Document:

exv10w3

 

Exhibit 10.3

***CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED
HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED AS
[****]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.

SUBSTRATE PRODUCT SUPPLY AGREEMENT

This Product Supply Agreement (“Agreement”) is between Seagate Technology International
(“Seagate”), Komag USA Malaysia Sdn. (“Komag Malaysia”) and Komag, Incorporated (“Komag” and
collectively “Supplier”). The individuals signing this Agreement represent that they are authorized
to sign on behalf of their companies.

Seagate
Technology International

	 	 	 
	Signature:

	 	4/s/ David A. Wickersham
	 
	 	 
	Print Name:

	 	David A. Wickersham
	 
	 	 
	Title:

	 	President and Chief Operating
Officer
	 
	 	 
	Date:

	 	February 23, 2007
	 
	 	 
	Address for Notices

	 	Attn: Corporate Contracts
	to Seagate:

	 	Mailstop SV15A2
	 

	 	c/o Seagate Technology LLC
	 

	 	920 Disc Drive
	 

	 	Scotts Valley, CA 95066
	 

	 	USA
	 
	 	 
	Phone No.:

	 	831-439-7646
	 
	 	 
	Fax No.

	 	831-438-7132
	 
	 	 
	Effective Date:

	 	January 1, 2007
	 
	 	 
	Expiration Date:

	 	December 31, 2008
	 
	 	 
	Agreement No.:

	 	53663

Komag USA Malaysia Sdn.

	 	 	 
	Signature:

	 	4/s/ Oung Kheng Huat
	 
	 	 
	Print Name:

	 	Oung Kheng Huat
	 
	 	 
	Title:

	 	Vice President & Managing Director
	 
	 	 
	Date:

	 	February 23, 2007
	 
	 	 
	Address for Notices

	 	Attn: Vice President &
Managing Director
	to Supplier:

	 	Komag USA Malaysia Sdn.
	 

	 	Bayan Lepas Free Industrial Zone
	 

	 	Phase III
	 

	 	11900 Penang
	 

	 	Malaysia
	 
	 	 
	Phone No.:

	 	(604) 6439-449
	 
	 	 
	Fax No.

	 	(604) 8506-125

Komag, Incorporated

	 	 	 
	Signature:

	 	4/s/ Tim Harris
	 
	 	 
	Print Name:

	 	Tim Harris
	 
	 	 
	Title:

	 	Chief Executive Officer
	 
	 	 
	Date:

	 	February 23, 2007
	 
	 	 
	Address for Notices

	 	Komag, Incorporated
	to Supplier:

	 	1710 Automation Parkway
	 

	 	San Jose, CA 95131
	 

	 	Attn: Chief Financial Officer
	 
	 	 
	Phone No.:

	 	(408) 576-2000
	 
	 	 
	Fax No.

	 	(408) 944-9234

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     The parties agree as follows:

     1. PRODUCT ORDERS 

          1.1. Product and Price List. Exhibit A provides a list of products (“Products”) that
Seagate may purchase from Supplier and the prices that Supplier will charge. Seagate and Supplier
may update the price list from time to time by agreement to reflect changes to the Products or
prices.

          1.2. Orders. Seagate will order Product by either issuing a pull signal or by submitting
purchase orders.

          1.3. Order Acceptance. All orders placed under this Agreement, will be deemed accepted by
Supplier unless Supplier notifies Seagate in writing to the contrary within [****] business days
after receiving the order.

          1.4. This Agreement Controls. If the terms of this Agreement contradict the terms of any
purchase order or order acknowledgment, the terms of this Agreement will take precedence. No
boilerplate terms in either party’s order-tracking documents will apply.

          1.5. Affiliated Purchasers. Seagate’s affiliates that control, are controlled by, or are under
common control with Seagate may purchase Products under this Agreement directly from Supplier at
the same prices and on the same terms set forth in this Agreement.

          1.6. Contract Manufacturers. Seagate’s contract manufacturers may purchase Products under this
Agreement directly from Supplier at the same prices and on the same terms as set forth in this
Agreement, so long as the contract manufacturer purchases the Products to incorporate into Seagate
products and Supplier will bill the contract manufacturer directly, subject to such contract
manufacturers meeting Supplier’s standard credit review criteria.

          1.7. Right to Incorporate and Resell. Seagate may incorporate the Products into Seagate
products and may resell the Products in any market Seagate elects. The right to resell the Product
is specifically limited to Seagate products, which are defined as any products made by or for
Seagate. Seagate may not resell the Supplier Products that are not incorporated into Seagate
products on a standalone basis.

     2. PRICING 

          2.1. [****].

          2.2. Cost Reductions. Supplier will work with Seagate to reduce the costs and expenses to make
and deliver the Products to Seagate. [****]

          2.3. Audit. Seagate may have a third party bound by an appropriate nondisclosure agreement
audit Supplier’s records, on reasonable notice not more than [****] and during regular business
hours, to confirm that Supplier is in compliance with this section. Seagate will give Supplier
reasonable notice before any audit, and will bear the cost of the audit. If the audit discloses
that Supplier has not complied with this section, Supplier will immediately refund Seagate the
difference in the amount it should have charged Seagate and Supplier will also reimburse Seagate
for the cost of the audit.

     3. SHIPMENT AND DELIVERY

          3.1. Incoterms. Unless specified otherwise on Exhibit A, Supplier will ship all
Products to Seagate “DDU DESTINATION.”

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     (a) The term DDU means Delivered Duty Unpaid, as defined in International Chamber of
Commerce, Incoterms 2000. Supplier will pay the costs and bear the risk of loss to deliver
the Products to Seagate’s destination. Supplier will pay the costs and bear the risk of loss
for any warehousing before delivery to the destination.

     (b) Seagate’s destination will always be the incoming dock at Seagate’s factory unless
shipped to Thailand in which the final destination is the designated warehouse, regardless
of whether the Products are shipped through an intermediary cross-dock facility, or stored
in a “just-in-time” warehouse or vendor managed inventory before delivery to the incoming
dock at Seagate’s factory.

          3.2. Supplier Managed Inventory. Supplier will establish a supplier managed inventory stocking
location system at a Seagate-designated location on Seagate’s premises (“SMI Location”) where
Supplier will maintain an inventory of its Products. Supplier will be responsible for the costs and
risk of loss for its Products at the SMI Location. Supplier shall maintain [****] of inventory, or
other mutually acceptable stocking level of inventory, at the SMI Location. Supplier will
replenish the SMI Location to the minimum stocking levels as Seagate pulls Products. After
receiving Seagate’s notice to pull Product, Supplier will have Products shipped from the SMI
Location to Seagate.

          3.3. Import and Export Formalities. If Products will be exported or imported before arriving
at Seagate’s final ship-to destination, Supplier will be the exporter of record and will be
responsible for performing all export formalities; Seagate will be the importer of record and will
be responsible for performing all import formalities. Unless otherwise agreed in writing between
the parties, Supplier will use Seagate’s freight forwarders and will coordinate transportation with
Seagate to minimize or eliminate import and export taxes, duties and freight charges. Any shipping
delay expenses will be the shipping party’s responsibility. For imports to the United States,
Supplier will provide the customs clearance documentation specified in Exhibit B.

          3.4. On-Time Delivery. If Supplier does not deliver any Product on the delivery date specified
by Seagate or fails to maintain the minimum inventory level in the SMI Location set forth above,
then Seagate may purchase substitute product and charge Supplier any additional cost incurred,
including the difference between a higher price charged for the substitute product and the price
Seagate would have paid to Supplier for the Product..

          3.5. Packaging and Marking. Supplier will mark the Products for shipment as designated by
Seagate and pursuant to Seagate’s marking specification. Supplier will package the Products for
shipment in accordance with standard commercial practices acceptable to common carriers at the
lowest shipping rate available.

          3.6. Electronic Delivery. The parties may exchange electronic documents in lieu of printed
purchase orders, order acknowledgements, forecasts and similar documents. Consistent with Section
17.9 below, each party will establish the necessary operating systems to support electronic data
interchange, which may include EDI, Web-DI, FTP or XML as mutually agreed, in standard formats.
Each party will be responsible for its respective costs incurred in sending and receiving
electronic transmissions.

          3.7. Product Acceptance. Products purchased under this Agreement will be subject to
inspection and test by Seagate or its designees at such times and places as agreed between the
parties. Unless otherwise specified in any order, final inspection and acceptance of Products by
Seagate will be at Seagate’s facilities.

     4. INVOICING AND PAYMENT

          4.1. Invoices and Payment Terms. Supplier may invoice Seagate with each delivery, Payment will
be due [****] from the date Seagate pulls the Product from the SMI Location. Seagate’s local
finance department may designate specific days of the month as deadlines for submitting invoices.
If Supplier submits

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its invoices after the deadline, then the invoice will not be deemed received by Seagate until
the next invoice deadline.

          4.2. Right to Offset. If at any time Seagate has any credits owing from Supplier, Seagate may
offset the credits against any payments due to Supplier.

     5. PRODUCT SPECIFICATIONS AND CHANGES

          5.1. Product Specifications. Supplier will comply with the Product descriptions and
specifications referenced in Exhibit C and any other agreed upon specifications, standard
operating procedures, or processes furnished or adopted by Seagate, and Products will be in full
compliance with Supplier’s corresponding samples furnished to and approved by Seagate (collectively
the “Specifications”).

          5.2. Specification Changes. Supplier may not change the form, fit, or function of any Product,
or its manufacturing process or manufacturing location without Seagate’s prior written approval.
Seagate may change the Specifications at any time. Supplier will use its best efforts to comply
with the changes. The parties will discuss in good faith any impact of Seagate’s proposed
Specifications changes on Supplier’s costs and applicable pricing.

          5.3. Product Information. Supplier will provide the following information regarding the
Products to Seagate upon request:

     (a) a bill of materials that includes all material used in manufacturing or assembly
processes, and the related costs;

     (b) a list of component and process sub-suppliers;

     (c) a complete diagram flow chart for all Products with lead-time identified for key
process steps; and

     (d) a description of the manufacturing process and a list of the equipment used in the
manufacturing process.

          5.4. Seagate Property. Supplier will return to Seagate any tools, drawings, or other materials
provided by Seagate at the termination of this Agreement or upon Seagate’s request.

     6. FORECASTS, CAPACITY PLANNING, AND FLEXIBILITY

          6.1. Forecasts. Seagate will provide forecasts to Supplier from time to time as agreed between
the parties. Seagate’s forecasts are not binding on Seagate.

          6.2. Capacity Planning. Supplier will provide a written notice to Seagate within [****]
working days after receiving Seagate’s forecasts, regarding whether it can meet Seagate’s
forecasts. Supplier will notify Seagate immediately if it is unable to meet any forecast. Supplier
will procure and maintain all necessary equipment, personnel, facilities, and other materials
required to manufacture Products according to the Specifications in volumes sufficient to meet
Seagate’s forecasts, up to the mutually-agreed volumes as specified by this Agreement.

          6.3. End-of-Life Capacity. Supplier will give Seagate at least [****] notice before it stops
accepting orders for any Product. During the [****] notice period, Seagate may continue to place
orders for the discontinued Product. Seagate may schedule deliveries of the discontinued Product
for up to [****] after the last date that Supplier will accept orders. If, at the time of Product
discontinuance, Supplier is Seagate’s sole-source of the discontinued Product, Supplier will
continue to manufacture and deliver the discontinued Product to Seagate until Seagate has qualified
a new source for the discontinued Product. Seagate will inform Supplier if

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Seagate intends to use Supplier as a sole source for a Product, which shall require Supplier’s
consent in Supplier’s sole discretion.

          6.4. [****]

          6.5. Downside Flexibility. Seagate may reschedule any delivery up to [****] beyond the
original delivery date. Seagate may cancel any purchase order, in whole or in part, without any
liability owed to Supplier, as follows:

     (a) [****]. If Product is customized for Seagate, then the parties will negotiate
cancellation charges in good faith based upon reasonable lead times and offsets using: (a)
Seagate’s Forecast related to Product mix, (b) reasonable component work-in-process, (c)
reasonable component lead time, (d) the level of component customization.

     (b) [****].

     7.  PRODUCT WARRANTY

          7.1. Warranty Period. The warranty period for the Products will be [****] from the date of
delivery to Seagate unless a different warranty period is specified in Exhibit A. The
Products will be free from defects in material, workmanship, and design for the warranty period
identified in the Product Warranty section of this Agreement, and will conform to the
Specifications (collectively “Quality Standards”). The warranty for the replaced or repaired
Product will be the same as the original Product.

          7.2. Warranties Terms. During the warranty period Supplier warrants the following:

     (a) The Products will fully comply with the Specifications;

     (b) The Products will fully comply with Seagate’s Product Stewardship Requirements;

     (c) The Products will be free from defects in material, workmanship and design;

     (d) The Products will meet the Quality Standards set forth in Exhibit D;

     (e) The Products will be of merchantable quality; and

     (f) The Products will be fit for the use intended by Seagate.

          7.3. Additional Warranties.

     (a) Supplier represents and warrants to Seagate as follows:

     (1) Supplier is a corporation duly organized, validly existing and in good
standing under the laws of the jurisdiction in which it was organized, (ii) Supplier
has the right, power and authority to enter into and perform its obligations under
this Agreement, and (iii) Supplier owns or has acquired and shall maintain all
necessary rights, power, and authority to provide Product contemplated herein.

     (2) The execution and delivery of this Agreement and the performance hereunder
by Supplier does not and will not violate, conflict with or constitute a breach of
or default under or require any consent pursuant to any law, rule or regulation
presently applicable to it, its articles of incorporation, bylaws or other governing
instruments, any order, decree, judgment or award of any court, regulatory body or
other tribunal, or any agreement, instrument or undertaking to which it is a party
or by which it or any of its property is bound.

