EX-10.2 3 dex102.htm ROYALTY SALE AGREEMENT Royalty Sale Agreement

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

EXHIBIT 10.2

 

ROYALTY SALE AGREEMENT

 

This Royalty Sale Agreement (this “Agreement”) is made and entered into as of July 18, 2005 by and among Gilead Sciences, Inc., a Delaware corporation (“Gilead”), Emory University, a not-for-profit corporation organized under the laws of the State of Georgia (“Emory”), and Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma, a unit trust organized under the laws of the Republic of Ireland (“Royalty Pharma”) (Gilead, Emory and Royalty Pharma are each a “Party” and collectively the ”Parties”).

 

W I T N E S S E T H:

 

WHEREAS, pursuant to that certain License Agreement dated as of April 17, 1996, by and between Emory and Gilead, as amended by the First Amendment to License Agreement dated as of May 6, 1999 (the “First Amendment”), the Second Amendment to License Agreement dated as of July 10, 2000, the Third Amendment to License Agreement dated as of May 31, 2002, the Fourth Amendment to License Agreement dated as of April 19, 2004 and the Fifth Amendment to License Agreement dated as of July 18, 2005 (the “Existing License Agreement”), Emory licensed to Gilead certain rights relating to FTC and the Licensed Products (each as defined therein);

 

WHEREAS, Gilead and Royalty Pharma together desire to purchase from Emory, and Emory desires to sell to them, all of the royalties payable by Gilead under the Existing License Agreement upon sale of Licensed Products for an aggregate purchase price of $525,000,000;

 

WHEREAS, at Closing, Emory and Gilead will amend and restate the Existing License Agreement, a copy of which Amended and Restated License Agreement is attached hereto as Exhibit A (the ”Amended and Restated License Agreement”), whereby in combination with this Agreement Gilead will buy from Emory, and Emory will sell to Gilead, all of Emory’s right, title and interest in and to 65% of the original royalties payable under the Existing License Agreement (the ”Gilead Purchased Royalties”), which purchase and sale will be effected by this Agreement and by reducing the royalties payable by Gilead to Emory upon sale of Licensed Products in the Amended and Restated License Agreement;

 

WHEREAS, simultaneously with the execution hereof, Emory and Royalty Pharma are entering into that certain Agreement for the Conveyance of Royalties, of even date herewith a copy of which has been delivered to each of Emory and Royalty Pharma (the “Conveyance Agreement”), whereby in combination with the Amended and Restated License Agreement, Royalty Pharma will buy from Emory, and Emory will sell to Royalty Pharma, all of Emory’s right, title and interest in and to the remaining 35% of the original royalties payable under the Existing License Agreement, which royalties are identified as the “Receivables” under the


Conveyance Agreement and which purchase and sale will be effected by the Conveyance Agreement and by adding Royalty Pharma as a party to the Amended and Restated License Agreement to provide for, among other things, the payment by Gilead to Royalty Pharma of the Receivables; and

 

WHEREAS, in consideration for the foregoing amendment and restatement of the Existing License Agreement and the purchases and sales pursuant to this Agreement and the Conveyance Agreement, Gilead will pay to Emory $341,250,000 as provided in this Agreement (the “Gilead Purchase Price”), and Royalty Pharma will pay to Emory $183,750,000 as provided in the Conveyance Agreement (the “Royalty Pharma Purchase Price”).

 

NOW, THEREFORE, in consideration of the promises hereinafter set forth, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto hereby agree as follows:

 

ARTICLE I

 

PURCHASE AND SALE OF ROYALTIES BY GILEAD

 

Subject to the terms and conditions of this Agreement and on the basis of the representations, warranties, covenants and agreements contained herein, at the Closing (as defined below), Emory shall sell, transfer, assign, convey and deliver to Gilead, and Gilead shall purchase and acquire from Emory, upon payment of the Gilead Purchase Price, the Gilead Purchased Royalties. For avoidance of doubt, the purchase and sale of the Receivables by Royalty Pharma by payment of the Royalty Pharma Purchase Price shall be as set forth herein and in the Conveyance Agreement.

 

ARTICLE II

 

THE CLOSING

 

The closing of the transactions contemplated by this Agreement (the ”Closing”) shall be held at the offices of Covington & Burling, 1330 Avenue of the Americas, New York, New York, 10019 at 10:00 a.m. on July 21, 2005, or at such other time or place as the Parties may mutually agree. The “Closing Date” shall be the date on which the Closing takes place. The Closing shall be subject to satisfaction of the conditions set forth below:

 

Section 2.1 Conditions to the Obligations of each Party. The obligation of each Party to consummate the Closing is, at each Party’s option, subject to the satisfaction, on or before the Closing Date, of the following conditions:

 

(a) Amended and Restated License Agreement. Each of the Parties shall execute and deliver the Amended and Restated License Agreement in the form attached hereto as Exhibit A.

 

(b) Conveyance Agreement. Each of Emory and Royalty Pharma shall have executed and delivered the Conveyance Agreement.

 

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(c) Secretary’s Certificates. Immediately prior to the Closing, each other Party shall deliver to the Parties a certificate of the Secretary or an Assistant Secretary of the certifying Party, dated the Closing Date, certifying as to (i) the incumbency of the officers of the certifying Party executing this Agreement and the Amended and Restated License Agreement and (ii) the attached copies of the certifying Party’s certificate of incorporation, bylaws and the resolutions adopted by the certifying Party’s Board of Directors, Board of Trustees or applicable corporate body authorizing the execution and delivery by such certifying Party of this Agreement and the Amended and Restated License Agreement and the consummation by such certifying Party of the transactions contemplated hereby and thereby.

 

Section 2.2 Closing. At the Closing:

 

(a) Payments by Gilead.

 

(i) Gilead shall deliver, and/or cause one or more of its Affiliates to deliver, to Emory payment, by wire transfer of immediately available funds to the account set forth on Exhibit B, the Gilead Purchase Price;

 

(ii) Gilead shall deliver, and/or cause one or more of its Affiliates to deliver, to Emory payment by wire transfer of immediately available funds to the account set forth on Exhibit B, $15,000,000 pursuant to a letter agreement between Gilead and Emory dated July 18, 2005; and

 

(iii) All payments by any Affiliate of Gilead to Emory pursuant to this Section 2.2(a) shall be made from a jurisdiction for which no withholding tax is applicable to such payment, taking into account all applicable tax laws and regulations.

