Exhibit 10.2
DEVELOPMENT AND SUPPLY AGREEMENT
This AGREEMENT is made and entered into this 17 day of December, 2002 (the
"Effective Date") by and between XXXXXXXXX-XXXXX LABORATORIES LLC, having a
principal place of business at 0000 Xxxxx Xxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxxx,
00000-0000 ("Xxxxxxxxx-Xxxxx") and GlycoGenesys, Inc., having a principal place
of business at 00 Xx. Xxxxx Xxxxxx, Xxxxxx, Xxxxxxxxxxxxx 00000 ("Client"). Both
Xxxxxxxxx-Xxxxx and Client are referred to herein individually as "Party" and
collectively as the "Parties."
WITNESSETH THAT:
WHEREAS, Xxxxxxxxx-Xxxxx has expertise, personnel, the facility for, and
experience in compounding and/or finishing of pharmaceutical products and is
willing to provide such services to client companies in the pharmaceutical area
and;
WHEREAS, Client has a commercial interest in the manufacture of the Product(s)
as hereafter defined and identified from time to time upon mutual agreement by
the Parties and requests the services of Xxxxxxxxx-Xxxxx in the manufacturing of
such products pursuant to the Product Development Programs identified from time
to time upon mutual agreement by the Parties, and Xxxxxxxxx-Xxxxx desires to
manufacture such Products on behalf of Client pursuant to such Product
Development Programs and in accordance with the terms and conditions contained
herein;
NOW, THEREFORE, in consideration of the premises and the mutual covenants and
agreements contained herein, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
1. As used in this Agreement, the following definitions shall apply:
1.1 "Act" shall mean the U.S. Food, Drug and Cosmetic Act of 1934, the
Public Health Service Act of 1944 and the regulations promulgated
thereunder, as the same may be amended from time to time.
1.2 "Active Pharmaceutical Ingredient" or "API" shall mean the active
pharmaceutical ingredient of the Product(s).
1.3 "Affiliate" shall mean any corporation or non-corporate business
entity, which directly or indirectly controls, is controlled by, or
is under common control with a Party. A corporation or non-corporate
business entity shall be regarded as in control of another
corporation if it owns or directly or indirectly controls at least
fifty percent (50%) of the voting stock of the other corporation or
(a) in the absence of the ownership of at least fifty percent (50%)
of the voting stock of a corporation or (b) in the case of a
non-corporate entity, the power to direct or cause the direction of
the management and policies of such corporation or non-corporate
entity, as applicable.
1.4 "Batch" or "Lot" shall mean, with respect to Product(s), each
separate and distinct quantity of Product processed under continuous
conditions and designated by a batch or lot number.
1.5 "cGMP Regulations" means Current Good Manufacturing Practices as
defined from time to time under the Act, as codified in 21 CFR Parts
210 and 211 and being currently utilized within the pharmaceutical
industry to manufacture the applicable type of Product(s).
1.6 "Certificate of Analysis" or "COA" shall mean a document certifying a
Batch or Lot of Product meets all established and mutually agreed
upon Specifications as referenced, signed and dated by a duly
authorized representative of the Quality Control or Quality Assurance
Department of Xxxxxxxxx-Xxxxx or Client as the case may be.
1.7 "Confidential Information" shall mean any nonpublic information of
Xxxxxxxxx-Xxxxx or Client that will be communicated to the other
Party including without limitation, trade secrets, business methods,
operating procedures, manufacturing methods and processes, prices,
and customer information, whether of a written, oral, visual or
electronic nature.
1.8 "FDA" shall mean the United States Food and Drug Administration.
1.9 "Intellectual Property" shall mean property that can be protected
under federal law, including copyrightable works, ideas, discoveries,
and inventions.
1.10 "Product(s)" shall mean those products as set forth from time to time
within the appropriate Product Development Program annexed hereto.
1.11 "Product Development Program" shall mean a written document or
documents as agreed to by the Parties, describing the activities
required to develop and manufacture a Product. The Product
Development Program will be consolidated within a single attachment
in Exhibit A to this Agreement.
1.12 "Quality Agreement" shall mean a written document, mutually agreed to
by the Parties, describing the obligations of the Parties with
regards to compliance, quality systems, and testing and release of
Product(s). The Quality Agreement will be attached as Exhibit B to
this Agreement.
1.13 "Regulatory Authority" shall mean any federal, state, local, or
international regulatory agency, department, bureau, or other
governmental agency having jurisdiction over the manufacture, sale,
or distribution of Product, including but not limited to the Canadian
Health Protection Branch, the European Medicines Evaluation Agency,
the U.S. Food and Drug Administration, and "Regulatory Authorities"
shall mean collectively all such regulatory authorities.
1.14 "Specially Regulated Waste" shall mean any Product refuse, remainder,
residue, waste water or other discard material, including solid,
liquid, semisolid, or contained gaseous material that arises from the
manufacture of the Product(s) which may be subject to or require
special handling, treatment, storage, or disposal under any federal,
state or local laws or regulations.
1.15 "Specifications" shall mean (1) the performance parameters for which
Product, ingredients and packaging components must comply to be
considered acceptable and (2) the written record of such Product
performance parameters annexed hereto within the applicable Product
Development Program attachment. Specifications may be amended from
time to time by written agreement of the Parties.
1.16 "Standard Shift" shall mean, as applied to most Xxxxxxxxx-Xxxxx
manufacturing personnel, ten (10) hours/day. Four (4) shifts are
normally worked, Monday through Thursday.
