Exhibit 10.24D
MANUFACTURING AND TECHNOLOGY
TRANSFER AGREEMENT
This Manufacturing and Technology
Transfer Agreement (this “ Agreement ”) is
effective as of July 1, 2008 (the “ Effective
Date ”), by and between XOMA (US) LLC, a Delaware limited
liability company with offices at 2910 Seventh Street, Berkeley,
California 94710 (“ XOMA ”), and Novartis
Vaccines and Diagnostics, Inc., a Delaware corporation with offices
at 4650 Horton Street, Emeryville, California 94608 (“
NVDI ”). XOMA and NVDI are sometimes referred to
herein individually as a “Party” and collectively as
“Parties.”
RECITALS
WHEREAS, the Parties have entered into that certain
Amended and Restated Research, Development and Commercialization
Agreement effective as of the Effective Date (the “
Collaboration Agreement ”);
WHEREAS , XOMA has substantial expertise in product
development and manufacturing of its own and its
collaborators’ biopharmaceutical products and, in addition,
has invested in biopharmaceutical manufacturing facilities;
and
WHEREAS , NVDI desires to engage XOMA to perform
technology transfer and other activities with respect to
NVDI’s anti-[*] monoclonal antibody, known as [*] and its
anti-CD40 monoclonal antibody, known as HCD122, and to manufacture
and supply two (2) GLP Batches of [*] and XOMA desires to
provide such services to NVDI, on the terms and subject to the
conditions set forth herein;
NOW, THEREFORE
, in consideration of the foregoing
premises and the mutual promises and covenants set forth below,
NVDI and XOMA mutually agree as follows;
ARTICLE 1
DEFINITIONS
Capitalized terms used but not
defined herein shall have the meanings set forth in the
Collaboration Agreement. As used in this Agreement, he following
terms will have the following meanings:
1.1 “[*] Scale ” means the
2750 liter nominal volume fermentation bioreactor production scale
for the [*] Drug Substance manufacturing process that will result
from scale-up work carried out by XOMA as part of the
Project.
1.2 “ AAA ” means the
American Arbitration Association or its successor
organization.
1.3 “ Affiliate ” means
any person or entity that, directly or indirectly, through one or
more intermediaries, owns, is owned by or is under common ownership
with, a Party, where “own,” “owned” and
“ownership” refer to (a) direct or indirect
possession of at least fifty percent (50%) of the outstanding
voting securities of a corporation or a comparable ownership in any
other type of entity; or (b) the actual ability of an entity,
person or group to control and direct the management of the person
or entity, whether by contract or otherwise.
1.4 “ Batch ” means the
quantity of [*] Drug Substance that is intended to have a uniform
character and quality, within specified limits, and that is
produced according to a single manufacturing order during the same
cycle of manufacture.
1.5 “ Confidential Information
” of a Party means all confidential or proprietary
information of such Party that the other Party receives or learns
under this Agreement. Confidential Information shall include
without limitation the manufacturing processes transferred to, used
by or improved by XOMA under this Agreement. Confidential
Information shall not include any information to the extent that
the receiving Party can demonstrate by competent
evidence:
1.5.1. is now, or hereafter becomes, through no act or
failure to act on the part of the receiving Party in breach of
Article 9, generally known or available;
1.5.2. is known by the receiving Party at the time of
receiving such information, as shown by written records predating
such receipt;
1.5.3. is furnished after the Effective Date to the
receiving Party by a Third Party, without breach of and not subject
to any obligation of confidentiality; or
1.5.4. is independently developed by the receiving
Party without use of or reference to Confidential Information of
the other Party, as shown by independent written records
contemporaneous with such development.
1.6 “ Control ,” “
Controls ” and “ Controlled
” mean, with respect to a particular item of information or
Intellectual Property Right, that the applicable Party owns or has
a license to such item or right and has the ability to grant to the
other Party access to and a license or sublicense (as applicable)
under such item or rights as provided for herein without violating
the terms of any agreement or other arrangement with any Third
Party.
1.7 “ CPR ” means the CPR
Institute for Dispute Resolution or its successor
organization.
1.8 “ Dedicated Equipment”
has the meaning set forth in Section 2.9.1.
1.9 “ Delivery ” has the
meaning set forth in Section 4.2.1.
1.10 “ Facility ” means
XOMA’s appropriate facilities located in Berkeley and
Emeryville, California.
1.11 “ FDA ” means the U.S.
Food and Drug Administration or any successor agency.
