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 0000 Xxxxxxx Xxxx, Xxxxx Xxxx, Xxxxxxxxxx 00000 X.X.X. ("Questcor")
and Diagnostic Chemicals Limited, doing business as BioVectra dcl, a corporation
organized under the laws of Xxxxxx Xxxxxx Island and having a place of business
at 00 XxXxxxxxxx Xxxxxx, Xxxxxxxxxxxxx, Xxxxxx Xxxxxx Xxxxxx, X0X 0X0 Xxxxxx
("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;
(c) Will not have been manufactured with
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
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Page 11 of 42
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
to
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Page 12 of 42
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, highly potent drugs, biological
preparations or non-pharmaceutical chemicals.
9.2.4 Transmissible Spongiform Encephalopathies (TSE)
Compliance. Upon request by Questcor, BioVectra will
promptly provide a written TSE declaration that all
materials (except porcine pituitary glands and
porcine gelatin supplied by or on behalf of Questcor)
used by BioVectra to manufacture Product are free
from animal derived material. BioVectra shall obtain
such written TSE declarations from each supplier of
raw material used in the manufacturing of Product and
shall maintain such TSE declarations for inspection
by Questcor upon its request.
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If BioVectra is unable to provide the above mentioned
declaration(s), BioVectra must comply with applicable
TSE laws and regulations and must supply all
associated TSE documentation, as requested by
Questcor, during the Term. Such documentation may
include, but is not limited to, an application for a
TSE Certificate of Suitability in accordance with
European Directive 75/318/EEC as amended by directive
1999/82/EEC, the note for guidance EMEA/410/01 rev1,
as amended and AP-CSP (99)4, Appendix 2, as amended.
9.2.5 Certificate of Compliance for Animal Derived
Components. BioVectra is to issue a Certificate of
Compliance (signed by BioVectra's Head of Quality
Assurance) that states that the only animal derived
components used in the manufacture of Product are
porcine pituitary glands and porcine gelatin. This
Certificate of Compliance is to be included in each
lot batch record. The format of a Certificate of
Compliance approved by Questcor is attached hereto as
Schedule 6.
9.3 Product Specifications. BioVectra will manufacture, package,
label and handle all Product in conformance with, and in order
for the Product to be in conformance with, the Specifications
and the NDA pertaining to the Product.
9.4 Manufacturing and Packaging of Product. BioVectra shall
manufacture, package, and label all Product in accordance with
specific procedures and instructions consistent with cGMPs,
all applicable laws, rules and regulations, and the NDA
pertaining to the Product, and industry standards.
BioVectra will prepare all appropriate and required
manufacturing and packaging batch documentation for each batch
of Product manufactured pursuant to this Agreement. BioVectra
shall retain such batch documentation in accordance with any
document retention schedules provided by Questcor and as
required in order to comply with applicable regulatory
requirements. BioVectra will make any such batch documentation
available for review and inspection by Questcor and/or any
regulatory personnel, and BioVectra shall provide to Questcor
all such batch documentation upon the expiration or
termination of this Agreement or upon request by Questcor.
BioVectra shall have all necessary and appropriate controls in
place to prevent cross-contamination of Product 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, highly potent drugs, biological preparations or
non-pharmaceutical chemicals. Beta-lactam and cephalosporin
antibiotics must be handled in facilities separate from those
in which Product is manufactured and packaged.
BioVectra shall assure that materials in its possession
containing any potentially hazardous component are
sufficiently isolated and segregated from the Product
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BioVectra Questcor BioVectra
Page 14 of 42
manufactured for Questcor. BioVectra shall make Questcor aware
of the presence of any potentially hazardous products and will
adhere to all reasonable requests of Questcor with respect to
the storage of such materials. BioVectra will adhere to any
regulatory requirements or restrictions with respect to the
storage of raw materials, intermediates, or Product.
BioVectra will destroy any waste material or labeling
materials in a secure and legal manner, in order to prevent
unauthorized use and/or environmental problems.
9.5 Inspection and Testing of Product. BioVectra will perform the
inspection and testing of Product as provided in Schedule 2 to
this Agreement. Questcor reserves the right to inspect and/or
test all batches of the Product delivered to Questcor or any
Questcor designee.
BioVectra will provide to Questcor a complete copy of the
entire batch record that shall include but not be limited to
(i) COA, (ii) executed batch record, (ii) all testing results
conducted by BioVectra and/or independent testing labs
contracted by BioVectra, (iii) Certificate of Compliance
concerning animal derived components (per Section 9.2.5
above), (iv) Deviation final reports that have been approved
by Questcor, and (v) any other associated documentation
mutually agreed to by both Parties for each batch of Product
delivered. BioVectra will deliver the complete batch record
and associated documents with each batch no later than the
time of delivery of the batch by BioVectra to Questcor or its
designee.
9.6 Notification and Approval of Deviations. BioVectra will have a
documented system for handling Deviations, Deviation
investigations, and corrective actions. All Deviations will be
investigated and fully documented by BioVectra. BioVectra is
to notify Questcor within five (5) business days from the time
that BioVectra discovers the Deviation. All Deviations
(including the final report which outlines the Deviation,
investigation and corrective actions taken) must be reviewed
and approved by Questcor. BioVectra will retain such
documentation as part of the batch documentation for the batch
affected. Shipment of a lot shall not occur until Questcor has
approved all Deviations.
9.7 Release and Shipment of Product. BioVectra has the
responsibility to release the Product for shipment to Questcor
or its designee, provided, however, that if Product does not
meet the Specifications in all respects, without any
deviations not approved by Questcor, the Product can be
released only with the prior written consent of Questcor.
BioVectra will not ship any Product to any Delivery Point, as
identified by Questcor, until the Product is released.
9.8 Retained Samples of Product. BioVectra shall retain samples of
all Product batches in accordance with the retention schedule
mutually agreed upon but for no less than seven (7) years. The
amount of such retained samples shall be of sufficient
quantity to conduct at least full Specification analyses in
duplicate. BioVectra shall store the
[ ] [ ]
BioVectra Questcor BioVectra
Page 15 of 42
retained samples under appropriate Product label storage
conditions in a secure area and in a suitable storage
facility, consistent with cGMPs, all applicable laws, rules
and regulations, and industry standards. All such samples
shall be available for inspection by Questcor during any audit
by Questcor of BioVectra's facilities or upon reasonable
notice to BioVectra by Questcor.