1.17 "Client's Technology Package" shall mean such technical information
to be supplied by Client to Xxxxxxxxx-Xxxxx to enable Xxxxxxxxx-Xxxxx
to carry out its obligations hereunder. Items which may be included
in the Technology Package include, but is not limited to, Client's
raw material and manufacturing component specifications, intermediate
and product specifications, analytical and microbiological method
validation reports, analytical method transfer protocols, filter
validation reports, raw material, intermediate and product storage
specifications.
1.18 "Third Party" shall mean any party other than Client or
Xxxxxxxxx-Xxxxx and their respective affiliates.
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ARTICLE 2
PRODUCT DEVELOPMENT
2. The Parties agree to the following provisions regarding Product Development:
2.1 Client and Xxxxxxxxx-Xxxxx shall jointly prepare and agree to in
writing Product Development Program documents, which will be amended
hereto, for each Product, which shall, at a minimum, incorporate the
following:
2.1.1 A Product development schedule;
2.1.2 the stages in which the Product Development Program is to be
carried out (if any) and whether the commencement of each
stage is dependent on successful completion of the previous
stage;
2.1.3 identify the facilities, staffing, supplies, and equipment
required for the Product Development Program and who (Client
or Xxxxxxxxx-Xxxxx) is responsible for providing each of
such items;
2.1.4 identify which Party is responsible for performing the
various tasks or stages of the Product Development Program;
2.1.5 Specifications as defined in Section 1.15;
2.1.6 a set of objective criteria whereby it can be assessed
whether the Product Development Program (and any stages
thereof) has achieved its objectives;
2.1.7 identify all documents (Client's Technology Package) and the
timeline for delivery of such documents by Client to
Xxxxxxxxx-Xxxxx.
2.1.8 identify all documents (including regulatory documents) and
other deliverables to be provided by Xxxxxxxxx-Xxxxx to
Client;
2.1.9 a good faith estimate of the number of Batches or Lots
required to complete the Product Development Program;
2.1.10 define Product Development Program prices; and
2.1.11 define Product Development Program payment schedule in
accordance with applicable milestones.
2.2 Xxxxxxxxx-Xxxxx shall provide a written report to Client on the
status of Product Development Program(s) within 15 days of the
completion of each month during the Product Development Program(s).
Such report shall include the following information: variance(s) from
plan (timing and budget), status (tasks completed and in progress),
and summary analysis of data.
2.3 Xxxxxxxxx-Xxxxx shall respond in a timely manner to Client's
inquiries regarding the status of any Product Development Program.
2.4 Xxxxxxxxx-Xxxxx and Client may from time to time negotiate in good
faith changes to any Product Development Program:
2.4.1 If such changes require Xxxxxxxxx-Xxxxx to perform additional
work or repeat work outside the original scope of the project,
and such additional work is not required due to Xxxxxxxxx-
Xxxxx'x fault or negligence, Xxxxxxxxx-Xxxxx and Client shall
negotiate in good faith the price and timing for such additional
work.
2.5 Each Party shall provide the other Party, in a timely fashion, with
all relevant information, documentation, and data necessary or
appropriate for the Parties' performance hereunder. Except as
explicitly otherwise provided in this Agreement, in the event a Party
is to review or approve any information, documentation, data, or
other
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materials supplied by the other Party, such review or approval shall
be completed within five (5) business days, unless additional time is
requested based on a reasonable explanation provided within five (5)
business days of the initial request.
2.6 Each Party shall use its commercially reasonable best efforts to
successfully complete the Product Development Program. However, the
Parties agree and understand that neither Party hereto guarantees
that the project will be successful or conducted in accordance with
the project timetable nor warrants nor guarantees that a marketable
product will result from the project.
2.7 Xxxxxxxxx-Xxxxx shall have the right to review those portions of
Client's proposed regulatory submissions relating to
Xxxxxxxxx-Xxxxx'x facilities or procedures before the submissions are
filed with Regulatory Authorities. Xxxxxxxxx-Xxxxx shall complete its
review of such submissions within ten (10) business days after
receipt. Xxxxxxxxx-Xxxxx shall consult with and advise Client in
responding to questions from Regulatory Authorities regarding
regulatory submissions for the Product(s).
2.8 Right of Negotiation to Manufacture: Subject to right which may be
granted by Client to third parties in connection with collaborative
development and marketing arrangements, prior to commencing
negotiations with any third party regarding the commercial
manufacture of the Product(s), Client shall commence good faith
negotiations regarding the same with Xxxxxxxxx-Xxxxx.
ARTICLE 3
INTELLECTUAL PROPERTY RIGHTS
3. The Parties agree to the following provisions regarding Intellectual Property
Rights:
3.1 Ownership: The Parties agree that: (a) Client shall retain all of its
ownership rights in and to Client's Intellectual Property, (b)
Xxxxxxxxx-Xxxxx shall retain all of its ownership rights in and to
Xxxxxxxxx-Xxxxx'x Intellectual Property; (c) Client shall own all
inventions made or conceived solely by Client; (d) Xxxxxxxxx-Xxxxx
shall own any inventions made or conceived solely by Xxxxxxxxx-Xxxxx
without utilizing the Confidential Information of GlycoGenesys, and
(e) Client shall own any inventions made or conceived jointly by the
Parties in connection with the performance of this Agreement or by
Xxxxxxxxx-Xxxxx utilizing the Confidential Information of
GlycoGenesys
3.2 License Grants: Client hereby grants to Xxxxxxxxx-Xxxxx a
nonexclusive, worldwide, royalty-free license during the term of this
Agreement to use such Client Intellectual Property rights as are
necessary for Xxxxxxxxx-Xxxxx to perform Xxxxxxxxx-Xxxxx'x
obligations under this Agreement. Xxxxxxxxx-Xxxxx hereby grants to
Client a nonexclusive, worldwide, royalty-free, perpetual license to
practice any inventions made or conceived solely by Xxxxxxxxx-Xxxxx
and incorporated into the manufacturing or packaging processes
associated with the Product.