 

(b) Payment of the Royalty Pharma Purchase Price. Royalty Pharma shall deliver to Emory payment, by wire transfer of immediately available funds to the account set forth on Exhibit B, of the Royalty Pharma Purchase Price pursuant to the terms of this Section 2.2(b) and Section 2.2 of the Conveyance Agreement.

 

Section 2.3 Conditions to the Obligations of Royalty Pharma. In addition to the conditions set forth in Section 2.1, the obligation of Royalty Pharma to consummate the Closing is subject to (i) Royalty Pharma’s receipt, on or before the Closing Date, of a certificate of an authorized officer of each of Gilead and Emory, respectively, to the effect that all representations and warranties of Gilead and Emory, respectively, contained in Article III shall be true and correct in all material respects as of the Closing Date and (ii) satisfaction of the conditions to Closing contained in Section 2.3(b) and (e) of the Conveyance Agreement.

 

Section 2.4 Conditions to Obligations of Emory. In addition to the conditions set forth in Section 2.1, the obligation of Emory to consummate the Closing is subject to (i) Emory’s receipt, on the Closing Date, of a certificate of an authorized officer of each of Gilead and Royalty Pharma, respectively, to the effect that all representations and warranties of Gilead and Royalty Pharma, respectively, contained in Article III shall be true and correct in all material respects as of the Closing Date and (ii) satisfaction of the conditions to Closing set forth Section 2.4(b) of the Conveyance Agreement.

 

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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


Section 2.5 Conditions to Obligations of Gilead. In addition to the conditions set forth in Section 2.1, the obligation of Gilead to consummate the Closing is subject to the receipt by Gilead on or before the Closing Date of a certificate of an authorized officer of each of Royalty Pharma and Emory, respectively, to the effect that all representations and warranties of Royalty Pharma and Emory, respectively, contained in Article III shall be true and correct in all material respects of the Closing Date.

 

ARTICLE III

 

REPRESENTATIONS, WARRANTIES AND COVENANTS

 

Section 3.1 Gilead Representations and Warranties. To Gilead’s Knowledge, except as disclosed in a letter from Gilead to Royalty Pharma dated as of the date hereof (a copy of which is annexed hereto as Annex A), Gilead represents, warrants and covenants to Royalty Pharma as of the Closing Date as follows:

 

(a) There have been no written agreements, amendments or modifications between Gilead and Emory with respect to the subject matter of the Existing License Agreement that are not reflected in the Existing License Agreement.

 

(b) All payments required to be made by Gilead under the Existing License Agreement have been made in full. Gilead has not deducted or withheld any amount from any payment of amounts made by Gilead to Emory under the Existing License Agreement, including any deduction or withholding for or on account of any tax, levy, impost, duty, assessment or fiscal or governmental charge, that Emory has disputed as having been wrongfully deducted or withheld. Gilead has paid to Emory the full amounts specified as payable by Gilead to Emory in the quarterly reports required to be furnished by Gilead to Emory pursuant to Section 4.1 of the Existing License Agreement.

 

(c) Gilead has not granted any written waiver under the Existing License Agreement and has not, in writing, released Emory, in whole or in part, from any of its obligations under the Existing License Agreement, nor has Emory or Gilead granted any waiver under the Existing License Agreement, after the date Gilead acquired Triangle Pharmaceuticals, Inc., that would reasonably be expected to affect any payments or activities under the Amended and Restated License Agreement after the date hereof.

 

(d) Gilead has not (i) given Emory any written notice of termination pursuant to Sections 11.5 and 11.6 of the Existing License Agreement, or (ii) received from Emory any written notice of termination pursuant to Sections 11.2 and 11.3 of the Existing License Agreement.

 

(e) Gilead has not made any adjustments, modifications, offsets, credits, reductions, deductions or escrows to the payments which are required to be made by Gilead under the Existing License Agreement. No such adjustments, modifications, offsets, credits, reductions, deductions or escrows have been disputed by Emory.

 

(f) Gilead has not received written notice that Emory has exercised any remedy specified in Section 6.2(b) of the Existing License Agreement.

 

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(g) Emory has not notified Gilead of any claim of indemnification pursuant to Section 9.5(a) or 9.7 of the Existing License Agreement. Gilead has not sent to Emory any written notice pursuant to Section 9.7(a) of the Existing License Agreement of any claim for which indemnification may be provided pursuant to Section 9.5(a) of the Existing License Agreement. Gilead has not sent to Emory any written notice pursuant to Section 9.7(b) of the Existing License Agreement of any claim for indemnification by Emory pursuant to Section 9.5(b) of the Existing License Agreement.

 

(h) Gilead has not terminated its obligations pursuant to Section 7.1 of the Existing License Agreement. Gilead has not failed to timely pursue any of its Patent Prosecution Activities (as such term is defined in the Existing License Agreement).

 

The term “Gilead’s Knowledge” shall mean the actual knowledge of [ * ].

 

Section 3.2 Additional Gilead Representations and Warranties. Gilead represents and warrants that:

 

(a) This Agreement is and the Amended and Restated License Agreement, when entered into by the Parties, will be the valid and binding obligation of Gilead, enforceable against Gilead in accordance with its terms, except as may be limited by applicable bankruptcy, insolvency, moratorium, reorganization and other similar laws of general applicability relating to or affecting creditors’ rights or by general principles of equity (whether considered in a proceeding in equity or at law).

 

(b) Each of this Agreement and the Amended and Restated License Agreement has been duly authorized by all necessary action on the part of Gilead. This Agreement has been validly executed and delivered by Gilead.

 

(c) The Existing License Agreement has not been satisfied, amended, modified, discharged, canceled, subordinated or rescinded, in whole or in part (other than by (i) the performance of the obligations thereunder in accordance with its terms or (ii) the Amended and Restated License Agreement that shall become effective upon the Closing).

