Document:

hznp-ex103_637.htm

Exhibit 10.3

 

	
 
	
 
	
***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 240.24b-2.

 

SECOND AMENDMENT

[Drafted as AMENDED AND RESTATED]

LICENSE AGREEMENT

BETWEEN

RAPTOR THERAPEUTICS, INC.

AND

THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

FOR

CASE NO. SD2006-092

 

 

Table of Contents

 

	
 
	
 
	
 
	
 
	
Page

	
Recitals
	
 
	
1

	
 
	
 
	
 
	
 
	
 

	
Article 1.
	
 
	
Definitions
	
 
	
2

	
 
	
 
	
 
	
 
	
 

	
Article 2.
	
 
	
Grants
	
 
	
4

	
 
	
 
	
 
	
 
	
 

	
Article 3.
	
 
	
Consideration
	
 
	
5

	
 
	
 
	
 
	
 
	
 

	
Article 4.
	
 
	
Reports, Records and Payments
	
 
	
11

	
 
	
 
	
 
	
 
	
 

	
Article 5.
	
 
	
Patent Matters
	
 
	
13

	
 
	
 
	
 
	
 
	
 

	
Article 6.
	
 
	
Governmental Matters
	
 
	
16

	
 
	
 
	
 
	
 
	
 

	
Article 7.
	
 
	
Termination or Expiration of the Agreement
	
 
	
16

	
 
	
 
	
 
	
 
	
 

	
Article 8.
	
 
	
Limited Warranty and Indemnification
	
 
	
17

	
 
	
 
	
 
	
 
	
 

	
Article 9.
	
 
	
Use of Names and Trademarks
	
 
	
19

	
 
	
 
	
 
	
 
	
 

	
Article 10.
	
 
	
Miscellaneous Provisions
	
 
	
20

	
 
	
 
	
 
	
 
	
 

	
Exhibit A:
	
 
	
Patent Rights as of Execution Date
	
 
	
Appendix

	
 
	
 
	
 
	
 
	
 

	
Exhibit B:
	
 
	
Transactions Occurring Between Effective Date and Execution Date
	
 
	
Appendix

	
 
	
 
	
 
	
 
	
 

	
Exhibit C:
	
 
	
Certificate of Merger of Encode Therapeutics, Inc., with and into Bennu
Pharmaceutical, Inc.
	
 
	
Appendix

	
 
	
 
	
 
	
 
	
 

	
Exhibit D:
	
 
	
Certificate of Amendment of Certificate of Incorporation of Bennu
Pharmaceuticals, Inc.
	
 
	
Appendix

 

 

 

 

LICENSE AGREEMENT

This agreement (“Agreement”) is made by and between Raptor Therapeutics, Inc. (f/k/a Encode Pharmaceuticals, Inc.), a Delaware corporation having an address at 9 Commercial Blvd., Suite 200, Novato, CA, 94949 (“LICENSEE”) and The Regents of the University of California, a California corporation having its statewide administrative offices at 1111 Franklin Street, Oakland, California 94607-5200 (“UNIVERSITY”), represented by its San Diego campus having an address at University of California, San Diego, Technology Transfer Office, Mail Code 0910, 9500 Gilman Drive, La Jolla, California 92093-0910 (“UCSD”).

This Agreement is effective on October 31, 2007 (“Effective Date”) with Raptor Therapeutics, which became LICENSEE upon a merger of Encode Pharmaceuticals, Inc. with and into Bennu Pharmaceuticals, Inc., effective December 17, 2007 (Exhibit C), which changed its name from Bennu Pharmaceuticals, Inc. to Raptor Therapeutics, Inc., effective November 5, 2008 (Exhibit D), was amended (“First Amendment”) effective November 11, 2008 (“First Amendment Date”) and is amended and restated, herein, as an Amended and Restated License (“Second Amendment”) as of 30 October 2012 (“Execution Date”).

RECITALS

WHEREAS, the inventions disclosed in UCSD Disclosure Docket No. SD SD2006-092 and titled “Enterically Coated Cysteamine” (“Invention”), were made in the course of research at UCSD by Drs. Ranjan Dohil and Jerry Schneider (hereinafter and collectively, the “Inventors”) and are covered by Patent Rights as defined below;

WHEREAS, the Inventors are employees of UCSD, and they are obligated to assign all of their right, title and interest in the Invention to UNIVERSITY;

WHEREAS, LICENSEE entered into a secrecy agreement (UC Control No. 2007-20¬0348) with UNIVERSITY, effective January 31, 2007, for the purpose of evaluating the Invention;

WHEREAS, LICENSEE entered into a secrecy agreement (UC Control No. 2008-03¬0236) with UNIVERSITY, effective November 11, 2007, for the purpose of evaluating the Invention;

WHEREAS, UNIVERSITY is desirous that the Invention be developed and utilized to the fullest possible extent so that its benefits can be enjoyed by the general public;

WHEREAS, LICENSEE is desirous of obtaining certain rights from UNIVERSITY for commercial development, use, and sale of the Invention, and the UNIVERSITY is willing to grant such rights;

WHEREAS, LICENSEE understands that UNIVERSITY may publish or otherwise disseminate information concerning the Invention and Technology (as defined below) at any time and that LICENSEE is paying consideration thereunder for its early access to the Invention and Technology, not continued secrecy therein;

 

 

 

WHEREAS, LICENSEE and UNIVERSITY wish to update terminology of the Agreement to current UNIVERSITY practice and harmonize terms of this Agreement with a separate license agreement, between LICENSEE and UNIVERSITY with respect to certain rights under the invention entitled “Intravenous cysteamine for rapid elevation of adiponectin levels during myocardial infarction and other situations of oxidative stress/ischemia,” (“CV License Agreement”), which is to be effective concurrently herewith;

WHEREAS, LICENSEE and UNIVERSITY wish to simultaneously update diligence timelines to reflect the commercial priorities of LICENSEE and to accommodate developmental delays; and

WHEREAS, transactions that have occurred between the Effective Date and the Execution Date, are listed in Exhibit B.

NOW, THEREFORE, the parties agree:

ARTICLE 1  DEFINITIONS

The terms, as defined herein, shall have the same meanings in both their singular and plural forms.

1.1“Affiliate” means any corporation or other business entity which is bound in writing by LICENSEE to the terms set forth in this Agreement and in which LICENSEE owns or controls, directly or indirectly, at least fifty percent (50%) of the outstanding stock or other voting rights entitled to elect directors, or in which LICENSEE is owned or controlled directly or indirectly by at least fifty percent (50%) of the outstanding stock or other voting rights entitled to elect directors; but in any country where the local law does not permit foreign equity participation of at least fifty percent (50%), then an “Affiliate” includes any company in which LICENSEE owns or controls or is owned or controlled by, directly or indirectly, the maximum percentage of outstanding stock or voting rights permitted by local law.

1.2“Field” means human therapeutics, subject to diligence specified in Section 3.4.

1.3“Licensed Method” means any method that uses Technology, or that is claimed in Patent Rights (as defined below), the use of which would constitute, but for the license granted to LICENSEE under this Agreement, an infringement, an inducement to infringe or contributory infringement, of any pending or issued claim within Patent Rights.

1.4“Licensed Product” means any service, composition or product that uses Technology, or that is claimed in Patent Rights, or that is produced by the Licensed Method, or the manufacture, use, sale, offer for sale, or importation of which would constitute, but for the license granted to LICENSEE under this Agreement, an infringement, an inducement to infringe or contributory infringement, of any pending or issued claim within the Patent Rights.

1.5“Net Sales” means [...***...]

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[...***...].

1.6“Patent Costs” means [...***...].

1.7“Patent Rights” means [...***...].

The “Patent Rights” in which UNIVERSITY has rights as of the Execution Date are set forth in Exhibit A, which are all such patent applications or patents described in this Section 1.7 as of the Execution Date.

1.8“Sublicense” means an agreement into which LICENSEE enters with a third party that is not an Affiliate for the purpose of (i) granting rights under the Patent Rights to make, have made, use, sell or import Licensed Products; (ii) granting an option under the Patent Rights to make, have made, use, sell or import Licensed Products; or (iii) forbearing the enforcement of any Patent Rights granted to LICENSEE under this Agreement. “Sublicensee” means a third party with whom LICENSEE enters into a Sublicense.

1.9“Sublicense Fees” means all upfront fees, milestone payments and similar license fees received by LICENSEE from its Sublicensees in consideration for the grant of a Sublicense, but excluding:

(i)any royalty payments; 

 

 

 

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(ii)payments for equity or debt securities of LICENSEE (except to the extent such payments exceed the fair market value of such securities upon date of receipt, in which case such premiums over fair market value shall be deemed to be “Sublicense Fees”);

(iii)research or development funding to be applied directly to the future research and/or development of Licensed Products; and

(iv)payments and reimbursement of Patent Costs paid to UNIVERSITY by LICENSEE with respect to the filing, preparation, prosecution or maintenance of the Patent Rights.

1.10“Technology” means the written technical information and know-how relating to the Invention, which the UNIVERSITY provides to LICENSEE prior to and during the Term of this Agreement.

1.11“Term” means the period of time beginning on the Effective Date and ending on the later of (i) the expiration date of the longest-lived Patent Rights on a country-by-country basis or (ii) ten (10) years after the first commercial sale of a Licensed Product.

1.12“Territory” means world-wide.

ARTICLE 2  GRANTS

2.1License. Subject to the limitations set forth in this Agreement, UNIVERSITY hereby grants to LICENSEE, and LICENSEE hereby accepts, a license under Patent Rights to make and have made, to use and have used, to sell and have sold, to offer for sale, and to import and have imported Licensed Products and to practice Licensed Methods and to use Technology, in the Field within the Territory and during the Term.

The license granted herein is exclusive for Patent Rights and non-exclusive for Technology.

2.2Sublicense.

(a)The license granted in Paragraph 2.1 includes the right of LICENSEE to grant Sublicenses to third parties during the Term but only for as long the license is exclusive.

(b)With respect to Sublicense granted pursuant to Paragraph 2.2(a), LICENSEE shall:

(i)not receive, or agree to receive, any non-cash consideration in lieu of cash as consideration from a third party under a Sublicense granted pursuant to Paragraph 2.2(a) without the express written consent of UNIVERSITY;

(ii)to the extent applicable, include all of the rights of and obligations due to UNIVERSITY and contained in this Agreement; 

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(iii)within thirty (30) days of the execution of the Sublicense agreement, provide UNIVERSITY with a copy of each Sublicense issued; and

(iv)collect and guarantee payment of all payments due, directly or indirectly, to UNIVERSITY from Sublicensees and summarize and deliver all reports due, directly or indirectly, to UNIVERSITY from Sublicensees.

(c)Upon termination of this Agreement for any reason, UNIVERSITY, at its sole discretion, shall determine whether LICENSEE shall cancel or assign to UNIVERSITY any and all Sublicenses.

2.3Reservation of Rights. UNIVERSITY reserves the right to:

(a)use the Invention, Technology and Patent Rights for educational and research purposes;

(b)publish or otherwise disseminate any information about the Invention and Technology at any time; and

(c)allow other nonprofit institutions to use and publish or otherwise disseminate any information about Invention, Technology and Patent Rights for educational and research purposes.

ARTICLE 3  CONSIDERATION

3.1Fees and Royalties. The parties hereto understand that the fees and royalties payable by LICENSEE to UNIVERSITY under this Agreement are partial consideration for the license granted herein to LICENSEE under Technology, and Patent Rights. LICENSEE shall pay UNIVERSITY:

(a)a license issue fee of fifty thousand dollars (US$50,000), within thirty (30) days after the Effective Date;

(b)license maintenance fees of fifteen thousand dollars (US$15,000) per year and payable on the first anniversary of the Effective Date and annually thereafter on each anniversary; provided however, that LICENSEE's obligation to pay this fee shall end on the date when LICENSEE is commercially selling a Licensed Product;

(c)milestone payments in the amounts payable according to the following schedule or events:

AmountDate or Event

	
 
	
(i)
	
For each orphan indication, the following amounts will be paid:

 

		
	
[...***...]
	
 

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[...***...]
	
 

	
 
	
 

	
 
	
 

	
 
	
 

	
 
	
 

	
 
	
 

(ii)For each non-orphan indication, the following amounts will be paid:

 

		
	
[...***...]
	
 

	
 
	
 

	
 
	
 

	
 
	
 

	
 
	
 

	
 
	
 

 

(d)an earned royalty of [...***...].

(e)a percentage of all Sublicense Fees received by LICENSEE from its Sublicensees [...***...] 

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[...***...];

(f)on each and every Sublicense royalty payment received by LICENSEE from its Sublicensees on Net Sales of Licensed Product by Sublicensee, the higher of (i) the percentage of royalties received by LICENSEE according to the schedule in 3.1(e); or (ii) royalties based on the royalty rate in Paragraph 3.1(d) as applied to Net Sales of Sublicensee. For the sake of clarity, royalties due for Net Sales by Licensee and/or Affiliate(s), Section 3.1(d) will apply and for Net Sales by Sublicensee, this Section 3.1(f), will apply;

(g)beginning the calendar year of commercial sales of the first Licensed Product by LICENSEE, its Sublicensee, or an Affiliate and if the total earned royalties paid by LICENSEE under Paragraphs3.1(d) and (f) to UNIVERSITY in any such year cumulatively amounts to less than:

a.[...***...]

b.[...***...]

