Exhibit 10.3

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WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

AMENDMENT NO. 7 TO COLLABORATION AND LICENSE AGREEMENT

 

This Amendment No.7 to the Collaboration and License Agreement (this
“Amendment”) is made and entered into as of December 5, 2018 (“Effective Date”),
by and between Kyowa Hakko Kirin Co., Ltd., a company organized and existing
under the laws of Japan, with an address at 1-9-2 Otemachi, Chiyoda-ku, Tokyo,
100- 0004, Japan (“KHK”) and Ultragenyx Pharmaceutical Inc., a company organized
and existing under the laws of the State of Delaware, with an address at 60
Leveroni, Novato, California 94949, USA (“UGNX”).

 

RECITALS

 

 

A.

KHK and UGNX are parties to a Collaboration and License Agreement dated August
29, 2013, regarding the joint development and commercialization of KRN23 (the
“Licensed Product”), an Amendment No. 1 to Collaboration and License Agreement
effective as of September 24, 2015, an Amendment No. 2 effective as of November
28, 2016, an Amendment No. 3 effective as of September 29, 2017, an Amendment
No. 4 effective as of January 29, 2018, an Amendment No. 5 effective as of April
30, 2018, and an Amendment No. 6 effective as of February 1, 2019 (collectively,
the “Collaboration Agreement”).  

 

B.

Pursuant to Section 13.6 of the Collaboration Agreement, KHK and UGNX are
conducting the Commercialization of the Licensed Product in the Canadian portion
of the Profit Share Territory through their Affiliates, respectively Kyowa Kirin
Canada, Inc. (“KKCA”) and Ultragenyx Canada Inc. (“UCI”).

 

C.

With the Marketing Approval and Commercialization of the Licensed Product in
Canada anticipated in the near future, the Parties desire to further clarify
their relationship related to the Canadian portion of the Profit Share
Territory.

 

D.

Terms defined in the Collaboration Agreement shall have the same meaning in this
Amendment as they have in the Collaboration Agreement.

 

E.

All terms and conditions of the Collaboration Agreement not expressly addressed
in this Amendment shall remain in full force and effect.

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, the Parties hereby agree as follows:

 

1.A new Section 5.4.1 shall be added that provides as follows.

 

“5.4.1 Call Center/Medical Information/Pharmacovigilance in Canada.

Notwithstanding the foregoing, for Canada, UGNX shall select a third party to
provide call center services, medical information and other patient support
services (“Call Center

 

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Provider”). UGNX and KKI will collaborate regarding the use of the Call Center
Provider for adverse event and other safety information intake, follow-up for
adverse events and other safety information, and other pharmacovigilance
services for Licensed Product in accordance with Canadian law, and for
forwarding adverse event and other safety information to KHK for processing and
submission to Health Canada in accordance with Canadian law.  KKI and the Call
Center Provider shall establish a Pharmacovigilance Agreement (PVA) to outline
safety exchange, reporting and safety surveillance responsibilities for Licensed
Product.

2.

A new Section 5.13 shall be added that provides as follows:

 

“5.13 Regulatory Matters in Canada.

(a)KHK’s Affiliate, Kyowa Kirin Limited (“KKL”), is the owner of the New Drug
Submission (NDS) for Licensed Product that has been approved in Canada.

(b)Until the Profit Share Territory Transition Date, KKL appoints UGNX as its
agent for regulatory matters associated with Licensed Product in Canada.

(c)UGNX shall be responsible for contact to and from Health Canada, including
emails and other correspondence, except as otherwise agreed to in writing by the
Parties.  UGNX shall promptly share all Health Canada contacts with KKL.  UGNX
and KKL will agree on an electronic method to accomplish this sharing.

 

3.

A new Section 5.14 shall be added that provides as follows:

 

“5.14 Canadian Labeling and Packaging. In Canada, the label, packaging and
labeling of the Licensed Product states as follows:

Manufactured by:

Kyowa Kirin Limited

Galabank Business Park,

Galashiels,

TD1 1QH

United Kingdom

Distributed by:

Innomar Strategies

4.

A new Section 5.15 shall be added that provides as follows:

 

“5.15 Other Reports to Health Canada and other Regulatory Authorities with
respect to the Commercialization of the Licensed Product in Canada.

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WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

(a)

Each Party shall be responsible for reporting as required under the Ontario
Health Sector Payment Transparency Act and any similar national or provincial
laws enacted in the future in Canada.

  

 

(b)

KHK and/or KKL shall be responsible for preparing all NDS supplements dealing
with manufacturing changes or issues.  KHK and/or KKL (as applicable) will
submit these supplements to UGNX for its review and approval at least [***]
prior to submission to Health Canada.

 

 

(c)

UGNX shall be responsible for drafting all other NDS supplements and Health
Canada submissions.  UGNX shall submit all routine or planned NDS supplements
and other submissions to KHK for its review and approval at least [***] prior to
submission to Health Canada.  For non-routine submissions to Health Canada that
require expedited processing, UGNX will discuss and agree with KKL on timing for
the KKL review.”

 

5.

