SUPPLY AGREEMENT

Supply Agreement

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Questcor Pharmaceuticals, Inc

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Title: SUPPLY AGREEMENT
Governing Law: California Date: 3/30/2004
Industry: Biotechnology and Drugs Sector: Healthcare

SUPPLY AGREEMENT, Parties: questcor pharmaceuticals inc

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Exhibit 10.30

SUPPLY AGREEMENT

THIS SUPPLY AGREEMENT is as entered into as of this 1st day of April, 2003

("Effective Date") between Questcor Pharmaceuticals, Inc., a corporation

organized under the laws of the State of California and having a place of

business at 3260 Whipple Road, Union City, California 94587 U.S.A. ("Questcor")

and Diagnostic Chemicals Limited, doing business as BioVectra dcl, a corporation

organized under the laws of Prince Edward Island and having a place of business

at 16 McCarville Street, Charlottetown, Prince Edward Island, C1E 2A6 Canada

("BioVectra") (each individually a "Party" and collectively the "Parties").

WITNESSETH:

WHEREAS, Questcor wishes to purchase from BioVectra and BioVectra desires to

sell to Questcor the Product (as hereinafter defined); and

WHEREAS, BioVectra represents that it has the technical and scientific

experience and expertise necessary to perform manufacturing, packaging,

analytical testing and/or quality assurance services for the manufacturing and

bulk packaging of such Product, and to handle materials associated with

manufacture of such Product in a safe and environmentally sound manner; and

WHEREAS, Questcor desires BioVectra to perform such services as set forth herein

and manufacture such Product for Questcor, and BioVectra desires to perform such

services and manufacture such Product for supply to Questcor or its designee,

all on the terms and conditions set forth in this Agreement;

NOW, THEREFORE, in consideration of the mutual covenants and promises set forth

herein, the Parties agree as follows:

1. DEFINITIONS

The following terms, whether used in the singular or plural, shall have the

meanings assigned to them below for purposes of this Agreement:

1.1 "Act" shall mean the United States Federal Food, Drug and

Cosmetics Act, as amended, and the regulations promulgated

under such Act.

1.2 "Affiliate" shall mean any corporation or non-corporate entity

that controls, is controlled by, or is under common control

with a Party. For purposes of this Section 1.2, "control,"

whether used as a noun or a verb, means the possession,

directly or indirectly, of the power to affirmatively direct,

or affirmatively cause the direction of, the management and

policies of an entity, whether through the ownership of voting

securities, by contract, or otherwise.

1.3 "Agreement" shall mean this Supply Agreement and any Schedules

appended hereto, as may be amended from time to time.

1.4 "API" shall mean Active Pharmaceutical Ingredient.

1.5 "Certificate of Compliance" shall mean a document indicating

that each batch of Product was manufactured in compliance with

cGMP, and that all deviations were

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evaluated for impact on Product.

1.6 "COA" shall mean Certificate of Analysis.

1.7 "Confidential Information" shall mean all proprietary

information, data and know-how of each Party, whether

disclosed orally or visually or in written, graphic,

electronic or other tangible form, which is disclosed by a

Party or any of its Affiliates (the "Disclosing Party") to the

other Party or any of its Affiliates (the "Receiving Party")

or which the Receiving Party obtains in the course of its

performance pursuant to this Agreement, and which: (a) if in

written, graphic, electronic or other tangible form, is

labeled as confidential or proprietary; (b) if disclosed

orally or visually, is identified as confidential or

proprietary at the time of disclosure and is confirmed to be

confidential or proprietary by the Disclosing Party in writing

to the Receiving Party within thirty (30) calendar days of

such disclosure; or (c) by its nature, should reasonably be

considered to be confidential or proprietary. With respect to

Questcor, "Confidential Information" shall be deemed to also

include (i) the Specifications; (ii) the Questcor Technology;

and (iii) all business, financial and technical data of

Questcor such as information regarding Questcor's plans,

plants, processes, products, costs, equipment, operations,

marketing plans, forecasts, customers or suppliers. With

respect to BioVectra, "Confidential Information" shall be

deemed to also include (i) its manufacturing processes and

practices; (ii) the BioVectra technology; and (iii) all

business, financial and technical data of BioVectra such as

information regarding BioVectra's plans, plants, processes,

products, costs, equipment, operations, marketing plans,

forecasts, customers or suppliers.