1.12 “ FD&C Act ” means
the U.S. Food, Drug and Cosmetics Act and applicable regulations
and guidances promulgated thereunder, as amended from time to
time.
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1.13 “ FTE ” has the
meaning set forth in Section 5.1.
1.14 “ GLP ” means the then
current standards for laboratory practice in relation to
biologicals, as set forth in the FD&C Act, and such standards
of good laboratory practice as are required by the FDA.
1.15 “ Governmental Authority
” means any supranational, national, regional, state or local
regulatory agency, department, bureau, or other governmental
entity.
1.16 “ Indemnitee ” has the
meaning set forth in Section 8.3.
1.17 “ Indemnitor ” has the
meaning set forth in Section 8.3.
1.18 “ Innovations ” means
inventions, discoveries, works of authorship, trade secrets and
other know-how or developments.
1.19 “ Intellectual Property
Rights ” means Patents, copyrights, trademarks,
service marks, trade secrets, mask works and applications for the
foregoing, in any country, supra-national organization or territory
of the world.
1.20 “[*] Drug Substance ”
means the anti-[*] monoclonal antibody known as [*] in purified
bulk form that has been manufactured and processed to the stage
where it meets the Master Production Records and is suitable for
further processing to yield Product.
1.21 “ Losses ” means
losses, claims, suits, damages, costs, fees and expenses (including
without limitation reasonable attorneys’ fees).
1.22 “ Master Production Records
” or “ MPRs ” means the
documentation generated by XOMA that collectively defines the
manufacturing methods, test methods, specifications, materials, and
other procedures, directions and controls associated with the
manufacture and testing of [*] Drug Substance. The Master
Production Records shall also include or incorporate by reference,
without limitation, such information as the specifications of raw
materials, resins and other consumables to be used in the
manufacture of [*] Drug Substance, in process and final [*] Drug
Substance sampling standards, equipment and instrumentation
specifications and standard operating procedures, including,
without limitation, standard operating procedures for in-process
quality control testing and [*] Drug Substance packaging and
aliquoting procedures.
1.23 “ Monthly Report ”
means a detailed report which shall set forth the costs for the
Services performed during such calendar month.
1.24 “ NVDI Indemnitees ”
means NVDI and its Affiliates and their respective directors,
officers, employees and agents.
1.25 “ NVDI Innovations ”
means all Innovations that NVDI either Controls as of the Effective
Date or gains Control of independently of activities under this
Agreement, including all Intellectual Property Rights in any of the
foregoing.
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1.26 “ NVDI IP ” means, to
the extent Controlled by NVDI, Intellectual Property Rights
claiming or covering NVDI Innovations or NVDI-owned Project
Innovations that, in the absence of a license thereunder, would be
infringed or misappropriated by XOMA’s performance of its
obligations under this Agreement.
1.27 “ Patents ” means
(a) United States issued patents, re-examinations, reissues,
renewals, extensions, patent term restorations, and foreign
counterparts of each of the foregoing; and (b) pending
applications for United States patents and foreign counterparts
thereof, whether issued or not.
1.28 “ Process ” means the
process and technology used to manufacture and test [*] Drug
Substance under this Agreement.
1.29 “ Product ” means the
finished dosage form of (a) NVDI’s [*] antibody product
candidate and/or (b) NVDI’s HCD122 antibody product
candidate, as the context requires.
1.30 “ Project ” means the
product development (including preclinical and production related
activities, technology transfer and regulatory and clinical
oversight) and manufacturing relationship established by this
Agreement.
1.31 “ Project Innovations
” shall mean all Innovations, whether or not patentable, that
are conceived in the course and as a result of the
Services.
1.32 “ Project Team ” means
a group constituted pursuant to Section 2.4 and comprised of
an appropriate number of representatives of each Party with
expertise appropriate to the current stage of the
Project.
1.33 “ Quality Agreement ”
means that certain Quality Agreement between the Parties dated as
of the Effective Date, a copy of which is attached hereto as
Appendix B and which is incorporated herein by this
reference.
1.34 “ Quarterly Invoice ”
has the meaning set forth in Section 5.2.
1.35 “ Regulatory Approval
” means all approvals, product and/or establishment licenses,
registrations or authorizations of all Regulatory Authorities
necessary for the manufacture, use, storage, import, export,
transport and sale of a biological product in a
jurisdiction.
1.36 “ Regulatory Authority
” means a supranational, national or local regulatory agency
or other governmental entity with the authority to grant a
Regulatory Approval.
