exv10w38






Exhibit 10.38




AMENDMENT TO

AMENDED AND RESTATED LICENSE,

DEVELOPMENT AND COMMERCIALIZATION AGREEMENT




     This Amendment to Amended and Restated License, Development and Commercialization Agreement
(the “Amendment”) is entered into effective as of April 15, 2010 (the “Effective
Date”) by and between Vanda Pharmaceuticals Inc., a Delaware corporation (“Vanda”), and
Bristol-Myers Squibb Company, a Delaware corporation (“BMS”).



     WHEREAS, Vanda and BMS are parties to that certain Amended and Restated License, Development
and Commercialization Agreement effective February 25, 2004, as amended to date (the “License
Agreement”) relating to certain compounds including tasimelteon (VEC-162, formerly designated
as BMS-214778); and



     WHEREAS, Vanda and BMS desire to amend and restate certain provisions of the License Agreement
as set forth herein.



     NOW, THEREFORE, in consideration of the premises and the mutual covenants contained herein,
Vanda and BMS agree as follows.



     1. All capitalized terms used in this Amendment shall have the meaning ascribed to such terms
in the License Agreement, unless otherwise specified herein. Unless otherwise expressly stated,
the Sections referred to herein refer to the Sections in the License Agreement.



     2. Section 1.33 of the License Agreement is hereby amended and restated to read in its
entirety as follows:




“1.33 “MGH License Agreement” means the agreement between The General Hospital Corporation
d/b/a Massachusetts General Hospital (“MGH”), Vanda and BMS that is currently being
negotiated and that will be entered into after the Effective Date, and as it may be modified
or supplemented after being entered into, under which Vanda will be obligated to pay MGH
certain payments in connection with the development and commercialization of Products.”



     3. Section 3.1.1 of the License Agreement is hereby amended and restated to read in its
entirety as follows:




“3.1.1 Vanda Development Option Period. Vanda will have the right, anytime prior to filing
an NDA for a Product (“Vanda Third Party Development Option Period”), to negotiate an
agreement to sublicense Vanda’s rights to Develop and Commercialize a Product (a
“Development and Commercialization Agreement”) with a Third Party in at least one Major
Market Country (“Vanda Third Party Development Option”); provided, however, that with
respect to each Product, upon Vanda locking the database for Vanda’s first Phase III
Clinical Study for the Product, Vanda shall have a limited time in which to exercise the
Vanda Third Party Development Option for the Product before the right to exercise such
option is suspended. Vanda shall have one hundred twenty (120) days from the date Vanda
locks the database for Vanda’s first Phase III Clinical Study for the Product to exercise
such option. If Vanda exercises such option during such one hundred twenty (120) day
period, BMS shall have a right of first negotiation to enter into a Development and
Commercialization Agreement for the Product with Vanda. BMS shall have a thirty (30) day
review period, from the receipt of Vanda’s written notice to seek a Third Party partner, to
elect to enter into negotiations with Vanda. During the













 







thirty (30) day review period, Vanda shall timely provide BMS with copies of any reports,
data, results or information, material to the Development of the Product that are or may
become available, including but not limited to those relating to the first Phase III
Clinical Study for the Product. Thereafter, BMS will have a ninety (90) day period of
exclusivity in which to negotiate and execute a Development and Commercialization Agreement,
and Vanda shall negotiate in good faith during such ninety (90) day period. During such
thirty (30) day review period and such ninety (90) day period of exclusivity, Vanda shall
not approach any Third Party concerning a Development and Commercialization Agreement or
disclose any of the Phase III Clinical Study data, results or conclusions to any Third Party
that may potentially enter into a Development and Commercialization Agreement for the
Product. If, during the thirty (30) day review period BMS does not formally notify Vanda in
writing of its intention to enter into a Development and Commercialization Agreement or
informs Vanda that it is not interested in entering into such an agreement or if BMS does
notify Vanda of its intention to enter into such an agreement but does not enter into a such
an agreement for the Product during such ninety (90) day period of exclusivity, then Vanda
shall have until the end of day of the earlier of (a) the day immediately prior to the day
that the BMS Option Period commences as specified in Section 3.2.1 and (b) May 31, 2013, to
negotiate and enter into a Development and Commercialization Agreement with a Third Party
for the Product. If Vanda does not enter into such an agreement with a Third Party prior to
the earlier of (i) the commencement of the BMS Option Period as specified in Section 3.2.1
and (ii) June 1, 2013 (the “Option Suspension Date”), then the Vanda Third Party Development
Option shall be suspended from the Option Suspension Date until the end of the BMS Option
Period for the Product. The Vanda Third Party Development Option is exercisable by written
notice from Vanda to BMS of Vanda’s intention to seek a Third Party partner. Such option
shall be exercisable on a Product-by-Product and on a Major Market Country-by-Major Market
Country basis. For the avoidance of doubt, rights to Develop and Commercialize a Product in
non-Major Market Countries may be included in the Development and Commercialization
Agreement for a Major Market Country. With respect to a Product, the Major Market Countries
together with all other countries that are not included in a Development and
Commercialization Agreement for the Product shall be referred to as the “Remaining
Countries.”