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     (3) There is no threatened (to Supplier’s knowledge) or pending litigation
relating to the Product and there is no actual or threatened (to Supplier’s
knowledge) claim against Supplier alleging the violation, infringement, or
misappropriation of any third party’s rights relating to the Product.

     (b) Seagate represents and warrants to Supplier as follows:

     (1) Seagate is a corporation duly organized, validly existing and in good
standing under the laws of the jurisdiction in which it was organized, and (ii)
Seagate has the right, power and authority to enter into and perform its obligations
under this Agreement.

     (2) The execution and delivery of this Agreement and the performance hereunder
by Seagate does not and will not violate, conflict with or constitute a breach of or
default under or require any consent pursuant to any law, rule or regulation
presently applicable to it, its articles of incorporation, bylaws or other governing
instruments, any order, decree, judgment or award of any court, regulatory body or
other tribunal, or any agreement, instrument or undertaking to which it is a party
or by which it or any of its property is bound.

          7.4. Warranty Remedies. If the Products do not meet the warranties, at Seagate’s option,
Seagate may elect one or more of the following remedies to be performed at Supplier’s expense:

     (a) Seagate may require Supplier to repair or replace Product;

     (b) Seagate may return Product to Supplier at Supplier’s expense for a full refund;

     (c) Seagate may correct the non-compliance and charge Supplier for the cost to make the
correction; and

     (d) Seagate may engage third parties to provide substitute products and charge Supplier
for the costs of obtaining the substitute products from the third parties, including the
difference between any higher price paid for the substitute products and the price Seagate
would have paid to Supplier for the Products.

          7.5. Remedies Nonexclusive. The remedies listed above are in addition to any other remedies
available to Seagate in law or equity.

     8. RELIANCE ON SUPPLIER 

          8.1. Advice Regarding Intended Use. Seagate will rely on Supplier’s expertise and advice in
the selection and use of Supplier’s Product. Supplier will assign personnel to work with Seagate
who are reasonably qualified to advise Seagate in the selection and use of Supplier’s Product.
Supplier must request relevant information from Seagate regarding Seagate’s selection and use of
Product, and must notify Seagate if it believes that there are potential problems in Seagate’s
selection and use of Product.

          8.2. Return of Product. If a Product does not function properly in the manner in which it is
used by Seagate, and if Seagate provided sufficient information to Supplier regarding Seagate’s
intended use for the Product such that Supplier should have known that the Product would not
function properly, then Seagate may return the Product to Supplier as non-conforming.

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          8.3. Limits on Reliance. Supplier will have no obligation to accept return of non-conforming
Products under this Reliance on Supplier section, if Seagate does not disclose sufficient
information about its intended use of Products, or if Supplier warns Seagate in writing of a
potential problem with Seagate’s intended use of Products and Seagate disregards Supplier’s
warnings.

     9. ONGOING QUALITY AND RELIABILITY

          9.1. Quality Standards. Supplier will comply with the Quality Standards set forth in
Exhibit D.

     10. CONTINUITY OF SUPPLY 

          10.1. Allocation of Resources. [****].

          10.2. Advisory Personnel. If Supplier is unable to provide the Products in the quantity and
quality actually ordered by Seagate to the extent of the committed capacity, Supplier will allow
Seagate to send advisory personnel to Supplier’s facility to review the manufacturing and delivery
of the Products. [****].

          10.3. March-In Rights. If Supplier is the sole source or exclusive source for Product in
accordance with Section 6.3, with reasonable advance notice, Seagate may enter into and use
Supplier’s facility to perform inspections, testing, physical inventory counts, and other
activities directed at assisting Supplier to restore continuity of supply. Supplier will cooperate
with Seagate and provide available space and facilities for Seagate’s activities. Seagate will pay
the actual operational expenses to use Supplier’s resources.

          10.4. Manufacturing Rights. If Supplier is the sole source or exclusive source for Product in
accordance with Section 6.3, and Seagate is unable, through exercise of its advisory personnel
rights and march-in rights as described in sections entitled “Advisory Personnel” and “March-In
Rights” above, to secure a continuity of supply of Products in the actual quantity and quality
ordered by Seagate, then Supplier will cooperate with Seagate in effecting the orderly transfer of
the manufacture and supply of Products to a facility operated by Seagate or a third party
designated by Seagate. Supplier grants to Seagate the royalty-bearing right to manufacture the
Products and to have the Products manufactured by third parties, including the rights to make, have
made, use, import, offer for sale, sell, use, reproduce, distribute, and make derivative works of
Products for the purposes of securing a continuity of supply of Products in the actually quantity
and quality ordered by Seagate.

     11. CONFIDENTIALITY 

          11.1. Marking Confidential Information. During this Agreement, each party may learn
confidential business or technical information related to the disclosing party (“Confidential
Information”). In order to be protected under this Agreement, any Confidential Information must be
clearly marked as “confidential,” “secret” or with a similar legend. No party will have any
responsibility under this Agreement for any information that is not so marked at the time of
disclosure. Any oral or visual disclosures must be designated as confidential at the time of the
disclosure and confirmed as confidential in a written notice delivered within 20 days after the
disclosure, describing the oral or visual information disclosed and stating that the information is
confidential.

          11.2. Nondisclosure. Each party will protect the Confidential Information of the other party
against unauthorized disclosure using the same degree of care, but no less than a reasonable care
as it uses to protect its own information of a similar kind. The Confidential Information may be
disclosed to employees, affiliates, or consultants of the recipient who have entered into
nondisclosure agreements with the recipient. Supplier may only use Seagate’s Confidential
Information for the benefit of Seagate.

          11.3. Confidentiality Period. The duty to protect Confidential Information expires [****]
after expiration of this Agreement.

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          11.4. Exclusions. The obligations of confidentiality do not apply to information that (a) is
generally known to the public or otherwise in the public domain other than through breach of
confidentiality; (b) the other party can show was known to the recipient before receipt from the
disclosing party; (c) is disclosed by a third party without breach of any obligation of
confidentiality; (d) is independently developed by the recipient; or (e) is required to be
disclosed by a court, administrative agency, or other governmental body, or by operation of law.

          11.5. Return of Information. Upon expiration or termination of this Agreement, each party will
return or destroy the Confidential Information of the other upon written request.

          11.6. Other Nondisclosure Agreements. The parties may enter into other nondisclosure
agreements governing specific disclosures. To the extent that the terms governing a specific
disclosure are more restrictive than the terms of this Agreement, the more restrictive terms will
control regarding the specific disclosure.

          11.7. Publicity. Neither party may disclose the existence or terms of this Agreement to any
third party without the prior written consent of the other except as required by law or as
necessary to comply with other obligations stated in this Agreement. Neither party may issue any
press releases related to this Agreement without the written consent of the other party.

     12. INDEMNIFICATION AND DEFENSE 

          12.1. General Indemnification. Supplier will defend and indemnify Seagate and Seagate’s
affiliates, directors, employees and contractors (collectively, “Indemnitees”) against any claim or
action and all resulting losses, damages and expenses (including reasonable attorneys’ fees and the
expenses of other professionals) (“collectively, “Claims”) brought by a third party against an
Indemnitee arising from an allegation of Supplier’s negligence or willful misconduct, or breach of
this Agreement.

          12.2. Infringement Indemnification. Supplier will defend and indemnify each Indemnitee
against all Claims arising out of, resulting from or related to any allegation that Product
provided by Supplier infringes or misappropriates any patent, copyright, trademark, trade secret,
trade name, trade dress, mask work or other intellectual property or proprietary right
(collectively “IP Rights”) of a third party. If Seagate or any if its subsidiaries or affiliates is
prevented or, in Seagate’s opinion is likely to be prevented from using Product by reason of any
such Claim, then Supplier will, at its sole expense, use its best efforts to (a) obtain all rights
required to permit the use of such Product by Seagate, its subsidiaries and affiliates; or (b)
modify or replace the Product to make it non-infringing, provided that the replacement of such
Product is satisfactory to Seagate. If Supplier is unable to achieve either option above within 30
days after issuance of an injunction or notice from Seagate, then either party may immediately
terminate this Agreement and upon termination, Supplier will promptly refund Seagate the price
originally paid by Seagate and all shipping, storage and all related costs for all affected Product
that is returned or destroyed. The foregoing is Seagate’s sole remedy for a breach of the warranty
in Section 7.3(a)(3) or any Claim of infringement or misappropriation of any intellectual property
right.

          12.3. Notification and Defense Obligations. Seagate will promptly notify Supplier of any Claim
for which it seeks indemnity under the terms of this Agreement, provided, however, that Seagate’s
failure to give prompt notice will not relieve Supplier of its indemnity obligation except to the
extent that the Supplier shows that such failure actually prejudiced the Supplier. Seagate will
permit Supplier to control, in a manner not adverse to the Indemnitees, the defense and settlement
of any such Claim using counsel reasonably acceptable to Indemnitees. Indemnitees may employ
counsel at their own expense with respect to any such Claim, provided that if counsel is employed
due to a conflict of interest or because Supplier does not assume control of the defense, then
Supplier will bear such expense. Indemnitees will give reasonable assistance and cooperation to
Supplier in the defense of the Claim. Supplier will not admit liability or enter into any
settlement that adversely affects Indemnitees’ rights or interests without their prior written
approval.

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     13. LIMITATION OF LIABILITY 

          13.1. Limitation of Type of Liability. Seagate will not be liable to Supplier, and Supplier
will not be liable to Seagate, for any consequential, incidental, indirect, special, economic, or
punitive damages, or any lost profits or lost revenues, even if it has been advised of the
possibility of such damages.

          13.2. Limitation of Amount of Liability. except for liability arising from willful or reckless
misconduct, breach of confidentiality, or misuse of intellectual property, Seagate will not be
liable to Supplier, and Supplier will not be liable to Seagate, regardless of the basis of
liability or the form of action, [****].

     14. TERM AND TERMINATION 

          14.1. Effective Date and Expiration Date. This Agreement is effective from the Effective Date
through the Expiration Date shown on the first page.

          14.2. Renewal. After the Expiration Date, this Agreement will automatically renew for
successive one year terms unless either party notifies the other party that they will not renew the
Agreement at the end of the then-current term.

          14.3. Termination for Convenience . Either party may terminate this Agreement for any reason
by providing [****] prior written notice to the other.

          14.4. Termination for Cause. Either party may terminate this Agreement (a) immediately upon
written notice if (i) the other party breaches a material obligation of this Agreement that by its
nature is incurable; (ii) a receiver is appointed for the other party or its property; (iii) the
other party makes an assignment for benefit of its creditors; (iv) proceedings are commenced by or
for the other party under any bankruptcy, insolvency, or debtor’s relief law, or (v) the other
party liquidates or dissolves its business or attempts to do so, or (b) upon written notice if the
other party breaches a material obligation of this Agreement and does not cure such breach within
thirty (30) days after delivery of written notice of such breach

          14.5. Effect of Termination or Expiration. Upon termination or expiration of this Agreement,
its provisions will continue to apply to all undelivered orders that were accepted by Supplier
while the Agreement was in force.

     15. DISPUTE RESOLUTION 

          15.1. Good-Faith Negotiation. The parties will attempt to resolve any dispute relating to this
Agreement through good-faith informal negotiation.

          15.2. Mediation. If the parties are unable to resolve the dispute through good faith informal
negotiation, they will participate in mediation before an agreed mediator from Judicial Arbitration
and Mediation Services (“JAMS”). Either party may initiate mediation by providing a written request
for mediation to the other party and to JAMS. The request must describe the dispute and the relief
requested. The mediation will be scheduled within ten business days after the request. The
mediation will take place at a JAMS facility in California. The parties will cooperate with JAMS
and with one another in selecting a mediator from a JAMS panel of neutrals, and in scheduling the
mediation proceedings. The parties will participate in the mediation in good faith. The parties
will bear their own expenses in mediation, but will share all fees to JAMS equally.

          15.3. Arbitration. If the parties are unable to resolve the dispute through mediation, they
will submit the dispute to final, binding arbitration under JAMS International Arbitration Rules
(www.jamsadr.com/rules/international_arbitration_rules.asp) (“JAMS Rules”). Either party
may initiate arbitration by providing a written request for arbitration to the other party and to
the JAMS. The arbitration will be held in Santa Clara County, California, USA. The arbitrator
will be selected in accordance with the JAMS

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Rules and must have expertise in the subject matter of the dispute. The arbitrator may award
specific performance, injunctions, or other equitable relief. Judgment upon any arbitration award
may be entered in any court with jurisdiction over either party. If either party fails to appear at
any properly noticed arbitration proceeding, an award may be entered against the absent party. The
parties will bear their own expenses in arbitration, but will share all fees to JAMS equally.

          15.4. Equitable Relief. Either party may seek equitable relief to enforce the rights granted
in this Agreement to obtain a temporary restraining order or other provisional remedy to preserve
the status quo or prevent irreparable harm. The rights granted in this section 15.4 are critical
to Seagate’s business and Seagate’s ability to service its customers; and the loss of these rights
cannot be adequately compensated or measured in monetary damages. Accordingly, the rights granted
under this section are the proper subject of an order of specific performance, mandatory
injunction, or other appropriate preliminary or permanent equitable relief.

          15.5. Survival and Attorney’s Fees. This Dispute Resolution section will survive the
Agreement’s termination or expiration. This Dispute Resolution section may be enforced by any court
of competent jurisdiction, and a party seeking enforcement will be entitled to an award of all
costs, fees and expenses, including attorney’s fees, to be paid by the party against whom
enforcement is ordered.