(“minimum annual royalty”), LICENSEE shall pay to UNIVERSITY on or before February 28 following the last quarter of such year the difference between the applicable minimum annual royalty above and the total earned royalty paid by LICENSEE for such year under Paragraphs3.1(d) and (f); provided, however, that for the year of commercial sales of the first Licensed Product, the amount of minimum annual royalty payable shall be pro-rated for the number of months remaining in that calendar year.

3.2Payment. All fees and royalty payments specified in Paragraphs 3.1(a) through 3.1(g) above shall be paid by LICENSEE pursuant to Paragraph 4.3 and shall be delivered by LICENSEE to UNIVERSITY as noted in Paragraph 10.1.

Notwithstanding anything to the contrary, in the event that LICENSEE would owe amounts (specifically not including annual license maintenance fees) to UNIVERSITY under this Agreement and also under the CV License Agreement with respect to a specific Licensed Product, only the higher amount shall be due. By way of example, in the event LICENSEE owes [...***...]

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[...***...].

3.3Patent Costs. LICENSEE shall reimburse UNIVERSITY all past (prior to the Effective Date) and future (on or after the Effective Date) Patent Costs within thirty (30) days following the date an itemized invoice is sent from UNIVERSITY to LICENSEE. In UNIVERSITY's discretion, for Patent Costs anticipated to exceed [...***...] (“Anticipated Costs”), UNIVERSITY will inform LICENSEE no less than thirty (30) days prior to the date when Anticipated Costs are incurred. UNIVERSITY may, at its discretion and in accordance with Paragraph 5.1(c), require full advance payment of Anticipated Costs at least fifteen (15) business days before required filing dates (“Advance Payment Deadline”). [...***...]. In the event that the Anticipated Costs paid by LICENSEE are greater than the actual cost, the excess amount is creditable against future Patent Costs. In the event that the actual costs exceed the Anticipated Costs paid in advance by LICENSEE, LICENSEE shall pay such excess costs within thirty (30) days following the date an itemized invoice is sent as set forth in Paragraph 4.3.

3.4Due Diligence.

(a)LICENSEE shall, either directly or through its Affiliate(s) or Sublicensee(s):

(i)secure one million dollars (US$1,000,000) of funding on or before December 15 2008 (“First Financing Milestone”);

(ii)[...***...];

(iii)[...***...] spend not less than [...***...] for the development of Licensed Products during [...***...] of this Agreement. LICENSEE may, at its sole option, fund the research of any one of the Inventors and credit the amount of such funding actually paid to UCSD against its obligation under this paragraph;

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(iv)For the indications of Cystinosis, Huntington's Disease, and Non-alcoholic Steatohepatitis (“NASH”) perform the following activities [...***...]:

 

	
Years from Effective
Date:
	
Activity

	
 
	
 

	
Cystinosis
	
 

	
[...***...]
	
[...***...]

	
 
	
 

	
 
	
 

	
 
	
 

	
 
	
 

	
NASH
	
 

	
[...***...]
	
[...***...]

	
 
	
 

	
 
	
 

	
 
	
 

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Years from Effective
Date:
	
Activity

	
Huntington's
	
 

	
Disease
	
 

	
[...***...]
	
[...***...]

	
 
	
 

	
 
	
 

	
 
	
 

	
 
	
 

 

(v)market Licensed Products in the United States [...***...] of receiving regulatory approval to market such Licensed Products;

(vi)fill the market demand for Licensed Products following commencement of marketing at any time during the term of this Agreement; and

(vii)obtain all necessary governmental approvals for the manufacture, use and sale of Licensed Products.

(b)If LICENSEE fails to perform any of its obligations specified in Paragraphs 3.4(a)(i)-(vii), then UNIVERSITY shall have the right and option to either terminate this Agreement or change LICENSEE' s exclusive license to a nonexclusive license. This right, if exercised by UNIVERSITY, supersedes the rights granted in Article 2.

(c)If, [...***...] the Effective Date, LICENSEE fails to show it has initiated and is maintaining an active development program for a clinical indication in the Field, and UNIVERSITY receives a bona fide inquiry from a third party with a bona fide financial plan that would enable the licensure and development of a therapy for such clinical indication, UNIVERSITY shall give notice to LICENSEE. LICENSEE shall, [...***...], either (i) complete a Sublicense grant to the third party, or (ii) shall provide UNIVERSITY a detailed plan for the development of a product to treat said clinical indication and shall begin actual implementation of, and maintain such plan immediately. If LICENSEE does not either (i) complete a Sublicense grant or (ii) demonstrate implementation of said development plan within [...***...] days of receipt of such notice from UNIVERSITY, then UNIVERSITY shall have the right to exclude such clinical indication from the Field. 

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ARTICLE 4  REPORTS, RECORDS AND PAYMENTS

4.1Reports.

(a)Progress Reports. Beginning six months after Effective Date and ending after first commercial sale of the last Licensed Product to be introduced, LICENSEE shall report to UNIVERSITY progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities for the preceding six (6) months to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty (60) days of the reporting period and include a summary of work completed, summary of work in progress, current schedule of anticipated events or milestones, market plans for introduction of Licensed Products, and summary of resources (dollar value) spent in the reporting period.

(b)Royalty Reports. After the first commercial sale of a Licensed Product anywhere in the world, LICENSEE shall submit to UNIVERSITY quarterly royalty reports on or before each February 28, May 31, August 31 and November 30 of each year. Each royalty report shall cover LICENSEE's (and each Affiliate's and Sublicensee's) most recently completed calendar quarter and shall show:

(i)the date of first commercial sale of a Licensed Product in each country;

(ii)the gross sales, deductions as provided in Paragraph 1.5 and Net Sales during the most recently completed calendar quarter and the royalties, in US dollars, payable with respect thereto;

(iii)the number of each type of Licensed Product sold;

(iv)Sublicense Fees and royalties received during the most recently completed calendar quarter in US dollars, payable with respect thereto;

(v)the method used to calculate the royalties; and

(vi)the exchange rates used.

If no sales of Licensed Products have been made and no Sublicense revenue has been received by LICENSEE during any reporting period, LICENSEE shall so report.

(c)Timely Reports. LICENSEE acknowledges the important value that timely reporting provides in UNIVERSITY's effective management of its rights under this Agreement. LICENSEE further acknowledges that failure to render the reports required under this Paragraph 4.1 may harm UNIVERSITY's ability to manage its rights under this Agreement. As such, reports not submitted by the required due date under this Paragraph 4.1 will cause to be due by LICENSEE to UNIVERSITY a late reporting fee of [...***...] per month until such report, compliant with the requirements of this Paragraph 4.1, is received by UNIVERSITY. Payment of this fee is subject to Paragraph 4.3, Paragraph 7.1 and Paragraph 10.1 herein. 

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4.2Records & Audits.

(a)LICENSEE shall keep, and shall require its Affiliates and Sublicensees to keep, accurate and correct records of all Licensed Products manufactured, used, and sold, and Sublicense fees received under this Agreement. Such records shall be retained by LICENSEE for at least five (5) years following a given reporting period.

(b)All records shall be available during normal business hours for inspection at the expense of UNIVERSITY by UNIVERSITY's Internal Audit Department or by a Certified Public Accountant selected by UNIVERSITY and in compliance with the other terms of this Agreement for the sole purpose of verifying reports and payments or other compliance issues. Such inspector shall not disclose to UNIVERSITY any information other than information relating to the accuracy of reports and payments made under this Agreement or other compliance issues. In the event that any such inspection shows an under reporting and underpayment in excess of [...***...]for any [...***...], then LICENSEE shall pay the cost of the audit as well as any additional sum that would have been payable to UNIVERSITY had the LICENSEE reported correctly, plus an interest charge at a rate of [...***...] per year. Such interest shall be calculated from the date the correct payment was due to UNIVERSITY up to the date when such payment is actually made by LICENSEE. For underpayment not in excess of [...***...] for any [...***...] period, LICENSEE shall pay the difference within [...***...] without interest charge or inspection cost.

4.3Payments.

(a)All fees reimbursements and royalties due UNIVERSITY shall be paid in United States dollars and all checks shall be made payable to “The Regents of the University of California”, referencing UNIVERSITY's taxpayer identification number, 95-6006144, and sent to UNIVERSITY according to Paragraph 10.1 (Correspondence). When Licensed Products are sold in currencies other than United States dollars, LICENSEE shall first determine the earned royalty in the currency of the country in which Licensed Products were sold and then convert the amount into equivalent United States funds, using the exchange rate quoted in the Wall Street Journal on the last business day of the applicable reporting period.

(b)Royalty Payments.

(i)Royalties shall accrue when Licensed Products are invoiced, or if not invoiced, when delivered to a third party or Affiliate.

(ii)LICENSEE shall pay earned royalties [...***...] on or before [...***...] of each calendar year. Each such payment shall be for earned royalties accrued within LICENSEE' s most recently completed calendar quarter.

(iii)Royalties earned on sales occurring or under Sublicense granted pursuant to this Agreement in any country outside the United States shall not be reduced by LICENSEE for any taxes, fees, or other charges imposed by the government of such country on the payment of royalty income, except that all payments made by LICENSEE in fulfillment of 

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UNIVERSITY's tax liability in any particular country may be credited against earned royalties or fees due UNIVERSITY for that country. LICENSEE shall pay all bank charges resulting from the transfer of such royalty payments.

(iv)If at any time legal restrictions prevent the prompt remittance of part or all royalties by LICENSEE with respect to any country where a Licensed Product is sold or a Sublicense is granted pursuant to this Agreement, LICENSEE shall convert the amount owed to UNIVERSITY into US currency and shall pay UNIVERSITY directly from its US sources of fund for as long as the legal restrictions apply.

(v)In the event that any patent or patent claim within Patent Rights is held invalid in a final decision by a patent office from which no appeal or additional patent prosecution has been or can be taken, or by a court of competent jurisdiction and last resort and from which no appeal has or can be taken, all obligation to pay royalties based solely on that patent or claim or any claim patentably indistinct therefrom shall cease as of the date of such final decision. LICENSEE shall not, however, be relieved from paying any royalties that accrued before the date of such final decision, that are based on another patent or claim not involved in such final decision, or that are based on the use of Technology.

(vi)Royalty payments under Article 3, recoveries and settlements under Article 5, and royalty reports under 4.1(b) shall be rendered for any and all Licensed Products even if due after expiration of the Agreement.

(c)Late Payments. In the event royalty, reimbursement and/or fee payments are not received by UNIVERSITY when due, LICENSEE shall pay to UNIVERSITY interest charges at a rate of [...***...] per year. Such interest shall be calculated from the date payment was due until actually received by UNIVERSITY.

ARTICLE 5  PATENT MATTERS

5.1Patent Prosecution and Maintenance.

(a)Provided that LICENSEE has reimbursed UNIVERSITY for Patent Costs pursuant to Paragraph 3.3, UNIVERSITY shall diligently prosecute and maintain the United States and, if available, foreign patents, and applications in Patent Rights using counsel of its choice. [...***...] UNIVERSITY shall provide LICENSEE with copies of all relevant documentation relating to such prosecution and LICENSEE shall keep this documentation confidential. The counsel shall take instructions only from UNIVERSITY, and all patents and patent applications in Patent Rights shall be assigned solely to UNIVERSITY. UNIVERSITY shall in any event control all patent filings and all patent prosecution decisions and related filings (e.g. responses to office actions) shall be at UNIVERSITY's final discretion (prosecution includes, but is not limited to, interferences, oppositions and any other inter partes matters originating in a patent office). 

 

 

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(b)UNIVERSITY shall consider amending any patent application in Patent Rights to include claims reasonably requested by LICENSEE to protect the products contemplated to be sold by LICENSEE under this Agreement.

(c)LICENSEE may elect to terminate its reimbursement obligations with respect to any patent application or patent in Patent Rights upon three (3) months' written notice to UNIVERSITY. UNIVERSITY shall use reasonable efforts to curtail further Patent Costs for such application or patent when such notice of termination is received from LICENSEE. UNIVERSITY, in its sole discretion and at its sole expense, may continue prosecution and maintenance of said application or patent, and LICENSEE shall have no further license with respect thereto. Non-payment of any portion of Patent Costs or Anticipated Costs with respect to any application or patent may be deemed by UNIVERSITY as an election by LICENSEE to terminate its reimbursement obligations with respect to such application or patent. UNIVERSITY is not obligated to file, prosecute, or maintain Patent Rights in any country where LICENSEE is not paying Patent Costs at any time or to file, prosecute, or maintain Patent Rights to which LICENSEE has terminated its license hereunder.

(d)LICENSEE shall apply for an extension of the term of any patent in Patent Rights if appropriate under the Drug Price Competition and Patent Term Restoration Act of 1984 and/or European, Japanese and other foreign counterparts of this law. LICENSEE shall prepare all documents for such application, and UNIVERSITY shall execute such documents and take any other additional action as LICENSEE reasonably requests in connection therewith.

5.2Patent Infringement.

