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Exhibit 10.13
DEVELOPMENT AND MANUFACTURING
SERVICES AGREEMENT
BETWEEN
LONZA BIOLOGICS ***
AND
GENECRAFT INC.
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THIS
AGREEMENT is made the 12th day of August, 2003 (the "Effective
Date")
BETWEEN
1.
LONZA BIOLOGICS ***, the registered office of which is at ***
(herein
after referred to as "LB"), and
2.
GENECRAFT INC., the registered office of which is at 2401 4th
Ave.,
Suite 1050, Seattle, WA 98121 USA (herein after referred to as the
"Customer").
WHEREAS
A.
The Customer has created or controls certain Cell Lines as
defined
herein; and
B.
LB has expertise in the evaluation and production of monoclonal
antibodies and proteins for therapeutic use using such Cell Lines;
and
C.
The Customer wishes to contract LB for Services relating to the
Cell
Line as described in the Agreement, and
D.
LB is prepared to perform such Services for the Customer under the
terms
and conditions set out herein.
NOW
IT IS AGREED AS FOLLOWS:
1.
The following terms shall have the following meanings unless the
context
requires otherwise:
"Affiliate" means any Company, partnership or other entity which
directly
or indirectly Controls, is Controlled by or is under common Control
with the
relevant party to this Agreement. "Control" means the ownership of
more than
fifty percent (50%) of the issued share capital or the legal power
to direct or
cause the direction of the general management and policies of the
party in
question;
"Agreement" means this agreement incorporating Schedules 1
(Definitions and
Specifications), 2 (Services) and 3 (Price and Terms of Payment) as
amended or
varied from time to time by written agreement of the parties;
"Cell Line" means the cell line provided by Customer to LB,
particulars of
which are set out in Schedule 1;
"Customer" means GENECRAFT INC and its successors in title and
lawful
assigns;
"Customer Information" means all technical and other information
not known
to LB or in the public domain relating to the Cell Line, the
Process (including
for the avoidance of doubt improvements or modifications thereto
from time to
time) and the Product, from time to time supplied by the Customer
to LB;
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"Customer Materials" means the materials supplied by Customer to LB
(if
any) and identified as such by Schedule 1 hereto;
"Customer Patent Rights" means all patents and patent applications
of any
kind throughout the world that are necessary or useful in
performance of the
Services excluding the LB Patent Rights;
"Deliver", "Delivered" or "Delivery" has the meaning given to it in
Clause
4.1;
"LB
Know-How" means all technical and other information relating
directly
or indirectly to the Process known to LB from time to time other
than
confidential Customer Information and information in the public
domain;
"LB
Patent Rights" means all patents and patent applications of any
kind
throughout the world relating to the Process which from time to
time LB is the
owner of or is entitled to use;
"Price" means the price specified in Schedule 3 for the
Services;
"Process" means the process for the production of the Product from
the Cell
Line, including any improvements or modifications thereto from time
to time;
"Product" means all or any part of the product manufactured using
the
Process (including any sample thereof), particulars of which are
set out in
Schedule 1 and includes all derivatives thereof;
"Services" means all or any part of the services performed by LB
under the
Agreement (including, without limitation, cell culture evaluation,
purification
evaluation, master, working and extended cell bank creation, and
sample and bulk
production), particulars of which are set out in Schedule 2;
"Terms of Payment" means the terms of payment specified in Schedule
3.
References to the singular number include the plural and vice
versa,
references to Clauses and Schedules are references to clauses and
schedules to
this Agreement.
2.
CUSTOMER OBLIGATIONS, WARRANTIES AND INDEMNITIES
2.1 Customer shall pay the Price set out in Schedule 3 for
provision
of the Services together with any additional costs and expenses
mutually agreed
upon by the parties that fall due under this Agreement in
accordance with the
Terms of Payment.
2.2 As agreed by the parties, the Customer shall supply to LB
the
Customer Information, together with full details of any hazards
known to
Customer relating to the Cell Line and/or the Customer Materials,
and their
storage and use. On review of this Customer Information, the Cell
Line and/or
the Customer Materials shall be provided to LB at LB's request. All
right,
title, and interest in and to the Cell Line and/or the Customer
Materials and/or
the Customer Information supplied to LB shall remain vested in the
Customer.
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2.3 Subject to the terms and conditions of this Agreement, the
Customer hereby grants LB the non-exclusive, non-transferable
(other than to
LB's Affiliates), right to use the Cell Line, the Customer
Materials and the
Customer Information during the term of this Agreement solely for
the purpose of
the Agreement.
2.4 The Customer warrants to LB that:
2.4.1 Customer has the right to enter into this Agreement;
2.4.2 ***;
2.4.3 ***;
2.4.4 ***;
2.4.5 ***.
2.5 The Customer undertakes to indemnify and to maintain LB
promptly
indemnified against any loss, damage, costs and expenses of any
nature
(including court costs and legal fees on a full indemnity basis),
whether direct
or consequential, and whether or not foreseeable or in the
contemplation of LB
or the Customer, that LB may ***.
2.6 The Customer shall further indemnify and maintain LB
promptly
indemnified against all claims, actions, costs, expenses (including
court costs
and legal fees on a full indemnity basis) or other liabilities
whatsoever in
respect of:
2.6.1 ***; and
2.6.2 ***.