3.3 Limitation on Use: Except as expressly stated in this Agreement, no
Intellectual Property rights of any kind or nature are conveyed by
this Agreement and neither Party shall have any right, title or
interest in or to the other Party's Intellectual Property rights for
any purpose whatsoever without such other Party's prior written
consent. Upon termination of this Agreement for whatever reason,
neither Party shall use or exploit in any manner whatsoever any
Intellectual Property rights or nature belonging solely to the other
Party.
ARTICLE 4
EQUIPMENT PRICE
4. The Parties agree to the following provisions regarding equipment price:
4.1 Client shall pay for the price of equipment specifically purchased
for the processing of Product(s) including the price for purchasing
and installing the equipment, subject to Client's prior approval of
such prices, which shall not be unreasonably withheld.
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4.2 Client shall own equipment paid for by Client pursuant to Section
4.1. Client shall have the right to file such UCC filings as
necessary to establish ownership of such equipment. Xxxxxxxxx-Xxxxx
may purchase such equipment at the termination of this Agreement at
the fair market value of such equipment at that time as mutually
agreed by the Parties.
4.3 Any price associated with the removal of equipment and to return the
facility in serviceable condition shall be borne by Client.
ARTICLE 5
REPRESENTATIONS AND WARRANTIES
5. The Parties agree to the following representations and warranties:
5.1 The Parties represent and warrant to the other as follows:
5.1.1 It has full power and authority to enter into this Agreement
and consummate the transactions contemplated hereby and that
the terms of this Agreement are not inconsistent with other
contractual obligations, expressed or implied, by which it
is bound
5.1.2 It has such permits, licenses, and authorizations of
government or regulatory authorities as are necessary to own
its respective properties, conduct its business and
consummate the transactions contemplated hereby, provided
however, that Client shall be solely responsible for
obtaining all permits, licenses, and authorizations for
Xxxxxxxxx-Xxxxx to process and ship Product(s), except for
securing approval of Xxxxxxxxx-Xxxxx'x facility as a
registered FDA facility, which shall be the responsibility
of Xxxxxxxxx-Xxxxx.
5.1.3 It is not currently under investigation for disbarment
action, debarred, suspended, or otherwise excluded by the
FDA or other Regulatory Authority from conducting business.
5.1.4 All laboratory, scientific, technical and/or other data
submitted by or on behalf of Client or Xxxxxxxxx-Xxxxx, as
the case may be, relating to Product(s) shall, to the best
of their knowledge, be true and correct and shall not
contain any material falsification, misrepresentation or
omission.
5.2 Xxxxxxxxx-Xxxxx represents and warrants to Client as follows:
5.2.1 Product(s) shall be processed in compliance with the Quality
Agreement and all applicable laws.
5.2.2 Product(s), as processed and delivered, shall comply with
specifications and shall not be adulterated or misbranded
within the meaning of the Act or other substantially similar
laws and statutes, provided however that the foregoing shall
not apply to the extent that any such breach is caused by
any materials provided by Client or due to compliance with
any specifications or instructions provided by Client.
5.2.3 The manufacturing facilities for Product(s) shall conform,
and will throughout the term of this Agreement, in all
respects to applicable laws, regulations, and approvals
governing such facility, including, but not limited to, the
cGMP's as defined by 21 Code of Federal Regulation Sections
210, 211, et seq., and will be adequate to produce the
quantities of Product(s) as detailed in the Product
Development Program(s). Xxxxxxxxx-Xxxxx shall implement such
requirements as may be necessary to comply with The Control
of Substance Hazardous to Health (COSHH) Regulations of
1988, consolidated in 1994, amended in 1996, 1997 and 1998
and further consolidated in 1999 in connection with the
performance of its obligations under this Agreement.
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5.2.4 Neither it nor any person employed by it or to be employed
by it to perform the Product Development Program(s) (i) is
presently under any obligation which conflicts with their
duties contemplated hereunder and agrees not to undertake
any project which will conflict with these duties during the
conduct of the Product Development Program(s) or (ii) has a
disqualification hearing pending or has been disqualified by
the FDA pursuant to 21 C.F.R. Section 312.70 or the European
Union equivalent. In the event any of the foregoing occurs,
Xxxxxxxxx-Xxxxx shall immediately notify Client.
5.3 Client represents and warrants to Xxxxxxxxx-Xxxxx as follows:
5.3.1 Client has the full power and authority to grant the license
it grants under this Agreement and neither the granting of
such license nor the exercise by Xxxxxxxxx-Xxxxx of the
rights granted by Client under such license breaches any
obligation to or right of any Third Party.
5.3.2 Neither the Client's Product technology, nor the use thereof
by Xxxxxxxxx-Xxxxx, shall infringe, violate nor
misappropriate any patent, copyright, trademark, trade
secret or other intellectual property of any Third Party.
5.3.3 Any excipients, API's or other materials provided by Client
to Xxxxxxxxx-Xxxxx shall comply with specifications and
shall not be adulterated or misbranded within the meaning of
the Act or other substantially similar laws and statutes.