(a)In the event that UNIVERSITY (to the extent of the actual knowledge of the licensing professional responsible for the administration of this Agreement) or LICENSEE learns of infringement of potential commercial significance of any patent licensed under this Agreement, the knowledgeable party will provide the other (i) with written notice of such infringement and (ii) with any evidence of such infringement available to it (the “Infringement Notice”). During the period in which, and in the jurisdiction where, LICENSEE has exclusive rights under this Agreement, neither UNIVERSITY nor LICENSEE will notify a third party (including the infringer) of infringement or put such third party on notice of the existence of any Patent Rights without first obtaining consent of the other. UNIVERSITY shall have the right to terminate this Agreement immediately without the obligation to provide sixty (60) days' notice as set forth in Paragraph 7.1 if LICENSEE notifies a third party of infringement or puts such third party on notice of the existence of any Patent Rights with respect to such infringement without first obtaining the written consent of UNIVERSITY. Both UNIVERSITY and LICENSEE will use their diligent efforts to cooperate with each other to terminate such infringement without litigation.

(b)If infringing activity of potential commercial significance by the infringer has not abated within ninety (90) days following the date the Infringement Notice takes effect, LICENSEE may institute suit for patent infringement against the infringer. UNIVERSITY may voluntarily join such suit at its own expense, but may not thereafter commence suit against the infringer for the acts of infringement that are the subject of LICENSEE's suit or any judgment rendered in that suit. LICENSEE may not join UNIVERSITY in a suit initiated by LICENSEE

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without UNIVERSITY'S prior written consent. If, in a suit initiated by LICENSEE, UNIVERSITY is involuntarily joined other than by LICENSEE, LICENSEE will pay any costs incurred by UNIVERSITY arising out of such suit, including but not limited to, any legal fees of counsel that UNIVERSITY selects and retains to represent it in the suit.

(c)If, within a hundred and twenty (120) days following the date the Infringement Notice takes effect, infringing activity of potential commercial significance by the infringer has not been abated and if LICENSEE has not brought suit against the infringer, UNIVERSITY may institute suit for patent infringement against the infringer. If UNIVERSITY institutes such suit, LICENSEE may not join such suit without UNIVERSITY'S consent and may not thereafter commence suit against the infringer for the acts of infringement that are the subject of UNIVERSITY'S suit or any judgment rendered in that suit.

(d)Any recovery or settlement received in connection with any suit will first be shared by UNIVERSITY and LICENSEE equally to cover the litigation costs each incurred, and next shall be paid to UNIVERSITY or LICENSEE to cover any litigation costs it incurred in excess of the litigation costs of the other. In any suit initiated by LICENSEE, any recovery in excess of litigation costs will be shared between LICENSEE and UNIVERSITY as follows: (i) for any recovery other than amounts paid for willful infringement: (A) UNIVERSITY will receive [...***...] of the recovery if UNIVERSITY was not a party in the litigation and did not incur any litigation costs; (B) UNIVERSITY will receive [...***...] of the recovery if UNIVERSITY was a party in the litigation, but did not incur any litigation costs, including the provisions of Paragraph 5.2(b) above, or (C) UNIVERSITY will receive [...***...] of the recovery if UNIVERSITY incurred any litigation costs in connection with the litigation; and (ii) for any recovery for willful infringement, UNIVERSITY will receive [...***...] of the recovery. In any suit initiated by UNIVERSITY, [...***...]. UNIVERSITY and LICENSEE agree to be bound by all determinations of patent infringement, validity, and enforceability (but no other issue) resolved by any adjudicated judgment in a suit brought in compliance with this Paragraph 5.2.

(e)Any agreement made by LICENSEE for purposes of settling litigation or other dispute shall comply with the requirements of Paragraph 2.2 (Sublicenses) of this Agreement.

(f)Each party will cooperate with the other in litigation proceedings instituted hereunder but at the expense of the party who initiated the suit (unless such suit is being jointly prosecuted by the parties).

(g)Any litigation proceedings will be controlled by the party bringing the suit, except that UNIVERSITY may be represented by counsel of its choice in any suit brought by LICENSEE.

5.3Patent Marking. LICENSEE shall mark all Licensed Products made, used or sold under the terms of this Agreement, or their containers, in accordance with the applicable patent marking laws. LICENSEE shall be responsible for all monetary and legal liabilities arising

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from or caused by (i) failure to abide by applicable patent marking laws and (ii) any type of incorrect or improper patent marking.

ARTICLE 6  GOVERNMENTAL MATTERS

6.1Governmental Approval or Registration. If this Agreement or any associated transaction is required by the law of any nation to be either approved or registered with any governmental agency, LICENSEE shall assume all legal obligations to do so. LICENSEE shall notify UNIVERSITY if it becomes aware that this Agreement is subject to a United States or foreign government reporting or approval requirement. LICENSEE shall make all necessary filings and pay all costs including fees, penalties, and all other out-of-pocket costs associated with such reporting or approval process.

6.2Export Control Laws. LICENSEE shall observe all applicable United States and foreign laws with respect to the transfer of Licensed Products and related technical data to foreign countries, including, without limitation, the International Traffic in Arms Regulations and the Export Administration Regulations.

ARTICLE 7  TERMINATION OR EXPIRATION OF THE AGREEMENT

7.1Termination by UNIVERSITY.

(a)If LICENSEE fails to perform or violates any term of this Agreement, then UNIVERSITY may give written notice of default (“Notice of Default”) to LICENSEE. If LICENSEE fails to cure the default within [...***...] of the Notice of Default, UNIVERSITY may terminate this Agreement and the license granted herein by a second written notice (“Notice of Termination”) to LICENSEE. If a Notice of Termination is sent to LICENSEE, this Agreement shall automatically terminate on the effective date of that notice. Termination shall not relieve LICENSEE of its obligation to pay any fees owed at the time of termination and shall not impair any accrued right of UNIVERSITY. During the term of any such Notice of Default or period to cure, to the extent the default at issue is a failure to pay past or ongoing Patent Costs as provided for under this Agreement, UNIVERSITY shall have no obligation to incur any new Patent Costs under this Agreement and shall have no obligation to further prosecute Patent Rights or file any new patents under Patent Rights.

(b)This Agreement will terminate immediately, without the obligation to provide [...***...] notice as set forth in Paragraph 7.1(a), if LICENSEE files a claim including in any way the assertion that any portion of UNIVERSITY' s Patent Rights is invalid or unenforceable where the filing is by the LICENSEE, a third party on behalf of the LICENSEE, or a third party at the written urging of the LICENSEE.

7.2Termination by LICENSEE.

(a)LICENSEE shall have the right at any time and for any reason to terminate this Agreement upon a [...***...] written notice to UNIVERSITY. Said notice shall state LICENSEE's reason for terminating this Agreement. 

 

 

***Confidential Treatment Requested

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(b)Any termination under Paragraph 7.2(a) shall not relieve LICENSEE of any obligation or liability accrued under this Agreement prior to termination or rescind any payment made to UNIVERSITY or action by LICENSEE prior to the time termination becomes effective. Termination shall not affect in any manner any rights of UNIVERSITY arising under this Agreement prior to termination.

7.3Survival on Termination or Expiration. The following Paragraphs and Articles shall survive the termination or expiration of this Agreement:

(a)Article 4 (Reports, Records and Payments);

(b)Paragraph 7.3 (Survival on Termination or Expiration);

(c)Paragraph 7.4 (Disposition of Licensed Products on Hand);

(d)Article 8 (Limited Warranty and Indemnification);

(e)Article 9 (Use Of Names and Trademarks);

(f)Paragraph 10.2 hereof (Secrecy);

(g)Paragraph 10.5 (Failure to Perform); and

(h)Paragraph 10.6 (Governing Law).

7.4Disposition of Licensed Products on Hand. Upon termination of this Agreement, LICENSEE may dispose of all previously made or partially made Licensed Product within a period of one hundred and twenty (120) days of the effective date of such termination provided that the sale of such Licensed Product by LICENSEE, its Sublicensees, or Affiliates shall be subject to the terms of this Agreement, including but not limited to the rendering of reports and payment of royalties required under this Agreement.

ARTICLE 8  LIMITED WARRANTY AND INDEMNIFICATION

8.1Limited Warranty.

(a)UNIVERSITY warrants that it has the lawful right to grant this license. This warranty does not include Patent Rights to the extent assigned, or otherwise licensed, by UNIVERSITY' s inventors to third parties prior to the Effective Date.

(b)The license granted herein and the associated Technology are provided “AS IS” and without WARRANTY OF MERCHANTABILITY or WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE or any other warranty, express or implied. UNIVERSITY makes no representation or warranty that the Licensed Product, Licensed Method or the use of Patent Rights or Technology will not infringe any other patent or other proprietary rights.

(c)EXCEPT WITH RESPECT TO A BREACH OF PARAGRAPH 8.1(a) ABOVE, UNIVERSITY WILL NOT BE LIABLE FOR ANY LOST PROFITS, COSTS OF

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PROCURING SUBSTITUTE GOODS OR SERVICES, LOST BUSINESS, ENHANCED DAMAGES FOR INTELLECTUAL PROPERTY INFRINGEMENT, OR FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE, OR OTHER SPECIAL DAMAGES SUFFERED BY LICENSEE, SUBLICENSEES, JOINT VENTURES, OR AFFILIATES ARISING OUT OF OR RELATED TO THIS AGREEMENT FOR ALL CAUSES OF ACTION OF ANY KIND (INCLUDING TORT, CONTRACT, NEGLIGENCE, STRICT LIABILITY AND BREACH OF WARRANTY) EVEN IF UNIVERSITY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

(d)Nothing in this Agreement shall be construed as:

(i)a warranty or representation by UNIVERSITY as to the validity or scope of any Patent Rights;

(ii)a warranty or representation that anything made, used, sold or otherwise disposed of under any license granted in this Agreement is or shall be free from infringement of patents of third parties;

(iii)an obligation to bring or prosecute actions or suits against third parties for patent infringement except as provided in Paragraph 5.2 hereof;

(iv)conferring by implication, estoppel or otherwise any license or rights under any patents of UNIVERSITY other than Patent Rights as defined in this Agreement, regardless of whether those patents are dominant or subordinate to Patent Rights; or

(v)an obligation to furnish any know-how not provided in Patent Rights and Technology; or

(vi)an obligation to update Technology.

8.2Indemnification.

(a)LICENSEE will, and will require Sublicensees to, indemnify, hold harmless, and defend UNIVERSITY and its officers, employees, and agents; the sponsors of the research that led to the Invention; and the inventors of patents or patent applications under Patent Rights, and their employers; against any and all claims, suits, losses, damages, costs, fees, and expenses resulting from, or arising out of, the exercise of this license or any Sublicense, except to the extent arising out of or related to Patent Rights to the extent assigned, or otherwise licensed, by UNIVERSITY' s inventors to third parties. This indemnification will include, but will not be limited to, any product liability.

(b)LICENSEE, at its sole cost and expense, shall insure its activities in connection with the work under this Agreement and obtain, keep in force and maintain insurance or an equivalent program of self-insurance as follows:

(i)Prior to [...***...]:

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(A)Prior to initiation of human clinical trials, comprehensive or commercial general liability insurance (contractual liability included) with limits of at least: (A) each occurrence, [...***...]; (B) products/completed operations aggregate, [...***...]; (C) personal and advertising injury, [...***...]; and (D) general aggregate (commercial form only), [...***...]; and

(B)Upon initiation of human clinical trials, comprehensive or commercial general liability insurance (contractual liability included) with limits of at least: (A) each occurrence, [...***...]; (B) products/completed operations aggregate, [...***...]; (C) personal and advertising injury, [...***...]; and (D) general aggregate (commercial form only), [...***...]; Worker's Compensation as legally required in the jurisdiction in which the LICENSEE is doing business;

(ii)On and after [...***...], comprehensive or commercial general liability insurance (contractual liability included) with limits of at least: (A) each occurrence, [...***...]; (B) products/completed operations aggregate, [...***...]; (C) personal and advertising injury, [...***...]; and (D) general aggregate (commercial form only), [...***...]; Worker's Compensation as legally required in the jurisdiction in which the LICENSEE is doing business;

(iii)the coverage and limits referred to above shall not in any way limit the liability of LICENSEE; and

(iv)If the above insurance is written on a claims-made form, it shall continue for three (3) years following termination or expiration of this Agreement. The insurance shall have a retroactive date of placement prior to or coinciding with the Effective Date.

(c)Upon request, LICENSEE shall furnish UNIVERSITY with certificates of insurance showing compliance with all requirements. Such certificates shall: (i) provide for thirty (30) day advance written notice to UNIVERSITY of any modification; (ii) indicate that UNIVERSITY has been endorsed as an additional insured party under the coverage referred to above; and (iii) include a provision that the coverage shall be primary and shall not participate with nor shall be excess over any valid and collectable insurance or program of self-insurance carried or maintained by UNIVERSITY.

(d)UNIVERSITY shall notify LICENSEE in writing of any claim or suit brought against UNIVERSITY in respect of which UNIVERSITY intends to invoke the provisions of this Article. LICENSEE shall keep UNIVERSITY informed on a current basis of its defense of any claims under this Article.

ARTICLE 9  USE OF NAMES AND TRADEMARKS

9.1Nothing contained in this Agreement confers any right to use in advertising, publicity, or other promotional activities any name, trade name, trademark, or other designation of either party hereto (including contraction, abbreviation or simulation of any of the foregoing). 

 

 

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Unless required by law, the use by LICENSEE of the name, “The Regents of the University of California” or the name of any campus of the University Of California is prohibited, without the express written consent of UNIVERSITY. 