1.8 "Delivery Point" shall mean the Questcor ship-to location

specified in the applicable Purchase Order for shipment of the

ordered Product.

1.9 "FDA" shall mean the United States Food and Drug

Administration or any successor entity thereof having or

performing substantially the same function.

1.10 "Firm Order" shall mean a binding commitment in writing made

by Questcor to purchase Product in accordance with Section 5.

1.11 "cGMP" shall mean all laws, guidelines and regulations

applicable to the manufacture of Product including the current

Good Manufacturing Practices as specified in the United States

Code of Federal Regulations, as the same may be amended or

re-enacted from time to time, and international guidelines and

regulations such as ICH Q7A.

1.12 "Non-Process Related Impurities" shall mean any substance that

would not be present as a result of the process used to

manufacture Product in compliance with cGMP.

1.13 "Product" shall mean the chemical substances or the

formulation(s) thereof thereof listed in Schedule 1, attached

hereto.

1.14 "Product Recall" shall mean any recall, withdrawal, field

correction or other action to

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recover possession of quantities of the Product shipped or

sold to Third Parties resulting in the event that (i) any

government authority or other regulatory agency issues a

request, directive or order that any Product or drug products

derived from Product be recalled, (ii) a court of competent

jurisdiction orders such a recall, (iii) Questcor reasonably

determines after consultation with BioVectra that any Products

should be recalled because they do not conform to the

Specifications or other requirements of this Agreement at the

time of shipment by BioVectra or (iv) Questcor reasonably

determines that any Products should be recalled for any

reason.

1.15 "Purchase Order" shall mean a written order for the purchase

of Product duly executed by Questcor and transferred to

BioVectra via mail, facsimile or electronically, and setting

forth the quantity of Product ordered, the required delivery

date, the Delivery Point, the price for the Product, the

Purchase Order number, the name of the requester, and any

special terms and conditions relevant to the particular

Purchase Order (special terms and conditions are those that

are not preprinted).

1.16 "Quality Assurance" shall mean the total organized

arrangements made with the object of ensuring that Product is

of the quality required for its intended use and that quality

systems are maintained so that all of the provisions set forth

in Section 7.1.1 and in Section 9 of this Agreement are met.

1.17 "Quarter" shall mean the period of three consecutive calendar

months ending 31 March, 30 June, 30 September and 31 December.

1.18 "Change" or "Deviation" shall mean any planned or unplanned

deviation, variance or change.

1.19 "Specifications" shall mean the specifications and quality

assurance and other testing for the Product which will be

attached hereto as Schedule 2, and made a part hereof, as

determined in accordance with the analytical methodology set

forth therein, as such Specifications may be amended from time

to time in writing by mutual agreement of the Parties.

1.20 "Third Party" shall mean any party other than Questcor,

BioVectra and their respective Affiliates and agents.

1.21 "Section" shall mean a Section of this Agreement.

1.22 "NDA" means a New Drug Application as defined in and

contemplated by the Act.

1.23 "DMF" means the Drug Master File pertaining to the manufacture

of the Product.

2. SUPPLY OF PRODUCT

2.1 Supply and Purchase. BioVectra agrees to manufacture for and

supply to Questcor or its designee on an exclusive basis such

quantities of Product as Questcor may order from BioVectra,

and Questcor agrees to purchase such quantities of Product

from

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BioVectra, in accordance with the terms and conditions of this

Agreement. Questcor shall be obligated to purchase a minimum

of One Hundred Eighty (180) kilograms of Product under this

Agreement.

2.2 Equipment. Questcor will provide to BioVectra at no cost to

BioVectra the equipment required to manufacture Product in

accordance with the manufacturing process specified by

Questcor, which equipment (and the location thereof) are

listed on Schedule 5 attached hereto. BioVectra will be

responsible for the costs of installation of the equipment,

and providing adequate facilities to house the equipment.

