Document:

Exhibit 10.1

 

Exhibit 10.1

AMENDMENT TO LOAN DOCUMENTS

     THIS AMENDMENT to Loan Documents (this “Amendment”) is entered into as of February 8, 2008, by
and between SILICON VALLEY BANK, a California corporation (“Bank”), and ENDOCARE, INC., a Delaware
corporation (“Borrower”), whose chief executive office is located at 201 Technology Drive, Irvine,
California 92618.

Recitals

     A. Borrower and Bank are parties to that certain Loan and Security Agreement, with an
Effective Date of October 26, 2005 (as amended, restated, supplemented or otherwise modified from
time to time, the “Loan Agreement”).

     B. Bank has extended credit to Borrower for the purposes permitted in the Loan Agreement.

     C. Borrower has requested that Bank amend the Loan Agreement to extend the Maturity Date, as
set forth in Section 2.1 below and as more fully set forth herein.

     D. Bank has agreed to so amend the Loan Agreement, but only to the extent, in accordance with
the terms, subject to the conditions and in reliance upon the representations and warranties set
forth below.

Agreement

     Now, Therefore, in consideration of the foregoing recitals and other good and
valuable consideration, the receipt and adequacy of which is hereby acknowledged, and intending to
be legally bound, the parties hereto agree as follows:

     1. Definitions. Capitalized terms used but not defined in this Amendment shall have the
meanings given to them in the Loan Agreement.

     2. Amendment to Loan Documents.

          2.1 Extension of Maturity Date. The definition of “Maturity Date” set forth in Section 13.1
of the Loan Agreement hereby is amended and restated in its entirety to read as follows:

          “Maturity Date” is February 26, 2009.

     3. Limitation of Amendments.

          3.1 The amendments set forth in Section 2, above, are effective for the purposes set forth
herein and shall be limited precisely as written and shall not be deemed to (a) be a consent to any
amendment, waiver or modification of any other term or condition of any Loan Document, or
(b) otherwise prejudice any right or remedy which

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Bank may now have or may have in the future under or in connection with any Loan Document.

          3.2 This Amendment shall be construed in connection with and as part of the Loan Documents and
all terms, conditions, representations, warranties, covenants and agreements set forth in the Loan
Documents, as amended hereby (as applicable), are hereby ratified and confirmed and shall remain in
full force and effect.

     4. Representations and Warranties. To induce Bank to enter into this Amendment, Borrower
hereby represents and warrants to Bank as follows:

          4.1 Immediately after giving effect to this Amendment (a) the representations and warranties
contained in the Loan Documents are true, accurate and complete in all material respects as of the
date hereof (except to the extent such representations and warranties relate to an earlier date, in
which case they are true and correct as of such date), and (b) no Event of Default has occurred and
is continuing;

          4.2 Borrower has the power and authority to execute and deliver this Amendment and to perform
its obligations under the Loan Documents, as amended by this Amendment;

          4.3 The organizational documents of Borrower delivered to Bank on the Effective Date remain
true, accurate and complete and have not been amended, supplemented or restated (except for the
amendment thereof attached as Exhibit 3.1 to the Form 8-K filed by Borrower with the S.E.C. on
August 21, 2007) and, as so amended, are and continue to be in full force and effect;

          4.4 The execution and delivery by Borrower of this Amendment and the performance by Borrower
of its obligations under the Loan Documents, as amended by this Amendment, have been duly
authorized;

          4.5 The execution and delivery by Borrower of this Amendment and the performance by Borrower
of its obligations under the Loan Documents, as amended by this Amendment, do not and will not
contravene (a) any law or regulation binding on or affecting Borrower, (b) any contractual
restriction with a Person binding on Borrower, (c) any order, judgment or decree of any court or
other governmental or public body or authority, or subdivision thereof, binding on Borrower, or
(d) the organizational documents of Borrower;

          4.6 The execution and delivery by Borrower of this Amendment and the performance by Borrower
of its obligations under the Loan Documents, as amended by this Amendment, do not require any
order, consent, approval, license, authorization or validation of, or filing, recording or
registration with, or exemption by any governmental or public body or authority, or subdivision
thereof, binding on Borrower, except as already has been obtained or made; and

          4.7 This Amendment has been duly executed and delivered by Borrower and is the binding
obligation of Borrower, enforceable against Borrower in

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accordance with its terms, except as such enforceability may be limited by bankruptcy,
insolvency, reorganization, liquidation, moratorium or other similar laws of general application
and equitable principles relating to or affecting creditors’ rights.

     5. Fee. In consideration for Bank entering into this Amendment, Borrower shall pay Bank a fee
of $40,000.00 concurrently with the execution and delivery of this Amendment, which fee shall be
non-refundable and in addition to all interest and other fees payable to Bank under the Loan
Documents. Bank is authorized to charge said fee to Borrower’s loan account.

     6. Counterparts. This Amendment may be executed in any number of counterparts and all of such
counterparts taken together shall be deemed to constitute one and the same instrument.