9.2UNIVERSITY may disclose to the Inventors the terms and conditions of this Agreement upon their request. If such disclosure is made, UNIVERSITY shall request the Inventors not disclose such terms and conditions to others.

9.3UNIVERSITY may acknowledge the existence of this Agreement and the extent of the grant in Article 2 to third parties, but UNIVERSITY shall not disclose the financial terms of this Agreement to third parties, except where UNIVERSITY is required by law to do so, such as under the California Public Records Act. LICENSEE hereby grants permission for UNIVERSITY (including UCSD) to include LICENSEE's name and a link to LICENSEE's website in UNIVERSITY's and UCSD's annual reports and on UNIVERSITY's (including UCSD's) websites that showcase technology transfer-related stories.

ARTICLE 10  MISCELLANEOUS PROVISIONS

10.1Correspondence. Any notice or payment required to be given to either party under this Agreement shall be deemed to have been properly given and effective:

(a)on the date of delivery if delivered in person, or

(b)five (5) days after mailing if mailed by first-class or certified mail, postage paid, to the respective addresses given below, or to such other address as is designated by written notice given to the other party.

If sent to LICENSEE:

Raptor Therapeutics, Corp.

9 Commercial Blvd., Suite 200

Novato, CA 94949

Attention: Ted Daley, President

Phone: 415-382-8111 x227

Fax: 415-382-1368

If sent to UNIVERSITY by mail:

University of California, San Diego

Technology Transfer Office

9500 Gilman Drive

Mail Code 0910

La Jolla, CA 92093-0910

Attention: Assistant Vice Chancellor

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If sent to UNIVERSITY by courier:

University of California, San Diego

Technology Transfer Office

10300 North Torrey Pines Road

Torrey Pines Center North, Third Floor

La Jolla, CA 92037

Attention: Assistant Vice Chancellor

10.2Secrecy.

(a)“Confidential Information” shall mean information, including Technology, relating to the Invention and disclosed by UNIVERSITY to LICENSEE during the term of this Agreement, which if disclosed in writing shall be marked “Confidential”, or if first disclosed otherwise, shall within thirty (30) days of such disclosure be reduced to writing by UNIVERSITY and sent to LICENSEE:

(b)LICENSEE shall:

(i)use the Confidential Information for the sole purpose of performing under the terms of this Agreement;

(ii)safeguard Confidential Information against disclosure to others with the same degree of care as it exercises with its own data of a similar nature;

(iii)not disclose Confidential Information to others (except to its employees, agents or consultants or Sublicensees who are bound to LICENSEE by a like obligation of confidentiality) without the express written permission of UNIVERSITY, except that LICENSEE shall not be prevented from using or disclosing any of the Confidential Information that:

(A)LICENSEE can demonstrate by written records was previously known to it;

(B)is now, or becomes in the future, public knowledge other than through acts or omissions of LICENSEE;

(C)is lawfully obtained by LICENSEE from sources independent of UNIVERSITY; or

(D)is required to be disclosed by law or a court of competent jurisdiction; and

-21-

(c)The secrecy obligations of LICENSEE with respect to Confidential Information shall continue for a period ending five (5) years from the termination date of this Agreement.

10.3Assignability. This Agreement is binding upon and inures to the benefit of UNIVERSITY, its successors and assigns. But it is personal to Licensee and assignable by Licensee only with the written consent of UNIVERSITY. Notwithstanding the foregoing, the consent of UNIVERSITY will not be required if the assignment is in conjunction with the transfer of all or substantially all of the business of LICENSEE to which this Agreement relates.

10.4No Waiver. No waiver by either party of any breach or default of any covenant or agreement set forth in this Agreement shall be deemed a waiver as to any subsequent and/or similar breach or default.

10.5Failure to Perform. In the event of a failure of performance due under this Agreement and if it becomes necessary for either party to undertake legal action against the other on account thereof, then the prevailing party shall be entitled to reasonable attorney's fees in addition to costs and necessary disbursements.

10.6Governing Laws. THIS AGREEMENT SHALL BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF CALIFORNIA, but the scope and validity of any patent or patent application shall be governed by the applicable laws of the country of the patent or patent application.

10.7Force Majeure. A party to this Agreement may be excused from any performance required herein if such performance is rendered impossible or unfeasible due to any catastrophe or other major event beyond its reasonable control, including, without limitation, war, riot, and insurrection; laws, proclamations, edicts, ordinances, or regulations; strikes, lockouts, or other serious labor disputes; and floods, fires, explosions, or other natural disasters. When such events have abated, the non-performing party's obligations herein shall resume.

10.8Headings. The headings of the several sections are inserted for convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement.

10.9Entire Agreement. This Agreement embodies the entire understanding of the parties and supersedes all previous communications, representations or understandings, either oral or written, between the parties relating to the subject matter hereof.

10.10Amendments. No amendment or modification of this Agreement shall be valid or binding on the parties unless made in writing and signed on behalf of each party.

10.11Severability. In the event that any of the provisions contained in this Agreement is held to be invalid, illegal, or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provisions of this Agreement, and this Agreement shall be construed as if the invalid, illegal, or unenforceable provisions had never been contained in it.

 

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IN WITNESS WHEREOF, both UNIVERSITY and LICENSEE have executed this Agreement, in duplicate originals, by their respective and duly authorized officers on the day and year written.

 

	
RAPTOR THERAPEUTICS, INC.:
	
 
	
THE REGENTS OF THE UNIVERSITY
OF CALIFORNIA:

	
By:
	
 
	
  /s/Thomas E. Daley
	
 
	
By:
	
 
	
 /s/Jane Moores, Ph.D

	
Name:
	
 
	
Thomas E. Daley
	
 
	
 
	
 
	
Jane Moores, Ph.D.

	
Title:
	
 
	
President
	
 
	
 
	
 
	
Assistant Vice-Chancellor –
Technology Transfer

	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
Date:
	
 
	
December 12, 2012
	
 
	
Date:
	
 
	
12/13/12

 

 

 

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Exhibit A: Patent Rights as of Execution Date

 

	
UC Case No.
	
Jurisdiction
	
Filing Date
	
Serial / Patent No.
	
Title

	
[...***...]
	
[...***...]
	
[...***...]
	
[...***...]
	
[...***...]

 

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Exhibit B: Transactions Occurring Between Effective Date and Execution Date

 

	
Date
	
Relevant Section of
Agreement
	
Transaction

	
[...***...]
	
[...***...]
	
[...***...]

 

 

 

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***Confidential Treatment Requested

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Exhibit C: Certificate of Merger of Encode Therapeutics, Inc., with and into Bennu Pharmaceutical, Inc.

 

 

CERTIFICATE OF MERGER

OF ENCODE PHARMACEUTICALS, INC.

WITH AND INTO BENNU PHARMACEUTICALS INC.

Pursuant to Title 8, Section 251 of the Delaware General Corporation Law, the undersigned corporation, organized and existing under the Delaware General Corporation Law, does HEREBY CERTIFY AS FOLLOWS:

FIRST:That the name and state of incorporation of each of the constituent corporations to the merger (each a “Constituent Corporation”) is as follows:

 

	
Name
	
 
	
State of Incorporation

	
Bennu Pharmaceuticals Inc. (“Bennu”)
	
 
	
Delaware

	
Encode Pharmaceuticals, Inc.
	
 
	
Delaware

SECOND:That Merger Agreement (the “Merger Agreement”) entered into as of November 29, 2007, by and among the Constituent Corporations, Raptor Pharmaceuticals Corp., a Delaware corporation (“Raptor”), and Nicholas Stergis has been approved, adopted, certified, executed and acknowledged by each of the Constituent Corporations and Raptor pursuant to Section 251 of the Delaware General Corporation Law.

THIRD:That the name of the surviving corporation of the merger shall be Bennu Pharmaceuticals Inc. (the “Surviving Corporation”) and that the Surviving Corporation shall be wholly owned by Raptor, immediately subsequent to the effective time of the merger.

FOURTH:The Certificate of Incorporation of the Surviving Corporation shall be the Certificate of Incorporation of Benner immediately prior to the effective time of the merger and was filed with the Secretary of State of Delaware on August 1, 2007 as amended on August 30, 2007.

FOURTH:That executed copies of the Merger Agreement are on file at the principal place of business of the Surviving Corporation at 9 Commercial Boulevard, Suite 200, Novato, CA 94949.

FIFTH:That this Certificate of Merger shall be effective at 11:59 P.M., Delaware time, on December 14, 2007.

SIXTH:That a copy of the Merger Agreement will be furnished by the Surviving Corporation, upon request and without cost to any stockholder of either constituent corporation.

[REMAINDER OF PAGE INTENTIONALLY BLANK]

 

 

 

 

IN WITNESS WHEREOF, Beam Pharmaceuticals Inc. has caused this Certificate of Merger to be executed by its duly authorized officer this 14th day of December, 2007.

 

	
	
BENNU PHARMACEUTICALS INC.

	
 

	
By /s/ Kim R. Tsuchimoto

	
Name: Kim R. Tsuchimoto

	
Title: Chief Financial Officer

 

 

 

[Signature Page to Certificate of Merger]

 

Exhibit D: Certificate of Amendment of Certificate of Incorporation of Bennu Pharmaceuticals, Inc.

CERTIFICATE OF AMENDMENT

OF

CERTIFICATE OF INCORPORATION

OF

BENNU PHARMACEUTICALS INC.

The undersigned hereby certifies as follows:

1.She is the duly elected, qualified and acting Secretary of Bennu Pharmaceuticals Inc., a corporation organized and existing under the General Corporation Law of the Slate of Delaware (the “Corporation”).

2.Article I of the Corporation's Certificate of Incorporation is hereby amended and restated in its entirety to read as follows:

“The name of the corporation (hereinafter called the `Corporation') is Raptor Therapeutics Inc.”

3.The amendment set forth herein has been duly approved and adopted by the Board of Directors of the Corporation.

4.The necessary number of Issued and outstanding shares of capital stock of the Corporation required by statute were voted in favor of the amendment.

5.Such amendment was duly adopted in accordance with the provisions of Sections 228 and 242 of the General Corporation Law of the State of Delaware.

IN WITNESS WHEREOF, Bennu Pharmaceuticals Inc. has caused this Certificate of Amendment to be signed by its Secretary this 4th day of November, 2008.

 

	
	
/s/ Kim. R. Tsuchimoto

	
Kim R. Tsuchimoto, Secretary

 

 

CERTIFICATE OF INCORPORATION

OF

PROMETHEUS PHARMACEUTICALS INC.

I.

The name of the Corporation is Prometheus Pharmaceuticals Inc.

II.

The address of the registered office of the Corporation in the State of Delaware is 2711 Centerville Road, Suite 400, in the City of Wilmington, County of New Castle, and the name of its registered agent at that address is Corporation Service Company.

III.

The purpose of the Corporation is to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of the State of Delaware.

IV.

The total number of shares of stock which the Corporation shall have authority to issue is Three Thousand (3,000). The par value of each of such shares is S0.001. An such shares are of one class and are shares of Common Stock.

V.

The number of directors which shall constitute the whole Board of Directors shall be fixed by, or in the manner provided in, the Bylaws of the Corporation.

VI.

In furtherance and not in limitation of the powers conferred by statute, the Board of Directors is expressly authorized to make, repeal, alter, amend and rescind the Bylaws of the Corporation.

VII.

Election of directors at an annual or special meeting of stockholders need not be by written ballot unless the Bylaws of the Corporation shall so provide.

VIII.

No director shall be personally liable to the Corporation or its stockholders for monetary damages for breach of fiduciary ditty as a director; provided that this Article VIII shall not eliminate or limit the liability of a director (i) for any breach of such director's duty of loyalty to the Corporation or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of the law, (iii) under Section 174 of the General Corporation Law of the State of Delaware, or (iv) for any transaction from which such director 

 

 

derives an improper personal benefit. If the General Corporation Law of the State of Delaware is amended to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director of the Corporation shall be eliminated or limited to the fullest extent permitted by the General Corporation Law of the State of Delaware as so amended.

IX.

The Corporation reserves the right to amend, alter, change or repeal any provision contained in this Certificate of Incorporation, in the manner now or hereafter prescribed by. statute, and all rights conferred on stockholders herein are granted subject to this reservation.

X.

The name and mailing address of the incorporator of the Corporation are:

 

	
Name
	
 
	
Mailing Address

	
Claudia Immerzeel
	
 
	
c/o Paul Hastings Janofsky & Walker LLP
515 S. Figueroa Street, 25th Floor
Los Angeles, CA 90071

 

 

 

IN WITNESS WHEREOF, this Certificate of Incorporation has been signed on the 1st day of August, 2007.

 

	
	
/s/ Claudia Immerzeel

	
Claudia Immerzeel, Incorporator

 

 

CERTIFICATE OF AMENDMENT OF CERTIFICATE

OF INCORPORATION BEFORE PAYMENT OF

ANY PART OF THE CAPITAL

OF

PROMETHEUS PHARMACEUTICALS INC.

It is hereby certified that

1.The name of the corporation (hereinafter called the “Corporation”) is Prometheus Pharmaceuticals Inc.

2.The Corporation has not received any payment for any of its stock.

3.The Certificate of Incorporation of the Corporation is hereby amended by striking out Article 1 thereof and by substituting in lieu of said Article the following new Article:

“I.

“The name of the Corporation is Bennu Pharmaceuticals Inc.”

