Exhibit 10.19





EXECUTION VERSION




EXHIBIT 10.19




Collaboration and License Agreement




This Agreement is entered into with effect as of the Effective Date (as defined below)




by and between




F. Hoffmann-La Roche Ltd




with an office and place of business at Grenzacherstrasse 124, 4070 Basel, Switzerland (“Roche
Basel”);



and




Hoffmann-La Roche Inc.




with an office and place of business at 340 Kingsland Street, Nutley, New Jersey 07110, U.S.A.
(“Roche Nutley”; Roche Basel and Roche Nutley together referred to as “Roche”)



on the one hand;




and




Raptor Pharmaceutical Inc.




with their office and place of business at 9 Commercial Blvd., Suite 200, Novato, California 94949.
(“Raptor”)



on the other hand.



WHEREAS, Raptor has expertise in the RAP proteins used to deliver therapeutics across the blood
brain barrier and possesses its Nuerotrans, proprietary technology and intellectual property rights
relating thereto; and



WHEREAS, Roche has expertise in the research, development, manufacture and commercialization of
pharmaceutical products; and


 


1/32









 





WHEREAS, Roche wishes to develop and commercialize products containing pharmaceutically active
compounds and RAP proteins as a delivery vehicle, and explore potential applications of such
products in various therapeutic areas; and



WHEREAS, Raptor wishes to work with Roche in generating, selecting and testing RAP proteins for use
with pharmaceutically active compounds in products and is willing to grant to Roche the right to
make, use, offer for sale, sell, import and export such products under certain of its intellectual
property rights, as contemplated herein.



NOW, THEREFORE, in consideration of the mutual covenants and promises contained in this
Agreement and other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the Parties hereto, intending to be legally bound, do hereby agree as follows:



1. Definitions




As used in this Agreement, the following terms, whether used in the singular or plural, shall have
the following meanings:



1.1 Affiliate

The term “Affiliate” shall mean, as to a Party:




	 	a)	 	An entity that owns directly or indirectly, a controlling interest in such Party, by
stock ownership or otherwise;







	 	b)	 	any entity in which such Party owns a controlling interest, by stock ownership or
otherwise, or;

	 
	 	c)	 	any entity under common control with such Party, directly or indirectly.






For purposes of this paragraph, “controlling interest” and “control” mean ownership of more than
fifty percent (50%) of the voting stock permitted to vote for the election of the board of
directors or any other arrangement resulting in control of or the right to control the management
and the affairs of the entity or Party in question. Anything to the contrary in this paragraph
notwithstanding, Chugai Pharmaceutical Co., Ltd, a Japanese corporation, (“Chugai”) shall not be
deemed an Affiliate of Roche unless Roche provides written notice to Raptor of its desire to
include Chugai as an Affiliate of Roche.



1.2 Agreement

The term “Agreement” shall mean this document including any and all appendices and amendments to it
as may be added and/or amended from time to time in accordance with the provisions of this
Agreement.



1.3 Agreement Term

The term “Agreement Term” shall mean the term of this Agreement as set forth in Section 14.1.


 


2/32









 





1.4 Business Day

The term “Business Day” shall mean 9.00 a.m. to 5.00 p.m. local time on a day other than a
Saturday, Sunday or bank or other public or federal holiday in Switzerland or the State of New
Jersey in the US.



1.5 Calendar Quarter

The term “Calendar Quarter” shall mean each period of three (3) consecutive calendar months, ending
March 31, June 30, September 30, and December 31.



1.6 Calendar Year

The term “Calendar Year” shall mean each twelve (12) month period ending on December 31.



1.7 Change of Control

The term “Change of Control” shall mean, with respect to Raptor: (a) the acquisition by any Third
Party of beneficial ownership of more than [*****] of the then-outstanding common shares or voting
power of Raptor, other than acquisitions by employee benefit plans sponsored or maintained by
Raptor or by existing shareholders of Raptor; or (b) the consummation of a business combination
with a Third Party, unless, following such business combination, the stockholders of Raptor
immediately prior to such business combination beneficially own directly or indirectly more than
[*****] of the then-outstanding common shares or voting power of the entity resulting from such
business combination or of the ultimate parent of such resulting entity.



1.8 Clinical Study

The term “Clinical Study” shall mean a Phase I Study, a Phase II Study or a Phase III Study, as
applicable.



1.9 Commercially Reasonable Efforts

The term “Commercially Reasonable Efforts” shall mean [*****].



1.10 Confidential Information

The term “Confidential Information” shall mean any and all information, data or know-how (including
Know-How), whether technical or non-technical, oral or written, that is disclosed by one Party or
its Affiliates (“Disclosing Party”) to the other Party or its Affiliates (“Receiving Party”).
Confidential Information shall not include any information, data or know-how which:




(i) was generally available to the public at the time of disclosure, or information which
becomes available to the public after disclosure by the Disclosing Party other than through
fault (whether by action or inaction) of the Receiving Party,

(ii) can be shown by clear and convincing written records to have been already known to the
Receiving Party prior to its receipt from the Disclosing Party,

(iii) is obtained at any time lawfully from a Third Party rightfully in possession of such
information, data or know-how and under circumstances permitting its use or disclosure,

(iv) is developed independently by the Receiving Party as evidenced by clear and convincing
written records other than through knowledge of Confidential Information, or

(v) is approved in writing by the Disclosing Party for release by the Receiving Party.



The terms of this Agreement shall be considered Confidential Information of both Parties.


 


3/32









 





1.11 Control

The term “Control” shall mean (as an adjective or as a verb including conjugations and variations
such as “Controls” “Controlled” or “Controlling”) (a) with respect to Patent Rights and/or
Know-How, the possession by a Party of the ability to grant a license or sublicense of such Patent
Rights and/or Know-How without violating the terms of any agreement or arrangement between such
Party and any other party and (b) with respect to proprietary materials, the possession by a Party
of the ability to supply such proprietary materials to the other Party as provided herein without
violating the terms of any agreement or arrangement between such Party and any other party [*****].



1.12 Cover

The term “Cover” shall mean (as an adjective or as a verb including conjugations and variations
such as “Covered,” “Coverage” or “Covering”) that the developing, making, using, offering for sale,
promoting, selling, exporting or importing of a given compound, formulation or product would
infringe a Valid Claim in the absence of a license under the Patent Rights to which such Valid
Claim pertains. The determination of whether a compound, formulation, process or product is Covered
by a particular Valid Claim shall be made on a country-by-country basis.



1.13 Dollars

The term “Dollars” shall mean US dollars.



1.14 Effective Date

The term “Effective Date” shall mean June 3, 2009.



1.15 EU

The term “EU” shall mean the European Union, as it may be constituted from time to time.



Exclusivity Period

The term “Exclusivity Period” shall mean [*****]. The Exclusivity Period can be extended pursuant
to Section 6.1.1.



1.17 FDA

The term “FDA” shall mean the Food and Drug Administration of the United States of America.



1.18 Field

The term “Field” shall mean all human uses for delivery of diagnostic or therapeutic agents across
the blood brain barrier for the diagnosis treatment and/or prevention of any Indication.



1.19 First Commercial Sale

The term “First Commercial Sale” shall mean the first invoiced sale of a Product to a Third Party
by the Roche Group.


 


4/32









 





1.20 Handle

The term “Handle” shall mean preparing, filing, prosecuting (including interference and opposition
proceedings) and maintaining (including interferences, reissue, re-examination, revocation and
opposition proceedings).



1.21 Indication

The term “Indication” shall mean any human disease or condition, or sign or symptom of a human
disease or condition, in each case determined by reference to the World Health Organization
International Classification of Diseases, version 10, as it may be revised and updated from time to
time.



1.22 Initiation

The term “Initiation” shall mean the date that a human is first dosed with the Product in a
Clinical Study conducted by or on behalf of Roche or any of its Affiliates or Sublicensees and
approved by the respective Regulatory Authority.



1.23 Insolvency Event

The term “Insolvency Event” shall mean circumstances under which a Party (i) has a receiver or
similar officer appointed over all or substantially all of its assets or undertaking; (ii) passes a
resolution for winding-up (other than a winding-up for the purpose of, or in connection with, any
solvent amalgamation, reorganization or restructuring) or a court makes an order to that effect or
a court makes an order for administration (or any equivalent order in any jurisdiction); (iii)
enters into any voluntary composition or arrangement with its creditors (other than relating to a
solvent amalgamation, reorganization or restructuring) relating to all or substantially all of its
assets; or (iv) permanently ceases to carry on business; in the case of each of the foregoing
clauses (i) and (ii), where the event shall have continued for [*****] undismissed, unbonded and
undischarged.