     7. Effectiveness. This Amendment shall be deemed effective upon the due execution and
delivery to Bank of this Amendment by each party hereto.

[Remainder of page intentionally left blank; signature page immediately follows.]

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     In Witness Whereof, the parties hereto have caused this Amendment to be duly executed
and delivered as of the date first written above.

ENDOCARE, INC.

	 	 	 	 	 
	By
	 	/s/ Michael R. Rodriguez	 	 
	 

	 	 

	 	 
	Name:
	 	Michael R. Rodriguez	 	 
	 

	 	 

	 	 
	Title:
	 	Senior Vice President, Finance and Chief Financial Officer	 	 
	 

	 	 

	 	 
	 
	 	 	 	 
	SILICON VALLEY BANK	 	 
	 
	 	 	 	 
	By
	 	/s/ Derek R. Brunelle	 	 
	 

	 	 

	 	 
	Name:
	 	Derek R. Brunelle	 	 
	 

	 	 

	 	 
	Title:
	 	Relationship Manager	 	 
	 

	 	 

	 	 

4exv10w3

 

Exhibit 10.3

MANUFACTURING AGREEMENT

     THIS MANUFACTURING AGREEMENT (the “Agreement”), effective as of the 1st day of January, 2006,
(the “Effective Date”), is by and between ALCON PHARMACEUTICALS LTD., a Swiss corporation with its
principal offices at Bösch 69, P.O. Box 62, 6331 Hünenberg, Switzerland (hereinafter referred to as
“ALCON”) and LIFECORE BIOMEDICAL, INC., a Minnesota corporation with its principal offices at 3515
Lyman Blvd., Chaska, MN 55318 (hereinafter referred to as “SELLER”).

WITNESSETH:

     WHEREAS, ALCON is desirous of entering into a contract supply arrangement with SELLER with
respect to Sodium Hyaluronate as specifically described in the Product Specifications referenced in
Article 1.02 (the “Product”), which Product shall be used by ALCON to manufacture ALCON’s finished
VISCOAT® ophthalmic viscoelastic solution (the “Alcon Finished Product”), and SELLER is willing to
enter into such an arrangement with ALCON, all on the terms and conditions set forth herein.

     NOW, THEREFORE, in consideration of the mutual covenants, promises, and agreements herein
contained, it is mutually agreed as follows:

ARTICLE I

MANUFACTURING AND SALE

     1.01 During the term of this Agreement, SELLER agrees that it shall manufacture for and sell
to ALCON (or its Affiliate) on a non-exclusive basis, and ALCON agrees that it (or its Affiliate)
shall, on a non-exclusive basis, purchase and accept from SELLER the Product as set forth in the
terms of this Agreement. “Affiliate” means any legal entity that directly or indirectly owns, is
owned by, or is under common control with the party specified.

     1.02 SELLER agrees that it shall manufacture the Product and perform all of its obligations
hereunder in accordance with (a) the written specification for the Alcon Product numbers
BE.Q02.7SPSHCC.S0032A and BE.Q02.7SPSHCC.S0032B, as amended or supplemented from time to time (the
“Product Specifications”) and quality control testing procedures corresponding to SELLER’S product
numbers 10025 and 80349, (b) Standard Purchase Description number BE.Q02.7SPDCC.S0042A for the
Product (“SPD”), as amended or supplemented from time to time, (c) the current good manufacturing
practices applicable to the manufacturing of the Product as defined by Good Manufacturing Practices
and Quality System Regulations as promulgated under the United States Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. § 301 et seq, as amended (the “FFDCA”), at 21 CFR Part 820 and
European Directive 93/42/EEC of 14 June 1993, the Medical Device Directive (including Annex 1
thereof), and applicable national implementing laws, regulations and guidelines, and including ISO
13485 standard, ISO 14971, EN 46001, EN 46002 and EN 724 standards, (d) the procedures, terms and
conditions set forth in Exhibit “A” hereto, and (e) all other applicable laws, rules and
regulations (the foregoing clauses (a) through (e) collectively, the “Product Standards”). The
parties acknowledge that the Product Specifications and the SPD referenced above are the versions
in

 

 

effect on the Effective Date; however, the parties agree that the Product Specifications and
the SPD may be updated from time to time with the written agreement of the parties as a separate
change control process. In that event, the referenced Product Specifications and SPD will
automatically be superceded and replaced by the new Product Specifications and SPD.

     1.03 Except as otherwise expressly set forth herein, all raw materials and packaging
components necessary to manufacture the Product will be supplied by SELLER.

     1.04 From time to time SELLER may recommend to ALCON changes in the design, processes or
procedures relative to the manufacturing, packaging and/or labeling of the Product. In the event
any of said recommendations are adopted by ALCON pursuant to Exhibit “A” attached hereto, they
shall be deemed to amend the Product Specifications. For the avoidance of doubt, SELLER may not
change the design, processes or procedures relative to the manufacture of the Product, including
the materials or components thereof, in any respect without the prior written consent of ALCON as
set forth in the preceding sentence. ALCON shall assess any requested changes based on the
potential risk and will not unreasonably withhold or delay consent.

