Document:

Exhibit 10.7

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

AMENDED AND RESTATED LICENSE AGREEMENT

 

THIS AMENDED AND RESTATED LICENSE AGREEMENT (this “Agreement”) is effective as of August 6, 2010 (the “Effective Date”), by and between Acceleron Pharma Inc., a corporation organized under the laws of Delaware with a principal place of business at 128 Sidney St., Cambridge, Massachusetts 02139, United States (“Licensee”) and Ludwig Institute for Cancer Research Ltd, a Swiss not for profit corporation with its registered office at Stadelhoferstrasse 22, Zurich 8001, Switzerland and having an office at 605 Third Avenue, New York, NY 10158, United States (“Licensor”).

 

WHEREAS, Licensor has been engaged in research in the field of Activin Receptor-Like Kinases;

 

WHEREAS, that research led to the patents, patent applications and other inventions listed in Exhibit A, which are owned solely by Licensor or jointly by Licensor and Licensee;

 

WHEREAS, Licensee and Licensor are parties to that certain License Agreement, effective as of August 30, 2006 and as amended March 21, 2007 (collectively, the “Prior Agreements”), and desire to amend and restate the Prior Agreements in their entirety and to accept the rights created pursuant to this Agreement in lieu of the rights granted to them under the Prior Agreements.

 

NOW, THEREFORE, the Licensee and Licensor hereby agree that the Prior Agreements shall be amended and restated, and further agree as follows:

 

ARTICLE 1

 

DEFINITIONS

 

1.1.                            “Affiliate” means any corporation, limited liability company or other legal entity which directly or indirectly controls, is controlled by, or is under common control with Licensee or its successors or assigns, or any successor or assign of such an entity.  For the purpose of this Agreement, “control” shall mean the direct or indirect

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

ownership of at least fifty-one percent (51%) of the outstanding shares on a fully diluted basis or other voting rights of the subject entity to elect directors, or if not meeting the preceding, any entity owned or controlled by or owning or controlling at the maximum control or ownership right permitted in the country where such entity exists.

 

1.2.                            “Agreement” has the meaning set forth in the preamble.

 

1.3.                            “ALK-1 Receptor Product” means any product which is comprised at least in part of an extracellular domain of an ALK-1 receptor, as exemplified by amino acids 1-118 of the human ALK-1 sequence presented in U.S. Patent No. 6,316,217, or an active portion thereof.

 

1.4.                            “ALK-1 Antibody Product” means any product which is comprised at least in part of an antibody or a domain of an antibody that binds to an ALK-1 receptor.

 

1.5.                            “ALK-2 Receptor Product” means any product which is comprised at least in part of an extracellular domain of an ALK-2 receptor, as exemplified by amino acids 1-124 of the human ALK-2 sequence presented in U.S. Patent No. 6,316,217, or an active portion thereof.

 

1.6.                            “ALK-3 Receptor Product” means any product which is comprised at least in part of an extracellular domain of an ALK-3 receptor, as exemplified by amino acids 1-152 of the human ALK-3 sequence presented in U.S. Patent No. 6,316,217, or an active portion thereof.

 

1.7.                            “ALK-3 Antibody Product” means any product which is comprised at least in part of an antibody or a domain of an antibody that binds to an ALK-3 receptor;

 

1.8.                            “ALK-4 Receptor Product” means any product which is comprised at least in part of an extracellular domain of an ALK-4 receptor, as exemplified by amino acids 1-126 of the human ALK-4 sequence presented in U.S. Patent No. 6,316,217, or an active portion thereof.

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1.9.                            “ALK-4 Antibody Product” means any product which is comprised at least in part of an antibody or a domain of an antibody that binds to an ALK-4 receptor.

 

1.10.                     “ALK-5 Receptor Product” means any product which is comprised at least in part of an extracellular domain of an ALK-5 receptor, as exemplified by amino acids 1-121 of the human ALK-5 sequence presented in U.S. Patent No. 6,316,217, or an active portion thereof.

 

1.11.                     “ALK-5 Antibody Product” means any product which is comprised at least in part of an antibody or a domain of an antibody that binds to an ALK-5 receptor.

