Contract Manufacturing Agreement - ICOS Corp. and Seattle Genetics Inc.
CONTRACT MANUFACTURING AGREEMENT
This CONTRACT MANUFACTURING AGREEMENT (the "Agreement") is entered into
as of January 3, 2003 (the "Effective Date"), by and between ICOS Corporation
("ICOS"), a corporation organized and existing under the laws of the State of
Delaware and having its principal place of business at 22021 20/th/ Avenue S E,
Bothell, WA 98021 USA and Seattle Genetics, Inc. ("SGI"), a corporation
organized and existing under the laws of the State of Delaware and having its
principal place of business at 21823 30th Drive S.E., Bothell, WA 98021.
RECITALS
WHEREAS, ICOS is in the business of manufacturing and testing
pharmaceutical products; and
WHEREAS, SGI is the proprietor of a certain DNA known as SGN-30
encoding a monoclonal antibody also known as SGN-30; and
WHEREAS, ICOS has expertise in the development, evaluation and
production of monoclonal antibodies for therapeutic use using cell lines; and
WHEREAS, subject to the terms and conditions set forth in this
Agreement, SGI wishes to have ICOS manufacture for SGI a pre-commercial
pharmaceutical Product (hereinafter defined); and
WHEREAS, subject to the terms and conditions set forth in this
Agreement, ICOS wishes to manufacture Product for SGI.
NOW, THEREFORE, the parties hereto, intending to be legally bound,
hereby agree as follows:
1. Definitions
For purposes of this Agreement, the following terms will have the
meanings set forth below:
1.1 "Affiliates" means, with respect to any Person, another Person
that, directly or indirectly, controls, is controlled by or is under common
control with such Person. The term "control" means the possession, directly or
indirectly, of the power to direct or cause the direction of the management and
policies of a Person, whether through the ownership of voting securities, by
contract or otherwise. The direct or indirect ownership of at least fifty
percent (50%) or, if smaller, the maximum allowed by applicable law, of the
voting securities of a business entity or of an interest in the assets, profits
or earnings of a Person shall be deemed to constitute "control" of the Person.
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1.2 "Applicable Laws" means all ordinances, rules and regulations of
any kind whatsoever of any governmental or regulatory authority, including,
without limitation, the FDCA, that are applicable with respect to the context in
which the term is used.
1.3 "Audit" means a [***] audit pursuant to which SGI or their
appointed representatives (such representatives to be reasonably acceptable to
ICOS) may (a) review the processes, procedures and documents of ICOS that are
used or maintained by ICOS to provide the Services, (b) assess of ICOS'
compliance with cGMP, Applicable Laws and quality assurance standards associated
with performing the Services, and (c) discuss any related issues with ICOS'
personnel and management involved in performing the Services.
1.4 "Calendar Quarter" means the three-month period ending on March
31, June 30, September 30 or December 31. The initial Calendar Quarter will be
deemed to begin on the Effective Date and end on the first to occur of March 31,
June 30, September 30 or December 31 of such same year.
1.5 "Calendar Year" means the twelve (12) month period ending on
December 31. The initial Calendar Year will be deemed to begin on the Effective
Date and end on December 31 of such same year.
1.6 "Cell Line" means a [***] known as [***], which has been [***]
with a [***] containing certain SGI Materials as described in Appendix B, and
will be used to provide the Services herein. Any cell bank provided containing
the transfected cell line will always be subject to the license granted under
Appendix G herein.
1.7 "cGMP" means Good Manufacturing Practices and General Biologics
Products Standards as promulgated under the FDCA.
1.8 "Damages" means any and all [***] costs, losses, claims, actions,
liabilities, fines, penalties, costs and expenses, court costs, and [***] fees
and disbursements of counsel, consultants and expert witnesses incurred by a
party hereto (including interest which may be imposed in connection therewith).
1.9 "FDA" means the United States Food and Drug Administration, any
comparable agency in any Foreign Jurisdiction, and any successor agency or
entity to any of the foregoing that may be established hereafter.
1.10 "FDCA" means the Federal Food, Drug and Cosmetic Act (21 U.S.C.
(S).301 et seq.).
1.11 "Foreign Jurisdiction" means any jurisdiction, not governed by the
United States or any political subdivision thereof, as agreed upon by the
parties.
1.12 "ICOS Know-How" means unpatented and/or unpatentable technical
information, including ideas, concepts, inventions, discoveries, data, designs,
formulas, specifications, procedures for experiments and tests and other
protocols, results of experimentation and testing, fermentation and purification
techniques, and assay protocols owned by ICOS as of the Effective
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Date which may be necessary for the performance of the Services. All ICOS
Know-How shall be Confidential Information of ICOS.