9.9 Storage of Product. BioVectra agrees to store the Product
under appropriate Product storage conditions and in a secure
area, consistent with cGMPs, all applicable laws, rules and
regulations, and the NDA pertaining to the Product, and
industry standards.
9.10 Annual Product Quality Review(s). BioVectra will prepare and
provide to Questcor a Product Quality Review Report ("PQRR")
on an annual basis, consisting of a systems review to confirm
1) processing, 2) that Product consistently meets the
Specifications and limits, 3) identification of any
significant trends (data or nonconformance) and 4) continued
support for established retest dating. Such PQRR shall be
provided by BioVectra to Questcor within thirty (30) calendar
days from each one-year anniversary of the Effective Date of
this Agreement or such other times as may be mutually agreed
upon by the Parties.
9.11 In addition, Questcor and BioVectra will meet as necessary to
review quality issues related to the obligations and
responsibilities as described in this Agreement. During this
review, quality issues related to the past production by
BioVectra of Product will be reviewed. The information
presented and discussed during this review meeting will be
documented by BioVectra and submitted to Questcor for its
review and approval.
9.12 Complaints about the Product. BioVectra will have a documented
system to receive, communicate with Questcor, investigate, and
resolve all complaints related to Product. BioVectra will
investigate the complaints as requested by Questcor and
provide a written report on the results of the investigation
to Questcor within thirty (30) calendar days. If necessary,
Questcor will communicate with the customers and/or the
regulatory authorities the results of the complaint
investigation.
9.13 Returned Goods. BioVectra will have a documented system for
handling returned goods, consistent with cGMPs, all applicable
laws, rules and regulations, and industry standards.
9.14 Audits and Inspections of Facilities and Product. BioVectra
will notify Questcor of any inspections of BioVectra's
facilities used in the manufacture or storage of Product, or
other actions that could potentially impact Product, by any
regulatory agencies or other enforcement entities. BioVectra
will provide Questcor with a written summary describing all
results of inspections within thirty (30) days after the visit
or inquiry. If any inspection is specifically related to the
Product, BioVectra shall promptly inform Questcor and give
Questcor representatives the opportunity to participate, at
Questcor's expense, in the inspection.
[ ] [ ]
BioVectra Questcor BioVectra
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Questcor reserves the right to audit BioVectra's facilities,
systems, and documentation as they relate to the manufacture
and control of Product, and to assure compliance with this
Agreement, including but not limited to Product manufacturing,
storage, quality control, environmental compliance and health
and safety compliance. These audits may be performed on a
periodic basis at times mutually agreed upon by both Parties.
The right to audit will also cover any subcontractors (e.g. a
contract laboratory) if utilized by BioVectra. Questcor also
reserves the right to be present at BioVectra's facility
during the manufacture of Product.
10. CONFIDENTIALITY
10.1 Restrictions. Except as otherwise provided in this Section 10,
during the Term of this Agreement, including any renewals
thereof, and for a period of ten (10) years thereafter: (i)
each Party will hold the Confidential Information of the other
Party in strict confidence and will protect such Confidential
Information with at least the same degree of care that it
exercises with respect to its own Confidential Information,
which shall be no less than a reasonable degree of care; (ii)
neither Party will disclose the Confidential Information of
the other without in each instance obtaining the prior written
consent of the Disclosing Party; (iii) each Party will use the
Confidential Information of the other only as is necessary to
fulfill its obligations under this Agreement and for achieving
the purposes of this Agreement and not for any other purpose;
and (iv) each Party will limit internal disclosure of the
other Party's Confidential Information to its and its
Affiliates' officers, employees or agents on a need-to-know
basis for purposes of fulfilling its obligations under this
Agreement and achieving the purposes of this Agreement,
provided, however, that each of these officers, employees and
agents shall have been advised of the confidential nature of
the Confidential Information, are bound by these restrictions,
and have been directed to treat such information
confidentially and otherwise comply with this Agreement. In
any event, the Receiving Party shall be responsible for any
breach of the terms of this Agreement by any of its or its
Affiliates' officers, employees or agents.
10.2 Exceptions. Notwithstanding the provisions of Section 10.1
above, neither Party shall have any obligations with respect
to information which the Receiving Party can demonstrate: (i)
is or becomes generally available to the public other than
through the Receiving Party's disclosure; (ii) was in the
Receiving Party's possession prior to it being furnished by or
on behalf of the Disclosing Party, provided that the Receiving
Party's source had the legal right to disclose such
information; (iii) becomes available to the Receiving Party on
a non-confidential basis from a source other than the
Disclosing Party, provided that the Receiving Party's source
had the legal right to disclose such information; (iv) is or
becomes independently developed by an employee of the
Receiving Party without access to the Confidential Information
and without violating any of the Receiving Party's obligations
under this Agreement; (v) is required to be disclosed to any
governmental agency for purposes of obtaining patents or
approvals to test or market the Product; or (vi) is required
to be disclosed by order of any court of competent
jurisdiction or other governmental authority, provided,
however, that the Receiving Party shall provide to the
Disclosing Party
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Page 17 of 42
prompt written notice (but in no event less than fourteen (14)
calendar days) prior to such disclosure so that the Disclosing
Party may attempt by appropriate legal means to limit such
disclosure at its cost and expense, and the Receiving Party
shall endeavor in good faith to limit the disclosure and
maintain the confidentiality of such Confidential Information
to the maximum extent possible, provided, however, that
nothing in this Agreement shall be deemed to require the
Receiving Party to violate and law or judicial order.
10.3 Return of Confidential Information. Each Party agrees to
promptly return all Confidential Information and all copies
thereof to the Disclosing Party, and to destroy all
information created by Receiving Party that contains
Confidential Information furnished by Disclosing Party, at the
expiration or termination of this Agreement, or at any time
prior to the expiration or termination of this Agreement upon
the Disclosing Party's written request (provided, however,
that the Receiving Party shall not be required to return such
Confidential Information to the Disclosing Party prior to the
expiration or termination or this Agreement that the Receiving
Party reasonably requires in order to perform its obligations
under this Agreement). Upon request of the Disclosing Party,
the Receiving Party shall provide written certification of
such return or destruction. Notwithstanding the foregoing, the
Receiving Party may retain one (1) copy of such Confidential
Information in its legal archive files solely for purposes of
identifying such Party's obligations under this Agreement or
complying with other legal requirements, including under the
Act. Notwithstanding the Receiving Party's return and
destruction of the Confidential Information, Receiving Party
will continue to be bound by its obligation of confidentiality
as otherwise provided herein.