1.37 “ SEC ” means the U.S.
Securities and Exchange Commission or any successor
agency.
1.38 “ Services ” means
those services to be performed by XOMA hereunder pursuant to the
Work Plan.
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1.39 “ Start Date ” means,
with respect to a scheduled production run, the date on which a
cell bank vial is scheduled in the Work Plan to be thawed for such
production run, provided that such date shall be adjusted to
account for any actual delays in the start of such production
run.
1.40 “ Third Party ” means
any person or entity other than the Parties or their respective
Affiliates.
1.41 “ Third Party Claim ”
means any Third Party claim, demand, suit, action or
proceeding.
1.42 “ Waste” means any
“hazardous substance” and/or “hazardous
material” as provided under the Comprehensive Environmental
Response, Compensation and Liability Act (CERCLA), any
“hazardous waste” as provided under the Resource
Conservation and Recovery Act (RCRA), and/or any other waste
material, pollutant and/or contaminant of any kind including,
without limitation, any routine process waste or any by-product
arising from any activities conducted pursuant to this
Agreement.
1.43 “ Work Plan ” means
the Work Plan attached hereto as Appendix A and incorporated
herein by this reference (as such Work Plan may be amended from
time to time by mutual written agreement of the
Parties).
1.44 “ XOMA Indemnitees ”
means XOMA and its Affiliates and their respective directors,
officers, employees and agents.
1.45 “ XOMA Innovations ”
means all Innovations that XOMA either Controls as of the Effective
Date or gains Control of independently of activities under this
Agreement, including all Intellectual Property Rights in any of the
foregoing.
1.46 “ XOMA IP ” means, to
the extent Controlled by XOMA, Intellectual Property Rights
claiming or covering XOMA Innovations or XOMA-owned Project
Innovations that, in the absence of a license thereunder, would be
infringed or misappropriated by the development, manufacture, use
or sale of [*] Drug Substance or Product.
ARTICLE 2
OVERVIEW;
GOVERNANCE.
2.1 Project; Schedule . XOMA and NVDI are
entering into this Agreement with the purpose of having XOMA
perform technology transfer and other activities as provided in the
Work Plan and produce [*] in compliance with the Master Production
Records at [*] Scale for NVDI. Subject to the terms and conditions
of this Agreement, XOMA will carry out the Project in accordance
with this Agreement and the Work Plan. XOMA will commit to the
Project appropriate personnel (including without limitation those
with expertise in technical development, manufacturing, operations,
quality control, quality assurance and regulatory affairs) and
conduct the Services at the Facility. NVDI will commit such of its
personnel with appropriate expertise to provide monitoring and, as
appropriate, technical consultation for the
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Project. XOMA and NVDI recognize the importance
of timely execution of the Project, and accordingly each Party will
give priority to the Project, assign adequate staffing and other
resources and use all diligent, commercially reasonable efforts to
maximize the potential of achieving successful completion of the
Project (including without limitation timely provision of all
deliverables in accordance with the Work Plan), it being understood
that the efforts and resources used to date by XOMA satisfy such
standard. More specifically:
2.1.1. NVDI and XOMA each will give priority to
completion, as promptly as reasonably practicable, of the
development and implementation of the Work Plan. NVDI has delivered
to XOMA certain materials and information and will deliver to XOMA
any further materials and information necessary for XOMA to
undertake its responsibilities hereunder, together with relevant
details of any hazards and/or characterization relating to the
materials delivered or to be delivered by NVDI to be used, and the
storage and use of such materials. With this information, XOMA has
initiated and will continue the process development
efforts.
2.1.2. Upon successful completion of cell banking,
process development and preparation for scale-up work, XOMA will
produce [*] and in each case according to the Work Plan. For the
avoidance of doubt, the GLP batch under production in November of
2008 shall count as one (1) [*]. In connection with the
foregoing, XOMA will also conduct related testing and deliver
related regulatory documentation to NVDI.
2.2 Work Plan .
2.2.1. Attached hereto as Appendix A is the Work
Plan for the technology transfer, manufacturing and other
activities as provided therein in accordance with the terms and
conditions of this Agreement. The Parties acknowledge that the
initial Work Plan attached hereto at the time of execution of this
Agreement is a preliminary version included for guidance but not
yet fully agreed to by the Parties. The Parties agree to use
commercially reasonable efforts to finalize such initial Work Plan
within [*] following full execution of this Agreement. For the
avoidance of doubt, once such initial Work Plan is agreed, it may
be further amended as provided herein.
