mutual agreement, destroy all Confidential
Information received from the other party, save and except for one (1) copy
which shall be kept by the Legal Department of each respective party for
archival purposes.


 


(d)           Unless
required by Law, court or governmental order or decree, COMPANY agrees not to
use or refer to PFIZER’s name, the name of PFIZER’s Affiliates or this
Agreement or any Addendum in any public statements, whether oral or written,
including but not limited to, annual reports or shareholder reports, statements
to other customers or prospective customers or other communications, without
PFIZER’s prior written consent which shall not be unreasonably withheld.


 


(e)           The
provisions of this Section 12 shall survive the termination or expiration
of this Agreement or any Addendum.


 


39

















 


SECTION 13. 
 TERM; TERMINATION.


 


13.1         Commencement
and Termination of the Agreement.


 


This
Agreement shall commence on the Effective Date and continue for three (3) years
(“Initial Term”). Termination of this Agreement will result in the termination
of any Addendum which has been executed in the interim period.


 


13.2         Initial
Term; Term of an Addendum.


 


Unless terminated in accordance with the provisions of
this Agreement, the Initial Term shall run concurrently with any Addendum. Following
the Initial Term PFIZER may extend this Agreement and any Addendum for
consecutive one (1) year periods (“Extended Term”). PFIZER shall provide
Notice prior to the expiration or renewal of the Initial Term or any Extended
Term. Such Notice shall be provided in writing one (1) year in advance of
such termination or extension. COMPANY may provide Notice to PFIZER to
terminate the Initial Term of the Agreement or any Addendum or any Extended
Term by providing PFIZER with written notice of intent to terminate one (1) year
in advance of such termination. The Initial Term and all Extended Terms of an
Addendum shall collectively be the “Term” of an Addendum. This Agreement and
any Addendum may be terminated as follows:


 


13.3         Termination
by PFIZER.


 


 (a)          Immediately
upon written notice to COMPANY if COMPANY makes an assignment for the benefit
of its creditors, is adjudged bankrupt, becomes insolvent, ceases or threatens
to cease to carry on business, files or consents to the filing of a petition in
bankruptcy, seeks to take any advantage of any legislation relating to
insolvency, arrangement or relief of debtors, winds-up or liquidates or if any
receiver, trustee, liquidator or similar officiate is appointed to COMPANY or
any of its property; or


 


(b)           Subject
to subparagraph (d), upon a material breach of this Agreement or any Addendum
by COMPANY, if COMPANY fails to cure such breach within thirty (30) days after
receipt of written notice thereof; or


 


(c)           Upon
written notice to COMPANY, with immediate effect, if in PFIZER’s reasonable
opinion following an inspection pursuant to this Agreement or any Addendum, it
is revealed that any Facility fails to comply with cGMP or other requirements
of applicable Law to such an extent that, in PFIZER’s reasonable opinion,
COMPANY cannot perform its obligations under this Agreement or any
Addendum; or


 


(d)           Upon
written notice to COMPANY, with immediate effect, (i) in the event of the
direct or indirect change in ownership or control or corporate reorganization
of


 


40

















 


COMPANY, which results in
a new party or group assuming control of COMPANY, or (ii) if at any time during the Initial or Extended
Term of this Agreement or any Addendum, COMPANY becomes an Affiliate of a
competitor of PFIZER, which competitor is a company, supplier and/or
distributor of products competitive with the Product(s). For purposes of this
subsection (d) the term “control” means the possession of the power
to direct or cause the direction of the management and policies of a Person
whether through ownership of voting securities, by contract or otherwise; or


 


(e)           Upon
at least one hundred and eighty (180) days prior written notice to COMPANY in
the event that any Product(s) is the subject of a final executed sale agreement
between PFIZER and a third party or is discontinued by PFIZER for any reason;
provided that PFIZER shall comply with the provisions of Section 3.5(b) hereof
with respect to such Product(s); or


 


(f)            Upon at
least one (1) year prior written notice to COMPANY for any reason other
than as set out in (a) to (e) above; provided that, PFIZER shall
compensate COMPANY for Product Materials pursuant to Section 13.5(c) below;
or


 


(g)           In
whole or in part upon any of the events described in this Agreement or any
Addendum which give rise to a party’s right to terminate, including pursuant to
Sections 10.3 or 14.1 of this Agreement.