 

1.12.                     “ALK-6 Receptor Product” means any product which is comprised at least in part of an extracellular domain of an ALK-6 receptor, as exemplified by amino acids 1-122 of the murine ALK-6 sequence presented in U.S. Patent No. 6,316,217, or an active portion thereof.

 

1.13.                     “ALK-6 Antibody Product” means any product which is comprised at least in part of an antibody or a domain of an antibody that binds to an ALK-6 receptor.

 

1.14.                     “Approval of NDA” means receipt of marketing authorization by the FDA for a Licensed Product.

 

1.15.                     “Claim” has the meaning set forth in Section 10.1.

 

1.16.                     “Completion of a Phase II Clinical Study” means completion of the Phase II clinical study in which the primary end point of the study has been met according to the pre-determined statistical analysis plan and that enables the initiation of one or several Phase III registrational studies intended to be used for filing an NDA or BLA with the FDA.

 

1.17.                     “Effective Date” has the meaning set forth in the preamble.

 

1.18.                     “Field” means all human therapeutic and diagnostic uses.

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1.19.                     “First Amendment Date” means March 21, 2007.

 

1.20.                     “First Demonstration of In Vivo Efficacy of a Licensed Product” means first results indicating that a Licensed Product has the desired effect in an animal model of human disease.

 

1.21.                     “Initiation of Phase I/Phase II Clinical Study” means dosing the first patient in the first Phase I or Phase II clinical study, as applicable.

 

1.22.                     “Investigational New Drug Application (“IND”)” means an Investigational New Drug Application, as defined in the United States Food Drug & Cosmetics Act, or similar application or submission that is required to be filed with the FDA before beginning clinical testing of a Licensed Product in human subjects in the United States.

 

1.23.                     “Licensed Patent Rights” means (a) Licensor’s rights under all patents and patent applications listed in Exhibit A attached hereto, as well as all foreign counterpart patents and patent applications (including future foreign counterparts to the patents and patent applications listed in Exhibit A);  (b) any patents which issue on the applications described in (a); (c) all reissues, reexaminations, renewals, extensions, divisionals, continuations, and continuations-in-part of the foregoing patents and patent applications; and (d) any foreign counterparts and any other forms of protection directed to a Licensed Product including the inventions covered by the patents or patent applications listed in Exhibit A.

 

1.24.                     “Licensed Product” means any products the making, selling, using or importing of which is covered by a Valid Claim of a Licensed Patent Right and is (i) an ALK-1 Receptor Product; (ii) an ALK-1 Antibody Product; (iii) an ALK-2 Receptor Product; (iv) an ALK-3 Receptor Product; (v) an ALK-3 Antibody Product; (vi) an ALK-4 Receptor Product; (vii) an ALK-4 Antibody Product (viii) an ALK-5 Receptor Product (ix) an ALK-5 Antibody Product; (x) an ALK-6 Receptor Product; (xi) an ALK-6 Antibody Product; provided, however, that any product that ceases to be a “Licensed

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Product” as a consequence of the expiration of a Valid Claim of a Licensed Patent Right shall continue to be considered a “Licensed Product” for the purposes of any milestone or royalty obligations set forth in Sections 4.2, 4.3 and 4.4, subject to applicable limitations set forth therein.  Each of the eleven categories of Licensed Product set forth in parts (i)- (xi) of this Section may be referred to herein as a “Category” of Licensed Product.  The parties shall reasonably agree on the classification of any Licensed Product into a single Category, as appropriate.  Licensed Products classified in any of parts (iii)-(xi) of this Section may be referred to herein as “Licensed Subsequent Products.”

 

1.25.                     “Licensee” has the meaning set forth in the preamble.

 

1.26.                     “Licensee Confidential Information” means any non-public scientific, technical, trade or business information that is provided to Licensor by Licensee, which is treated by Licensee as confidential or proprietary, whether or not labeled or identified as “Confidential”.

 

1.27.                     “Licensor” has the meaning set forth in the preamble.

