Document:

exv10w5

 

Exhibit 10.5

PRODUCTION SERVICE AGREEMENT

THIS PRODUCTION SERVICE AGREEMENT (the “Agreement”), entered into and effective this
18th day of March, 2003 (the “Effective Date”), is by and between MOLECULAR MEDICINE
BIOSERVICES, INC.(“MOLECULAR MEDICINE”), located at 11772 Sorrento Valley Road, Suite 200,
San Diego, CA 92121 and GeneMax Corporation (“SPONSOR”) located at 3432 West 13th
Ave, Vancouver, British Columbia, V6R2S1.

INTENDING TO BE LEGALLY BOUND, the parties agree as follows:

	1.  	The PROJECT.

MOLECULAR MEDICINE will perform production services for SPONSOR relating to
the fill of adenoviral vector product (the “PRODUCT”), and the performance of such
production services, (the “PROJECT”), each term as more fully defined in Section 2
below) using due care in accordance with:

	 	a.  	the Scope of Work attached as Exhibit A
	 
	 	b.  	Price and Payment Schedule attached as Exhibit B;
	 
	 	c.  	the Schedule of Work attached as
Exhibit C; and 
	 
	 	d.  	current Good Manufacturing Practices as set forth in US 21CFR Parts 210 and 211
applicable to pilot scale facilities and 21 CFR Part 600 applicable to biologies;

all as may be amended from time to time. MOLECULAR MEDICINE will make a good faith
effort to start and complete the PROJECT in a timely fashion and will notify SPONSOR
if it determines there are likely to be substantial changes in the proposed start or
completion dates of the PROJECT.

	2.  	Definitions. As used herein, the following capitalized terms shall have the meanings
set forth below:

2.1 DATA: All documentation, records, data, required retain samples, or other work
generated by MOLECULAR MEDICINE during and in connection with the PROJECT.

2.2 PRODUCT: Finished product to be produced by MOLECULAR MEDICINE as described in
Exhibit A and meeting the Technical Specifications set forth in Exhibit A.

2.3 PROJECT: Scope of activities necessary to deliver the PRODUCT to the SPONSOR under
the terms as set forth in this agreement; the Scope of Work under Exhibit A and the
Schedule of Work attached as Exhibit C.

2.4 PROJECT MATERIALS: All compounds, materials, or other substances necessary to
perform the PROJECT and deliver the finished PRODUCT described in Exhibit A including
sufficient and comprehensive data as may be required by MOLECULAR MEDICINE concerning
stability, storage and safety requirements.

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	3.  	Project Procedures.

3.1 Project Materials. SPONSOR shall provide MOLECULAR MEDICINE with sufficient
quantities of PROJECT MATERIALS necessary to perform the PROJECT and deliver the finished
PRODUCT described in Exhibit A. Except as specifically agreed by the parties, or unless
prohibited by law or regulation, any remaining supplies of PROJECT MATERIALS shall be
returned to SPONSOR upon completion of the project..

3.2 Timetable. MOLECULAR MEDICINE will make a good faith effort to start and complete the
PROJECT in a timely fashion in accordance with the Schedule of Work attached as Exhibit C,
it being understood that as long as MOLECULAR MEDICINE makes such good faith efforts, the
failure of MOLECULAR MEDICINE to meet the Schedule of Work shall not be deemed to be a
default by MOLECULAR MEDICINE of its obligations hereunder. MOLECULAR MEDICINE will notify
SPONSOR if it determines there are likely to be substantial changes in the proposed start
or completion dates of the PROJECT.

3.3 Data. All DATA generated by MOLECULAR MEDICINE in the course of the PROJECT shall be
the property of MOLECULAR MEDICINE, and shall be maintained by MOLECULAR MEDICINE for the
benefit of SPONSOR during the term of this Agreement. SPONSOR shall have access to DATA
produced in connection with the PROJECT described in this Agreement. Unless otherwise
agreed between the parties, upon completion of the PROJECT, MOLECULAR MEDICINE shall store
and maintain all DATA in accordance with all applicable legal and regulatory requirements
for a period of five (5) years (or such shorter period as may be permitted by law). Upon
the expiration of such five-year retention period, MOLECULAR MEDICINE shall make a good
faith effort to contact SPONSOR concerning the disposition of DATA. MOLECULAR MEDICINE will
limit access to DATA relating to the PROJECT to MOLECULAR MEDICINE staff as needed. To the
extent practicable, MOLECULAR MEDICINE will remove any references to the SPONSOR’S
technology from the DATA. Any information related directly to SPONSOR’S technology will be
returned to SPONSOR at completion of the Agreement. In the event SPONSOR wishes the DATA to
be retained by MOLECULAR MEDICINE beyond the five-year retention period, SPONSOR will pay
MOLECULAR MEDICINE, in advance, its then-current standard annual storage fee for the
retention of such DATA. If for any reason the fee is not paid, (e.g. SPONSOR cannot be
located, SPONSOR has not responded, etc.) MOLECULAR MEDICINE may dispose of the DATA as it
sees fit. It shall be SPONSOR’S responsibility to assure MOLECULAR MEDICINE has a current
address for SPONSOR.