1.13 "ICOS Patent Rights" mean the patent applications and patents
listed on Exhibit A to Appendix G hereto and all divisions, continuations,
continuations-in-part, and substitutions thereof; all foreign patent
applications corresponding to the preceding applications; and all U.S. and
foreign patents issuing on any of the preceding applications, including
extensions, reissues, and re-examinations.
1.14 "IND" means an Investigation New Drug application or any
comparable application required by a Foreign Jurisdiction filed for the Product
by SGI with the FDA and all subsequent submissions, supplements or amendments
related thereto.
1.15 "Manufacturing Specifications" means the specifications for
manufacturing the Product. Prior to the initiation of the first cGMP
manufacturing run, an Appendix C-1 signed by both parties setting forth the
initial Manufacturing Specifications shall be appended to this Agreement and
shall contain at a minimum a collection of documents containing certain
specifications, procedures, assay methods (QC Release Tests), personnel contacts
and any other information as may be needed and agreed by the parties relating to
the manufacture of Product by ICOS for SGI. This Appendix C-1 shall also contain
a statement to be agreed and acknowledged by ICOS and SGI that SGI adopts the
initial Manufacturing Specifications as its own specification in conformance
with Clause 6.7 herein. Any changes or additions to the Manufacturing
Specifications shall be made by the written agreement of ICOS and SGI.
1.16 "NDA" means New Drug Application or any comparable application
required by a Foreign Jurisdiction filed for the Product by SGI with the FDA and
all subsequent submissions, supplements or amendments related thereto.
1.17 "Person" means a natural person, a corporation, a partnership, a
trust, a joint venture, a limited liability company, any governmental authority
or any other entity or organization.
1.18 "Price" means the price specified in Appendix E for the
Services.
1.19 "Process" means the process for the production of the Product from
the Cell Line using the Manufacturing Specifications, including any improvements
thereto from time to time made as a result of the Services.
1.20 "Product" means a monoclonal antibody derived from the Cell Line
manufactured by ICOS utilizing the Process, and incorporating technology
licensed to SGI from ICOS pursuant to the license agreement previously entered
into by the parties in the form set forth in Appendix G.
1.21 "Product Specifications" means the product specifications listed
under the column "Acceptance Criteria" as listed in Appendix C.
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1.22 "Services" means all or any part of the services to be provided by
ICOS (or any permitted subcontractor) for the benefit of SGI pursuant to this
Agreement as further described in Appendix A.
1.23 "SGI Patent Rights" means all patents and patent applications of
any kind throughout the world relating to the Process which from time to time
SGI is the owner of or is entitled to use.
1.24 "SGI Information" means all confidential and proprietary technical
information not in the public domain relating to the Cell Line, the Process and
the Product, from time to time supplied by SGI to ICOS, or arranged by SGI to be
supplied by a third party (such as a prior manufacturer) to ICOS.
1.25 "SGI Materials" means the Materials supplied by SGI to ICOS (if
any) and identified as such by Appendix B hereto.
1.26 "SGI Technology" means the SGI Patent Rights and SGI Information
necessary to manufacture the Product.
1.27 "SGI Tests" means the tests to be carried out on the Product
immediately following receipt of the Product by SGI, particulars of which are
set out in Appendix C.
1.28 "Terms of Payment" means the terms of payment specified in
Section 5 and Appendix E.
1.29 "Testing Laboratories" means any third party instructed by ICOS to
carry out tests on the Cell Line or the Product.
1.30 "United States" means the fifty (50) states, the District of
Columbia and all of the territories of the United States of America.
2. Supply by SGI
2.1 Prior to or immediately following the Effective Date of this
Agreement SGI shall supply to ICOS SGI Information, together with full details
of any known hazards relating to SGI Materials with respect to their storage and
use. On review of this SGI Information and details SGI Materials shall be
provided to ICOS at ICOS's request when ICOS has satisfactorily determined that
SGI Materials do not pose a hazard to ICOS. SGI shall assist ICOS in making such
determination, but [***]. All property rights in the SGI Technology and/or SGI
Materials supplied to ICOS shall remain vested in SGI.
2.2 SGI hereby grants ICOS the non-exclusive right to use the SGI
Materials and SGI Technology for the sole purpose of providing the Services.
ICOS hereby undertakes not to use SGI Materials or SGI Technology (or any part
thereof) for any other purpose.
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2.3 ICOS shall:
2.3.1 at all times use all reasonable efforts to keep the SGI
Materials secure and safe from loss or damage but in no case in a lesser manner
than ICOS stores its own material of similar nature;
2.3.2 not transfer to a third party any part of the SGI
Materials or the Product, except for the purpose of any tests at the Testing
Laboratories, provided, that, SGI is given prior notification or if SGI has
given prior written consent to such transfer; and
2.3.3 provide that such Testing Laboratories are subject to
obligations of confidence materially in the form of those obligations of
confidence imposed on ICOS under this Agreement.