BioVectra will receive written authorization from Questcor

prior to contracting to purchase additional equipment as may

be required to produce Product for Questcor hereunder.

2.3 Applicability and Hierarchy of Terms. The terms and conditions

of this Agreement shall apply to any Purchase Order issued by

Questcor to BioVectra during the term of this Agreement for

the Product that is the subject of this Agreement, whether or

not this Agreement or its terms and conditions are expressly

referenced in the Purchase Order. In the event of a conflict

between the pre-printed terms provided in any Purchase Order

and the terms of this Agreement, the terms of this Agreement

shall prevail.

2.4 Maintenance of Equipment. BioVectra shall be responsible for

maintaining Questcor equipment (and any other BioVectra

equipment required to manufacture Product) in good working

order. Maintenance required of BioVectra includes, but is not

limited to, preventative maintenance, calibration and repairs.

2.5 Use of Questcor Equipment. Questcor equipment is to be only

used to manufacture the Product for Questcor hereunder.

3. TERM AND TERMINATION

3.1 Term. This Agreement shall commence on the Effective Date and

shall continue in effect through December 31, 2007 (the

"Initial Term"), unless terminated earlier as provided herein.

Questcor, with the prior written approval of BioVectra, may

extend this Agreement for successive two (2) year periods

(each an "Extension Period") by giving BioVectra written

notice of such extension of the Agreement at least ninety (90)

calendar days prior to the expiration of the Initial Term or

the applicable Extension Period, as the case may be, provided,

however, that any refusal by BioVectra shall not be effective

unless and until it provides for at least twenty-four (24)

months prior written notice to Questcor of BioVectra's

intention to end this supply relationship.

3.2 Termination Without Cause. Questcor may terminate this

Agreement at any time without cause upon twelve (24) months

prior written notice to BioVectra. Such termination shall not

affect the Parties' obligations with respect to Purchase

Orders issued to BioVectra by Questcor, nor relieves Questcor

of its obligation to purchase minimum quantities as specified

in Section 2.1 prior to the effective date of such

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termination. BioVectra may terminate this Agreement without

cause and without liability upon twenty-four (24) months prior

written notice to Questcor, during which period Questcor shall

endeavor in good faith to locate and qualify a substitute

manufacturer for Product, but if such manufacturer cannot be

located and/or qualified in such period, this Agreement shall

be extended for one six (6) month period to give Questcor

additional time to locate and qualify such a manufacturer

3.3 Termination for Cause. Without prejudice to any other

available legal or equitable rights or remedies, the Parties

may terminate this Agreement immediately upon written notice

to the other Party as follows:

3.3.1 Material Breach. Either Party may terminate this

Agreement in the event of the material breach by the

other Party of the terms and conditions hereof

("Default"), through no fault of the non-Defaulting

Party, which remains uncured ninety (90) calendar

days after the non-Defaulting Party provides written

notice of such Default to the Defaulting Party;

provided however, that in the event that the

Defaulting Party reasonably believes that the Default

is incapable of being cured within such ninety (90)

day period, then the Defaulting party shall provide

written notice to the non-Defaulting Party within

seven (7) calendar days from the date of the notice

of such Default, specifying that such Default is not

capable of being cured within such period and the

actions the Defaulting Party is taking to diligently

cure such Default, and the non-Defaulting Party may,

in its sole discretion, agree in writing to extend

the time period for curing such Default for up to an

additional thirty (30) calendar days or such time as

is reasonably necessary to cure such Default.

3.3.2 Insolvency; Bankruptcy. Either Party may terminate

this Agreement in the event that the other Party (a)

becomes insolvent; (b) makes an assignment for the

benefit of creditors; (c) files or has filed against

it a petition in bankruptcy; (d) has a receiver

appointed for its assets; or (e) is dissolved or

liquidated.

