Exhibit 10.50
NOTE : Portions of this document marked
“***” have been omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for
confidential treatment of the omitted and separately filed
portions.
SUPPLY
AGREEMENT
THIS SUPPLY AGREEMENT (the
“Agreement”) is made and entered into as of
March 10, 2006, (the “Effective Date”) between AVI
BIOPHARMA, INC. (as defined below, “Supplier”), an
Oregon corporation, and COOK GROUP INCORPORATED (as defined below,
“Company”), an Indiana corporation.
WITNESSETH:
WHEREAS, Supplier is establishing
manufacturing facilities to manufacture drugs such as the Drug (as
defined below);
WHEREAS, Company and Supplier have
entered into a License and Development Agreement of even date
herewith with respect to the Drug (the “License and
Development Agreement”);
WHEREAS, Company and Supplier have
entered into an Investment Agreement of even date herewith with
respect to the Drug (the “Investment
Agreement”);
WHEREAS, Supplier and Company wish
to enter into this Agreement regarding Supplier’s supplying
the Drug (as defined below) to Company;
AGREEMENTS:
NOW THEREFORE, in consideration of
the representations, warranties, covenants and agreements contained
herein, and for other valuable consideration, the receipt and
adequacy of which is hereby acknowledged, the parties mutually
agree as follows:
ARTICLE 1.
DEFINITIONS
1.1.
Specific
Definitions . As used in this Agreement,
the following terms shall have the meanings set forth or as
referenced below:
“ Actual
Cost ” means the cost of non-manufacturing activities
performed by AVI personnel pursuant to this Agreement, including
direct labor, materials, travel, and allocated overhead
costs.
“ Affiliate ” of
a specified person (natural or juridical) means a person that
directly, or
indirectly through one or more intermediaries,
controls, or is controlled by, or is under common control with, the
person specified. “ Control ” shall mean
ownership of more than 50% of the shares of stock entitled to vote
for the election of directors in the case of a corporation, and
more than 50% of the voting power in the case of a business entity
other than a corporation.
“ Agreement ”
means this Agreement and all Exhibits and Schedules
hereto.
“ Company ” means
Cook Group Incorporated and its Affiliates.
“ Confidential
Information ” means know-how, trade secrets, and
unpublished information disclosed (whether before or during the
term of this Agreement) by one of the parties (the
“disclosing party”) to the other party (the
“receiving party”) or generated under this Agreement,
excluding information which:
(a)
was already in
the possession of receiving party prior to its receipt from the
disclosing party (provided that the receiving party is able to
provide the disclosing party with reasonable documentary proof
thereof and, if received from a third party, that such information
was acquired without any party’s breach of a confidentiality
or non-disclosure obligation to the disclosing party related to
such information);
(b)
is or becomes
part of the public domain by reason of acts not attributable
to the receiving party;
(c)
is or becomes
available to receiving party from a source other than the
disclosing party which source, has rightfully obtained such
information and has no obligation of non-disclosure or
confidentiality to the disclosing party with respect thereto;
or
(d)
has been
independently developed by the receiving party without breach of
this Agreement or use of any Confidential Information of the other
party.
“ Drug ” has the
meaning given such term in the License and Development
Agreement.
“ Effective Date
” has the meaning set forth in the recitals
hereto.
“ FDA ” means the
United States Food and Drug Administration.
“ Force Majeure ”
means any event or condition, not existing as of the date of this
Agreement, not reasonably foreseeable as of such date and not
reasonably within the control of either party, which prevents in
whole or in material part the performance by one of the
parties of its obligations hereunder, such as an act of government,
war or related actions, civil insurrection, act of terrorism, riot,
sabotage, strike, epidemic, fire, flood, windstorm, and similar
events.
“ GMP ” means
Good Manufacturing Practices as defined in 21 CFR Parts 210 through
226 and Parts 600 through 680 and any successor provisions thereof
that apply to production of the Drug under this
Agreement.
“ Intellectual Property
” means U.S. and foreign patents and patent applications,
trademarks, service marks and registrations thereof and
applications therefor, copyrights and
2
copyright registrations and applications, mask
works and registrations thereof, know-how, trade secrets,
inventions, discoveries, ideas, technology, data, information,
processes, drawings, designs, licenses, computer programs and
software, and technical information including but not limited to
information embodied in material specifications, processing
instructions, equipment specifications, product specifications,
confidential data, electronic files, research notebooks, invention
disclosures, research and development reports and the like related
thereto and all amendments, modifications, and improvements to any
of the foregoing.