3.4 Changes. SPONSOR may request reasonable changes in the Technical Specifications
described in Exhibit A prior to PROJECT completion. To be effective, all such proposed
changes, including changes in the price and projected completion date of the PROJECT, shall
be described in writing by authorized representatives of both MOLECULAR MEDICINE and
SPONSOR and signed by both parties.

3.5 Testing. Should, during the course of conducting this PROJECT, regulatory testing
requirements covering the PRODUCT change such that additional expense would be incurred by
MOLECULAR MEDICINE to satisfy the terms of this Agreement, those expenses will be the
responsibility of the SPONSOR.

3.6 Inventions; Grant Back License. In performing the PROJECT, MOLECULAR MEDICINE may
develop ideas, know-how, inventions, techniques, improvements and other technology, whether
or not patentable or copyrightable, and associated intellectual property relating to the
PROJECT (collectively “INVENTIONS”). SPONSOR agrees that all INVENTIONS shall be owned by
MOLECULAR MEDICINE. MOLECULAR MEDICINE hereby agrees to grant to SPONSOR a non-exclusive
license, with the limited right to sub-license as described herein below, to any and all
inventions made, conceived and/or reduced to practice by MOLECULAR MEDICINE during the
course of, and/or resulting from, the performance of the PROJECT, provided that such
inventions relate directly and exclusively to the manufacture of the PRODUCT. SPONSOR’S
license right under this clause shall not extend to

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inventions, processes or technology that are developed by MOLECULAR prior to its
undertaking the PROJECT or that is not related directly and exclusively to the manufacture
of the PRODUCT. SPONSOR shall only sublicense its rights under this clause to existing and
future users of the PRODUCT. With respect to any inventions arising from and the PROJECT,
US patent laws will be followed. This project infers no license or intellectual property
rights to MOLECULAR MEDICINE by SPONSOR for any SPONSOR-related intellectual property
existing prior to undertaking the project.

	4.  	Project Completion.

4.1 Notice and Delivery. MOLECULAR MEDICINE shall notify SPONSOR by overnight mail when
PRODUCT is complete and when quality assurance review of PRODUCT has been completed by
MOLECULAR MEDICINE. Risk of loss for the PRODUCT shall be the responsibility of SPONSOR
upon release of PRODUCT from MOLECULAR MEDICINE’S premises (FOB shipping point) to a
commercially reliable shipper that carries sufficient insurance in accordance with industry
standards. SPONSOR must acknowledge notification of PROJECT Completion to an authorized
representative of MOLECULAR MEDICINE within ten (10) working days of formal notification by
MOLECULAR MEDICINE.

4.2
Product Storage. MOLECULAR MEDICINE agrees to hold SPONSOR’S PRODUCT for up to 90 days
after SPONSOR’S acknowledgement of PROJECT Completion or 90 days after MOLECULAR MEDICINE’S
notice to SPONSOR of the PROJECT Completion, whichever is shorter. PRODUCT held at
MOLECULAR MEDICINE beyond the foregoing Product Storage intervals shall be subject to
MOLECULAR MEDICINE’S standard terms and conditions of storage and its standard group
storage fees.

	5.  	Confidentiality. During the performance of the PROJECT and for five (5) years after the
termination or expiration of this Agreement, each party shall treat the trade secrets and
other proprietary or confidential information disclosed to such party (the “RECEIVING PARTY”)
by the other party (the “DISCLOSING PARTY”) under this Agreement and marked by the DISCLOSING
PARTY as confidential, as the proprietary and confidential information of the DISCLOSING PARTY
(“PROPRIETARY INFORMATION”), and shall maintain all PROPRIETARY INFORMATION in strict trust
and confidence and shall not disclose any PROPRIETARY INFORMATION to any third party or use
any PROPRIETARY INFORMATION except as may be authorized elsewhere in this Agreement or by the
DISCLOSING PARTY’S prior written consent. For purposes of this Agreement (i) PROPRIETARY
INFORMATION of the SPONSOR shall include the Technical Specifications described in Exhibit A,
and (ii) PROPRIETARY INFORMATION of MOLECULAR MEDICINE shall include all DATA.