3.3.3 Continued Manufacture. Termination under this Section

3.3 shall not cause Product to be unavailable to

persons who are in need thereof. In the event this

Section 3.3 becomes applicable, the Parties agree to

collaborate in good faith to develop a new source of

manufacture thereof so as to keep Product available

in the marketplace for the benefit of the users

thereof. Questcor agrees to diligently locate and

qualify a new manufacturer of the Product and

BioVectra agrees that it will not discontinue

manufacture of the Product until such new

manufacturer is qualified; provided, however, that if

BioVectra's inability to manufacture specification -

conforming Product is the basis for termination under

Section 3.3.1 above, then Questcor shall not obligate

BioVectra to manufacture further non-conforming

Product, but BioVectra agrees that it will, to the

best of its ability, correct any deficiencies at its

own expense and manufacture specification-conforming

Product hereunder after

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any such notice of termination is received until such

new manufacturer is qualified.

3.3.4 Transfer of Materials and Equipment. If this

Agreement is terminated under this Section 3.3,

BioVectra shall promptly transfer to Questcor or

Questcor's designee, at Questcor's written request

and expense, all raw materials purchased by Questcor

and supplied to BioVectra and all Questcor equipment.

4. PRICE AND PAYMENT

4.1 Price of Product. The price for Product provided hereunder

shall be as set forth in Schedule 3 to this Agreement. Such

prices shall be firm through the entire "Initial Term" and

through any subsequent contract extensions.

4.2 Price Adjustments. The price for Product may only be adjusted

as provided in Schedule 3 hereto.

4.3 Billing and Payment. BioVectra will submit invoices to

Questcor at the address designated in the applicable Purchase

Order. Invoices shall include the following information, where

applicable: the description and quantity of Product delivered;

the date of shipment of Product; the price for the Product;

any applicable taxes, transportation charges or other charges

provided for in the applicable Purchase Order; and the

applicable Purchase Order number. Questcor shall pay all

invoices to BioVectra in U.S. dollars within thirty (30) days

from when the Product is delivered to or on behalf of Questcor

at the Delivery Point, provided that: i) Questcor has received

from BioVectra complete and accurate certificates of analysis

and any other Process records required to be provided to

Questcor pursuant to the provisions of Section 9 for such lot;

ii) Questcor or its designee has actually received the

applicable lots of Product; and iii) the lot (or partial lot)

is not rejected by Questcor or its designee. In the event that

any shipment does not contain the entire invoiced quantity of

Product, Questcor shall only be obligated to pay for the

quantity of Product actually received by or on behalf of

Questcor. Payment by Questcor shall not result in a waiver of

any of its rights under this Agreement.

4.4 Documentation Delays. For each day that such complete and

accurate required documentation is delayed, the due and

payable date of the related invoice will be delayed by one (1)

business day. Questcor will notify BioVectra if payment is to

be delayed due to incomplete or inaccurate documentation

stating in sufficient detail the reasons therefor. Questcor

shall not be obligated to make payment for a lot of Product if

Product is rejected. If a lot of rejected Product is

subsequently approved by Questcor, Questcor shall pay

BioVectra for such lot within thirty (30) calendar days

following such approval date.

4.5 Disputed Amounts. If Questcor disputes in good faith all or

any portion of any invoice submitted by BioVectra, Questcor

shall be required to pay that portion of the invoiced amount

that is not in dispute. In such event, Questcor shall notify

BioVectra in writing of the amount and nature of the dispute

within thirty (30) calendar days

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after receipt of the applicable invoice, and the Parties shall

promptly attempt in good faith to amicably resolve such

dispute. Once the matter is resolved, Questcor shall promptly

pay any amount as may be due BioVectra.

4.6 Taxes. The Prices stated in this Agreement or a Purchase Order

include all taxes except such sales and use taxes that

BioVectra is required by law to collect from Questcor. Such

taxes, if any, will be separately stated in BioVectra's

invoice and will be paid by Questcor to BioVectra unless an

exemption is available. BioVectra shall be responsible for the

timely payment of all such taxes to the applicable taxing

authority, and BioVectra shall pay (without reimbursement by

Questcor), and shall hold Questcor harmless against, any

penalties, interest or additional taxes that may be levied or

assessed as a result of the failure or delay of BioVectra to

pay any taxes. Questcor shall be responsible for any duties

that result from BioVectra shipping Product to any Questcor

designated Delivery Point.