     16. INSURANCE 

          16.1. General Insurance Requirements. at its own expense, at all times during the term of this
Agreement and as otherwise provided below, provide and maintain in effect those insurance policies
and minimum limits of coverage as designated below, and any other insurance required by law,
regulations or orders in any state or country where this Agreement is to be performed, with
companies licensed to do business in the state or country in which the Agreement is to be
performed, with an A.M. Best’s Insurance Rating of [****] or better, and that will comply with each
of the requirements below. These minimum insurance requirements must not be interpreted in any way
to limit Supplier’s liability under this Agreement, including but not limited to Supplier’s defense
and indemnity obligations.

          16.2. Workers’ Compensation and Employer’s Liability Insurance. If Supplier has employees or
acquires employees during the term of this Agreement, then Supplier must maintain Workers’
Compensation insurance as required by statute, law or regulation of the nation, state, territory or
province having jurisdiction over such employees, and Employer’s Liability insurance with limits
not less than [****].

          16.3. Commercial General Liability Insurance. Supplier must maintain Commercial General
Liability insurance on an occurrence, not claims-made, basis, with limits of not less than [****]
per occurrence and [****] in the annual aggregate. Such limits may be provided either by a
Commercial General Liability policy alone, or by a combination of Commercial General Liability,
Umbrella Liability or Excess Liability insurance provided that the Umbrella Liability or Excess
Liability insurance is on terms at least as broad as the underlying Commercial General Liability
policy. Such insurance must include coverage for bodily injury, property damage, advertising and
personal injury, products/completed operations, contractual liability and cross-liability. Such
insurance must include Seagate, its subsidiaries and affiliates, and their respective directors,
officers, employees and agents as additional insureds. Such insurance must be primary to and
noncontributory with any insurance otherwise maintained by or afforded to Seagate, its subsidiaries
and affiliates, and their respective directors, officers, employees and agents.

          16.4. Automobile Liability Insurance. Supplier must maintain Automobile Liability insurance
covering all owned, non-owned and hired vehicles used by Supplier in connection with this
Agreement, with limits of not less than [****].

          16.5. Errors and Omissions (Professional Indemnity) Insurance. Supplier must maintain Errors
and Omissions (Professional Indemnity) insurance with coverage limits of no less than [****] per
occurrence or

-10-

 

     

per claim and [****] in the annual aggregate. If such insurance is maintained on a
claims-made basis, then Supplier must continue to maintain such insurance for three years after
termination of this Agreement

          16.6. Proof of Insurance. Supplier must provide Seagate with proof of insurance satisfactory
to Seagate at the time this Agreement is executed or within a reasonable time thereafter and within
a reasonable time after coverage is renewed or replaced. Any acceptance of insurance certificates
by Seagate, or Supplier’s failure to provide such certificates, will not limit or relieve Supplier
of its duties and responsibilities with respect to maintaining insurance assumed by Supplier under
this Agreement. Supplier’s certificate of insurance must note that the insurers issuing such
coverage must endeavor to provide Seagate with 30 days’ prior written notice in the event of
cancellation or non-renewal of coverage.

          16.7. Waiver of Subrogation. Except where prohibited by law and except with respect to the
(Errors and Omissions) Professional Liability insurance required above, Supplier and its insurers
waive all rights of recovery or subrogation against Seagate, its subsidiaries and affiliates, and
their respective directors, officers, employees and agents, but only to the extent of liabilities
falling within Supplier’s indemnity obligations under the terms of this Agreement.

     17. MISCELLANEOUS

          17.1. Relationship of the Parties. Supplier and Seagate are independent contractors.

          17.2. No Intellectual Property Rights Granted. Except as expressly provided, this Agreement
does not grant either party any right to the other party’s patents, copyrights, trademarks, trade
secrets, or other forms of intellectual property.

          17.3. Assignment. Unless permitted by this Section, neither party may assign this Agreement
in whole or in part without the consent of the other party. A party will not unreasonably withhold
its consent to a request for assignment. Subject to Seagate’s right to terminate below, either
party may assign this Agreement, without the need for consent, pursuant to a sale of all or
substantially all of its assets, a merger, corporate reorganization of corporate form, or change of
control (a “Change of Control”). Supplier will give Seagate notice of an impending Change of
Control as soon as feasible (subject to confidentiality and other requirements). If Supplier
undergoes a Change of Control, Seagate will have the right to terminate this Agreement on written
notice to Supplier, which notice shall be effective, at Seagate’s option, either immediately upon
the closing of the transaction that results in the Change of Control, or on such later date as set
forth in the notice. If, and to the extent, this Agreement continues for any period of time
following the effective date of such Change of Control, Supplier agrees that it will (i) allow
Seagate representatives reasonable access to Supplier’s manufacturing facilities to permit Seagate
to monitor and protect its interests under the Agreement and (ii) ensure that Seagate’s
intellectual property, Specifications, product roadmap and other Confidential Information will not
be disclosed to any third party without Seagate’s prior written consent. No such termination by
Seagate will be deemed a material breach of the Agreement by either party.

          17.4. Compliance with all Laws. Supplier, and all Product supplied and work performed under
this Agreement, must comply with all applicable laws and regulations in effect, including those
governing environment, health and safety, and labor and employment practices. Supplier must require
that its sub-suppliers also comply with all applicable laws and regulations in effect. Upon
request, Supplier will certify that it complies with all applicable laws and regulations. Seagate
may audit Supplier to confirm Supplier’s compliance with this Section.

          17.5. Manufacturing Process Inspections. Seagate may inspect Supplier’s manufacturing
locations, warehouses, and other facilities during normal business hours with reasonable notice to
Supplier. Supplier will provide Seagate with its own inspection, quality and reliability data upon
request.

-11-

 

     

          17.6. Export Controls. Each party will comply with all applicable export, re-export and
foreign policy controls and restrictions imposed by the U.S. and the country in which they are
located, including the U.S. Export Administration Regulations. Supplier may not export, re-export
or allow to be disclosed, any technical data received from Seagate or the product of any technical
data to any person or destination to the extent prohibited by law.

          17.7. English Language; Governing Law. English is the authoritative text of this Agreement,
and all communications and proceedings must be conducted in English. If this Agreement is
translated, then the English language version will control. The laws of the State of California,
USA govern this Agreement, without regard to any conflicts of laws rules. The United Nations
Convention on Contracts for International Sale of Goods does not apply to this Agreement.

          17.8. Continued Provision of Service.

               (a) Written Disaster Recovery Plan. Supplier must provide a written disaster recovery plan to
Seagate within 30 days after execution of this Agreement. The disaster recovery plan must
demonstrate Supplier’s ability to ensure continuity of supply of the Products in the quantity
forecasted by Seagate and the quality required under this Agreement. Upon Seagate’s request,
Supplier will evaluate and test its disaster recovery plan and certify to Seagate that the plan is
fully operational.

               (b) Force Majeure. Neither party will be liable to the other if its performance is delayed by
acts of nature beyond its control. If a force majeure condition prevents Supplier’s performance for
more than 30 days, then Seagate may terminate this Agreement or cancel any unfilled orders without
liability owed to Supplier.

          17.9. Severability; Survival. The terms of this Agreement are severable. If any term is
unenforceable for any reason, then that term will be enforced to the fullest extent possible, and
the Agreement will remaining in effect. All obligations that by their terms or nature survive
termination of this Agreement will continue until fully performed.

          17.10. Written Amendments; Electronic Business Transactions. This Agreement may be changed
only by written amendment signed by both parties. The parties may exchange electronic documents in
lieu of printed purchase orders, order acknowledgments, or forecasts. Supplier will comply with
Seagate’s designated system of exchanging electronic documents and will bear its own costs to
participate in the system. Neither party will contest the validity or enforceability of
electronically transmitted purchase orders or order acknowledgments on the grounds that they fail
to comply with the Statute of Frauds or similar laws requiring that contracts be in writing (such
as UCC Section 2-201 or any state-law equivalent). Neither party is prohibited from asserting that
an electronic document is invalid for any reason that would also invalidate a written document.

          17.11. Entire Agreement; No Waiver; Notices. This Agreement and the documents referred to in
it are the entire agreement of the parties with respect to this subject matter, superseding all
prior or contemporaneous agreements. No failure or delay in exercising any right will be considered
a waiver of that right. All notices and other communications must be delivered to the addresses
designated on the first page of this Agreement.

          17.12. Headings. The headings of the sections of this Agreement are inserted for convenience
of reference only and are not intended to be part of or to affect the meaning or interpretation of
this Agreement.

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

-12-

 

EXHIBIT A

PRODUCT AND PRICE LIST

	a.	 	Volume. Komag will supply and Seagate will purchase,
provided Product meets Seagate’s specifications, pricing and quality targets,
up to the following total volume of nickel plated and polished substrates
(“NPP”) Product during the term of this Agreement:

	 	 	 	 	 
	 

	 	Q1 07
	 	[****] pieces
	 

	 	Q2 07
	 	[****] pieces
	 	 	Q3 07 and for the remaining term of the Agreement [****] pieces per
quarter.

	b.	 	Volume Adjustments. Komag will make available to
Seagate, up to a total of [****] pieces in Q1 07 and up to [****] pieces in Q2
07. [****].
	 
	c.	 	Pricing. The following Komag prices are considered
[****] commitments and are based on Seagate fiscal calendar consumption. All
prices are [****], as defined in International Chamber of Commerce Incoterms
2000, and both parties mutually agreed freight forwarder subcontractors.

	 	i.	 	The price for [****] is [****].
	 
	 	ii.	 	The price for [****] is [****].
	 
	 	iii.	 	The price for [****] will be based on the
following:

	 	1.	 	For [****] pieces a quarter: the
price will be [****].
	 
	 	2.	 	For [****] pieces a quarter: the
price will be [****]; and
	 
	 	3.	 	For [****] pieces or more a
quarter: [****].

	 	iv.	 	The price for [****] will be based on the
following:

	 	1.	 	[****].
	 
	 	2.	 	[****].
	 
	 	3.	 	Pricing based on [****] price
schedule.

	d.	 	[****] Flexibility. The parties agree on the following
[****] flexibility:

	 	i.	 	[****].
	 
	 	ii.	 	[****].
	 
	 	iii.	 	[****].
	 
	 	iv.	 	[****].
	 
	 	v.	 	Komag will make reasonable effort to meet
[****] supply requests and at a minimum provide the following [****]
production for Seagate products:

	 	1.	 	From 1/1/07 to 7/1/07: [****].
	 
	 	2.	 	From 7/1/07 to 12/31/07: [****].
	 
	 	3.	 	From 1/1/08 to the end of the
agreement: [****].

	 	vi.	 	Komag will make reasonable effort to respond
with shipments to meet all Seagate product schedules and purchase
order changes. Komag lead time for shipment to meet Seagate schedules
and purchase order changes will not exceed [****] upon Aluminum Blank
supply availability.

-13-

 

EXHIBIT B

CUSTOMS CLEARANCE DOCUMENTATION

International Trade Compliance. The goods licensed or sold under this Agreement, and the
transaction contemplated by this Agreement, which may include technology and software, are subject
to the customs and export control laws and regulations of the United States (“U.S.”) and may also
be subject to the customs and export laws and regulations of the country in which the products are
manufactured or received. Further, under U.S. law, the goods shipped under this Agreement may not
be sold, leased or otherwise transferred to restricted countries, or used by a restricted end-user
or an end-user engaged in activities related to weapons of mass destruction including, without
limitation, activities related to designing, developing, producing or using nuclear weapons,
materials, or facilities, missiles or supporting missile projects, or chemical or biological
weapons. Supplier acknowledges that it is Supplier’s responsibility to comply with and abide by
those laws and regulations, and that any customer or vendor that Supplier requests that Seagate
route Product to directly has also been made aware of the associated export controls.

For Product that must be cleared through customs, Supplier must provide customs documentation
(sometimes referred to as a “proforma invoice” or “customs invoice”) for the purpose of
facilitating customs clearance. The customs documentation must be in English and must include the
following information:

1. SHIPPING INFORMATION

	 	§	 	Date of shipment;
	 
	 	§	 	Invoice number and shipment number;
	 
	 	§	 	Seagate purchase order number;
	 
	 	§	 	Shipper name and address;
	 
	 	§	 	Ship to party (name and address) and bill to party (name and address);
	 
	 	§	 	Supplier Custom Broker (name);
	 
	 	§	 	Wood packaging material adherence with ISPM15 ( International Standard for Phytosanitary
Measures No. 15) (i.e., must be either heat treated or fumigated with methyl bromide and
marked with an approved international mark certifying treatment);
	 
	 	§	 	Name, contact information and signature of responsible individual — must be a
responsible employee of the exporter who has knowledge or who can readily obtain knowledge
of the transaction;
	 
	 	§	 	Incoterm and named place; and
	 
	 	§	 	Shipment gross weight.

2. PRODUCT INFORMATION

	 	§	 	Description of Product, grade or quality, as well as marks, numbers, and symbols under
which the Product is sold, if applicable — for product description, use generic terms by
which each item is commonly known.
	 
	 	§	 	Product quantities, including quantity of Product per each individual package/box, the
number of packages/boxes, the number per pallet, the number of pallets, and the
corresponding weights – the information must be sufficiently detailed to enable
identification and matching of Product in the shipment against line items on the shipping
invoice;
	 
	 	§	 	Seagate part numbers

-14-

 

	 	§	 	Seagate Descriptions as indicated in P.O.
	 