4.The amendment of the Certificate of Incorporation of the corporation herein certified was duly adopted, pursuant to the provisions of Section 241 of the General Corporation Law of the State of Delaware, by the sole incorporator, no directors having been named in the Certificate of Incorporation and no directors having been elected.

Signed on the 30th-day of August, 2007.

 

	
	
/s/ Claudia Immerzeel

	
Claudia Immerzeel, Sole Incorporator

 

 

 

THIRD AMENDMENT to LICENSE AGREEMENT

UC CONTROL NUMBER 2008-03-0236, EFFECTIVE OCTOBER 31, 2007

between

RAPTOR THERAPEUTICS, INC.

and

THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

for:

CASE NO. SD2006-092: “Enterically Coated Cysteamine”

This third amendment (“Third Amendment”) to the License Agreement, UC Control No. 2008-03- 0236, for Case No. SD2006-092 “Enterically Coated Cysteamine” effective October 31, 2007, as amended and restated as of October 30, 2012, (“Agreement”) is made as of 1 March, 2013 (the “Amendment Date”) by and between Raptor Pharmaceuticals, Inc. (f/k/a Raptor Therapeutics, Inc.), a Delaware corporation having an address at 9 Commercial Blvd., Suite 200, Novato, CA, 94949 (“LICENSEE”) and The Regents of the University of California, a California corporation having its statewide administrative offices at 1111 Franklin Street, Oakland, California 94607-5200 (“UNIVERSITY”), represented by its San Diego campus having an address at University of California, San Diego, Technology Transfer Office, Mail Code 0910, 9500 Gilman Drive, La Jolla, California 92093- 0910 (“UCSD”).

Whereas, on December 28, 2012, Raptor Therapeutics, Inc. was merged with Raptor Discoveries, Inc. and as part of such reorganization was renamed Raptor Pharmaceuticals, Inc.

Whereas, LICENSEE and UNIVERSITY wish to amend the Agreement to clarify certain of LICENSEE’s obligations with respect to the development of Licensed Products under such Agreement.

NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants set forth below, the parties amend the Agreement and otherwise agree as follows:

	
1.
	
Each reference to “Raptor Therapeutics, Inc.” in the Agreement is hereby replaced with “Raptor Pharmaceuticals, Inc.”.

	
2.
	
The following Section 1.13 is hereby added to the Agreement:

“1.13 “Regulatory Authority” means (a) the FDA in the United States or (b) any equivalent agency or governmental authority in any country or other jurisdiction outside the United States that has responsibility for granting any licenses or approvals necessary for the marketing and/or sale of a Licensed Product in such country or other jurisdiction (including, without limitation, any supra-national agency such as the “European Medicines Agency” (EMA)).” 

 

 

3.Section 3.4(b) of the Agreement is hereby deleted and restated in its entirety as follows:

(b)If LICENSEE fails to perform any of its obligations specified in Paragraphs 3.4(a)(i)-(vii), then:

(i)UNIVERSITY shall have the right and option to either terminate this Agreement or change LICENSEE’s exclusive license to a nonexclusive license;

(ii)Notwithstanding Paragraph 3.4(b)(i), in the event that LICENSEE believes in good faith that there exists a significant issue related to the safety and/or efficacy of a Licensed Product for treatment of any indication, or that further development of a Licensed Product is not commercially viable in such indication, then LICENSEE shall so notify UNIVERSITY in writing, and upon University’s written agreement, LICENSEE shall have the right to delay or discontinue development of such Licensed Product for the treatment of such indication for up to six (6) months. In the event that LICENSEE does not receive a response from UNIVERSITY within thirty (30) days of LICENSEE’s written notice, UNIVERSITY shall be deemed to have provided its written agreement upon the end of such thirty (30) day period. If, after six (6) months, LICENSEE does not resume development of such Licensed Product for that particular indication (e.g., cystinosis), UNIVERSITY shall have the right and option, from and after the date of written notice from UNIVERSITY: (A) to terminate this Agreement solely with respect to such indication, in which event, such indication shall be deemed to be excluded from the definition of “Field”; or (B) to change LICENSEE’s exclusive license to a non-exclusive license solely with respect to such indication; and

(iii)Notwithstanding Paragraph 3.4(b)(i), from and after the date on which LICENSEE first obtains regulatory approval from a Regulatory Authority for any indication (e.g., cystinosis), UNIVERSITY would not exercise its rights under Paragraph 3.4(b)(i) with respect to such indication, or to change LICENSEE’s exclusive license to a non-exclusive license for such indication, as a result of LICENSEE’s failure to satisfy its obligations under Paragraph 3.4(a) with respect to a different indication, which is not yet approved for sale.”

These rights, if exercised by UNIVERSITY, supersede the rights granted in Article 2.

	
4.
	
MISCELLANEOUS.

4.1Defined Terms. All terms used, but not defined, herein shall have the respective
meanings set forth in the Agreement.

4.2Continuing Effect. This Third Amendment shall be effective for all purposes from and after the Amendment Date. Except as otherwise expressly modified by this Third Amendment, the Agreement shall remain in full force and effect in accordance with its terms.

4.3Governing Laws. This Third Amendment shall be governed by, interpreted and construed in accordance with the laws of the State of California, without regard to conflicts of law principles. 

2

 

4.4Counterparts. The parties agree that this Third Amendment may be executed in
counterparts, each of which shall be deemed an original and all of which together shall constitute but one and the same instrument. Signatures to this Third Amendment delivered by facsimile or other form of electronic transmission will be deemed to be binding as originals.

[Signature Page Follows]

3

 

IN WITNESS WHEREOF, both UNIVERSITY and LICENSEE have executed this Third Amendment, in duplicate originals, by their respective and duly authorized officers on the day and year written below.

 

	
RAPTOR PHARMACEUTICALS, INC.:
	
 
	
THE REGENTS OF THE
UNIVERSITY OF CALIFORNIA:

	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
By:
	
 
	
/s/ Thomas E. Daley
	
 
	
By:
	
 
	
/s/ Jane Moores, Ph.D.

	
Name:
	
 
	
Thomas E. Daley
	
 
	
 
	
 
	
Jane Moores, Ph.D.

	
Title:
	
 
	
Chief Business Officer
	
 
	
 
	
 
	
Assistant Vice-Chancellor, Intellectual Property

	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
Date:
	
 
	
3/11/13
	
 
	
Date:
	
 
	
3/6/13

 

 

4

 

FOURTH AMENDMENT to LICENSE AGREEMENT

UC CONTROL NUMBER 2008-03-0236, EFFECTIVE OCTOBER 31, 2007

between

RAPTOR PHARMACEUTICALS, INC.

and

THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

for:

CASE NO. SD2006-092: “Enterically Coated Cysteamine”

This fourth amendment (“Fourth Amendment”) to the License Agreement, UC Control No. 2008-03-0236, for Case No. SD2006-092 “Enterically Coated Cysteamine” effective October 31, 2007, as amended as of November 11, 2008, amended and restated as of October 30, 2012 and amended as of March 1, 2013 (“Agreement”) is made as of December 16, 2013 (the “4th Amendment Date”) by and between Raptor Pharmaceuticals, Inc. (f/k/a Raptor Therapeutics, Inc.), a Delaware corporation having an address at 5 Hamilton Landing, Suite 160, Novato, CA, 94949 (“LICENSEE”) and The Regents of the University of California, a California corporation having its statewide administrative offices at 1111 Franklin Street, Oakland, California 94607-5200 (“UNIVERSITY”), represented by its San Diego campus having an address at University of California, San Diego, Technology Transfer Office, Mail Code 0910, 9500 Gilman Drive, La Jolla, California 92093-0910 (“UCSD”).

Whereas, LICENSEE has moved its physical address and the address for correspondence will be updated to reflect this new situation;

Whereas, LICENSEE has changed its fiscal calendar such that it is now on a calendar year fiscal calendar; and

Whereas, LICENSEE and UNIVERSITY wish to amend the Agreement to clarify certain of LICENSEE’s obligations with respect to the timing of reports and payments for royalties.

NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants set forth below, the parties amend the Agreement and otherwise agree as follows:

1.Section 4.1(b) of the Agreement is hereby deleted and restated in its entirety as follows:

(b)Royalty Reports. After the first commercial sale of a Licensed Product anywhere in the world, LICENSEE shall submit to UNIVERSITY quarterly royalty reports on or before each March 31, June 30, September 30 and December 31 of each year. Each royalty report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar quarter (until the expiration or termination of such period or the earlier expiration or termination of this Agreement) and shall show:

 

 

	
 
	
(i)
	
the date of first commercial sale of a Licensed Product in each country;

	
 
	
(ii)
	
the gross sales, deductions as provided in Paragraph 1.5 and Net Sales during the most recently completed calendar quarter and the royalties, in US dollars, payable with respect thereto;

	
 
	
(iii)
	
the applicable Indication for each type of Licensed Product sold;

	
 
	
(iv)
	
the number of each type of Licensed Product sold;

	
 
	
(v)
	
Sublicense Fees and royalties received during the most recently completed calendar quarter in US dollars, payable with respect thereto;

	
 
	
(vi)
	
the method used to calculate the royalties; and

	
 
	
(vii)
	
the exchange rates used.

If no sales of Licensed Products have been made and no Sublicense revenue has been received by LICENSEE during any reporting period, LICENSEE shall so report.

2.Section 4.3(b)(ii) of the Agreement is hereby deleted and restated in its entirety as follows:

“(ii) LICENSEE shall pay to UNIVERSITY earned royalties within forty-five (45) days after the end of each previously stated quarter [noted in section 4.1(b)]. Each such payment shall be for earned royalties accrued within such preceding quarter.”

3.Section 10.1 of the Agreement is hereby deleted and restated in its entirety as follows:

10.1Correspondence. Any notice or payment required to be given to either party under this Agreement shall be deemed to have been properly given and effective:

(b)on the date of delivery if delivered in person, or

(c)five (5) days after mailing if mailed by first-class or certified mail, postage paid, to the respective addresses given below, or to such other address as is designated by written notice given to the other party.

If sent to LICENSEE:

Raptor Pharmaceuticals, Inc.

5 Hamilton Landing, Suite 160

Novato, CA 94949

Attention: Ted Daley, Chief Business Officer

Phone: 415-408-6207 (direct)

Fax: 415-382-8002

2

 

If sent to UNIVERSITY by mail:

University of California, San Diego

Technology Transfer Office 9500 Gilman Drive

Mail Code 0910

La Jolla, CA 92093-0910

Attention: Assistant Vice Chancellor

If sent to UNIVERSITY by courier:

University of California, San Diego

Technology Transfer Office

10300 North Torrey Pines Road

Torrey Pines Center North, Third Floor

La Jolla, CA 92037

Attention: Assistant Vice Chancellor

4.MISCELLANEOUS.

4.1Defined Terms. All terms used, but not defined, herein shall have the respective meanings set forth in the Agreement.

4.2Continuing Effect. This Fourth Amendment shall be effective for all purposes from and after the 4th Amendment Date. Except as otherwise expressly modified by this Fourth Amendment, the Agreement shall remain in full force and effect in accordance with its terms.

4.3Governing Laws. This Fourth Amendment shall be governed by, interpreted and construed in accordance with the laws of the State of California, without regard to conflicts of law principles.

4.4Counterparts. The parties agree that this Fourth Amendment may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute but one and the same instrument. Signatures to this Fourth Amendment delivered by facsimile or other form of electronic transmission will be deemed to be binding as originals.

3

 

IN WITNESS WHEREOF, both UNIVERSITY and LICENSEE have executed this Fourth Amendment, in duplicate originals, by their respective and duly authorized officers on the day and year written below.

 

	
RAPTOR PHARMACEUTICALS, INC.:
	
 
	
THE REGENTS OF THE
UNIVERSITY OF CALIFORNIA:

	
 
	
 
	
 

	
 By: 
	
/s/ Thomas E. Daley
	
 
	
By: 
	
/s/ Jane Moores, Ph.D.

	
Name: 
	
Thomas E. Daley
	
 
	
 
	
Jane Moores, Ph.D.

	
Title: 
	
Chief Business Officer
	
 
	
 
	
Assistant Vice-Chancellor, Intellectual
Property

	
 
	
 
	
 
	
 
	
 

	
Date: 
	
12/16/13
	
 
	
Date: 
	
1/6/14

 

4hznp-ex104_635.htm

Exhibit 10.4

 

	
 
	
***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 240.24b-2.

 

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API SUPPLY AGREEMENT

This API Supply Agreement (“Agreement”) is made as of the 3rd day of November, 2010 (“Effective Date”), by and between Raptor Therapeutics, Inc., a Delaware Corporation, with a place of business at 9 Commercial Boulevard, Suite 200, Novato, California 94949, U.S.A. (“RAPTOR”), and Cambrex Profarmaco Milano, Via Cucchiari 17, 20155 Milan, Italy (“CAMBREX”).  RAPTOR and CAMBREX may be referred to individually as a “Party” or collectively as the “Parties.”

Background

RAPTOR is engaged in the business of developing and commercializing therapeutic products through the application of specialized drug targeting platforms and formulation expertise for under-served patient populations;

CAMBREX is engaged in the manufacture and supply of active pharmaceutical ingredients for research and development purposes and/or commercial use;

RAPTOR desires to purchase from CAMBREX, and CAMBREX desires to supply to RAPTOR, the active pharmaceutical ingredient known as cysteamine bitartrate (as further defined below, the “API”) for use by RAPTOR in manufacturing finished products incorporating such active pharmaceutical ingredient, all in accordance with the terms and conditions of this Agreement.