1.24 Inventions

The term “Invention” shall mean an invention that is conceived and/or reduced to practice in the
course of performing an activity pursuant to the Research Plan under this Agreement. Under this
definition, an Invention may be made by employees of Raptor or of its Affiliates solely or jointly
with a Third Party (a “Raptor Invention”), by employees of the Roche Group solely or jointly with a
Third Party (a “Roche Invention”), or jointly by employees of Raptor or its Affiliates and by
employees of a member of the Roche Group with or without a Third Party (a “Joint Invention”).
Notwithstanding the above, all intellectual property related solely to Transport Candidates shall
be deemed to be a Raptor Invention, and all intellectual property related solely to Products
(excluding Transport Candidates included therein) shall be deemed to be a Roche Invention.



1.25 Joint Know-How

The term “Joint Know-How” shall mean Know-How that is made jointly by the Parties or their
Affiliates or their Sublicensees in the course of performing an activity pursuant to this
Agreement.



1.26 Joint Patent Rights

The term “Joint Patent Rights” shall mean Patent Rights claiming a Joint Invention.


 


5/32









 





1.27 Joint Steering Committee

The term “Joint Steering Committee” or “JSC” shall mean the steering committee, otherwise referred
to as the JSC, further described in Article 5.



1.28 Know-How

The term “Know-How” shall mean data, knowledge and information, including materials, samples,
chemical manufacturing data, toxicological data, pharmacological data, preclinical data, assays,
platforms, formulations, specifications, quality control testing data, whether or not patentable.



1.29 Law

The term “Law” shall mean any law, statute, rule, regulation, ordinance or other pronouncement
having the effect of law of any federal, national, multinational, state, provincial, county, city
or other political subdivision, domestic or foreign.



1.30 Major Market Countries

The term “Major Market Countries” shall mean the U.S., Germany, France, United Kingdom, Italy,
Spain and Japan.



1.31 NDA

The term “NDA” shall mean a new drug application or a Biologics License Application, including all
necessary documents, data, and other information concerning a Product, required for Regulatory
Approval of the Product as a pharmaceutical product by the FDA or an equivalent application to the
equivalent agency in any other country or group of countries (e.g. the marketing authorization
application (MAA) in the EU).



1.32 Net Sales

The term “Net Sales” shall mean the amount calculated by subtracting from the amount of Adjusted
Gross Sales (as defined below) a lump sum deduction of [*****] of Adjusted Gross Sales [*****].



For purposes of this definition of “Net Sales”, “Adjusted Gross Sales” shall mean [*****] less
deductions (which deductions shall in all cases be as consistently applied by Roche to its
products) for [*****].



In case of doubt, the “Adjusted Gross Sales” [*****].



1.33 Non-cancellable Obligation

The term “Non-cancellable Obligation” shall mean a Third Party Cost which, in either case, cannot
be canceled without penalty upon termination of this Agreement.



1.34 Party

The term “Party” shall mean Raptor or Roche, as the case may be, and “Parties” shall mean Raptor
and Roche collectively.



1.35 Patent Rights

The term “Patent Rights” shall mean all rights under any patent or patent application, in any
country of the Territory, including any patents issuing on such patent application, and further
including any substitution, extension or supplementary protection certificate, reissue,
reexamination, renewal, division, continuation or continuation-in-part of any of the foregoing.


 


6/32









 





1.36 Person

The term “Person” shall mean any corporation, limited or general partnership, limited liability
company, joint venture, trust, unincorporated association, governmental body, authority, bureau or
agency, any other entity or body, or an individual.



1.37 Phase I Study

The term “Phase I Study” shall mean a human clinical trial in any country that would satisfy the
requirements of 21 C.F.R. § 312.21(a), as amended from time to time.



1.38 Phase II Study

The term “Phase II Study” shall mean a human clinical trial, for which the primary endpoints
include a determination of dose ranges and/or a preliminary determination of efficacy in patients
being studied as described in 21 C.F.R. § 312.21(b).



1.39 Phase III Study

The term “Phase III Study” shall mean a human clinical trial that is prospectively designed to
demonstrate statistically whether a product is safe and effective for use in humans in a manner
sufficient to obtain regulatory approval to market such product in patients having the disease or
condition being studied as described in 21 C.F.R. § 312.21(c).



1.40 Product

The term “Product” shall mean any product comprising (1) a Transport Candidate, and (2) a
pharmaceutically active ingredient or an ingredient for the diagnosis or prognosis of an
Indication.



1.41 Regulatory Approval

The term “Regulatory Approval” shall mean any approvals (including, if applicable, pricing and
reimbursement approvals), licenses, registrations or authorizations by Regulatory Authority,
necessary for the marketing and sale of a Product in the Field in a regulatory jurisdiction in the
Territory.



1.42 Raptor Base Patent Rights

The term “Raptor Base Patent Rights” shall mean any and all Raptor Patent Rights which are
Controlled by Raptor as of the Effective Date, said Patent Rights being listed in Appendix 1.42 of
this Agreement.



1.43 Raptor Know-How

The term “Raptor Know-How” shall mean all Know-How that Raptor Controls as of the Effective Date
and during the Agreement Term that is necessary or useful for the discovery, manufacture,
development or commercialization of Products in the Field.



1.44 Raptor Patent Rights

The term “Raptor Patent Rights” shall mean the Patent Rights that Raptor Controls as of the
Effective Date and during the Agreement Term, necessary or useful for the discovery, manufacture,
development or commercialization of or Covering a Product in the Field. The term Raptor Patent
Rights shall include Raptor Base Patent Rights.


 


7/32









 





1.45 Research Plan

The term “Research Plan” shall mean the plan of research outlining the work expected to be
performed by each Party, a copy of which initial plan is attached as Appendix 1.45, as such plan is
approved by the JSC and as it may be updated from time to time as provided in this Agreement.



1.46 Research Program

The term “Research Program” shall mean the activities undertaken by the Parties pursuant to the
Research Plan to identify Products, and such other activities with regard to Transport Candidates
and Products as the Parties may agree in writing.



1.47 Research Term

The term “Research Term” shall mean the period of time in which the Research Program shall be
conducted, commencing on the Effective Date and continuing until the completion of Development
Phase 1 or Development Phase 2, unless earlier terminated pursuant to Section 14.2.



1.48 Roche Group

The term “Roche Group” shall mean collectively Roche, its Affiliates and its Sublicensees.



1.49 Roche Patent Rights

The term “Roche Patent Rights” shall mean all Patent Rights Controlled by Roche Covering a Product
or that otherwise claim Roche Inventions.



1.50 Royalty Term

The term “Royalty Term” shall mean, with respect to a Product and for a given country, the period
of time commencing on the date of First Commercial Sale of the Product in such country and ending
on the later of the date that is [*****].



1.51 Sublicensee

The term “Sublicensee” means an entity to which Roche or its Affiliates have licensed rights
pursuant to this Agreement.



1.52 Territory

The term “Territory” shall mean all countries of the world.



1.53 Third Party

The term “Third Party” shall mean a Person other than (i) Raptor or any of its Affiliates or (ii) a
member of the Roche Group.



1.54 Transport Candidate

The term “Transport Candidate” shall mean any receptor associated protein or any derivative or
fragment thereof Covered by Raptor Base Patent Rights or invented or discovered in the conduct of
the research collaboration, and any protein that has seventy-five percent (75%) or greater homology
thereto.



1.55 US

The term “US” shall mean the United States of America and its territories and possessions.


 


8/32









 





1.56 Valid Claim

The term “Valid Claim” shall mean, as applicable, a claim in any (i) unexpired and issued Raptor
Patent Rights or Joint Patent Rights that have not been disclaimed, revoked or held invalid by a
final nonappealable decision of a court of competent jurisdiction or government agency or (ii)
pending patent application of any Raptor Patent Rights or Joint Patent Rights in any country of the
Territory that has been on file with the applicable patent office for [*****] from the earliest
date to which the patent application claims its earliest priority.