 

(d) Other than Lazard Ltd. (whose fees and expenses shall be paid by Gilead), there is no investment banker, broker, finder, financial advisor or other intermediary who has been retained by or is authorized to act on behalf of Gilead who might be entitled to any fee or commission in connection with the transactions contemplated by this Agreement and the Amended and Restated License Agreement.

 

Section 3.3 Emory Representations and Warranties. Emory represents and warrants that:

 

(a) This Agreement is and the Amended and Restated License Agreement, when entered into by the Parties, will be the valid and binding obligation of Emory, enforceable against Emory in accordance with its terms, except as may be limited by applicable bankruptcy,

 

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insolvency, moratorium, reorganization and other similar laws of general applicability relating to or affecting creditors’ rights or by general principles of equity (whether considered in a proceeding in equity or at law).

 

(b) Each of this Agreement and the Amended and Restated License Agreement has been duly authorized by all necessary action on the part of Emory. This Agreement has been validly executed and delivered by Emory.

 

(c) The Existing License Agreement has not been satisfied, amended, modified, discharged, canceled, subordinated or rescinded, in whole or in part (other than by (i) the performance of the obligations thereunder in accordance with its terms or (ii) the Amended and Restated License Agreement that shall become effective upon the Closing).

 

(d) There is no investment banker, broker, finder, financial advisor or other intermediary who has been retained by or is authorized to act on behalf of Emory who might be entitled to any fee or commission in connection with the transactions contemplated by this Agreement, other than Citigroup Global Markets Inc., whose fees and expenses shall be paid by Emory.

 

Section 3.4 Royalty Pharma Representations and Warranties. Royalty Pharma represents and warrants that:

 

(a) This Agreement and the Amended and Restated License Agreement, when entered into by the Parties, will be the valid and binding obligation of Royalty Pharma, enforceable against Royalty Pharma in accordance with its terms, except as may be limited by applicable bankruptcy, insolvency, moratorium, reorganization and other similar laws of general applicability relating to or affecting creditors’ rights or by general principles of equity (whether considered in a proceeding in equity or at law).

 

(b) Each of this Agreement and the Amended and Restated License Agreement is duly authorized by all necessary action on the part of Royalty Pharma. This Agreement has been validly executed and delivered by Royalty Pharma.

 

(c) There is no investment banker, broker, finder, financial advisor or other intermediary who has been retained by or is authorized to act on behalf of Royalty Pharma who might be entitled to any fee or commission in connection with the transactions contemplated by this Agreement.

 

Section 3.5 License Agreement. Each of the parties hereto agrees that, effective immediately upon the occurrence of the Closing, the Existing License Agreement shall be amended and restated in the form attached hereto as Exhibit A and the Amended and Restated License Agreement shall be effective and in full force and effect and shall constitute the valid and binding obligation of each such party. Emory and Gilead shall be released from all of their respective duties, obligations, covenants and other liabilities to one another under the Existing License Agreement, whether presently known or unknown, none of which shall survive amending and restating except as set forth in the Amended and Restated License Agreement. Emory and Gilead further acknowledge and agree that Royalty Pharma is not assuming any of

 

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Emory’s or Gilead’s duties, obligations or covenants under the Existing License Agreement, except as expressly set forth in the Amended and Restated License Agreement.

 

Section 3.6 Excluded Obligations. Gilead agrees that it (and not Royalty Pharma) is and shall remain liable for any payment of any reimbursements, remuneration, fees, indemnification, damages, awards, settlement payments, milestone payments or any other payments, compensation or consideration of any kind pursuant to Sections 2.7, 3.1 through 3.3, 6.2, 7.1, 8.2, 9.5(a) and 9.6 of the Existing License Agreement and Sections 2(h) and 2(n) of the First Amendment (the “Excluded Obligations”) outstanding under the Existing License Agreement and that it shall pay directly to Emory or GSK, as applicable, such Excluded Obligations.

 

ARTICLE IV

 

CONFIDENTIALITY

 

Section 4.1 Termination of Confidentiality Agreements. Effective upon the Closing, the Confidentiality Agreement dated May 4, 2005, between RP Management, LLC and Citigroup Global Markets Inc. on behalf of Emory and the Confidentiality Agreement dated May 5, 2005, between Gilead and Citigroup Global Markets Inc. on behalf of Emory shall both terminate and be of no further force or effect.

 

Section 4.2 Public Announcements. Except for a press release substantially in the form attached hereto as Exhibit C, none of the Parties shall, and each Party shall cause its affiliates not to, issue a press release or other public announcement or otherwise make any public disclosure with respect to this Agreement, the Amended and Restated License Agreement or the Conveyance Agreement or the subject matter hereof or thereof without the prior consent of the other Parties (which consent shall not be unreasonably withheld or delayed), except as may be required by applicable law or regulation (in which case the Party required to make the release or statement shall allow the other Parties reasonable time to comment on such release or statement in advance of such issuance).

 

ARTICLE V

 

TERMINATION

 

Section 5.1 Grounds for Termination. This Agreement may be terminated at any time prior to the Closing:

 

(a) by mutual written agreement of Gilead, Emory and Royalty Pharma; or

 

(b) by notice in writing from Emory to the other Parties at or after 5:00 pm (New York time) on July 22, 2005 unless, by that time, Royalty Pharma has deposited or caused to be deposited by wire transfer of immediately available funds into the account of Emory set forth on Exhibit B the sum of [ * ] (the “Deposit”), in which case this Agreement may be terminated by notice in writing from Emory to the other Parties at or after 5:00 pm (New York time) on July 29, 2005, unless, in the case of either time, the Closing shall not have been consummated due to non-satisfaction on the part of Emory of a condition set forth in this Agreement that has not been waived; or

 

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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


(c) after 5:00 p.m. (New York City time) on July 29, 2005, by any Party by notice in writing to the other Parties, if the Closing shall not have been consummated prior to 5:00 p.m. (New York City time) on July 29, 2005; provided that no Party shall have the right to terminate this Agreement pursuant to this Section 5.1(c) if such Party has willfully failed to fulfill a condition to the consummation of Closing relating to such Party.