     4. Section 3.2.1 of the License Agreement is hereby amended and restated to read in its
entirety as follows:




     “3.2.1 BMS Option Period. The BMS Option Period for a Product will commence for the
Remaining Countries (providing Vanda has not entered into one or more Development and
Commercialization Agreements for the Product which when taken together include all of the
Major Market Countries prior to the Option Suspension Date for the Product) on the date that
(1) Vanda provides BMS with a full written report of the Phase III Clinical Studies,
including the results and conclusions thereof, on which Vanda intends to rely for filing for
Marketing Authorization for the Product in the first Major Market Country and (2) either (i)
both Parties agree in writing is the commencement date for the BMS Option Period or (ii)
there is acceptance by the applicable Regulatory Authority of the filing of a Marketing
Authorization for the Product in a Major Market Country. The BMS Option Period shall
terminate ninety (90) days later (“BMS Option Period”). At any time during the BMS Option
Period, BMS may provide Vanda with written notice that either: (a) it does not wish to
Develop or Commercialize the Product in the Remaining Countries; or (b) it wishes to
reacquire all rights to the Product in the Remaining Countries ((b) shall be referred to as
the “BMS Option”). Such option shall be exercisable on a Product-by-Product basis. For the
avoidance of doubt, if BMS does not exercise the BMS Option for the Remaining Countries
within the BMS Option Period, then upon completion of the BMS Option Period, the Vanda Third
Party Development Option shall be exercisable for the Remaining Countries for the remainder
of the Vanda Third Party Development Option Period.”



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     5. Section 5.2.2 of the License Agreement is hereby amended and restated to read in its
entirety as follows::




“5.2.2 As soon as reasonably practicable after the Effective Date, Vanda shall commence
Phase II Clinical Studies of the Product in accordance with the Development Plan set forth
in Schedule 1.19 and this Agreement. In any event, Vanda (a) shall initiate Phase II
Clinical Studies for the first Product no later than six (6) months after the Effective
Date, (b) shall complete (at least) one Phase II Clinical Study for the first Product no
later than twelve (12) months after commencement of the first Phase II Clinical Study (i.e.,
the date when the first patient in the study is dosed), (c) shall initiate Phase III
Clinical Studies for the first Product no later than twenty-four (24) months after
completing the first Phase II Clinical Study, and (d) shall file an NDA for the first
Product no later than June 1, 2013. In the event that any of such milestones are missed, it
shall be deemed a material breach of this Agreement for the purposes of Article 13. BMS’
ability to terminate this Agreement pursuant to Section 13.2 shall apply without regard to
whether any circumstances falling within Section 14.4 might otherwise excuse (in whole or in
part) any inability or failure to meet any such milestones. If Vanda misses any of the
above milestone dates, Vanda may request that BMS grant a reasonable extension to allow it
to meet such milestone, and BMS agrees that it will not unreasonably withhold its assent to
any such reasonable revision where supported by clear evidence that Vanda has been making
good faith and diligent efforts to achieve the milestones but has failed as a result of
technical difficulties or delays that the parties could not have reasonably avoided in the
achievement of such milestones; and provided, that BMS may also need to seek approval of MGH
in such event, and any approval by BMS shall further be conditioned on receipt of approval
of MGH.”



     6. This Amendment shall not amend or modify the terms, conditions, rights and obligations of
the parties under the License Agreement (as amended), except as specifically set forth herein. The
License Agreement (as amended) shall continue in full force and effect in accordance with its terms
as amended by this Amendment.



     7. This Amendment may be executed in counterparts, each of which shall be deemed an original,
but both of which together shall constitute one and the same instrument.



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     IN WITNESS WHEREOF, BMS and Vanda have caused this Amendment to be executed by their duly
authorized representatives.



BRISTOL-MYERS SQUIBB COMPANY




	 	 	 	 	 

	By:

	 	/s/ Graham R. Brazier
 

(Signature of Authorized Representative)
	 	 
	 
	 	 	 	 
	Printed Name: Graham R. Brazier

	 	 
	 
	 	 	 	 
	Title:

	 	Vice President Strategic Transactions Group	 	 






VANDA PHARMACEUTICALS INC.




	 	 	 	 	 

	By:

	 	/s/ Gunther Birznieks
 

(Signature of Authorized Representative)
	 	 
	 
	 	 	 	 
	Printed Name: Gunther Birznieks

	 	 
	 
	 	 	 	 
	Title:

	 	Vice President, Business Development	 	 







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