1.57 Additional Definitions

Each of the following definitions is set forth in the Section of this Agreement indicated below:



	 	 	 	 	 
	Definition	 	Section
	“Accounting Period”

	 	 	7.1	 
	“Adjusted Gross Sales”

	 	 	1.32	 
	“Alliance Director”

	 	 	5.6	 
	“Bankruptcy Code”

	 	 	15	 
	[*****]
	 	 	 	 
	“Breaching Party”

	 	 	14.2.1	 
	“Chairperson”

	 	 	5.2	 
	“Chugai”

	 	 	1.1	 
	“Development Phase 1”

	 	 	3.1.1	 
	“Development Phase 2”

	 	 	3.1.1	 
	“Disclosing Party”

	 	 	1.10	 
	“Genentech”

	 	 	1.1	 
	[*****]
	 	 	 	 
	“Indemnified Party”

	 	 	12.3	 
	“Indemnifying Party”

	 	 	12.3	 
	“Joint Invention”

	 	 	1.24	 
	“Material(s)”

	 	 	13.7	 
	“Member(s)”

	 	 	5.2	 
	“Non-Breaching Party”

	 	 	14.2.1	 
	“Notice of Comments”

	 	 	13.4	(b)
	“Payment Breach”

	 	 	14.2.1	 
	“Peremptory Notice Period”

	 	 	14.2.1	 
	“Publishing Party”

	 	 	13.4	(b)
	“Raptor”

	 	Preamble

	“Raptor Invention”

	 	 	1.24	 
	“Receiving Party”

	 	 	1.10	 
	“Roche Basel”

	 	Preamble

	“Roche Entity”

	 	 	1.1	 
	“Roche Invention”

	 	 	1.24	 
	“Roche Nutley”

	 	Preamble

	“SEC”

	 	 	11.4	 
	“Subject Disclosure”

	 	 	13.3.1	 





 


9/32









 





2. Grant of License




2.1 Licenses




2.1.1 Commercial Licenses




Subject to the terms and conditions of this Agreement, Raptor grants to Roche and its Affiliates an
exclusive (even as to Raptor except as provided below), non-transferable (except as permitted under
Section 16.4) right and license under Raptor’s interest in the Raptor Patent Rights and Raptor
Know-How and Raptor’s interest in the Joint Patent Rights and Joint Know-How to use, make, have
made, import, offer to sell, sell and have sold Transport Candidates and Products in the Field in
the Territory.



2.1.2 Research Cross Licenses




Each Party grants to the other Party and its Affiliates during the Research Term a non-exclusive
right and license under Know-How and Patent Rights Controlled by such Party and that are necessary
or useful for the discovery, manufacture or development of Products solely to enable the other
Party and its Affiliates to perform the activities contemplated under the Research Plan under this
Agreement.



Notwithstanding the exclusive license grant to Roche and its Affiliates in Section 2.1.1, Raptor
reserves the rights under the Raptor Patent Rights, Raptor Know-How, Joint Patent Rights and Joint
Know-How to use, make, have made, and transfer Transport Candidates and Products in the Field in
the Territory solely for performing the Research Project.



2.2 Sublicense

The rights and licenses granted to Roche and its Affiliates shall include the right of Roche to
grant written sublicenses to Affiliates and Third Parties under such rights and licenses, in whole
or in part, solely to the extent necessary to make, use, offer for sale, sell or import Transport
Candidates or Products in the Territory for use in the Field, provided that Roche will be
responsible for the sublicensees’ compliance to the applicable terms and conditions of this
Agreement.



2.3 Exclusivity

During the Exclusivity Period, Raptor shall work exclusively with Roche on the use of Transport
Candidates to cross the blood brain barrier. The Exclusivity Period can be extended if Roche makes
the payments set forth in Section 6.1.1.



2.4 No Other Rights

Except for the rights expressly granted under this Article 2, no license, right, title or interest
of any nature whatsoever is granted hereunder by implication, estoppel, reliance or otherwise, by
Raptor to Roche or any of Roche’s Affiliates, and any of Raptor’s rights to Raptor Patent Rights,
Raptor Know-How, Joint Patent Rights and Joint Know-How not specifically licensed to Roche under
this Article 2 shall be retained by Raptor.



3. Research Collaboration


 


10/32









 





3.1 Conduct of the Research Program




3.1.1 Scope



Initially, Roche and Raptor shall conduct a mutually agreed-upon Research Program pursuant to the
Research Plan attached as Appendix 1.45 with the objective of performing the initial feasibility
study with full RAP protein and existing fragments (“Development Phase 1”). Upon successful
completion of the Development Phase 1, Roche will have the option to retain Raptor to perform an
additional Research Plan to expand the NeuroTransTM platform to develop neurobiologicals
for delivery to the brain (“Development Phase 2”) subject to mutual agreement on the scope of
Development Phase 2 and payment of prospective fees based on FTEs. The activities conducted in
connection with the Research Program will be overseen by the JSC.




3.1.2 Commercially Reasonable Efforts




Roche and Raptor shall each use Commercially Reasonable Efforts to perform their respective tasks
and obligations in conducting the activities assigned to it in the then-current Research Plan.




3.1.3 Research Plan




The Parties will conduct the Research Program in accordance with the Research Plan. The Research
Plan will set forth (i) the scope of the Research Program and the resources that are expected to be
dedicated to the activities contemplated within the scope of the Research Program, including the
responsibilities of each Party and (ii) specific objectives for each year, which objectives will be
updated or amended, as appropriate, by the JSC as research progresses. The initial Research Plan
for activities is attached hereto as Appendix 1.45. The JSC shall review the Research Plan on an
ongoing basis and may amend the Research Plan, subject to Section 5.7. Any such changes shall be
reflected in written amendments to the Research Plan.




3.1.4 Duration




The Research Program shall commence on the Effective Date and shall continue until the end of the
Research Term.




4. Diligence and Third Party Obligations




4.1 Diligence

Roche and Raptor shall each use Commercially Reasonable Efforts to perform their other respective
activities contemplated by this Agreement or as may be agreed upon in any subsequent written
agreements with respect to the subject matter hereof. [*****]



[*****]




5. Governance




5.1 Joint Steering Committee

Within sixty (60) days after the Effective Date of this Agreement, the Parties shall establish a
Joint Steering Committee to oversee the Research Program activities under this Agreement.


 


11/32









 





5.2 Members



The JSC shall be composed of four (4) persons (each a “Member”). Roche and Raptor each shall be
entitled to appoint two (2) Members with appropriate seniority and expertise. Each Party may
replace any of its Members and appoint a person to fill the vacancy arising from each such
replacement. A Party that replaces a Member shall notify the other Party at least ten (10) days
prior to the next scheduled meeting of the JSC. Both Parties shall use Commercially Reasonable
Efforts to keep an appropriate level of continuity in representation. Both Parties may invite a
reasonable number of additional experts and/or advisors who are subject to confidentiality
obligations at least as restrictive as those set forth in Article 13 to attend part or the whole
JSC meeting with prior notification to the JSC. Members may be represented at any meeting by
another person designated by the absent Member. The JSC shall be chaired by a Roche Member
(“Chairperson”).




5.3 Meetings



The Chairperson or his/her delegate is responsible for sending invitations and agendas for all JSC
meetings to all Members at least ten (10) days before the next scheduled meeting of the JSC. The
venue for the meetings shall be agreed by the JSC. The JSC shall hold meetings at least twice per
Calendar Year, either in person or by tele-/video-conference, and in any case as frequently as the
Members of the JSC may agree shall be necessary, but not more than four (4) times a year. The
Alliance Director of each Party shall attend the JSC meetings as permanent participant.




5.4 Minutes

The Chairperson is responsible for designating a Member to record in reasonable detail and
circulate draft minutes of JSC meetings to all members of the JSC for comment and review within
twenty (20) days after the relevant meeting. The Members of the JSC shall have thirty (30) days to
provide comments. The Party preparing the minutes shall incorporate timely received comments and
distribute finalized minutes to all Members of the JSC within sixty (60) days of the relevant
meeting. Both Parties shall approve the final version of the minutes before its distribution.



5.5 Decisions




5.5.1 Decision Making Authority




Subject to Section 5.7, the JSC shall decide matters related to the Research Program, as well as
approve and amend the Research Plan.




5.5.2 Consensus; Good Faith




The Members of the JSC shall act in good faith to cooperate with one another and seek agreement
with respect to issues to be decided by the JSC. The Parties shall endeavor to make decisions by
consensus.




5.5.3 Failure to Reach Consensus




If the JSC is unable to decide a matter by consensus, then Roche shall have the final decision
authority on any matter.




5.6 Alliance Director

Each Party shall appoint an Alliance Director (“Alliance Director”). The Alliance Directors shall
be the point of contact within each Party with responsibility for facilitating communication and
collaboration between the Parties. They are permanent participants of the JSC meetings (but not
members of the JSC) and may attend JSC meetings as appropriate. The Alliance Directors shall
seek to facilitate resolution of potential and pending issues and potential disputes to enable the
JSC to reach consensus and avert escalation of such issues or potential disputes.


 


12/32









 





5.7 Limitations of Authority

Neither the JSC, nor Roche unilaterally, shall have the authority to amend or waive any terms of
this Agreement or impose additional obligations on Raptor without Raptor’s prior written consent.



5.8 Expenses

Each Party shall be responsible for its own expenses including travel and accommodation costs
incurred in connection with the JSC.



5.9 Lifetime

The JSC shall exist during the Research Term and for six (6) months thereafter.



6. Payment




6.1 Signing Fee

Within thirty (30) days after the Effective Date and receipt of an invoice from Raptor, Roche shall
pay to Raptor a fee of [*****].



6.1.1 Extension of Exclusivity Period




Roche can extend the Exclusivity Period for an additional twelve (12) months by notifying Raptor in
writing on or before the end of the Exclusivity Period. Roche shall also pay Raptor [*****] within
thirty (30) days after such notice has been provided, and Roche has received an invoice for such
amount from Raptor.