5. FORECASTS AND FIRM ORDERS

5.1 Forecasts. Questcor shall provide to BioVectra quarterly

forecasts of its estimated requirements for Product

("Forecast"). Questcor shall provide such Forecasts to

BioVectra at least sixty (60) calendar days before the

beginning of each calendar Quarter during the Term of this

Agreement (beginning with the first Quarter in which Questcor

intends to purchase Product hereunder), and such Forecasts

shall provide an estimate of Questcor's requirements for

Product for such Quarter and for the next succeeding three (3)

Quarters. Such Forecasts shall be estimates for planning

purposes only and shall not constitute commitments by Questcor

to purchase Product. Questcor shall only be obligated to

purchase such quantities of Product as may be ordered by

Questcor pursuant to a Purchase Order issued by Questcor to

BioVectra, as provided in Section 5.2 below.

5.2 Firm Orders. BioVectra will provide Product to Questcor

pursuant to orders placed by Questcor in the form of

individual Purchase Orders issued by Questcor to BioVectra. At

least forty-five (45) calendar days prior to the beginning of

each Quarter during the Term of this Agreement, beginning with

the first Quarter in which Questcor intends to purchase

Product under this Agreement, Questcor shall issue a Purchase

Order for its requirements of Product for such Quarter.

Questcor shall ensure that BioVectra has sufficient raw

materials therefor in accordance with Section 9.2.1 below.

6. DELIVERY; ACCEPTANCE; TITLE; RISK OF LOSS

6.1 Delivery of Product. BioVectra will deliver Product to

Questcor FOB, Charlottetown, per UCC Section 2-319(1)(a), at

the Delivery Point by the date(s) specified in the applicable

Purchase Order (the "Delivery Date"). BioVectra may not

deliver Product more than seven (7) calendar days prior to

such Delivery Date without the prior written consent of

Questcor. Questcor shall not be obligated to accept any

untimely, incomplete shipments less than sixty five percent

(65%) of the Purchase

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Order amount or excessive shipments greater than one hundred

thirty five percent (135%) of the Purchase Order amount, and

such shipments, in whole or in part, may, at Questcor's

option, be returned to BioVectra or held for disposition at

BioVectra's expense and risk.

6.2 Timely Delivery. In the event that BioVectra fails to deliver

fully conforming Product by the Delivery Date, Questcor, at

its option and in addition to any of its other rights or

remedies, may: (a) require BioVectra to expedite delivery of

Product at BioVectra's own expense; (b) extend the required

Delivery Date; or (c) cancel the applicable Purchase Order.

6.3 Transportation. BioVectra will be responsible for routing of

all freight, unless Questcor specifies otherwise in writing

for a particular Purchase Order. Questcor shall be responsible

for all transportation charges on Product shipped from

BioVectra to Questcor or its designee, subject to Section

6.2(a) above. BioVectra shall bear the cost of transportation

for Product shipped to Questcor or its designee to replace

non-conforming or defective Product, and BioVectra shall bear

the cost of transportation for Product returned to BioVectra

by Questcor due to any defect or non-conformance, whether for

the convenience of BioVectra or pursuant to a demand by

Questcor as provided herein.

6.4 Title and Risk of Loss. Title to and risk of loss of or damage

to the Product sold hereunder shall pass to Questcor upon

loading of the Product at BioVectra, Charlottetown. Questcor

shall assume the risk of loss of or damage to the Product

after such loading of the Product at BioVectra, except to the

extent that such loss or damage results from the negligence or

willful misconduct of BioVectra or its representatives, for

which BioVectra shall retain the risk of loss of or damage to

Product.

6.5 Acceptance; Rejection. All Product delivered by BioVectra to

Questcor or its designee shall be subject to inspection by or

on behalf of Questcor and Final Release (as defined in Section

9 below) by Questcor's Quality Assurance representative.