“ Indemnifiable Losses
” has the meaning set forth in Section 7.1
.
“ Indemnitee ”
has the meaning set forth in Section 7.3 .
“ Indemnitor ”
has the meaning set forth in Section 7.3 .
“ Investment Agreement
” has the meaning set forth in the recitals
hereto.
“ License and Development
Agreement ” has the meaning set forth in the recitals
hereto.
“ Product Liability
Damages ” means any liability, claim or expense,
including but not limited to reasonable attorneys’ fees and
medical expenses, arising in whole or in part out of claims of
third parties for personal injury or loss of or damage to property
relating to or arising out of the Products, whether based on strict
liability in tort, negligent manufacture of product, or any other
allegation of liability arising from the design, testing,
manufacture, packaging, labeling (including instructions for use),
or sale of the Products.
“ Product ” means
the final formulation or configuration of the Drug with or without
a device or delivery mechanism such as a stent, catheter, or
microbubble formulation.
“ Specifications
” means the specifications and formulations for the Products
as agreed to by the parties. Within sixty (60) days of the
Effective Date, the parties will agree in writing to initial
Specifications for each Product to be developed. Thereafter,
Specifications for a particular Product may be amended from
time to time upon mutual agreement of the parties. Specifications
specifically developed by Company or included in any FDA approval
of the Drug, but excluding in either case Supplier Specifications
(as defined herein), shall be referred to as “ Company
Specifications .” “ Supplier
Specifications ” shall mean specifications developed by
Supplier and incorporated into the Specifications without
modification by Company.
“ Supplier ”
means AVI BioPharma, Inc. and its Affiliates.
“ Term ” has the
meaning set forth in Section 8.1 .
“ Warranty Exclusions
” has the meaning set forth in Section 5.1
.
1.2.
Other
Terms . Other terms may be
defined elsewhere in the text of this Agreement and shall have the
meaning indicated throughout this Agreement.
3
1.3.
Definitional
Provisions .
(a)
The words
“hereof,” “herein,” and
“hereunder” and words of similar import, when used in
this Agreement, shall refer to this Agreement as a whole and not to
any particular provisions of this Agreement.
(b)
The terms defined
in the singular shall have a comparable meaning when used in the
plural, and vice versa.
(c)
References to an
“Exhibit” or to a “Schedule” are, unless
otherwise specified, to one of the Exhibits or Schedules attached
to or referenced in this Agreement, and references to an
“Article” or a “Section” are, unless
otherwise specified, to one of the Articles or Sections of this
Agreement.
(d)
The term
“person” includes any individual, partnership, joint
venture, corporation, trust, unincorporated organization or
government or any department or agency thereof.
ARTICLE 2.
SUPPLY
2.1.
Supply of
Drug .
Commencing upon the closing of transactions contemplated by the
Investment Agreement, Supplier shall manufacture,
or have manufactured, and supply to Company all of Company’s
orders for Drug made under Article 3 , in accordance
with the Specifications in effect at the time of order for each
Product and with Company’s schedule for deliveries. In
the event of any Drug or material shortages or temporary or
long-term production capacity restraints or Force Majeure events,
Supplier may allocate production capacity among customers,
but, in all events will supply Company on a priority basis over
supplying any other customers.
2.2.
Promotion and
Training . Upon a reasonable request
by Company and subject to staff and support availability, Supplier
will assist Company in preparing promotional, marketing and
training literature and instructions for the Products, including
any artwork, will conduct training courses and seminars to
educate medical professionals on the use of Products and their use
in connection with Company’s medical devices and for training
its marketing, sales, and distribution groups, and will provide
Company with training related to the sale of Products. Company
shall reimburse Supplier’s Actual Costs in providing all
services and support pursuant to this Section 2.2. Within
thirty (30) days of the end of each calendar quarter in which costs
were incurred, Supplier will send Company an invoice specifying the
Actual Cost of services and support provided in the just-ended
quarter and the payment due. Within thirty (30) days of receiving
each such invoice, Company will make a payment to Supplier for the
full amount due.
2.3.
Packaging and
Labeling . Supplier shall package and
label the Drug in accordance with packaging and labeling
specifications to be mutually agreed upon by Company and Supplier
and approved by the FDA.