 


13.4         Termination
by COMPANY.


 


(a) Immediately,
upon written notice to PFIZER, if PFIZER makes an assignment for the benefit of
its creditors, is adjudged bankrupt, becomes insolvent, ceases or threatens to
cease to carry on business, files or consents to the filing of a petition in
bankruptcy, seeks to take any advantage of any legislation relating to
insolvency, arrangement or relief of debtors, winds-up or liquidates or if any
receiver, trustee, liquidator or similar officiate is appointed to PFIZER or
any of its property; or


 


(b) Upon
a material breach of this Agreement by PFIZER if PFIZER fails to cure such
breach within thirty (30) days after receipt of written notice thereof.


 


13.5         Effect
of Termination.


 


(a)           Upon
a termination pursuant to the provisions of subparagraphs (a), (b), (c), (d),
or (g) of Section 13.3, COMPANY shall cooperate with, and grant a
perpetual royalty-free license to and/or supply to PFIZER and any alternative
supplier, all necessary Intellectual Property of COMPANY for the manufacture
and packaging of the Product(s) at the expense of COMPANY, and COMPANY shall provide
reasonable assistance (including, but not limited to its personnel) in the
transfer of such Intellectual Property to PFIZER and such alternative supplier,
and PFIZER shall have complete access to the COMPANY’S Intellectual Property
relating to such Product(s) as long as PFIZER continues to sell the Product(s).


 


41

















 


(b)           Termination
of this Agreement and/or any Addendum shall not affect any obligation to pay
money due hereunder, indemnify, or maintain confidentiality, which either party
hereto may have incurred during the Initial or any Extended Term hereof. Termination
pursuant to this Section 13 shall be in addition to, and not in place of,
a party’s other rights and causes of action which were in existence prior to
such termination.


 


(c)           Within
a reasonable time after PFIZER gives notice of termination pursuant to the
provisions of subparagraphs (e) or (f) of Section 13.3, PFIZER
agrees to have discussions with COMPANY regarding mitigation of unrecoverable
losses resulting from amounts paid toward the purchase price of new equipment
and/or Product Materials specific to PFIZER.


 


13.6         Unused
Materials.


 


Within ninety (90) days
of the effective date of the expiration or termination of this Agreement or any
Addendum by PFIZER for any reason, PFIZER may, at its option, purchase at cost
any work in process, Raw Materials, or Packaging Materials and any other
material that COMPANY has purchased exclusively for PFIZER in accordance with
this Agreement or any Addendum for the production of the Product(s)  (“Product Materials”). In the event of the
termination of this Agreement or any Addendum by PFIZER in accordance with
Sections 13.3(f) or the termination of this Agreement by COMPANY in
accordance with Section 13.4, PFIZER shall purchase at cost all Product
Materials purchased in accordance with PFIZER’s Firm Orders submitted pursuant
to Section 3.5(a) (subject to any adjustments made to Firm Order
pursuant to Section 3.5(b); provided, however, that PFIZER shall not be
obligated to purchase Product Materials purchased to manufacture Product(s)
after the Firm Order Period; and provided further, COMPANY uses its reasonable
commercial efforts to exhaust existing stocks of such Product Materials prior
to the date of termination unless the parties mutually agree otherwise in
writing. In the event of the termination or expiration of this Agreement or any
Addendum for any other reason, PFIZER shall have no obligation to purchase any
Product Materials. Upon the expiration or termination of this Agreement for any
reason, PFIZER may also, at its option, place orders with COMPANY for the
manufacture and packaging of additional products in order to exhaust existing
stocks of Product Materials and shall pay for such Product(s) in accordance
with Section 4.1. Any Product Materials that are not purchased by PFIZER
pursuant to this Section 13.6 shall be disposed of or destroyed in
accordance with PFIZER’s instructions, which costs shall be borne by COMPANY,
except in the event this Agreement is terminated by PFIZER in accordance with
Sections 13.3(f) or by COMPANY in accordance with Section 13.4, in
which case, such costs shall be borne by PFIZER.