Not withstanding any other provision of this Agreement, the RECEIVING PARTY shall have no
liability or obligation to the DISCLOSING PARTY for, nor be in any way restricted in, its
disclosure of or use of any information that:

	 	a)  	is already known to the RECEIVING PARTY at the time of the DISCLOSING PARTY’S
disclosure;
	 
	 	b)  	is or becomes publicly known by any means other than through a wrongful act
of the RECEIVING PARTY, its employees or agents;
	 
	 	c)  	is received from a third party entitled to make such a transfer without
violating an obligation of confidentiality;
	 
	 	d)  	is independently developed by or for the RECEIVING PARTY;
	 
	 	e)  	is disclosed in response to an order of a court or other governmental body or
regulatory authority with competent jurisdiction over the RECEIVING PARTY; or is
otherwise required to be disclosed by law.

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	6.  	Facility Visits. MOLECULAR MEDICINE shall permit SPONSOR’S representatives to visit
MOLECULAR MEDICINE facilities during normal working hours, upon reasonable notice and with
reasonable frequency to observe PROJECT progress, discuss the PROJECT with appropriate
officials of MOLECULAR MEDICINE, and to inspect records and DATA relevant to the PROJECT.
Facility visits shall also be permitted during the DATA retention period.
	 
	7.  	Use of Names. SPONSOR shall not use the name of MOLECULAR MEDICINE or its employees in any
advertising or sales promotion materials or in any publication without prior written consent
of MOLECULAR MEDICINE. MOLECULAR MEDICINE shall not use SPONSOR’S name or the names of
SPONSOR’S employees in any advertising or sales promotion materials or in any publication
without prior written consent of SPONSOR. Notwithstanding the foregoing, SPONSOR may identify
MOLECULAR MEDICINE as the source of the PRODUCT in any regulatory submission associated with
the PROJECT without prior written consent.
	 
	8.  	Regulatory Issues: SPONSOR acknowledges that the MOLECULAR MEDICINE’S manufacturing
technology, as well as any technology licensed to MOLECULAR MEDICINE from third parties, and
any information related respectively thereto that is filed with the FDA or other health
regulatory authorities in countries other than the United States, is of crucial importance to
MOLECULAR MEDICINE and to such licensing parties, as well as to all other SPONSORS benefiting
from MOLECULAR MEDICINE’S technology. Such information includes all process related Biologic
(Type II) Master Files and Facility (Type V) Drug Master Files. MOLECULAR MEDICINE agrees to
provide SPONSOR with letters of cross-reference to all Master Files as appropriate. To assist
in preserving the integrity and value of such technology, SPONSOR agrees that it will not, on
its own initiative, analyze or engage in any research of such technology that may be
reasonably expected to raise safety concerns with the FDA regarding the use of such technology
in the PROJECT. If SPONSOR reasonably believes that such a study is necessary, SPONSOR shall
consult with MOLECULAR before engaging in such a study. SPONSOR further agrees to promptly
notify MOLECULAR MEDICINE of any and all communications and/or concerns expressed by the FDA
or any other health regulatory authority relating to the development and manufacture of the
PRODUCT including MOLECULAR MEDICINE’S manufacturing technology, and agrees to consult with
MOLECULAR MEDICINE to resolve any such concerns with the FDA or such other authority.
Non-compliance with the obligation to consult with MOLECULAR MEDICINE to resolve such concerns
with the FDA by SPONSOR shall be deemed to be a material breach of SPONSOR’S obligations under
this Agreement, permitting MOLECULAR MEDICINE at its sole discretion to terminate immediately
all or part of this Agreement pursuant to Section 23.3, in addition to such other rights that
MOLECULAR MEDICINE may have under law.
	 