2.4 SGI warrants to ICOS that SGI is and shall at all times
throughout the duration of this Agreement remain entitled to supply the SGI
Materials and SGI Technology to ICOS for the performance of the Services.
2.5 SGI warrants that the use by ICOS of SGI Materials and SGI
Technology for the Services will not infringe or is not alleged to infringe any
rights (including, without limitation, any intellectual or other proprietary
rights) vested in any third party.
2.6 SGI shall indemnify, defend and hold harmless ICOS against any
loss, damage, costs and expenses of any nature (including court costs and legal
fees incurred by ICOS or ordered as payable by ICOS), whether or not foreseeable
or in the contemplation of ICOS or SGI, that ICOS may suffer as a result of any
third party claims, suits or actions arising out of or incidental to (a) any
breach of the warranties given in Clauses 2.4 and 2.5 above, (b) the
distribution or use of the Product, except to the extent such loss, damage,
costs and expenses are caused by ICOS's gross negligence or willful misconduct,
or (c) any claims by third parties alleging ICOS's use of the Cell Line, SGI
Materials, SGI Technology or the Manufacturing Specifications infringes any
rights (including, without limitation, any intellectual or other proprietary
rights) vested in any third party (whether or not SGI knew or should have known
about such alleged infringement) except to the extent ICOS infringes any rights
of any third parties by application of its production techniques while
performing the Services unless such application or production technique has been
developed as part of the Services. For the purposes of Clauses 2.6 and 2.7, the
term, production technique(s), is limited to all and any physical arrangement
and use of plant and equipment in the provision of Services.
2.7 ICOS shall indemnify, defend and hold harmless SGI against any
loss, damage, costs and expenses of any nature (including court costs and legal
fees incurred by SGI or ordered as payable by SGI), whether or not foreseeable
or in the contemplation of SGI or ICOS, that SGI may suffer as a result of any
third party claims, suits or actions arising from ICOS's performance of the
Services except to the extent the loss or damage is a result of (a) SGI's gross
negligence or willful misconduct or (b) ICOS's use of an application or
production technique that has been developed as part of the Services for SGI or
is supplied by SGI. For the avoidance of doubt where ICOS's application or
production techniques, existed prior to the Effective Date, are not
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developed as part of the Services hereto and whether or not included in the
Manufacturing Specifications, then they are covered by ICOS's undertaking of
indemnity and hold harmless.
2.8 Notwithstanding the above, ICOS shall be at liberty to use SGI
Information as it sees fit in providing the Services subject to nondisclosure
pursuant to Section 7.
2.9 The obligations of each party under this Section 2 shall survive
the termination of this Agreement for whatever reason.
3. Provision of the Services
3.1 ICOS shall diligently perform the Services as provided in Appendix
A and shall use all reasonable commercial efforts to achieve the estimated
schedules, specifications and amounts of Product. Furthermore, ICOS shall keep
SGI regularly informed of any changes to the estimated schedules for performance
of the Services and provide a monthly report, in a form agreed by the parties.
3.2 With respect to all services provided by ICOS from time to time
that are agreed upon by the Parties but are listed on Appendix A as Additional
Services ("Additional Services"), SGI shall pay to ICOS an [***] of [***]. ICOS
will invoice SGI monthly for all Additional Services performed, with each such
invoice containing a reference to the services performed and the personnel used.
All such invoices will be payable under the terms described in Section 5.
3.3 Except as set forth in Section 8.2, due to the unpredictable nature
of the biological processes involved in the Services, the schedules set down for
the performance of the Services (including, without limitation, the dates for
production and delivery of Product) set out in Appendix D are estimates only.
3.4 The parties acknowledge that ICOS will ship each batch of cGMP
Product as soon as possible upon ICOS' completing the manufacture (including,
without limitation, the completion of all QA/QC tests) of such batch. Risk of
loss for Product shipped shall pass to SGI upon [***]; provided, however, that
[***]. Unless the parties agree otherwise, ICOS shall on behalf of and in
consultation with SGI (a) arrange for the transportation of Product, which shall
be made at the sole risk and expense of SGI and (b) pay shipping costs and be
reimbursed by SGI. In addition to reimbursing ICOS for the shipping costs, SGI
shall be responsible to ICOS for the payment of fees for Additional Services (as
set forth in Section 3.2) associated with arranging for the transportation of
the Product.