11. INDEMNIFICATION
11.1 Indemnification by Questcor. Except as otherwise specifically
provided in Section 11.2 below, Questcor shall indemnify,
defend and hold harmless BioVectra, its Affiliates, and its
and their respective directors, officers, employees, agents,
successors and assigns from and against any and all claims,
demands, losses, damages, judgments, settlement amounts,
suits, actions, liabilities, costs and expenses (including,
but not limited to, court costs and reasonable attorneys'
fees) arising out of or resulting from: (i) any negligence or
willful misconduct of Questcor, its employees or agents in the
use, handling (after title has passed to Questcor), shipment,
distribution, marketing or sale of any Product; (ii) any
injury or death to persons or theft of or damage to property
resulting from the use, handling (after title has passed to
Questcor), shipment, distribution, marketing or sale of any
Product unless caused by defective or non-conforming Product;
(iii) the material default by Questcor in the performance of
any obligation hereunder or Questcor 's breach of any of its
warranties or representations hereunder; (iv) any labeling of
any Product to the extent that such labeling has been supplied
by or at the direction of Questcor and applied in accordance
with instructions from Questcor; and/or (v) any proceeding
instituted by or on behalf of a Third Party based upon a claim
that the manufacture, use or sale of the Product infringes any
intellectual property right, including any patent, trademark
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BioVectra Questcor BioVectra
Page 18 of 42
or trade secret of such Third Party.
11.2 Indemnification by BioVectra. Except as otherwise specifically
provided in Section 11.1 above, BioVectra shall indemnify,
defend and hold harmless Questcor, its Affiliates, and its and
their respective directors, officers, employees, agents,
successors and assigns from and against any and all claims,
demands, losses, damages, judgments, settlement amounts,
suits, actions, liabilities, costs and expenses (including,
but not limited to, court costs and reasonable attorneys'
fees) arising out of or resulting from: (i) any injury or
death to persons or theft of or damage to property caused
directly or indirectly by defective or non-conforming Product
or by the negligence or willful misconduct of BioVectra, its
employees or agents; (ii) the material default by BioVectra in
the performance of any obligation hereunder or BioVectra's
breach of any of its warranties or representations hereunder;
(iii) BioVectra's negligent acts or omissions or willful
misconduct in the manufacture, labeling, packaging, storage,
or handling of Product; and/or (iv) BioVectra's failure to
comply with the provisions of any applicable law or
regulation, including, but not limited to, the NDA pertaining
to the Product, those of the Act and those relating to the
environment and health and safety.
11.3 A Party (the "Indemnitee") which intends to claim
indemnification under this Section 11 shall promptly notify
the other Party (the "Indemnitor") in writing of any action,
claim or other matter in respect of which the Indemnitee or
any of its Affiliates, or any of their respective directors,
officers, employees or agents, or any Third Party entitled to
indemnification under Sections 11.1 or 11.2 above, intend to
claim such indemnification; provided, however, the failure to
provide such notice within a reasonable period of time shall
not relieve the Indemnitor of any of its obligations hereunder
except to the extent the Indemnitor is prejudiced by such
failure. The Indemnitee shall permit, and shall cause its
Affiliates, and their respective directors, officers,
employees and agents to permit, the Indemnitor, at its
discretion, to settle any such action, claim or other matter
and the Indemnitee agrees to the complete control of such
defense or settlement by the Indemnitor; provided that such
settlement does not adversely affect the Indemnitee's rights
hereunder or impose any obligations on the Indemnitee in
addition to those set forth herein in order for it to exercise
such rights. No such action, claim or other matter shall be
settled without the prior written consent of the Indemnitee,
and the Indemnitee shall not be responsible for any attorneys'
fees or other costs incurred other than as provided herein.
The Indemnitee, its Affiliates, and their respective
directors, officers, employees and agents shall reasonably
cooperate with the Indemnitor and its legal representatives in
the investigation and defense of any action, claim or other
matter covered by this indemnification. The Indemnitee shall
have the right, but not the obligation, to be represented by
counsel of its own selection and at its own expense.
11.4 The provisions of this Section 11 shall survive the expiration
or termination of this Agreement.
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12. LIMITATIONS ON LIABILITY
12.1 In no event shall either Party be liable to the other Party
for any indirect, incidental, special, consequential, punitive
or exemplary damages (including, but not limited to, damages
based upon lost profits, business interruption, lost business,
or lost savings) for any acts or failure to act under this
Agreement, even if it has been advised of their possible
existence. Notwithstanding the foregoing, there shall be no
limitation on a Party's liability for claims: a) arising out
of a breach of its confidentiality obligations under this
Agreement; or b) arising out of its indemnification
obligations under this Agreement.
BioVectra shall reimburse Questcor for loss or damage to (i)
raw materials purchased by Questcor, supplied to BioVectra and
stored at BioVectra and (ii) Questcor equipment. Reimbursement
of raw materials and equipment shall be at replacement value.
13. INSURANCE
Each Party shall obtain and maintain at its expense during the term of
this Agreement and for a period of at least one (1) year after the
expiration or termination of this Agreement, all insurance coverage
required by law as well as appropriate insurance coverage to protect
against any and all claims or liabilities that may arise directly or
indirectly as a result of its performance under this Agreement. In this
regard, each Party shall maintain at least three million dollars
($3,000,000) of product liability insurance for the duration of this
Agreement and for five (5) years thereafter.
14. MISCELLANEOUS
14.1 Independent Contractors. The relationship between Questcor and
BioVectra is that of independent contractors and nothing
contained in this Agreement shall be deemed to constitute or
create any other relationship, including employment,
partnership, agency or joint venture, between Questcor and
BioVectra. Neither Party shall have any express or implied
right or authority to employ any person as agent or employee
for or on behalf of the other, or to bind or attempt to bind
the other Party to any obligation with any Third Party.
BioVectra has and retains full control and supervision over
the performance of its obligations hereunder and over the
employment, direction, compensation and discharge of all
employees, agents and subcontractors it utilizes in the
performance of such obligations. BioVectra is responsible for
its acts and omissions and those of its employees, agents and
subcontractors.