	 	§	 	Quantities
	 
	 	§	 	Unit of Measurement
	 
	 	§	 	Country of origin (place of manufacture) by part and quantity
	 
	 	§	 	FCC ID number, if any
	 
	 	§	 	FDA accession number, if any; if the invoice contains multiple pages, each page must be
number, preferably in the following format: X of Y pages
	 
	 	§	 	Product net metric weight
	 
	 	§	 	Manufacturer’s Identification code/MID number (for textile products shipped to the U.S.)
	 
	 	§	 	Third Party product appraisal report on used equipment (if applicable)
	 
	 	§	 	Product classification information including:

	 	o	 	Harmonized Tariff Schedule number
	 
	 	o	 	Export Control Classification Number (ECCN)

	 	§	 	U.S. Commodity Classification Automated Tracking System number (CCATS number, if
applicable)
	 
	 	§	 	U.S. export license number and expiration date (if applicable)
	 
	 	§	 	U.S. License Exception designator (if applicable)

3. PRICING INFORMATION

	 	§	 	Unit purchase price and type of currency (if the merchandise is not purchased, the value
or usual price in the country or exportation);
	 
	 	§	 	All charges upon the Product, itemized by name and amount, including freight, insurance,
commission, cases, containers, coverings and cost of packing, repair and calibration;
	 
	 	§	 	Total purchase price and terms of payment – customs regulations require every shipping
invoice accurately reflect the price to be paid by Seagate. The shipping invoices are used
to declare the value of the imported Product for customs entry. Software purchases must
indicate the full purchase price of the software regardless of delivery method, e.g.
CD-ROM, download. Accordingly, 100% accuracy is required. Post-shipment price increases
can render declarations inaccurate; therefore, price increases may not be applied to
Product already shipped or in JIT or VMI inventories;
	 
	 	§	 	All “free of charge” items must have a commercial value listed for Customs purposes.

Any goods or services furnished to Supplier for the production of the Product not included in the
invoice price (e.g. assists such as dies, molds, tools, engineering work) — however, goods or
services furnished in the destination country are excluded.

4. GLOBAL SUPPLY CHAIN SECURITY PROGRAMS

In addition to the customs documentation listed above, Supplier will provide Seagate with
verification that they have reviewed their supply chain processes and have the appropriate security
measures in place to guard against cargo theft and cargo terrorism. Supplier will conduct a
self-audit of its transit lanes and of the carriers that are bringing the Products into the USA.

If Supplier is eligible to participate in the US Customs-Trade Partnership Against Terrorism
(“C-TPAT”) program, Seagate may require that supplier apply for participation and Supplier will
provide Seagate with written updates regarding the status of Supplier’s C-TPAT application every 90
days. Upon acceptance,

-15-

 

Supplier will provide Seagate with a copy of its Memorandum of Understanding with U.S. Customs and
Border Protection and a copy of its C-TPAT compliance certificate.

Seagate may require Supplier to apply for and participate in similar programs in other
jurisdictions as they are implemented and as Supplier becomes eligible, such as the New
Computerized Transit System (“NCTS”) proposed for the European Union.

-16-

 

EXHIBIT C

PRODUCT DESCRIPTION AND SPECIFICATIONS INCORPORATED BY REFERENCE

	 	 	 	 	 	 	 	 	 	 	 	 	 
	Form	 	 	 	 	 	 	 	Document	 	 	 
	Factor	 	Platform	 	Product	 	Document Title/Description/Part No.	 	Number	 	Rev	 
	[****]
	 	[****]	 	[****]	 	[****]	 	[****]	 	 	[****]	 

-17-

 

 

EXHIBIT D

QUALITY STANDARDS

Commitment to Seagate’s Quality Requirement

1. Yield Benchmark. [****].

2. Product Stewardship Requirements. Seagate’s current Product Stewardship Requirements are
referenced in Exhibit C. Seagate will update the Product Stewardship Requirements from
time to time and will make the updated versions available to Suppler. Updated versions of the
Product Stewardship Requirement will automatically be incorporated into, and become a part of, this
Agreement without any further action by the parties. Supplier must immediately notify Seagate if
any of its Products include chemicals or compounds in amounts that exceed the threshold amounts
listed in the Product Stewardship Requirements. Each shipment of Products to Seagate will
constitute a certification by Supplier that the Products shipped meet the Product Stewardship
Requirements. Upon Seagate’s request, Supplier will provide sufficient documentation to Seagate to
show that the Products conform to the Product Stewardship Requirements. Supplier will maintain
processes and policies designed to protect the environment and employee health and safety at any
facility where services related to this Agreement are performed.

3. ISO 9000 Certification. Supplier must have a total quality system in place that meets ISO 9000
certification requirements.

4. Corrective Action. Whenever a Product does not perform as warranted, Seagate may request that
Supplier implement a containment plan within [****] after the failure. Supplier must provide
Seagate with a detailed failure analysis identifying root cause within five days after the failure.
Supplier will work with Seagate to determine the effect of the failures on Seagate’s products and
customers; and Supplier will implement a corrective action plan that is acceptable to Seagate to
eliminate the effect of the failures on Seagate’s products and customers. Supplier will maintain
the effectiveness of all corrective actions implemented as well as apply these corrective actions
to other Products when and where applicable.

5. Epidemic Failure; Product Recall. In addition to the warranty in Section 7 of the Agreement,
Supplier will be obligated to remedy any Epidemic Failure of Products. An Epidemic Failure will be
defined as the occurrence of multiple failures of the same Products for the same cause, to the
extent that the failure rate of the Products exceeds Seagate’s allowable DPPM described in the
Specifications If there is an Epidemic Failure, then Seagate may require Supplier to accept
return of all affected Products and Seagate may elect to recall and return to Supplier any
affected Products that have been incorporated into Seagate’s products and distributed to Seagate’s
customers or end users. If Seagate recalls affected Products from Seagate’s customers or end users,
[****] will BEAR THE COST OF recalling and returning the Products. Seagate to provide documentation
detailing costs.

6. Failure Rate. With respect to each Product, Supplier shall comply with the failure rate
limit(s) set forth below. Supplier will report to Seagate the failure rates for each Product on a
monthly basis. If the actual failure rate for any Product exceeds the goal, then Supplier will
designate a team that will determine the root cause of the failure and will report to Seagate at
weekly meetings until the actual failure rate for the Product is below the goal.

-18-

 

Early Failure Rate Defective Parts Per Million (“DPPM”). The early failure rate DPPM, which
represents the line fallout in Seagate’s printed circuit board assembly, substrate, media
and drive build factories, shall be less than [****] DPPM. Supplier will demonstrate the
early failure rate DPPM by performing appropriate accelerated life testing on a
statistically significant number of parts, which are representative of the fabrication and
package assembly processes. If the Supplier’s process is not in control, then a [****] test
screen under appropriate environmental stress conditions may be required to achieve the
desired reliability level.

Defective Parts Per Million (“DPPM”). During the volume production phase, the DPPM
shall be no greater than [****] DPPM.

Even if a Product passes Seagate’s initial drive qualification testing and meets the
Specifications during the Product qualification procedure, the Product will be deemed to have
failed Seagate’s Quality Standards if any Seagate disc drive incorporating the Products fails to
achieve its specifications and the failure is proven to be attributable to the incorporated
Products. When material does not meet Seagate’s Quality Standards, Supplier is expected to make
commercially reasonable efforts to assist Seagate in satisfying Seagate’s overall quality
objectives and in re-qualifying the Product for use by Seagate. Commercially reasonable efforts
include, but are not limited to, repair, replacement with new Product, or return of Product with
full credit in accordance with terms of this Supply Agreement.

7. Quality Standard. To meet Seagate’s Quality Standards, Supplier agrees:

(a) To produce Product in accordance with all applicable Seagate Specifications and all
documents referenced in Specifications, including but not limited to Exhibit C,
Receiving Inspection and Testing Procedure, Discrepant Material Procedure, and General
Inspection Plan (GIP) Procedures;

(b) To provide, at Seagate’s request, actual performance metrics;

(c) To comply with DPPM levels as established by Seagate;

(d) To conduct ongoing reliability testing of Products as defined by Seagate’s Quality
Engineering department; and

(e) To meet Seagate’s Quarterly Business Review Scorecard Acceptance Level as defined by
Seagate’s Materials department and Supplier Quality Engineering department.

Seagate may change its Quality Standards with [****] prior written notice to Supplier. Supplier
will use commercially reasonable efforts to comply with the Quality Standards change requests and
provide Seagate with a plan to implement the Quality Standards changes, or an alternate proposal
subject to Seagate’s written approval, within [****].

-19-

 

EXHIBIT E

BUSINESS CONTINUITY AND

EMERGENCY RESPONSE PLAN; DISASTER RECOVERY PLAN

A. GENERAL

     1. Supplier recognizes that these terms and conditions apply to each of Supplier’s facilities,
buildings, or operations that will be used to supply Products under this Agreement, including those
warehouses that will be used to store property used in connection with the supply of Products.

     2. Supplier will maintain site-specific Emergency Response Plans and Disaster Recovery Plans,
which will be made available to Seagate upon request.

     3. Supplier shall disclose to Seagate upon request, fire protection designs and capabilities
for each warehouse building or operation that will store or distribute property used in connection
with supply of the Products.

B. COMPLIANCE WITH LAW

     1. Supplier must have a written and implemented plan that ensures compliance with local
environmental, health, safety and fire protection laws. The plan must contain a description of
potential hazards and corresponding control plans, and details of how Supplier will ensure
compliance with laws and regulations and with the terms of the Agreement and this exhibit.

     2. Supplier must implement and maintain appropriate risk control and response measures for
foreseeable emergencies, including fire, natural disasters at the operations or warehouse sites or
during shipment.

     3. Seagate reserves the right, but not the obligation, to require Supplier, to undertake
periodic inspections in order to verify compliance with this standard and any other requirements of
the contract with Seagate. Seagate reserves the right to inspect buildings and operations upon
reasonable notice.

C. PROHIBITIONS FOR ALL FACILITIES USED TO STORE SEAGATE WIP AND FINISHED GOODS

     The following business risk conditions are prohibited at or near warehouses used to store
Seagate materials, such as finished product, components, or manufacturing equipment:

     1. Storage of flammable liquids in any quantities greater than those required for maintenance
and operation of Supplier’s facilities.

     2. Storage of flammable or oxidizing gases or aerosols in any quantities greater than those
required for maintenance and operation of Supplier’s facilities.

     3. Storage of toxic or corrosive liquids or gases in any quantities greater than those
required for maintenance and operation of Supplier’s facilities.

-20-

 

D. REPORTING OF DISRUPTION OF PRODUCT SUPPLY

          Supplier will report to Seagate within one business day the discovery of any incident that
could result in the disruption of the supply of Product to Seagate.

E. DISASTER RECOVERY PLAN

          Supplier will implement the following disaster recovery plan to ensure the continuity of
Product supply in the event of a major interruption to its facilities’ ability to maintain
production. These requirements include the recovery of documentation, manufacturing systems,
materials, key personnel, and plan and equipment.

          1. General

          The objective of these requirements is to enable reinstitution of supply of Product within a
time period agreed upon by Seagate and Supplier.

          2. Requirements

     (a) Supplier will maintain backup copies of all documentation needed to ensure supply
of the Product, including but not limited to: drawings, files, process aids, tooling
drawings, process control data, materials receiving inspection data, floor layouts, process
flowcharts, bills of material, and training plans.

     (b) Supplier will plan for restoration or replacement of manufacturing IT systems and
hardware.

     (c) Supplier will back up materials relating to supplier records, and will negotiate
supplier agreements to ensure replacement of critical parts.

     (d) Supplier will cross-train key personnel for purposes of replacement due to a loss
of any key individuals. Supplier will maintain adequate job description and training
materials to allow for hiring of replacements.

     (e) Supplier will identify a contingency plan for moving production to an alternate
facility if interruption of Product supply is estimated to exceed 10 days.

-21-exv10w62

 

EXHIBIT 10.62

Confidential Treatment Requested

Cooperative Research and

Development Agreement

(CRADA 02177)

Cooperative and Research Development Agreement for the

Development of Introgen Proprietary Vectors and

Recombinants for the Treatment of Cancer

Steven A. Rosenberg, M.D., Ph.D.

Surgery Branch

Center for Cancer Research

National Cancer Institute

Robert E. Sobol, M.D.

Introgen Therapeutics, Inc.

Prepared by

Technology Transfer Branch

National Cancer Institute

 

 

PUBLIC HEALTH SERVICE

COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT

FOR INTRAMURAL-PHS CLINICAL RESEARCH

This Agreement is based on the model Cooperative Research and Development Agreement (“CRADA”)
adopted by the U.S. Public Health Service (“PHS”) Technology Transfer Policy Board for use by
components of the National Institutes of Health (“NIH”), the Centers for Disease Control and
Prevention (“CDC”), and the Food and Drug Administration (“FDA”), which are agencies of the PHS
within the Department of Health and Human Services (“HHS”).

This Cover Page identifies the Parties to this CRADA:

The U.S. Department of Health and Human Services, as represented by

the National Cancer Institute

an Institute, Center, or Division (hereinafter referred to as the “ICD”) of the

National Institutes of Health

and

Introgen Therapeutics, Inc.,

hereinafter referred to as the “Collaborator”,

having offices at 2250 Holcombe Blvd. Houston, Texas 77030,

created and operating under the laws of Delaware.

			
	 	 	 
	PHS ICT-CRADA
	 	Model Adopted 2005
	Page 1 of 20	 	 

 

 

COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT

FOR INTRAMURAL-PHS CLINICAL RESEARCH

Article 1. Introduction

This CRADA between ICD and Collaborator will be effective when signed by the Parties, which are
identified on both the Cover Page and the Signature Page (page 18). The official contacts for the
Parties are identified on the Contacts Information Page (page 19). Publicly available information
regarding this CRADA appears on the Summary Page (page 20). The research and development
activities that will be undertaken by ICD and Collaborator in the course of this CRADA are detailed
in the Research Plan, attached as Appendix A. The staffing, funding, and materials contributions
of the Parties are set forth in Appendix B. Any changes to the model CRADA are set forth in
Appendix C.