     1.05 SELLER shall conduct all manufacturing of the Product at its facility located at Chaska,
Minnesota, or such other facility as the parties may agree. SELLER shall supply all equipment or
machinery used by SELLER in the production, packaging, labeling, holding or quality control testing
of the Product, unless specified otherwise herein, and shall maintain its facilities, including
such equipment, in a state of repair and operating efficiency consistent with the requirements of
the Product Standards. SELLER shall obtain and maintain during the term hereof all government and
regulatory authority licenses, permits, registrations, and approvals required in order to
manufacture the Product pursuant to the terms hereof, including, without limitation, to the extent
applicable, registration as a device establishment and submission to the FDA of a device list
pursuant to 21 CFR 807.20, and compliance with the Medical Device Directive (including Annex 1
thereof).

ARTICLE II

FORECASTS, ORDERS AND DELIVERY

     2.01 During the term of this Agreement, SELLER agrees that it will sell to ALCON and ALCON
agrees that it will purchase from SELLER, such requirements of the Product that ALCON orders
pursuant to the terms of this Agreement.

     2.02 ALCON shall furnish SELLER with a written updated six (6) month rolling forecast of the
quantities of the Product that ALCON intends to order from SELLER during the next following six (6)
months. It is understood and agreed that any forecasts issued to SELLER by ALCON pursuant to the
terms hereof, shall not be binding nor constitute a firm order of the Products. The ordering of
Products shall be by means of individual purchase orders and change orders thereto (hereinafter
referred to collectively as “Purchase Order(s)”), issued from time to time by ALCON’s procurement
personnel and ALCON’s subcontractors who are authorized herein to do so. ALCON’s sole liability to
SELLER shall be limited to actual quantities ordered against individual Purchase Orders. In the
event that the terms of any Purchase Order are not consistent with those of this Agreement, then
the terms of this Agreement will prevail.

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     2.03 If ALCON requests changes to any Purchase Order after receipt thereof by SELLER, SELLER
shall be obligated to comply with all changes to Purchase Orders that increase or decrease by
twenty percent (20%) or less the aggregate quantity of Product ordered by ALCON for the relevant
period. SELLER shall exercise its best efforts to comply with all other changes to Purchase Orders
that ALCON may request.

     2.04 In the event SELLER discovers that there is a likelihood that it will fail to deliver a
shipment of Product on the date set forth in a Purchase Order, SELLER shall notify ALCON within
five (5) business days of the discovery of such failure. Furthermore, in the event that because of
SELLER’s failure to timely deliver a shipment of Product as set forth herein, ALCON is forced to
purchase a Product equivalent from a third party, ALCON shall have the right to terminate all or a
portion of the Purchase Order related to the Product delivery in question.

     2.05 SELLER shall deliver the quantities of each Product set forth in each Purchase Order on
the delivery date specified therein. All shipments shall be F.C.A. (INCOTERMS 2000) SELLER’S
facilities, at which point all title to, and risk of loss of, the Products shall pass to ALCON (or
its Affiliate issuing the purchase order). SELLER shall not be liable for any delay in shipment of
the Product that is beyond the reasonable control of SELLER.

     2.06 ALCON shall purchase a minimum of ** of Product during each 12-month period of this
Agreement (Minimum Volume). If ALCON fails to purchase the Minimum Volume, ALCON shall pay to
SELLER, pursuant to the terms of Paragraph 3.02, the difference between the Minimum Volume and the
volumes actually purchased by ALCON as of the end of each such 12 month period.

ARTICLE III

PRICE AND TERMS OF PAYMENT

     3.01 ALCON shall pay SELLER for the Product in accordance with the following price schedule:

	 	 	 	 	 
	Year	 	Price-USD	 	 
	 
	 	 	 	 
	2006

	 	USD **
	 	 
	2007

	 	USD **	 	 
	2008

	 	USD **	 	 

 

			
	**	 	The appearance of a double asterisk denotes confidential information that has been omitted from
the exhibit and filed separately, accompanied by a confidential treatment request, with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934.

3

 

     3.02 ALCON will pay for the Product within thirty (30) days of the date of SELLER’s invoice.

     3.03 If the Product Specifications are changed in accordance with the terms hereof and said
change affects SELLER’s costs to manufacture the Product, a revised price for the Product shall be
determined by mutual agreement of the parties, provided that SELLER shall not withhold its
agreement to any revised price proposed by ALCON if such revised price includes reimbursement of
SELLER’s reasonably documented increased costs to manufacture the Product as a result of such
changes.

     3.04 ALCON agrees that any sales taxes, gross receipts or similar taxes that are assessed as a
result of this Agreement (except taxes on SELLER’s net income), including, without limitation,
Value Added Tax, are the responsibility and liability of ALCON, and will not be transferred to, or
paid by, SELLER, in any form.