14.2 Assignment and Subcontracting. BioVectra shall not assign any
of its rights nor delegate or subcontract any of its duties
under this Agreement without the prior written consent of
Questcor. Any such attempted assignment of rights or
delegation or subcontracting of duties without the prior
written consent of Questcor shall be void and ineffective. Any
such assignment, delegation or subcontracting consented to by
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Page 20 of 42
Questcor shall not relieve BioVectra of its responsibilities
and liabilities hereunder, and BioVectra shall remain liable
to Questcor for the conduct and performance of each permitted
delegate and subcontractor hereunder. Questcor shall have the
right to assign this Agreement, in whole or in part, to any
Third Party, provided, however, that such Third Party assumes
in writing the rights, duties and obligations of Questcor as
set forth in this Agreement that are being assumed by such
Third Party and guarantees such in writing to BioVectra.
14.3 Advertising and Publicity. BioVectra shall not use the name or
any trademark, trade name, logo or symbol of Questcor or any
Questcor Affiliates, or disclose any matters relating to this
Agreement, in any advertising, promotion, press/publicity
release, written articles or other form of public written
disclosure without the prior written consent of Questcor.
Questcor shall not disclose and matters relating to this
Agreement nor issue any press/publicity release referring to
BioVectra without the prior written permission of BioVectra,
which shall not be unreasonably withheld, conditioned or
delayed. It is understood by BioVectra that Questcor, as the
holder of the Product NDA, will have to make certain
disclosures and regulatory filings indicating that BioVectra
is manufacturing the Product for Questcor.
14.4 Force Majeure. Neither Party shall be liable for delays in
performance or nonperformance in whole or in part due to any
causes that are beyond its reasonable control and not due to
its acts or omissions, such as acts of God, fire, strikes,
embargo, war, acts of terrorism, acts of the government, or
any other similar causes, but not acts which could be
anticipated, such as raw material price increases, shortages
of raw materials, or an increase in demand for Product. In
such event, the Party delayed shall promptly give notice to
the other Party, and shall endeavor in good faith to
eliminate, cure or overcome any such causes and to resume
performance of its obligations as soon as possible. The Party
affected by the other Party's delay may elect to: (a) suspend
performance and extend the time for performance for the
duration of the event, or (b) cancel all or part of any part
of the unperformed part of this Agreement or any individual
Purchase Order(s) hereunder.
Questcor shall have the right, but not the obligation, to
terminate this Agreement under this Section 14.4 upon not less
than ninety (90) days written notice to BioVectra if BioVectra
cannot, or appears unable in Questcor's good faith opinion, to
supply Product hereunder to Questcor to meet Questcor's needs
therefor due to a condition of Force Majeure.
14.5 Notices. Any notice, communication, or statement required or
permitted to be given under this Agreement shall be in writing
and shall be deemed to have been sufficiently given when
delivered to the person(s) listed below in any of the
following manners: (i) in person; (ii) by registered or
certified mail, postage pre-paid, return receipt requested;
(iii) by a nationally-recognized courier service guaranteeing
next-day delivery, charges prepaid; or (iv) by facsimile with
the original promptly sent by any of the foregoing manners.
Notice or receipt of a particular communication shall
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be considered given or received when actually received. Either
Party may, by notice to the other, change the names and
addresses given below for receipt of notices. 14.6 If to
BioVectra:
BioVectra dcl
Attn: Chief Executive Officer
00 XxXxxxxxxx Xxxxxx
Xxxxxxxxxxxxx, Xxxxxx Xxxxxx Xxxxxx
X0X0X0 Xxxxxx
Facsimile No.: (000) 000-0000
With a copy to:
BioVectra dcl
Attn: VP, Finance
00 XxXxxxxxxx Xxxxxx
Xxxxxxxxxxxxx, Xxxxxx Xxxxxx Xxxxxx
X0X0X0 Xxxxxx
Facsimile No.: (000) 000-0000
If to Questcor:
Questcor Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxx
Xxxxx Xxxx, Xxxxxxxxxx 00000
Attn: Chief Executive Officer
Facsimile No. (510) 400 -0715
With a copy to:
Questcor Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxx
Xxxxx Xxxx, Xxxxxxxxxx 00000
Attn: VP Manufacturing
Facsimile No. (510) 400 -0715
14.7 Non-Waiver. The failure of either Party to strictly enforce
any of the terms or conditions of this Agreement shall not be
considered as a waiver of any right hereunder nor shall it
deprive that Party of the right at some other time to insist
upon strict adherence to that term or condition or to any
other terms or conditions.
14.8 Severability. If any section, subsection, sentence or clause
of this Agreement shall be adjudged illegal, invalid or
unenforceable, such illegality, invalidity or unenforceability
shall not affect the legality, validity or enforceability of
this Agreement as a whole or of any section, subsection,
sentence or clause hereof not so adjudged, and the remaining
terms and provisions of this Agreement shall remain unimpaired
and in full force and effect.
14.9 Paragraph Headings. All paragraph headings in this Agreement
are for convenience of reference only and shall not be
construed as a limitation of the scope of the
[ ] [ ]
BioVectra Questcor BioVectra
Page 22 of 42
particular sections to which they refer.
14.10 Governing Law and Arbitration. This Agreement will be governed
by the laws of the State of California U.S.A., without regard
to its, or any other jurisdictions, conflicts of laws
provisions or rulings. Any dispute, claim or controversy that
may arise under, out of, in connection with or relating to
this Agreement or any breach or default in the performance of
the terms and conditions thereof, which cannot be settled by
the Parties, shall be settled by final and binding arbitration
in the English language in New York, New York, U.S.A. in
accordance with the then-existing Rules of Commercial
Arbitration (the "Rules") promulgated by the American
Arbitration Association (the "AAA"). The arbitrator(s) shall
apply the governing law as set forth above in this Section
14.10 and judgment upon the award of the arbitrator(s) may be
entered in any court having appropriate jurisdiction.
14.11 Successors and Assigns. This Agreement shall apply to, inure
to the benefit of and be binding upon the Parties hereto and
upon their respective successors and permitted assigns. The
Parties agree that this Agreement is not intended by either
Party to give any benefits, rights, privileges, actions or
remedies to any person, partnership, firm or corporation as a
third party beneficiary or otherwise under any theory of law,
except as expressly set forth herein.
14.12 Survival of Obligations. The termination or expiration of this
Agreement shall not affect the survival and continuing
validity of the Sections entitled "Representations and
Warranties; "Product Recalls", "Confidentiality",
"Indemnification" and "Limitations on Liability" nor of any
other provision that is expressly or by implication intended
to continue in force after such termination or expiration.