2.2.2. Each Party agrees to perform its obligations
under this Agreement in accordance with the Work Plan and the
Quality Agreement. The Project Team members shall review the Work
Plan and consult as to its continuing suitability at their meetings
pursuant to Section 2.4 and shall propose appropriate
revisions thereto. Any such revised Work Plan or amendment or
supplement to the Work Plan shall be in writing and shall become
effective only upon execution by both Parties.
2.3 Cooperation. Adherence to the schedules
set out in the Work Plan is contingent in part on each
Party’s reasonably expedient reviews, decisions and approvals
of the requisite documents, data and paths, where such review and
approval is necessary, it being understood and agreed that, in
order to maintain adherence to the schedules set forth in the Work
Plan (taking into consideration the custom and practice of the
industry as well as XOMA’s standard operating procedures),
this may require a prompt response from either NVDI or XOMA
following a request from the other Party.
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2.4 Project Team . As of the Effective Date,
the Parties have formed a Project Team. Each Party may replace or
supplement its members on the Project Team and will at all times
ensure that its current Project Team members have expertise
appropriate to the current stage of the Project. Each Party shall
use commercially reasonable efforts to maintain the same Project
Team manager throughout the term of this Agreement unless such
individual leaves the employ of such Party. The Project Team will
be responsible for reviewing progress of the Project under the Work
Plan and to discuss and decide on any potential revisions to the
Work Plan. The Project Team shall seek to make decisions by
consensus. The Project Team shall hold monthly meetings by
teleconference or in person unless otherwise agreed by Project Team
members. At each such meeting, a representative of XOMA shall be
responsible for keeping the minutes of such meeting and for
circulating a draft of such minutes thereafter for approval by the
attendees.
2.5 Senior Management Oversight
and Dispute Resolution .
In the event that the Project Team is unable to reach consensus
regarding any matter, either Party may, by written notice to the
other Party, refer such matter to the CEOs of the Parties (or to
their respective senior executive designees) for attempted
resolution. If a Party refers any matter to the CEOs of the Parties
(or such designees) pursuant to this Section 2.5, then the
CEOs of the Parties (or such designees) will attempt in good faith
to resolve such matter within [*]. If the matter remains unresolved
at the end of such [*] period, the matter may be submitted for
resolution pursuant to Section 11.3.
2.6 Master Production Records;
Changes to Master Production Records and Work Plan
.
2.6.1. NVDI or XOMA may change the Master Production
Records or the Work Plan from time to time, with the review and
approval of the other Party in advance as to such changes, and such
revised MPRs or Work Plan, as the case may be, shall replace the
previous MPRs or Work Plan, as applicable, and shall be deemed to
be part of this Agreement. The work of each Party hereunder will be
performed in a professional and workmanlike manner in accordance
with the standards of performance in the industry.
2.6.2. NVDI shall be responsible for any incremental
costs incurred by XOMA as a result of any changes to the MPRs or
the Work Plan pursuant to Section 2.6.1. If such changes
significantly and adversely affect the ability of XOMA to
manufacture [*] Drug Substance in compliance with the MPRs or
require significant modifications to the Facility in order to
permit XOMA to manufacture [*] Drug Substance in accordance with
the MPRs, then at XOMA’s election, the Parties will
renegotiate the terms of this Agreement so as to permit XOMA to
perform its obligations under this Agreement with substantially the
same proportional economic benefit for its efforts.
2.7 NVDI Representatives . NVDI shall be
allowed to have, at its cost, such number of representatives [*]
escorted by XOMA personnel, with reasonable access to the Facility
during the manufacture of [*] Drug Substance for the purpose of
observing, reporting on, and consulting as to such manufacturing
efforts. Prior to receiving such access, NVDI representative(s)
will enter into XOMA’s standard form of confidentiality
agreement, which will be commercially reasonable and will permit
XOMA personnel to disclose information learned to NVDI. XOMA will
reasonably cooperate in enabling (e.g., providing necessary
training to allow for compliance with XOMA procedures) NVDI
representatives to carry out their responsibilities and will make
adequate temporary desk space and other reasonable resources
available to these representatives during the periods they are
working at the Facility.
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2.8 Other Manufacturing
Relationships . The
manufacturing relationship set forth in this Agreement will be
non-exclusive.
2.9 Additional
Equipment .