6.2 Events




Roche shall pay to Raptor up to a total of [*****] in relation to the achievement of events with
respect to each Product. The event payments under this Section 6.2 shall be paid by Roche according
to the following schedule of development events:



	 	 	 
	[*****]

	 	[*****]






Each event payment for a given Product shall be paid only once for a given Product, the first time
a Product reaches such event, regardless of the number of times such events are reached for the
given Product.



Upon achievement by Roche, its Affiliates and/or Sublicensees of any of the foregoing events, Roche
shall promptly (and in no event more than thirty (30) days following achievement thereof) notify
Raptor and event payments shall be paid by Roche to Raptor within thirty (30) days after occurrence
of the applicable event and receipt of an invoice from Raptor.


 


13/32









 





6.3 Royalty Payments



6.3.1 Royalty Term



Royalties shall be payable by Roche on Net Sales of Products on a Product-by Product and
country-by-country basis until the expiry of the Royalty Term for a Product in a given country.
Thereafter, the licenses shall be fully paid up and royalty-free with respect to such Product in
such country, on a Product-by-Product and country-by-country basis.




Subject to the remainder of this Section 6.3, the following royalty rates shall apply to the
respective tiers of worldwide, aggregate Calendar Year Net Sales of a Product in the Territory, on
an incremental basis, as follows:



[*****]




For the purpose of calculating royalties payable with respect to a Product, royalties on Calendar
Year Net Sales shall be subject to [*****]



7. Accounting and reporting




7.1 Timing of Payments

Roche shall calculate royalties on Net Sales quarterly as of March 31, June 30, September 30 and
December 31 (each being the last day of an “Accounting Period”) and shall pay royalties on Net
Sales within sixty (60) days after the end of each Accounting Period in which such Net Sales occur.



7.2 Late Payment

Any payment under this Agreement that is not paid on or before the date such payment is due shall
bear interest, to the extent permitted by applicable law [*****] calculated on the number of days
such payment is overdue. [*****]



7.3 Method of Payment

Royalties on Net Sales and all other amounts payable by Roche hereunder shall be paid by or on
behalf of Roche in U.S. Dollars. All payments due to Raptor hereunder shall be made directly from
an account located in either (at Roche’s option) the United States or Switzerland to account(s)
designated by Raptor.



7.4 Currency Conversion




Whenever calculating royalties requires conversion from any currency, Roche shall make such
conversion as follows:
When calculating the Net Sales for countries other than the United States of America, Roche shall
convert the amount of such sales in currencies other than Swiss Francs into Swiss Francs using for
internal foreign currency translation Roche’s then current standard practices actually used on a
consistent basis in preparing its audited financial statements.



Upon converting the amount of Adjusted Gross Sales into Swiss Francs, Roche shall convert into US
Dollars (or other currency) [*****].


 


14/32









 





7.5 Reporting



With each payment Roche shall provide Raptor in writing for the relevant Calendar Quarter on a
Product-by-Product basis the following information with respect to each of the following
territories: (1) the United States, (2) the Major Market Countries (other than the United States)
and Canada, and (3) all territories other than those set forth in the foregoing clause (1) and (2):




a) Net Sales and Adjusted Gross Sales;


b) taxes withheld, if applicable;

; and

d) Total royalty payable to Raptor.




7.6 United States Dollars



All dollar ($) amounts specified in this Agreement are United States dollar amounts.




7.7 Nonrefundable

All payments made by Roche to Raptor under this Agreement shall be non-refundable and
non-creditable, except for those set forth in Section 6.3 or as set forth in 6.2 or 9.3.



8. Taxes




Raptor shall pay all sales, turnover, income, revenue, value added, and other taxes levied on
account of any payments accruing or made to Raptor under this Agreement. If provision is made in
law or regulation of any country for withholding of taxes of any type, levies or other charges with
respect to any royalty payable under this Agreement to Raptor, then Roche shall promptly pay such
tax, levy or charge for and on behalf of Raptor to the proper governmental authority, and shall
promptly furnish Raptor with receipt of payment. Roche shall be entitled to deduct any such tax,
levy or charge actually paid from royalty due Raptor or be promptly reimbursed by Raptor if no
further payments are due Raptor. Each Party agrees to reasonably assist the other Party in claiming
exemption from such deductions or withholdings under double taxation or similar agreement or treaty
from time to time in force and in minimizing the amount required to be so withheld or deducted.




9. Auditing




9.1 Raptor Right to Audit




9.1.1 Roche shall keep, and shall require its and its Affiliates and Sub-licensees to keep, for
three (3) years, full, true and accurate books of account containing all particulars that may be
necessary for the purpose of calculating all royalties and all other amounts payable under this
Agreement. Such books of accounts shall be kept at Roche’s or the relevant Affiliate’s or
Sublicensee’s principal place of business. At the expense of Raptor, Raptor has the right to engage
an independent public accountant to perform, on behalf of Raptor an audit of such books and records
of Roche and its Affiliates and Sub-licensees, that are deemed necessary by Raptor’s independent
public accountant to report on Net Sales of Products for the period or periods requested by Raptor
and the correctness of any report or payments made under this Agreement.


 


15/32









 





9.1.2 Upon timely request and at least thirty (30) Business Days prior written notice from Raptor,
such audit shall be conducted in the countries specifically requested by Raptor, during regular
business hours in such a manner as to not unnecessarily interfere with Roche’s normal business
activities, and shall be limited to results in the three (3) Calendar Years prior to audit
notification.



9.1.3 Such audit shall not be performed more frequently than once per Calendar Year nor more
frequently than once with respect to records covering any specific period of time. The auditors
shall not interpret the agreement.



9.1.4 All information, data documents and abstracts herein referred to shall be used only for the
purpose of verifying royalty statements, shall be treated as Roche Confidential Information subject
to the obligations of this Agreement and need neither be retained more than the longer of one (1)
year after completion of an audit hereof, if an audit has been requested; nor more than three (3)
years from the end of the Calendar Year to which each shall pertain; nor more than one (1) year
after the date of termination of this Agreement.



9.2 Sharing of reports

The final audit report shall be shared by Roche and Raptor.



9.3 Over- or Underpayment

If the audit reveals an underpayment, Roche shall reimburse Raptor for the amount of the
underpayment within thirty (30) days with interest as set forth in Section 7.2. If the audit
reveals an overpayment, Roche shall have the right to credit the amount of such overpayment against
the next royalty payment payable to Raptor hereunder. [*****] Section 16.2 shall apply to this
Section 9.3.



9.4 Duration of Audit Rights

The failure of Raptor to request verification of any royalty calculation within the period during
which corresponding records must be maintained under this Section 10 will be deemed to be
acceptance of the royalty payments and reports.



10. Intellectual Property




10.1 Ownership of Inventions

Raptor shall own all Raptor Inventions, Roche shall own all Roche Inventions, and Raptor and Roche
shall jointly own all Joint Inventions. Each Party shall require all of its employees, and shall
cause its Affiliates performing under this Agreement to require all of such Affiliates’ employees,
to assign all Inventions made by them to such Party or such Party’s Affiliates, as the case may be.



The determination of inventorship for Inventions shall be in accordance with US inventorship laws.



Except as specifically set forth herein, this Agreement shall not be construed as (i) granting any
license or right under any intellectual property rights; or (ii) representing any commitment by
either party to enter into any additional agreement, by implication or otherwise.


 


16/32









 





10.2 Prosecution of Patent Rights Claiming Raptor Inventions

Raptor shall, at its expense discretion, (i) Handle all Raptor Patent Rights, (ii) consult with
Roche as to the Handling of such Raptor Patent Rights, (iii) apprise Roche of significant events
(such as issuance, reissuance, reexamination, interference, revocation or opposition proceedings)
encountered in such Handling, and (iv) provide to Roche an annual report identifying all Raptor
Patent Rights and their status. At Raptor’s reasonable request, Roche shall cooperate with the
Handling of all Raptor Patent Rights. Raptor will not abandon any Raptor Patent Rights without the
prior consent of Roche. Roche acknowledges that if Raptor (based on consultation with Roche) elects
not to Handle, or (with prior consent of Roche) elects to abandon, any Raptor Patent Rights that
Cover a Product to which Roche retains a license under Section 2.1, BioMarin has the right to take
over the prosecution of such Raptor Patent Rights pursuant to the Asset Purchase Agreement.



10.3 Prosecution of Patent Rights Claiming Roche Inventions

Roche shall, at its own expense and discretion, (i) Handle all Roche Patent Rights that claim Roche
Inventions, (ii) consult with Raptor as to the Handling of such Roche Patent Rights, (iii) apprise
Raptor of significant events (such as issuance, reissuance, reexamination, interference, revocation
or opposition proceedings) encountered in such Handling, and (iv) provide to Raptor an annual
report identifying all Roche Patent Rights and their status. At Roche’s expense and reasonable
request, Raptor shall cooperate with the Handling of all such Roche Patent Rights.