 

Section 5.2 Effect of Termination. If this Agreement is terminated as permitted by Section 5.1, such termination shall be without liability of any Party (or any Affiliate of such Party) to any other Party to this Agreement; provided, that if such termination shall result from the willful failure of a Party to fulfill a condition to the consummation of the Closing that relates to such Party in this Agreement or the Conveyance Agreement, such Party shall be fully liable for any and all loss, liability, damage or expense incurred or suffered by the other Parties as a result of such failure or breach.

 

Section 5.3 Deposit. Once the Deposit is made by Royalty Pharma, all rights to such Deposit (and any interest thereon) shall belong to Emory and Emory shall have no obligation to return the Deposit (or any portion thereof) to Royalty Pharma or any other Party; provided, however, that [ * ] of such Deposit (i) may be applied in the circumstances and the manner described in Section 1.3 of the Conveyance Agreement and (ii) shall be returned by Emory to Royalty Pharma, if, but only if, the Closing shall not have been consummated by 5:00 p.m. (New York City time) on July 29, 2005 as a result of the willful failure by Emory to fulfill a condition to Closing that relates to Emory.

 

ARTICLE VI

 

MISCELLANEOUS

 

Section 6.1 Certain Interpretations. Except where expressly stated otherwise in this Agreement, the following rules of interpretation apply to this Agreement:

 

(a) “include”, “includes” and “including” are not limiting;

 

(b) “hereof”, “hereto”, “herein” and “hereunder” and words of similar import when used in this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement;

 

(c) references to a person or entity are also to its permitted successors and assigns;

 

(d) references to an “Article”, “Section” or “Exhibit” refer to an Article or Section of, or an Exhibit or Schedule to, this Agreement;

 

(e) references to “$” or otherwise to dollar amounts refer to the lawful currency of the United States;

 

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(f) references to a law include any amendment or modification to such law and any rules and regulations issued thereunder, whether such amendment or modification is made, or issuance of such rules and regulations occurs, before or after the date of this Agreement;

 

Section 6.2 No Personal Liability. It is expressly understood and agreed by Gilead, Royalty Pharma and Emory that:

 

(a) each of the representations, warranties, covenants and agreements made in this Agreement, the Conveyance Agreement and the Amended and Restated License Agreement on the part of Emory is made by Emory and is not intended to be a personal representation, warranty, covenant or agreement of any other Person, including those Persons named in the definition of “Knowledge of Assignor” (in the Conveyance Agreement) and any other Representative (as such term is defined in the Conveyance Agreement) of Emory or Emory’s Affiliates (as such term is defined in the Conveyance Agreement);

 

(b) other than Emory, no Person, including those Persons named in the definition of “Knowledge of Assignor” (in the Conveyance Agreement) and any other Representative of Emory or Emory’s Affiliates, shall have any liability whatsoever for breach of any representation, warranty, covenant or agreement herein made on the part of Emory or in respect of any claim or matter arising out of, relating to, or in connection with, this Agreement, the Conveyance Agreement and the Amended and Restated License Agreement and the transactions contemplated hereby and thereby;

 

(c) each of the representations, warranties, covenants and agreements herein made on the part of Royalty Pharma is made by Royalty Pharma and is not intended to be a personal representation, warranty, covenant or agreement of any other Person, including any Representative of Royalty Pharma or Royalty Pharma’s Affiliates;

 

(d) other than Royalty Pharma, no Person, including any other Representative of Royalty Pharma or Royalty Pharma’s Affiliates, shall have any liability whatsoever for breach of any representation, warranty, covenant or agreement herein made on the part of Royalty Pharma or in respect of any claim or matter arising out of, relating to, or in connection with, this Agreement and the transactions contemplated hereby;

 

(e) each of the representations, warranties, covenants and agreements made in this Agreement and the Amended and Restated License Agreement on the part of Gilead is made by Gilead and is not intended to be a personal representation, warranty, covenant or agreement of any other Person, including those Persons named in the definition of “Gilead’s Knowledge” and any other Representative of Gilead or Gilead’s Affiliates; and

 

(f) other than Gilead, no Person, including those Persons named in the definition of “Gilead’s Knowledge” and any other Representative of Gilead or Gilead’s Affiliates, shall have any liability whatsoever for breach of any representation, warranty, covenant or agreement herein made on the part of Gilead or in respect of any claim or matter arising out of, relating to, or in connection with, this Agreement and the Amended and Restated License Agreement and the transactions contemplated hereby and thereby.

 

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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


Section 6.3 Headings. The descriptive headings of the several Articles and Sections of this Agreement and the Exhibits are for convenience only, do not constitute a part of this Agreement and shall not control or affect, in any way, the meaning or interpretation of this Agreement.

 

Section 6.4 Notices. All notices and other communications under this Agreement shall be in writing and shall be by facsimile, courier services or personal delivery to the following addresses, or to such other addresses as shall be designated from time to time by a Party in accordance with this Section 6.4:

 

If to:


  

Address:


  

With a copy to:


Emory   

Emory University

Administrative Building, Suite 409

1380 Oxford Road

Atlanta, GA 30322

Facsimile: (404) 727-5592

Attention: Executive Vice President for

Finance and Administration

  

Office of the General Counsel

Emory University

Administrative Building, Suite 409

1380 Oxford Road

Atlanta, GA 30322

Facsimile: (404) 727-6098

Attention: General Counsel

          And
         

Office of Technology Transfer

Emory University

1784 North Decatur Road, Suite 130

Atlanta, GA 30322

Facsimile: (404) 727-1271

Attention: Director

Gilead   

Gilead Sciences, Inc.

333 Lakeside Drive

Foster City, CA 94404

Facsimile: (650) 522-5488

Attention: Executive Vice President and

Chief Financial Officer

  

Gilead Sciences, Inc.

333 Lakeside Drive

Foster City, CA 94404

Facsimile: (650) 522-5537

Attention: Executive Vice President and General Counsel

          And
         

Arnold & Porter LLP

1600 Tysons Boulevard

Suite 900

McLean, VA 22102

Attention: Steve Parker, Esq.

