Exhibit
10.24


 


LICENSE
AGREEMENT


 


This Agreement is made
and entered into between the President and Fellows of Harvard College
(hereinafter HARVARD) having offices at the Office for Technology and Trademark
Licensing, 124 Mt. Auburn Street, Suite 440, Cambridge, Massachusetts, 02138
and Virus Research Institute (hereinafter LICENSEE), a corporation of
Cambridge, MA, having offices at 61 Moulton Street, Cambridge, MA 02139.


 


Whereas HARVARD and The
General Hospital Corporation (GENERAL) doing business as Massachusetts General
Hospital are or will be the Owners by assignment, of the entire right, title
and interest in the following United States patent applications, and in the
foreign patent applications corresponding thereto, and in the inventions
described and claimed therein and any patents issuing thereon, and whereas
GENERAL and HARVARD have agreed to cooperate in the patent and license
administration of such patent applications:


 


U.S.S.N. 629,602 -
“Improved Vaccines”; filed December 18, 1990; Inventors: John Mekalanos
and Samuel Miller.


 


U.S.S.N. 629,102 -
“Vibrio Cholerae Strains Defective in irgA Expression and Cholera Vaccines
Derived Therefrom”; filed December 18, 1990; Inventors: John Mekalanos and
Stephen Calderwood.


 


U.S.S.N. 000,000 -
“Doubly-Attenuated Strain of Vibrio Cholerae to Deliver Heterlogous Antigens
for Vaccination” to be filed in 1992; Inventors: John Mekalanos and Stephen
Calderwood (serial number and filing date to be inserted when available;


 


Whereas GENERAL has
agreed HARVARD is its sole licensing agent for these jointly owned patent
applications; and


 


Whereas HARVARD is the
Owner by assignment of the entire right, title and interest in the following
United States Patents or Patent Applications and in the foreign patent
applications corresponding thereto, and in the inventions described and
contained therein:


 


U.S.S.N. 043,907 -
“Cholera Vaccines”; filed April 29, 1987 and its CIP USSN 5,098,998, filed
April 29, 1988; Inventors: John Mekalanos and Ronald Taylor.


 


U.S. 4,882,278 - “Non-Toxic
Vibrio Cholera Mutants”; issued November 21, 1989; Inventor: John
Mekalanos.


 


U.S.S.N 000,000 -
“Peruvian Strain of Cholera Vaccine”; to be filed in 1992; Inventor: John
Mekalanos (serial number and filing date to be inserted when available); and


 

















 


Whereas HARVARD and
GENERAL are the Owners by assignment from the inventors of the BIOLOGICAL
MATERIAL as defined in Appendix B and have the right to license the BIOLOGICAL
MATERIAL; and


 


Whereas HARVARD and the
GENERAL are committed to a policy that ideas or creative works produced at
HARVARD and the GENERAL should be used for the greatest possible public
benefit; and


 


Whereas HARVARD
accordingly believes that every reasonable incentive should be provided for the
prompt introduction of such ideas into public use, all in a manner consistent
with the public interest; and


 


Whereas LICENSEE is
desirous of obtaining an exclusive worldwide license in order to practice the
above referenced inventions covered by PATENT RIGHTS and to use the BIOLOGICAL
MATERIAL in the United States and in certain foreign countries, and to
manufacture, use and sell in the commercial market the products made in
accordance therewith; and


 


Whereas HARVARD is
desirous of granting such a license to LICENSEE in accordance with the terms of
this Agreement. Now therefore, in consideration of the foregoing premises, the
parties agree as follows:


 


ARTICLE
I - DEFINITIONS


 


1.1                                 PATENT
RIGHTS shall mean any and all United States patents or patent applications
listed above and attached hereto in Appendix A, the inventions described and
claimed therein, and any divisions, continuations, continuations-inpart
directed to subject matter specifically described in the application and
patents listed in Appendix A, patents issuing thereon or reissues thereof; and
any and all foreign patents and patent applications corresponding thereto;
which will be automatically incorporated in and added to this Agreement and
shall periodically be added to Appendix A and made a part thereof. To the
extent HARVARD’s obligations to third parties permit, PATENT RIGHTS shall also
include all IMPROVEMENT INVENTIONS. IMPROVEMENT INVENTIONS shall mean any
inventions or discoveries that enhance, substitute for, or are useful with the
products, procedures or processes described in PATENT RIGHTS to the extent they
are (i) dominated by any claims of a pending and/or issued patent or patent
application which is then included in the PATENT RIGHTS, and HARVARD’s
ownership interest in any United States or foreign patents and patent application
thereon, and (ii) made (i.e., conceived and reduced to practice) by Dr. John
Mekalanos solely or jointly with others directly supervised in his laboratory
at Harvard Medical School. IMPROVEMENT INVENTIONS shall not include inventions
assignable to GENERAL


 


1.2                                 LICENSED
PRODUCTS shall mean products covered in whole or in part by an issued,
unexpired claim or a pending claim contained in PATENT RIGHTS which has not
been declared invalid by a court of competent jurisdiction.