 


13.7         Return
of Materials, etc. Supplied by PFIZER.


 


(a)           Upon
the effective date of expiration or termination of this Agreement or any
Addendum for any reason whatsoever, COMPANY shall immediately deliver to PFIZER
all Specifications (and copies thereof), artwork, labels, bottles, all premiums
and


 


42

















 


PFIZER supplied Raw
Materials and Packaging Materials and those purchased by PFIZER and Equipment
provided by, or purchased on behalf of, PFIZER. COMPANY shall maintain
ownership of all other equipment utilized in connection with the manufacture
and packaging of the Product(s). COMPANY will remove all PFIZER Equipment from
the Facility and have such PFIZER Equipment on its dock ready for PFIZER to
transport. All delivery, removal and transportation costs incurred in
connection with this Section 13.7 shall be borne by PFIZER except in the
event PFIZER terminates this Agreement pursuant to Section 13.3 (a), (b),
(c), (d) or (g), in which case all such reasonable costs shall be borne by
COMPANY.


 


(b)           Upon
the effective date of expiration or termination of this Agreement or any
Addendum for any reason whatsoever, COMPANY shall also deliver to PFIZER all
Product(s) manufactured hereunder and shall invoice PFIZER in accordance with
the terms of Section 4.1. Any Product(s) quarantined at the time of
expiration or termination of this Agreement or any Addendum shall be disposed
of or destroyed in accordance with PFIZER’s written instructions. Subsequent to
the expiration or termination of this Agreement or any Addendum, the parties
shall continue to be responsible for rejected and non-complying Product(s) and
Product Materials in accordance with the terms of Section 5.12.


 


SECTION 14. 

FORCE MAJEURE.


 


14.1         Force Majeure.


 


Performance under this
Agreement or any Addendum shall be excused to the extent prevented or delayed
by fire, flood, explosion, hydro electric power failures, terrorist actions,
governmental acts or regulations, war, any act of God, or by any other similar
circumstances of any character reasonably beyond the control of the party so
excused. The party affected shall promptly notify in writing the non-affected
party or parties of the event of force majeure and the probable duration of the
delay. Any delay caused by an event of force majeure shall toll the term of
this Agreement or any Addendum, which shall be extended by the length thereof. In
the event a force majeure prevents performance by COMPANY for more than one (1) month,
PFIZER shall have the right to terminate this Agreement or any Addendum.


 


SECTION 15

EXCLUSIVITY.


 


15.1         Manufacture
of Competing Product.


 


***


 


43

















 


SECTION 16.

MISCELLANEOUS.


 


16.1         Relationship
of the Parties.


 


The parties shall be
deemed independent contractors with respect to the terms and provisions of this
Agreement and any Addendum and shall not in any respect act as an agent or
employee of the other party. All persons employed by COMPANY in connection with
the manufacture and supply of the Product(s) to PFIZER shall be employees,
agents or contractors of COMPANY. Under no circumstances shall employees or
agents of COMPANY be deemed to be employees or agents of PFIZER.


 


16.2         Successors
and Assigns; Subcontracting.


 


COMPANY shall not,
without the prior written consent of PFIZER, delegate, transfer, convey, assign
or pledge this Agreement or any Addendum, in whole or part, or any of its
rights or obligations under this Agreement or any Addendum to any other Person.
COMPANY shall not subcontract any obligation or duty owed under this Agreement
or any Addendum without the prior written consent of PFIZER. This Agreement and
any Addendum shall be binding upon and inure to the benefit of the parties
hereto, and subject to the terms of this Section 16.2, its respective
successors, legal representatives and permitted assigns. Any assignment or
subcontract in contravention of this Section 16.2 shall be ineffective and
considered null and void.