3.5 Unless otherwise agreed, ICOS shall package and label Product for
delivery in accordance with its standard operating procedures. It shall be the
responsibility of SGI to provide prior written notice to ICOS of any special
packaging and labeling requirements for Product. All additional costs and
expenses (including reasonable profit) of whatever nature incurred by ICOS in
complying with such special requirements shall be charged to SGI in addition to
the Price.
3.6 Upon completion of the Services, or as soon thereafter as can be
mutually agreed, ICOS will deliver to SGI a cell bank, generated by ICOS,
comprised of the Cell Line and used to provide the Services herein.
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3.7 Joint Communication on Manufacturing: ICOS and SGI shall
communicate and cooperate on a regular basis during the provision of Services
herein and in the event that the parties observe the need for a regular and
active committee, such body shall be established and meet regularly to discuss
and communicate the progress of the Services.
3.8 ICOS shall provide SGI, at SGI's expense, with all documents SGI
reasonably requests regarding ICOS' performance of the Services and conducting
the Process of manufacturing the Product; provided, however, in the event that
SGI requests any documentation beyond that which ICOS is expressly required to
maintain pursuant to this Agreement, or which is otherwise already prepared by
ICOS and related to the Products or the Process, SGI shall be responsible to
ICOS for the payment of fees for Additional Services as set forth in Section
3.2.
3.9 Once during this Agreement upon at least [***] ([***]) [***] prior
notice to ICOS, SGI shall have the right to have SGI representatives visit ICOS'
manufacturing facilities during normal business hours to conduct an Audit.
Notwithstanding the foregoing notice period, for purposes of confidentiality,
safety and to avoid the possibility of contamination, if a third party's product
is being produced during the time that SGI intends to conduct an Audit, such
Audit may be reasonably delayed upon prior written notice to SGI. The form,
participants and procedures of the Audit shall be subject to ICOS' reasonable
approval. When conducting an Audit, each of SGI's representatives will (a) be
subject to a nondisclosure obligation comparable in scope to Section 7, (b)
follow such security and facility access procedures as are reasonably designated
by ICOS, (c) be accompanied by an ICOS representative, (d) not enter areas of
any ICOS facility at times when any third party's products are being
manufactured to assure protection of ICOS' or third party confidential
information, and (e) use good faith efforts to avoid disrupting ICOS'
operations. In addition to an Audit, ICOS agrees to reasonably cooperate with
all regulatory authorities and shall submit to reasonable Product-specific
inspections by such authorities ("Regulatory Inspection"). Any Audits by SGI or
Regulatory Inspections in excess of one during this Agreement shall be [***]
([***]) [***] prior written notice. SGI shall pay to ICOS fees for all Audits by
SGI and Regulatory Inspections as Additional Services pursuant to Section 3.2.
4. SGI Tests and Return Procedures
4.1 Except where SGI has accepted ICOS Product tests and provided
written notice to ICOS of such acceptance, promptly following delivery of
Product or a sample of Product (if such sample is requested by SGI), SGI shall
carry out SGI Tests. If SGI Tests show that the Product fails to meet Product
Specifications due to ICOS failing to meet its obligations hereunder, SGI shall
give ICOS written notice thereof as soon as practicable but in no case later
than [***] ([***]) [***] from the date SGI takes delivery of the Product (or
sample of the Product, if applicable) and shall return such Product (or sample)
to ICOS's premises for further testing. In the absence of such written notice
Product shall be deemed to have been accepted by SGI as meeting Product
Specifications. If ICOS agrees that Product is Nonconforming Product, it shall
at SGI's discretion replace such Product at its own cost and expense, subject to
Section 4.3. "Nonconforming Product" means any Product that has been delivered
to SGI but fails to meet Product Specifications, and such failure is not due (in
whole or in part) to (a) acts or omissions of SGI, (b) [***], or (c) any third
party after delivery of such Product to SGI.
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FOR THE AVOIDANCE OF DOUBT, WHERE THE SPECIFICATION HAS NOT BEEN AGREED
BY THE PARTIES HERETO ICOS SHALL BE OBLIGED ONLY TO USE ITS REASONABLE
ENDEAVOURS TO PRODUCE PRODUCT THAT MEETS DRAFT PRODUCT SPECIFICATIONS.
4.2 If there is any dispute concerning whether Product is Nonconforming
Product (as defined in Section 4.1), such dispute shall be referred for decision
to an independent expert (acting as an expert and not as an arbitrator) to be
appointed by agreement between ICOS and SGI.
The costs of such independent expert shall be borne by the parties
equally; provided that the party that is determined to be incorrect in the
dispute shall be responsible for all such costs and shall indemnify the correct
party for its share of the costs incurred. The decision of such independent
expert shall be in writing and shall be binding on both ICOS and SGI.