Article 2. Definitions

The terms listed in this Article will carry the meanings indicated throughout the CRADA. To the
extent a definition of a term as provided in this Article is inconsistent with a corresponding
definition in the applicable sections of either the United States Code (U.S.C.) or the Code of
Federal Regulations (C.F.R.), the definition in the U.S.C. or C.F.R. will control.

“Adverse Drug Experience” or “ADE” means an Adverse Event associated with the use of the Test
Article, that is, an event where there is a reasonable possibility that the Test Article may have
caused the event (a relationship between the Test Article and the event cannot be ruled out), in
accordance with the definitions of 21 C.F.R. Part 310, 305, or 312, or other applicable
regulations.

“Adverse Event” or “AE” means any untoward medical occurrence in a Human Subject administered Test
Article. An AE does not necessarily have a causal relationship with the Test Article, that is, it
can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or
disease temporally associated with the use of the Test Article, whether or not it is related to it.
See FDA Good Clinical Practice Guideline (FDA GCP, from International Conference on Harmonisation
(ICH) E6: “Good Clinical Practice: Consolidated Guidance, 62 Federal Register 25, 691 (1997)).

“Affiliate” means any corporation or other business entity controlled by, controlling, or under
common control with Collaborator at any time during the term of the CRADA. For this purpose,
“control” means direct or indirect beneficial ownership of at least fifty percent (50%) of the
voting stock or at least fifty percent (50%) interest in the income of the corporation or other
business entity.

“Annual Report” means the report of progress of an IND-associated investigation that ICD, as the
IND Sponsor, must submit to the FDA within sixty (60) days of the anniversary of the effective date
of the IND (pursuant to 21 C.F.R. § 312.33).

“Background Invention” means an Invention conceived and first actually reduced to practice before
the Effective Date.

“Clinical Investigator” means, in accordance with 21 C.F.R. § 312.3, an individual who
actually conducts a clinical investigation, that is, who directs the administration or
dispensation of Test Article to a subject, and who assumes responsibility for studying Human
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and ensuring the integrity of research data, and for protecting the welfare and safety of
Human Subjects.

“Collaborator Materials” means all tangible materials not first produced in the performance of this
CRADA that are owned or controlled by Collaborator and used in the performance of the Research
Plan. The term “Collaborator Materials” does not include “Test Article” (defined below).

“Confidential Information” means confidential scientific, business, or financial information
provided that the information does not include:

	 	(a)	 	information that is publicly known or that is available from public sources;
	 
	 	(b)	 	information that has been made available by its owner to others without a
confidentiality obligation;
	 
	 	(c)	 	information that is already known by the receiving Party, or information that
is independently created or compiled by the receiving Party without reference to or use
of the provided information; or
	 
	 	(d)	 	information that relates to potential hazards or cautionary warnings associated
with the production, handling, or use of the subject matter of the Research Plan.

“Cooperative Research and Development Agreement” or “CRADA” means this Agreement, entered into
pursuant to the Federal Technology Transfer Act of 1986, as amended (15 U.S.C. § 3710a et seq.),
and Executive Order 12591 of April 10, 1987.

“CRADA Data” means all recorded information first produced in the performance of the Research Plan.

“CRADA Materials” means all tangible materials first produced in the performance of the Research
Plan other than CRADA Data.

“CRADA Principal Investigator(s)” or “CRADA PI(s)” means the person(s) designated by the Parties
who will be responsible for the scientific and technical conduct of the Research Plan.

      The CRADA PI may also be a Clinical Investigator.

“CRADA Subject Invention” means any Invention of either or both Parties, conceived or first
actually reduced to practice in the performance of the Research Plan.

“Drug Master File” or “DMF” is described in 21 C.F.R. Part 314.420. A DMF is a submission to the
FDA that may be used to provide confidential detailed information about facilities, processes, or
articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

“Effective Date” means the date of the last signature of the Parties executing this Agreement.

“Government” means the Government of the United States of America.

“Human Subject” means, in accordance with the definition in 45 C.F.R. § 46.102(f), a living
individual about whom an investigator conducting research obtains:

	 	(a)	 	data through intervention or interaction with the individual; or
	 
	 	(b)	 	Identifiable Private Information.

			
	 	 	 
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“ICD Materials” means all tangible materials not first produced in the performance of this CRADA
that are owned or controlled by ICD and used in the performance of the Research Plan.

“IND” means an “Investigational New Drug Application”, filed in accordance with 21 C.F.R. Part 312
under which clinical investigation of an experimental drug or biologic (Test Article) is performed
in Human Subjects in the United States or intended to support a United States licensing action.

“Identifiable Private Information” or “IPI” about a Human Subject means private information from
which the identity of the subject is or may readily be ascertained. Regulations defining and
governing this information include 45 C.F.R. Part 46 and 21 C.F.R. Part 50.

“Institutional Review Board” or “IRB” means, in accordance with 45 C.F.R. Part 46, 21 C.F.R. part
56, and other applicable regulations, an independent body comprising medical, scientific, and
nonscientific members, whose responsibility is to ensure the protection of the rights, safety, and
well-being of the Human Subjects involved in a study.

“Invention” means any invention or discovery that is or may be patentable or otherwise protected
under Title 35 of the United States Code, or any novel variety of plant which is or may be
protectable under the Plant Variety Protection Act, 7 U.S.C. §§ 2321 et seq.

“Investigator’s Brochure” means, in accordance with the definition in 21 C.F.R. § 312.23(a)(5), a
document containing information about the Test Article, including animal screening, preclinical
toxicology, and detailed pharmaceutical data, including a description of possible risks and side
effects to be anticipated on the basis of prior experience with the drug or related drugs, and
precautions, such as additional monitoring, to be taken as part of the investigational use of the
drug.

“Patent Application” means an application for patent protection for a CRADA Subject Invention with
the United States Patent and Trademark Office (“U.S.P.T.O.”) or the corresponding patent issuing
authority of another nation.

“Patent” means any issued United States patent, any international counterpart(s), and any
corresponding grant(s) by a non-U.S. government in place of a patent.

“Placebo” means an inactive substance identical in appearance to the material being tested that is
used to distinguish between drug action and suggestive effect of the material under study.

“Protocol” means the formal, detailed description of a study to be performed as provided for in the
Research Plan. It describes the objective(s), design, methodology, statistical considerations, and
organization of a trial. For the purposes of this CRADA, the term, Protocol, for clinical research
involving Human Subjects, includes any and all associated documents, including informed consent
forms, to be provided to Human Subjects and potential participants in the study.

“Raw Data” means the primary quantitative and empirical data first collected from experiments and
clinical trials conducted within the scope of this CRADA.

“Research Plan” means the statement in Appendix A of the respective research and development
commitments of the Parties. The Research Plan should describe the provisions for sponsoring the
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“Sponsor” means, in accordance with the definition in 21 C.F.R. § 312.3, an organization or
individual who assumes legal responsibility for supervising or overseeing clinical trials with Test
Articles, and is sometimes referred to as the IND holder.

“Steering Committee” means the research and development team whose composition and responsibilities
with regard to the research performed under this CRADA are described in Appendix A.

“Summary Data” means any extract or summary of the Raw Data, generated by, or on behalf of, ICD or
by, or on behalf of, Collaborator. Summary Data will not include extracts or summaries that
incorporate IPI.

“Test Article” means, in accordance with 21 C.F.R. 50.3 (j), any drug (including a biological
product), medical device, food additive, color additive, electronic product, or any other Article
subject to regulation under the Federal Food, Drug, and Cosmetic Act that is intended for
administration to humans or animals, including a drug or biologic as identified in the Research
Plan and Appendix B, that is used within the scope of the Research Plan. The Test Article may also
be referred to as Investigational Agent, Study Material, or Study Product.

Article 3. Cooperative Research and Development

3.1 Performance of Research and Development. The research and development activities to be carried
out under this CRADA will be performed solely by the Parties identified on the Cover Page, unless
specifically stated elsewhere in the Agreement. The CRADA PIs will be responsible for coordinating
the scientific and technical conduct of this project on behalf of their employers. Any
Collaborator employees who will work at ICD facilities will be required to sign a Guest Researcher
or Special Volunteer Agreement appropriately modified in view of the terms of this CRADA.

3.2 Research Plan. The Parties recognize that the Research Plan describes the collaborative
research and development activities they will undertake and that interim research goals set forth
in the Research Plan are good faith guidelines. Should events occur that require modification of
these goals, then by mutual agreement the Parties can modify them through an amendment, according
to Paragraph 13.6.

3.3 Use and Disposition of Collaborator Materials and ICD Materials. The Parties agree to use
Collaborator Materials and ICD Materials only in accordance with the Research Plan and Protocol(s),
not to transfer these materials to third parties except in accordance with the Research Plan and
Protocol(s) or as approved by the owning or providing Party, and, upon expiration or termination of
the CRADA, to dispose of these materials as directed by the owning or providing Party.

3.4 Third Party Rights in Collaborator’s CRADA Subject Inventions. If Collaborator has received
(or will receive) support of any kind from a third party in exchange for rights in any of
Collaborator’s CRADA Subject Inventions, Collaborator agrees to ensure that its obligations to the
third party are both consistent with Articles 6-8 and subordinate to Article 7 of this CRADA.

3.5 Disclosures to ICD. Prior to execution of this CRADA, Collaborator agrees to disclose to ICD
all instances in which outstanding royalties are due under a PHS license agreement and in which
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disclosures will be treated as Confidential Information upon request by Collaborator in accordance
with Paragraphs 2.4, 8.3, and 8.4.

3.6 Clinical Investigator Responsibilities. The Clinical Investigator will be required to submit,
or to arrange for submission of, each Protocol associated with this CRADA to the IRB. In addition
to the Protocol all associated documents, including informational documents and advertisements,
must be reviewed and approved by the IRB before starting the research. The research will be done
in strict accordance with the Protocol(s) and no substantive changes in a finalized Protocol will
be made unless mutually agreed upon by the Parties. Research will not commence (or will continue
unchanged, if already in progress) until each substantive change to a Protocol, including those
required by either the FDA or the IRB, has been integrated in a way acceptable to the Parties,
submitted to the FDA and approved by the IRB.

3.7 Investigational Applications.

3.7.1 If an IND is required, ICD will be the IND Sponsor and will submit an IND. All
Clinical Investigators must have completed registration documents on file (1572 forms).

3.7.2 When ICD files the IND, Collaborator agrees to provide ICD background data and
information necessary to support the IND. Collaborator further agrees to provide a letter
of cross-reference to all pertinent regulatory filings sponsored by Collaborator.
Collaborator’s employees will be reasonably available to respond to inquiries from the FDA
regarding information and data contained in the Collaborator’s IND, DMF, other filings, or
other information and data provided to ICD by the Collaborator pursuant to this Article 3.

3.7.3 If Collaborator supplies Confidential Information to ICD in support of an IND filed by
ICD, this information will be protected in accordance with the corresponding confidentiality
provisions of Article 8.

3.7.4 Collaborator may sponsor its own clinical trials and hold its own IND for studies
performed outside the scope of this CRADA. These studies, however, should not adversely
affect the ability to accomplish the goal of the Research Plan, for example, by competing
for the same study population. All data from those clinical trials are proprietary to
Collaborator for purposes of this CRADA.

3.8 Test Article Information and Supply. Collaborator agrees to provide ICD without charge and on
a schedule that will ensure adequate and timely performance of the research, a sufficient quantity
of formulated and acceptably labeled, clinical-grade Test Article (and, as required by the
Protocol(s), Placebo) to complete the clinical trial(s) agreed to and approved under this CRADA.
Collaborator will provide a Certificate of Analysis to ICD for each lot of the Test Article
provided.

3.9 Test Article Delivery and Usage. Collaborator will ship the Test Article and, if required,
Placebo to ICD in containers marked in accordance with 21 C.F.R. § 312.6. ICD agrees that the
Clinical Investigators will keep appropriate records and take reasonable steps to ensure that the
Test Article is used in accordance with the Protocol(s) and applicable FDA regulations. In
addition, ICD agrees that the Test Article (and all Confidential Information supplied by
Collaborator relating to the Test Article) will be used solely for the conduct of the CRADA
research and development activities. Furthermore, ICD agrees that no analysis or modification of
the Test Article will be performed without Collaborator’s prior written consent. At the completion
of the Research Plan, any unused quantity of Test Article will be returned to Collaborator or
disposed as directed by Collaborator. Pharmacy contacts at ICD will be determined by ICD and
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3.10 Monitoring. Subject to the restrictions in Article 8 concerning IPI, and with reasonable
advance notice and at reasonable times, ICD will permit Collaborator or its designee(s) to monitor
the conduct of the research, as well as to audit source documents containing Raw Data, to the
extent necessary to verify compliance with FDA Good Clinical Practice (International Conference on
Harmonisation (ICH) E6: A Good Clinical Practice: Consolidated Guidance; 62 Federal Register 25,
691 (1997)) and the Protocol(s).

3.11 FDA Meetings/Communications. All meetings with the FDA concerning any clinical trial within
the scope of the Research Plan will be discussed by Collaborator and ICD in advance. Each Party
reserves the right to take part in setting the agenda for, to attend, and to participate in these
meetings. ICD will provide Collaborator with copies of FDA meeting minutes, all transmittal
letters for IND submissions, IND safety reports, formal questions and responses that have been
submitted to the FDA, Annual Reports, and official FDA correspondence, pertaining either to the
INDs under this CRADA or to the Clinical Investigators on Protocols performed in accordance with
the Research Plan, except to the extent that those documents contain the proprietary information of
a third party or dissemination is prohibited by law.