5.3.4 Client will disclose to Xxxxxxxxx-Xxxxx any information
currently known or learned subsequent to the execution of
this Agreement regarding toxicity, or other known health or
environmental hazards or other safe handling requirements
for the API or Product(s) as the case may be.
5.4 THE WARRANTIES SET FORTH HEREIN ARE THE SOLE AND EXCLUSIVE WARRANTIES
MADE BY EITHER PARTY UNDER THIS AGREEMENT, AND NEITHER PARTY MAKES
ANY OTHER WARRANTIES EXPRESS OR IMPLIED OR ARISING BY LAW, INCLUDING,
BUT NOT LIMITED TO, ANY IMPLIED WARRANTY ARISING FROM THE COURSE OF
PERFORMANCE, COURSE OF DEALING OR USAGE OF TRADE.
5.5 EXCEPT FOR THE INDEMNITY OBLIGATIONS SET FORTH IN THIS AGREEMENT AND
IN THE EVENT OF A BREACH OF THE CONFIDENTIALITY OBLIGATIONS SET FORTH
IN THIS AGREEMENT, UNDER NO CIRCUMSTANCES WILL EITHER PARTY BE LIABLE
TO THE OTHER UNDER ANY CONTRACT, TORT, STRICT LIABILITY, NEGLIGENCE
OR OTHER LEGAL OR EQUITABLE THEORY, FOR COVER OF ANY INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOST PROFITS IN CONNECTION
WITH THE SUBJECT MATTER OF THIS AGREEMENT INCLUDING WITHOUT
LIMITATION THE PRODUCT(S) OR ANY SERVICES PROVIDED IN CONNECTION WITH
THE PRODUCT(S) EXCEPT FOR THE INDEMNITY OBLIGATIONS SET FORTH IN THIS
AGREEMENT.
ARTICLE 6
NONCONFORMING PRODUCT
6. In the event of Client finding the quality of Product(s) is/are not
acceptable in terms of Specifications, Client shall have thirty (30) calendar
days from the date of its receipt of the Product(s) to notify
Xxxxxxxxx-Xxxxx, specifying the respects in which the Product(s) is/are not
acceptable. In the event that Xxxxxxxxx-Xxxxx shall dispute any such
determination by Client, the Parties shall use their best efforts to resolve
the dispute amicably. If the Parties are unable to do so, the matter shall be
referred to an independent laboratory or consultant, mutually agreed to by
both Parties, who's decision shall be final and binding. The Party against
whom the dispute is decided shall pay for any charges for such laboratory or
consultant. Xxxxxxxxx-Xxxxx'x liability will be limited to replacement of the
services provided Client for the lot of product in question.
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ARTICLE 7
PRICE - PAYMENT
7. The Parties agree to the following price and payment provisions:
7.1 The price to be paid by Client for the Product Development Program
shall be defined in the Product Development Program Documents as such
may be amended to this Agreement from time to time.
7.2 Xxxxxxxxx-Xxxxx shall submit invoices to Client reflecting the work
completed in accordance with the applicable milestones described in
the applicable Product Development Program documents. The invoices
shall be sent to the following address:
GlycoGenesys, Inc,
Attention: Accounts Payable
00 Xx. Xxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
7.3 All payments due hereunder to Xxxxxxxxx-Xxxxx shall be sent to
Xxxxxxxxx-Xxxxx by wire transfer of funds via the Federal Reserve
Wire Transfer System to:
Xxxxx Fargo Bank
ABA# 000000000
Beneficiary: Xxxxxxxxx-Xxxxx Laboratories LLC
Account# 4131352601
Swift Code XXXXXX0X
7.4 Client shall pay invoices net thirty (30) calendar days from receipt
of the invoice. All amounts not paid when due shall bear interest
from the due date at the rate of one and one-half percent (1.5%) per
month.
7.5 All prices for Product shall be on the basis of Product being shipped
F.O.B. Xxxxxxxxx-Xxxxx'x plant in Spokane, Washington, under "Freight
Collect" terms. Shipment of Product(s) shall be arranged by Client,
and the price and liability of such shipment borne by Client.
Xxxxxxxxx-Xxxxx shall make up to one (1) shipment per batch or lot at
no additional charge to Client. Any other shipment requested shall be
at a fee of Four Hundred Dollars (US $400) per shipment, plus
shipping price.
ARTICLE 8
CONFIDENTIALITY
8. In carrying out Product Development Program(s) it is recognized by
Xxxxxxxxx-Xxxxx and Client that each may have to disclose to the other
Confidential Information. Since both Parties wish to assume that
Confidential Information is properly protected they hereby agree as follows:
8.1 Form of Disclosure: Confidential Information may be disclosed in
either oral, written or electronic form.
8.2 Obligations: The receiving Party agrees to hold Confidential
Information in strict confidence and to use it only for the purposes
under this Agreement. The receiving Party agrees not to disclose the
Confidential Information to any Third Party unless prior written
authorization has been obtained from the disclosing Party. These
obligations shall not apply to:
8.2.1 Information which, at the time of disclosure, is in the
public domain.
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8.2.2 Information which, after disclosure, becomes part of the
public domain by publication or otherwise, except by breach
of this Agreement by the receiving Party.
8.2.3 Information which the receiving Party can demonstrate by its
written records was in the receiving Party's possession at
the time of the disclosure, and which was not acquired
directly or indirectly, from the disclosing Party.
8.2.4 Information which is lawfully disclosed to the receiving
Party on a non-confidential basis by a Third Party who is
not obligated to the disclosing Party or any other Third
Party to retain such information in confidence.
