Exhibit
10.25


 


AMENDMENT
TO LICENSE AGREEMENT


 


This amendment is 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, having offices at 61 Moulton Street, Cambridge, MA
02139.


 


WHEREAS HARVARD and LICENSEE have entered into a
License Agreement effective as of May 1, 1992 with respect to certain
patents and technology directed to cholerae (the “License Agreement”);


 


WHEREAS the parties desire to amend such License
Agreement.


 


NOW THEREFORE, in consideration of the foregoing
premises, and the mutual promises and other good and valuable consideration,
the parties agree as follows:


 


1.                                       Section 1.4
of the License Agreement is deleted in its entirety and rewritten as follows:


 


—”NET SALES” means the total received by LICENSEE from
sale of LICENSED PRODUCTS less transportation charges and insurance, sales
taxes, use taxes, excise taxes, value added taxes, customs duties or other
imports, to the extent itemized on invoice, normal and customary quantity and
cash discounts (to the extent allowed), allowances and credits on account of rejection
or return of LICENSED PRODUCTS. In the event that a LICENSED PRODUCT includes,
a component which has therapeutic and/or prophylactic activity (“Active
Component(s)”) covered by a PATENT RIGHT (Patented Component(s)) and Active
Components not covered by a PATENT RIGHT (Unpatented Component(s)) (such
PRODUCT being a Combined Product), then NET SALES shall be the amount which is
normally received by LICENSEE from a sale of the Patented Component(s) when
sold separately in an arm’s length transaction with an unaffiliated third
party. If the Patented Component(s) are not sold separately, then NET SALES
upon which royalty is paid shall be the NET SALES of the Combined Product
multiplied by a fraction, the numerator of which is the cost for


 

















 


producing the Patented Components and the denominator
of which is the cost for producing the Combined Product.


 


2.                                       Add
the following Section 1.6 to the License Agreement.


 


—1.6 The term “SUBLICENSEE” shall mean any
non-AFFILIATE third party licensed by LICENSEE to make, have made, use or sell
any product or use any process under PATENT RIGHTS.


 


3.                                       Paragraphs
2.2(c), 2.2(d), 2.2(e) and 2.2(f) of the License Agreement are deleted in the
entirety.


 


4.                                       Paragraph
2.2(g) of the License Agreement is renumbered as Paragraph 2.2(c).


 


5.                                       The
following paragraph is added to the License Agreement as Paragraph 2.5.


 


—2.5 LICENSEE has provided HARVARD with a development
plan for developing and obtaining regulatory approval of the LICENSED PRODUCT
selected by LICENSEE, which development plan includes milestones.


 


LICENSEE shall exert reasonable efforts under the
circumstances to achieve such milestones. In the event LICENSEE subsequently
indicates in writing to HARVARD that such milestones cannot be met or fails to
meet such milestones, LICENSEE shall promptly notify HARVARD, and LICENSEE and
HARVARD shall promptly enter into good faith negotiations to reconsider such
milestones. In the event that the parties cannot agree to the milestones within
sixty (610) days after beginning good faith negotiations, the matter shall be
submitted to arbitration to determine the milestones and the time period
therefor which should be met pursuant to this Section. The arbitrator in
setting and determining milestones shall consider the state of technology; the
efforts exerted by LICENSEE, the business circumstances of LICENSEE and the
public interest objectives to HARVARD’S licensing program; and technical and
regulatory problems. Thereafter, LICENSEE shall exert reasonable efforts to
achieve such milestones.


 


In the event that LICENSEE cannot meet the milestones
set by arbitration because of technological or regulatory problems, HARVARD
shall not unreasonably deny an extension of time to meet the milestones, upon a
showing by LICENSEE that it has made good faith reasonable efforts to meet the
milestones.


 


If LICENSEE (i) fails to meet the milestones
established by agreement of the parties and (ii) fails to obtain extensions of
such milestones established by arbitration and (iii) LICENSEE has not exerted good
faith reasonable efforts to meet such milestones, as its sole and exclusive
remedy HARVARD shall have the right to terminate or convert the licenses to
non-exclusive licenses by providing to LICENSEE sixty (60) days prior written
notice.


 


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Notwithstanding anything else to the contrary, in the
event that LICENSEE and/or its AFFILIATE(s) and/or SUBLICENSEE(s) have expended
at least two hundred fifty thousand dollars ($250,000) in research and
developing a LICENSED PRODUCT and LICENSEE intends to continue development of a
LICENSED PRODUCT, the rights and licenses granted hereunder shall not terminate
and shall be converted to a non-exclusive right and license, and further
provided that LICENSEE or a SUBLICENSEE or an entity on its behalf spends at
least one hundred thousand dollars ($100,000) per year in pursuing development
of PRODUCT for commercial sale.


 


LICENSEE shall ensure that for any PRODUCT being
developed or commercialized by a SUBLICENSEE, such SUBLICENSEE shall assume the
obligations imposed on LICENSEE under this paragraph.