	9.  	Limited Warranty. MOLECULAR MEDICINE shall perform the PROJECT with due care in accordance
with the Technical Specifications set forth in Exhibit A, Good Manufacturing Practices, and
all legal requirements. Any claim by SPONSOR for a breach of such warranty shall be made in
writing to MOLECULAR MEDICINE on or before the first anniversary of the date that SPONSOR is
notified PRODUCT is complete. The sole remedy of SPONSOR for breach of this warranty shall be,
at the SPONSOR’S option, for MOLECULAR MEDICINE to perform the PROJECT again, or to perform
again such portions of the PROJECT as may be required to correct the deficiency, or to refund
money spent equivalent to the value of work done by MOLECULAR MEDICINE. MOLECULAR MEDICINE
SHALL NOT BE RESPONSIBLE FOR GENETIC ALTERATIONS, INCLUDING THE FORMATION OF REPLICATION-
COMPETENT VIRUSES (SUCH AS REPLICATION-COMPETENT ADENOVIRUS OR REPLICATION-COMPETENT
RETROVIRUS) THAT OCCURS DURING PRODUCTION OF THE PRODUCT. SUCH GENETIC ALTERATIONS SHALL NOT
BE THE BASIS

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FOR A WARRANTY CLAIM BY SPONSOR. UNDER NO CIRCUMSTANCES SHALL MOLECULAR MEDICINE BE
LIABLE TO SPONSOR OR ANY THIRD PARTY CLAIMING BY OR THROUGH SPONSOR FOR ANY CONSEQUENTIAL,
SPECIAL, OR OTHER DAMAGES, AND THE WARRANTY SET FORTH HEREIN IS IN LIEU OF ANY AND ALL OTHER
WARRANTIES, WHETHER EXPLICIT OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. MOLECULAR MEDICINE’S
LIABILITY TO SPONSOR FOR THE BREACH OF ANY TERMS AND CONDITIONS OF THE SPECIFICATIONS SHALL
IN NO EVENT EXCEED THE FEE PAID BY SPONSOR TO MOLECULAR MEDICINE IN CONNECTION WITH THE
PROJECT.

	10.  	Indemnification.

10.1 Indemnification by SPONSOR. SPONSOR shall defend, indemnify and
hold harmless MOLECULAR MEDICINE, its members, managers, officers, employees
and agents (collectively the “MOLECULAR MEDICINE Indemnitees”) from and against
any and all liability, loss, expense (including reasonable attorneys’ fees), or claims for
injury or damages arising out of the manufacture, sale or use of the PRODUCT,
provided that SPONSOR shall have no obligation to indemnify the MOLECULAR
MEDICINE Indemnitees for any liability, loss, expense (including attorney’s fees), or
claims for injury or damages arising solely from the negligence or willful misconduct of
the MOLECULAR MEDICINE Indemnitees.

10.2 Indemnification bv MOLECULAR MEDICINE. MOLECULAR MEDICINE shall
defend, indemnify and hold harmless SPONSOR, its officers, directors, employees
and agents (collectively the “SPONSOR’S Indemnitees”) from and against any and
all liability, loss, expense (including reasonable attorneys’ fees), or claims for injury
or damages arising solely out of the negligence or willful misconduct of the
MOLECULAR MEDICINE Indemnitees, provided that MOLECULAR MEDICINE shall
have no obligation to indemnify the SPONSOR’S Indemnitees for any liability, loss,
expense (including attorneys’ fees), or claims for injury or damages arising solely from
the negligence or willful misconduct of the Sponsor’s Indemnitees.

10.3 Notification. The obligation of either party to indemnify the other pursuant
to this Agreement shall be contingent upon timely notification by the indemnitee to the
indemnitor of any claims, suit or service of process; control by the indemnitor over the
conduct and disposition of any claim, demand or suit; and cooperation by the
indemnitee in the defense of the demand or suit.

	11.  	Payment Terms. SPONSOR agrees to pay promptly all fees and expenses in
accordance with the terms set forth in this Agreement. Failure to timely pay any of
such amounts shall be deemed to be a material breach of SPONSOR’S obligations
under this Agreement, permitting MOLECULAR MEDICINE at its sole discretion to
terminate immediately all or part of this Agreement pursuant to Section 23.3, in
addition to such other rights that MOLECULAR MEDICINE may have under law.
	 
	12.  	Compliance with Law. SPONSOR will not use, transport, store, or dispose of the
PRODUCT in a manner inconsistent with (a) laws, regulations, rules or ordinances
applicable to the PRODUCT, including without limitation, all applicable requirements
and procedures of the United States Food and Drug Administration, or (b) health and
safety standards and procedures generally used in the industry. SPONSOR shall
obtain assurance of compliance with the preceding sentence from any of its affiliates,
agents, or assignees who use, transport, store, or dispose of the PRODUCT.