Article 4. Reports

4.1 Interim Research and Development Reports. The CRADA PIs should exchange information regularly,
in writing. This exchange may be accomplished through meeting minutes, detailed correspondence,
circulation of draft manuscripts, Steering Committee reports, copies of Annual Reports and any
other reports updating the progress of the CRADA research. However, the Parties must exchange
updated Investigator’s Brochure, formulation and preclinical data, and toxicology findings, as they
become available.

4.2 Final Research and Development Reports. The Parties will exchange final reports of their
results within [*] after the expiration or termination of this CRADA. These reports will set forth
the technical progress made; any publications arising from the research; and the existence of
invention disclosures of potential CRADA Subject Inventions and/or any corresponding Patent
Applications.

4.3 Fiscal Reports. If Collaborator has agreed to provide funding to ICD under this CRADA and upon
the request of Collaborator, then concurrent with the exchange of final research and development
reports according to Paragraph 4.2, ICD will submit to Collaborator a statement of all costs
incurred by ICD for the CRADA. If the CRADA has been terminated, ICD will specify any costs
incurred before the date of termination for which ICD has not received funds from Collaborator, as
well as for all reasonable termination costs including the cost of returning Collaborator property
or removal of abandoned Collaborator property, for which Collaborator will be responsible.

4.4 Safety Reports. In accordance with FDA requirements ICD, as the IND Sponsor, will establish
and maintain records and submit safety reports to the FDA, as required by 21 C.F.R. § 312.32 and 21
C.F.R. 812.150(b)(1), or other applicable regulations. In the conduct of research under this
CRADA, the Parties will comply with specific ICD guidelines and policies for reporting ADEs and
AEs, as well as procedures specified in the Protocol(s). ICD must provide Collaborator with copies
of all Safety Reports concurrently with their submission to the FDA, and with any other information
affecting the safety of Human Subjects in research conducted under this CRADA.

 

			
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4.5 Annual Reports. ICD will provide Collaborator a copy of the Annual Report concurrently with
the submission of the Annual Report to the FDA. Annual Reports will be kept confidential in
accordance with Article 8.

Article 5. Staffing, Financial, and Materials Obligations

5.1 ICD and Collaborator Contributions. The contributions of any staff, funds, materials, and
equipment by the Parties are set forth in Appendix B. The Federal Technology Transfer Act of 1986,
15 U.S.C. § 3710a(d)(1) prohibits ICD from providing funds to Collaborator for any research and
development activities under this CRADA.

5.2 ICD Staffing. No ICD employees will devote 100% of their effort or time to the research and
development activities under this CRADA. ICD will not use funds provided by Collaborator under
this CRADA for ICD personnel to pay the salary of any permanent ICD employee. Although personnel
hired by ICD using CRADA funds will focus principally on CRADA research and development activities,
Collaborator acknowledges that these personnel may nonetheless make contributions to other research
and development activities, and the activities will be outside the scope of this CRADA.

5.3 Collaborator Funding. Collaborator acknowledges that Government funds received by Collaborator
from an agency of the Department of Health and Human Services may not be used to fund ICD under
this CRADA. If Collaborator has agreed to provide funds to ICD then the payment schedule appears
in Appendix B and Collaborator will make payments according to that schedule. If Collaborator
fails to make any scheduled payment, ICD will not be obligated to perform any of the research and
development activities specified herein or to take any other action required by this CRADA until
the funds are received. ICD will use these funds exclusively for the purposes of this CRADA. Each
Party will maintain separate and distinct current accounts, records, and other evidence supporting
its financial obligations under this CRADA and, upon written request, will provide the other Party
a Fiscal Report according to Paragraph 4.3, which delineates all payments made and all obligated
expenses, along with the Final Research Report described in Paragraph 4.2.

5.4 Capital Equipment. Collaborator’s commitment, if any, to provide ICD with capital equipment to
enable the research and development activities under the Research Plan appears in Appendix B. If
Collaborator transfers to ICD the capital equipment or provides funds for ICD to purchase it, then
ICD will own the equipment. If Collaborator loans capital equipment to ICD for use during the
CRADA, Collaborator will be responsible for paying all costs and fees associated with the
transport, installation, maintenance, repair, removal, or disposal of the equipment, and ICD will
not be liable for any damage to the equipment.

Article 6. Intellectual Property

6.1 Ownership of CRADA Subject Inventions, CRADA Data, and CRADA Materials. Subject to the
Government license described in Paragraph 7.5, the sharing requirements of Paragraph 8.1 and the
regulatory filing requirements of Paragraph 8.2, the producing Party will retain sole ownership of
and title to all CRADA Subject Inventions, all copies of CRADA Data, and all CRADA Materials
produced solely by its employee(s). The Parties will own jointly all CRADA Subject Inventions
invented jointly and all CRADA Materials developed jointly.

6.2 Reporting. The Parties will promptly report to each other in writing each CRADA Subject
Invention reported by their respective personnel, and any Patent Applications filed thereon,
resulting from the research and development activities conducted under this CRADA. Each Party will
report all CRADA Subject Inventions to the other Party in sufficient detail to determine
inventorship, which will be determined in accordance with U.S. patent law. These reports will be
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Article 8. Formal reports will be made by and to the Patenting and Licensing Offices identified on
the Contacts Information Page herein.

6.3 Filing of Patent Applications. Each Party will make timely decisions regarding the filing of
Patent Applications on the CRADA Subject Inventions made solely by its employee(s). Collaborator
will have the first opportunity to file a Patent Application on joint CRADA Subject Inventions and
will notify PHS of its decision within [*] of an Invention being reported or at least [*] before
any patent filing deadline, whichever occurs sooner. If Collaborator fails to notify PHS of its
decision within that time period or notifies PHS of its decision not to file a Patent Application,
then PHS has the right to file a Patent Application on the joint CRADA Subject Invention. Neither
Party will be obligated to file a Patent Application. Collaborator will place the following
statement in any Patent Application it files on a CRADA Subject Invention: “This invention was
created in the performance of a Cooperative Research and Development Agreement with the [INSERT
into Agency’s model as appropriate: National Institutes of Health, Food and Drug Administration,
Center for Disease Control and Prevention], an Agency of the Department of Health and Human
Services. The Government of the United States has certain rights in this invention.” If either
Party files a Patent Application on a joint CRADA Subject Invention, then the filing Party will
include a statement within the Patent Application that clearly identifies the Parties and states
that the joint CRADA Subject Invention was made under this CRADA.

6.4 Patent Expenses. Unless agreed otherwise, the Party filing a Patent Application will pay all
preparation and filing expenses, prosecution fees, issuance fees, post issuance fees, patent
maintenance fees, annuities, interference expenses, and attorneys’ fees for that Patent Application
and any resulting Patent(s). If a license to any CRADA Subject Invention is granted to
Collaborator, then Collaborator will be responsible for all expenses and fees, past and future, in
connection with the preparation, filing, prosecution, and maintenance of any Patent Applications
and Patents claiming exclusively licensed CRADA Subject Inventions and will be responsible for a
pro-rated share, divided equally among all licensees, of those expenses and fees for
non-exclusively licensed CRADA Subject Inventions. Collaborator may waive its exclusive option
rights at any time, and incur no subsequent financial obligation for those Patent Application(s) or
Patent(s).

6.5 Prosecution of Patent Applications. The Party filing a Patent Application will provide the
non-filing Party with a copy of any official communication relating to prosecution of the Patent
Application within [*] of transmission of the communication. Each Party will also provide the
other Party with the power to inspect and make copies of all documents retained in the applicable
Patent Application or Patent file. With respect to joint CRADA Subject Inventions and sole ICD
CRADA Subject Inventions for which Collaborator has exercised its licensing option in accordance
with Paragraph 7.2, the Parties agree to consult with each other regarding the prosecution of
Patent Applications. If Collaborator elects to file and prosecute Patent Applications on joint
CRADA Subject Inventions, then Collaborator agrees to use the U.S.P.T.O. Customer Number Practice
and/or grant PHS a power(s) of attorney (or equivalent) necessary to assure PHS access to its
intellectual property rights in these Patent Applications. PHS and Collaborator will cooperate
with each other to obtain necessary signatures on Patent Applications, assignments, or other
documents.

 

			
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Article 7. Licensing

7.1 Background Inventions. Other than as specifically stated in this Article 7, nothing in this
CRADA will be construed to grant any rights in one Party’s Background Invention(s) to the other
Party, except to the extent necessary for the Parties to conduct the research and development
activities described in the Research Plan.

7.2 Collaborator’s Option for Commercialization License. With respect to Government rights to any
CRADA Subject Invention made solely by an ICD employee(s) or made jointly by an ICD employee(s) and
a Collaborator employee(s) for which a Patent Application was filed, PHS hereby grants to
Collaborator an exclusive option to elect an exclusive or nonexclusive commercialization license.
The license will be substantially in the form of the appropriate model PHS license agreement and
will fairly reflect the nature of the CRADA Subject Invention, the relative contributions of the
Parties to the CRADA Subject Invention and the CRADA, a plan for the development and marketing of
the CRADA Subject Invention, the risks incurred by Collaborator, and the costs of subsequent
research and development needed to bring the CRADA Subject Invention to the marketplace. The field
of use of the license will not exceed the scope of the Research Plan.

7.3 Exercise of Collaborator’s License Option. To exercise the option of Paragraph 7.2
Collaborator must submit a written notice to the PHS Patenting and Licensing Contact identified on
the Contacts Information Page (and provide a copy to the ICD Contact for CRADA Notices) within [*]
after either (i) Collaborator receives written notice from PHS that the Patent Application has been
filed or (ii) the date on which Collaborator files the Patent Application. The written notice
exercising this option will include a completed “Application for License to Public Health Service
Inventions” and will initiate a negotiation period that expires [*] after the exercise of the
option. If PHS has not responded in writing to the last proposal by Collaborator within this [*]
period, the negotiation period will be extended to expire [*] after PHS so responds, during which
[*] Collaborator may accept in writing the final license proposal of PHS. In the absence of
Collaborator’s exercise of the option, or upon election of a nonexclusive license, PHS will be free
to license the CRADA Subject Invention to others. These time periods may be extended at the sole
discretion of PHS upon good cause shown in writing by Collaborator.

7.4 Government License in ICD Sole CRADA Subject Inventions and Joint CRADA Subject Inventions.
Pursuant to 15 U.S.C. § 3710a(b)(1)(A), for CRADA Subject Inventions owned solely by ICD or jointly
by ICD and Collaborator, and licensed pursuant to the option of Paragraph 7.2, Collaborator grants
to the Government a nonexclusive, nontransferable, irrevocable, paid-up license to practice the
CRADA Subject Invention or have the CRADA Subject Invention practiced throughout the world by or on
behalf of the Government. In the exercise of this license, the Government will not publicly
disclose trade secrets or commercial or financial information that is privileged or confidential
within the meaning of 5 U.S.C. § 552(b)(4) or which would be considered privileged or confidential
if it had been obtained from a non-federal party.

7.5 Government License in Collaborator Sole CRADA Subject Inventions. Pursuant to 15 U.S.C. §
3710a(b)(2), for CRADA Subject Inventions made solely by an employee of Collaborator, Collaborator
grants to the Government a nonexclusive, nontransferable, irrevocable, paid-up license to practice
the CRADA

 

			
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Subject Invention or have the CRADA Subject Invention practiced throughout the world by or on
behalf of the Government for research or other Government purposes.

7.6 Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants an exclusive
license to a CRADA Subject Invention made solely by an ICD employee or jointly with a Collaborator
employee, the Government will retain the right to require Collaborator to grant to a responsible
applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject
Invention in Collaborator’s licensed field of use on terms that are reasonable under the
circumstances; or if Collaborator fails to grant a license, to grant a license itself. The
exercise of these rights by the Government will only be in exceptional circumstances and only if
the Government determines (i) the action is necessary to meet health or safety needs that are not
reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public
use specified by federal regulations, and such requirements are not reasonably satisfied by
Collaborator; or (iii) Collaborator has failed to comply with an agreement containing provisions
described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this
Paragraph is subject to administrative appeal and judicial review under 35 U.S.C. § 203(2).

7.7 Third-Party Rights In ICD Sole CRADA Subject Inventions. For a CRADA Subject Invention
conceived prior to the Effective Date solely by an ICD employee that is first actually reduced to
practice after the Effective Date in the performance of the Research Plan, the option offered to
Collaborator in Paragraph 7.2 may be restricted if, prior to the Effective Date, PHS had filed a
Patent Application and has either offered or granted a license in the CRADA Subject Invention to a
third party. Collaborator nonetheless retains the right to apply for a license to any such CRADA
Subject Invention in accordance with the terms and procedures of 35 U.S.C. § 209 and 37 C.F.R. Part
404.

7.8 Joint CRADA Subject Inventions Not Exclusively Licensed by Collaborator. If Collaborator does
not acquire an exclusive commercialization license in a joint CRADA Subject Invention in all fields
of use then, for those fields of use not exclusively licensed to Collaborator, each Party will have
the right to use the joint CRADA Subject Invention and to license its use to others, and each Party
will cooperate with the other, as necessary, to fulfill international licensing requirements. The
Parties may agree to a joint licensing approach for any remaining fields of use.