10.4 Prosecution of Patent Rights Claiming Joint Inventions




10.4.1 Roche shall (i) Handle all Patent Rights that claim Joint Inventions, (ii) consult with
Raptor as to the Handling of such Patent Rights, and (iii) furnish to Raptor copies of all
documents relevant to any such Handling. Roche shall furnish such documents and consult with
Raptor in sufficient time before any action by Roche is due to allow Raptor to provide comments
thereon, which comments Roche must consider. Raptor shall reasonably cooperate, with the Handling
of all such Patent Rights. If Roche wishes to abandon any of such Patent Rights, then sufficiently
in advance to permit Raptor to undertake Handling of such Patent Rights without a loss of rights,
Roche shall offer to assign its interest in such Patent Rights to Raptor and, upon Raptor’s
request, shall promptly assign its interest in such Patent Rights to Raptor.



10.4.2 The Parties shall equally share all reasonable and documented external costs incurred in
Handling Patent Rights claiming Joint Inventions. Each Party shall have the right, exercisable by
written notice, to terminate its obligation to share such costs. If Roche exercises such right,
then from and after the date thereof Roche shall assign its interest in such Patent Right to
Raptor, which Patent Right shall be deemed to be a Raptor Patent Right for purposes of this
Agreement. If Raptor exercises such right, then from and after the date thereof Raptor shall assign
its interest in such Patent Right to Roche, which Patent Right shall be deemed to be a Roche Patent
Right for purposes of this Agreement. If neither Party Handles any such Patent Right, then the
underlying Invention shall be deemed Joint Know-How.



11. Representations and Warranties




Except as expressly set forth in a letter dated as of even date herewith from Raptor to Roche,
Raptor represents and warrants to Roche as of the Effective Date as follows:



 


17/32









 







11.1 Ownership of Patent Rights



Raptor is the exclusive owner of all right, title and interest in, or is the exclusive licensee of,
the Raptor Base Patent Rights. Appendix 1.42 contains a complete and accurate list of all patents
and patent applications included in the Raptor Base Patent Rights as of the Effective Date. The
Raptor Base Patent Rights are free and clear of all liens, claims, security interests and other
encumbrances of any kind or nature [*****]. Raptor has not granted any licenses to the Raptor
Patent Rights to any Third Party, nor has Raptor effectuated any prior transfer, sale or assignment
of any part of the Raptor Patent Rights to a Third Party, that conflicts in any material respect
with any of the terms of this Agreement or the licenses granted to Roche hereunder.




11.2 Inventors

All of Raptor’s employees, officers and consultants performing work on behalf of Raptor under this
Agreement have executed agreements with Raptor requiring assignment to Raptor of all Inventions
made by such individuals during the course of their employment or consulting relationship with
Raptor.



11.3 Grants

Raptor has the right to grant Roche and its Affiliates the rights and licenses described in this
Agreement.



11.4 Authorization

The execution, delivery and performance of this Agreement by Raptor: (i) are within the corporate
power of Raptor; (ii) have been duly authorized by all necessary corporate action; (iii) are not
in contravention of any provision of the certificate of incorporation of Raptor; (iv) to the
knowledge of Raptor, will not violate any Law or regulation or any order or decree of any court of
governmental instrumentality; (v) will not violate the terms of any indenture, mortgage, deed of
trust, lease, agreement, or other instrument to which Raptor is a party or by which Raptor or any
of its property is bound, which violation would have a material adverse effect on the financial
condition of Raptor or on the ability of Raptor to perform its obligations hereunder; and (vi) do
not require any filing or registration with, or the consent or approval of, any governmental body,
agency, authority or any other Person, which has not been made or obtained previously, except for
any filing required to comply with the laws and regulations of the Securities and Exchange
Commission (“SEC”) as permitted under Section 13.3.3.



11.5 Validity of Patent Rights

To the best of Raptor’s knowledge, the claims in any issued patent included in the Raptor Base
Patent Rights licensed to Roche pursuant to this Agreement are valid and enforceable. To Raptor’s
knowledge, there is no dispute concerning inventorship of any Raptor Base Patent Rights.



11.6 Ownership and Validity of Know-How

To the best of Raptor’s knowledge, the Raptor Know-How has not been misappropriated from any Third
Party. Raptor has taken reasonable measures to protect the confidentiality of the Raptor Know-How.



11.7 No Claims

There are no claims or investigations pending or, to the best of Raptor’s knowledge, threatened
against Raptor or any of its Affiliates, at Law or in equity, or before or by any governmental
authority relating to the subject matter of this Agreement or that would materially adversely
affect Raptor’s ability to perform its obligations hereunder.


 


18/32









 





11.8 No Conflict

Raptor is not under any obligation to any Person, contractual or otherwise, that conflicts in any
material respect with the terms of this Agreement.



11.9 Roche Representations and Warranties

Roche represents and warrants to Raptor as of the Effective Date as follows:



(a) The execution, delivery and performance of this Agreement by Roche: (i) are within the
corporate power of Roche; (ii) have been duly authorized by all necessary corporate action; (iii)
are not in contravention of any provision of the certificate of incorporation of Roche; (iv) to the
knowledge of Roche, will not violate any Law or regulation or any order or decree of any court of
governmental instrumentality; (v) will not violate the terms of any indenture, mortgage, deed of
trust, lease, agreement, or other instrument to which Roche is a party or by which Roche or any of
its property is bound, which violation would have a material adverse effect on the financial
condition of Roche or on the ability of Roche to perform its obligations hereunder; and (vi) do not
require any filing or registration with, or the consent or approval of, any governmental body,
agency, authority or any other Person, which has not been made or obtained previously.



(b) There are no claims or investigations pending or, to Roche’s knowledge, threatened against
Roche or any of its Affiliates, at Law or in equity, or before or by any governmental authority
relating to the subject matter of this Agreement or that would materially adversely affect Roche’s
ability to perform its obligations hereunder.



(c) Roche is not under any obligation to any Person, contractual or otherwise, that conflicts in
any material respect with the terms of this Agreement.



11.10 No Other Representations; Disclaimer

EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS
OR EXTENDS ANY WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT OF RIGHTS OF
THIRD PARTIES, WITH RESPECT TO ANY PRODUCT, TRANSPORT CANDIDATE, KNOW-HOW, MATERIALS OR PATENT
RIGHTS.



12. Indemnification




12.1 Indemnification by Roche

Roche shall indemnify, hold harmless and defend Raptor, its Affiliates and their respective
directors, officers, employees and agents from and against any and all losses, expenses, cost of
defense (including without limitation reasonable attorneys’ fees, witness fees, damages, judgments,
fines and amounts paid in settlement) and any amounts Raptor becomes legally obligated to pay
because of any claim or claims against it to the extent that such claim or claims arise out of (a)
activities related to Products (including, without limitation, product liability claims) conducted
by or on behalf of Roche, its Affiliates or Sublicensees, (b) the breach of any of Roche’s
representations or warranties hereunder, or (c) any infringement of any Third Party Patent Rights
or
misappropriation of any Third Party Know-How in connection with the manufacture, use, offer for
sale, sale, import or export of any Products, in all cases except to the extent such losses,
expenses, costs and amounts are due to the gross negligence or willful misconduct of Raptor or
breach of any of Raptor’s representations and warranties hereunder.


 


19/32









 





12.2 Indemnification by Raptor

Raptor shall indemnify, hold harmless and defend Roche, its Affiliates and their respective
directors, officers, employees and agents from and against any and all losses, expenses, cost of
defense (including without limitation reasonable attorneys’ fees, witness fees, damages, judgments,
fines and amounts paid in settlement) and any amounts Roche becomes legally obligated to pay
because of any claim or claims against it to the extent that such claim or claims arise out of the
breach of any of Raptor’s representations or warranties hereunder, in all cases except to the
extent such losses, expenses, costs and amounts are due to the gross negligence or willful
misconduct of Roche or breach of any of Roche’s representations and warranties hereunder.