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	13.  	Excused Performance. Neither party shall be responsible for failure or
delay in performance of its obligations under or in connection with this Agreement due to
causes beyond its reasonable control, including but not limited to acts of God,
governmental actions, fire, labor difficulty, shortages, war, revolution, civil
disturbances, terrorism, sabotage, blockade, embargo, explosion, transportation
problems, interruptions of power or of communication, failure of suppliers or
subcontractors, or natural disasters.
	 
	14.  	Assignment. This agreement shall be binding upon and inure to the benefit of the
parties hereto, and their respective successors, assigns, legal representatives and
heirs. Either party may assign or transfer its rights and obligations under this
Agreement to a successor to all or substantially all of its assets or business relating to
this Agreement, whether by sale, merger, operation of law or otherwise upon written
notice to the other party. SPONSOR has the right to approve assignment of rights
and obligations of this agreement to a successor should the nature of business of the
assignee compromise the technical position of SPONSOR. If SPONSOR does not
approve of the assignee then SPONSOR has the right to terminate the Agreement
upon written notice within ten days. In this event SPONSOR will be responsible for
cost borne by MOLECULAR MEDICINE to date of termination as well as costs
incurred by MOLECULAR MEDICINE that are caused by the termination.
	 
	15.  	Independent Contractors. Nothing in this Agreement shall be construed to create
any relationship between MOLECULAR MEDICINE and SPONSOR other than of
independent contracting parties. Neither party shall have any right, power, or
authority to assume, create or incur an expense, liability, or obligation, express or
implied, on behalf of the other.
	 
	16.  	Waiver. No waiver by either party of any breach of any provision hereof shall
constitute a waiver of any other breach of that or any provision of this Agreement.
	 
	17.  	Severability. If any part, term or provision of this Agreement is determined to be
invalid or unenforceable, the remainder of the Agreement shall not be affected, and
the agreement shall remain in full force and effect.
	 
	18.  	Choice of Law. This Agreement shall be governed by the laws of the State of
California, regardless of the choice of law provisions of California or any other
jurisdiction.
	 
	19.  	Exhibits and Schedules. All exhibits and schedules attached hereto are hereby
incorporated in and made a part of this Agreement as if fully set forth herein.
	 
	20.  	Counterparts. This Agreement may be executed simultaneously in two or more
counterparts, each of which shall be deemed an original, but all of which together
shall constitute one and the same instrument.
	 
	21.  	Entire Agreement. This Agreement contains the final, complete and exclusive
agreement of the parties relative to the subject matter hereof and supersedes all prior
and contemporaneous understandings and agreements relating to its subject matter.
This Agreement may not be changed, modified, amended or supplemented except by
a written instrument signed by both parties.

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	22.  	Non-solicitation and non-hire. SPONSOR agrees not to solicit or hire personnel
from MOLECULAR MEDICINE for production or process development of viral vectors
for a period of two (2) years after completion of PROJECT unless agreed to in writing
by MOLECULAR MEDICINE.
	 
	23.  	Term and Termination. The term of this Agreement is from the Effective Date
through the completion of projects described in Exhibit A (the “Term”), unless
extended upon the agreement of the parties.

23.1
Termination by SPONSOR. SPONSOR may terminate this AGREEMENT at
any time for any reason, or no reason, upon thirty (30) days written notice. Upon
receipt of notice of termination from SPONSOR, MOLECULAR MEDICINE shall use its
best efforts to limit or terminate any outstanding financial commitments for which
SPONSOR is to be held responsible. SPONSOR shall reimburse MOLECULAR
MEDICINE for all costs incurred by it for services set forth in Exhibit A performed by
MOLECULAR MEDICINE prior to the effective date of termination, including all
noncancellable obligations. If SPONSOR terminates the Agreement under this
Section (23.1) or MOLECULAR MEDICINE terminates this Agreement pursuant to
Section (23.3) due to SPONSOR’S breach, in addition to any reimbursable expenses
provided for above, SPONSOR is obligated to pay a termination fee equal to ninety
four thousand and two hundred and fifty dollars ($94,250). The contract initiation fee
represents termination charges. At MOLECULAR MEDICINE’S sole discretion,
MOLECULAR MEDICINE will make a good faith effort to reduce this termination fee
by replacing lost production time made available by such termination with an
alternative production. In this event, MOLECULAR MEDICINE will return any residual
portion of SPONSOR’S initiation fee as determined by MOLECULAR MEDICINE.
MOLECULAR MEDICINE will co-operate with SPONSOR in the transfer of material
and DATA related to SPONSOR’S PROJECT as directed by the SPONSOR. If
SPONSOR terminates as provided for in section 23.3, it shall not be obligated for
payment of the Termination Fee.