Termination or expiration of this Agreement shall not relieve
either Party from full performance of any obligations incurred
prior to the Effective Date of such termination or expiration.
14.13 Schedules. All schedules referred to herein form an integral
part of this Agreement and are incorporated into this
Agreement by such reference.
14.14 Review by Legal Counsel. Each of the Parties agrees that it
has had the opportunity to review this Agreement with its
legal counsel. Accordingly, the rule of construction that any
ambiguity in this Agreement is to be construed against the
drafting Party shall not apply.
14.15 Amendments. No modification, alteration or amendment of this
Agreement or any Purchase Order(s) hereunder shall be binding
upon the Parties unless contained in a writing signed and
delivered by a duly authorized representative of each
respective Party and specifically referring hereto or thereto,
as the case may be.
14.16 Counterparts. This Agreement and any amendment or supplement
hereto may be executed in any number of counterparts, each of
which when executed and delivered shall be deemed to be an
original and all of which counterparts taken together shall
constitute but one and the same instrument. The execution of
this Agreement and any
[ ] [ ]
BioVectra Questcor BioVectra
Page 23 of 42
such amendment or supplement by any Party hereto will not
become effective until counterparts hereof have been executed
(i.e., signed and delivered) by both Parties hereto.
14.17 Entire Agreement. This Agreement, together with any documents
attached hereto, constitutes the entire agreement of the
Parties with respect to its subject matter and merges and
supersedes all prior discussions and writings with respect
thereto. No modification to this Agreement shall be affected
by the acknowledgment or acceptance of any purchase order or
shipping instruction forms or similar documents containing
terms or conditions at variance with or in addition to those
set forth herein.
Notwithstanding the above, the Mutual Nondisclosure Agreement
dated August 15, 2002 (a signed copy of which is attached
hereto as Schedule 7) and the Equipment & Materials Transfer
Agreement (a signed copy of which is attached hereto as
Schedule 8) shall remain in full force and effect for the
Initial Term, any Extension Period and the period of
Confidentiality as set forth in Section 10.1 above, except for
the provisions of the Equipment & Materials Transfer Agreement
entitled: "Term; "Termination", "Development and Supply
Agreement" and "Non-Binding Term Sheet", which shall be
superseded hereby. In the event of any direct conflict of the
terms and conditions of the Mutual Nondisclosure Agreement and
the Equipment & Materials Transfer Agreement with the terms
and conditions of this Agreement, the terms and conditions of
this Agreement shall control. The period of confidentiality of
the Mutual Nondisclosure Agreement shall be as set forth in
Section 10.1 hereof.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their respective duly authorized representatives to be effective as of the
Effective Date set forth above.
QUESTCOR PHARMACEUTICALS, INC. DIAGNOSTIC CHEMICALS LIMITED
(doing business as BioVectra dcl)
Signature: /s/ Xxxxx Xxxxxxxx Signature: /s/ Xxxxxx Xxxxxx
---------------------- -----------------------------
Name: Xxxxx Xxxxxxxx Name: Xxxxxx Xxxxxx
Title: VP, Manufacturing Title: VP, Finance & Corporate Systems
Date: October 22, 2003 Date: October 28, 2003
[ ] [ ]
BioVectra Questcor BioVectra
Page 24 of 42
SCHEDULE 1
To the April 1, 2003 Supply Agreement between QUESTCOR and BIOVECTRA DCL.
PRODUCT
ACTHAR BULK CONCENTRATE (API)
[ ] [ ]
BioVectra Questcor BioVectra
Page 25 of 42
SCHEDULE 2
To the April 1, 2003 Supply Agreement between QUESTCOR and BIOVECTRA DCL.
SPECIFICATIONS
ALL SPECIFICATIONS AND INSPECTION AND TESTING METHODS WILL BE CONSISTENT WITH
THE DMF AND OTHER REGULATORY FILINGS FOR THE PRODUCT AND SUBSEQUENT UPDATES TO
THE DMF AND OTHER REGULATORY FILINGS FOR THE PRODUCT INCLUDING:
STARTING MATERIALS,
API REGISTRATION SPECIFICATIONS,
API CONTROL TARGETS, AND
INSPECTION AND TESTING METHODS.
[ ] [ ]
BioVectra Questcor BioVectra
Page 26 of 42
SCHEDULE 3
To the April 1, 2003 Supply Agreement between Questcor and BioVectra dcl.
PRICE
The price for ACTHar Gel shall be Nine Thousand Five Hundred Fifty-Five Dollars
United States ($9,555 USD) per kilogram for the first One Hundred Eighty (180)
kilograms of Product purchased by Questcor hereunder. The price for subsequent
Product purchased by Questcor hereunder shall be Seven Thousand Six Hundred
Seventy-five Dollars United States ($7,675 USD) per kilogram of Product.
Documented raw material increases greater than three percent (3%) will be added
to the price per kilogram on an actual cost basis, with documentation of the
increase provided to Questcor in advance of any such adjustment being made.
[ ] [ ]
BioVectra Questcor BioVectra
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SCHEDULE 4
To the April 1, 2003 Supply Agreement between QUESTCOR and BIOVECTRA DCL.
DEVIATION/CHANGE FORM
CP0006-0
BIOVECTRA
STANDARD OPERATING PROCEDURE FOR WRITING AND MANAGING SOPS
ATTACHMENT 1: DOCUMENT CREATION/CHANGE CONTROL FORM
SOP Title:____________________________
SOP Form ID:__________________________ Date:___________________________
Change Type:
[ ] Major
[ ] Minor
Check One:
[ ] Annual Review
[ ] Revision
[ ] New Issue
SUMMARY OF CHANGES AND JUSTIFICATIONS
(Attach additional pages as necessary.)
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
Comments: ______________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
_____________________________________________________
Signature Date
[ ] [ ]
BioVectra Questcor BioVectra
Page 28 of 42
Reviewed by_____________________________________________________________________
Approved by_____________________________________________________________________
QA/RA Approval__________________________________________________________________
DOCUMENT CONTROL
[ ] Revision History Ledger updated_____________________ ________________
Signature Date
[ ] Training Requirements Completed_____________________ ________________
Signature Date
[ ] Read and Understood
[ ] Additional Training Required (Explain)_________________________________
_______________________
ATTACHMENT 2: REVISION HISTORY LEDGER
PERFORMED BY
FORM ID TITLE REVISION # COMMENTS (INITIAL AND DATE)
--------- ----- ---------- -------- ------------------
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
[ ] [ ]
BioVectra Questcor BioVectra
Page 29 of 42
FORM ID CP0006 REVISION NO. Zero (0)
WRITTEN BY APPROVED BY
QA APPROVAL EFFECTIVE DATE
[ ] [ ]
BioVectra Questcor BioVectra
Page 30 of 42
SCHEDULE 5
To the April 1, 2003 Supply Agreement between QUESTCOR and BIOVECTRA
DCL.