Telecopy: (703) 720-7006

 

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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


If to:


  

Address:


  

With a copy to:


Royalty Pharma   

Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma

Block D

Iveagh Court

Harcourt Road

Dublin 2, Ireland

Attention: William McManus

Telecopy: (353) 14 75 71 50

  

RP Management, LLC
110 East 59th Street

Suite 3300

New York, NY 10022

Attention: Pablo Legorreta

Telecopy: (212) 883-2260

          And
         

Goodwin Procter LLP

Exchange Place

53 State Street

Boston, MA 02109

Attention: F. George Davitt, Esq.

Telecopy: (617) 523-1231

          And
         

Sidley Austin Brown & Wood LLP

787 Seventh Avenue

New York, NY 10019

Attention: Max Von Hollweg, Esq.

Telecopy: (212) 839-5599

 

All notices and communications under this Agreement shall be deemed to have been duly given (a) when delivered by hand, if personally delivered, (b) when sent, if sent by facsimile, with an acknowledgement of sending being produced by the sending facsimile machine or (c) one Business Day following sending within the United States by overnight delivery via commercial one-day overnight courier service.

 

Section 6.5 Expenses. Except as otherwise provided in Article V of the Conveyance Agreement, all fees, costs and expenses (including any legal, accounting and banking fees) incurred in connection with this Agreement and to consummate the transactions contemplated hereby shall be paid by the Party incurring such fees, costs and expenses. This Section 6.5 shall survive any termination of this Agreement.

 

Section 6.6 Assignment. Neither this Agreement nor any of the rights, interests or obligations hereunder may be assigned, in whole or in part, by operation of law, change of control, or otherwise by any Party without the prior written consent of the other Parties, and any such purported assignment or transfer without such consent shall be void and of no effect; provided, that nothing herein shall prohibit or restrict Royalty Pharma from assigning any of its rights and obligations hereunder to any Affiliate of Royalty Pharma or to any collateral

 

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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


trustee under its applicable financing facility. Subject to the preceding sentence, this Agreement shall be binding upon, inure to the benefit of and be enforceable by, the Parties hereto and their respective permitted successors and assigns.

 

Section 6.7 Amendment and Waiver.

 

(a) This Agreement may be amended, modified or supplemented only in a writing signed by each of the Parties hereto. Any provision of this Agreement may be waived only in a writing, which writing may be signed only by the Party granting such waiver.

 

(b) No failure or delay on the part of any Party in exercising any right, power or remedy hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any such right, power or remedy preclude any other or further exercise thereof or the exercise of any other right, power or remedy. No course of dealing between the Parties shall be effective to amend, modify, supplement or waive any provision of this Agreement.

 

Section 6.8 Entire Agreement. This Agreement, the exhibits annexed hereto, the Amended and Restated License Agreement, the Conveyance Agreement and a letter agreement between Gilead and Emory of even date herewith constitute the entire understanding between the Parties with respect to the subject matter hereof, and supersede all other understandings and negotiations with respect thereto.

 

Section 6.9 No Third Party Beneficiaries. This Agreement is for the sole benefit of Emory, Gilead and Royalty Pharma and their permitted successors and assigns and nothing herein expressed or implied shall give or be construed to give to any person or entity, other than the Parties and such successors and assigns, any legal or equitable rights hereunder.

 

Section 6.10 Governing Law. This Agreement shall be governed by, and construed in accordance with, the substantive law of the State of Georgia, without regard to the laws that might otherwise govern under applicable principles of conflicts of laws thereof.

 

Section 6.11 Arbitration. Except for any action prior to the Closing for specific performance, injunctive or other equitable relief, any controversy, claim or dispute arising out of, relating to, or in connection with, this Agreement or the transactions contemplated hereby shall be resolved through arbitration conducted under the auspices of the American Arbitration Association pursuant to that organization’s rules for commercial arbitration. Any such arbitration proceedings shall be held in Atlanta, Georgia.

 

Section 6.12 Severability. If any term or provision of this Agreement shall for any reason be held to be invalid, illegal or unenforceable in any situation in any jurisdiction, then, to the extent that the economic and legal substance of the transactions contemplated hereby is not affected in a manner that is materially adverse to any Party, all other terms and provisions of this Agreement shall nevertheless remain in full force and effect and the enforceability and validity of the offending term of provision shall not be affected in any other situation or jurisdiction.

 

Section 6.13 Counterparts. This Agreement may be executed in any number of

 

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counterparts and by the Parties hereto in separate counterparts, each of which when so executed shall be deemed to be an original and all of which taken together shall constitute one and the same agreement. Copies of executed counterparts transmitted by telecopy, facsimile or other electronic transmission service shall be considered original executed counterparts, provided receipt of such counterparts is confirmed.

 

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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed and delivered by their respective representatives thereunto duly authorized as of the date first above written.

 

 

GILEAD SCIENCES, INC.

By:

 

/s/ John C. Martin


Name:

 

John C. Martin


Title:

 

President and CEO


EMORY UNIVERSITY

By:

 

/s/ Michael J. Mandl


Name:

 

Michael J. Mandl


Title:

 

Executive Vice President for Finance and Administration


INVESTORS TRUST & CUSTODIAL SERVICES (IRELAND) LIMITED, SOLELY IN ITS CAPACITY AS TRUSTEE OF ROYALTY PHARMA

By:

 

/s/ Paul M. McGuiggan


Name:

 

Paul M. McGuiggan


Title:

 

Director


 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


EXHIBIT A

 

TO THE ROYALTY SALE AGREEMENT

 

AMENDED AND RESTATED LICENSE AGREEMENT

 

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.



 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

AMENDED AND RESTATED

LICENSE AGREEMENT

 

among

 

EMORY UNIVERSITY

 

GILEAD SCIENCES, INC.