 

1.28.                     “Net Revenues” means the combined amount received by Licensee, its Affiliates or its Sublicensees from the sale to unrelated third parties of Licensed Products, less the following items but only insofar as they are actually taken and actually pertain to the disposition of such Licensed Product by Licensee, its Affiliates or its Sublicensees, and are included in such gross revenue:

 

(a)                     Import, export, excise and sales taxes, and custom duties;

(b)                     Costs of insurance, packing, and transportation from the place of manufacture to the customer’s premises or point of installation;

(c)                      Credit for rebates, returns, allowances, or trades.

 

Notwithstanding the foregoing, in the event a Licensed Product is sold in conjunction with another active component so as to be a combination product (whether packaged together or in the same therapeutic formulation), Net Revenues shall be calculated by multiplying the Net Revenues of such combination product by a fraction, the numerator

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

of which shall be the fair market value of the Licensed Product as if sold separately (determined in accordance with generally accepted accounting principles), and the denominator of which shall be the aggregate fair market value of all the active components of such combination product, including the Licensed Product, as if sold separately.  In the event no such separate sales are made by Licensee or its Sublicensees, Net Revenues of the combination product shall be calculated in a manner to be negotiated and agreed upon by Licensor and Licensee, reasonably and in good faith, prior to any sale of such combination product, which shall be based upon the respective estimated commercial values of the active components of such combination product.

 

1.29.                     “New Drug Application (“NDA”)” means a New Drug Application pursuant to 21 U.S.C. Section 505 (b)(1), or a Biological License Application (BLA) pursuant to 21 CFR 601.2 or PLA or similar application for marketing approval of a Licensed Product in the United States.

 

1.30.                     “Original License Date” means August 30, 2006.

 

1.31.                     “Prior Agreements” has the meaning set forth in the recitals.

 

1.32.                     “Royalty Term” has the meaning set forth in Section 4.7.

 

1.33.                     “Sublicensee” means any non-Affiliate third party to whom Licensee has granted the right to research, develop, make, have made, import, have imported, use, have used, sell, have sold, offer for sale, have offered for sale and/or otherwise exploit Licensed Products.

 

1.34.                     “Sublicensed Product” means, with respect to a particular sublicense hereunder, a Licensed Product covered by the grant of rights included in such sublicense, including with respect to the field and scope of such sublicense.

 

1.35.                     “Sublicensing Revenue” means all upfront, license, and technology access fees, product milestone payments received by Licensee and specifically related to

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

any sublicense of the rights granted pursuant to Section 2.1(a) to a third party, except for (i) direct reimbursement of fully burdened research expenditures, patent prosecution costs and other expenditures, (ii) payments based on the level of sales, profits or other levels of commercialization (including, without limitation, Licensee’s royalties on net sales and/or sharing of Sublicensee’s profits with Licensee) and (iii) consideration received in connection with the issuance of equity by Licensor to the extent that such consideration is not in excess of the fair market value of such equity.

 

1.36.                     “Valid Claim” means an issued claim of an issued patent within the Licensed Patent Rights, which has not (i) expired or been canceled, (ii) been declared invalid by an unreversed and unappealable decision of a court or other appropriate body of competent jurisdiction, (iii) been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, and/or (iv) been abandoned in accordance with or as permitted by the terms of this Agreement or by mutual written agreement.

 

ARTICLE 2

 

LICENSE GRANT

 

2.1.                            Grant of License.  Licensor hereby grants to Licensee an exclusive, royalty-bearing license under the Licensed Patent Rights to research, develop, make, have made, import, have imported, use, have used, sell, have sold, offer for sale, have offered for sale and otherwise exploit Licensed Products in the Field throughout the world.

 

2.2.                            Reservation of Rights.  The licenses granted to Licensee hereunder are subject to the reservation of Licensor’s right to make, have made, and use Licensed Products for internal, noncommercial educational and research purposes, but not for sale or other distribution to commercial third parties for use in the Field.  This license is not transferable by Licensee except as provided in Section 12.11, but Licensee shall have the right to grant nonexclusive or exclusive sublicenses hereunder, and to grant to Sublicensees the right to freely grant sublicenses.  Licensee may grant sublicenses of no greater scope than the license granted under Section 2.1.