 


1.3                                 LICENSED
PROCESSES shall mean processes covered in whole or in part by an issued,
unexpired claim or a pending claim contained in PATENT RIGHTS which has not
been declared invalid by a court of competent jurisdiction.


 


2

















 


1.4                                 NET
SALES shall mean the amount billed or invoiced on sales of LICENSED PRODUCTS
less:


 


(a)                                  Customary
trade, quantity or cash discounts and non-affiliated brokers’ or agents’
commissions actually allowed and taken;


 


(b)                                 Amounts
repaid or credited by reason of rejection or return; and/or


 


(c)                                  To
the extent separately stated on purchase orders, invoices or other documents of
sale, taxes levied on and/or other governmental charges made as to production,
sale, transportation, delivery or use and paid by or on behalf of LICENSEE.


 


1.5                                 AFFILIATES
shall mean any company, corporation, or business (i) in which LICENSEE directly
or indirectly owns or controls at least fifty percent (50%) of the voting
stock, or (ii) which directly or indirectly owns or controls at least fifty
percent (50%) of the voting stock of LICENSEE or (iii) the majority ownership
of which is directly or indirectly under common control with LICENSEE.


 


1.6                                 BIOLOGICAL
MATERIAL shall mean the materials supplied by HARVARD and GENERAL (identified
in Appendix B).


 


1.7                                 TECHNOLOGY
shall mean any and all information or PATENT RIGHTS, or BIOLOGICAL MATERIAL
supplied by HARVARD and GENERAL to LICENSEE.


 


ARTICLE
II - GRANT


 


2.1                                 For
the term of this Agreement, HARVARD hereby grants to LICENSEE and LICENSEE accepts,
subject to the terms and conditions hereof, a worldwide license under PATENT
RIGHTS and a worldwide license to use the BIOLOGICAL MATERIAL, to make and have
made, to use and have used, to sell and have sold the LICENSED PRODUCTS, and to
practice the LICENSED PROCESSES. Such license shall include the right to grant
sublicenses. In order to provide LICENSEE with a period of exclusivity, HARVARD
agrees it will not grant licenses to others except as required under Paragraph
2.2 (a) or as permitted in paragraph 2.2 (b). LICENSEE agrees during the period
of exclusivity of this license in the United States that any LICENSED PRODUCT
produced for sale in the United States will be manufactured substantially in
the United States.


 


2.2                                 The
granting and acceptance of this license is subject to the following conditions:


 


(a)                                  HARVARD’s
“Statement of Policy in Regard to Inventions, Patents and Copyrights” dated
March 17, 1986, Public Law 96-517, Public Law 98-620 and HARVARD’s and
GENERAL’S obligations under agreements with other sponsors of research. Any
right granted in this Agreement greater than that permitted under Public Law
96-517 or Public Law 98-620 shall be subject to modification as may be required
to conform to the provisions of that statute.


 


(b)                                 HARVARD’s
and GENERAL’s right to make and to use and to grant non-exclusive licenses to
make and to use, for academic research purposes only and for GENERAL’s


 


3

















 


internal inpatient care purposes and not for any commercial purpose,
the subject matter described and claimed in PATENT RIGHTS, or the BIOLOGICAL
MATERIAL.


 


(c)                                  LICENSEE
shall use reasonable effort to effect introduction of the LICENSED PRODUCTS
into the commercial market as soon as practicable, consistent with sound and
reasonable business practices and judgment; thereafter, until the expiration of
this Agreement, LICENSEE shall endeavor to keep LICENSED PRODUCTS reasonably
available to the public.


 


(d)                                 HARVARD
shall have the right to terminate or render non-exclusive any license granted
hereunder if in HARVARD’s reasonable judgement, LICENSEE:


 


(i)                                has
not, within five years from the date of this Agreement, commenced clinical
trials of a LICENSED PRODUCT or LICENSED PROCESS in the country or countries
where licensed; and/or


 


(ii)                             is
not, within one year of the date of this Agreement, demonstrably engaged in
on-going research, development, or marketing or licensing programs as
appropriate, directed toward commercial use of the LICENSED PRODUCT or LICENSED
PROCESSES.