4
2.4.
Compliance
With Laws and Regulations .
(a)
Supplier shall be
responsible for compliance with present and future applicable
statutes, laws, ordinances and regulations of national, federal,
state and local governments now or hereafter in effect materially
relating to its manufacture of the Drug. If required or necessary
in connection with sales of Products by Company, Supplier shall
have its manufacturing facilities become ISO 9001 certified.
Without limitation of the foregoing, Supplier represents and
warrants to Company that all Drugs sold and delivered to Company
under this Agreement will have been manufactured, labeled and
packaged in accordance with applicable FDA GMP requirements and, if
applicable, Supplier’s ISO 9001 certifications, and that
continually during the term of this Agreement no Drugs delivered by
Supplier to Company shall be adulterated or misbranded at the time
of delivery within the meaning of the U.S. Food, Drug and Cosmetic
Act and regulations thereunder or any similar law or regulation.
Supplier shall cause Company’s regulatory personnel to be
provided with reasonable access from time to time to the facilities
and records of Supplier for the purpose of confirming
Supplier’s compliance with any applicable FDA GMP and all
other applicable requirements noted in this Article 2 .
Supplier agrees to provide Company with reasonable prior written
notice of any FDA inspection of Supplier’s facilities or
records prior to such FDA inspection, or if such prior written
notice is not feasible, then within three business days thereafter.
Supplier also agrees to provide Company with written notice of its
receipt of any claim by the FDA or other governmental agency of any
actual or alleged violation by Supplier of any GMP or other
applicable requirements as soon as practicable following receipt of
such notice (but in no event more than 5 business days thereafter).
Company shall have the right, at any time and from time-to-time
upon not less than 72 hours prior notice to the Supplier, to
inspect Supplier’s manufacturing facilities in order to
examine all phases of the manufacturing process and inspect or
audit any or all of the Supplier’s data and records related
thereto and the Products compliance with the terms and conditions
hereunder or with respect to any applicable law, rule or
regulation. In the event Supplier uses a sub-contractor or third
party to perform any part of the manufacturing, Supplier
shall obtain the agreement of such sub-contractor or third party
that Company shall have similar inspection rights.
(b)
Company and
Supplier (except where Supplier has the responsibility under
Section 2.4(a) or elsewhere herein) shall comply
with all applicable laws, rules, regulations, codes, and standards
of all federal, state, local and municipal government agencies
which affect their respective performance and activities under this
Agreement. Notwithstanding anything contained herein, Company shall
be responsible for compliance with present and future applicable
statutes, laws, ordinances and regulations of national, federal,
state and local governments now or hereafter in effect including
applicable import and export laws materially relating to its
purchase, distribution or sale of the Products.
2.5.
Exclusivity
. During the term
of this Agreement, or if longer, the term of the License and
Development Agreement, (a) Supplier shall not promote, make,
have made, market or sell the Drug for use in the Field (as defined
in the License and Development Agreement) to any person or entity
other than Company, and (b) Company shall purchase 100% of its
requirements for the Drug for use in the Field from Supplier. Prior
to any sale, transfer or other disposition to any third party of
Drug for use outside the Field, Supplier shall obtain the agreement
of such third party that it will not use, promote, market or sell
the Drug in the Field or resell the Drug for use in the
Field.
5
2.6.
Complaints and
Adverse Events . Each party agrees to
inform the other party promptly (but in no event no later than
forty-eight (48) hours after becoming aware of same) of any
information concerning any complaint involving the Products or that
might be applicable to the Products or adverse drug experience (as
defined in 21 C.F.R. § 314.80), injury, toxicity, or
sensitivity reaction associated with the use of the Products or
that might be applicable to the Products, provided
that:
(a)
if the adverse
drug experience is serious, as defined in 21 C.F.R.
§ 314.80 (including any adverse drug reaction that is
fatal or life-threatening, is permanently disabling, requires
inpatient hospitalization, or is a congenital anomaly, cancer or
overdose), then each party shall notify the other party within
twenty-four (24) hours;
(b)
all notifications
to Company shall be by facsimile and on Company’s designated
adverse event forms; and
(c)
all notifications
to Supplier shall be by facsimile and on Supplier’s
designated adverse event forms.
2.7.