4.3 In the event Product is determined to be Nonconforming Product
(whether by agreement of ICOS pursuant to Section 4.1 or by an independent
expert pursuant to Section 4.2), ICOS shall replace such Product at its own cost
and expense and shall use commercially reasonable efforts to replace such
Product [***], provided that ICOS shall (a) [***] of such [***] within [***]
from the date the [***] and (b) [***] within [***] from the date ICOS [***] of
the [***]. If ICOS is [***] with the [***], then SGI shall [***] to a [***] of
the [***] of such [***].
4.4 In the event that the parties hereto agree that a shipment or batch
of Product fails to meet Product Specifications as a result of ICOS failing to
meet its obligations hereunder, the entire shipment or batch of Product that
failed to meet Product Specifications shall either be returned to ICOS or
destroyed, at ICOS's option.
4.5 The provisions of this Clause 4 shall be the sole remedies
available to SGI in respect of Product that fails to meet Product
Specifications.
5. Price and Terms of Payment
5.1 SGI shall pay the Price in accordance with the Terms of Payment
all as specified in Appendix E.
5.2 Unless otherwise indicated in writing by ICOS, all prices and
charges are exclusive of state sales tax or of any other applicable taxes,
levies, duties and fees of whatever nature imposed by or under the authority of
any government or public authority, which shall be paid by SGI (other than taxes
on ICOS's income). All invoices are strictly net and payment must be made within
[***] ([***]) [***] of date of invoice. Payment shall be made without deduction,
deferment, set-off, lien or counterclaim of any nature.
5.3 In default of payment on due date interest shall accrue on a day to
day basis with effect from the date which is [***] ([***]) [***] after the due
date for payment on any amount overdue at the [***] or the maximum rate
allowable under Washington law.
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6. Warranty and Limitation of Liability
6.1 ICOS warrants that:
6.1.1 the Services shall be performed in accordance with
Clause 3.1; and
6.1.2 the Product when made available at ICOS' shipping docks
shall meet Product Specifications, except where the Product Specifications has
not been agreed between the parties hereto in which case ICOS shall be obliged
only to use its reasonable commercial efforts to produce Product that meets
draft Product Specifications.
6.1.3 the Product delivered to SGI pursuant to this Agreement
shall conform to the Product Specifications and that such Product shall (i) be
free from defects in material and workmanship, (ii) be manufactured in
accordance with cGMP and Applicable Laws and (iii) be manufactured in accordance
with Appendix C hereof.
6.2 Clause 6.1 is in lieu of all conditions, warranties and statements
in respect of the Services and/or the Product whether expressed or implied by
statute, custom of the trade or otherwise (including but without limitation any
such condition, warranty or statement relating to the description or quality of
the Product, its fitness for a particular purpose or use under any conditions
whether or not known to ICOS) and any such condition, warranty or statement is
hereby excluded. ICOS MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH
RESPECT TO THE PRODUCT. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE ARE HEREBY DISCLAIMED BY ICOS. IN NO EVENT SHALL ICOS BE
LIABLE FOR INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES.
6.3 Without prejudice or modification to the terms of Clauses 6.1 and
6.2 the liability of ICOS to SGI, its permitted assigns and successors in
interest, for any loss suffered by SGI or its permitted assigns and successors
in interest, arising as a direct result of a breach of this Agreement, or of any
other liability, including without limitation, misrepresentation and negligence
(whether active, passive or imputed), arising out of this Agreement and Services
provided thereunder, including without limitation the production and/or supply
of the Product, shall be limited to the payment of damages which shall not
exceed in US Dollars THE PRICE FOR SERVICES PAID BY SGI UNDER THE AGREEMENT;
provided, however, if and to the extent such damages are caused by ICOS's
willful or intentional breach of this Agreement or willful or intentional
misconduct in the performance of the Services, then the damage limitation in
this Clause 6.3 shall not apply.
6.4 ICOS shall in no event be liable for the following loss or damage
howsoever caused (even if foreseeable or in the contemplation of ICOS or SGI):
6.4.1 loss of profits, business or revenue suffered by SGI or
any other person who may be subrogated to, or assigned rights in the loss or
damage; or
6.4.2 special, indirect or consequential loss, whether suffered
by SGI or any other person.
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6.5 SGI shall indemnify, defend and hold harmless and maintain ICOS
indemnified and held harmless against all Damages in respect of:
6.5.1 any product liability in respect of Product, except for
ICOS's obligations to indemnify in Clause 2.7 above; and
6.5.2 any negligent (active, passive or imputed), gross
negligence or intentional act or omission of SGI in relation to the use,
processing, storage or sale of the Product.
6.6 SGI represents and warrants that unless already expressly agreed
in a written and executed document immediately prior to the initiation of the
first cGMP manufacturing run, SGI will adopt the initial Manufacturing
Specifications as its own specification. Any changes or additions to the
Manufacturing Specifications shall be made with the written approval of SGI.