Questcor may, on written notice to BioVectra within sixty (60)

calendar days from receipt of delivery, reject any Product

that does not fully conform to the requirements of this

Agreement and the applicable Purchase Order, and Questcor may

return any shipment or any portion of any shipment that does

not fully conform. Payment for Product by Questcor shall not

constitute acceptance thereof. Questcor may revoke its

acceptance of any Product in the event that any

non-conformance is discovered after acceptance by Questcor.

7. REPRESENTATIONS AND WARRANTIES

7.1 Warranties by BioVectra. BioVectra represents and warrants to

Questcor that:

7.1.1 Product. All Product provided to Questcor by

BioVectra pursuant to this Agreement:

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(a) Will conform in all respects with the

Specifications for such Product in effect at

the time title to such Product passes from

BioVectra to Questcor pursuant to this

Agreement;

(b) Will not be adulterated or misbranded within

the meaning of the Act or any similar law of

any other jurisdiction; will be free from

Non-Process Related Impurities; and will be

free of any defects;

Deviation(s) unless approved in writing by

Questcor prior to release by BioVectra and

subsequent delivery of the Product to

Questcor or its designee;

(d) Will conform to and will be manufactured,

packaged, labeled, stored and shipped in

conformity with FDA regulations, cGMP

requirements, the Specifications, the NDA

pertaining to the Product, and all

applicable national, federal, state,

provincial, and local laws, orders, rules

and regulations.

(e) Will be manufactured, packaged and stored in

facilities that are approved by the

applicable regulatory authorities for the

manufacture of Product at the time of such

manufacture, packaging and storage, to the

extent such approval is required by law or

regulation.

7.1.2 Title. BioVectra has good title to all Product

provided to Questcor pursuant to this Agreement and

passes such title to Questcor free and clear of any

security interests, liens, or other encumbrances.

7.1.3 Debarment. BioVectra represents and warrants that it

is not debarred under subsections 306(a) or (b) of

the Act and that it has not and will not use in any

capacity the services of any person or entity

debarred under such law with respect to its

performance of this Agreement. BioVectra will

immediately notify Questcor in the event that it or

any such person or entity is debarred during the term

of this Agreement.

7.1.4 No Conflict. The execution, delivery and performance

of this Agreement by BioVectra does not conflict with

any agreement, instrument or understanding, oral or

written, to which it is a party or by which it may be

bound, and does not violate any law or regulation of

any court, governmental body or administrative or

other agency having authority over it; BioVectra is

not currently a party to, and during the term of this

Agreement will not enter into, any agreements, oral

or written, that are inconsistent with its

obligations under this Agreement.

7.1.5 Authority. BioVectra is validly existing and in good

standing under the laws of the province of its

incorporation and has the corporate power and

authority to enter into this Agreement. This

Agreement has been duly executed and delivered by

BioVectra and constitutes the valid and binding

obligation of BioVectra, enforceable against it in

accordance with its terms except as

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enforceability may be limited by bankruptcy,

fraudulent conveyance, insolvency,

reorganization, moratorium and other laws

relating to or affecting creditors' rights

generally and by general equitable

principles. The execution, delivery, and

performance of this Agreement have been duly

authorized by all necessary action on the

part of BioVectra, its officers and

directors.

7.2 Breach of Warranty by BioVectra. In the event that

any Product does not meet any of BioVectra's

warranties then, in addition to any other rights or

remedies available to Questcor, BioVectra shall, at

Questcor 's option, either use its best efforts to

replace the non-conforming Product as soon as

practicable or promptly refund the payments by

Questcor for such non-conforming Product.

7.3 Independent Laboratory Testing. If Questcor and

BioVectra are unable to agree as to whether any

Product conforms to the Specifications for such

Product, the Parties shall cooperate to have the

Product in dispute analyzed by an independent testing

laboratory of recognized repute selected by BioVectra

and approved by Questcor, which approval shall not be

unreasonably withheld, conditioned or delayed. The

results of such laboratory testing shall be final and

binding on the Parties on the issue of conformance of

the Product to the Specifications. If the Product is

determined to so conform, then Questcor shall bear

the cost of the independent laboratory testing and

pay for the Product in accordance with this

Agreement. If the Product is determined not to

conform, then BioVectra shall bear the cost of the

independent laboratory testing, and BioVectra shall,

at Questcor's sole discretion, within thirty (30)

calendar days of the date of such determination,

either replace the rejected Product at no cost to

Questcor or promptly refund to Questcor the price

paid for such Product.