 

and

 

INVESTORS TRUST & CUSTODIAL SERVICES (IRELAND) LIMITED,

 

solely in its capacity as Trustee of Royalty Pharma

 



THIS AMENDED AND RESTATED LICENSE AGREEMENT is made and entered into as of this 21st day of July, 2005 (the “Effective Date”), by and among EMORY UNIVERSITY, a Georgia nonprofit corporation with offices at 1380 South Oxford Road, N.E., Atlanta, Georgia 30322 (hereinafter referred to as “LICENSOR”), GILEAD SCIENCES, INC., a for-profit Delaware corporation with principal offices located at 333 Lakeside Drive, Foster City, CA 94404 (hereinafter referred to as “COMPANY”), and INVESTORS TRUST & CUSTODIAL SERVICES (IRELAND) LIMITED, solely in its capacity as Trustee of Royalty Pharma, a unit trust organized under the laws of the Republic of Ireland, with principal offices located at Block D, Iveagh Court, Harcourt Road, Dublin 2, Ireland (hereinafter referred to as “ROYALTY PHARMA”) and amends and restates in its entirety that certain License Agreement, dated April 17, 1996 (“Original Agreement”), between LICENSOR and Triangle Pharmaceuticals, Inc., as amended by the First Amendment to License Agreement, dated May 6, 1999, as further amended by the Second Amendment to License Agreement dated July 10, 2000, as further amended by the Third Amendment to License Agreement dated May 31, 2002, as further amended by the Fourth Amendment to License Agreement dated April 19, 2004 and as further amended by the Fifth Amendment to License Agreement dated July 18, 2005 (the Original Agreement as amended by the First, Second, Third, Fourth and Fifth Amendments is referred to herein as the “Existing Agreement”).

 

WITNESSETH

 

WHEREAS, LICENSOR is the assignee of all right, title, and interest in certain inventions developed by employees of LICENSOR and is responsible for the protection and commercial development of such inventions; and

 

WHEREAS, Woo-Baeg Choi, Dennis C. Liotta and Raymond Schinazi, each a current or former employee of LICENSOR, are named as inventors in the patents and patent applications identified as owned by LICENSOR in Appendix “A” to this Agreement and are hereinafter referred to as the “Inventors”; and

 

WHEREAS, LICENSOR wanted to have such inventions developed, commercialized, and made available for use by the public and thus entered into the Original Agreement; and

 

WHEREAS, LICENSOR and COMPANY, entered into the First, Second, Third, Fourth and Fifth Amendments described in the preamble hereto;

 

WHEREAS, Triangle Pharmaceuticals, Inc., an Affiliate of COMPANY, assigned the Existing Agreement to COMPANY, and COMPANY accepted such assignment, pursuant to Article 12 of the Original Agreement, as of June 30, 2003; and

 

WHEREAS, ROYALTY PHARMA and COMPANY together desire to purchase from LICENSOR, and LICENSOR desires to sell to them all royalties payable by COMPANY under the Existing Agreement, and the parties hereto are, as of this date, entering into a Royalty Sale Agreement (“Royalty Sale Agreement”) and Agreement for the Conveyance of Royalties (“Conveyance Agreement”) to effect such transaction; and

 

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WHEREAS, to facilitate the purchase of the royalties, LICENSOR, COMPANY and ROYALTY PHARMA wish, as contemplated by the Conveyance Agreement and the Royalty Sale Agreement, to enter into this Agreement, which constitutes an amendment and restatement of the Existing Agreement, in order to, among other things, reduce the royalties payable by the COMPANY to LICENSOR upon sale of Licensed Products by 65%; add ROYALTY PHARMA as a party to this AGREEMENT; provide payment by the COMPANY of the remaining 35% of royalties payable directly to ROYALTY PHARMA rather than to LICENSOR in accordance with the terms of this Agreement; incorporate the five amendments to the Original Agreement; and effect certain other amendments as provided herein.

 

NOW, THEREFORE, for and in consideration of the mutual covenants and the premises herein contained, the parties, intending to be legally bound, hereby agree as follows.

 

ARTICLE 1.

DEFINITIONS

 

The following terms as used herein shall have the following meaning:

 

1.1 “Affiliate” shall mean any corporation or non-corporate business entity which controls, is controlled by, or is under common control with a party to this Agreement. A corporation or non-corporate business entity shall be regarded as in control of another corporation if it owns, or directly or indirectly controls, at least [ * ] of the voting stock of the other corporation, or (a) in the absence of the ownership of at least [ * ] of the voting stock of a corporation or (b) in the case of a non-corporate business entity, or non-profit corporation, if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of such corporation or non-corporate business entity, as applicable. For the avoidance of doubt, Affiliates of ROYALTY PHARMA shall include those entities identified in a letter dated July 18, 2005, from ROYALTY PHARMA to COMPANY and LICENSOR delivered on July 18, 2005.

 

1.2 “Agreement” shall mean this Amended and Restated License Agreement, including all Exhibits and Appendices attached to this Agreement.

 

1.3 “Dollars” shall mean United States dollars.

 

1.4 “FDA” shall mean the United States Food and Drug Administration or successor entity.

 

1.5 “Field of Use” shall mean the prevention and treatment of human immunodeficiency virus (HIV) and hepatitis B virus (HBV).

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.6 “Fully Absorbed Costs” shall mean an amount equal to COMPANY’s costs directly allocated to the production of Licensed Products distributed under a Treatment IND or through an expanded access program or the Global Access Program, consisting of: (i) direct labor, including all resources utilized in support of COMPANY’s manufacturing operations; (ii) materials; (iii) a reasonable allocation of overhead, facilities expense (including depreciation over the expected life of the buildings and equipment), and administrative costs directly in support of COMPANY’s manufacturing operations and such Treatment IND distribution program, expanded access program or the Global Access Program, if applicable, calculated by COMPANY in accordance with reasonable cost accounting methods consistent with the way COMPANY allocates such costs to other products; and (iv) third-party costs.

 

1.7 “Global Access Program” shall mean a program through which COMPANY provides Licensed Products to government agencies, not-for-profit non-governmental organizations, physicians, pharmacies or patients in identified countries at reduced costs. The countries are identified on Appendix C hereto, which Exhibit may be amended from time to time by the Parties.