2.9.1. Dedicated Equipment Purchases . The
Parties acknowledge that certain equipment has been obtained for
the Project and do not expect that additional equipment will be
needed. In the unlikely event that additional equipment is needed,
XOMA shall purchase for delivery to the Facility all equipment that
is to be dedicated to the Project, as either set forth in the Work
Plan or otherwise approved in writing in advance by NVDI, which
approval shall not be unreasonably withheld or delayed (any such
additional equipment, the “Dedicated Equipment”)
. NVDI will reimburse XOMA for the cost of Dedicated Equipment
purchases (including, without limitation, reimbursement for the
time and efforts of XOMA personnel, and the costs for delivery,
installation and qualification) in accordance with the Work Plan or
as otherwise approved in writing in advance by NVDI and NVDI will
have ownership of the Dedicated Equipment. XOMA will operate and
maintain the Dedicated Equipment as per approved procedures once
such equipment is commissioned and in operation. NVDI shall be
liable for repair of all damage and risk of any loss to Dedicated
Equipment unless caused by XOMA’s negligence, willful
misconduct or breach of this Agreement. NVDI shall be responsible
for any delays to the Work Plan caused in whole or in part by
delays in the delivery, testing, qualification or validation of
Dedicated Equipment. If any piece of Dedicated Equipment is not or
no longer used for the Project or for other NVDI products, then
XOMA at its option will either transfer such Dedicated Equipment to
NVDI or keep such Dedicated Equipment and reimburse NVDI for the
depreciated cost thereof. NVDI will pay any costs of the physical
transfer of such Dedicated Equipment to NVDI.
2.9.2. General Equipment Purchases . It may also
be necessary to obtain additional equipment of general utility to
XOMA for the development or scale-up of the Process or the
manufacture of [*] Drug Substance. Upon mutual agreement of the
Parties that additional equipment is needed for the Project, XOMA
will purchase for its own account and for delivery to the Facility
any such additional equipment. XOMA and NVDI will share the cost of
purchasing this equipment in a [*] arrangement. However,
NVDI’s portion of the purchase cost will be subtracted from
future revenues to XOMA for work performed under this Agreement.
XOMA will have ownership of such equipment from the date of
purchase.
2.10 Handling of Materials;
Wastes . At NVDI’s
expense, XOMA or a designated Third Party contractor shall handle,
label, package, store, transport and dispose of all Wastes
generated through performance of the manufacturing and processing
activities hereunder in material compliance with all federal, state
and local laws, rules, and regulations applicable to such handling,
labeling, packaging, storage, transport and disposal. Each Party
shall promptly notify the other of any health hazards or potential
health hazards of which it is or becomes aware concerning exposure
to or handling of the [*] Drug Substance or Wastes.
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ARTICLE 3
TECHNOLOGY TRANSFER AND OTHER
ACTIVITIES; PRODUCTION.
3.1 Technology Transfer to XOMA . To the
extent not already completed, the Parties will complete as quickly
as practicable the transfer from NVDI to XOMA of all relevant
materials and information related to the Project. NVDI shall be
responsible for obtaining all relevant technology, other necessary
information and assistance from relevant Third Parties, if needed.
Throughout the course of the Project, NVDI will make scientific and
technical staff available as necessary and reasonably useful to
assist XOMA’s efforts.
3.2 Technology Transfer to NVDI;
Manufacture . In
accordance with the provisions and timelines in the Work Plan, XOMA
will perform technology transfer and other activities as provided
therein and manufacturing at [*] and will take such actions and
generate such data and documentation as are necessary to meet the
MPRs.
ARTICLE 4
TESTING, DELIVERY AND REGULATORY
MATTERS.
4.1 Raw Materials Services; In-Process
Testing . XOMA has provided and will continue to provide in
accordance with the Work Plan the ordering, testing, inventorying
and releasing services for raw materials used in the manufacture of
[*] Drug Substance under this Agreement and in-process testing for
continued manufacture of [*] Drug Substance under this Agreement.
XOMA shall obtain raw materials, resins, buffers, consumables and
other like materials for manufacture of [*] Drug Substance under
this Article 4. XOMA shall not be responsible for delays in the
purchase and/or delivery of any such materials that occur outside
of the reasonable control of XOMA and despite XOMA using
commercially reasonable efforts to avoid such delays. All such
materials shall be invoiced to NVDI by XOMA at one hundred percent
(100%) of XOMA’s cost.
4.2 Delivery; Risk of Loss ; Storage
Fees.