8.2.5 Information which results from research and development by
the receiving Party independent of such disclosure as shown
by competent evidence.
8.2.6 Information which is required to be disclosed by legal
process, but only that portion of Information which is
legally required to be disclosed; provided, in each case the
Party so required to disclose such Information informs the
other Party as promptly as practicable in order to enable
the other Party to seek a protective order or other
appropriate remedy. The Party required to disclose such
Information shall use its best efforts to limit the
disclosure and maintain confidentiality to the extent
possible. The Party required to disclose such Information
shall give the other Party written notice of any
Confidential Information disclosed pursuant to this Section
8.2.6.
8.3 Both Parties covenant and agree that they have and shall maintain an
appropriate internal program limiting the internal distribution of
Confidential Information to those of its officers, servants, or
agents who require said Confidential Information so that either Party
may use Confidential Information for the purpose set forth in this
Agreement. The Parties may disclose each other's Confidential
Information to third-party consultants but only to the extent that
they require access to Confidential Information in order to enable
each other to carry out the purpose of this Agreement. The Parties
covenant and agree that before making any Confidential Information
available to said officers, servants, agents, or third-party
consultants, they shall inform such parties of the confidential
nature of such information and obtain their agreement to be bound by
obligations of confidentiality and non-use which are equivalent to or
greater than those set forth in this Agreement. The receiving Party
agrees to promptly notify the disclosing Party in writing if it
becomes aware of a breach of this Article 8 by it or any party to
whom it disclosed Confidential Information pursuant to this Section
8.3.
8.4 The receiving Party hereby acknowledges that disclosure or use of
Confidential Information may result in irreparable harm to the
disclosing Party. Accordingly, the receiving Party agrees that the
disclosing Party shall have the right to seek equitable relief,
including without limitation an injunction or temporary restraining
order, in the event of any actual or threatened breach of this
Article 8.
8.5 Upon the written request of the disclosing Party, Confidential
Information in tangible or electronic form received by the receiving
Party from the disclosing Party shall, at the disclosing Party's sole
option and expenses either be destroyed or immediately returned and
the receiving Party shall provide written certification that all
copies of Confidential Information have been destroyed or returned;
provided, however the receiving Party may maintain a single copy of
the Confidential Information and its work product containing
Confidential Information solely for the purposes of monitoring or
demonstrating its compliance with this Agreement or applicable laws
or regulations.
ARTICLE 9
INDEMNIFICATION
9. The Parties agree to the following Indemnification clauses:
9.1 Indemnification by Client: Client shall indemnify, defend and hold
Xxxxxxxxx-Xxxxx, its Affiliates and their respective directors,
officers, employees, agents, successors and assigns harmless from and
against any
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damages, judgements, claims, suits, actions, liabilities, costs and
expenses (including, but not limited to, reasonable attorneys' fees)
resulting from any Third Party claims or suits arising solely out of
(1) the use, handling, distribution, marketing or sale of the
Product(s) except to the extent caused by Xxxxxxxxx-Xxxxx'x negligent
acts or omissions or willful misconduct in its performance of the
Product Development Program(s) or the manufacture or bulk packaging
of the Product(s), (2) Client's uncured material breach of any of its
warranties or representations hereunder, or (3) Client's grossly
negligent acts or omissions or willful misconduct.
9.2 Indemnification by Xxxxxxxxx-Xxxxx: Except as otherwise provided in
Section 9.1 above, Xxxxxxxxx-Xxxxx shall indemnify, defend and hold
Client, its Affiliates and their respective directors, officers,
employees, agents, successors and assigns harmless from and against
any damages, judgements, claims, suits, actions, liabilities, costs
and expenses (including, but not limited to, reasonable attorneys'
fees) resulting from any Third Party claims or suits arising solely
out of (1) Xxxxxxxxx-Xxxxx'x material breach of any of its warranties
or representations hereunder or (2) Xxxxxxxxx-Xxxxx'x grossly
negligent acts or omissions or willful misconduct in its performance
of the Product Development Program(s) or the manufacture or bulk
packaging of the Intermediate(s) and Product(s).
9.3 Indemnification Procedures:
9.3.1 Any Party hereto seeking indemnification hereunder (in this
context the "Indemnified Party") shall notify the other
Party (in this context the "Indemnifying Party") in writing
reasonably promptly after the assertion against the
Indemnified Party any claim or suit by a Third Party (a
"Third Party Claim") in respect of which the Indemnified
Party intends to base a claim for indemnification hereunder.
9.3.2 (1) The Indemnifying Party shall have the right, upon
written notice given to the Indemnified Party within thirty
(30) calendar days after receipt of the notice from the
Indemnified Party of any Third Party Claim, to assume the
defense and handling of such Third Party Claim, at the
Indemnifying Party's sole expense, in which case the
provisions of Section 9.3.2 (2) below shall govern. (2) The
Indemnifying Party shall select counsel reasonably
acceptable to the Indemnified Party in connection with
conducting the defense and handling of such Third Party
Claim, and the Indemnifying Party shall defend or handle the
same in consultation with the Indemnified Party, and shall
keep the Indemnified Party appraised of the status of the
Third Party Claim. The Indemnifying Party shall not, without
the prior written consent of the Indemnified Party, which
consent will not be unreasonably withheld, agree to a
settlement of any Third Party Claim that could directly or
indirectly lead to liability or create any financial or
other obligation on the part of the Indemnified Party for
which the Indemnified Party is not entitled to
indemnification hereunder. The Indemnified Party shall
cooperate with the Indemnifying Party and shall be entitled
to participate in the defense or handling of such Third
Party Claim with its own counsel at its own expense.