 

1.8 “GSK/Shire Agreement” shall mean the Settlement And Exclusive License Agreement between LICENSOR and SmithKline-Beecham Corp. d/b/a GlaxoSmithKline, Glaxo Group Limited, GlaxoSmithKline, Inc., Shire Pharmaceuticals Group PLC and Shire Biochem, Inc. dated May 31, 2002.

 

1.9 “GW” shall mean GlaxoWellcome plc and its Affiliates including, but not limited to, all corporate entities acquired, directly or indirectly, by GlaxoWellcome plc and its Affiliates as a result of the acquisition of Wellcome plc and its Affiliates.

 

1.10 “GW Agreements” shall mean the GW License Agreement and the Settlement Agreement.

 

1.11 “GW Know How” shall mean the data package, regulatory filings and any other know-how, information or technology to which LICENSOR acquires any right, title, license or other interest under the GW Agreements.

 

1.12 “GW License Agreement” shall mean the Exclusive License Agreement by and among Glaxo Group Limited, The Wellcome Foundation Limited, Glaxo Wellcome, Inc. (collectively “GW”), LICENSOR and COMPANY, dated as of May 6, 1999, pursuant to which GW has, among other things, granted LICENSOR certain rights under patents and patent applications relating to FTC.

 

1.13 “GW Patents” shall mean the patents and patent applications under which LICENSOR has an exclusive license or a covenant not to sue under the GW Agreements. For purposes of this definition, patents and patent applications shall include any and all substitutions, extensions, divisionals, continuations, continuations-in-part, renewals, supplementary protection certificates or foreign counterparts of such patent applications and patents which issue thereon, including reexamined and reissued patents.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.14 “IND” shall mean an Investigational New Drug application or its domestic or foreign equivalent.

 

1.15 “Indemnitees” shall mean (a) in the case of the indemnity set forth in Subsection 8.5(a), and for purposes of Section 8.6, the Inventors, LICENSOR, and their trustees, directors, employees and students and all of their heirs, executors, administrators, successors and legal representatives, ROYALTY PHARMA, its Affiliates, their directors, trustees, officers, employees and all of their heirs, successors, executors, administrators and legal representatives; and (b) in the case of the indemnity set forth in Subsection 8.5(b), COMPANY, its Affiliates, sublicensees, their directors, officers, employees, ROYALTY PHARMA, its Affiliates, their directors, trustees, officers, employees and all of their heirs, successors, executors, administrators and legal representatives.

 

1.16 “Inventors” shall mean Woo-Baeg Choi, Dennis C. Liotta and Raymond Schinazi.

 

1.17 “Licensed Compound” or “FTC” shall mean: (a) the (-) enantiomer with the chemical name (2R-cis)-4-amino-5-fluoro-1-{2-(hydroxymethyl)-1,3-oxathiolan-5-yl}-2(1H)-pyrimidinone; (b) any mixture of the (-) enantiomer described in clause (a) and the (+) enantiomer with the chemical name (2S-cis)-4-amino-5-fluoro-1-{2-(hydroxymethyl)-1,3-oxathiolan-5-yl}-2(1H)-pyrimidinone, [ * ]; (c) any salts, esters (including, but not limited to, all [ * ]) and N alkylated derivatives of any of the foregoing; or (d) any and all polymorphs, hydrates and solvates of any of the foregoing. “Licensed Compounds” shall mean all of the foregoing.

 

1.18 “Licensed Patents” shall mean (a) the patents and patent applications identified in Appendix “A,” together with any and all substitutions, extensions, divisionals, continuations, continuations-in-part, renewals, supplementary protection certificates or foreign counterparts of such patent applications and patents which issue thereon, anywhere in the world, including reexamined and reissued patents; (b) all of the patents and patent applications included within “Shire FTC-Only Patents” and the “Shire FTC-Plus Patents,” as defined in Sections 1.15 and 1.16 respectively of the GSK/Shire Agreement; and (c) all other patents and patent applications in which or to which LICENSOR has acquired or acquires rights during the term hereof which contain claims covering the manufacture, use or sale of any Licensed Product to the extent that LICENSOR possesses the right to license such patents and patent applications to COMPANY for commercial purposes without incurring financial or other non-contingent, material obligations to any third parties.

 

1.19 “Licensed Product(s)” shall mean any Licensed Compound or any pharmaceutical product containing one or more Licensed Compounds as active ingredients, alone or in combination with other active ingredients, the manufacture, use, importation, offer for sale or sale of which would, but for the license granted herein, infringe any Valid Claim or which is made using Licensed Technology.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.20 “Licensed Technology” shall mean all technical information and data, whether or not patented, known or learned, invented, or developed by the Inventors or any employees of LICENSOR working under the Inventors’ direct or indirect supervision, prior to or during the term hereof and while they are under a duty to assign intellectual property rights to the LICENSOR, to the extent that (a) such technical information and data are useful for the manufacture, use, importation, offer for sale or sale of any Licensed Product; and (b) LICENSOR possesses the right to license the use of such information to COMPANY for commercial purposes without incurring financial or other non-contingent, material obligations to any third parties and without breaching any obligations of confidentiality with such parties. The GW Know How shall be deemed to constitute “Licensed Technology.”

 

1.21 “Licensed Territory” shall mean the world.

 

1.22 “LICENSOR” shall mean Emory University.

 

1.23 “Major Market Country” shall mean Japan, Germany, France, the United Kingdom or the United States of America.

 

1.24 “NDA” shall mean a New Drug Application or its domestic or foreign equivalent.