 


In making this determination HARVARD shall take into
account the normal course of such programs conducted with sound and reasonable
business practices and judgment and shall take into account the reports
provided hereunder by LICENSEE.


 


(e)                                  All
sublicenses granted by LICENSEE hereunder shall include a requirement that the
sublicensee use its good faith efforts to bring the subject matter of the
sublicense into commercial use as quickly as is reasonably possible consistent
with sound and reasonable business practices and judgement and shall bind the
sublicensee to meet LICENSEE’s obligations to HARVARD under this Agreement.
Royalties charged for sublicenses by LICENSEE shall not be in excess of normal
trade practice. Copies of all sublicense agreements shall be provided to
HARVARD.


 


(f)                                    In
the event that LICENSEE is in default of its obligations under Section 2.2
(c) or (e) or Article III, and such default remains unresolved following
notice as provided in Section 8.2 or LICENSEE fails to meet the milestones
specified in Section 2.2 (d) and HARVARD does not thereafter exercise it
right to terminate this license, and LICENSEE is thereafter unable or unwilling
to grant sublicenses, either as suggested by HARVARD or a potential sublicensee
or otherwise, HARVARD may directly license such potential sublicensee unless
LICENSEE reasonably satisfies HARVARD that such sublicense would be contrary to
sound and reasonable business practice, and that the granting of such
sublicense would not materially increase the availability to the public of
products manufactured under this license.


 


(g)                                 HARVARD
shall have the right to terminate this Agreement if LICENSEE does not have
commitments for a minimum of one million dollars ($1,000,000) of investment
capital within six (6) months of the signing of this Agreement, and three
million dollars ($3,000,000) of total funding within thirty-six (36) months of
the signing of this Agreement.


 


4

















 


2.3                                 HARVARD
hereby grants to LICENSEE the right to extend the licenses granted or to be
granted in paragraph 2.1 to an AFFILIATE subject to the terms and conditions
hereof.


 


2.4                                 All
rights reserved to the United States Government and others under Public Law
96-517 and 98-620 shall remain and shall in no way be affected by this
Agreement.


 


ARTICLE
III - ROYALTIES


 


3.1                                 LICENSEE
shall pay to HARVARD a non-refundable license fee in the sum of $200,000 in two
equal installments, the first upon execution of this Agreement, and the second
six months after the signing of this Agreement.


 


3.2                                 LICENSEE
shall pay HARVARD, during the term of the license granted in Section 2.1,
a royalty of four percent (4%) of the NET SALES of all LICENSED PRODUCTS sold
by LICENSEE and its AFFILIATES or sublicensees to commercial organizations, and
two percent (2%) of the NET SALES of all LICENSED PRODUCTS sold by LICENSEE and
its AFFILIATES or sublicensees to non-profit or government agencies. In the
case of sublicenses, LICENSEE shall also pay to HARVARD twenty-five percent (25%)
of non-royalty sublicense income (e.g., license issue fees, license maintenance
fees, etc.) from commercial organizations, and ten percent (10%) of all such
income from government or non-profit organizations. If this license is
converted to a non-exclusive one and if other non-exclusive licenses are
granted, this royalty shall not exceed the royalty being paid by other
licensees during the term of the non-exclusive license. On sales between
LICENSEE and its AFFILIATES or sublicensees for resale, the royalty shall be
paid on the resale.


 


3.3                                 HARVARD
shall have the right to terminate or render non-exclusive this license in the
event that LICENSEE does not pay to HARVARD at least the following amounts in
license maintenance fees and/or minimum royalties:


 


	
  First
  calendar year

  	
   

  	
  -$

  	
  10,000

  	
   

  
	
  Next
  calendar year

  	
   

  	
  -$

  	
  15,000

  	
   

  
	
  Next
  calendar year and each year thereafter.

  	
   

  	
  -$

  	
  20,000

  	
   

  



 


In the event that actual royalties are not at least equal to the above
amounts for the specified periods, LICENSEE shall have the right to pay any
difference between such minimum amounts and the actual royalties paid in
satisfaction of its obligations under this Section 3.3.


 


3.4                                 In
the event that LICENSEE is required to pay royalties to one or more third
parties under patents other than PATENT RIGHTS covering LICENSED PRODUCTS or
LICENSED PROCESSES, LICENSEE shall be entitled to a credit against royalties
due HARVARD in an amount equal to fifty percent (50%) of royalties paid to such
third parties, provided that in no event shall the royalties otherwise due
HARVARD be reduced by more than one-half.