9.3.3 (1) If the Indemnifying Party does not give written notice
to the Indemnified Party, within thirty (30) calendar days
after receipt of the notice from the Indemnified Party of
any Third Party Claim, of the Indemnifying Party's election
to assume the defense or handling of such Third Party Claim,
the provisions of Section 9.3.3 (2) below shall govern. (2)
The Indemnified Party may, at the Indemnifying Party's
expense, select counsel in connection with conducting the
defense or handling of such Third Party Claim and defend or
handle such Third Party Claim in such manner as it may deem
appropriate, provided, however, that the Indemnified Party
shall keep the Indemnifying Party timely appraised of the
status of such Third Party Claim and shall not settle such
Third Party Claim without the prior written consent of the
Indemnifying Party, which consent shall not be unreasonably
withheld. If the Indemnified Party defends or handles such
Third Party Claim, the Indemnifying Party shall cooperate
with the Indemnified Party and shall be entitled to
participate in the defense or handling of such Third Party
Claim with its own counsel and at its own expense.
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9.3.4 If the Indemnified Party intends to seek indemnification
hereunder, other than for a Third Party Claim, then it shall
notify the Indemnifying Party in writing within three (3)
months after its discovery of facts upon which it intends to
base its Claim for indemnification hereunder; provided,
however, the failure to timely give such notice shall limit
the Indemnifying Party's liability for indemnification only
to the extent the Indemnifying Party's defense of such
matter has been prejudiced.
9.3.5 Except with regard to fraud or pursuant to Section 8.4, the
indemnification remedies in this Article 9, enforced in
accordance with Section 9.3, shall constitute the sole and
exclusive remedies of the Parties with respect to any
matters arising under or relating to this Agreement.
9.4 Survival of Indemnification Obligations: The provisions of this
Article 9 shall survive the expiration or termination of this
Agreement for a period of five (5) years.
9.5 Limitation of Liability and Claims: Neither Party shall be liable to
the other Party for indirect, special, punitive, or consequential
damages of any kind, including without limitation lost profits or
loss of good will or otherwise. Neither Party's liability to the
other under this Agreement shall exceed Five Million Dollars
($5,000,000).
9.6 Insurance: Both Client and Xxxxxxxxx-Xxxxx shall obtain and maintain,
either itself or through one or more of its affiliates, with
reputable carriers, product liability insurance with limits of not
less than Five Million Dollars ($5,000,000) per claim/annual
aggregate by no later than the scheduled manufacturing date for the
first Batch of Product(s) delivered as part of the first Product
Development Program(s) conducted under this Agreement. In addition,
Xxxxxxxxx-Xxxxx shall maintain commercial general liability insurance
including premises and operations coverage of not less than
$1,000,000 per occurrence and $2,000,000 per accident and property
damages liability insurance of not less than $1,000,000 per
occurrence and $1,000,000 per accident. Each Party hereto shall have
its insurance carrier(s) furnish the other Party hereto with a
certificate that such insurance is in force. In the event of any
proposed cancellation, non-renewal, or material adverse change in
such coverage, the other Party hereto shall be given at least thirty
(30) calendar day's advance written notice thereof.
ARTICLE 10
TERM AND TERMINATION
10. The Parties agree to the following Term and Termination clauses:
10.1 Term: This Agreement shall remain in full force and effect until
terminated in accordance with the provisions of this Article.
10.2 Termination by Mutual Agreement: This Agreement may be terminated,
on a Product Development Program by Product Development Program basis
or in its entirety, at any time upon mutual written agreement between
the Parties.
10.3 Termination for Default: This Agreement may be terminated by either
Party in the event of material breach or default by the other Party
of the terms and conditions hereof; provided, however, the other
Party shall first give to the defaulting Party written notice of the
proposed termination or cancellation of this Agreement, specifying
the grounds therefor. Upon receipt of such notice, with respect to
such defaults as are capable of being cured, the defaulting Party
shall have forty-five (45) calendar days to respond by curing such
default. If the breaching Party does not respond or fails to work
diligently to cure such breach within the additional time set forth
above, then the other Party may either suspend the Agreement
indefinitely or terminate the Agreement. Termination of this
Agreement pursuant to this Section 10.3 shall not affect any other
rights or remedies which may be available to the nondefaulting Party.
10.4 Bankruptcy; Insolvency:
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10.4.1 Either Party may terminate this Agreement upon the
occurrence of any of the following with respect to the other
Party:
10.4.1.1 The entry of a decree or order for the relief by a
court having jurisdiction in the premises in
respect of such other Party in an Involuntary case
under the Federal Bankruptcy Code, as now
constituted or hereafter amended, or any other
applicable federal or state insolvency or other
similar law and the continuance of any such decree
or order unstayed and in effect for a period of
sixty (60) consecutive calendar days;
10.4.1.2 The filing of such other Party of a petition for
relief under the Federal Bankruptcy Code, as now
constituted or hereafter amended, or by any other
applicable federal or state insolvency or other
similar law, or;
10.4.1.3 The failure of such other Party to pay its debts
when due.