QUESTCOR PROVIDED EQUIPMENT AND LOCATION THEREOF
Item Part Number Description
1 L-8269 SS Pot
2 NC-5735 Pump
3 L-4244 MOD I Recon Pot
4 NC-3344 Pump
5 L-8224 100 Gal SS Pot
6 LM-4029 MOD IC Potentiation Tk
7 NC-2849 Phenol Hood
8 L-5750 Twin Shell V Blender
9 L-6125 Fitzmill Comminutor
10 N/A MOD IC Recon Vessel
11 N/A MOD IC Glass Filter #1
12 N/A MOD IC Glass Filter #2
13 N/A Air/Nitrogen Filter
14 NC-5262 Orion 310 PH Meter
15 N/A 2 Glass bottles
16 L-6780 AAAP G/L Blow Tank
17 L-6511 18" Xxxxxxx Funnel
18 L-4490 Millipore Cart, Housing
19 L-9119 D Pot
20 L-9119 E Pot
21 L-9119 F Pot
22 L-9119 (2) Pots
23 L-4066 AAAP Oven and Trays
24 L-5912 Wiley Mill
25 L-6965 Scale 0-200KG
26 N/A Bowl Stand For Centrifuge
27 L-1629 MOD I Drum Roller
28 L-6211 MOD I Drum
29 L-4143 Bomb Freezer
30 K-7652 AAP Precipitation Tank
31 NC-3366 Scale
32 N/A 2 Stainless Steel Pots
33 K-7650 AAAP Extraction Tank
34 L-6370 32% Gel Tank
00 X-0000 Xxxxx Xxxxxxxxxx
00 X-0000 Xxxxx Xxxxxxxxxx
37 NC-2848 MOD IC Gel Bomb
38 N/A 9 Stainless Steel Bombs
39 L-9119 C Utensil Cart
[ ] [ ]
BioVectra Questcor BioVectra
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40 NC-2847 MOD I Resin Column
41(new) N/A Xxxx - 12 Ton chiller
42(new) Not Assigned Yet Amsco 3033 Autoclave
43(new) Not Assigned Yet Reitschlie VC-100 Vacuum Pump
44(new) Not Assigned Yet Xxxxx 1374M-01 High Vacuum Pump
45(new) N/A Culligan Mixed Bed DI Water System
[ ] [ ]
BioVectra Questcor BioVectra
Page 32 of 42
SCHEDULE 6
To the April 1, 2003 Supply Agreement between QUESTCOR and BIOVECTRA DCL.
FORMAT OF AN APPROVED CERTIFICATE OF COMPLIANCE
To the April 1, 2003 Supply Agreement between Questcor and BioVectra dcl
(as referred to in Section 9.2.5 of that Agreement)
CERTIFICATE OF COMPLIANCE
The only animal-sourced materials used in the production of Acthar Bulk
Concentrate, Lot YYYY, were porcine pituitary glands and porcine gelatin.
BIOVECTRA DCL
By: ________________________ ________________________
Signature
Date
_________________________________________________________
Print name and title
[ ] [ ]
BioVectra Questcor BioVectra
Page 33 of 42
SCHEDULE 7
To the April 1, 2003 Supply Agreement between QUESTCOR and BIOVECTRA DCL.
MUTUAL NONDISCLOSURE AGREEMENT (dated August 15, 2002)
THIS AGREEMENT is made on Aug 15, 2002, by and between Questcor Pharmaceuticals,
Inc., a California Corporation located at 0000 Xxxxxxx Xxxx, Xxxxx Xxxx, XX
00000 ("Questcor") and BioVectra,dcl LLC located at ("BioVectra").
1. Purpose. Questcor and BioVectra wish to evaluate the possibility of,
establishing a business relationship. For this purpose, either party may
disclose information it regards as confidential to the other.
2. Definition. "Confidential Information" means any information, technical data,
or know-how, including, but not limited to, that which relates to research,
development, products, biological materials, chemical compounds, processes, test
data, animal studies, clinical trials, markets, inventions, marketing or
finances, which Confidential Information is designated in writing to be
confidential or proprietary, or if given orally, is confirmed promptly in
writing as having been disclosed as confidential or proprietary. Confidential
Information does not include information, technical data or knowhow which (i) is
in the possession of the receiving party at the time of disclosure as shown by
the receiving party's files and records immediately prior to the time of
disclosure; or (ii) prior to or after the time of disclosure becomes part of the
public knowledge or literature, not as a result of any action or inaction of the
receiving party; or (iii) is approved for release by the disclosing party, or
(iv) is at any time disclosed to the receiving party by a third party without,
to the knowledge of the receiving party, violation of any obligation of
confidentiality.
3. Non-Disclosure of Confidential Information. Questcor and BioVectra each agree
not to use the Confidential Information disclosed to it by the other party for
its own use or for any purpose except as specified in paragraph 1. Neither will
disclose the Confidential Information of the other to third parties or to its
own employees and advisors except those employees and advisors who are required
to have the information in order to evaluate it. Each agrees to advise such
employees and advisors of the confidential nature of the information they are
receiving, and to take all other reasonable steps to protect the secrecy of and
avoid disclosure or use of Confidential Information of the other in order to
prevent it from falling into the public domain or the possession of unauthorized
persons. Each agrees to notify the other in writing of any misuse or
misappropriation of such Confidential Information of the other which may come to
its attention. .
4. Return of Material. Upon request, any materials or documents which have been
furnished by one party to the other will be returned, accompanied by all copies
of such documentation. Except that one copy may be retained for legal archival
purposes.
5. Patent or Copyright Infringement. Nothing in this Agreement is intended to
grant any rights under any patent or copyright of either party, nor shall this
Agreement grant either party any rights in or to the others party's Confidential
Information, except the limited right to review such Confidential Information
solely for the purpose specified in
[ ] [ ]
BioVectra Questcor BioVectra
Page 34 of 42
paragraph 1.