 


3.5                                 In
the event that the royalties paid to HARVARD are so significant a factor in the
return realized by LICENSEE as to diminish LICENSEE’s capability to respond to
competitive pressures in the market, HARVARD agrees to consider a reasonable
reduction in the royalty paid to HARVARD as to each LICENSED PRODUCT for the
period during which such market


 


5

















 


condition exists. Factors determining the size of the reduction will
include profit margin on LICENSED PRODUCTS and on analogous products, prices of
competitive products, total prior sales by LICENSEE, and LICENSEE’s
expenditures on LICENSED PRODUCT development.


 


ARTICLE
IV - REPORTING


 


4.1                                 Prior
to signing this Agreement, LICENSEE has provided to HARVARD a written research
and development plan under which LICENSEE intends to bring the subject matter
of the licenses granted hereunder into commercial use upon execution of this
Agreement. Such plan includes projections of sales and proposed marketing
efforts.


 


4.2                                 LICENSEE
shall provide written annual reports within sixty (60) days after June 30
of each calendar year which shall include but not be limited to: reports of
progress on research and development, regulatory approvals, manufacturing,
sublicensing, marketing and sales during the preceding twelve (12) months as
well as plans for the coming year. If progress differs from that anticipated in
the plan provided under Section 4.1, LICENSEE shall explain the reasons
for the difference and propose a modified plan for HARVARD’s review and
approval. LICENSEE shall also provide any reasonable additional data HARVARD
requires to evaluate LICENSEE’s performance.


 


4.3                                 LICENSEE
shall report to HARVARD the date of first sale of LICENSED PRODUCTS (or results
of LICENSED PROCESSES) in each country within thirty (30) days of occurrence.


 


4.4                                 Commencing
with the calendar year half in which Net Sales first occur, LICENSEE agrees to
submit to HARVARD within sixty (60) days after the calendar half years ending
June 30 and December 31, reports setting forth for the preceding six
(6) month period the amount of the LICENSED PRODUCTS sold by LICENSEE, its
AFFILIATES and sublicensees in each country, the NET SALES thereof, and the
amount of royalty due thereon and with each such royalty any non-royalty
sublicense income and pay the amount of royalty due. Such report shall be
certified as correct by an officer of LICENSEE and shall include a detailed
listing of all deductions from NET SALES, sublicensee income or from royalties
as specified herein. Such report shall also specify which PATENT RIGHTS are
used in or by each LICENSED PRODUCT generating royalty income. If no royalties
are due to HARVARD for any reporting period, the written report shall so state.
If royalties for any calendar year do not equal or exceed the minimum royalties
established in paragraph 3.3, LICENSEE shall include the balance of the minimum
royalty with the payment for the half year ending December 31. All
royalties due hereunder shall be payable in United States dollars. Conversion
of foreign currency to U.S. dollars shall be made at the conversion rate
existing in the United States on the, last business day in the reporting period
as reported in the Wall Street Journal. All such reports shall be maintained in
confidence by HARVARD, except as required by law, including Public Law 96-517
and 98-620.


 


4.5                                 If
by law, regulation, of fiscal policy of a particular country, conversion into
United States dollars or transfer of funds of a convertible currency to the
United States is restricted or forbidden, LICENSEE shall give HARVARD prompt
notice in writing and shall pay the royalty and other amounts due through such
means or methods as are lawful in such country


 


6

















 


as HARVARD may reasonably designate. Failing the designation by HARVARD
of such lawful means or methods within thirty (30) days after such notice is
given to HARVARD, LICENSEE shall deposit such royalty payment in local currency
to the credit of HARVARD in a recognized banking institution designated by
HARVARD, or if none is designated by HARVARD within the thirty (30) day period
described above, in a recognized banking institution selected by LICENSEE and
identified in a written notice to HARVARD by LICENSEE, and such deposit shall
fulfill all obligations of LICENSEE to HARVARD with respect to such royalties.


 


ARTICLE V - RECORD KEEPING


 


5.1                                 LICENSEE
shall keep, and shall require its AFFILIATES and sublicensees to keep accurate
and correct records of LICENSED PRODUCTS made, used or sold under this
Agreement, appropriate to determine the amount of royalties due hereunder to
HARVARD. Such records shall be retained for at least three (3) years following
a given reporting period. They shall be available during normal business hours
for inspection at the expense of HARVARD by HARVARD’s Internal Audit Department
or by a Certified Public Accountant selected by HARVARD and approved by
LICENSEE for the sole purpose of verifying reports and payments hereunder. Such
accountant shall not disclose to HARVARD any information other than information
relating to accuracy of reports and payments made under this Agreement. In the
event that any such inspection shows an under reporting and underpayment in
excess of five percent (5%) for any twelve (12) month period, then LICENSEE
shall pay the cost of such examination.