6.7 The obligations of SGI under this Section 6 shall survive the
termination for whatever reason of this Agreement.
7. Confidentiality
7.1 Each party agrees to keep the other party's Confidential
Information (as defined in Clause 7.3) strictly confidential and to respect the
other's proprietary rights therein and not at any time for any reason whatsoever
to disclose or use the other party's Confidential Information for any purpose
other than as expressly provided herein.
7.2 SGI and ICOS shall each ensure that all their respective
employees, consultants and contractors having access to confidential ICOS
Know-How or confidential SGI Materials or SGI Technology shall be subject to the
same obligations of confidence as the principals pursuant to Clause 7.1 and
shall be subject to written confidentiality agreements in support of such
obligations.
7.3 For purposes of this Agreement, "Confidential Information" means
any business or technical information, trade secrets, know-how, techniques, data
or other information, disclosed by the disclosing party to the receiving party
in writing or that is disclosed orally and confirmed in writing as confidential
within [***] following such disclosure. The parties agree that SGI `s
Confidential Information includes, without limitation, the SGI Materials and SGI
Technology. The parties further agree that ICOS's Confidential Information
includes, without limitation, ICOS Know-How.
7.4 The obligations of confidence referred to in this Section 7 shall
not extend to any Confidential Information that:
7.4.1 is or becomes generally available to the public
otherwise than by reason of a breach by the recipient party of the provisions of
this Section 7;
7.4.2 is lawfully known to the recipient party prior to its
receipt from the other;
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7.4.3 is subsequently disclosed to the recipient party without
being made subject to an obligation of confidence by a third party that does not
have a prior obligation of confidence to SGI or ICOS, as the case may be; or
7.4.4 which may be required to be disclosed under any statutory,
regulatory or similar legislative requirement, subject to the imposition of
obligations of confidentiality to the extent allowed and provided further that
each party shall, unless prohibited by law, use reasonable efforts to notify the
other party of such compelled disclosure prior to such disclosure in order to
seek injunctive or any other relief provided in law or equity; or
7.4.5 is independently developed by the recipient party
without reliance on the Confidential Information of the disclosing party as
shown by its written records.
7.5 SGI acknowledges that:
7.5.1 ICOS Know-How and ICOS Patent Rights are vested in
ICOS; and
7.5.2 Except as expressly provided herein, SGI shall not at any
time have any right, title, license or interest in or to ICOS Know-How, ICOS
Patent Rights or any other intellectual property rights relating to the Process
which are vested in ICOS or to which ICOS is otherwise entitled.
7.6 ICOS acknowledges that:
7.6.1 except as provided herein, all right, title and interest in
the SGI Materials and SGI Technology are vested in SGI; and
7.6.2 except as provided herein, ICOS shall not at any time
have any right, title, license or interest in or to SGI Technology or any other
intellectual property rights vested in SGI or to which SGI is entitled.
7.7 The obligations of ICOS and SGI under this Section 7 shall survive
the termination of this Agreement for whatever reason.
8. Termination
8.1 If it becomes apparent to either ICOS or SGI at any stage in the
provision of the Services that it will not be possible to complete the Services
for [***] reasons due solely to any [***] that are [***] from those [***] (the
"[***]"), the parties will use good faith commercially reasonable efforts for up
to a [***] ([***]) [***] period to mutually resolve such problems. If, after
using the foregoing level of effort, the parties are unable to resolve such
problems within the [***] ([***]) [***] period, ICOS and SGI shall each have the
right to terminate this Agreement. In the event of such termination, SGI shall
pay to ICOS a termination sum equal to the [***]; provided, however, that in the
event ICOS is [***] the [***], ICOS and SGI shall [***] a [***], with
consideration of the [***] in [***].
8.2 If, [***], it becomes apparent to either ICOS or SGI at any stage
in the provision of the Services that it will not be possible to complete the
Services (including delivery of all [***]
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cGMP clinical production runs of Product in compliance with this Agreement by
[***]) based on [***] reasons other than those described in Section 8.1, the
parties will use good faith commercially reasonable efforts for up to a [***]
([***]) [***] period to mutually determine the cause of the problems so as to
permit ICOS to manufacture and deliver Product that conforms with the Product
Specifications (even if the mutual determination and subsequent delivery of
conforming Product [***]). If, after using the foregoing level of effort, the
parties are unable to mutually determine the cause of such problems within the
[***] ([***]) [***] period, ICOS and SGI shall each have the right to terminate
this Agreement. In the event of such termination, SGI shall pay to ICOS a
termination sum calculated by reference to [***] (including a [***] (as
demonstrated by [***] in so far as they are applicable) of the [***] for any
[***] which is [***]) and all [***] in [***], including the [***] under the
Agreement, such termination sum not to exceed the [***]; provided, however, that
if the termination sum is less than the amount of any advance payments made by
SGI against the performance of the Services, ICOS will refund the residue of
such advance payments to SGI.