12.3 Procedure

In the event of a claim by a Third Party against any indemnitee entitled to indemnification under
this Agreement (in such capacity, the “Indemnified Party”), the Indemnified Party shall promptly
notify the other Party (in such capacity, the “Indemnifying Party”) in writing of the claim (it
being understood that the failure by the Indemnified Party to give prompt notice of a Third Party
claim as provided in this Section 12.3 shall not relieve the Indemnifying Party of its
indemnification obligation under this Agreement except and only to the extent that such
Indemnifying Party is actually prejudiced as a result of such failure to give prompt notice).
Within thirty (30) days after delivery of such notification, the Indemnifying Party may, upon
written notice thereof to the Indemnified Party, undertake and solely manage and control, at its
sole expense and with counsel reasonably satisfactory to the Indemnified Party, the defense of the
claim. If the Indemnifying Party does not undertake such defense, the Indemnified Party shall
control such defense. The Party not controlling such defense shall cooperate with the other Party
and may, at its option and expense, participate in such defense; provided that, if the Indemnifying
Party assumes control of such defense and the Indemnified Party in good faith concludes, based on
advice from counsel, that the Indemnifying Party and the Indemnified Party have conflicting
interests with respect to such action, suit, proceeding or claim, the Indemnifying Party shall be
responsible for the reasonable fees and expenses of counsel to the Indemnified Party solely in
connection therewith. The Party controlling such defense shall keep the other Party advised of the
status of such action, suit, proceeding or claim and the defense thereof and shall consider
recommendations made by the other Party with respect thereto. The Indemnifying Party shall not be
liable for any litigation costs or expenses incurred by the Indemnified Party without the
Indemnifying Party’s written consent. The Indemnified Party shall not settle any such action, suit,
proceeding or claim without the prior written consent of the Indemnifying Party, which shall not be
unreasonably withheld, delayed or conditioned. The Indemnifying Party shall not settle any such
action, suit, proceeding or claim, or consent to any judgment in respect thereof, that does not
include a complete and unconditional release of the Indemnified Party from all liability with
respect thereto, that imposes any liability or obligation on the Indemnified Party or that
acknowledges fault by the Indemnified Party without the prior written consent of the Indemnified
Party.



12.4 No Consequential Damages

IN NO EVENT SHALL EITHER RAPTOR OR ROCHE BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL, EXEMPLARY,
MULTIPLE OR CONSEQUENTIAL DAMAGES ARISING OUT OF
THIS AGREEMENT BASED ON CONTRACT, TORT OR ANY OTHER LEGAL THEORY. NOTHING IN THIS SECTION 12.4 IS
INTENDED TO LIMIT OR RESTRICT (A) THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER
ARTICLE 12 OR (B) REMEDIES AVAILABLE TO EITHER PARTY WITH RESPECT TO A BREACH OF ARTICLE 13.


 


20/32









 





13. Obligation Not to Disclose Confidential Information




13.1 Non-Use and Non-Disclosure

During the Agreement Term and for five (5) years thereafter, the Receiving Party shall (i) treat
Confidential Information provided by the Disclosing Party as it would treat its own information of
a similar nature (but with no less than reasonable care), (ii) take reasonable precautions not to
disclose such Confidential Information to Third Parties, without the Disclosing Party’s prior
written consent, (iii) not use such Confidential Information other than for fulfilling its
obligations under this Agreement and (iv) shall disclose such Confidentiality Information only to
the Receiving Party’s employees, consultants, advisors and contractors who have a need-to-know such
Confidential Information to perform their obligations in connection herewith, solely under
conditions of confidentiality and non-use that are at least as restrictive as those set forth in
this Article 13.



13.2 Permitted Disclosure

Notwithstanding the obligation of non-use and non-disclosure set forth in Section 13.1, the Parties
recognize the need for certain exceptions to this obligation, specifically set forth below, with
respect to press releases, patent rights, publications, and certain commercial considerations.



13.3 Press Releases; Disclosure of Terms




13.3.1 During the Agreement Term, the content of any press release or public disclosure relating to
this Agreement or the Parties’ activities hereunder (each such press release or public disclosure,
a “Subject Disclosure”) shall be mutually agreed by the Parties, which agreement shall not be
unreasonably withheld, delayed or conditioned, except that a Party may, without the other Party’s
agreement, issue or make such Subject Disclosure (a) if the contents of such Subject Disclosure
have previously been made public other than through a breach of this Agreement by the issuing
Party, or (b) if it is advised by counsel that such Subject Disclosure is required by applicable
Law, including without limitation the rules or regulations of the SEC or similar regulatory agency
in a country other than the United States or of any stock exchange or other securities trading
institution.



13.3.2 In light of the foregoing, each Party shall provide the other Party with a draft Subject
Disclosure that requires such other Party’s approval hereunder at least five (5) Business Days
prior to its intended issuance or disclosure for such other Party’s review. During such period, the
reviewing Party shall either (i) approve the draft Subject Disclosure and permit the submitting
Party to issue such Subject Disclosure, (ii) contact the submitting Party to discuss modification
to the draft Subject Disclosure, or (iii) contact the submitting Party and disapprove the Subject
Disclosure, in each case subject to the reviewing Party’s obligation not to unreasonably withhold,
condition or delay any approval which is sought by the submitting Party with respect to such draft
Subject Disclosure. If the reviewing Party asks for modification, then the submitting Party shall
either make such modification or work with the reviewing Party to arrive at a Subject Disclosure
that is agreeable to both Parties.


 


21/32









 





13.3.3 Notwithstanding anything in this Agreement to the contrary, each Party shall have the right
to disclose the terms of this Agreement [*****] and (b) as required by applicable Law, including
without limitation the rules or regulations of the SEC or similar regulatory agency in a country
other than the United States or of any stock exchange or other securities trading institution. In
the event that this Agreement shall be included in any report, statement or other document filed by
either Party or an Affiliate of either Party with the SEC or similar regulatory agency in a country
other than the United States or any stock exchange or other securities trading institution, such
Party shall use, or shall cause such Party’s Affiliate, as the case may be, to use, reasonable
efforts to obtain confidential treatment from the SEC, similar regulatory agency, stock exchange or
other securities trading institution of any financial information or other information of a
competitive or confidential nature, and shall include in such confidentiality request such
provisions of this Agreement as may be reasonably requested by the other Party.



13.4 Publications

During the Agreement Term, the following restrictions shall apply with respect to disclosure by any
Party of Confidential Information relating to the Product (or any component thereof) in any
publication or presentation:




	 	a)	 	Both Parties acknowledge that it is their policy for the studies and results thereof to
be registered and published in accordance with their internal guidelines. Roche, in
accordance with its internal policies and procedures, shall have the right to publish all
studies and clinical trials conducted under this Agreement, and results thereof, on the
clinical trial registries which are maintained by or on behalf of Roche.







	 	b)	 	A Party (“Publishing Party”) shall provide the other Party with a copy of any proposed
publication or presentation at least sixty (60) days (or at least thirty (30) days in the
case of oral presentations) prior to submission for publication or presentation so as to
provide such other party with an opportunity to recommend any changes it reasonably
believes are necessary to continue to maintain the Confidential Information of the
non-Publishing Party in accordance with the requirements of this Agreement. If such
non-Publishing Party notifies (“Notice of Comments”) the Publishing Party in writing,
within sixty (60) days after receipt of the copy of the proposed publication or
presentation (or at least thirty (30) days in the case of oral presentations) that such
publication or presentation in its reasonable judgment (i) contains an Invention, conceived
and reduced to practice either solely or jointly by the non-Publishing Party, for which
such Party desires to obtain patent protection or (ii) contains Confidential Information of
the Non-Publishing Party or could otherwise be reasonably expected to have a material
adverse effect on the commercial value of any Confidential Information disclosed by the
non-Publishing Party to the Publishing Party, the Publishing Party shall delete such
Confidential Information or other relevant disclosure and prevent such publication or delay
such publication for a mutually agreeable period of time. In the case of Inventions, the
proposed publication or presentation shall be delayed for a period reasonably sufficient to
permit the timely preparation and filing of a patent application(s) on such Invention, and
in no event less than an additional ninety (90) days from the date of the Notice of
Comments.





 


22/32









 





13.5 Commercial Considerations

Nothing in this Agreement shall prevent Roche or its Affiliates from disclosing Confidential
Information of Raptor to (i) governmental agencies to the extent required or desirable to secure
government approval for the development, manufacture or sale of Product in the Territory, (ii)
Third Parties acting on behalf of Roche and bound by obligations of confidentiality and non-use
which are
at least as restrictive as those set forth in this Article 13, solely to the extent reasonably
necessary for the development, manufacture or sale of Product in the Territory, or (iii) Third
Parties bound by obligations of confidentiality and non-use which are at least as restrictive as
those set forth in this Article 13, solely to the extent reasonably necessary to market the Product
in the Territory. The Receiving Party may disclose Confidential Information of the Disclosing Party
to the extent that such Confidential Information is required to be disclosed by the Receiving Party
(x) to comply with applicable Laws, or (y) to the extent necessary to exercise the rights granted
to or retained by the Receiving Party under this Agreement in connection with the Handling of
Patent Rights or to defend or prosecute litigation, provided that the Receiving Party provides
prior written notice of such disclosure to the Disclosing Party and, to the extent practicable,
takes reasonable and lawful actions to, and reasonably cooperates with the Disclosing Party in the
Disclosing Party’s efforts to, minimize the degree of such disclosure.



13.6 Clinical Trial Registry.

Roche, in accordance with its internal policies and procedures, shall have the right to publish all
studies, clinical trials and results thereof regarding Products on the clinical trial registries
which are maintained by or on behalf of Roche.