4.2.1. On or prior to the applicable date of delivery
of [*] Drug Substance to NVDI or its designee, XOMA will deliver
such [*] Drug Substance to NVDI or its designee F.O.B. the
Facility, along with samples and copies of Batch production
records. XOMA will test each Batch of [*] Drug Substance pursuant
to the Master Production Records and will include with each Batch
of [*] Drug Substance a certificate of analysis confirming that
such Batch has been tested according to the MPRs. XOMA shall
package for shipment each Batch of [*] Drug Substance in accordance
with NVDI’s written instructions, and NVDI shall bear all
packaging, shipping and insurance charges. Delivery of [*] Drug
Substance by XOMA shall be deemed to have taken place upon the
earlier to occur of (i) delivery to a carrier at the Facility
or (ii) [*] after release by XOMA (“ Delivery
”). [Draft note to XOMA: Has this been resolved?]
Title and risk of loss shall transfer to NVDI upon Delivery. XOMA
shall accept no liability or responsibility and risk associated
with the loss of any Batch of [*] Drug Substance once this transfer
has occurred. XOMA shall retain representative samples of [*] Drug
Substance for record keeping, testing and regulatory purposes,
including in accordance with applicable laws, rules and
regulations.
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XOMA shall bear the risk of loss
prior to Delivery, except to the extent such loss is due to
circumstances beyond its reasonable control, including without
limitation earthquakes, governmental regulation, fire, flood, labor
difficulties, interruption of supply of key raw materials, civil
disorder, and acts of God. XOMA shall provide for the storage of
any Batch, upon release of such Batch at the Facility in accordance
with guidelines to be agreed to by the Parties at the Facility for
up to [*]; provided , that any additional storage beyond
such [*] period will be charged to NVDI at XOMA’s customary
rates. Unless otherwise agreed in writing by the Parties, XOMA
shall not be required to store any Batch for more than [*] after
release of such Batch pursuant to this Section 4.2; provided
that, XOMA will notify NVDI in writing before disposing of any
Batch, and shall continue storage of the affected Batch for a
reasonable period of time (not to exceed [*]) sufficient to allow
NVDI to arrange for alternate disposition of the Batch. NVDI shall
pay applicable storage costs for any portion of the Batch
remaining. XOMA shall not be required to deliver any Batch to the
carrier until the carrier informs XOMA that it has obtained all
appropriate approvals and consents of any Governmental Authority
necessary for the transportation or shipment of such
Batch.
4.2.2. XOMA hereby agrees to obtain and carry general
liability insurance with coverage in an amount equal to or greater
than the aggregate amount of expected payments under this
Agreement. Upon written request, XOMA shall provide NVDI a
certificate evidencing such insurance.
4.3 Regulatory
Matters. Upon
NVDI’s decision to file regulatory documentation for Drug
Substance or Product with the FDA or other Regulatory Authorities
in accordance with the Collaboration Agreement, and upon
NVDI’s request and at NVDI’s expense, XOMA will, in
accordance with the applicable regulatory requirements, provide the
necessary documentation according to the Work Plan.
ARTICLE 5
PRICES AND
PAYMENT.
5.1 Price for Services, Batches
and Technology Transfer .
In consideration for XOMA’s performance of its obligations
under this Agreement and the Work Plan, and subject to the terms
and conditions of this Agreement, NVDI shall pay to XOMA an amount
equal to the sum of (a) XOMA’s fully burdened costs,
measured, where applicable, by its standard full-time equivalent
(“ FTE ”) rates as set forth in the Work Plan
for the functions providing the Services plus (b) [*] with
respect to Services provided on or after the Effective Date and
prior to November 1, 2008, ten percent (10%) or
(ii) with respect to Services provided on or after
November 1, 2008, twenty percent (20%). The Parties expressly
acknowledge that the dollar amounts for expected time and materials
set forth in the Work Plan are estimates. NVDI must approve in
writing any deviations of [*] or more from either the aggregate
amount in the Work Plan for manufacturing Services or the aggregate
amount in the Work Plan for technology transfer
Services.
5.2 Quarterly Invoices
. Upon execution of this Agreement
in full, and on a calendar quarterly basis thereafter, XOMA shall
send to NVDI an invoice in an amount equal to the sum of
(a) (in case of the first invoice only) XOMA’s fees for
(i) the work undertaken on or after the
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Effective Date through such date of full
execution, (ii) the actual costs of materials, other than
materials procured under the Original Agreement as such term is
defined in the Collaboration Agreement, procured before the
Effective Date but used or to be