MANUFACTURING QUALITY AGREEMENT

This Manufacturing Quality Agreement (hereinafter "Agreement"), is made and effective [DATE],

BETWEEN: [MANUFACTURER/COMPANY NAME] a Limited Liability Company (hereinafter called the “Manufacturer”) organized and existing under the laws of the [STATE/PROVINCE] with its head office located at:

[COMPLETE ADDRESS]

 

AND: [CUSTOMER/COMPANY NAME] a Limited Liability Company ( hereinafter called the “Customer”) organized and existing under the Laws of the [STATE/PROVINCE]; located at:

[COMPLETE ADDRESS]

 

WHEREAS the Manufacturer supplies [DESCRIBE PRODUCT] suitable for use to the Customer and;

 

WHEREAS the Manufacturer is involved in the manufacturing, selling and distribution of [DESCRIBE PRODUCT] to the Customer.

 

 

NOW, THEREFORE, THE PARTIES AGREE AS FOLLOWS:

 

PRODUCTS

COVERED

BY THE AGREEMENT

 

This

agreement

pertains

to

the

following

produc

t(s)(or

product

processes/types/locations,

etc.

),

hereafter

referred

to

as Products

:

 

[LIST PRODUCTS]

 

 

QUALITY

&

CRITERIA

 

2.1 The Manufacturer will manufacture, test and release the product in accordance with the following quality criteria:

 

[LIST QUALITY CRITERIA]

 

2.2 This Quality Agreement will outline the responsibilities of the Manufacturer and the Customer with regard to the quality activities described in the quality criteria listed above.

 

 

SITE(S)

INVOLVED

 

The s

ites

manufacturing the

Products

are

mutually agreed upon

and

located at:

 

[MANUFACTURING SITE LOCATION]

 

 

USE

OF

THIRD

PARTIES

 

If

the

Manufacturer

uses third parties to manufacture, package, label,

test or release the product(s)

, such use is set forth

[

LIST HERE OR

SPECIFY ATTACHMENT

]

.

 

 

Changes

in the use of third parties as

set forth

in this agreement will not be made without prior written

notification

to

the

Customer.

The

Manufacturer

shall,

however

, retain

all obligations under this Agreement

whether

a

third

-party

manufacture

, packages, labels, inspects, tests, releases

or handles

the produc

t

(

s

)

.

 

 

TERM

OF AGREEMENT

 

5.1 This Agreement shall become effective and binding upon the date of the final signature and shall remain in effect until [TOTAL YEARS] years after the last delivery of product(s) by the Manufacturer to the Customer unless the Customer specifically requests an extension of the Agreement. Either party may terminate this Agreement by giving 6 (six) months written notice to the other party. After such termination, and if so, requested by the Customer, the Supplier will negotiate with the Customer in good faith a subsequent Quality Agreement.

 

 

ASSIGNMENT

 

6.1 Neither party shall have the right to assign any or all of its rights or obligations under this agreement without the other party’s prior written consent, which shall not unreasonably be withheld. The foregoing notwithstanding, prior written consent shall not be required in connection with a merger, consolidation, or a sale of all or substantially all of party’s assets to a third party, except if such merger, consolidation, or sale is with a competitor of the other party.

 

 

OTHER AGREEMENTS

 

7.1 If a Manufacturer and/or Supply Agreement is in place between the Manufacturer and the Customer, and there are any inconsistencies between the Manufacturer and/or Supply Agreement and the Quality Agreement, the Manufacturer and/or Supply Agreement will take precedence over the Quality Agreement.

 

 

COMPLIANCE

 

The Manufacturer and Customer c

onform

to

the quality criteria defined in

Section 2 of this

agreement.

 

The Manufacturer and Customer m

utually

agree

upon

specifications

for

the

products

which

are

the

subject

of

this

agreement.

 

Changes to the agreed upon specifications must

be mutually agreed upon and communicated in

writing between the parties to this agreement,

except

for

compendial

changes

which

can

be

implemented

without

mutual

agreement.

Compendial changes must be implemented by

the

compendial

implementation

date.

 

The Manufacturer and Customer ensure

that

the

specifications

for

compendial

products

are

in

compliance

with

the

current

compendia.

 

The Manufacturer agrees to m

anufacture

products

that

conform

to

the

mutually

agreed

upon

specifications.

 

Upon request,

the Manufacturer will

disclose to the Customer recent

regulatory

agency

inspections

and

findings

pertaining

to

the products

.

 

The Manufacturer and Customer will promptly notify one another

if,

in

the

course

of

a

regulatory

inspection,

negative

findings

are

made

related

to

the

quality

of

the

products

supplied.

 

The Manufacturer s

hall have a quality agreement with third parties

used

for

production,

packaging,

testing

or

processing the produc

ts in any manner, which

could

be

viewed

during an

audit.

 

MANUFACTURING, PACKAGING AND LABELING

 

The Manufacturer shall d

ocument

that

manufacturing

and

packaging

process

are

fit

for

purpose.

 

The Manufacturer shall d

emonstrate

the

commissioning of critical systems and equipment

used

in

the

manufacture

and

control

of

the

product.

 

The Manufacturer shall d

emonstrate that cleaning procedures

are appropriate, and their effectiveness has been

proven

.

 

Product s

amples

will

be

retained

for

a

period

of

[TOTAL YEARS] years by the Manufacturer.