 


16.3         Notice.


 


All notices, requests,
demands or other communications to or upon the parties hereto shall be in
writing and, unless otherwise specified herein, deemed to have been given or
made when deposited in the mails, registered mail or certified, return receipt
requested, postage prepaid, or overnight courier or by facsimile transmission,
the receipt of which is confirmed by telephone, addressed to the appropriate
party at the following address (or to such other person or address as is
specified elsewhere in this Agreement for specific purposes):


 


If to
PFIZER:


Pfizer
Canada Inc.


365
Madawaska Blvd.


Arnprior,
Ontario  K7S 3K2


Attention: 
Manager, Quality Operations


Facsimile
No.:  613-623-1329


 


With a
copy to:


 


Pfizer
Inc.


100
Route 206 North, P.O. Box 800


Peapack,
New Jersey  U.S.A. 07977


 


44

















 


Attention: 
Director, Contract Manufacturing, Latin America/Canada


Facsimile
No.:  908-901-1745


 


And
with a copy to:


 


Pfizer
Canada Inc., Pfizer Consumer Healthcare division


88
McNabb Street


Markham,
ON L3R 5L2


Attention: 
Senior Legal Counsel


Facsimile
No.:  905-968-2008


 


If to
COMPANY:


DRAXIS
Pharma, a Division of DRAXIS Specialty Pharmaceuticals Inc.


 


16751
Trans Canada Highway


Kirkland,
Quebec  H9H 4J4


Attention: 
President


Facsimile
No.:  514-694-3841


 


with a
copy to:


 


DRAXIS
Health Inc.


16751
Trans Canada Highway


Kirkland,
Quebec   H9H 4J4


Attention:  General Counsel & Secretary


Facsimile
No.:  514-630-7159


 


The above addresses for receipt of notice may be
changed by any party by notice, given as provided herein.


 


16.4         Entire
Agreement.


 


This Agreement,
including all Addendum and Attachments attached hereto and made a part hereof
contain the entire understanding of the parties, superseding in all respects
any and all prior oral or written agreements or understandings pertaining to
the subject matter hereof. This Agreement, or any Addendum, may be amended
or modified only by written agreement executed by the parties hereto.


 


16.5         Severability.


 


If any provision of this
Agreement or any Addendum is held to be illegal, invalid or unenforceable under
any applicable Law, and if the rights or obligations of any party hereto under
this Agreement or any Addendum will not be materially and adversely affected
thereby, (a) such provision will be fully severable, (b) this
Agreement or any Addendum will be construed and enforced as if such illegal,
invalid or unenforceable provision had never comprised a part hereof, (c) the
remaining provisions of this Agreement or any Addendum will remain in full
force and effect and will not be affected


 


45

















 


by the illegal, invalid or unenforceable
provision or by its severance therefrom and (d) in lieu of such illegal,
invalid or unenforceable provision, there will be added automatically as a part of
this Agreement or any Addendum, a legal, valid and enforceable provision as
similar in terms to such illegal, invalid or unenforceable provision as may be
possible.


 


16.6         Waiver.


 


Any term or condition of
this Agreement or any Addendum may be waived at any time by the party that
is entitled to the benefit thereof, but no such waiver shall be effective
unless set forth in a written instrument duly executed by or on behalf of the
party or parties waiving such term or condition. No waiver by any party of any
term or condition of this Agreement or any Addendum, in any one or more
instances, shall be deemed to be or construed as a waiver of the same or any
other term or condition of this Agreement or any Addendum on any future
occasion. All remedies, either under this Agreement or any Addendum or by Law
or otherwise afforded, will be cumulative and not alternative.


 


16.7         Headings.


 


Headings in this
Agreement or any Addendum are included for ease of reference only and have no
legal effect.


 


16.8         Counterparts.


 


This Agreement or any
Addendum may be executed in two or more counterparts, each of which shall be
deemed an original and all of which together shall constitute one and the same
instrument.