23.2
Termination by MOLECULAR MEDICINE. MOLECULAR MEDICINE may
terminate this AGREEMENT at any time for any reason, or no reason, upon thirty (30)
days’ written notice. Upon giving notice of such termination, MOLECULAR MEDICINE
shall use its best efforts to limit or terminate any outstanding financial commitments for
which SPONSOR is to be held responsible. SPONSOR shall reimburse MOLECULAR
MEDICINE for all costs incurred by it for services set forth in Exhibit A performed by
MOLECULAR MEDICINE prior to the effective date of termination, including all
noncancellable obligations.

23.3 Termination for Material Breach. Either party shall have the right to
terminate this Agreement upon written notice to the other party if, after receiving written notice
of a material breach of this Agreement, the other party fails to cure such breach within
(i) ten (10) days from the date of such notice concerning a breach of any payment
obligation, or (ii) thirty (30) days from the date of such notice pertaining to all other
breaches.

23.4 Surviving Obligations. Termination or expiration of this Agreement shall not
affect any accrued rights of either party. The terms of Sections 2, 3.1, 3.3,3.6, 4.2, 5,
7, 8, 9, 10, 11, 12, 18, 19, 21,22, 23 and 25 of this Agreement shall survive
termination of this Agreement.

23.5 Notice. Notice of termination shall be in writing, by registered mail,
to the terminated party.

	24.  	Additional Projects. The parties acknowledge that from time to time SPONSOR
may request MOLECULAR MEDICINE to undertake additional projects involving
production services. In such event, the parties shall agree upon new Exhibits A, B,
and C for each project, with such exhibits to reference this Agreement. Except as set

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forth in such revised exhibits, all other terms and conditions of this Agreement shall
apply to subsequent projects.

	25.  	Notices. All notices required or permitted to be given under this Agreement shall be in
writing and shall be (a) mailed by registered or certified first-class mail, return receipt
requested, (b) mailed by Federal Express or other overnight delivery service, (c) transmitted
by facsimile, or (d) delivered personally. Such notices will be deemed to have been
sufficiently given for all purposes (i) five (5) days after mailing by registered first class
mail, (ii) two (2) days after sending by overnight delivery service, (iii) the same day if
sent by facsimile transmission with electronic confirmation of transmission if transmission is
confirmed during the recipient’s normal business hours, or otherwise on the recipient’s next
business day, or (iv) immediately if personally delivered. Unless otherwise specified in
writing, any notices will be sent to the following addresses:

	 	 	 	 	 
	

	 	If to MOLECULAR MEDICINE:
	 	MOLECULAR MEDICINE BIOSERVICES, INC.
	

	 	 	 	11772 Sorrento Valley Road
	

	 	 	 	Suite 200
	

	 	 	 	San Diego, CA 92121
	

	 	 	 	Attention: Renee Bozeat
                   c/o Greg Cerra
	 
	 	 	 	 
	

	 	If to SPONSOR:
	 	GENEMAX CORPORATION
	

	 	 	 	400 – 1681 Chestnut Street
	

	 	 	 	Vancouver, British Columbia V6J 4M6
	 
	 	 	 	 
	

	 	 	 	Attention: Tim Vitalis Ph.D.

[Signature page follows.]

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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first
above written.

MOLECULAR MEDICINE BIOSERVICES, INC.

	 	 	 	 	 
	By:

	 	/s/ David Backer
	 	3/18/03
	

	 	 
	 	 
	

	 	David Backer	 	Date
	

	 	President	 	 
	 
	 	 	 	 
	GENEMAX CORPORATION	 	 
	 
	 	 	 	 
	By:

	 	/s/ Ronald Handford
	 	3/18/03
	

	 	 
	 	 
	

	 	Ronald Handford	 	Date
	

	 	CEO	 	 

9exv10w6

 

Exhibit 10.6

NIAID BIOLOGICAL MATERIALS TRANSFER AGREEMENT

This Agreement is entered into by the National Institute of Allergy and Infectious Diseases
(“NIAID”), an institute of the National Institutes of Health (“NIH”), which is part of the U.S.
Public Health Service (“PHS”) and the Department of Health and Human Services (“DHHS”), an agency
of the U.S. Government, having an address at 6610 Rockledge Drive, Room 4071, Bethesda, Maryland
20892, U.S.A. and GeneMax Pharmaceuticals Inc. (“Recipient”), a corporation of Delaware, having an
office at 400 — 1681 Chestnut Street, Vancouver BC V6J 4M6, Canada.