Article 8. Rights of Access and Publication

8.1 Right of Access to CRADA Data and CRADA Materials. ICD and Collaborator agree to exchange all
CRADA Data and to share all CRADA Materials. If the CRADA is terminated, both Parties agree to
provide CRADA Materials in quantities needed to complete the Research Plan. Such provision will
occur before the termination date of the CRADA or sooner, if required by the Research Plan. If
Collaborator possesses any human biological specimens from clinical trials under the CRADA, the
specimens must be handled as described in the Protocol or as otherwise directed by ICD before the
termination date of the CRADA.

8.2 Use of CRADA Data and CRADA Materials. The Parties will be free to utilize CRADA Data and
CRADA Materials internally for their own purposes, consistent with their obligations under this
CRADA. The Parties may share CRADA Data or CRADA Materials with their Affiliates, agents or
contractors provided the obligations of this Article 8.2 are simultaneously conveyed.

8.2.1 CRADA Data.

Collaborator and ICD will use reasonable efforts to keep CRADA Data confidential until
published or until corresponding Patent Applications are filed. To the extent permitted by
law, each Party will have the right to use any and all CRADA Data in and for any regulatory
filing by or on behalf of the Party.

			
	 	 	 
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8.2.2 CRADA Materials.

Collaborator and ICD will use reasonable efforts to keep descriptions of CRADA Materials
confidential until published or until corresponding Patent Applications are filed.
Collaborator acknowledges that the basic research mission of PHS includes sharing with third
parties for further research those research resources made in whole or in part with NIH
funding. Consistent with this mission and the tenets articulated in “Sharing of Biomedical
Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and
Contracts”, December 1999, available at
http://ott.od.nih.gov/NewPages/RTguide_final.html, following publication either
Party may make available to third parties for further research those CRADA Materials made
jointly by both PHS and Collaborator. Notwithstanding the above, if those joint CRADA
Materials are the subject of a pending Patent Application or a Patent, or were created using
a patent-pending or patented material or technology, the Parties may agree to restrict
distribution or freely distribute them. Either Party may distribute those CRADA Materials
made solely by the other Party only upon written consent from that other Party or that other
Party’s designee.

8.3 Confidential Information. Each Party agrees to limit its disclosure of Confidential
Information to the amount necessary to carry out the Research Plan, and will place a
confidentiality notice on all this information. A Party orally disclosing Confidential Information
to the other Party will reduce the disclosure to writing within fifteen (15) days of the
disclosure. Each Party receiving Confidential Information agrees to use it only for the purposes
described in the Research Plan. Either Party may object to the designation of information as
Confidential Information by the other Party.

8.4 Protection of Confidential Information. Confidential Information will not be disclosed,
copied, reproduced or otherwise made available to any other person or entity without the consent of
the owning or providing Party except as required by a court or administrative body of competent
jurisdiction, or federal law or regulation. Each Party agrees to use reasonable efforts to
maintain the confidentiality of Confidential Information, which will in no instance be less effort
than the Party uses to protect its own Confidential Information. Each Party agrees that a Party
receiving Confidential Information will not be liable for the disclosure of that portion of the
Confidential Information which, after notice to and consultation with the disclosing Party, the
receiving Party determines may not be lawfully withheld, provided the disclosing Party has been
given a reasonable opportunity to seek a court order to enjoin disclosure.

8.5 Human Subject Protection. The research to be conducted under this CRADA involves Human
Subjects or human tissues within the meaning of 45 C.F.R. Part 46, and all research to be performed
under this CRADA will conform to applicable federal laws and regulations. Additional information
is available from the HHS Office for Human Research Protections (http://www.hhs.gov/ohrp/).

8.6 Duration of Confidentiality Obligation. The obligation to maintain the confidentiality of
Confidential Information will expire at the earlier of the date when the information is no longer
Confidential Information as defined in Paragraph 2.4 or [*] after the expiration or termination
date of this CRADA. Collaborator may request an extension to this term when necessary to protect
Confidential Information relating to products not yet commercialized.

 

			
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8.7 Publication. The Parties are encouraged to make publicly available the results of their
research and development activities. Before either Party submits a paper or abstract for
publication or otherwise intends to publicly disclose information about a CRADA Subject Invention,
CRADA Data, or CRADA Materials, the other Party will have [*] to review proposed manuscripts and
[*] to review proposed abstracts to assure that Confidential Information is protected. Either
Party may request in writing that the proposed publication or other disclosure be delayed for up to
[*] as necessary to file a Patent Application.

Article 9. Representations and Warranties

9.1 Representations of ICD. ICD hereby represents to Collaborator that:

9.1.1 ICD has the requisite power and authority to enter into this CRADA and to perform
according to its terms, and that ICD’s official signing this CRADA has authority to do so.

9.1.2 To the best of its knowledge and belief, neither ICD nor any of its personnel involved
in this CRADA is presently subject to debarment or suspension by any agency of the
Government which would directly affect its performance of the CRADA. Should ICD or any of
its personnel involved in this CRADA be debarred or suspended during the term of this CRADA,
ICD will notify Collaborator within thirty (30) days of receipt of final notice.

9.2 Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to
ICD that:

9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to
perform according to its terms, and that Collaborator’s official signing this CRADA has
authority to do so.

9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including
Affiliates, agents, and contractors are presently subject to debarment or suspension by any
agency of the Government. Should Collaborator or any of its personnel involved in this
CRADA be debarred or suspended during the term of this CRADA, Collaborator will notify ICD
within thirty (30) days of receipt of final notice.

9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide
funding under Appendix B, Collaborator is financially able to satisfy these obligations in a
timely manner.

9.2.4 The Test Article provided has been produced in accordance with the FDA’s current Good
Manufacturing Practice set out in 21 C.F.R. § 210-211 and ICH QA7, and meets the
specifications cited in the Certificate of Analysis and Investigator’s Brochure provided.

 

			
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Article 10. Expiration and Termination

10.1 Expiration. This CRADA will expire on the last date of the term set forth on the Summary
Page. In no case will the term of this CRADA extend beyond the term indicated on the Summary Page
unless it is extended in writing in accordance with Paragraph 13.6.

10.2 Termination by Mutual Consent. ICD and Collaborator may terminate this CRADA at any time by
mutual written consent.

10.3 Unilateral Termination. Either ICD or Collaborator may unilaterally terminate this CRADA at
any time by providing written notice at least sixty (60) days before the desired termination date.
ICD may, at its option, retain funds transferred to ICD before unilateral termination by
Collaborator for use in completing the Research Plan. If Collaborator terminates this Agreement
before the completion of all approved or active Protocol(s), then Collaborator will supply enough
Test Article (and Placebo, if applicable) to complete these Protocol(s) unless termination is for
safety concerns.

10.4 Funding for ICD Personnel. If Collaborator has agreed to provide funding for ICD personnel
and this CRADA is mutually or unilaterally terminated by Collaborator before its expiration, then
Collaborator agrees that funds for that purpose will be available to ICD for a period of [*] after
the termination date or until the expiration date of the CRADA, whichever occurs sooner. If there
are insufficient funds to cover this expense, Collaborator agrees to pay the difference.

10.5 New Commitments. Neither Party will incur new expenses related to this CRADA after
expiration, mutual termination, or a notice of a unilateral termination and will, to the extent
feasible, cancel all outstanding commitments and contracts by the termination date. Collaborator
acknowledges that ICD will have the authority to retain and expend any funds for up to [*]
subsequent to the expiration or termination date to cover any unpaid costs obligated during the
term of the CRADA in undertaking the research and development activities set forth in the Research
Plan.

10.6 Collaborator Failure to Continue Development. If Collaborator suspends development of the
Test Article without the transfer of its active development efforts, assets, and obligations to a
third party within [*] of discontinuation, Collaborator agrees that ICD may continue developing the
Test Article. In that event, the following will apply:

10.6.1 Collaborator agrees to transfer to ICD all information necessary to enable ICD to
contract for the manufacture of the Test Article and, unless abandoned for reasons relating
to safety as determined by the data safety monitoring board, to provide the Test Article
(and Placebo, if any) in Collaborator’s inventory to ICD.

10.6.2 Further, Collaborator hereby grants to ICD a nonexclusive, irrevocable, world-wide,
paid-up license to practice, or have practiced for or on behalf of the Government, any
Background Invention that Collaborator may currently have or will obtain on the Test
Article, its manufacture, or on any

 

			
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method of using the Test Article for the indication(s) described in the Research Plan,
including the right to sublicense to third parties.

Article 11. Disputes

11.1 Settlement. Any dispute arising under this CRADA which is not disposed of by agreement of the
CRADA Principal Investigators will be submitted jointly to the signatories of this CRADA. If the
signatories, or their designees, are unable to jointly resolve the dispute within thirty (30) days
after notification thereof, the Assistant Secretary for Health (or his/her designee or successor)
will propose a resolution. Nothing in this Paragraph will prevent any Party from pursuing any
additional administrative remedies that may be available and, after exhaustion of such
administrative remedies, pursuing all available judicial remedies.

11.2 Continuation of Work. Pending the resolution of any dispute or claim pursuant to this Article
11, the Parties agree that performance of all obligations will be pursued diligently.

Article 12. Liability

12.1 NO WARRANTIES. EXCEPT AS SPECIFICALLY STATED IN ARTICLE 9, THE PARTIES MAKE NO EXPRESS OR
IMPLIED WARRANTY AS TO ANY MATTER WHATSOEVER, INCLUDING THE CONDITIONS OF THE RESEARCH OR ANY
INVENTION OR MATERIAL, WHETHER TANGIBLE OR INTANGIBLE, MADE OR DEVELOPED UNDER OR OUTSIDE THE SCOPE
OF THIS CRADA, OR THE OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE
RESEARCH OR ANY INVENTION OR MATERIAL, OR THAT A TECHNOLOGY UTILIZED BY A PARTY IN THE PERFORMANCE
OF THE RESEARCH PLAN DOES NOT INFRINGE ANY THIRD-PARTY PATENT RIGHTS.

12.2 Indemnification and Liability. Collaborator agrees to hold the Government harmless and to
indemnify the Government for all liabilities, demands, damages, expenses and losses arising out of
the use by Collaborator for any purpose of the CRADA Data, CRADA Materials or CRADA Subject
Inventions produced in whole or part by ICD employees under this CRADA, unless due to the
negligence or willful misconduct of ICD, its employees, or agents. The Government has no statutory
authority to indemnify Collaborator. Each Party otherwise will be liable for any claims or damages
it incurs in connection with this CRADA, except that ICD, as an agency of the Government, assumes
liability only to the extent provided under the Federal Tort Claims Act, 28 U.S.C. Chapter 171.

12.3 Force Majeure. Neither Party will be liable for any unforeseeable event beyond its reasonable
control and not caused by its own fault or negligence, which causes the Party to be unable to
perform its obligations under this CRADA, and which it has been unable to overcome by the exercise
of due diligence. If a force majeure event occurs, the Party unable to perform will promptly
notify the other Party. It will use its best efforts to resume performance as quickly as possible
and will suspend performance only for such period of time as is necessary as a result of the force
majeure event.

Article 13. Miscellaneous

13.1 Governing Law. The construction, validity, performance and effect of this CRADA will be
governed by U.S. federal law, as applied by the federal courts in the District of Columbia. If any
provision in this CRADA conflicts with or is inconsistent with any U.S. federal law or regulation,
then the U.S. federal law or regulation will preempt that provision.

			
	 	 	 
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13.2 Compliance with Law. ICD and Collaborator agree that they, and advise their contractors and
agents to comply with, will comply with all applicable statutes, Executive Orders, and HHS
regulations relating to research on human subjects (45 C.F.R. Part 46, 21 C.F.R. Parts 50 and 56)
and relating to the appropriate care and use of laboratory animals (7 U.S.C. §§ 2131 et seq.; 9
C.F.R. Part 1, Subchapter A). ICD will advise all contractors or grantees conducting clinical
trials that they must comply with all applicable federal regulations for the protection of Human
Subjects, which may include the Standards for Privacy of Individually Identifiable Health
Information set forth in 45 C.F.R. Part 164. Collaborator agrees to ensure that employees,
contractors, and agents of Collaborator who might have access to a “select agent or toxin” (as that
term is defined in 42 C.F.R. §§ 73.4-73.5) transferred from ICD is properly licensed to receive the
“select agent or toxin”.

13.3 Waivers. None of the provisions of this CRADA will be considered waived by any Party unless a
waiver is given in writing to the other Party. The failure of a Party to insist upon strict
performance of any of the terms and conditions hereof, or failure or delay to exercise any rights
provided herein or by law, will not be deemed a waiver of any rights of any Party.

13.4 Headings. Titles and headings of the articles and paragraphs of this CRADA are for convenient
reference only, do not form a part of this CRADA, and will in no way affect its interpretation.

13.5 Severability. The illegality or invalidity of any provisions of this CRADA will not impair,
affect, or invalidate the other provisions of this CRADA.

13.6 Amendments. Minor modifications to the Research Plan may be made by the mutual written
consent of the Principal Investigators. Substantial changes to the CRADA, extensions of the term,
or any changes to Appendix C will become effective only upon a written amendment signed by the
signatories to this CRADA or by their representatives duly authorized to execute an amendment. A
change will be considered substantial if it directly expands the range of the potential CRADA
Subject Inventions, alters the scope or field of any license option governed by Article 7, or
requires a significant increase in the contribution of resources by either Party.

13.7 Assignment. Neither this CRADA nor any rights or obligations of any Party hereunder will be
assigned or otherwise transferred by either Party without the prior written consent of the other
Party. This CRADA will be binding upon and inure to the benefit of the Parties and their
respective successors and permitted assigns.