7.4 Warranties by Questcor. Questcor represents and

warrants to BioVectra that:

7.4.1 No Conflict. The execution, delivery and

performance of this Agreement by Questcor

does not conflict with any agreement,

instrument or understanding, oral or

written, to which it is a party or by which

it may be bound, and does not violate any

law or regulation of any court, governmental

body or administrative or other agency

having authority over it; Questcor is not

currently a party to, and during the term of

this Agreement will not enter into, any

agreements, oral or written, that are

inconsistent with its obligations under this

Agreement.

7.4.2 Authority. Questcor is validly existing and

in good standing under the laws of the state

of its incorporation and has the corporate

power and authority to enter into this

Agreement. This Agreement has been duly

executed and delivered by Questcor and

constitutes the valid and binding obligation

of Questcor, enforceable against it in

accordance with its terms except as

enforceability may be limited by bankruptcy,

fraudulent conveyance, insolvency,

reorganization, moratorium and other laws

relating to or affecting creditors' rights

generally and by general equitable

principles. The execution,

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delivery and performance of this Agreement

have been duly authorized by all necessary

action on the part of Questcor, its officers

and directors.

8. PRODUCT RECALLS

8.1 Cooperation. In the event of any Product Recall, the Parties

shall take all appropriate corrective actions and shall

cooperate in the investigations and all necessary activities

surrounding the Product Recall.

8.2 Consultation. In the event that BioVectra or Questcor

determines that Product should be recalled, the Parties shall

consult with each other prior to taking any corrective

actions. Given that in the marketplace the Product is or will

be associated with Questcor, in no event shall BioVectra

institute a Product Recall without the prior written approval

of an officer of Questcor.

8.3 Product Recall Caused by BioVectra. To the extent that any

Product Recall results from any cause or event arising from

the manufacturing, packaging, labeling, testing, storage, or

handling of the recalled Product by BioVectra, by any breach

of BioVectra's warranties, by any materials or facilities

provided by BioVectra, or otherwise by the acts or omissions

of BioVectra or its agents, BioVectra shall be responsible for

all expenses of such Product Recall.

8.4 Product Recall Caused by Questcor. To the extent that any

Product Recall results from any cause or event arising from

the Specifications, the raw materials supplied by or on behalf

of Questcor, marketing, distribution, shipment, handling

(after title passes to Questcor) or sale of the recalled

Product by Questcor or its Affiliates or designee at the

Delivery Point, or the negligence of Questcor or its

Affiliates or designee at the Delivery Point, Questcor shall

be responsible for all expenses of such Product Recall,

including, without limitation, reasonable and necessary

expenses incurred by BioVectra after written notification to

Questcor and written approval by Questcor therefor.

8.5 Expenses of Product Recall. In the event that a Product Recall

is caused by BioVectra, BioVectra shall be liable to reimburse

Questcor for all expenses of such Product Recall, including,

without limitation, the following: (i) all amounts paid by

Questcor to BioVectra for the Product subject to the Product

Recall, (ii) all reasonable costs and expenses incurred and

not recovered by Questcor directly resulting from such Product

Recall (including, without limitation, shipping charges, hours

spent coordinating the Product Recall, expenses of

notification and destruction or return of the recalled

Product, all costs associated with the distribution of

replacement Product, and all other costs incurred in

connection with such Product Recall). The foregoing remedies

shall be in addition to such other rights and remedies as

Questcor may have under this Agreement and applicable law.