6. Term. The foregoing commitments in this Agreement shall terminate on the
later of five (5) years following the date of this Agreement, or five (5) years
following the termination of any business relationship between the parties.
7. Q~ Neither this letter agreement nor any action taken in connection with this
letter agreement will give rise to any obligation on the part of either party to
(i) engage in any discussions or negotiations with the other party with regard.
to a possible transaction, or (ii) pursue or enter into any transaction of any
nature with the other party.
8. Miscellaneous. This Agreement shall be binding upon and for the benefit of
the undersigned parties, their successors and assigns, provided that
Confidential Information may not be assigned without consent of the disclosing
party. Failure to enforce any provision of this Agreement shall not constitute a
waiver of any term hereof.
9. Governing Law and Jurisdiction. This Agreement shall be governed by and
construed under the laws of the State of California. The federal and state
courts within the State of California shall have exclusive jurisdiction to
adjudicate any dispute arising out of this Agreement.
10. Remedies. Each party agrees that its obligations hereunder are necessary and
reasonable in order to protect the other party and the other party's business.
Accordingly, each party agrees and acknowledges that any such violation or
threatened violation may cause irreparable injury to the other party and that,
in addition to any other remedies that may be available, in law, in equity or
otherwise, the other party shall be entitled to obtain injunctive relief against
the threatened breach of this Agreement or the continuation of any such breach.
[ ] [ ]
BioVectra Questcor BioVectra
Page 35 of 42
SCHEDULE 8
To the April 1, 2003 Supply Agreement between QUESTCOR and BIOVECTRA DCL.
EQUIPMENT & MATERIALS TRANSFER AGREEMENT
[ ] [ ]
BioVectra Questcor BioVectra
Page 36 of 42
CONFIDENTIAL
TERM SHEET
EQUIPMENT & MATERIALS TRANSFER AGREEMENT
PARTIES Questcor Pharmaceuticals, Inc. ("Questcor")
Diagnostic Chemicals Limited, doing business as
BioVectra ("BIO")
MATERIAL AND
EQUIPMENT TRANSFER Upon reasonable prior notice to BIO, Questcor will
cause to be delivered, and BIO will accept for
delivery, the certain manufacturing equipment (the
"Equipment") and the raw materials (the "Materials")
described and listed on Exhibit A as associated with
the commercial production of Acthar bulk concentrate
(corticotropin in a concentrated gel matrix) (the
"Concentrate"). Questcor will be responsible for all
costs associated with the delivery of the Materials
and Equipment to the Storage Location (defined
below), including applicable import/export costs
actually and reasonably incurred by BIO. BIO will
reasonably assist Questcor to arrange for the
delivery and receipt of the Materials and Equipment.
HANDLING AND STORAGE BIO will (i) handle, store, maintain and deliver the
Materials and Equipment in accordance with the terms
and conditions of this Term Sheet and applicable laws
and regulations and (ii) take such action as
reasonably requested by Questcor in respect of the
handling, storage, maintenance or delivery of such
Materials and Equipment. BIO will store and maintain
the Equipment and the Materials in a secure location
within the premises located at BioVectra DCL,
Charlottetown Airport Business Park, 000 Xxxxxxxx
Xxxxx Xxxx, Xxxxxxxxxxxxx, XX X0X 0X0 (the "Storage
Location") and in a manner that preserves the
operation and effectiveness of the Materials and
Equipment, but in no event in a manner less than the
specifications described on Exhibit A. Except as
directed in writing by Questcor, BIO will not remove
the Equipment from its original shipping packaging or
otherwise tamper with, remove or relocate the
Equipment or Materials from the Storage Location. BIO
will provide Questcor or its designee access to the
Equipment and/or Materials in the Storage Location,
upon reasonable prior notice. BIO shall immediately
notify Questcor at the address provided below of any
breach of this Term Sheet or any theft of and/or
damage or unauthorized access to the Equipment and/or
Materials.
OWNERSHIP Questcor will retain ownership over all rights in and
to the Equipment and Materials delivered to BIO. BIO
shall not use, retain for itself or grant to any
third party any access or rights in or to the
Materials or Equipment, including, without
limitation, the imposition of any xxxx, xxxx or
encumbrance of any nature whatsoever.
INSURANCE; DAMAGE Questcor will maintain general commercial liability
and property insurance covering the Equipment and
Materials during the Term in reasonable and customary
amounts as it may determine. BIO will be responsible
to
BioVectra [ ] [ ]
Questcor BioVectra
Page 37 of 42
Questcor for any loss, damage or destruction of the
Equipment and Materials or any claim by any third
party with respect to personal injury relating to the
Equipment or Materials, in each case to the extent
arising out of BIO's negligence or willful
misconduct.
TERM; TERMINATION This Term Sheet will be in effect from the date last
written below until the earlier of (a) the execution
by the parties of a definitive Development and Supply
Agreement or (b) June 30, 2003, unless otherwise
earlier terminated by either party in accordance with
this Term Sheet or extended in writing by the mutual
agreement of the parties (the "Term").
Either party may terminate this Term Sheet upon 60
days prior written notice to the other for any reason
or within 30 days upon the uncured material breach by
either party; provided however, that Questcor may at
any time request the return and delivery of the
Materials and/or Equipment to itself or its designee
as described below.
RETURN & DELIVERY Promptly upon the request of Questcor (but in no
event later than five business days), BIO will
prepare the Equipment and Materials for shipment and
make them available for transfer to Questcor or its
designee at the Storage Location. Questcor will
reimburse BIO with respect to its reasonable and
actual costs incurred in connection with the
foregoing and will bear the costs of transporting the
Equipment and/or Materials from the Storage Location.
FEES BIO will handle and store the Equipment and Materials
in consideration for the negotiation by the parties
of a Development and Supply Agreement as described
herein and no additional fees or charges will apply.
QUALITY AUDIT At a time as mutually agreed by the parties, BIO will
permit Questcor, at no cost to Questcor, access to
its facilities, records and personnel necessary for
Questcor to conduct a Quality System Audit. Questcor
will bear the costs of conducting such audit.
DEVELOPMENT AND SUPPLY Subject to the successful completion of the Quality
AGREEMENT Audit described above, the parties will use their
good faith, commercially reasonable efforts to
negotiate a definitive Development and Supply
Agreement pursuant to which BIO will provide the
Concentrate for Questcor's commercial requirements.