13.8 Notices. All notices pertaining to or required by this CRADA will be in writing, signed by an
authorized representative of the notifying Party, and delivered by first class, registered, or
certified mail, or by an express/overnight commercial delivery service, prepaid and properly
addressed to the other Party at the address designated on the Contacts Information Page, or to any
other address designated in writing by the other Party. Notices will be considered timely if
received on or before the established deadline date or sent on or before the deadline date as
verifiable by U.S. Postal Service postmark or dated receipt from a commercial carrier. Notices
regarding the exercise of license options will be made pursuant to Paragraph 7.3. Either Party may
change its address by notice given to the other Party in the manner set forth above.

13.9 Independent Contractors. The relationship of the Parties to this CRADA is that of independent
contractors and not agents of each other or joint venturers or partners. Each Party will maintain
sole and exclusive control over its personnel and operations.

13.10 Use of Name; Press Releases. By entering into this CRADA, the Government does not directly
or indirectly endorse any product or service that is or will be provided, whether directly or
indirectly related to either this CRADA or to any patent or other intellectual-property license or
agreement that implements this CRADA by Collaborator, its successors, assignees, or licensees.
Collaborator will not in any way state or

			
	 	 	 
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imply that the Government or any of its organizational units or employees endorses any product or
services. Each Party agrees to provide proposed press releases that reference or rely upon the
work under this CRADA to the other Party for review and comment at least five (5) business days
before publication. Either Party may disclose the Title and Abstract of the CRADA to the public
without the approval of the other Party.

13.11 Reasonable Consent. Whenever a Party’s consent or permission is required under this CRADA,
its consent or permission will not be unreasonably withheld.

13.12 Export Controls. Collaborator agrees to comply with U.S. export law and regulations. If
Collaborator has a need to transfer any CRADA Materials made in whole or in part by ICD, or ICD
Materials, or ICD’s Confidential Information to a person located in a country other than the United
States, to an Affiliate organized under the laws of a country other than the United States, or to
an employee of Collaborator in the United States who is not a citizen or permanent resident of the
United States, Collaborator will acquire any and all necessary export licenses and other
appropriate authorizations, if necessary.

13.13 Entire Agreement. This CRADA constitutes the entire agreement between the Parties concerning
the subject matter of this CRADA and supersedes any prior understanding or written or oral
agreement.

13.14 Survivability. The provisions of Paragraphs 3.3, 3.4, 3.8, 4.2, 4.3, 5.3, 5.4, 6.1-9.2,
10.3-10.6, 11.1, 11.2, 12.1-12.3, 13.1-13.3, 13.7, 13.10 and 13.14 will survive the expiration or
early termination of this CRADA.

SIGNATURES BEGIN ON THE NEXT PAGE

			
	 	 	 
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SIGNATURE PAGE

ACCEPTED AND AGREED

By executing this agreement, each party represents that all statements made herein are true,
complete, and accurate to the best of its knowledge. Collaborator acknowledges that it may be
subject to criminal, civil, or administrative penalties for knowingly making a false, fictitious,
or fraudulent statement or claim.

FOR ICD:

	 	 	 
	/s/ Anna D. Barker

	 	03/01/07
	 
	 	 
	Signature

	 	Date
	 
	 	 
	Anna D. Barker, Ph.D.
	 	 
	Typed Name
	 	 
	 
	 	 
	Deputy Director, NCI
	 	 
	Title
	 	 
	 
	 	 
	FOR COLLABORATOR:
	 	 
	 
	 	 
	/s/ David L. Parker

	 	3/22/07
	 
	 	 
	Signature

	 	Date
	 
	 	 
	David L. Parker
	 	 
	Typed Name
	 	 
	 
	 	 
	Senior V.P. — I.P.
	 	 
	Title
	 	 

			
	 	 	 
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CONTACTS INFORMATION PAGE

CRADA Notices

	 	 	 
	For ICD:

	 	For Collaborator:
	 
	 	 
	Technology Transfer Branch, NCI

	 	David L. Parker, Ph.D., J.D.
	6120 Executive Blvd., Suite 450

	 	Introgen Therapeutics, Inc.
	Rockville, MD 20852

	 	301 Congress Avenue, Suite 1850
	 

	 	Austin, Texas 78701

Patenting and Licensing

	 	 	 
	For ICD:

	 	For Collaborator (if separate from above):
	 
	 	 
	Division Director, Division of Technology
	 	 
	 

	 	 
	and Transfer
	 	 
	 

	 	 
	 
	NIH Office of Technology Transfer
	 	 
	 

	 	 
	6011 Executive Blvd., Suite 325
	 	 
	 

	 	 
	Rockville, Maryland 20852-3804
	 	 
	 

	 	 
	Tel: 301-396-7057
	 	 
	Fax: 301-402-0220
	 	 

Delivery of Materials Identified In Appendix B (if any)

	 	 	 
	For ICD:

	 	For Collaborator:
	 
	 	 
	Steven A. Rosenberg, M.D., Ph.D.

	 	Robert E. Sobol, M.D.
	Surgery Branch, NCI

	 	Introgen Therapeutics, Inc.
	10 Center Drive, MSC 120

	 	2250 Holcombe Blvd.
	Bldg. 10, CRC Room 3-3940

	 	Houston, TX 77030
	Bethesda, MD 20892-1201
	 	 

			
	 	 	 
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SUMMARY PAGE

Either party may, without further consultation or permission, 

release this summary page to the public. 

TITLE OF CRADA: Cooperative and Research Development Agreement for the Development of Introgen
Proprietary Vectors and Recombinants for the Treatment of Cancer

	 	 	 
	ICD Component:

	 	National Cancer Institute, Surgery Branch
	 
	 	 
	ICD Principal Investigator:

	 	Steven A. Rosenberg, M.D., Ph.D.
	 
	 	 
	Collaborator:

	 	Introgen Therapeutics, Inc.
	 
	 	 
	Collaborator Principal Investigator:

	 	Robert E. Sobol, M.D.
	 
	 	 
	TERM OF CRADA:

	 	Five (5) years from the Effective Date.

ABSTRACT OF THE RESEARCH PLAN:

The principal goals of this CRADA between the National Cancer Institute and Introgen Therapeutics,
Inc. are to develop Introgen’s proprietary cancer immunotherapies utilizing immunization with
adenoviruses expressing p53 utilizing immunization either alone or in dendritic cells and/or in
conjunction with adoptive transfer of anti-p53 lymphocytes.

			
	 	 	 
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CRADA #02177

APPENDIX A

RESEARCH PLAN

TITLE OF CRADA: Cooperative and Research Development Agreement for the Development of Introgen

Proprietary Vectors and Recombinants for the Treatment of Cancer

	 	 	 
	NIH PRINCIPAL INVESTIGATOR:

	 	Steven A. Rosenberg
	and his/her laboratory:

	 	Surgery Branch

COLLABORATOR PRINCIPAL INVESTIGATOR: Robert E. Sobol

	 	 	 
	 

	 	Senior Vice President, Medical and Scientific Affairs
	 

	 	Introgen Therapeutics, Inc.

TERM OF CRADA: (5) years.

The Research Plan which follows this page should be concise but of sufficient detail to permit
reviewers of this CRADA to evaluate the scientific merit of the proposed collaboration. The RP
should explain the scientific importance of the collaboration and the research goals of PHS and the
Collaborator. The respective contributions in terms of expertise and/or research materials of PHS
and Collaborator should be summarized. Initial and subsequent projects contemplated under the RP,
and the time periods estimated for their completion, should be described, and pertinent
methodological considerations summarized. Pertinent literature references may be cited and
additional relevant information included.

Page A-i

 

APPENDIX A

RESEARCH PLAN

Title of CRADA

Cooperative Research and Development Agreement for the Development of Introgen Proprietary Vectors and

Recombinants for the Treatment of Cancer

NCI Principal Investigator:

Steven A. Rosenberg, M.D., Ph.D.

Surgery Branch, CCR, NCI

Collaborator Principal Investigators

Robert E. Sobol, M.D.

Senior Vice President, Medical and Scientific Affairs

Introgen Therapeutics, Inc.

Term of CRADA

Five (5) years from the date of the final CRADA signature.

Goals of this CRADA

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CACR-02177

APPENDIX B

FINANCIAL AND STAFFING CONTRIBUTIONS OF THE PARTIES

[Insert the Financial and Staffing Contributions as Appendix B behind this page.]

Page B-i

 

Public Health Service

Cooperative Research and Development Agreement

APPENDIX B

STAFFING, FUNDING AND MATERIALS/EQUIPMENT CONTRIBUTIONS

OF THE PARTIES

[*]

 

			
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CACR-02177

APPENDIX C

EXCEPTIONS OR MODIFICATIONS TO THIS CRADA

Page C-i

 

Public Health Service

Cooperative Research and Development Agreement

APPENDIX C

MODIFICATIONS TO THE MODEL CRADA

(Additions are indicated by underline, deletions by strike-out)

Amend Section 4.4 as follows:

4.4 Safety Reports. In accordance with FDA requirements ICD, as the IND Sponsor, will establish
and maintain records and submit safety reports to the FDA, as required by 21 C.F.R. § 312.32 and 21
C.F.R. 812.150(b)(1), or other applicable regulations. In the conduct of research under this
CRADA, the Parties will comply with specific Collaborator and ICD guidelines and policies for
reporting ADEs and AEs, as well as procedures specified in the Protocol(s). ICD must provide
Collaborator with copies of all Safety Reports concurrently with their submission to the FDA, and
with any other information affecting the safety of Human Subjects in research conducted under this
CRADA.

Amend Section 8.3 to read as follows:

8.3 Confidential Information. Each Party agrees to limit its disclosure of Confidential
Information to the amount necessary to carry out the Research Plan, and will place a
confidentiality notice on all this information. A Party orally disclosing Confidential Information
to the other Party will reduce the disclosure to writing within fifteen (15) days of the
disclosure. Each Party receiving Confidential Information agrees to use it only for the purposes
described in the Research Plan. Either Party may object to the designation of information as
Confidential Information by the other Party. Although certain information provided under this
Agreement is CONFIDENTIAL and will be so stamped, Collaborator recognizes that the NIH PI may need
to disclose certain information concerning Confidential Information to patients (or to physicians
or scientists where such disclosure is made in order to directly facilitate the ongoing treatment
of a patient, or the development of a treatment for a patient). Collaborator hereby authorizes
such limited disclosures and the NIH PI agrees to promptly acknowledge to Collaborator the making
of any such disclosure.

Amend Section 8.4 to read as follows:

8.4 Protection of Confidential Information. Subject to Paragraph 8.3, Confidential Information
will not be disclosed, copied, reproduced or otherwise made available to any other person or entity
without the consent of the owning or providing Party except as required by a court

					
	 	 	 	 	 
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or administrative body of competent jurisdiction, or federal law or regulation. Each Party agrees
to use reasonable efforts to maintain the confidentiality of Confidential Information, which will
in no instance be less effort than the Party uses to protect its own Confidential Information.
Each Party agrees that a Party receiving Confidential Information will not be liable for the
disclosure of that portion of the Confidential Information which, after notice to and consultation
with the disclosing Party, the receiving Party determines may not be lawfully withheld, provided
the disclosing Party has been given a reasonable opportunity to seek a court order to enjoin
disclosure.

Amend Section 8.6 to read as follows:

8.6 Duration of Confidentiality Obligation. The obligation to maintain the confidentiality of
Confidential Information as described in Paragraph 8.3, will expire at the earlier of the date when
the information is no longer Confidential Information as defined in
Paragraph 2.4 or [*] after
the expiration or termination date of this CRADA. Collaborator may request an extension to this
term when necessary to protect Confidential Information relating to products not yet
commercialized.

Amend Section 10.3 to read as follows:

10.3 Unilateral Termination. Either ICD or Collaborator may unilaterally terminate this CRADA at
any time by providing written notice at least ninety (90) days before the desired termination date.
If Collaborator terminates this Agreement before the completion of all approved or active
Protocol(s), then Collaborator will supply enough Test Article (and Placebo, if applicable) to
complete these Protocol(s) unless termination is for safety concerns.

Amend Section 10.6 to read as follows:

10.6 Collaborator Failure to Continue Development. If Collaborator elects to suspend development
of the Test Article without the transfer of its active development efforts, assets, and obligations
to a third party within [*] of discontinuation, Collaborator agrees that ICD may continue
developing the Test Article. In that event, the following will apply:

10.6.1 Collaborator agrees to transfer to ICD all information necessary to enable ICD
to contract for the manufacture of the Test Article and, unless abandoned for reasons
relating to safety as determined by the data safety monitoring board, to provide the
Test Article (and Placebo, if any) in Collaborator’s inventory to ICD.

 

			
	[*]	 	Certain information on this page has been omitted and
filed separately with the Commission. Confidential treatment has been requested
with respect to the omitted portion.

					
	 	 	 	 	 
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10.6.2 Further, Collaborator hereby grants to ICD a nonexclusive, irrevocable,
world-wide, paid-up license to practice, or have practiced for or on behalf of the
Government, any Background Invention that Collaborator may currently have or will
obtain on the Test Article, its manufacture, or on any method of using the Test
Article for the indication(s) described in the Research Plan, including the right to
sublicense to third parties.

Amend Section 13.13 to read as follows:

13.13 Entire Agreement. This CRADA constitutes the entire agreement between the Parties concerning
the subject matter of this CRADA and supersedes any prior understanding or written or oral
agreement. In furtherance, but not in limitation of the foregoing, the Parties agree that all
activities relating to Introgen’s proprietary Adenovirus p53 pursuant to the Material Transfer
Agreement No. 2-21011-06 executed on March 8, 2006 are hereby terminated as of the execution date
of this CRADA, and shall, as of the CRADA execution date, be conducted solely pursuant to, and
subject to, the terms and conditions of this CRADA.

					
	 	 	 	 	 
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