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

ARTICLE 1

DEFINITIONS

1.1“Affiliate” or “Affiliates” shall mean, with respect to a Party, any corporation, limited liability company or other business entity controlling, controlled by or under common control with such Party, for so long as such relationship exists.  For the purposes of this definition, control means: (a) to possess, directly or indirectly, the power to direct affirmatively the management and policies of such corporation, limited liability company or other business entity, whether through ownership of voting securities or by contract relating to voting rights or corporate governance; or (b) ownership of more than fifty percent (50%) of the voting stock in such corporation, limited liability company or other business entity (or such lesser percent as may be the maximum that may be owned pursuant to Applicable Laws of the country of incorporation or domicile, as applicable).

1.2“API” shall mean cysteamine bitartrate, with the chemical structure set forth in Exhibit 1.2 attached hereto.

 

 

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1.3“Applicable Laws” shall mean: (a) all relevant federal, state and local laws, statutes, rules, regulations, and ordinances in the United States, Europe and/or any other jurisdiction, as well as industry standards and guidelines applicable to the manufacture and supply of API, including, the United States Federal Food, Drug and Cosmetic Act; (b) cGMPs; and (c) all applicable regulations and guidelines of any Regulatory Authority; in each case, together, with any and all amendments thereto.

1.4“cGMPs” shall mean current good manufacturing practices, as provided for (and as amended from time to time) in the Current Good Manufacturing Practice regulations promulgated by the FDA under the United States Food, Drug and Cosmetic Act and in the European Community Directive 91/356/EEC (Principles and guidelines of good manufacturing practice for medicinal products), as well as applicable documents developed by the International Conference on Harmonization (ICH), and similar requirements of other Regulatory Authorities, and subject to any arrangements, additions or clarifications, and the respective roles and responsibilities, agreed from time to time between the Parties.

1.5“Drug Master File” or “DMF” shall mean a drug master file filed with the FDA or the EMEA which includes information relating to the facilities, processes, or articles used in manufacturing, processing, packaging, and storing of the API, or any equivalent filing in any jurisdiction outside the United States or Europe.

1.6“EMEA” shall mean the European Medicines Evaluation Agency, or any successor entity thereto performing substantially similar functions.

1.7“Facility” shall mean CAMBREX’s cGMP-compliant facilities located at Via Cucchiari 17, 20155 Milan, Italy.

1.8“FDA” shall mean the United States Food and Drug Administration, or any successor entity thereto performing substantially similar functions.

1.9“Inflation Index” shall mean the annual average rate of change in the Harmonized Indices of Consumer Prices for the European Union, as published by Eurostat (or, to the extent that such index ceases to exist, any alternative inflation index mutually agreed by the Parties).

1.10“Price” shall mean the price for the API set forth in Exhibit 3.1.

1.11“Product” shall mean a finished pharmaceutical product incorporating the API.

1.12“Regulatory Authority” shall mean the FDA, EMEA or a regulatory body with similar regulatory authority in a jurisdiction other than the United States or Europe.

1.13“Specifications” shall mean those specifications and release requirements and/or procedures and/or other similar requirements for the manufacture of API, as the same are set forth in Exhibit 1.13. 

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1.14Additional Defined Terms.  Each of the following terms shall have the meaning described in the corresponding section of this Agreement indicated below:

 

	
Term
	
 
	
Section Defined
	
 
	
Term
	
 
	
Section Defined

	
Agreement
	
 
	
Introduction
	
 
	
[...***...]
	
 
	
2.1

	
CAMBREX
	
 
	
Introduction
	
 
	
Party / Parties
	
 
	
Introductions

	
Confidential Information
	
 
	
8.1
	
 
	
Purchase Order
	
 
	
2.3.2

	
Effective Date
	
 
	
Introduction
	
 
	
Q1, Q2, Q3, Q4
	
 
	
2.2

	
Force Majeure Event
	
 
	
11.6
	
 
	
Quality Agreement
	
 
	
4.2

	
Indemnitee
	
 
	
10.3
	
 
	
RAPTOR
	
 
	
Introduction

	
Indemnitor
	
 
	
10.3
	
 
	
Renewal Term
	
 
	
7.1

	
Initial Term
	
 
	
7.1
	
 
	
Required Changes
	
 
	
4.4

	
JAMS
	
 
	
11.4
	
 
	
Rolling Forecast
	
 
	
2.2

	
Laboratory
	
 
	
4.3.2
	
 
	
Shortage of Supply
	
 
	
2.5

	
Late Shipment
	
 
	
7.3
	
 
	
Term
	
 
	
7.1

 

ARTICLE 2

SUPPLY

2.1API Supply.  Subject to the terms and conditions of this Agreement, CAMBREX shall supply to RAPTOR, such quantities of the API as may be specified in purchase orders submitted by RAPTOR pursuant to Section 2.3 below from time to time during the Term.  All API to be supplied under this Agreement shall be manufactured by CAMBREX at the Facility, in conformance with Applicable Laws, the Specifications and the Quality Agreement.  Subject to Section 2.5, RAPTOR agrees that during the Term, RAPTOR will purchase: [...***...].

2.2Forecasts.  Beginning no later than [...***...], RAPTOR shall provide CAMBREX with an initial forecast of the quantities of the API estimated to be required during [...***...] (each, a “Rolling Forecast”).  Subject to Section 2.3 below, such Rolling Forecasts are non-binding and serve only to facilitate CAMBREX’ s production scheduling.

2.3Orders.

2.3.1Orders.  Together with each Rolling Forecast provided under Section 2.2 above, RAPTOR shall place a firm order with CAMBREX for supplies of API for delivery in [...***...]. The total quantity of API ordered by RAPTOR for delivery in [...***...] shall equal at least the 

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quantity of API forecasted for [...***...] in such Rolling Forecast.  For the avoidance of doubt, RAPTOR may order quantities of API in addition to those specified in the then-current Rolling Forecast for delivery hereunder in accordance with the lead times therefor and subject to CAMBREX’s total capacity constraints; provided that CAMBREX shall use commercially reasonable efforts to accept and fulfill all orders for API provided by RAPTOR under this Agreement.

2.3.2Form of Orders.  RAPTOR’s orders shall be made pursuant to a written purchase order (each, a “Purchase Order”) that specifies [...***...]; provided that the maximum lead time shall not [...***...] unless otherwise mutually agreed and CAMBREX shall use commercially reasonable efforts to achieve a maximum lead time of no more than [...***...].  RAPTOR is informed and understands that production of the API is scheduled based upon demand, and no campaign for production of the API will be scheduled until a firm Purchase Order is placed.  To the extent a particular Purchase Order issued by RAPTOR pursuant to this Section 2.3.2 is for less than a full lot of API (or a multiple thereof), upon CAMBREX’s reasonable written request, RAPTOR will confirm its acceptance to increase the applicable Purchase Order to a full lot of API (or the nearest whole multiple thereof).  Subject to the preceding sentence, CAMBREX shall accept all orders RAPTOR submits to CAMBREX in accordance with this Article 2.  CAMBREX shall provide to RAPTOR written notice of CAMBREX’s acceptance (each, an “Acceptance Notice”) of each Purchase Order within [...***...] of CAMBREX’s receipt of such Purchase Order and each such notice shall include confirmation of the delivery date of the applicable quantity of API; provided that to the extent no delivery date is included in an Acceptance Notice issued by CAMBREX or CAMBREX fails to issue an Acceptance Notice within the applicable time period, the applicable delivery date shall be deemed to be the delivery date specified by RAPTOR in the corresponding Purchase Order.  Except as to the quantity of API, delivery date and delivery location specified in a Purchase Order which shall be binding on the Parties, NO TERMS OR CONDITIONS CONTAINED IN ANY PURCHASE ORDER, ORDER ACKNOWLEDGMENT OR SIMILAR STANDARDIZED FORM SHALL BE CONSTRUED TO AMEND OR MODIFY THE TERMS OF THIS AGREEMENT, AND ALL SUCH TERMS AND CONDITIONS ARE HEREBY EXCLUDED.

2.4Shipping.  CAMBREX shall deliver quantities of API ordered by RAPTOR in accordance with Section 2.3 above, to the location specified in the applicable Purchase Order.  All shipments shall be [...***...].  CAMBREX shall ship API, together with all relevant documentation relating to the API, in accordance with any agreed-upon shipment specifications or as otherwise reasonably directed by RAPTOR in writing and in accordance with this Agreement.  RAPTOR shall only be obligated to pay for quantities of API actually delivered in compliance with the applicable Purchase Order and the terms of this Agreement.

2.5Shortage of Supply.  If CAMBREX is unable, or anticipates that it will not be able, to supply RAPTOR’s requirements for the API in accordance with Section 2.3 above (a “Shortage 

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of Supply”), CAMBREX shall immediately notify RAPTOR in writing of the same, and shall include in such notice its best estimate of the duration of the delay.  CAMBREX shall, at its own cost, use commercially reasonable efforts to remedy any Shortage of Supply and resume supplying API meeting the requirements of this Agreement to RAPTOR as soon as possible.  In addition to the foregoing measures, if CAMBREX is unable to supply RAPTOR’s requirements of API, CAMBREX shall allocate the quantities of the API that CAMBREX has in inventory, and that CAMBREX is able to produce, on a reasonable worldwide basis (based upon sales history and realistic forecasted demand).  [...***...] In the event of a Shortage of Supply exceeding [...***...], in addition to any other rights or remedies that RAPTOR may have under this Agreement, or at law or in equity, RAPTOR shall be relieved from its obligations to purchase any quantities of API identified in any outstanding Purchase Order.

ARTICLE 3

PAYMENTS

3.1Price.  Except as otherwise provided herein, the Price for the API subject to this Agreement shall be listed on Exhibit 3.1.  [...***...]

3.2Invoicing; Payment. CAMBREX (or CAMBREX’s agent, GYMA Laboratories) shall submit an invoice to RAPTOR upon shipment of API ordered by RAPTOR hereunder.  All invoices shall be sent to the address specified in the Purchase Order therefor, and each invoice shall state the Price for the API in a given shipment, plus any taxes and other costs incident to the purchase or shipment initially paid by CAMBREX but to be borne by RAPTOR hereunder.  All payments shall be made by direct bank transfer to an account designated in CAMBREX’ s invoice.  Payment terms shall be [...***...] from invoice date.  Payment by RAPTOR shall

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not constitute acceptance of any shipment of API or impair RAPTOR’s right of inspection and rejection under Article 4 below.

ARTICLE 4

QUALITY

4.1Quality Assurance.  All API supplied by CAMBREX shall meet the current Specifications and shall be manufactured in accordance with all Applicable Laws and the Quality Agreement at the Facility.  CAMBREX agrees that, prior to each shipment of API hereunder, it shall perform quality control procedures reasonably necessary to ensure that the API to be shipped conforms fully with the Specifications.  Each shipment of API shall be accompanied by a certificate of analysis [...***...] and such additional documents as may be specified in the Quality Agreement or as otherwise reasonably required by RAPTOR from time to time.

4.2Quality Agreement.  Prior to RAPTOR issuing its first Purchase Order to CAMBREX pursuant to this Agreement (and in any event, [...***...] after the Effective Date), the Parties shall enter into an agreement specifying the Parties’ respective responsibilities for storage, release, quality control and quality assurance with respect to the API (the “Quality Agreement”).  The Quality Agreement is not intended and shall not be construed to limit any of the rights and obligations of the Parties set forth in the body of this Agreement.  Subject to the foregoing, to the extent possible, the Quality Agreement will be interpreted with the terms set forth in the body of this Agreement.  If there is any conflict or inconsistency between the terms of the Quality Agreement and the terms set forth in the body of this Agreement, however, the terms set forth in the body of this Agreement shall control.

4.3Rejection and Replacement of API.

4.3.1Inspection by RAPTOR.  RAPTOR and/or its designee shall have [...***...] following its receipt of a shipment of API to reject such API on the grounds that all or part of the shipment fails to conform to the applicable Specifications or otherwise fails to conform to the warranties given by CAMBREX in Section 9.2, which rejection shall be accomplished by giving written notice to CAMBREX summarizing the manner in which all or part of such shipment fails to meet the foregoing requirements.

4.3.2Resolution of Disputes.  CAMBREX shall respond in writing to a rejection notice from RAPTOR within [...***...] from the date of receipt of such rejection notice in accordance with Section 4.3.1 above.  If CAMBREX does not agree with RAPTOR’s determination that such API fails to conform to the Specifications or the warranties provided by CAMBREX in Section 9.2, then CAMBREX and RAPTOR shall use reasonable efforts to resolve such disagreement as promptly as possible.  Without limiting the foregoing, [...***...]

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[...***...].

4.3.3Replacement of API. API accepted by CAMBREX as not meeting the applicable requirements and/or the Specifications, or which is determined by the Laboratory not to meet such requirements and/or the Specifications, shall be returned by RAPTOR to CAMBREX, or disposed of, as directed by CAMBREX and at CAMBREX’s expense.  CAMBREX shall replace all such rejected API within the shortest possible time, but in any event, within [...***...] days after its receipt of notice of such rejection (or, if applicable, the Laboratory’s determination that such API was non-conforming), [...***...].  Without limiting any other provision in this Agreement, RAPTOR may withhold payment for such shipment or the portion thereof that has been rejected by RAPTOR pursuant to this Section 4.3.  The warranties given by CAMBREX in Section 9.2 below shall survive any failure to reject by RAPTOR under this Section 4.3.