The definitive Development and Supply Agreement will
contain the following batch pricing by BIO to
Questcor: (a) US$9,555/kg for each of the first three
60 kg qualification batches; and (b) US$7,675/kg for
any subsequent qualification and/or production
batches. Under the terms of such definitive
Development and Supply Agreement, Questcor will agree
to purchase at least three (3) batches of
approximately 60 kg each prior to December 31, 2006.
The definitive Development and Supply Agreement
BioVectra [ ] [ ]
Questcor BioVectra
Page 38 of 42
will contain other usual and customary terms for
agreements of this type.
GOVERNING LAW This Term Sheet and the terms of the definitive
agreement will be governed by the laws of the State
of California, United States, without regard to its
conflicts of laws.
CONFIDENTIALITY The parties agree that the contents of this Term
Sheet and any and all information provided by one
party to the other pursuant to this Term Sheet shall
be "Confidential Information" subject to the terms of
that certain Mutual Nondisclosure Agreement between
Questcor and BIO dated as of August 15, 2002.
NON-BINDING TERM SHEET The terms provided in the paragraph entitled "Supply
Agreement" are for discussion purposes only, and such
terms shall not constitute a binding agreement, an
offer to enter into a binding agreement or an
amendment to or termination of the certain terms and
conditions provided to Questcor by BIO in a letter
dated March 18, 2003 (the "Non-Binding Terms"). The
Non-Binding Terms and any proposals contained herein
are subject to additional due diligence, the
negotiation of a definitive agreement, the terms and
conditions provided to Questcor by BIO in a letter
dated march 18, 2003, and approval by the parties'
respective Board of Directors.
Notwithstanding the foregoing, the parties agree and
acknowledge that all provisions other than the
Non-Binding Terms will constitute a binding agreement
between the parties as of the date last written
below. It is the intention of BIO and Questcor to
promptly and in good faith negotiate and finalize a
definitive agreement regarding the terms and
conditions set forth herein and other usual and
customary terms for transactions of this type. In the
event that the parties fail to reach a definitive
agreement on or before June 30, 2003 or otherwise
extend the term hereof by mutual agreement in
writing, this Term Sheet shall terminate as of June
30, 2003 and be of no further force and effect,
except for provisions regarding confidentiality. In
such event, BIO shall promptly return the Materials
and Equipment to Questcor in accordance with the
paragraph entitled "Return & Delivery".
QUESTCOR PHARMACEUTICALS, INC. DIAGNOSTIC CHEMICALS LIMITED
By: /s/ Xxxxxxx X. Xxxxxxxxxx By: /s/ Xxxxxx Xxxxxx
Name: Xxxxxxx X. Xxxxxxxxxx Name: Xxxxxx Xxxxxx
Title: Vice President, Commercial Operations Title: VP, Finance & Corporate
Systems
Date: March 28, 2003 Date: April 1, 2003
Address: 0000 Xxxxxxx Xx. Address: 00 XxXxxxxxxx Xxxxxx
Xxxxx Xxxx, XX 00000 Xxxxxxxxxxxxx, Xxxxxx
Xxxxxx Xxxxxx
Xxxxxx, X0X 0X0
BioVectra [ ] [ ]
Questcor BioVectra
Page 39 of 42
CONFIDENTIAL
EXHIBIT A
EQUIPMENT DESCRIPTION AND INVENTORY:
(see attached list)
MATERIALS DESCRIPTION AND INVENTORY:
600 lbs. of frozen porcine pituitaries
ENVIRONMENTAL AND OTHER STORAGE REQUIREMENTS:
Equipment: clean, dry, secure at normal room temperature
Materials: cGMP storage at -20 degrees Celsius
BioVectra [ ] [ ]
Questcor BioVectra
Page 40 of 42
EQUIPMENT FOR HP ACTHAR GEL
TRUCK 1
TRUCK 1
SKID PART NUMBER DESCRIPTION
1 L-8269 SS POT
2 NC-5735 PUMP/VENT LM-4029
3 L-4244 MOD 1 RECON POT
3 NC-3344 PUMP
4 L-8224 100 GAL SS POT
5 LM-4029 MOD IC POTENTIATION TK
6 NC-2849 PHENOL HOOD
7 NC-2849 PHENOL HOOD
8 L-5750 TWIN SHELL V BLENDER
9 L-6125 FITZMILL COMMINUTOR
10 N/A MOD IC RECON AGITATOR (2)
10 N/A MOD IC RECON VESSEL
10 N/A MOD IC GLASS FILTER #1
10 N/A MOD IC GLASS FILTER #2
10 N/A AIR/NITROGEN FILTER
10 NC-5262 ORION 310 PH METER
10 N/A 2 GLASS BOTTLES
11 L-6780 AAAP G/L BLOW TANK
12 L-6511 18" XXXXXXX XXXXXX
00 X-0000 XXXXXXXXX CART, HOUSING
13 L-9119 D POT
13 L-9119 E POT
13 L-9119 F POT
13 L-9119 (2) POT
14 L-4066 AAAP OVEN AND TRAYS
14 L-5912 WILEY MILL
15 L-6965 SCALE 0-200KG
16 N/A TABLE & 1 BOMB HOLDER
17 L-6782 AAAP 80 GAL G/L POT
18 N/A BOWL STAND FOR CENTRIFUGE
18 L-6370 PIPING FOR GEL TANK
19 L-1629 MOD 1 DRUM ROLLER
19 L-6211 MOD 0 XXXX
00 X-0000 XXXX XXXXXXX
EQUIPMENT FOR HP ACTHAR GEL
TRUCK 2
TRUCK 2
SKID PART NUMBER DESCRIPTION
1 K-7652 AAP PRECIPITATION TANK
2 N/A MISC. EQUIPMENT
2 NC-3366 SCALE
2 N/A 2 STAINLESS STEEL POTS
BioVectra [ ] [ ]
Questcor BioVectra
Page 41 of 42
2 N/A 2 XXXXXXX XXXXXXX
3 K-7650 AAAP EXTRACTION TANK
4 L-6370 32% GEL TANK
0 X-0000 XXXXX XXXXXXXXXX
0 X-0000 XXXXX XXXXXXXXXX
6 NC-2848 MOD IC GEL BOMB
6 N/A 9 STAINLESS STEEL BOMBS
6 N/A MOD 1 BOMB HEADER
6 N/A MISC. PIPING
7 L-9119 C UTENSIL CART
8 NC-2847 MOD 1 RESIN COLUMN
BioVectra [ ] [ ]
Questcor BioVectra
Page 42 of 42