ARTICLE IV

RECORDS

     4.01 SELLER agrees to maintain accurate records of Product production, shipment, and such
other records as are required by the Product Standards, including any requirements applicable to
electronic records and signatures (21 CFR Part 11), or otherwise mutually agreed upon by the
parties for such period as may be required by applicable laws (and in any case for a minimum of six
years), and shall provide to ALCON, upon ALCON’s request, copies of all such records. The
obligations of SELLER under this Paragraph 4.01 shall survive the expiration or termination for
whatever reason of this Agreement for a period of six years.

ARTICLE V

WARRANTIES INDEMNITIES, AND INSURANCE

     5.01 SELLER warrants that Product delivered to ALCON under this Agreement (a) shall have been
manufactured, packaged, labeled, held and shipped in accordance with the written Product
Specifications and quality control testing procedures for the Product; and (b) shall conform to the
current good manufacturing practices applicable to the manufacturing of the Product as defined in
Article 1.02; (c) shall conform to the procedures, terms and conditions set forth in Exhibit A; and
(d) shall conform to the Product Standards as defined in Article 1.02; and (e) will be free from
defects in material and workmanship for a period of twelve (12) months from delivery to ALCON.
SELLER also warrants to ALCON that SELLER has not been debarred and is not subject to debarment and
will not use in any capacity, in connection with the services to be performed under this Agreement,
any person who has been debarred pursuant to section 306 of the FFDCA, 21 U.S.C. § 335a, or who is
the subject of a conviction described in such section (or undergoes any analogous proceedings under
foreign law). SELLER shall not be obligated under the foregoing warranty if any nonconformance in
the Product results from ALCON’s mishandling, misuse or improper storage of the Product.

     5.02 ALCON shall have a period of ninety (90) days from date of receipt to inspect and reject,
by written notice to SELLER, any Product shipment on the grounds that it does not comply with the
warranty set forth in Paragraph 5.01. In the event ALCON rejects any Product

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as a result of such non-compliance, ALCON shall return such rejected Product (or a sample
thereof) to SELLER for further testing. If SELLER confirms that such returned Product fails to
comply with the warranty set forth in Paragraph 5.01, SELLER shall, promptly replace such Product
with substitute Product that complies with the warranty set forth in Paragraph 5.01 at SELLER’s own
cost and expense. Such replacement of the Product by SELLER shall be ALCON’s sole and exclusive
remedy, and SELLER’s sole and exclusive liability, with the exception of any indemnification
obligations pursuant to Article 5.04, for any breach of the warranty set forth in Paragraph 5.01.
If there is any dispute between the parties concerning whether any Product complies with the
warranty set forth in Paragraph 5.01 at the time of delivery to ALCON, such dispute shall be
referred for decision to an independent expert to be appointed by agreement between SELLER and
ALCON. The costs of such independent expert shall be borne by SELLER if the testing confirms the
non-conformity and otherwise by ALCON. The decision of such independent expert shall be in writing
and, save for manifest error, shall be binding on both SELLER and ALCON. Acceptance by ALCON of
any Product pursuant to this Article V shall not in any way affect ALCON’s rights under the
warranty provisions of this Agreement.

     5.03 ALCON will indemnify and hold SELLER harmless from and against any and all liability,
damage, loss, cost or expense resulting from any third party claim(s) made or suits brought against
SELLER to the extent arising out of (a) any sale or other distribution of the ALCON Finished
Product except to the extent that the claim arises out of SELLER’s breach, negligent act or
omission, or willful act or omission as described in Article 5.04; or (b) any negligent or willful
act or omission of ALCON in relation to the promotion, distribution, sale or use of the Product
which SELLER manufactured hereunder and which complies with the warranty set forth in Paragraph
5.01 hereof. Upon the filing of any such claim or suit, SELLER shall immediately notify ALCON
thereof and shall permit ALCON, at its cost, to handle and control such claim or suit;
provided, however, that SELLER may, at its own expense, retain such additional
attorneys as it may deem necessary. SELLER’s attorneys will be permitted by ALCON and their
attorneys to reasonably observe and/or participate in all aspects of the defense of such claims or
suits. ALCON shall not settle or consent to an entry of judgment in any such claims or suits
without the prior written consent of SELLER, which shall not be unreasonably withheld.

     5.04 SELLER will indemnify and hold ALCON harmless from and against any and all liability,
damage, loss, cost, or expense resulting from any third party claims made or suits brought against
ALCON to the extent arising out of (a) SELLER’s breach of any representation or warranty set forth
in Article 5.01; or (b) any negligent or willful act or omission of SELLER in relation to the
manufacture or delivery of the Product hereunder. Upon the filing of any such claim or suit, ALCON
shall immediately notify SELLER thereof and shall permit SELLER, at its cost, to handle and control
such claim or suit; provided, however, that ALCON may, at its own expense, retain
such additional attorneys as it may deem necessary. ALCON’s attorneys will be permitted by SELLER
and their attorneys to reasonably observe and/or participate in all aspects of the defense of such
claims or suits. SELLER shall not settle or consent to an entry of judgment in any such claims or
suits without the prior written consent of ALCON, which shall not be unreasonably withheld.