	 	1.  	Definitions:

	 	a.  	“Materials” means the following biological
materials: Modified Vaccinia Ankara (MVA) virus
572.FHE-22.02.1974, as described in Mayr et al., Passage
history, properties and applicability of the attenuated
vaccinia virus strain MVA, Infection 3:6-14 (1975) and which
was plaque purified by Dr. Bernard Moss of the NIAID.
	 
	 	b.  	“Commercial Products” means a Modified Vaccinia
Ankara (MVA) Vaccine, which includes Materials or its
derivatives.

	 	2.  	Recipient wishes to use the Materials provided under this Agreement in its internal
commercial research, product development and marketing of Commercial Products. Recipient
represents that it has the facilities, personnel, and expertise to use the Materials for
such commercial purposes and agrees to expend reasonable efforts and resources to develop
Commercial Products in a timely manner using the Materials.
	 
	 	3.  	NIAID hereby grants to Recipient worldwide, non-exclusive rights to make, have
made, and use the Materials and to make and have made, to use and have used, to sell
and have sold, and to offer to sell Commercial Products in the Field of Use of
Smallpox Vaccines.
	 
	 	4.  	To the extent permitted by law, Recipient agrees to treat in confidence, for a period
of three (3) years from the date of its disclosure, any of NIAID’s written information
about the Materials that is stamped “CONFIDENTIAL,” except for information that was
previously known to Recipient or that is or becomes publicly available or which is
disclosed to Recipient without a confidentiality obligation. Any oral disclosures from
NIAID to Recipient shall be identified as being CONFIDENTIAL by notice delivered to
Recipient within ten (10) days after the date of the oral disclosure. Recipient may publish
or otherwise publicly disclose the results of its research activities with the Materials,
but if NIAID has given CONFIDENTIAL information to Recipient such public disclosure may be
made only after NIAID has had thirty (30) days to review the proposed disclosure to
determine if it includes any CONFIDENTIAL information, except when a shortened time period
under court order pertains.
	 
	 	5.  	Recipient agrees to provide a written report to NIAID within sixty (60) days after the
end of each calendar year during the term of this Agreement. This report shall document the
progress made towards producing a smallpox vaccine and list all activities and results
obtained using the Materials during the preceding calendar year. Recipient shall submit
these reports to NIAID at the Mailing Address for Notices indicated on the Signature Page
of this Agreement.
	 
	 	6.  	Recipient agrees to provide, at no charge, the laboratory of Dr. Bernard Moss at NIAID
reasonable quantities of Materials and Commercial Products that Recipient makes, uses,
sells, or offers for sale or otherwise makes available for public use under terms no more
restrictive than those of the NIH Simple Letter Agreement (Federal Register [64 FR 72090]
p. 72094).
	 
	 	7.  	Recipient agrees to retain control over the Materials, and not to distribute them to
third parties without the prior written consent of NIAID a) except as permitted in
Paragraph 3 and b) except that Recipient may transfer the Materials to its contractor for
the sole purpose of developing Licensed Products or Licensed Processes. In the case of b)
above, Recipient agrees to notify the NIAID in writing and to ensure that the

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	 	   	agreement between Company and the contractor will be consistent with the Company’s obligations
under this Agreement.
	 
	 	8.  	Recipient agrees that this Agreement does not preclude NIAID from distributing the Materials
to third parties for research or commercial purposes.
	 
	 	9.  	By this Agreement, NIAID grants no patent rights expressly or by implication to any
anticipated or pending NIAID patent applications or issued patents.
	 
	 	10.  	NO WARRANTIES, EXPRESS OR IMPLIED, ARE OFFERED AS TO THE MERCHANTABILITY OR FITNESS FOR ANY
PURPOSE OF THE MATERIALS PROVIDED TO RECIPIENT UNDER THIS AGREEMENT, OR THAT THE MATERIALS OR
COMMERCIAL PRODUCTS MAY BE EXPLOITED WITHOUT INFRINGING THE PATENT RIGHTS OF ANY THIRD
PARTIES. Recipient accepts transfer of the Materials “as is”, and NIAID does not offer any
guarantee of any kind.
	 
	 	11.  	Recipient agrees to indemnify and hold harmless the United States Government from any claims,
costs, damages, or losses that may arise from or through Recipient’s use of the Materials or
Commercial Products. Recipient further agrees that it will not by its action bring the United
States Government into any lawsuit involving the Materials or Commercial Products.
	 