8.3 SGI shall be entitled to terminate this Agreement at any time for
any reason by [***] ([***]) [***] notice to ICOS in writing provided that for
any termination under this Section 8.3 SGI shall be responsible to pay to ICOS
the termination sum described in Section 8.1 (subject to any potential refund as
described therein).
8.4 ICOS and SGI may each terminate this Agreement by notice in writing
to the other upon the occurrence of any of the following events:
8.4.1 if the other commits a breach of this Agreement which
(in the case of a breach capable of remedy) is not remedied within [***] ([***])
[***] of the receipt by the other of written notice identifying the breach with
specificity and requiring its remedy; provided, however, if the breach is as a
result of nonpayment of any amounts owing, the breaching party must remedy the
breach within [***] ([***]) [***] after receiving such written notice; or
8.4.2 if the other ceases for any reason to carry on business
or convenes a meeting of its creditors or has a receiver or manager appointed in
respect of all or any part of its assets or is the subject of an application for
an administration order or of any proposal for a voluntary arrangement or enters
into liquidation (whether compulsorily or voluntarily) or undergoes any
analogous act or proceedings under foreign law; provided, however, either party
may merge with or into another equity pursuant to which the obligations of this
Agreement will be assumed or effect the sale of all its assets or substantially
all of its assets pursuant to which the acquiring party will assume such party's
obligations under this Agreement without notice to or waiver by the other party.
If this Agreement is terminated due to SGI's breach (which SGI
fails to cure as described in Section 8.4.1), then SGI shall be responsible to
pay to ICOS the termination sum described in Section 8.1 (subject to [***] as
described therein).
8.5 Unless terminated earlier pursuant to Sections 8.1 through 8.4,
this Agreement shall terminate upon SGI's acceptance of [***] cGMP clinical
production runs of Product in compliance with this Agreement.
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8.6 Upon the termination of this Agreement for whatever reason:
8.6.1 ICOS shall promptly return all SGI Information to SGI and
shall dispose of or return to SGI all SGI Materials, and any materials
therefrom, as directed by SGI;
8.6.2 SGI shall promptly return to ICOS all ICOS Know-How it has
received from ICOS except as set forth in Section 8.6.3 below;
8.6.3 If, after expiration or termination of this Agreement,
SGI determines to manufacture the Product, or have the Product manufactured by a
third party, ICOS will supply to SGI and/or SGI's third party designee all
reasonably available information and data relating to the Process and the
Manufacturing Specifications. In addition, ICOS will [***] and/or its [***] a
[***] to all [***], if any, [***] to [***] or its [***] to [***] in accordance
with the [***]. ICOS [***] that SGI will not [***] to the [***], other than the
[***] previously [***], to [***] or its [***] to [***] in accordance with the
[***]. Except as permitted by the foregoing, following [***] shall not [***] the
[***].
8.6.4 ICOS may thereafter use or exploit the ICOS Know-How and
ICOS Patent Rights in any way whatsoever without restriction; and
8.6.5 ICOS and SGI shall do all such acts and things and shall
sign and execute all such deeds and documents as the other may reasonably
require to evidence compliance with this Clause 8.6.
8.6.6 The license agreement previously entered into by the
parties in the form attached hereto as Appendix G shall remain in full force and
effect regardless of any termination of this Agreement.
8.7 Termination of this Agreement for whatever reason shall not affect
the accrued rights of either ICOS or SGI arising under or out of this Agreement
and Sections 2, 3.8, 3.9, 6, 7, and 8 and any definitions in Section 1 required
to interpret such surviving provisions, and all provisions which are expressly
to survive this Agreement or have a continuing obligation shall remain in full
force and effect.
9. Force Majeure
Neither ICOS nor SGI shall be deemed to be in default nor be liable for
loss, damage, or delay in performance, when and to the extent due to causes
beyond its reasonable control or from fire, strike, labor difficulties,
insurrection or riot, embargo, or inability to obtain materials from usual
sources, or any other unforeseeable cause or causes beyond the reasonable
control and without the fault or negligence of the party so affected, or from
defects or delays in the performance of its suppliers or subcontractors due to
any of the foregoing enumerated causes. If ICOS is prevented or delayed in the
performance of any of its obligations under this Agreement by Force Majeure and
shall give written notice thereof to SGI specifying the matters constituting
Force Majeure together with such evidence as ICOS reasonably can give and
specifying the period for which it is estimated that such prevention or delay
will continue, ICOS shall be excused from the performance or the punctual
performance of such obligations as the case may be from the date of such notice
for so long as such cause of prevention or delay shall continue,
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provided that within [***] ([***]) [***] from the date of such notice, ICOS
shall provide SGI with written notice of the anticipated date of resumption of
performance. In the event that the anticipated date of such resumption is
greater than [***] ([***]) [***] from the date of the original notice, SGI may
terminate this Agreement under Section 8.4.1 hereof.