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     5.05 SELLER, at the time of signing, shall furnish ALCON with a Certificate of Insurance
(provided by an insurance carrier(s) reasonably acceptable to ALCON) evidencing that SELLER has in
effect and shall throughout the term of this Agreement maintain comprehensive General Liability
insurance coverage including Products Liability and Blanket Contractual, affording a limit of IUD
5,000,000 Bodily Injury/Property Damage Liability per occurrence and in the aggregate. SELLER’s
insurance policies shall name ALCON as an additional insured party and shall be endorsed to provide
that ALCON shall be notified at least sixty (60) days in advance of any material change or
cancellation of insurance.

     5.06 Except as specifically set forth in this agreement, SELLER makes no warranties with
respect to the Product, express or implied, including without limitation, any warranty of
merchantability, fitness for a particular purpose or non-infringement.

     5.07 The provisions of this Article V shall survive the expiration or termination for whatever
reason of this Agreement.

ARTICLE VI

CONFIDENTIALITY

     6.01 All information, including, without limitation, know-how, furnished by or on behalf of
one party hereto (the “Disclosing Party”) to the other party hereto (the “Receiving Party”) either
in connection with the discussions and negotiations pertaining to, or in the course of performing,
this Agreement (the “Confidential Information”) shall he kept confidential by the Receiving Party
and the Receiving Party shall not make use of said Confidential Information, except for purposes
authorized by this Agreement, nor disclose the same to any person or firm unless previously
authorized in writing by the Disclosing Party to do so; provided, however, that the
Receiving Party may disclose such Confidential Information to its responsible officers and
employees who require said information for the purposes contemplated by this Agreement, provided
that said officers and employees shall be subject to like obligations of confidentiality.

     6.02 Any other provision hereof to the contrary notwithstanding, it is expressly understood
and agreed by the parties hereto that the obligations of confidence and non-use set forth in
Paragraph 6.01 shall not apply to any information which:

	 	(a)	 	is lawfully, at the time of disclosure or thereafter so
becomes, a part of the public domain;
	 
	 	(b)	 	is independently discovered or developed by, or otherwise in
the lawful possession of, the Receiving Party without the use of Confidential
Information belonging to the Disclosing Party, as shown by its written records;
	 
	 	(c)	 	is lawfully disclosed to the Receiving Party by a third party
who is not in violation of an obligation of confidentiality to the Disclosing
Party relative to said information; or
	 
	 	(d)	 	is, by mutual agreement of the parties hereto, released from a
confidential status; or

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	 	(e)	 	the Receiving Party must disclose pursuant to applicable laws,
regulations or court order, provided that the Receiving Party gives the
Disclosing Party reasonable notice of its intent to disclose such information.

     6.03 Neither party shall use the name of the other party in any discussions with third
parties, advertising, press release, sales literature, or fund-raising efforts without the prior
written consent of the other party.

     6.04 The provisions of this Article VI shall survive the expiration or termination for
whatever reason of this Agreement

ARTICLE VII

TERM AND TERMINATION

     7.01 Unless terminated in accordance with the provisions of Paragraph 7.02 below, the term of
this Agreement shall be for a period of thirty-six (36) months starting from the Effective Date and
shall cover all Purchase Orders issued during such term.

     7.02 This Agreement may be terminated as follows:

	 	(a)	 	By either party, immediately upon written notice to the other,
if the other party becomes insolvent or seeks protection under any bankruptcy,
receivership, trust deed, creditors arrangement, composition or comparable
proceeding, or if any such proceeding is instituted against the other party
which proceeding remains undismissed for a period of thirty (30) days; or
	 
	 	(b)	 	By either party, in the event that the other party fails to
perform or otherwise breaches any of its material obligations hereunder (except
to the extent permitted by Paragraph 8.01 due to a Force Majeure Event), by
giving notice of its intent to terminate and stating the grounds therefor. The
party receiving such notice shall have sixty (60) days from the receipt thereof
to cure the failure or breach, after which sixty (60)-day period this Agreement
shall terminate if said failure or breach has not been cured. In no event,
however, shall such notice of intention to terminate be deemed to waive any
rights to damages or any other remedy which the party giving notice of breach
may have as a consequence of such failure or breach.

     7.03 The termination or expiration of this Agreement for any reason shall be without prejudice
to any rights that shall have accrued to the benefit of a party, and shall not relieve either party
from any obligation or liability arising, prior to such termination or expiration and all
provisions which are expressed to survive this Agreement, including this Paragraph 7.03, shall
remain in full force and effect after any termination or expiration.