 


16.9         Governing
Law.


 


This Agreement shall be
governed by and construed in accordance with the laws of the Province of
Ontario and Canada as applicable, without giving effect to the conflict of law
principles thereof.


 


IN
WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly
executed and to be effective as of the date first above written.


 


 


	
   

  	
  PFIZER
  CANADA INC.,

  
	
   

  	
  Pfizer
  Consumer Healthcare division

  
	
   

  	
   

  
	
   

  	
  By:

  	
    /s/ Jon Coleman

  	
   

  
	
   

  	
  Name:

  	
  Jon Coleman

  
	
   

  	
  Title:

  	
  V.P. &
  General Manager, Pfizer

  Consumer Healthcare Canada &

  Caribbean

  
					



 


46

















 


	
   

  	
  By:

  	
    /s/
  Peter Lovery

  	
   

  
	
   

  	
  Name:

  	
  Peter Lovery

  
	
   

  	
  Title:

  	
  Senior Director of
  Finance and

  Corporate Services

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  Acknowledged By:

  
	
   

  	
   

  
	
   

  	
    /s/
  Peter Stevenson

  	
   

  
	
   

  	
  Name:

  	
  Peter Stevenson

  
	
   

  	
  Title:

  	
  VP Global
  Contract Manufacturing,

  
	
   

  	
  Procurement and
  Pfizer Centre Source

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  DRAXIS
  PHARMA,

  
	
   

  	
  A
  DIVISION OF DRAXIS SPECIALTY

  PHARMACEUTICALS INC. (an

  amalgamation of DRAXIS Pharma Inc. and

  DRAXIMAGE Inc.)

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
    /s/
  John Durham

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Name:

  	
    John
  Durham

  	
   

  
	
   

  	
  Title:

  	
   President,
  DRAXIS Pharma Division

  	
   

  
							



 


47

















 


Schedule “A”


 


Price/Purchase
Order/Invoicing Requirements:


 


	
  1.1.

  	
  Information to be
  contained in Purchase Order

  
	
   

  	
   

  
	
  1.2.

  	
  Invoices to be directed to:
  Pfizer Canada Inc., Pfizer Consumer Healthcare Division, 88 McNabb Street,
  Markham, ON L3R 5L2

  
	
   

  	
  Attention:
  Accounts Payable

  



 


	
  Territory

  	
   

  	
  Product

  	
   

  	
  Price

  	
   

  	
  Item Code #

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


48

















 


Schedule “B” .


 


Form of Addendum


 


DRAFT


 


1.     ***


 


2.     ***


 


3.     ***


 


4.     ***


 


5.     ***


 


6.     ***


 


7.     ***


 


8.     ***


 


9.     ***


 


10.   ***


 


11.   ***


 


12.   ***


 


	
  Activity / Responsibility

  	
   

  	
  PFIZER

  	
   

  	
  COMPANY

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


49

















 


	
  Activity / Responsibility

  	
   

  	
  PFIZER

  	
   

  	
  COMPANY

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


	
  DRAXIS
  PHARMA, a division

  	
  [PFIZER
  LEGAL ENTITY]

  
	
  of
  DRAXIS Specialty Pharmaceuticals

  	
   

  
	
  Inc.

  	
   

  
	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
   

  	
  Name:

  	
   

  
	
  Title:

  	
   

  	
  Title:

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
   

  	
  Name:

  	
   

  
	
  Title:

  	
   

  	
  Title:

  	
   

  



 


50

















 


Schedule B-1 Addendum.