Records and
Recall . Company shall maintain
complete and accurate records of all Products sold by Company in
sufficient detail to enable Supplier to conduct an effective recall
of Drugs purchased by Company under this Agreement if Supplier
determines that such a recall is required or otherwise necessary or
appropriate. In the event of a recall of any of the Drugs by
Supplier, Company will cooperate with and assist Supplier in
effecting such recall, including promptly contacting any purchasers
that Supplier reasonably desires to be contacted and promptly
communicating to such purchasers the information or instructions
Supplier reasonably desires to be transmitted relating to such
recall. Company shall be responsible for all costs of effecting
such recall of Products, including any shipping costs related to
returning recalled Drugs to Supplier and replacing such recalled
Drugs with new Drugs, except, such costs shall instead be paid by
Supplier (directly or through reimbursement of Company for costs
reasonably incurred by Company) where the recall relates to a
matter for which Supplier would be required to indemnify Company
under Article 7 of this Agreement. Notwithstanding the
foregoing, Company shall control any recall of any products sold by
Company to third parties that may incorporate the
Drug.
2.8.
Certain
Responsibilities . Notwithstanding anything
contained herein, Supplier shall not be responsible for any loss or
damage , including Products Liability Damages, from the use
or performance of the Drugs manufactured under this Agreement where
(a) such use or performance did not result from a breach of
this Agreement by Supplier, including, without limitation,
Supplier’s warranties, (b) the Drugs complied with the
description and form described in any documents used for all
governmental approvals, applications, submissions, and approvals
filed by Company with the FDA, or given to Company by the FDA, and
(c) the Drugs complied with the packaging, shipping, and
labeling for the Drugs. Company further agrees that no Products
will be released for public use or consumption until all requisite
governmental approvals therefore have been obtained for such use
and consumption.
6
2.9.
Supply
. Supplier
agrees: (i) to have in place prior to the first
regulatory approval of the commercial sale of the Product an agreed
upon reserve supply of the Drug to support the Product and maintain
during the term of this Agreement a commercially reasonable supply
for the Drug and (ii) to produce commercially reasonable
quantities of the Drug in compliance with FDA GMP requirements and
other regulatory requirements. The Company agrees to pay for the
agreed upon reserve supply of Drug prior to the first regulatory
approval. Supplier agrees to store in a safe and secure off-site
location a reserve supply of the Drug and Supplier agrees to
exercise commercially reasonable efforts to replenish such supply
if it is used. The Drugs shall be stored in compliance with the
Specifications and any applicable law or regulation.
ARTICLE 3.
ORDERS AND DELIVERY
3.1.
Purchase
Orders . To assist the Supplier in
determining the reserve supply of Drug to be maintained, the
Company will make its commercially reasonable efforts to forecast
its requirements for Drugs six (6) months in advance of
ordering Drugs and updating a rolling forecast at three
(3) month intervals. Such rolling forecasts by Company shall
be used for purposes of facilitating Company’s clinical,
sales and marketing plans and meeting the lead times required by
certain of Supplier’s suppliers, but they are not legally
binding on Company in any manner. Company shall submit purchase
orders for the Drugs to Supplier in writing, whether by mail,
facsimile, email or otherwise, which shall, at a minimum, set forth
the product numbers, quantities, delivery dates, and shipping
instructions and shipping addresses for all Drugs ordered. Each
purchase order shall constitute a contract between Company and
Supplier for the sale of the Drugs ordered and shall be subject to
and governed by the terms of this Agreement. The terms and
conditions of this Agreement shall so govern and supersede any
additional or contrary terms set forth in Company’s purchase
order or any Supplier or Company acceptance, confirmation, invoice
or other document unless duly signed by an officer of Company and
an executive officer of Supplier and expressly stating and
identifying which specific additional or contrary terms shall
supersede the terms and conditions of this Agreement. With respect
to all purchase orders submitted at least sixty (60) days in
advance of the earliest scheduled delivery date set forth in such
order, Supplier shall fill such orders in accordance with the
scheduled delivery dates set forth therein, and with respect to all
other purchase orders, Supplier shall exercise commercially
reasonable efforts to fill such orders in accordance with the
scheduled delivery dates set forth therein.
3.2.
Modification
of Orders . No purchase order shall be
modified or canceled except upon the mutual agreement of the
parties; provided, however, that Company may cancel a purchase
order based upon actions of a regulatory authority and Company
may make changes to a purchase order in quantities that do not
exceed ten (10)&nbs
|