 


ARTICLE VI - DOMESTIC AND FOREIGN PATENT FILING AND
MAINTENANCE


 


6.1                                 LICENSEE
shall reimburse HARVARD for all reasonable expenses HARVARD and GENERAL have
incurred and shall incur for the preparation, filing, prosecution and
maintenance of PATENT RIGHTS for which HARVARD or GENERAL has not been, and is
not eligible to be reimbursed by any third party. HARVARD and GENERAL shall
take responsibility for the preparation, filing, prosecution and maintenance of
any and all patent applications and patents included in PATENT RIGHTS using
patent counsel reasonably acceptable to LICENSEE, provided however that HARVARD
and GENERAL shall first consult with LICENSEE as to the preparation, filing,
prosecution and maintenance of such patent applications and patents and shall
furnish to LICENSEE copies of documents relevant to any such preparation,
filing, prosecution or maintenance.


 


6.2                                 HARVARD,
GENERAL, and LICENSEE shall cooperate fully in the preparation, filing,
prosecution and maintenance of PATENT RIGHTS and of all patents and patent
applications licensed to LICENSEE hereunder, executing all papers and
instruments or requiring members of HARVARD and GENERAL to execute such papers
and instruments so as to enable HARVARD and GENERAL to apply for, to prosecute
and to maintain patent applications and patents in HARVARD’s and/or GENERAL’s
name in any country. Each party shall provide to the other prompt notice as to
all matters which come to its attention and which may affect the preparation,
filing, prosecution or maintenance of any such patent applications or patents.


 


6.3                                 If
LICENSEE elects not to pay the expenses of a patent application or patent
included within PATENT RIGHTS in a particular country, LICENSEE shall notify
HARVARD


 


7

















 


not less than sixty (60) days prior to such action and shall thereby
surrender its rights under such patent or patent application in such country.
LICENSEE agrees that it shall not exercise this right for the purpose of
avoiding the payment of royalties otherwise due in such country.


 


ARTICLE
VII - INFRINGEMENT


 


7.1                                 With
respect to any PATENT RIGHTS under which LICENSEE is exclusively licensed
pursuant to this Agreement, LICENSEE or its sublicensee shall have the right to
prosecute in its own name and at its own expense any infringement of such
patent, so long as such license is exclusive at the time of the commencement of
such action. HARVARD agrees to notify LICENSEE promptly of each infringement of
such patents of which HARVARD is or becomes aware. Before LICENSEE or its
sublicensees commences an action with respect to any infringement of such patents,
LICENSEE shall give careful consideration to the views of HARVARD and to
potential effects on the public interest in making its decision whether or not
to sue and in the case of a LICENSEE sublicense, shall report such views to the
sublicensee.


 


7.2                                 If
LICENSEE or its sublicensee elects to commence an action as described above and
HARVARD and/or GENERAL is a legally indispensable party to such action, HARVARD
and/or GENERAL shall have the right to assign to LICENSEE all of HARVARD’s
and/or GENERAL’s right, title and interest in each patent which is a part of
the PATENT RIGHTS and is the subject of such action (subject to all HARVARD’s
and/or GENERAL’s obligations to the government and others having rights in such
patent). In the event that HARVARD and/or GENERAL makes such an assignment,
such assignment shall be irrevocable, and such action by LICENSEE on that
patent or patents shall thereafter be brought or continued without HARVARD
and/or GENERAL as a party, if HARVARD and/or GENERAL is no longer an
indispensable party. Notwithstanding any such assignment to LICENSEE by HARVARD
and/or GENERAL and regardless of whether HARVARD and/or GENERAL is or is not an
indispensable party, HARVARD and/or GENERAL shall cooperate fully with
LICENSEE, at LICENSEE’s expense, in connection with any such action. In the
event that any patent is assigned to LICENSEE by HARVARD and/or GENERAL,
pursuant to this paragraph, such assignment shall require LICENSEE to continue
to meet its obligations under this Agreement as if the assigned patent or
patent application were still licensed to LICENSEE.


 


7.3                                 If
LICENSEE or its sublicensee elects to commence an action as described above,
LICENSEE may reduce, by up to 50%, the royalty due to HARVARD earned under the
patent subject to suit by the amount of the expenses and costs of such action,
including attorney fees. In the event that such expenses and costs exceed the
amount of royalties withheld by LICENSEE for any calendar year, LICENSEE may to
that extent reduce the royalties due to HARVARD from LICENSEE in succeeding
calendar years, but never by more than 50% of the royalty due in any one year.