10.4.2 Xxxxxxxxx-Xxxxx shall notify Client of its intent to file
for protection under the Federal Bankruptcy Code as soon as
such a determination is made. Xxxxxxxxx-Xxxxx will segregate
all Client-related documents, including, but not limited to,
manufacturing and analytical equipment protocols,
qualifications, procedures, methods, calibrations reports
and/or certificates, Specifications, Manufacturing
Procedures, Intermediate and Product analytical data,
Xxxxxxxxx-Xxxxx facility documentation in support of Product
Development Programs; all Client provided manufacturing and
analytical testing equipment, including any equipment
purchased by Client for Xxxxxxxxx-Xxxxx in conjunction with
Product Development Programs; all unconsumed raw materials
provided by Client to Xxxxxxxxx-Xxxxx in conjunction with
Product Development Programs; and all Product Batches,
including stability samples, that were produced in
accordance with Product Development Programs.
Xxxxxxxxx-Xxxxx will provide Client complete and total
access to these materials at Client's request.
10.5 Rights and Duties Upon Termination:
10.5.1 Upon termination of this Agreement, Xxxxxxxxx-Xxxxx shall,
promptly as practicable, cease work on Product Development
Programs and turn over to Client all results, documentation
and information obtained during Product Development Programs
(whether in written or electronic form) and all Product
Batches, including stability samples, as well as all
unconsumed raw materials provided by Client which are then
in Xxxxxxxxx-Xxxxx'x possession and which are the property
of Client in accordance with this Agreement.
10.5.2 Upon termination of this Agreement, Client shall remain
liable for all fees, expenses, and uncancellable obligations
incurred hereunder through the date of such termination.
ARTICLE 11
FORCE MAJEURE/DISPUTE RESOLUTION
11. The Parties agree to the following Force Majeure/Dispute Resolution
clauses:
11.1 Effect of Force Majeure: Neither Party shall be held liable or
responsible for any loss or damages resulting from any failure or
delay in its performance due hereunder (other than payment of money)
caused by force majeure. As used herein, force majeure shall be
deemed to include any condition beyond the reasonable control of the
affected Party including, without limitation, war, riot, earthquake,
tornado, hurricane, flood or other natural disasters, fire, civil
disorder, explosion, accident, sabotage, lack of or inability to
obtain adequate fuel, power, materials, labor, containers,
transportation, supplies or equipment, compliance with governmental
requests, laws, rules, regulations, orders or actions; inability
despite best efforts to renew operating permits or licenses from
local, state or federal governmental authorities; breakage or failure
of machinery or apparatus; national defense requirements; or supplier
strike, lockout or injunction. Xxxxxxxxx-Xxxxx shall notify Client of
any
11
foreseeable force majeure events, including, but not limited to,
shipping interruptions or problems, and inability to procure supplies
necessary for Xxxxxxxxx-Xxxxx to perform any of its obligations under
this Agreement.
11.2 Notice of Force Majeure: In the event either Party is delayed or
rendered unable to perform due to force majeure, the affected Party
shall give notice of the same and its expected duration to the other
Party promptly after the occurrence of the cause relied upon, and
upon the giving of such notice the obligations of the Party giving
the notice will be suspended during the continuance of the force
majeure; provided, however, such Party shall take commercially
reasonable steps to remedy or mitigate the force majeure with all
reasonable dispatch.
11.3 Dispute Resolution: The Parties hereto agree to perform the terms of
this Agreement in good faith, and to attempt to resolve any
controversy, dispute or claim arising hereunder in good faith. Any
dispute regarding the validity, construction, interpretation, or
performance of this Agreement (other than provisions, hereof relating
to any intellectual property rights, or the confidentiality
obligations contained in Article 8 hereof) shall be (1) first
attempted to be resolved between the CEO/President of each Party and
failing that (2) submitted to binding arbitration in Seattle,
Washington, U.S.A. to be conducted in accordance with the Arbitration
Rules of the American Arbitration Association ("AAA"); provided,
however, that nothing in this Section 11.3 shall be construed to
preclude either Party from seeking provisional remedies, including,
but not limited to, temporary restraining orders and preliminary
injunctions, from any court of competent jurisdiction, in order to
protect its rights pending arbitration, but such preliminary relief
shall not be sought as a means of avoiding arbitration. Any
arbitration hereunder shall be submitted to an arbitration tribunal
made up of three (3) members, one of whom shall be selected by
Client, one of whom shall be selected by Xxxxxxxxx-Xxxxx, and one of
whom shall be selected by the other two arbitrators. All arbitration
proceedings shall be conducted in English. The order or award of the
arbitrators shall be final and may be enforced in any court of
competent jurisdiction. The prevailing Party in any legal or
arbitration action brought by one Party against the other Party shall
be entitled, in addition to any other rights and remedies it may
have, to reimbursement for its expenses incurred thereby, including
court cost and reasonable attorney's fees. The Parties shall have the
right of limited prehearing discovery, including:
11.3.1 exchange of witness lists;
11.3.2 exchange of documentary evidence and reasonably related
documents;
11.3.3 written interrogations; and
11.3.4 subject to reasonable discretion of the arbitrators and upon
good cause shown dispositions under oath of any witnesses
who are to be called to testify at the arbitration hearing.
11.4 As soon as the discovery is concluded, the arbitrators shall hold a
hearing in accordance with the aforesaid AAA rules.
ARTICLE 12
NOTICES
12. All notices provided herein shall be in writing and shall be deemed to be
delivered when deposited in the United States mail, postage prepaid, or
hand-delivered to an authorized representative of the Party to whom notice
is directed, or sent by facsimile, or express service courier, charges
prepaid, to the address of the other Party designated below:
Client
GlycoGenesys, Inc.