13.7 Material Transfer.

Either Party may provide the other Party with sample molecules and other materials (“Material(s)”)
in connection with the Research Plan. The Party supplying the Materials shall provide the other
Party with all safety information and handling instructions pertaining to the Material that it is
aware of. The party receiving any Materials will use the Materials solely for carrying out the
Research Plan and for no other purposes and will not transfer the Materials to any third party. The
Party providing the Materials will retain all rights in and title to the Materials. Under no
circumstances shall the Party receiving the Material use the Material in humans or chemically or
biologically modify the Material, except in accordance with the Research Plan. The Party receiving
the Material shall take no action to determine the chemical structure of the Material or to reverse
engineer the Material.



14. Term and Termination




14.1 Commencement and Term

The term of this Agreement shall commence upon the Effective Date and, unless this Agreement is
terminated sooner as provided in this Article 14, expire on the date when no royalty or other
payment obligations under this Agreement are or will become due (“Agreement Term”). Upon expiration
of this Agreement, all licenses from Raptor to Roche shall be fully paid-up, perpetual and
irrevocable.



14.2 Termination




14.2.1 Termination for Breach




A Party (in such capacity, the “Non-Breaching Party”) shall have the right to terminate this
Agreement in its entirety or on a country-by-country or Product-by Product basis in the event the
other Party (in such capacity, the “Breaching Party”) is in material breach under this Agreement.




The Non-Breaching Party shall provide written notice to the Breaching Party, which notice shall
identify the material breach and the countries in which the Non-Breaching Party intends to have
this Agreement terminate. The Breaching Party shall have a period of sixty (60) days (or thirty
(30) days
with respect to any payment breach (“Payment Breach”)) after such written notice is provided to
cure such material breach (“Peremptory Notice Period”).


 


23/32









 





If any breach set forth above in this Section 14.2.1 is not cured within the Peremptory Notice
Period, this Agreement shall effectively terminate in its entirety or with respect to specific
country(ies), or Product(s), as applicable, at the end of such Peremptory Notice Period, unless the
Breaching Party provides written notice to Non-Breaching Party during such Peremptory Notice Period
that the Breaching Party disputes in good faith the existence of such breach, in which event this
Agreement shall terminate only upon the issuance by an arbitrator pursuant to Section 16.3 of an
award upholding the basis for termination (or once the Breaching Party is no longer disputing such
basis in good faith, if earlier). Notwithstanding the foregoing, (a) in the case of a Payment
Breach that is so arbitrated but that is upheld in an arbitration award as a basis for termination,
this Agreement shall not terminate if both (x) Roche shall have paid all disputed amounts into a
Third Party escrow within thirty (30) days after the commencement of the arbitration, and (y)
within fifteen (15) days after such arbitration award (or such time as Roche is no longer disputing
such amounts, if earlier), all amounts held to be owed to Raptor (or that Roche is no longer
disputing) are paid to Raptor, and (b) in the case of a material breach by Raptor, this Agreement
shall not terminate unless and until (x) an arbitral tribunal issues a final award pursuant to
Section 16.3 upholding such basis for termination (or unless and until Raptor is no longer
disputing such basis, if earlier) and (y) within twenty (20) days thereafter Raptor fails to cure
the breach(es) on which the arbitral tribunal based such award.



14.2.2 Termination for Insolvency Event




A Party shall have the right to terminate this Agreement upon notice to the other Party, if such
other Party incurs an Insolvency Event.




14.2.3 Termination by Roche without a Cause




Roche shall have the right to terminate this Agreement at any time on a Product-by-Product,
patent-by-patent, and country-by-country basis upon sixty (60) days prior written notice. The
effective date of termination under this Section 14.2.3 shall be the date sixty (60) days after
Roche provides such written notice to Raptor. Upon termination of this Agreement in any country,
Roche will cease manufacturing, marketing, and/or selling the Products in such country, if and only
if the Royalty Term has not yet expired.




14.3 Consequences of Termination




14.3.1 Termination by Raptor for Breach by Roche, or Roche Insolvency Event; Termination by Roche
without Cause



Upon any termination of this Agreement with respect to any patent(s) and/or country(ies) by Roche
without cause pursuant to Section 14.2.3, all rights and licenses granted by Raptor to Roche under
this Agreement with respect to such terminated patent(s) and/or terminated country(ies) shall also
terminate on the effective date of termination.



 


24/32









 





Upon any termination of this Agreement in its entirety or with respect to any country(ies), or
Product(s) by Raptor for an uncured material breach by Roche pursuant to Section 14.2.1, for a
Roche Insolvency Event pursuant to Section 14.2.2, or any termination of this Agreement in its
entirety or with respect to any Product(s) by Roche without cause pursuant to Section 14.2.3 all
rights and licenses granted by Raptor to Roche under this Agreement, in the terminated country(ies)
and/or with respect to the terminated Product(s), shall also terminate on the effective date of
termination.



14.3.2 Termination by Roche for Breach by Raptor or Raptor Insolvency Event




Upon any termination of this Agreement with respect to any country(ies) or in its entirety by Roche
for an uncured material breach by Raptor pursuant to Section 14.2.1, all rights and obligations of
each Party under this Agreement, with respect to the terminated country(ies) or this Agreement in
its entirety, shall terminate on the effective date of termination (except as set forth in Section
14.4); provided, however, that Roche shall have the right to elect, by
written notice to Raptor, to (i) continue the licenses granted to Roche by Raptor under Section
2.1.1, (and, (ii) solely if and to the extent that the discovery, manufacture and development
activities contemplated under the Research Plan have not been completed with respect to any Product
as of the effective date of termination, continue the licenses granted to Roche by Raptor under
Section 2.1.2 of this Agreement, in each case subject to Roche’s continued compliance with (a)
Roche’s payment obligations under Article 6 (Payments) with respect to Products developed and/or
commercialized by Roche under such licenses, and (b) the terms of Section 2.2 (Sublicense), Article
7 (Accounting and Reporting), and Article 9 (Auditing) .




Upon any termination of this Agreement in its entirety by Roche for a Raptor Insolvency Event
pursuant to Section 14.2.2, all rights and licenses granted to Roche by Raptor under this Agreement
in the terminated country(ies) shall also terminate on the effective date of termination.



14.3.3 Royalty and Payment Obligations




Raptor shall use Commercially Reasonable Efforts to mitigate the cost of Non-cancellable
Obligations, and Roche shall cooperate with Raptor in such efforts, and Raptor shall promptly
notify Roche as to the amount of such mitigation. In the event of termination of this Agreement by
Raptor under Section 14.2.1 or 14.2.2, or by Roche under Section 14.2.3, Roche will reimburse
Raptor for Non-cancellable Obligations, except to the extent any Non-cancellable Obligations have
been or will be mitigated by Raptor.




Termination of this Agreement by a Party, for any reason, shall not release Roche from any
obligation to pay royalties or make any payments to Raptor which are due and payable prior to the
effective date of termination.



Other than as set forth in the first paragraph of this Section 14.3.3, termination of this
Agreement by a Party, for any reason, will release Roche from any obligation to pay royalties or
make any payments to Raptor which would otherwise become due or payable on or after the effective
date of termination.



14.4 Survival

Article 6 (Payment) (solely to the extent that any amounts are due hereunder but not paid as of the
effective date of termination), Article 7 (Accounting and Reporting), Article 8 (Taxes), Article 9
(Auditing), Article 10 (Intellectual Property), , Article 12 (Indemnification), Section 13.1
(Non-Use and Non-Disclosure), Section 13.2 (Permitted Disclosure), Section 14.1 (Commencement and
Term), Section 14.2 (Termination), Section 14.3 (Consequences of Termination), Section 14.4
(Survival), Section 16.1 (Governing Law), Section 16.2 (Disputes), Section 16.3 (Arbitration),
Section 16.4 (Assignment), and Section 16.14 (Actions of Affiliates) shall survive any expiration
or termination of this Agreement for any reason in accordance with their terms.



 


25/32









 







15. Bankruptcy




All licenses (and to the extent applicable rights) granted under or pursuant to this Agreement by
Raptor to Roche are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title
11, US Code (the “Bankruptcy Code”) licenses of rights to “intellectual property” as defined under
the Bankruptcy Code. Unless Roche elects to terminate this Agreement, the Parties agree that Roche,
as a licensee or sub-licensee of such rights under this Agreement, shall retain and may fully
exercise all of its rights and elections under the Bankruptcy Code, subject to the continued
performance of its obligations under this Agreement.




16. Miscellaneous




16.1 Governing Law

This Agreement shall be governed by and construed in accordance with the laws of the State of New
Jersey, U.S.A., without reference to its conflict of laws principles, and shall not be governed by
the United Nations Convention of International Contracts on the Sale of Goods (the Vienna
Convention).