 


The efforts of an AFFILIATE, SUBLICENSEE or
collaborator of LICENSEE shall be considered as efforts of LICENSEE.-


 


6.                                       Rewrite
Paragraph 3.2 of the License Agreement in its entirety to read as follows:


 


—3.2 LICENSEE shall pay HARVARD, during the term of
the license granted in Section 2.1, (1) a royalty of four percent (4%) of
the NET SALES of the LICENSED PRODUCTS sold by LICENSEE and its AFFILIATES to
commercial organizations, and two percent (2%) of the NET SALES of the LICENSED
PRODUCTS sold by LICENSEE and its AFFILIATES to non-profit or government
agencies, or (ii) twenty-five percent (25%) of royalties received by LICENSEE
or its AFFILIATES from a SUBLICENSEE for all LICENSED PRODUCTS covered by a
PATENT RIGHT licensed to LICENSEE, and twenty-five percent (25%) of upfront
license and license maintenance fees received from a SUBLICENSEE for a license
under PATENT RIGHTS, in the case where the SUBLICENSEE is a commercial organization,
and ten percent (10%) of such royalties and fees where the SUBLICENSEE, is a
government or non-profit organization.-


 


7.                                       Delete
Paragraph 4.1 of the License Agreement in its entirety.


 


8.                                       Rewrite
Paragraph 4.2 of the License Agreement in its entirety to read as follows:


 


—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.-


 


9.                                       Rewrite
Paragraph 8.4 of the License Agreement in its entirety to read as follows:


 


—8.4 In the event that the licenses granted to
LICENSEE under this Agreement are terminated, any granted sub-licenses shall
remain in full force and effect as a


 


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direct license from HARVARD to the SUBLICENSEE,
provided that the SUBLICENSEE is not then in breach of its sub-license
agreement and the SUBLICENSEE agrees to be bound (as a licensee) to HARVARD (as
a licensor) under the terms and conditions of the sub-license agreement.-


 


10.                                 In
Paragraph 9.3(a) of the License Agreement, delete the last sentence in its
entirety.


 


11.                                 Delete
Paragraphs 9.3(b), 9.3(c), 9.3(d) and 9.3(e) of the License Agreement and in
lieu thereof insert the following:


 


(b)                                 LICENSEE’S
indemnification under (a) above shall not apply to any liability, damage, loss
or expense to the extent to apply to any liability, damage, loss or expense to
the extent that it is attributable to the negligent activities or willful
misconduct of the Indemnitees.


 


(c)                                  HARVARD
shall notify LICENSEE promptly of any claim or threatened claim under this
Paragraph 9.3 and shall fully cooperate with all reasonable requests of
LICENSEE with respect thereto.


 


(d)                                 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 and LICENSEE shall
have the right to control the defense, settlement or compromise of any such
claim or action.


 


(e)                                  At
such time as any PRODUCT is being commercially distributed or sold (other than
for research purposes or for the purpose of obtaining regulatory approvals) by
LICENSEE, or by an AFFILIATE, SUBLICENSEE or agent of LICENSEE (hereunder
“Other Seller”), LICENSEE shall itself or in the alternative shall ensure that
Other Seller either (1) at its sole cost and expense, procure (s) and maintain
(s) comprehensive general liability insurance in amounts not less than
$2,000,000 per incident and $2,000,000 annual aggregate and naming the
Indemnitees as additional insureds or (ii) pay(s) for the procurement and
maintenance by HARVARD of insurance in the amounts and in the form set forth in
this paragraph. Such comprehensive general liability insurance shall provide
(I) product liability coverage and (ii) broad form contractual liability
coverage for LICENSEE’S Indemnification under Paragraph 9.3(a) of this
Agreement. LICENSEE shall ensure that if LICENSEE or the Other Seller 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. The minimum amounts of insurance coverage required under this
Paragraph 9.3(c) shall not be construed to create a limit of LICENSEE’S
liability with respect to its indemnification under Paragraph 9.3(a) of this
Agreement. At such time, or at any time, LICENSEE can request that HARVARD
ascertain


 


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whether Risk Management Foundation has in effect
Uniform Indemnification and Insurance Provisions more favorable than those of
this Agreement, in which event LICENSEE and HARVARD shall amend this Agreement
to include such more favorable provisions.


 


(f)                                    LICENSEE
shall provide HARVARD with written evidence of such insurance upon request of
HARVARD. LICENSEE shall provide HARVARD with written notice of at least thirty
(30) 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 thirty (30) days period, HARVARD shall have the
right to terminate this Agreement effective at the end of such thirty (30) day
period by written notice to LICENSEE.


 


(g)           LICENSEE
shall itself maintain, or shall ensure that Other Seller maintains or that
payments are made for the maintenance by HARVARD of, as the case may be, such
comprehensive general liability insurance beyond the expiration or termination
of this Agreement during (i) the period that any LICENSED PRODUCT is being
commercially distributed or sold (other than for research purposes or the
purpose of obtaining regulatory approvals) by Other Seller and (ii) a reasonable
period after the period referred to in (g) (1) above which shall in no event be
less than ten (10) years. The obligations of (g) (ii) above can be satisfied by
the purchase of insurance by LICENSEE or a third party which covers claims
resulting from occurrences during such period of (g) (ii) above for LICENSED
PRODUCT commercially distributed or sold by LICENSEE or Other Seller during the
period referred to in (g) (i) above.


 


12.                                 Except
as modified herein, the License Agreement and the terms, conditions and
obligations thereof remain in full force and effect as originally written.


 


IN WITNESS WHEREOF, the parties hereto intending to be
bound have set their hands and seal effective as of the date first above
written.


 


	
  PRESIDENT AND FELLOWS OF

  HARVARD COLLEGE

  	
  VIRUS RESEARCH INSTITUTE

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ Joyce Brinton

  	
   

  	
  By:

  	
  /s/ William A. Packer

  	
   

  
	
   

  	
  Name:

  	
  Joyce Brinton

  	
   

  	
  Name:

  	
  William A. Packer

  
	
   

  	
  Title :

  	
  Director

  Office for Technology and

  Trademark Licensing

  Harvard University

  	
   

  	
  Title:

  	
  President

  
	
   

  	
  Date:

  	
  7/9/93

  	
   

  	
  Date:

  	
  7/23/93

  
								



 


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