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ARTICLE VIII

GENERAL PROVISIONS

     8.01 Force Majeure. The provisions of this Agreement are binding upon the parties
hereto except where prevented, delayed or interfered with by causes beyond the reasonable control
of the non-performing party, including, without limitation, riot, terrorism, war or hostilities
between nations, governmental action (other than action taken in response to violation or failure
to act of a party or any of its Affiliates with respect to any law or governmental regulation, in
which case the party at fault shall not be permitted to claim the benefit of this Paragraph 8.01),
acts of God (including, for example, floods, windstorms, earthquakes and other natural disasters),
fire, accidents, and strikes and other labor disputes (a “Force Majeure Event”). The party
affected by a Force Majeure Event shall give notice to the other party of such Force Majeure Event
promptly after the occurrence thereof, stating therein the nature of the suspension of performance
and reasons therefor. Such party shall use its best efforts to resume performance as soon as
reasonably possible. Upon restoration of the affected party’s ability to perform its obligations
hereunder, the affected party shall give immediate notice to the other party. Under no
circumstances shall a Force Majeure Event relieve either party of any obligation hereunder for a
period of more than ninety (90) days.

     8.02 Assignment: Successors In Interest. Neither party shall be entitled to sell,
assign, transfer, or otherwise dispose of this Agreement or any of its rights or duties hereunder
without the prior written consent of the other party, which consent shall not be unreasonably
withheld or delayed provided, however, that without such consent either party may assign this
Agreement, in whole or in part, to an Affiliate of such party. Any purported assignment or
transfer in violation of this Paragraph shall be void ab initio and of no force or effect.
This Agreement shall be binding upon and inure to the benefit of and be enforceable by and against
the successors and permitted assigns of ALCON and SELLER, as the case may be.

     8.03 Entire Understanding. This Agreement shall constitute the entire agreement
between parties hereto and shall supersede any other agreements, whether oral or written, expressed
or implied, as they pertain to the subject matter hereof (including but not limited to the
Hyaluronate Purchase Agreement dated March 28, 1990, as amended, between Lifecore Biomedical, Inc.
and Alcon Pharmaceuticals Ltd., including the renewal of the Hyaluronate Purchase Agreement and
terms sheet dated December 22, 2004), and shall supersede any conflicting preprinted portions of
SELLER’s quotation and acknowledgment forms. This Agreement may not be changed or modified except
as specifically and mutually agreed upon in writing.

     8.04 Relationship.

	 	(a)	 	The relationship created by this Agreement shall be strictly
that of independent contractors and shall not constitute a partnership, joint
venture or agency. Neither party is hereby constituted an agent nor legal
representative of the other party for any purpose whatsoever and is granted no
right or authority hereunder to assume or create an obligation, expressed or
implied, or to make any representation, warranties or guarantees, except as are
expressly granted or made in this Agreement.

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	 	 	 	All persons employed by a party shall be employees of such party and not of
the other party and all costs and obligations incurred by reason of any such
employment shall be for the account and expense of such party.
	 
	 	(b)	 	Neither SELLER nor ALCON has relied in any way upon the other,
directly or indirectly, or any legal, financial or similar professional advice
relating to its execution of this Agreement, and each has sought such advice on
its own behalf from professionals of its choice.

     8.05 Litigation. In the event that the Parties hereto become involved in litigation
with one another with reference to all or any part of the subject matter of this Agreement, or with
reference to any issue connected with or related thereto, the unsuccessful party in such litigation
shall pay the legal fees, costs and expenses, including, without limitation, all reasonable and
verifiable attorneys’ fees, of the successful party. This Paragraph shall survive the expiration
or termination for whatever reason of this Agreement.

     8.06 Notice. Any notice required hereunder may be served by either party on the other
by sending same, by first class or certified mail to the address first set forth above or such
other address as either party may subsequently designate to the other in writing as the address for
mailing notice(s) under this Agreement. This Paragraph shall survive the expiration or termination
for whatever reason of this Agreement.

     8.07 Waiver. The parties hereto mutually agree that a waiver by either party of any
right hereunder or the failure to perform or breach of any of the terms of this Agreement by the
other party shall not be deemed a waiver of any other right hereunder or of any other breach or
failure by such other party.

     8.08 Governing Law. This Agreement is to be performed in accordance with the laws of
Delaware, USA and shall be construed and enforced in accordance with the laws of Delaware, USA
excluding any conflicts or choice of law rule or principle that might otherwise refer construction
or interpretation of this Agreement to the substantive law of another jurisdiction. The parties
further agree to exclude the application to this Agreement of the United Nations Convention on
Contracts for the International Sale of Goods. This Paragraph shall survive the expiration or
termination for whatever reason of this Agreement.

     8.09 Severability. The illegality, invalidity or unenforceability of any provision
(or any part thereof) of this Agreement shall not affect or limit the legality, validity or
enforceability of any other provision or the other parts of such provision as the case may be,
provided the rights or obligations of either party under this Agreement will not be
materially and adversely affected thereby. In lieu of any such illegal, invalid or unenforceable
provision, there shall be added automatically as a part of this Agreement a legal, valid and
enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as
may be possible and reasonably acceptable to the parties.