00 Xx. Xxxxx Xxxxxx
Xxxxxx, XX 00000
Attention: Xxxx Xxxxxxx
FAX: (000) 000-0000
Xxxxxxxxx-Xxxxx
Xxxxxxxxx-Xxxxx Laboratories LLC
0000 Xxxxx Xxxxx Xxxxxx
Xxxxxxx, XX 00000
Attention: Xxxxxxx X. Xxxxxxxxx
FAX: (000) 000-0000
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The addresses and persons provided above may be changed by either Party by
providing the other Party with written notice of such change.
ARTICLE 13
MISCELLANEOUS
13. The Parties agree to the following Miscellaneous clauses:
13.1 Entire Agreement: This Agreement, attachments and exhibits contain
the entire understanding between the Parties with respect to the
subject matter hereof, and may be modified, only by a written
instrument duly executed by each Party's authorized representative.
13.2 Independent Contractor: Nothing herein shall create any equity
association, partnership, joint venture, or ownership relation of
principal and agent between the parties hereto, it being understood
that Client is purchasing Xxxxxxxxx-Xxxxx services as an independent
company, and neither Party shall have the authority to bind the other
party or the other's representatives in any way.
13.3 Publicity: Except as explicitly set forth below in Section 13.4, any
press release, publicity or other form of public written disclosure
related to this Agreement prepared by one Party shall be submitted to
the other party prior to release for written approval, which approval
shall not be unreasonably withheld or delayed by such other Party.
13.4 Use of Party's Name: Except as expressly provided or contemplated
hereunder and except as otherwise required by applicable law, no
right is granted pursuant to this Agreement to either Party to use in
any manner the trademarks or name of the other Party, or any other
trade name, service xxxx, or trademark owned by or licensed to the
other Party in connection with the performance of the Agreement. To
the extent required by applicable law, the Parties shall be permitted
to use the other Party's name and disclose the existence and terms of
this Agreement in connection with required public regulatory
fillings, public securities filings and private placement memoranda
and documentation, using reasonable commercial efforts to protect the
confidentiality of the terms of this Agreement.
13.5 Severability: Each Party hereby expressly agrees that it has no
intention to violate any public policy, statutory or common laws,
rules, regulations, treaty or decision of any government agency or
executive body of any country or community or association of
countries; that if any word, sentence, paragraph, clause or
combination thereof in this Agreement is found by a court or
executive body with judicial powers having jurisdiction other this
Agreement or either Party hereto, in a final unappealed order, to be
in violation of any such provisions in any country or community or
association of countries, such words, sentences, paragraphs, clauses
or combination shall be inoperative in such country or community or
association of countries and the remainder of this Agreement shall
remain binding upon the Parties, so long as enforcement of the
remainder does not violate the Parties' overall intentions in this
transaction.
13.6 Assignment; Subcontractors: This Agreement may not be assigned or
otherwise transferred by either Party without the prior written
consent of the other Party; provided, however, either Party may,
without such consent, assign this Agreement
13.6.1 in connection with the transfer or sale of all or
substantially all of the assets or voting securities of such
Party or the line of business of which this Agreement forms
a part,
13.6.2 in the event of a merger or consolidation of a Party hereto
with another company or to any Affiliate of the assigning
Party fully capable of performing hereunder.
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Any purported assignment in violation of the proceeding shall be
void. Any permitted assignee shall assume all obligations of its
assignor under this Agreement. No assignment shall relieve either
Party of responsibility for the performance of any obligation which
accrued prior to the effective date of such assignment.
13.7 Governing Law: This Agreement shall be governed by and construed in
accordance with the laws of the state of Washington, irrespective of
any conflicts of law rule which may direct or refer such
determination of applicable law to any other state; and if this
Agreement were performed wholly within the state of Washington.
13.8 Headings: Paragraph headings and captions used herein are for
convenience of reference only and shall not be used in the
construction or interpretation of this Agreement.
13.9 Continuing Obligations: Termination, assignment or expiration of this
Agreement shall not relieve either Party from full performance of any
obligations incurred prior thereto.
13.10 Waiver: Neither Party's waiver of any breach or failure to enforce
any of the terms and conditions of this Agreement, at any time, shall
not in any way affect, limit or waive such Party's right thereafter
to enforce and compel strict compliance with every term and condition
of this Agreement.
13.11 Construction: This Agreement has been jointly prepared on the basis
of the mutual understanding of the Parties and shall not be construed
against either Party by reason of such Party's being the drafter
hereof or thereof.
13.12 Exhibits, Schedules and Attachments: Any and all exhibits, schedules
and attachments referred to herein form an integral part of this
Agreement and are incorporated into this Agreement by such reference.
13.13 Specially Regulated Waste: The prices associated with the removal of
Specially Regulated Waste shall be borne by Client. Client will be
notified of the determination of Specially Regulated Waste and
advised of the price for destruction of said waste.
IN WITNESS WHEREOF, this Agreement has been executed by the Parties as of the
day and year first written above.
FOR: XXXXXXXXX-XXXXX LABORATORIES LLC FOR: GLYCOGENESYS, INC.
/s/ Xxxxxxx Xxxxxxxxx /s/ Xxxx Xxxxxxx
------------------------------ --------------------------------
Signature Signature
Xxxxxxx X. Xxxxxxxxx, Ph. D. Xxxx X. Xxxxxxx, MBA, Ph.D.
------------------------------ --------------------------------
Printed Name Printed Name
President and CEO VP Development and Manufacturing
------------------------------ --------------------------------
Title Title
January 16, 2003 January 16, 2003
------------------------------ --------------------------------
Date Signed Date Signed
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Exhibit A
Attachment 1
GCS-100
Product Development Program
A-1
EXHIBIT B
Quality Systems Agreement
B-1