8.6 Disputes Regarding Cause of Product Recall. If the Parties are

unable to agree as to which Party's acts or omissions gave

rise to a Product Recall, such dispute shall be referred for

decision to a mutually agreed upon independent expert of

recognized

[ ] [ ]

BioVectra Questcor BioVectra

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repute (acting as an expert and not as an arbitrator, and who

may be an attorney knowledgeable in FDA/pharmaceutical product

recall law) selected by Questcor and approved by BioVectra,

which approval shall not be unreasonably withheld, conditioned

or delayed. The results of such independent expert shall be

final and binding on the Parties on the issue of which Party's

acts or omissions gave rise to the Product Recall. The costs

of such independent expert shall be borne by the Party

determined to be responsible for the Product Recall.

8.7 Notification Regarding Product Recall. Subject to Section 8.2

above, in the event that any Product Recall is required

because Product violates applicable laws, regulations, agreed

upon Specifications, the NDA pertaining to the Product, or is

deemed unacceptable for some other reason, whether or not such

action is requested by any governmental agency, the initiating

Party shall notify the Quality Assurance Representative of the

other Party as soon as possible, but not later than the end of

the next business day following the decision to implement such

action.

9. QUALITY ASSURANCE

9.1 Change Control. BioVectra will utilize a documented system of

procedures for the control of changes to raw materials,

packaging materials, suppliers, equipment, manufacturing

methods, Product, intermediates and raw materials

specifications, sampling, test methods, and release

requirements, consistent with cGMPs, all applicable laws,

rules and regulations, including the NDA pertaining to the

Product, and industry standards. BioVectra shall not implement

any Change without the express prior written approval of

Questcor. BioVectra will submit any proposed Change to

Questcor in writing for its review, using the Deviation/Change

Form attached hereto as Schedule 4. The Parties will provide

written responses to requests from the other pursuant to this

Section 9.1 as soon as commercially possible but in no event

more than twenty (20) business days from receipt of the

request from the other Party hereto. All updates to

BioVectra's DMF (and any other of BioVectra's regulatory

documents) related to the Product (or manufacture of the

Product) are the responsibility of BioVectra. Updates to

regulatory applications such as the NDA pertaining to the

Product are the responsibility of Questcor

9.2 Raw Materials.

9.2.1 Procurement of Raw Materials. BioVectra will utilize

a documented system of procedures to evaluate,

qualify and approve raw materials and suppliers.

BioVectra is responsible for procuring suitable raw

materials (other than pituitary gland starting

material and oxycellulose gauze) from the approved

and qualified sources.

Questcor, at Questcor's expense, shall provide

pituitary gland starting material and oxycellulose

gauze to BioVectra in amounts required for BioVectra

[ ] [ ]

BioVectra Questcor BioVectra

Page 12 of 42

<PAGE>

fulfill its supply obligations to Questcor hereunder.

In this regard, Questcor will provide sufficient

quantity of appropriate quality pituitary gland

starting material and oxycellulose gauze necessary to

fulfill Questcor's obligation to purchase minimum

quantities of Product as set forth in Section 2.1

above.

9.2.2 Inspection and Testing of Raw Materials. BioVectra

must utilize documented material inspection plans and

testing procedures. The results of this inspection

and testing must be in accordance with BioVectra

established specifications and the NDA pertaining to

the Product.

BioVectra shall inspect all containers of raw

materials (including the pituitary gland starting

material) promptly upon receipt by BioVectra.

BioVectra will inspect and/or test all raw materials

on a batch-by-batch basis. BioVectra may accept and

release certain starting materials utilizing the COA

with abbreviated or no additional testing. However, a

minimum of an identification test is required unless

the material is too hazardous or reactive to sample.

9.2.3 Storage and Handling of Raw Materials. BioVectra

agrees to store and handle the materials under

appropriate conditions, consistent with cGMPs, all

applicable laws, rules and regulations, including the

NDA pertaining to the Product, and industry

standards.

BioVectra agrees to store Product labeling materials

under appropriate controlled and secured conditions,

consistent with cGMPs, all applicable laws, rules and

regulations, including the NDA pertaining to the

Product, and industry standards.

BioVectra shall have all necessary and appropriate

controls in place to prevent cross-contamination of

the raw materials and intermediates used in the

manufacture of Product from other chemicals stored,

used, or manufactured by BioVectra, including but not

limited to potent hormones, cytotoxic compounds,

beta-lactams, hig

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