16.2 Disputes

Unless otherwise set forth in this Agreement, in the event of any dispute in connection with this
Agreement, such dispute shall be referred to the respective executive officers of the Parties
designated below or their designees, for good faith negotiations attempting to resolve the dispute.
The designated executive officers are as follows:



	 	 	 
	For Raptor:

	 	CEO
	For Roche:

	 	Head of Pharma Partnering






16.3 Arbitration




Should the Parties fail to agree within one (1) month after a dispute is referred to the executive
officers for resolution under Section 16.2, it shall be finally settled by arbitration in
accordance with the commercial arbitration rules of the American Arbitration Association (AAA) as
in force at the time when initiating the arbitration. The tribunal shall consist of a single
arbitrator who shall be appointed in accordance with such rules. The place of arbitration shall be
New York City, New York. The language to be used shall be English. 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. Nothing in Section 16.2 or 16.3 shall prevent or limit either
Party from seeking or obtaining injunctive relief from any court of competent jurisdiction.



16.4 Assignment

Neither Party may assign this Agreement or any of its rights or obligations under this Agreement to
a Third Party absent the prior written consent of the other Party, except that either Party may,
without the other Party’s prior written consent, make an assignment to any of its Affiliates or in
connection with the merger or sale of all or substantially all of the assets or business of such
Party to which this Agreement relates. Any permitted assignment shall be binding on the successors
of the assigning Party. Any assignment notwithstanding, the assigning Party in all cases shall
remain primarily liable hereunder for the prompt and punctual payment and performance of all
obligations
of the assignee (i.e., to that extent, no such assignment shall constitute a novation or otherwise
release the assigning Party from liability hereunder).


 


26/32









 





16.5 Debarment





	 	(a)	 	Raptor hereby certifies that it has not been debarred under the provisions of
the Generic Drug Enforcement Act of 1992, 21 U.S.C. Sec. 335a(a) and (b). In the event
that during the term of this Agreement Raptor or any of its employees (i) becomes
debarred; or (ii) receives notice of an action or threat of an action with respect to
its debarment, Raptor agrees to immediately notify Roche. Raptor also agrees that in
the event that it becomes debarred it shall immediately cease all activities relating
to this Agreement.







	 	(b)	 	In the event that Raptor becomes debarred, this Agreement shall automatically
terminate, without any further action or notice by either party. In the event that
Roche receives notice from Raptor or otherwise becomes aware that (i) a debarment
action has been brought against Raptor or any of its employees; or (ii) Raptor has been
threatened with a debarment action, then Roche shall have the right to terminate this
Agreement immediately.







	 	(c)	 	Raptor hereby certifies that it has not and will not use in any capacity the
services of any individual, corporation, partnership or association which has been
debarred under 21 U.S.C. Sec. 335(a) or (b). In the event that Raptor becomes aware of
the debarment or threatened debarment of any individual, corporation, partnership or
association providing services to Raptor which directly or indirectly relate to the
activities under this Agreement, Raptor shall notify Roche immediately. Upon the
receipt of such notice by Roche or if Roche otherwise becomes aware of such debarment
or threatened debarment, Roche shall have the right to terminate this Agreement
immediately.






16.6 Independent Contractor

No employee or representative of either Party shall have any authority to bind or obligate the
other Party to this Agreement for any sum or in any manner whatsoever or to create or impose any
contractual or other liability on the other Party without said Party’s prior written approval. For
all purposes, and notwithstanding any other provision of this Agreement to the contrary, Raptor’s
legal relationship to Roche under this Agreement shall be that of independent contractor.



16.7 Unenforceable Provisions and Severability

If any of the provisions of this Agreement are held to be void or unenforceable, then such void or
unenforceable provisions shall be replaced by valid and enforceable provisions which will achieve
as far as possible the economic business intentions of the Parties. However, the remainder of this
Agreement will remain in full force and effect, provided that the material interests of the Parties
are not affected, i.e. the Parties would presumably have concluded this Agreement without the
unenforceable provisions.


 


27/32









 





16.8 Waiver

The failure by either Party to require strict performance and/or observance of any obligation,
term, provision or condition under this Agreement will neither constitute a waiver thereof nor
affect in any way the right of the respective Party to require such performance and/or observance.
The waiver by either Party of a breach of any obligation, term, provision or condition hereunder
shall not constitute a waiver of any subsequent breach thereof or of any other obligation, term,
provision or condition.



16.9 Appendices

All Appendices to this Agreement shall form an integral part to this Agreement.



16.10 Entire Understanding

This Agreement contains the entire understanding between the Parties with respect to the within
subject matter and supersedes any and all prior agreements, understandings and arrangements,
whether written or oral.



16.11 Amendments

No amendments of the terms and conditions of this Agreement shall be binding upon either Party
unless in writing and signed by both Parties.



16.12 Notice

All notices which are required or permitted hereunder shall be in writing and sufficient if
delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or
certified mail or overnight courier), sent by nationally recognized overnight courier or sent by
registered or certified mail, postage prepaid, return receipt requested, addressed as follows:



	 	 	 
	if to Raptor, to:

	 	Raptor Pharmaceutical Inc.
	 

	 	9 Commercial Blvd., Suite 200
	 

	 	Novato, CA 94949
	 

	 	Attn: Christopher M. Starr, Ph.D., CEO
	 

	 	Facsimile No.: 415-382-1458
	 
	 	 
	And:
	 	 
	 
	 	 
	if to Roche, to:

	 	F. Hoffmann-La Roche Ltd
	 

	 	Grenzacherstrasse 124
	 

	 	4070 Basel
	 

	 	Switzerland
	 

	 	Attn: Legal Department
	 

	 	Facsimile No.: +41 61 688 13 96
	 
	 	 
	And:

	 	Hoffmann-La Roche Inc.
	 

	 	340 Kingsland Street
	 

	 	Nutley, New Jersey 07110
	 

	 	U.S.A.
	 

	 	Attn. Corporate Secretary
	 

	 	Facsimile No.: +1 973 235-3500





 


28/32









 





or to such other address as the Party to who notice is to be given may have furnished to the other
Party in writing in accordance herewith. The effective date of notice shall be the actual date of
receipt by the Party receiving the same.



16.13 Change of Control

In the event of a Change of Control of Raptor pursuant to which Raptor is acquired by, or
consummates a business combination with, a direct competitor of Roche or such a direct competitor
acquires more than [*****] of the common shares or voting power of Raptor, Roche shall not be
required under to provide any competitively-sensitive information to such Roche competitor. A
direct competitor of Roche is any pharmaceutical or biotechnology company which markets or is
developing one or more products directed to an Indication or target for which Roche or its
Affiliates are developing and/or commercializing products.



16.14 Actions of Affiliates

For purposes of clarity, each Party may perform its obligations hereunder personally or through one
or more Affiliates, provided, that such Party shall nonetheless be primarily liable for the
performance of its Affiliates and for any failure by its Affiliates to comply with the
restrictions, limitations and obligations set forth in this Agreement. To the extent that the
rights granted to a Party hereunder may be and are exercised by an Affiliate of such Party, such
Affiliate shall be bound by the corresponding obligations of such Party. Notwithstanding any of the
foregoing, Roche Nutley and Roche Basel shall be jointly and severally liable under this Agreement.



16.15 Execution in Counterparts

This Agreement may be executed in counterparts, each of which counterparts, when so executed and
delivered, shall be deemed an original and all of which counterparts, taken together, shall
constitute one and the same instrument.



* * * * *




[Signature Page to Follow]



 


29/32









 





EXECUTION VERSION




IN WITNESS WHEREOF, the Parties have entered into this Agreement as of the Effective Date.



Raptor Pharmaceutical Inc.




By: /s/ Kim R. Tsuchimoto




Name: Kim R. Tsuchimoto




Title: Chief Financial Officer




F. Hoffmann-La Roche Ltd




	 	 	 	 	 	 	 
	By:

	 	[Illegible]
	 	By:
	 	/s/ Stefan Arnold
	 
	 	 	 	 	 	 
	Name:

	 	 	 	Name:
	 	Stefan Arnold
	 
	 	 	 	 	 	 
	Title:

	 	 	 	Title:
	 	Head Corporate Law Pharma
	 
	 	 	 	 	 	 
	Hoffmann-La Roche Inc.	 	 	 	 
	 
	 	 	 	 	 	 
	By:

	 	/s/ A. Waseem Malick	 	 	 	 
	 
	 	 	 	 	 	 
	Name:

	 	A. Waseem Malick	 	 	 	 
	 
	 	 	 	 	 	 
	Title:
	 	VP, PARD	 	 	 	 






[*****] Raptor Pharmaceutical Corp. has requested confidential treatment of certain portions of
this agreement which have been omitted and filed separately with the U.S. Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934.



[Signature Page to Collaboration and License Agreement]




 


 









 







Appendix 1.42




Raptor Base Patent Rights as of the Effective Date




[*****]




[Appendix 1.42-1]




 


 









 







Appendix 1.45

Initial Research Plan




[*****]




[Appendix 1.45]