10. Governing Law, Jurisdiction and Enforceability
10.1 This Agreement shall be governed and interpreted, and all rights
and obligations of the parties shall be determined, in accordance with the laws
of the State of Washington and the United States of America without regards to
principles of conflicts of law.
10.2 No failure or delay on the part of either ICOS or SGI to exercise
or enforce any rights conferred on it by this Agreement shall be construed or
operate as a waiver thereof nor shall any single or partial exercise of any
right, power or privilege or further exercise thereof operate so as to bar the
exercise or enforcement thereof at any time or times thereafter of any other
right.
10.3 The illegality or invalidity of any provision (or any part
thereof) of this Agreement shall not affect the legality, validity or
enforceability of the remainder of its provisions or the other parts of such
provision as the case may be and this Agreement shall continue in full force and
effect without such provision.
11. Miscellaneous
11.1 Assignment. Neither party shall be entitled to assign, or in any
way transfer the benefit and/or the duties of this Agreement without the prior
written consent of the other which consent shall not be unreasonably withheld or
delayed, except that either party shall be entitled without the prior written
consent of the other to assign transfer, charge, subcontract, deal with or in
any other manner make over the benefit and/or burden of this Agreement to an
Affiliate, or to any limited liability partner or to any 50/50 joint venture
company of which the party in question is the beneficial owner of fifty percent
(50%) of the issued share capital thereof or to any company with which the party
in question may merge or to any company to which that party may transfer its
assets and undertakings.
11.2 Publicity. The text of any press release or other communication to
be published by or in the media concerning the subject matter of this Agreement
shall require the prior written approval of ICOS and SGI.
11.3 Notices. All notices, requests, demands, waivers, consents,
approval or other communications to any party hereunder shall be in writing and
shall be deemed to have been duly given if delivered personally to such party or
sent to such party by recorded electronic transmission (facsimile) or by
registered or certified mail, postage prepaid, to its address as shown below:
SGI: Seattle Genetics, Inc.
21823 30/th/ Drive S.E.
Bothell, WA 98021
Attention: General Counsel
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ICOS: ICOS Corporation
22021 20/th/ Avenue S.E.
Bothell, WA 98021
Attention: Legal Department
or to such other address as the addressee may have specified in a notice duly
given to the sender as provided herein. Such notice, request, demand, waiver,
consent, approval or other communications will be deemed to have been given as
of the date so delivered, telegraphed, telexed, or five (5) days after so
mailed.
11.4 Independent Contractor. Each party shall be and shall act as the
independent contractor of the other party. Neither party shall be the legal
agent of the other for any purpose whatsoever and therefore has no right or
authority to make or underwrite any promise, warranty or representation, to
execute any contract or otherwise to assume any obligation or responsibility in
the name of or on behalf of the other party, except to the extent specifically
authorized in writing by the other party. Neither of the parties hereto shall be
bound by or liable to any third persons for any act or for any obligation or
debt incurred by the other toward such third party, except to the extent
specifically agreed to in writing by the party so to be bound.
11.5 Headings. All section headings and numbering contained in this
Agreement are for convenience of reference only, do not form a part of this
Agreement and shall not affect in any way the meaning or interpretation of this
Agreement.
11.6 Entire Agreement. The Agreement, and the attached appendixes,
embodies the entire understanding of ICOS and SGI and there are no promises,
terms, conditions or obligations, oral or written, expressed on implied, other
than those contained in this Agreement, and the attached appendixes. The terms
of this Agreement shall supersede all previous agreements (if any) which may
exist or have existed between ICOS and SGI relating to the Services.
11.7 Modifications. Any and all modifications or amendments to this
Agreement, or any Appendix hereto, shall be binding only if made in writing and
signed by both parties.
11.8 Counterparts. This Agreement may be executed simultaneously in any
number of counterparts, each of which shall be deemed an original and all of
which together shall constitute one in the same agreement.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as
of the date first above written.
ICOS CORPORATION SEATTLE GENETICS, INC.
By: /s/ Gary Wilcox By: /s/ Clay Siegall
-------------------------------- ------------------------------------
Name: Gary Wilcox Name: Clay Siegall
------------------------------ ----------------------------------
Title: EVP, Operations Title: President & CEO
----------------------------- ---------------------------------
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