2.7 The obligations of the Customer under this Clause 2 shall
survive
the termination for whatever reason of the Agreement.
3.
Provision of the Services
3.1 LB shall diligently carry out the Services as provided in
Schedule
2 and shall use all reasonable efforts to achieve the estimated
timescales set
out in that Schedule.
3.2 LB shall manufacture Product using *** as outlined in Schedule
2,
Stage 1.
3.3 Owing to the unpredictable nature of the biological
processes
involved in the Services, the timescales set down for the
performance of the
Services (including without limitation the dates for production and
Delivery of
Product) and the quantities of Product for Delivery set out in
Schedule 2 are
estimated only.
3.4 Without prejudice to LB's obligations under Clauses 3.1 and
3.2,
***:
3.4.1 ***; or
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3.4.2 ***.
Provided that if a significant failure to perform the Services or
produce
the Product for Delivery arises due to gross negligence by LB the
parties shall
agree a commercially reasonable mechanism by which to compensate
Customer.
3.5 LB shall comply with the International Committee for
Harmonisation
regulatory requirements from time to time applicable to the
Services as set out
in Schedule 2.
3.6 LB hereby undertakes not to use the Cell Line, the Customer
Materials or the Customer Information (or any part thereof) for any
purpose
other than to perform the Services and supply Product under this
Agreement.
3.7 LB shall:
3.7.1 at all times use *** to keep the Cell Line and/or the
Customer Materials secure and safe from loss and damage in such
manner as LB
!stores its own material of similar nature;
3.7.2 not part with possession of the Cell Line and/or the
Customer Materials or the Product, save for the purpose of tests at
the Testing
Laboratories; and
3.7.3 procure that all Testing Laboratories are subject to
obligations of confidence substantially in the form of those
obligations of
confidence imposed on LB under this Agreement.
4.
DELIVERY, TRANSPORTATION OF PRODUCT AND CUSTOMER TESTS
4.1 Product shall be *** and (b) risk and title to Product pass
to
Customer upon Delivery ("Deliver," "Delivery," or "Delivered," as
appropriate).
4.2 Unless otherwise agreed, LB shall package and label Product
for
Delivery in accordance with its standard operating procedures. It
shall be the
responsibility of the Customer to inform LB in writing in advance
of any special
packaging and labelling requirements for Product. All additional
costs and
expenses of whatever nature incurred by LB in complying with such
special
requirements shall be charged to the Customer in addition to the
Price.
4.3 If requested in writing by the Customer, LB will (acting as
agent
for Customer) arrange for insurance of Product whilst held by LB
after Delivery
(awaiting transportation) for a maximum of *** on terms equivalent
to those
under which LB insures other comparable products prior to Delivery.
All
additional costs and expenses of whatever nature incurred by LB in
arranging
such insurance shall be charged to the Customer in addition to the
Price.
4.4 If requested in writing by the Customer, LB will (acting as
agent
of the Customer for such purpose) arrange the transportation of
Product from
LB's premises to the destination indicated by the Customer together
with
insurance cover for Product in transit at its
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invoiced value. All additional costs and expenses of whatever
nature incurred by
LB in arranging such transportation and insurance shall be charged
to the
Customer in addition to the Price.
4.5 Where LB has made arrangements for the transportation of
Product,
the Customer shall diligently examine the Product as soon as
practicable after
receipt. Notice of all claims (time being of the essence) arising
out of:
4.5.1 visible damage to or total or partial loss of Product in
transit shall be given in writing to LB and the carrier within ***
of receipt by
Customer; or
4.5.2 non-Delivery shall be given in writing to LB within ***
after the date of LB's despatch notice.
4.6 The Customer shall make damaged Product and associated
packaging
materials available for inspection and shall comply with the
requirements of any
insurance policy covering the Product notified by LB to the
Customer. LB shall
offer the Customer all reasonable assistance (at the cost and
expense of the
Customer) in pursuing any claims arising out of the transportation
of Product.
5.
PRICE AND TERMS OF PAYMENT
5.1 Unless otherwise indicated in writing by LB, all prices and
charges are exclusive of Value Added Tax or of any other applicable
taxes,
levies, imposts, duties and fees of whatever nature imposed by or
under the
authority of any government or public authority, which shall be
paid by the
Customer (other than taxes on LB'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.
5.2 In default of payment on due date:
5.2.1 interest shall accrue on any amount overdue at the rate
of
*** above the base lending rate from time to time of National
Westminster Bank
plc, interest to accrue on a day to day basis both before and after
judgment;
and
5.2.2 LB shall, at its sole discretion, and without prejudice
to
any other of its accrued rights, be entitled to suspend the
provision of the
Services or to treat the Agreement as repudiated on not less than
*** prior
notice in writing to Customer given at any time thereafter.
6.
LB Warranties and Indemnity
6.1 LB warrants that:
6.1.1 the Services shall be performed in accordance with Clause
3.1;
6.1.2 unencumbered title (save for any intellectual property
rights which may exist) to Product will be conveyed to Customer
upon Delivery;
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6.1.3 as of the date of this Agreement the LB Know-How and LB
Patent Rights are owned by LB or LB is otherwise entitled to use
them for the
purposes