 

The Manufacturer and Customer agree

upon

special

labelling

requirements.

 

 

DOCUMENTATION AND RECORDS

 

The Manufacturer agree to provide a Certificate of Analysis with the release of each product batch sent to the Customer.

The C

ertificate

of

Analysis

will

be

prepared

according

to

an

agreed

upon manner

that

is

defined

below:

 

[DEFINE MANNER]

 

The Manufacturer and Customer agree upon the special Certificate of Analysis requirements.

 

Where applicable, electronic signatures used on

the Certificates of Analysis must conform to the

requirements agreed upon

in

this agreement.

 

Records

required

by

the

agreed

upon

quality

system

will

be

maintained

for

a

period

of

[TOTAL YEARS]

years

by the Manufacturer.

 

 

STORAGE AND DISTRIBUTION

 

The Manufacturer will m

aintain and supply upon request documentation that supports the recommended storage and transportation conditions plus re- evaluation or expiry dates.

 

The Manufacturer

and Customer e

nsure

s

that products are stored and shipped according with the manufacturer’s recommended storage conditions.

 

Where applicable,

the Manufacturer and Customer

agree upon requirements for reusable shipping containers.

 

 

CHANGE CONTROL

 

12.1 Any changes made by the Manufacturer will be evaluated and communicated based upon agreed criteria and timelines or specified alternative that is defined in this agreement.

 

 

NON-CONFORMANCE

 

The Manufacturer will investigate any and all

non-conformance

.

Where applicable this includes the identification

of the root cause, a risk analysis (including the

risk to other lots and the impact to other test

results) of the actions taken for correction of the

problem, prevention of future occurrence and the

formal

conclusion

by

Manufacturer

’s

Quality Assurance

.

 

If an investigation reveals that there

is

an

impact

to

products

received

by

the

Customer,

Manufacturer

shall

inform

Customer

without unreasonable delay.

If

significant

deviations

from

an

established

process are recorded, there should be evidence

of

suitable

investigations

and

a

review

of

quality

of the

products

.

 

The Manufacturer will have

a

written

procedure

to

investigate

and

document

quality

related

complaints.

A

root

cause

analysis,

actions

taken

for

correction

of the problem

, prevention of future occurrence and

the

formal

conclusion

will

be

provided

to

the

Customer within a reasonable time after receipt

of the complaint.

 

Complaints

made

by the Customer

shall

at

least

indicate

the

Manufacturer’s

batch

number

of

the

product

and

complaint

subject.

The

complaint

shall

be

communicated

to

the

Manufacturer

within

a

reasonable

time

after

receipt

of

the

product

.

Samples will be provided where appropriate and

available.

 

Both

parties shall cooperate in the exchange of

information

required

to

effectively

conduct

an

investigation.

 

In the c

ase of a recall of the product

s,

the Manufacturer

shall

inform

the

Customer

without

unreasonable

delay

of

the planned

recall.

 

The Manufacturer will have

a

written

recall

procedure

and will follow it

.

 

The C

ustomer

shall

notify

Manufacturer

of

a

product recall which has been investigated or is

under

investigation

and

has

potential

to

be

related

to

the

quality

of

the

produc

ts,

as

soon

as possible.

 

 

AUDITING

 

The Customer has the right to audit Manufacturer’s facilities, systems and documentation, as they relate to the manufacture of products, at mutually agreed upon times.

 

The Manufacturer will allow the Customer to audit facilities, systems and documentation, as they relate to the manufacture of products, at mutually agreed upon times.

 

If required, a confidentiality agreement will be executed within a reasonable period of time prior to the audit.

 

The Customer shall issue a confidential written audit report to the Manufacturer, which will include audit observations, within [NUMBER OF DAYS] days; a mutually agreed

upon timeline.

 

Manufacturer shall issue responses within [NUMBER OF DAYS] days (mutually agreed upon timeline) to all observations in writing to Customer Quality Assurance. Where the Manufacturer commits to a corrective action, a description and time frame for completion will be included in the written response.

 

Where applicable, both parties agree upon requirements for auditing third parties used in association with production of products, processing, warehousing, or testing.

.

 

TERMINATION

 

15.1 Either party may terminate this agreement due to a breach of the terms herein by serving a One (1) month notice on the party in breach.

 

 

ARBITRATION

 

16.1 In the event of a dispute between the parties herein, they may refer to an arbitrator to settle the dispute.

 

 

 

LEGAL COUNSEL

 

17.1 Each of the Parties acknowledges and agrees that they have had the opportunity to have this Agreement reviewed by legal counsel and either they have done so or waived that right. The Parties agree that they are entering into this Agreement voluntarily and with full understanding of the Terms contained herein.

 

 

ENTIRE AGREEMENT

 

18.1 This written Agreement constitutes the entire agreement between the Parties. No other understanding, whether written or oral, made prior or contemporaneous with this Agreement, shall be in given effect and this Agreement shall supersede any other communication between the Parties as to the subject matter contained herein.

 

 

GOVERNING LAWS

 

19.1 This Agreement shall be governed in all respects by the laws of the [STATE/PROVINCE]

 

 

 

IN WITNESS WHEREOF, the parties have executed this agreement at [ DESIGNATE PLACE OF EXECUTION] with full knowledge of its content and significance and intending to be legally bound by the terms hereof the day and year first above written.

 

 

SUPPLIER CUSTOMER

 

 

 

Authorized Signature Authorized Signature

 

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