 


***


 


This ADDENDUM dated January 1, 2005 (“Effective
Date”) is to the Manufacturing and Supply Master Agreement (“Agreement”) dated
as of January 1, 2005 by and between


 


DRAXIS PHARMA, a division of Draxis Specialty
Pharmaceuticals Inc. (an amalgamation of Draxis Pharma Inc. and Draximage Inc.)
(“Company”) and PFIZER LABORATORIES (PTY) LTD. ***


 


1.             Start-up
Activities (Section 2.1)


 


***


 


2.             Shipment
Reports (Section 3.6)


 


•      ***


 


3.             Price
/ Quantity / Term 


 


•      ***


 


4.             Specifications
(Section 5) ***.


 


5.             Raw
Materials (Section 11.1)


 


•      ***


 


6.             Description
of Work


 


•      ***


 


7.             Purchase
Order/Invoicing Requirements


 


•      ***


 


8.             Documents
to Accompany Batch Release: ***.


 


9.             Commercial
Launch Date (Section 3.3):  ***.


 


10.           Territory: ***


 


11.           Exclusivity
(***):


 


51

















 


12.           Activity/Responsibility
Summary:  ***


 


	
  Activity / Responsibility

  	
   

  	
  PFIZER

  	
   

  	
  COMPANY

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


52

















 


	
  Activity / Responsibility

  	
   

  	
  PFIZER

  	
   

  	
  COMPANY

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


13.           Other
Terms and Conditions:


 


***


 


14.           Contacts (Excluding QA):


 


***


 


 


	
  DRAXIS PHARMA, a division

  	
  PFIZER
  LABORATORIES (PTY) LTD.

  
	
  of DRAXIS Specialty Pharmaceuticals Inc.

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ John Durham

  	
   

  	
  By:

  	
  /s/ A.M.
  Bush

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  John Durham

  	
   

  	
  Name:

  	
  A.M. Bush

  	
   

  
	
  Title:

  	
  President,
  DRAXIS Pharma division

  	
   

  	
  Title:

  	
  Regional Director

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ John Raney

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Name:

  	
  John Raney

  	
   

  
	
   

  	
  Title:

  	
  Commercial
  Director

  	
   

  
											



 


With a courtesy copy
to:  Pfizer Canada Inc.,


Senior Legal Counsel


Fax: (905) 968-2008


 


And to:


 


DRAXIS Health Inc.


General Counsel and
Secretary


Fax: (514) 630-7159


 


53

















 


Schedule “C” .


 


PFIZER
Owned Equipment,


Dedicated Change Parts
and/or Tooling


 


Tooling:


 


1.     ***


 


2.     ***


 


3.     ***


 


4.     ***


 


5.     ***


 


54

















 


Schedule “D” .


 


Approved Carriers


 


Andlauer
Transportation Services Inc.


Logisti-Solve
Inc.


South
Central Transport


 


55

















 


Schedule “E” .


 


Raw Materials to be supplied by
PFIZER. (Section 3.9)


 


1.     ***


2.     ***


3.     


 


56

















 


Attachment A  .


 


Canada Product / Price
List


 


Please see attached.


 


57

















 


	
   

  	
  ATTACHMENT A

  
	
   

  
	
  CANADA PRODUCT / PRICE LIST WITH DRAXIS PHARMA INC.

  
	
  ***

  
	
   

  
	
  08/Jul/2004

  16:54

  	
  ***

  
			



 


	
  Material

  	
   

  	
   

  	
   

  	
  2003

  	
   

  	
  2004 Pricing

  	
   

  	
  2004 Pricing

  	
   

  	
  2004 Pricing

  	
   

  
	
  Number

  	
   

  	
   

  	
   

  	
  Pricing

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  ***

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  ***

  	
   

  
	
   

  	
   

  	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  	
  ***

  	
   

  
	
  ***

  	
   

  	
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58

















 


	
   

  	
   

  	
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* Excludes freight, duty and any other
costs.


 


59

















 


Attachment B .

Quality Agreement


 


 


QUALITY AGREEMENT


 


 


BETWEEN


 


 


PFIZER CANADA INC. (“PFIZER”)


 


 


AND


 


 


DRAXIS PHARMA INC. (“COMPANY”)


 


 


EFFECTIVE DATE:  October 4, 2004


 


 


DATE OF ISSUE:  September 20, 2004


 


60