     8.10 Subcontracting. SELLER shall be responsible for identifying and qualifying all
sub-contractors of materials, testing and services necessary to manufacture the Product. Unless

9

 

the parties agree otherwise, SELLER shall remain solely liable for the performance of any of
SELLER’s obligations by its approved subcontractor.

     8.11 Further Assurance. Each party shall execute such other instruments, give such
further assurance and perform such acts which are or may become necessary or appropriate to
effectuate and carry out the provisions of this Agreement.

     8.12 Remedies Cumulative. Except as provided herein, each and every right granted
hereunder and the remedies provided for under this Agreement are cumulative and are not exclusive
of any remedies or rights that may be available to any party at law, in equity, or otherwise.

     8.13 No Benefit to Others. Except as provided in Paragraphs 5.03 and 5.04, the
provisions set forth in this Agreement are for the sole benefit of the parties hereto and their
successors and permitted assigns, and they shall not be construed as conferring any rights on any
other persons or entities.

     8.14 Counterparts. This Agreement may be executed in two (2) or more counterparts,
each of which shall be deemed an original, but all of which together shall constitute one and the
same instrument. This Agreement may be executed by facsimile signatures and such signatures shall
be deemed to bind each party hereto as if they were original signatures.

[The remainder of this page has been intentionally left blank]

10

 

     IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed by their duly
authorized representative.

	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	ALCON PHARMACEUTICALS LTD.	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ JOANNE BECK

 

Name: Joanne Beck

Its: General Manager
	 	 
	 	By:
	 	/s/ STEFAN BASLER

 

Name: Stefan Basler

Its: Finance Manager
	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	LIFECORE BIOMEDICAL, INC.	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By

	 	/s/ LARRY HIEBERT
 

Name: Larry Hiebert

Its: Vice President of Operations	 	 	 	 	 	 	 	 

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EXHIBIT “A”

	1.	 	Ownership and Maintenance of Regulatory Approvals: ALCON shall own and maintain all
regulatory applications, notifications, and dossiers with respect to the ALCON Finished
Product (or any other ALCON product that results from use of the Product), including, without
limitation, PMAs, 510(k)s, Technical Files and other marketing authorizations. SELLER shall
provide ALCON with all data and information necessary or reasonably useful to maintain such
regulatory approvals, including, without limitation, chemistry, manufacturing and control
data.
	 
	2.	 	Device Master Record and Device History Record: To the extent applicable, ALCON
shall maintain an accurate Device Master Record for the ALCON Finished Product in accordance
with 21 CFR 820.181 and grant to SELLER a right of access to the Device Master Record as
reasonably necessary to manufacture the Product. SELLER shall maintain a Device History
Record (DHR) in accordance with 21 CFR 820.184 and shall provide ALCON with a right to audit
and obtain copies of the DHR as may be necessary or reasonably useful to comply with
requirements of the FDA or other governmental or regulatory authorities.
	 
	3.	 	Quality System Requirements: SELLER shall have in place and maintain for the
duration of the contract, a Quality System that is in compliance with ISO 13485, and EN 724
standards and, where applicable, that has been inspected and determined to be satisfactory by
a European Union Notified Body in accordance with the Medical Device Directive 93/42/EEC.
SELLER shall make available to ALCON all relevant documentation, reports, decisions,
registrations and Surveillance Audit Reports, upon request.
	 
	4.	 	Changes to the Technical File: Changes in specifications, manufacturing or packaging
agreed to by ALCON and SELLER may result in amendments to the Technical File. As necessary,
the amendments will be submitted to the affected Notified Body within the requested time
frame.
	 
	5.	 	It is understood that ALCON’s Notified Body is not obligated to accept any non-EU Notified
Body registrations or certifications and may elect to perform inspections or audits of SELLER.
	 
	6.	 	Labeling: SELLER shall be responsible for labeling the Product in accordance with
applicable Good Manufacturing Practices Regulations or other applicable standards.
	 
	 	 	To the extent applicable, SELLER shall be responsible for placing labeling on the Product in
accordance with artwork and drawings provided by ALCON.
	 
	7.	 	Product or Manufacturing Chances Informed Prior to Implementation:

	 	(a)	 	SELLER shall be responsible for manufacturing, packaging and labeling the
Product in accordance with the Product Specifications. SELLER agrees to promptly
incorporate all changes to the Product Specifications implemented

A-1

 

	 	 	 	pursuant to this Section, consistent with appropriate manufacturing procedures and
regulatory requirements.
	 
	 	(b)	 	ALCON from time to time may amend or supplement the Product Specifications, in
its sole discretion, for the purpose of complying with applicable laws, rules and
regulations. In addition, ALCON may amend or supplement the Product Specifications for
any other reason, with the prior written approval of SELLER, which consent shall not be
unreasonably delayed or withheld. ALCON shall notify SELLER in writing of any such
amendment or proposed amendment, as the case may be. In the event that SELLER shall
fail to notify ALCON in writing of its approval or disapproval thereof within ten (10)
days after receipt thereof, then SELLER shall be deemed to have given its prior written
approval thereof.
	 