A new Section 6.8 shall be added that provides as follows:

 

“6.8 Branding and Messaging in Canada.

 

Brand Book. KHK and UGNX have jointly created and plan to periodically update a
branding and messaging platform for the Licensed Product, which contain key
claims and imagery. UGNX and UCI agree that written material used in Canada for
Licensed Product will conform to that platform.”

 

6.

A new Section 6.9 shall be added that provides as follows:

 

“6.9 Third Party Logistics in Canada. To the extent of the Commercialization of
the Licensed Product in Canada, KHK’s Affiliate, Kyowa Kirin Services Limited
(“KKS”), will select and contract with a third party logistics provider (“Third
Party Logistics Provider”) to manage and control inventory of the Licensed
Product, including picking, packing and shipping of Licensed Product.  The Third
Party Logistics Provider will hold on consignment KKS-titled Licensed Product.
UCI shall be responsible for the creation of customer accounts at the Third
Party Logistics Provider and providing of all related and necessary information
to the Third Party Logistics Provider to ensure that the Third Party Logistics
Provider can fulfill its obligations under its contract with KKS. KKS will
provide a weekly report to UCI reflecting the Third Party Logistics Provider’s
data related to customer account management.”  

 

7.

A new Section 6.10 shall be added that provides as follows:

“6.10. Transition of Commercial and Regulatory Activities in Canada.

 

6.10.1. Quarterly Commercial Meeting.  To the extent of the Commercialization of
the Licensed Product in the Canada, during the Profit Share Period, UCI and KKCA
shall meet

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each quarter under the guidance of the JCT to review significant commercial
developments related to the Licensed Product.

 

6.10.2 Year Preceding Transition. To the extent of the Commercialization of the
Licensed Product in the Canada, UCI and KKCA agree to cooperate with each other
and use best efforts to ensure a seamless transition of the Licensed Product
from UCI to KKCA upon the Profit Share Territory Transition Date.  The following
activities shall occur during the year preceding the Profit Share Territory
Transition Date:

(a)KKCA and UCI shall form a transition committee (“Canada Transition
Committee”) that will hold a transition planning meeting to map and outline
steps and key activities and timing in the Canada; provided, however, (i) Canada
Transition Committee shall be a part of the Transition Committee established for
transition activities in the United States pursuant to Section 6.7 (“U.S.
Transition”) and (ii) all activities under this Section 6.10 will be coordinated
with the U.S. Transition.

(b)The Canada Transition Committee shall draft plans for transition of supply,
packaging, and labeling responsibilities, regulatory responsibilities and
reporting (including payment reporting laws, government pricing and adverse
experience reporting), clinical trials, advisory boards, grants and
sponsorships, continuing medical education programs, and communications with
UCI’s customers of the Licensed Product (“UCI Customer”) and other third
parties.  These plans will include transfer to KKCA of all documents and data
that will assist in such transitions.

(c)Any required contract amendments with third parties will be initiated.  UCI
will cooperate as requested by KKCA to complete the assignment process.

(d) KKCA and UCI will create a schedule that will allow KKCA personnel to
observe in real time existing patient support service programs and other
interactions with service providers and UCI Customers, and to accompany UCI
personnel to these observations.  The schedule will be reasonable and not
significantly disrupt the work of UCI personnel.

 

6.10.3 Training. UCI and KKCA will train KKCA personnel on the programs,
procedures and tasks that will be transitioned from UCI to KKCA.”

8.

A new Section 9.4 shall be added that provides as follows:

 

“9.4 Licensed Product-Related Contracts with Respect to Commercialization of the
Licensed Product in Canada.

 

9.4.1 UCI will upon request of KKCA send or otherwise make a copy of all supply,
pricing, rebate, discount and other commercial contracts related to Licensed
Product within [***] of the request.  Other commercial contracts set forth above
shall include sponsorships, grants and charitable contributions but not such
things as minor consulting agreements.  

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BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II)
WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

9.4.2 UCI shall ensure that all UCI Customer contracts provide UCI and KKCA with
access to and the right to audit the data supporting Net Sales calculations, as
described in Section 9.1 of this Agreement.  All commercial contracts related to
the Commercialization of the Licensed Product in Canada entered into by UCI and
the UCI’s Customer shall permit assignment to KKCA upon UCI’s written notice to
the corresponding UCI Customer and without any consent of such UCI
Customer.  Notwithstanding the foregoing, UCI shall not assign any commercial
contracts to KKCA without KKCA’s prior written consent for such assignment.”

 

 

IN WITNESS WHEREOF, the Parties have executed this Amendment, by their
representatives duly thereunto authorized as of the Effective Date.

 

 

KYOWA HAKKO KIRIN CO., LTD.

ULTRAGENYX PHARMACEUTICAL INC.

 

 

By:/s/ Yasuo FujiiBy:/s/ Thomas Kassberg

 

Name:Yasuo FujiiName:_Thomas Kassberg  ______________

 

Title:Director, Business Development Dept.Title:   _Chief Business Officer
__________

 

Date:March 28, 2019Date:April 1, 2019

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