 


7.4                                 Recoveries
or reimbursements from such action shall first be applied to reimburse LICENSEE
and HARVARD and GENERAL for litigation costs not paid from royalties (if any)
and then to reimburse HARVARD for royalties withheld. Any remaining recoveries
or reimbursements shall be distributed two-thirds to LICENSEE and one-third to
HARVARD.


 


8

















 


7.5                                 In
the event that LICENSEE and its sublicensee, if any, elect not to exercise
their right to prosecute an infringement of the PATENT RIGHTS pursuant to the
above paragraphs, HARVARD and/or GENERAL may do so at its own expense,
controlling such action and retaining all recoveries therefrom.


 


ARTICLE VIII - TERMINATION OF AGREEMENT


 


8.1                                 This
Agreement, unless extended or terminated as provided herein, shall remain in
effect for the life of the last to expire of PATENT RIGHTS licensed hereunder.


 


8.2                                 In
the event that one party to this Agreement shall be in default in the
performance of any obligations under this Agreement, and if the default has not
been remedied within ninety (90) days after the date of notice in writing of
such default, the party giving such notice may terminate this Agreement by
written notice.


 


8.3                                 In
the event that LICENSEE shall cease to carry on its business, HARVARD shall
have the right to terminate this entire Agreement by giving LICENSEE written
notice of such termination.


 


8.4                                 Any
sublicenses granted by LICENSEE under this Agreement shall provide for
termination or assignment to HARVARD, at the option of HARVARD, of LICENSEE’s
interest therein upon termination of this Agreement.


 


8.5                                 LICENSEE
shall have the right to terminate this Agreement by giving thirty (30) days
advance written notice to HARVARD to that effect. Upon termination, a final
report shall be submitted and any royalty payments and unreimbursed patent
expenses due to HARVARD become immediately payable.


 


8.6                                 Sections
8.5, 9.2, 9.3 and 9.4 of this Agreement shall survive termination.


 


ARTICLE
IX - GENERAL


 


9.1                                 HARVARD
represents and warrants that the entire right, title, and interest in the
patent applications or patents comprising the PATENT RIGHTS have been or will
be assigned to it and/or GENERAL and that HARVARD has the authority to issue
the licenses under said PATENT RIGHTS set forth herein. HARVARD does not
warrant the validity of the PATENT RIGHTS licensed hereunder and makes no
representations whatsoever with regard to the scope of the licensed PATENT
RIGHTS or that such PATENT RIGHTS may be exploited by LICENSEE, an AFFILIATE,
or sublicensee without infringing other patents.


 


9.2                                 EXCEPT
AS PROVIDED IN SECTION 9.1, HARVARD EXPRESSLY DISCLAIMS ANY AND ALL IMPLIED OR
EXPRESS WARRANTIES AND MAKES NO EXPRESS OR IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS OF THE TECHNOLOGY, LICENSED PROCESSES OR LICENSED
PRODUCTS CONTEMPLATED BY THIS AGREEMENT.


 


9.3                                 (a)                                  LICENSEE
shall indemnify, defend and hold harmless HARVARD and GENERAL and their
directors, governing board members, trustees, officers, faculty, medical and


 


9

















 


professional staff, employees, students, and agents and their
respective successors, heirs and assigns (the “Indemnitees”), against any
liability, damage, loss or expenses (including reasonable attorneys’ fees and
expenses of litigation) incurred by or imposed upon the Indemnities or any one
of them in connection with any claims, suits, actions, demands or judgments
arising out of any theory of product liability (including, but not limited to,
actions in the form of tort, warranty, or strict liability) concerning any
product, process or service used or sold pursuant to any right or license
granted under this Agreement. LICENSEE’s indemnification under this
Section shall apply to any liability, damage, loss or expense whether or
not it is attributable to the negligent activities of the Indemnities.


 


(b)                                 LICENSEE
agrees, at its own expense, to provide attorneys reasonably acceptable to
HARVARD to defend against any actions brought or filed against any party
indemnified hereunder with respect to the subject of indemnity contained
herein, whether or not such actions are rightfully brought.