	 	(c)	 	In the event that ALCON shall amend the Product Specifications, ALCON shall, if
required, (i) amend the PMA, Technical File or other registration relevant to the
intended use of the Product, (ii) obtain any required approval of such amendment, or
(iii) file a 510(k) notification or any other required regulatory submission, and (iv)
reimburse SELLER for reasonable costs actually incurred by SELLER in connection with
such change, including, without limitation, reasonable costs of obsolescence of raw
materials, goods-in-process, packaging materials and finished goods not suitable.

	8.	 	Customer Complaint Handling/Post Marketing Vigilance: ALCON will handle, process and
respond to all customer complaints related to the Alcon Finished Product, including complaints
related to the Product included therein, for all markets. ALCON and SELLER shall maintain
complaint files regarding the Product, including, without limitation, any Product quality
complaints for such period as may be required by applicable law. All complaints received by
SELLER relating to a Product provided to ALCON will be promptly forwarded, in no event later
than ten (10) days after receipt thereof, to ALCON for appropriate and timely reporting and
response in accordance with applicable law, including, without limitation, medical device
adverse event reporting pursuant to 21 CFR Part 803 or near incident or incident reporting
pursuant to European Community Medical Devices Vigilance System requirements;
provided, however, SELLER shall notify ALCON of any serious adverse event, as
defined in FDA or other applicable regulations, pertaining to the Product, within twenty-four
(24) hours after receipt thereof. SELLER agrees to cooperate with ALCON to investigate and
resolve all complaints and to take remedial action to avoid similar complaints in the future.
This Section shall survive the expiration or termination for whatever reason of this
Agreement.
	 
	9.	 	Product Validation: It is understood and agreed by the parties hereto that all
processes affecting the purported identity, strength, or quality of the Product being
manufactured, assembled and/or packaged shall be qualified and maintained in a validated
state. ALCON shall be notified in advance of such validations and the protocols describing
these validations shall be reviewed by ALCON’s Quality Assurance Department prior to the
commencement of any validation and in accordance with Article I, Section 1.04. ALCON shall
assess any intended product validation protocols based on the potential risk and will not
unreasonably withhold or delay consent. Copies of validation reports and

A-2

 

	 	 	data will be made available to ALCON by the SELLER in the event such documentation is needed
to support Product applications or dossiers.
	 
	10.	 	Recall: At any time, should information come into the possession of SELLER which
would indicate the need or the necessity for a review for a possible recall of the Product.
SELLER will notify ALCON immediately and will assist ALCON as required in the course of any
recall. In the event ALCON shall be required or shall voluntarily decide to recall any Alcon
Finished Product which incorporates any Product manufactured by SELLER pursuant to this
Agreement, then SELLER shall cooperate with ALCON in implementing such recall. ALCON shall
bear the cost and expense of any such recall, provided, however, if such
recall is initiated because of the failure of the Product to conform to the warranty set forth
in Paragraph 5.01, SELLER shall promptly reimburse ALCON for all direct costs and expenses
associated with such recall. The obligations of SELLER under this Section shall survive the
expiration or termination for whatever reason of this Agreement. Any reimbursement obligation
of SELLER hereunder shall not include lost profits, lost revenues or internal costs of ALCON
resulting from any recall.
	 
	11.	 	Inspections/Audits by ALCON: SELLER agrees that ALCON may send representatives to
SELLER’s manufacturing facility to observe, audit and inspect the production facilities for
the Product, and SELLER will allow ALCON’s representatives reasonable access to all
manufacturing records for the Product so as to ensure that SELLER is in compliance with the
Product Standards, provided that ALCON shall give SELLER at least five (5) business
days in advance of any such audit the names of the representatives and the visit agenda. Any
observation, audit, or inspection of SELLER by ALCON shall be during normal working hours, of
reasonable duration, at the sole expense of ALCON and shall be subject to the obligations of
confidentiality set forth in Article VI of this Agreement. For the avoidance of doubt, the
right to inspect granted to ALCON shall not be deemed as granting to ALCON access to any trade
secrets owned by SELLER. SELLER shall use reasonable commercial efforts to correct any
material non-compliance with the Product Standards or other applicable laws, standards, rules,
regulations or requirements that are discovered and brought to its attention as a result of
such visits.
	 
	12.	 	Inspections/Audits by Regulatory Organizations: SELLER shall notify ALCON in
writing, within three (3) business days after receipt of notice thereof, of any proposed or
unannounced visit or inspection of SELLER’s facility or the manufacturing process for the
Product by any government or regulatory agency, including, without limitation the FDA or a
Notified Body. SELLER shall provide to ALCON a copy of any report and other written
communications received from such government or regulatory agency in connection with such
visit or inspection and any written correspondence received from any governmental agency
relating to the Product, or SELLER’s facility including support systems or manufacturing
processes impacting the Product, within five (5) business days after receipt thereof, and
shall provide to ALCON SELLER’s response to each such communication.

A-3

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