4.4Changes.

4.4.1CAMBREX shall maintain change control systems that ensure that all major changes are appropriately notified in a timely manner and in certain cases, as provided in Section 4.4.2 below or otherwise agreed by the Parties in the Quality Agreement, are agreed with RAPTOR.

4.4.2CAMBREX shall promptly inform RAPTOR in writing of any proposal of major change to the manufacturing process, equipment, packaging, testing, specifications, or any item specially mentioned in the DMF.  [...***...]  Notwithstanding the foregoing, in no event will CAMBREX implement any major changes with respect to quantities of API to be supplied to RAPTOR, before obtaining RAPTOR’s approval (if applicable) and prior to all necessary filings with and approvals by applicable Regulatory Authorities have been made or obtained by CAMBREX and/or RAPTOR, as applicable.

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ARTICLE 5

RECORDS; INSPECTIONS

5.1Record Keeping.  CAMBREX shall generate and maintain complete and accurate records and samples as necessary to evidence compliance with this Agreement and all Applicable Laws and other requirements of applicable governmental authorities relating to the manufacture of APL All such records and samples shall be maintained by CAMBREX in accordance with the procedures set out in the Quality Agreement for the applicable time period specified therein.

5.2Inspection.  During the term of this Agreement, and for [...***...] thereafter, or as otherwise required by Applicable Laws, RAPTOR (and/or its designee) shall have the right to inspect and audit, during regular business hours: (a) any facility at which any of the manufacturing or processing activities relating to the API are performed, including the Facility; (b) any of CAMBREX’ s manufacturing and quality control records and all other documentation relating to the manufacturing and processing activities with respect to the API (including any internal quality control audits or reviews conducted by CAMBREX); and (c) accounts and records for the purpose of determining the amounts payable or owed under this Agreement.  Such inspections and audits shall be conducted [...***...] and in accordance with any procedures for audits specified in the Quality Agreement; provided however that RAPTOR shall have the right to conduct additional inspections and audits under this Section 5.2 [...***...].

ARTICLE 6

REGULATORY MATTERS

6.1Regulatory Actions.  CAMBREX shall permit the FDA and other Regulatory Authorities, as applicable, to conduct such inspections of the Facility, and/or any other facility at which any of the manufacturing or processing activities relating to the API are performed, as such Regulatory Authorities may request, including pre-approval inspections, and shall cooperate with such Regulatory Authorities with respect to such inspections and any related matters, in each case that is related to the manufacture and supply of APL CAMBREX shall (a) give RAPTOR prior written notice of any such inspections related to the API; and (b) keep RAPTOR informed about the results and conclusions of each such regulatory inspection, including any actions taken by CAMBREX to remedy any conditions cited in such inspections related to the API; all as further described, and in accordance with the procedures specified, in the Quality Agreement.

6.2Regulatory Cooperation.  CAMBREX agrees to provide to RAPTOR, as requested, with all information and data in CAMBREX’s possession or control necessary or reasonably useful for RAPTOR (and/or its designees) to apply for, obtain and maintain regulatory approvals for any Product in any country, including information relating to the Facility, or the methodology, raw materials and intermediates used in the manufacture, processing or packaging of API, or any other matters required or requested to be provided to the FDA or any other Regulatory Authority.  In addition, CAMBREX agrees to cooperate with RAPTOR (and/or its designees) with respect to 

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obligations to submit or report information relevant to API pursuant to FDA regulations and other Applicable Laws.

6.3Drug Master Files.  CAMBREX shall provide, or cooperate with RAPTOR to provide, the appropriate authorizations to each applicable Regulatory Authority allowing RAPTOR (and/or its designee) the right to reference all Drug Master Files to support any regulatory filing for any Product developed, manufactured and/or commercialized by RAPTOR, its Affiliates and/or licensees.  If the [...***...] filed with the FDA as of the Effective Date is not sufficient to support the applicable regulatory filing for a Product, CAMBREX shall supplement such Drug Master File or file a separate Drug Master File(s) with the applicable Regulatory Authority(ies) (including, if applicable, the EMEA,) as necessary to support such regulatory filing(s); provided that [...***...].  Any such new DMF filing will also require process validation and pilot work, and [...***...].  In addition, RAPTOR agrees to purchase [...***...] of API manufactured for the purposes of performing such validation/pilot work.  CAMBREX shall use commercially reasonable efforts to correct any deficiencies of such Drug Master File(s) identified by any Regulatory Authority in a prompt and efficient manner so as to prevent any delay in RAPTOR (or any of its Affiliates or licensees) obtaining regulatory approval for a Product based on such Drug Master File(s).  In addition, CAMBREX shall be responsible for maintaining such Drug Master File(s) in accordance with Applicable Laws and ensuring that all data and information incorporated therein is accurate and current as necessary to support obtaining and maintaining the applicable regulatory filing(s) and regulatory approval(s) by RAPTOR (and/or its designees) provided that [...***...].

6.4Recall.  Any recalls of any of RAPTOR’s Products shall, as between the Parties, be controlled solely by RAPTOR; provided, however, that if CAMBREX reasonably believes a recall may be necessary with respect to any API provided under this Agreement, CAMBREX shall immediately notify RAPTOR in writing.  CAMBREX shall provide assistance to RAPTOR (and/or its designee), as reasonably requested, in conducting such recall, including providing all pertinent records that may assist RAPTOR in effecting such recall.

ARTICLE 7

TERM AND TERMINATION

7.1Term.  The term of this Agreement shall commence on the Effective Date and shall continue for an initial term of ten (10) years (“Initial Term”).  Thereafter, this Agreement shall automatically be renewed for successive two (2) year periods (each, a “Renewal Term;” and all such Renewal Terms together with the Initial Term, collectively, the “Term”), unless either Party notifies the other Party in writing at least one (1) year prior to the expiration of the then-current Term that such Party does not wish to renew this Agreement for an additional term. 

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7.2Termination for Material Breach.  If either Party materially breaches this Agreement or the Quality Agreement at any time, the non-breaching Party shall have the right to terminate this Agreement by written notice to the breaching Party, if such breach is not cured [...***...] after written notice is given by the non-breaching Party to the breaching Party specifying the breach.

7.3Termination for Failure to Supply.  Without limiting any other provision of this Agreement, including Sections 2.5 and 7.2 above, if [...***...] Late Shipments of API occur in any [...***...], then RAPTOR shall have the right to terminate this Agreement immediately by written notice to CAMBREX.  For purposes of this Section 7.3, a “Late Shipment” shall mean [...***...].

7.4Termination by RAPTOR.  RAPTOR may terminate this Agreement immediately upon written notice to CAMBREX if: (a) RAPTOR, in its sole discretion, determines that Products will not be marketed by RAPTOR (or its designee); or (b) the FDA or EMEA withdraws approval of, or fails to approve, the manufacturing or marketing by RAPTOR (or its designee) of all Products then in development.

7.5Effects of Termination.  It is understood that termination or expiration of this Agreement shall not relieve a Party from any liability that, at the time of such termination or expiration, has already accrued to the other Party, except as specified in this Section 7.5.  Upon expiration or termination of this Agreement for any reason (other than by RAPTOR pursuant to Section 7.2 above), to the extent CAMBREX so notifies RAPTOR, RAPTOR shall have the obligation to purchase all API ordered under any outstanding Purchase Orders.  [...***...].

7.6Survival.  The provisions of Sections 4.l, 5.1, 5.2, 7.5, 11.2, 11.3 and 11.4 and Articles 6, 8, 9 and 10 shall survive the expiration or termination of this Agreement for any reason.  In addition, the provisions of the Quality Agreement shall survive expiration or termination of this Agreement until the date of expiration of the last-to-expire batch of API delivered by CAMBREX to RAPTOR hereunder.  All other rights and obligations of the Parties shall cease upon termination of this Agreement.  Except as otherwise expressly provided in this Section 7.6, all other rights and obligations of the Parties shall terminate. 

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ARTICLE 8

CONFIDENTIALITY

8.1Confidential Information.  Except as otherwise provided in this Article 8, during the Term and for a period of [...***...] thereafter, each Party shall maintain in confidence and only use for the purposes of this Agreement any confidential information, data and/or materials supplied to such Party by the other Party (“Confidential Information”).  A receiving Party’s obligations under this Article 8 shall not apply to any information, data or material that, in each case as demonstrated by written documentation: (a) was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure; (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party; (c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; (d) was subsequently lawfully disclosed to the receiving Party by a person other than the disclosing Party; or (e) was independently developed by the receiving Party without reference to any Confidential Information of the disclosing Party.

8.2Confidentiality; Non-Disclosure.  Each Party agrees not to disclose any Confidential Information of the other Party except to those employees and consultants who have a need to know and provided that each person to whom Confidential Information is disclosed agrees to be bound by the same terms regarding the disclosure and use of Confidential Information as set forth in this Article 8.  Each Party further agrees not to use or disclose the Confidential Information of the other Party except as otherwise permitted by this Agreement, or as may be necessary to exercise its rights or perform its obligations under this Agreement.  Nothing contained in this Article 8 shall prevent either Party from disclosing any Confidential Information of the other Party to: (a) regulatory agencies for the purpose of obtaining approval to distribute and market Products; provided, however, that all reasonable steps are taken to maintain the confidentiality of such Confidential Information to be disclosed; (b) to accountants, lawyers or other professional advisors or in connection with a merger, acquisition, securities offering or other strategic transaction, subject in each case, to the recipient entering into an agreement to protect such Confidential Information from disclosure; or (c) is required by law or regulation to be disclosed; provided, however, that the Party subject to such disclosure requirement has provided written notice to the other Party promptly upon receiving notice of such requirement in order to enable the other Party to seek a protective order or otherwise prevent disclosure of such Confidential Information.

ARTICLE 9

REPRESENTATIONS AND WARRANTIES

9.1Mutual Warranties.  Each Party represents and warrants to the other Party that: (a) it has the power and authority to enter into this Agreement and to perform its obligations hereunder and to grant to the other Party the rights granted to such other Party under this Agreement; (b) it has obtained all necessary corporate approvals to enter into and execute this Agreement and to perform its obligations hereunder; and (c) the execution, delivery and 

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performance of this Agreement does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor will it enter into or assume during the Term, any contract or other obligation with a third party that would in any way limit the performance of its obligations under this Agreement.

9.2CAMBREX Warranties.  CAMBREX represents and warrants that:

9.2.1.1API.  All API supplied hereunder shall comply with all Applicable Laws and the Quality Agreement and meet all Specifications, and CAMBREX shall perform and document all manufacturing and supply activities contemplated herein in compliance with all Applicable Laws.

9.2.1.2Shelf Life.  The API has a shelf life of [...***...].  All API supplied by CAMBREX under this Agreement shall have a shelf life of no less than [...***...] at the time of delivery of such API to RAPTOR (or its designee).

9.2.1.3Facilities and Equipment.  The Facility, all equipment used for the manufacture of API within the Facility and the activities contemplated herein will comply with all Applicable Laws and CAMBREX shall obtain and maintain all governmental registrations, permits, licenses and approvals necessary for CAMBREX to manufacture and supply API to RAPTOR, and otherwise to perform its obligations, under this Agreement

9.2.1.4No Encumbrance.  Title to all API provided to RAPTOR under this Agreement shall pass as provided in this Agreement, free and clear of any security interest, lien, or other encumbrance.

9.2.1.5Personnel.  Neither CAMBREX, nor any of its Affiliates, nor, to the best of CAMBREX’s knowledge, any of their respective employees have been “debarred” by the FDA, or subject to a similar sanction from any Regulatory Authority in any jurisdiction outside the United States, nor have debarment proceedings against CAMBREX, any of its Affiliates, or any of their respective employees been commenced.  CAMBREX will promptly notify RAPTOR in writing if any such proceedings have commenced or if CAMBREX, any of its Affiliates, or any of their respective employees are debarred by the FDA or any other Regulatory Authority.

9.3RAPTOR Warranties.  RAPTOR represents and warrants that it shall comply in all materials respects with all Applicable Laws pertaining to the distribution, sale, and/or marketing of Product.

9.4DISCLAIMER.  EXCEPT AS PROVIDED IN THIS ARTICLE 9, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES (EXPRESS, IMPLIED, STATUTORY OR OTHERWISE) WITH RESPECT TO THE SUBJECT MATTER HEREOF AND EACH PARTY EXPRESSLY DISCLAIMS ANY SUCH ADDITIONAL REPRESENTATIONS AND WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES

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OF FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY OR NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS.

ARTICLE 10

INDEMNIFICATION AND LIMITATION OF LIABILITY

10.1RAPTOR.  It is understood that CAMBREX has no control over the ultimate use of the API or Products.  RAPTOR shall indemnify, defend and hold harmless CAMBREX, its directors, officers, employees, agents, successors and assigns from and against any liabilities, expenses or costs (including reasonable attorneys’ fees and court costs) arising out of [...***...].

10.2CAMBREX.  CAMBREX shall indemnify, defend and hold harmless RAPTOR, its directors, officers, employees, agents, successors and assigns from and against all liabilities, expenses, and costs (including reasonable attorneys’ fees and court costs) arising out of any [...***...].