	 	12.  	Recipient agrees in its use of Materials to comply with all applicable statutes, regulations,
and guidelines, including PHS and DHHS regulations and guidelines. Recipient agrees not to use
the Materials or the Commercial Products for research involving human subjects or clinical
trials in the United States without complying with 21 C.F.R. Part 50 and 45 C.F.R. Part 46.
Recipient agrees not to use the Materials or Commercial Products for research involving hitman
subjects or clinical trials outside of the United States without notifying NIAID, in writing,
of such research or trials and complying with the applicable regulations of the appropriate
national control authorities. Written notification to NIAID of research involving human
subjects or clinical trials outside of the United States shall be given no later than sixty
(60) days prior to commencement of such research or trials.
	 
	 	13.  	Recipient may terminate this Agreement upon sixty (60) days written notice to NIAID.
	 
	 	14.  	NIAID may terminate this Agreement if Recipient is in default in the performance of any
material obligation under this Agreement, and if the default has not been remedied within
ninety (90) days after the date of written notice by NIAID of such default.
	 
	 	15.  	Upon termination of this Agreement, Recipient agrees to return all Materials and Commercial
Products to NIAID, or provide NIAID with certification of their destruction.
	 
	 	16.  	Within ninety (90) days of termination of this Agreement, Recipient agrees to submit a final
report to NIAID that specifies all activities and results
related to use of Materials and
Commercial Products by Recipient.
	 
	 	17.  	This Agreement shall be construed in accordance with U.S. Federal law, as interpreted and
applied by the U.S. Federal courts in the District of Columbia. Federal law and regulations
will preempt any conflicting or inconsistent provisions in this Agreement. Recipient agrees to
be subject to the jurisdiction of U.S. courts.
	 
	 	18.  	This Agreement constitutes the entire understanding of NIAID and Recipient and supersedes all
prior agreements and understandings with respect to the Materials.
	 
	 	19.  	This Agreement shall become effective on the date when the last party has signed this
Agreement.
	 
	 	20.  	The provisions of this Agreement are severable, and in the event that any provision of this
Agreement shall be determined to be invalid or unenforceable under any controlling body of
law, such invalidity or unenforceability shall not in any way affect the validity or
enforceability of the remaining provisions of this Agreement.

NIAID Biological Materials Transfer Agreement CONFIDENTIAL

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10-09-2003

 

 

	21.  	Each Party has caused this Agreement to be executed on its behalf in duplicate, each
of which shall be deemed to be an original.
	 
	22.  	Paragraphs 4, 10, 11, 12, 15, 17, 18, 20, and 22 shall survive termination of this Agreement.

SIGNATURES BEGIN ON NEXT PAGE

NIAID Biological Materials Transfer Agreement CONFIDENTIAL

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NIAID BIOLOGICAL
MATERIALS TRANSFER AGREEMENT

 SIGNATURE PAGE

In Witness Whereof, the parties have executed this Agreement on the dates set forth below. Any
communication or notice to be given shall be forwarded to the respective addresses listed below.

For NIAID:

	 	 	 
	Michael R. Mowatt

	 	Date 10 Oct 2003
	

	 	 
	Michael R. Mowatt, Ph.D.
	 	 
	Director, Office of Technology Development
	 	 

		
	Mailing Address for Notices: 	OFFICE OF TECHNOLOGY DEVELOPMENT

NIAID, NTH

6610 Rockledge Drive Room 4071

Bethesda MD 20892-6606

Tel: 301/496-2644    Fax: 301/402-7123

For Recipient (Upon, information and belief, the undersigned expressly certifies or affirms that
the contents of any statements of Recipient made or referred to in this document are truthful and
accurate.):

By: GeneMax Pharmaceuticals Inc.

	Signature of Authorized Official

	 	Date 21 Oct 2003
	

	 	 
	 
	Ronald L. Handford
	 	 
	President & CEO
	 	 

Official and Mailing Address for Notices:

GeneMax Pharmaceuticals Inc.

400-1681 Chestnut Street,

Vancouver B.C.

Canada

V6J4M6

Any false or misleading statements made, presented, or submitted to the U.S. Government, including
any relevant omissions, under this Agreement and during the course of negotiation of this Agreement
are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. §§
3801-3812 (civil liability) and 18 U.S.C. § 1001 (criminal liability including fine(s) and/or
imprisonment).

NIAID Biological Materials Transfer Agreement CONFIDENTIAL

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