 


(c)                                  At
such time as any such product, process, service is being commercially
distributed or sold (other than for the purpose of obtaining regulatory
approvals) by LICENSEE or by a sublicensee, AFFILIATE or agent of LICENSEE,
LICENSEE shall, at its sole cost and expense, procure and maintain
comprehensive general liability insurance in amounts not less $2,000,000 per
incident and $2,000,000 annual aggregate and naming the Indemnitees as
additional insureds. During clinical trials of any such product, process or
service, LICENSEE shall, at its sole cost and expense, procure and maintain
comprehensive general liability insurance in such equal or lesser amount as
HARVARD shall require, naming the Indemnitees as additional insureds. Such
comprehensive general liability insurance shall provide (i) product liability
coverage and (ii) broad form contractual liability coverage for LICENSEE’s
indemnification under this Agreement. If LICENSEE elects to self-insure all or
part of the limits described above (including deductibles or retentions which
are in excess of $250,000 annual aggregate) such self-insurance program must be
acceptable to HARVARD and the Risk Management Foundation of the Harvard Medical
Institutions, Inc. The minimum amounts of insurance coverage required shall not
be construed to create a limit of LICENSEE’s liability with respect to its
indemnification under this Agreement.


 


(d)                                 LICENSEE
shall provide HARVARD with written evidence of such insurance upon request of
HARVARD. LICENSEE shall provide HARVARD with written notice at least fifteen
(15) days prior to the cancellation, non-renewal or material change in such
insurance; if LICENSEE does not obtain replacement insurance providing
comparable coverage within such fifteen (15) day period, HARVARD shall have the
right to terminate this Agreement effective at the end of such fifteen (15) day
period without notice or any additional waiting periods.


 


(e)                                  LICENSEE
shall maintain such comprehensive general liability insurance beyond the
expiration or termination of this Agreement during (i) the period that any
product, process, or service, relating to, or developed pursuant to, this
Agreement is being commercially distributed or sold by LICENSEE or by a
sublicensee, AFFILIATE or agent of LICENSEE and (ii) a reasonable period after
the period referred to in (e) (i) above which in no event shall be less than
fifteen (15) years.


 


10

















 


9.4                                 LICENSEE
shall not use HARVARD’s or GENERAL’S name or any adaptation of it in any
advertising, promotional or sales literature without the prior written assent
of HARVARD or GENERAL, as the case may be.


 


9.5                                 Without
the prior written approval of HARVARD, the entire license granted pursuant to
this Agreement shall not be transferred by LICENSEE to any party other than to
a successor to the business interest of LICENSEE relating to the PATENT RIGHTS.
This Agreement shall be binding upon the successors, legal representatives and
assignees of HARVARD and LICENSEE.


 


9.6                                 The
interpretation and application of the provisions of this Agreement shall be
governed by the laws of the Commonwealth of Massachusetts.


 


9.7                                 LICENSEE
agrees to comply with all applicable laws and regulations. In particular, it is
understood and acknowledged that the transfer of certain commodities and
technical data is subject to United States laws and regulations controlling the
export of such commodities and technical data, including all Export
Administration Regulations of the United States Department of Commerce. These
laws and regulations, among other things, prohibit or require a license for the
export of certain types of technical data to certain specified countries.
LICENSEE hereby agrees and gives written assurance that it will comply with all
United States laws and regulations controlling the export of commodities and
technical data, that it will be solely responsible for any violation of such by
LICENSEE or its AFFILIATES or sublicensees, and that it will defend and hold
HARVARD and GENERAL harmless in the event of any legal action of any nature
occasioned by such violation.


 


9.8                                 Written
notices required to be given under this Agreement shall be addressed as
follows:


 


	
  If to HARVARD:

  	
   

  	
  Office of Technology
  and Trademark

  Licensing

  Harvard University

  124 Mt. Auburn Street

  Suite 440

  Cambridge, MA 02138

  
	
   

  	
   

  	
   

  
	
  CC:

  	
   

  	
  Office of Technology
  Licensing and Industry

  Sponsored Research

  333 Longwood Ave.

  Boston, MA 02115

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Director

  Office of Technology Affairs

  Massachusetts General Hospital

  13th Street, Building 149

  Charlestown, MA 02129

  



 


11

















 


	
  If to LICENSEE:

  	
   

  	
  Virus Research
  Institute

  61 Moulton Street

  Cambridge, MA 02139

  Attn: John Littlechild, President

  



 


or such other address as
either party may request in writing.


 


9.9                                 Should
a court of competent jurisdiction later consider any provision of this
Agreement to be invalid, illegal, or unenforceable, it shall be considered
severed from this Agreement. All other provisions, rights and obligations shall
continue without regard to the severed provision, provided that the remaining
provisions of this Agreement are in accordance with the intention of the
parties.