10.3Indemnification Procedure.  Any Party seeking indemnification under this Article 10 (the “Indemnitee”) shall: (a) promptly notify the indemnifying Party (the “Indemnitor”) of such claim; (b) provide the Indemnitor sole control over the defense and/or settlement thereof; and (c) at the Indemnitor’s request and expense, provide full information and reasonable assistance to Indemnitor with respect to such claims.  Without limiting the foregoing, with respect to claims brought under Section 10.1 or 10.2 above, the Indemnitee, at its own expense, shall have the right to participate with counsel of its own choosing in the defense and/or settlement of any such claim.  The indemnification under this Article 10 shall not apply to amounts paid in settlement of any claim if such settlement is effected without the consent of the Indemnitor. 

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10.4Insurance.  During the Term and for a period of [...***...] thereafter, CAMBREX shall maintain, with financially sound and reputable insurers, insurance reasonably sufficient to cover CAMBREX’s activities and obligations under this Agreement.  Without limiting the foregoing, CAMBREX shall maintain: [...***...].  At the reasonable request of RAPTOR, CAMBREX shall provide to RAPTOR copies of certificates of insurance evidencing coverage in accordance with this Section 10.4.

10.5LIMITATION OF LIABILITY.  EACH PARTY’S LIABILITY SHALL BE LIMITED AS SET FORTH HEREIN AND IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, CONSEQUENTIAL OR EXEMPLARY OR PUNITIVE DAMAGES; INCLUDING LOST PROFITS, OR OPPORTUNITY OR GOODWILL, HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY AND EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES; PROVIDED HOWEVER THAT THE FOREGOING SHALL NOT BE DEEMED TO LIMIT THE INDEMNIFICATION OBLIGATIONS OF EITHER PARTY UNDER THIS ARTICLE 10 TO THE EXTENT A THIRD PARTY RECOVERS ANY PUNITIVE, EXEMPLARY, SPECIAL, CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES.  CAMBREX’S MAXIMUM LIABILITY TO RAPTOR FOR EACH EVENT GIVING RISE TO ANY INJURIES, CLAIMS, LOSSES, EXPENSES, OR DAMAGES, INCLUDING, BUT NOT LIMITED TO EVENTS RESULTING FROM NEGLIGENCE, ERRORS, OMISSIONS OR STRICT LIABILITY, SHALL NOT EXCEED [...***...].  To the extent that this clause conflicts with any other clause of this Agreement, this clause shall take precedence over such conflicting clause.  If applicable law prevents enforcement of this Section 10.5, then this Section shall be deemed modified to provide the maximum protection to each Party as is allowable under applicable law.

ARTICLE 11

GENERAL PROVISIONS

11.1Assignment.  The Parties agree that their rights and obligations under this Agreement may not be assigned or otherwise transferred to a third party without the prior written consent of the other Party hereto.  Notwithstanding the foregoing, either Party may transfer or assign its rights and obligations under this Agreement to a successor to all or substantially all of its business or assets relating to this Agreement whether by sale, merger, operation of law or otherwise; provided that such assignee or transferee has agreed to be bound by the terms and

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conditions of this Agreement.  Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the Parties hereto, their successors and assigns.

11.2Governing Law.  This Agreement shall be governed by, and construed and interpreted in accordance with, the laws of the State of New York, as if entered into by New York residents and executed and wholly performed within the State of New York.

11.3Disputes.  Except for any disputes with respect to non-conforming API, which shall be resolved in accordance with Section 4.3 above, if CAMBREX and RAPTOR are unable to resolve any dispute between them, either CAMBREX or RAPTOR may, by written notice to the other, have such dispute referred to the senior management of CAMBREX and RAPTOR for attempted resolution by good faith negotiations within [...***...]  after such notice is received.  If the Parties are unable to resolve such dispute in accordance with the aforementioned procedure or within such [...***...] period, subject to Section 11.4 below, either Party shall have the right to pursue any and all other remedies available to such Party.

11.4Arbitration.  Except for any disputes with respect to non-conforming API, which shall be resolved in accordance with Section 4.3 above, any dispute or claim arising out of or in connection with this Agreement or the performance, breach or termination thereof which is unable to be resolved pursuant to discussions between the Parties in accordance with Section 11.3 above, shall, upon notice by either Party to the other, be submitted to binding arbitration in New York City, New York under the Rules of the Judicial Arbitration and Mediation Services, Inc.  (or any successor entity thereto, collectively, “JAMS”) by one (1) arbitrator appointed in accordance with said rules.  The arbitrator may engage an independent expert with experience in the subject matter of the dispute to advise the arbitrator.  The decision and/or award rendered by the arbitrator shall be written, final and non-appealable and may be entered in any court of competent jurisdiction.  The Parties agree that, any provision of applicable law notwithstanding, they will not request, and the arbitrator shall have no authority to award, punitive or exemplary damages against any Party.  The costs of any arbitration, including administrative fees and fees of the arbitrator, shall be shared equally by the Parties, unless otherwise determined by the arbitrator.  Each Party shall bear the cost of its own attorneys’ and expert fees.  Notwithstanding the foregoing, either Party may apply to any court of competent jurisdiction for injunctive relief without breach of this arbitration provision.

11.5Notices.  Any notice or report required or permitted to be given or made under this Agreement by either Party shall be in writing and in English and delivered to the other Party at its address indicated below (or to such other address as a Party may specify by like notice) by courier or by registered or certified airmail, postage prepaid, or by facsimile; provided, however, that all facsimile notices shall be promptly confirmed, in writing, by courier or by registered or certified airmail, postage prepaid.  All notices shall be effective as of the date received by the addressee. 

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If to RAPTOR:
	
 
	
Raptor Therapeutics, Inc.

9 Commercial Boulevard

Suite 200

Novato, CA 94949

Attn: President

Fax: (415) 382-1368

	
 
	
 
	
 

	
If to CAMBREX:
	
 
	
Cambrex Profarmaco Milano

Via Cucchiari 19

20129 Milan, Italy

Attn: Aldo Magnini

Fax: +39 02 33105730

	
 
	
 
	
 

	
 
	
 
	
Cambrex Corporation

One Meadowlands Plaza

East Rutherford NJ 07073

Attn: General Counsel

Fax: (201) 804-9852

 

11.6Force Majeure.  Neither Party will be liable for its failure to perform any of its obligations hereunder during any period in which such performance is delayed by acts of God, fire, war, embargo, riots, or other similar cause outside the reasonable control of such Party (“Force Majeure Event”).  A Party affected by a Force Majeure Event will promptly notify the other Party, explaining the nature and expected duration thereof and such Party shall use all reasonable efforts to remedy or mitigate such Force Majeure Event and the effects thereof.  Notwithstanding the foregoing, if a Party is unable to perform any of its obligations under this Agreement for a period of more than [...***...] as a result of a Force Majeure Event, the other Party may terminate this Agreement upon written notice to the affected Party.

11.7Interpretation.  The headings to the several Articles and Sections of this Agreement are not a part of this Agreement, but are included for convenience of reference only and shall not affect its meaning or interpretation.  In this Agreement: (a) the word “including” shall be deemed to be followed by the phrase “without limitation” or like expression; (b) the singular shall include the plural and vice versa; and (c) masculine, feminine and neuter pronouns and expressions shall be interchangeable.

11.8Waiver.  Any waiver of the terms and conditions hereof must be explicitly in writing and executed by a duly authorized officer of the Party waiving compliance.  The waiver by either of the Parties of any breach of any provision hereof by the other shall not be construed to be a waiver of any succeeding breach of such provision or a waiver of the provision itself.  The delay or failure of any Party at any time to require performance of any provision of this Agreement shall in no manner affect such Party’s rights at a later time to enforce the same.

 

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11.9Severability.  Should any section, or portion thereof, of this Agreement be held invalid or unenforceable in any jurisdiction by any court of competent authority or by a legally enforceable directive of any governmental body, such section or portion thereof shall be validly reformed so as to approximate the intent of the Parties as nearly as possible and, if unreformable, shall be deemed divisible and deleted with respect to such jurisdiction, but the Agreement shall not otherwise be affected.

11.10Independent Contractors.  The relationship of RAPTOR and CAMBREX established by this Agreement is that of independent contractors.  Nothing in this Agreement shall be construed to create a partnership, joint venture, agency or other fiduciary relationship between RAPTOR and CAMBREX.  Neither Party shall have any right, power or authority to assume, create or incur any expense, liability or obligation, express or implied, on behalf of the other.

11.11Entire Agreement; Amendment.  The terms and provisions contained in the Agreement (including the Exhibits hereto and any Purchase Orders issued pursuant hereto) and the Quality Agreement constitute the entire agreement between the Parties and shall supersede all previous communications, representations, agreements or understandings, either oral or written, between the Parties with respect to the subject matter hereof.  No agreement or understanding varying or extending this Agreement shall be binding upon either Party hereto, unless set forth in a writing which specifically refers to the Agreement signed by duly authorized officers or representatives of the respective Parties, and the provisions hereof not specifically amended thereby shall remain in full force and effect.

11.12Counterparts.  This Agreement may be executed in counterparts, each of which shall be deemed an original, but which together shall constitute one and the same instrument.

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IN WITNESS WHEREOF, the Parties hereto have caused their duly authorized representatives to execute this API Supply Agreement as of the Effective Date.

 

	
RAPTOR THERAPEUTICS, INC.
	
 
	
CAMBREX PROFARMACO MILANO

	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
By:
	
 
	
/s/ Thomas E. Daley
	
 
	
By:
	
 
	
/s/ Paolo Russolo

	
Name:
	
 
	
Thomas E. Daley
	
 
	
Name:
	
 
	
Paolo Russolo

	
Title:
	
 
	
President
	
 
	
Title:
	
 
	
President

 

 

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Exhibit 1.2

[...***...]

 

 

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Exhibit 1.13

Specifications

 

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Exhibit 3.1

Price

[...***...]

 

 

 

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Amendment to API Supply Agreement

between Cambrex Profarmaco Milano, and Raptor Pharmaceuticals Inc.

Background: This Amendment is made by and between Cambrex Profarmaco Milano, (“Cambrex”) and Raptor Pharmaceuticals Inc. (formerly named Raptor Therapeutics, Inc.) (“Raptor”) pursuant to Section 11.11 of that certain API Supply Agreement dated November 3, 2010 by and between the parties (the “Agreement”). Cambrex and Raptor wish to amend the Agreement to add Raptor’s wholly owned subsidiary, Raptor Pharmaceuticals Europe B.V., as an additional party to the Agreement.

NOW THEREFORE in consideration of the premises hereof and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged by the parties, the parties agree to amend the Agreement as follows:

	
1.
	
Amendment to Agreement:

Raptor Pharmaceuticals Europe B.V. (“Raptor BV”), a wholly owned subsidiary of Raptor, located at Naritaweg 165, Telestone-Teleport, 1043 BW Amsterdam, the Netherlands, is hereby added as a party to the Agreement and will thereupon have all the rights and obligations of “RAPTOR” thereunder. All references to “RAPTOR” in the Agreement shall refer to Raptor and/or Raptor BV, as applicable. Raptor BV may procure its API supply from Cambrex separately from Raptor.

	
2.
	
API Supply. For the avoidance of doubt, the purchases made by both Raptor and Raptor BV in [...***...]  shall be included in determining whether RAPTOR has satisfied the [...***...] requirement set forth in Section 2.1 of the Agreement.

	
3.
	
Forecasts. For the further avoidance of doubt, the Rolling Forecasts set forth in Section 2.2 of the Agreement may be provided by either Raptor or Raptor BV.

	
4.
	
No Other Modifications. The “Background” section of this document is incorporated into the Amendment. Except as expressly amended by this Amendment, the terms and conditions of the Agreement shall remain in full force and effect.

	
5.
	
Counterparts. This Amendment may be executed in two or more counterparts, each of which shall be deemed an original and all or which together shall constitute one instrument.

	
6.
	
Entire Agreement. The Agreement, as amended hereby, together with this Amendment, constitute the full, complete, final and integrated agreement between the parties related to the subject matter hereof and thereof and supersede all previous written or oral negotiations, commitments, agreements, transactions or understandings concerning the subject matter hereof.

 

 

 

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IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed by their authorized representatives, effective as of April 9, 2013.

 

	
RAPTOR PHARMACEUTICALS INC.
	
 
	
CAMBREX PROFARMACO MILANO

	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
By:
	
 
	
/s/ Georgia Erbez
	
 
	
By:
	
 
	
/s/ Paolo Russolo

	
Name:
	
 
	
Georgia Erbez
	
 
	
Name:
	
 
	
Paolo Russolo

	
Title:
	
 
	
CFO
	
 
	
Title:
	
 
	
President

	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
RAPTOR PHARMACEUTICALS EUROPE B.V.
	
 
	
 

	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
By:
	
 
	
/s/ Henk Doude von Troostwijk
	
 
	
 
	
 
	
 

	
Name:
	
 
	
Henk Doude von Troostwijk
	
 
	
 
	
 
	
 

	
Title:
	
 
	
Director B
	
 
	
 
	
 
	
 

	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
By:
	
 
	
/s/ Kim R. Tsuchimoto
	
 
	
 
	
 
	
 

	
Name:
	
 
	
Kim R. Tsuchimoto
	
 
	
 
	
 
	
 

	
Title:
	
 
	
Director A

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