 

1.25 “Net Selling Price” of a product (including a Licensed Product) shall mean, with respect to a particular fiscal quarter, the gross invoice price (i.e. the total invoiced price therefore prior to any deductions made pursuant to clauses (i) through (iv)) paid by a purchaser of such product (including Distributors), to COMPANY, an Affiliate or sublicensee of COMPANY and their sublicensees or any other party authorized by COMPANY to sell that product (which shall not include Distributors) (collectively the “Sellers”), plus, if applicable, the value of all properties and services received in consideration of a Sale of such product, less only:

 

(i) discounts, including cash and quantity discounts, charge-back payments and rebates granted to managed health care organizations or to federal, state and local governments, their agencies, purchasers and reimbursers or to trade customers;

 

(ii) credits or allowances actually granted upon claims, damaged goods, rejections or returns of such Licensed Products, including recalls;

 

(iii) freight, postage, shipping, transportation and insurance charges actually allowed or paid for delivery of Licensed Products to the extent billed; and

 

(iv) taxes (other than income taxes), duties or other governmental charges levied on, absorbed or otherwise imposed on sale of such Licensed Products, including without limitation value-added taxes, or other governmental charges otherwise measured by the billing, when included in the billing, as adjusted for rebates and refunds.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(a) Notwithstanding the foregoing in this Section 1.25, amounts received by COMPANY, its Affiliates or sublicensees for the sale of Licensed Products among COMPANY, its Affiliates and sublicensees for resale shall not be included in the computation of Net Selling Price hereunder.

 

(b) For purposes of this Section 1.25, “Distributor” shall mean any third party (i) to which a Seller has granted (at any time during the term) a right to sell or distribute a Licensed Product, (ii) that sells Licensed Products to hospitals and/or pharmacies for their sale to or use with patients (rather than to other third parties for resale to hospitals and/or pharmacies for their sale to or use with patients), and (iii) that does not make payments to COMPANY or such COMPANY Affiliate that are calculated on the basis of a percentage of, or profit share on, such third party’s sales of Licensed Products. For purposes of calculating Net Selling Price, no Distributor shall be deemed to be a sublicensee of COMPANY or its Affiliates. Net Selling Price for the quantities of License Product sold by Distributors shall be calculated based on the amount invoiced the Distributors by COMPANY and/or its Affiliates and/or sublicensees of Affiliates and COMPANY rather than by the Distributors to their customers.

 

(c) Where Licensed Product is sold in the form of a combination product containing one or more active ingredients in addition to a Licensed Compound (“Combination Product”), Net Selling Price for such Combination Product for purposes of determining royalties payable under this Agreement will be calculated by multiplying the actual Net Selling Price of such Combination Product by the fraction A/(A+B) where A is the Net Selling Price for the stock keeping unit most comparable in formulation and dosing to that used for the Combination Product of the Licensed Product containing the relevant Licensed Compound as the sole active ingredient, if sold separately, in such country during the relevant fiscal quarter, and B is the Net Selling Price for the stock keeping unit, most comparable in formulation and dosing to that used for the Combination Product, of any other active ingredient, if sold separately, in such country during the relevant fiscal quarter. For clarity, if there are three or more active ingredients (including the Licensed Compound), additional B terms calculated in the same manner, shall be included in the denominator so that such fraction shall be A/(A+Bl+B2+...). If, on a country-by-country basis, one or more of the other active ingredients in the Combination Product are not sold separately in said country, Net Selling Price for the purpose of determining royalties payable under this Agreement for the Combination Product shall be calculated by multiplying the actual Net Selling Price of such Combination Product by the fraction A/C where A is the Net Selling Price for the stock keeping unit most comparable in formulation and dosing to that used for the Combination Product of the Licensed Product containing the relevant Licensed Compound as the sole active ingredient, if sold separately, in such country during the relevant fiscal quarter and C is the Net Selling Price for the Combination Product in such country during the relevant fiscal quarter. If, on a country-by-country basis, the Licensed Product containing a Licensed Compound as the sole active ingredient is not sold separately in

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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said country during the relevant fiscal quarter but one or more of the other active ingredients in the Combination Product are sold separately in said country during the relevant fiscal quarter, the Net Selling Price for the Combination Product shall be calculated by multiplying the actual Net Selling Price of such Combination Product by the fraction (1-(D/C)) where D is the Net Selling Price for the stock keeping unit most comparable in formulation and dosing to that used for the Combination Product of the product containing the other active ingredient as the sole active ingredient and C is the Net Selling Price for the Combination Product in such country during the relevant fiscal quarter. If, on a country-by-country basis, the Licensed Product containing a Licensed Compound as the sole active ingredient is not sold separately and one or more of the other active ingredients in the Combination Product are not sold separately in such country during the relevant fiscal quarter Net Selling Price for the purposes of determining royalties of the Combination Product shall be deemed to be the Net Selling Price of such Combination Product multiplied by a fraction, the numerator of which is the number of Licensed Compounds in such Combination Product and the denominator of which is the number of all active ingredients in such Combination Product.

 

1.26 “Other Change” shall mean (i) an amendment, supplement or modification (other than a written amendment) to an agreement that might reasonably be expected to have an adverse effect on LICENSOR’s or ROYALTY PHARMA’s rights or obligations under this Agreement, or (ii) a waiver of a term of an agreement that might reasonably be expected to have an adverse effect on LICENSOR’s or ROYALTY PHARMA’s rights or obligations under this Agreement.

 

1.27 “Registration” shall mean, in relation to any Licensed Product, such approvals by the regulatory authorities in a given country (including pricing approvals) as may be legally required before such Licensed Product may be commercialized or Sold in such country.

 

1.28 “Royalty Pharma Indemnitees” shall mean ROYALTY PHARMA and all its Affiliates and their respective trustees, directors, employees, investors, partners (limited or otherwise), members and other equity and interest holders.

 

1.29 “Sale” or “Sold” shall mean the sale, transfer, exchange or other disposition of Licensed Products whether by gift or otherwise, subsequent to Registration in a given country (if such Registration is required) by a Seller to make such sale, transfer, exchange or disposition, to any party that is not a Seller. Sales of Licensed Products shall be deemed consummated upon the first to occur of: (a) receipt of payment from the purchase; (b) delivery of Licensed Products to the purchaser or a common carrier; (c) release of Licensed Products from consignment; or (d) if otherwise transferred, exchanged or disposed of, whether by gift or otherwise, when such transfer, exchange, gift or other disposition occurs. Notwithstanding the foregoing definition of Sale, to the extent COMPANY distributes any Licensed Product under a Treatment IND or through an expanded access program or the Global Access Program, only to the extent that the actual Net Selling Price exceeds Fully Absorbed Costs therefor will such distribution be considered a Sale. If the actual Net Selling Price exceeds the Fully

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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