 


9.10                           In the
event of any controversy or claim arising out of or relating to any provision
of this Agreement or the breach thereof, the parties shall try to settle such
conflicts amicably between themselves. Subject to the limitation stated in the
final sentence of this section, any such conflict which the parties are unable
to resolve shall be settled through arbitration conducted in accordance with
the rules of the American Arbitration Association. The demand for arbitration
shall be filed within a reasonable time after the controversy or claim has
arisen, and in no event after the date upon which institution of legal
proceedings based on such controversy or claim would be barred by the
applicable statute of limitation. Such arbitration shall be held in Boston,
Massachusetts. The award through arbitration shall be final and binding. Either
party may enter any such award in a court having jurisdiction or may make
application to such court for judicial acceptance of the award and an order of
enforcement, as the case may be. Notwithstanding the foregoing, either party
may, without recourse to arbitration, assert against the other party a
third-party claim or cross-claim in any action brought by a third party, to
which the subject matter of this Agreement may be relevant.


 


9.11                           This
Agreement constitutes the entire understanding between the parties and neither
party shall be obligated by any condition or representation other than those
expressly stated herein or as may be subsequently agreed to by the parties
hereto in writing.


 


12

















 


IN WITNESS WHEREOF, the parties hereto have caused
this Agreement to be executed by their duly authorized representatives.


 


The effective date of this Agreement is May 1st,
1992


 


	
   

  	
  PRESIDENT AND FELLOWS
  OF

  HARVARD COLLEGE

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Joyce Brinton

  
	
   

  	
   

  	
  Name and Title:

  	
  Joyce Brinton

  	
   

  
	
   

  	
   

  	
  Director, Office for
  Technology and

  Trademark Licensing, Harvard

  University

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Virus Research
  Institute

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ John Littlechild

  
	
   

  	
   

  	
  Name and Title:

  	
  President

  	
   

  
							



 


13

















 


APPENDIX
A


 


U.S.S.N. 629,602 -
“Improved Vaccines”; filed December 18, 1990; Inventors: John Mekalanos
and Samuel Miller.


 


U.S.S.N. 629,102 -
“Vibrio Cholerae Strains Defective in irgA Expression and Cholera Vaccines
Derived Therefrom”; filed December 18, 1990; Inventors: John Mekalanos and
Stephen Calderwood.


 


U.S.S.N. 000,000 - “Doubly-Attenuated
Strain of Vibrio Cholerae to Deliver Heterlogous Antigens for Vaccination” to
be filed in 1992; Inventors: John Mekalanos and Stephen Calderwood (serial
number and filing date to be inserted when available).


 


U.S.S.N. 043,907 -
“Cholera Vaccines”; filed April 29, 1987 and its CIP USSN 5,098,998, filed
April 29, 1988; Inventors John Mekalanos and Ronald Taylor.


 


U.S. 4,882,278 -
“Non-Toxic Vibrio Cholera Mutants”; issued November 21, 1989; Inventor:
John Mekalanos.


 


U.S.S.N. 000,000 -
“Peruvian Strain of Cholera Vaccine”; to be filed in 1992; Inventor: John
Mekalanos (serial number and filing date to be inserted when available).


 

















 


APPENDIX
B


 


Biological
Materials


 


1.                                       All
strain and plasmid inventions described in the following patents, patent
applications and unfiled patent applications.


 


a.                                       U.S.
Patent No. 4,882,278


 


b.                                      U.S.
Patent Application Serial No. 629,602


 


c.                                       U.S.
Patent Application Serial No. 629,102


 


d.                                      U.S.
Patent Application Serial No. 043,907


 


e.                                       Unfiled
Patent Application entitled “Doubly-Attenuated Strain of Vibrio Cholerae to
Deliver Heterologous Antigens for Vaccination”


 


f.                                         Unfiled
Patent Application entitled “Cholera Vaccine Strains derived from a 1992
Peruvian Isolate of Vibrio Cholerae and other El Tor Strains”


 


2.                                       The
following, recently constructed Vibrio Cholerae Strains


 


a.                                       Peru
1,2,3,4 and 5; each derived from wild-type C6709


 


b.                                      Bang
1,2,3,4 and 5; each derived from wild-type P27459


 


c.                                       Bah
1,2,3,4 and 5; each derived from wild-type E7946


 


d.                                      Any
additional Vibrio Cholerae strains derived from items 2(a) - 2(c) above.


 


3.                                       All
progeny, mutants, derivatives and replications of the biological materials in
sections 1 and 2 above which are developed by Dr. John Mekalanos solely or
jointly with others directly supervised in his laboratory at Harvard Medical
School, but only to the extent that Harvard is able to license such biological
materials consistent with its obligations to third parties.