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

2.3.                            Sublicenses.  Except as otherwise provided in a sublicense agreement, if this Agreement terminates for any reason, any Sublicensee shall, from the effective date of such termination, automatically become a direct licensee of Licensor with respect to the rights, terms and conditions granted to the Sublicensee by Licensee; provided however that such Sublicensee is not in breach of its sublicense agreement and continues to perform thereunder.  Notwithstanding the foregoing, Licensor shall not be liable to such Sublicensee with respect to any obligations of Licensee to the Sublicensee.

 

ARTICLE 3

 

PROSECUTION OF PATENT APPLICATIONS AND
 PAYMENT OF PATENT COSTS

 

3.1.                            Prosecution of Licensed Patent Rights Owned Solely by Licensor.

 

(a)                                 Licensor shall prosecute and maintain any and all patent application(s) and patents included in the Licensed Patent Rights that are solely owned by Licensor.  Licensor shall, to the extent reasonably practical, permit Licensee to review all such patent applications and claims made therein as well as all other such filings made in connection with the prosecution and maintenance of the Licensed Patent Rights related to Licensed Product, and Licensor shall reasonably consider all comments of Licensee to such applications, claims and filings.  Licensee shall reimburse Licensor for 100% of all reasonable out-of-pocket expenses incurred by Licensor for the filing for, prosecution and maintenance of the Licensed Patent Rights after the date hereof.  Such expenses shall be reimbursed within thirty (30) days following receipt by Licensee from Licensor of (i) an invoice covering such fees (including copies of invoices for legal fees describing the legal services performed in reasonable detail) and (ii) reasonably satisfactory evidence that such fees were paid.

 

(b)                                 If Licensor declines to file, prosecute or maintain a patent or patent application to obtain one or more patent(s) included in the Licensed Patent Rights which is solely owned by Licensor then, except as set forth in Section 3.1(b)

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

hereof, Licensor shall so notify Licensee, and Licensee may elect to file or take over the prosecution or maintenance of any such patent or patent application, and Licensee shall bear all expenses incurred in connection with such prosecution or maintenance.

 

(c)                                  In the event that Licensee elects not to pay any of the foregoing patent application costs and fees described in this Section 3.1 with respect to a particular application or patent included in the Licensed Patent Rights following the date hereof, Licensor may, at its option, continue such prosecution or maintenance, although any patent resulting from such prosecution or maintenance will thereafter no longer be subject to the license granted hereunder.

 

3.2.                            Prosecution of Licensed Patent Rights Jointly Owned by Licensor and Licensee.

 

(a)                                 Licensee shall, at its sole expense, prosecute and maintain any and all patent application(s) and patents included in the Licensed Patent Rights that are jointly owned by Licensor and Licensee.  Licensee shall, to the extent reasonably practical, permit Licensee to review all jointly owned patent applications and claims made therein as well as all other jointly owned filings made in connection with the prosecution and maintenance of the Licensed Patent Rights related to Licensed Product, and Licensee shall reasonably consider all comments of Licensor to such jointly owned applications, claims and filings.  Licensee shall reimburse Licensor for 100% of all reasonable out-of-pocket expenses incurred by Licensor for the filing for, prosecution and maintenance of the Licensed Patent Rights after the date hereof.  Such expenses shall be reimbursed within thirty (30) days following receipt by Licensee from Licensor of (i) an invoice covering such fees (including copies of invoices for legal fees describing the legal services performed in reasonable detail) and (ii) reasonably satisfactory evidence that such fees were paid.

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

(b)                                 If Licensee declines to file, prosecute or maintain a jointly owned patent or patent application to obtain one or more patent(s) included in the Licensed Patent Rights then Licensee shall so notify Licensor, and Licensor may elect to file or take over the prosecution or maintenance of any such patent or patent application, and Licensor shall bear all expenses incurred in connection with such prosecution or maintenance, and any patent resulting from such prosecution or maintenance will thereafter no longer be subject to the license granted hereunder.  The Parties shall be permitted to independently use any jointly owned patent rights that cease to be subject to a license hereunder, without any requirement for mutual consultation or agreement except as may be required by law.

 

3.3.                            Cooperation.  The Parties shall use commercially reasonable efforts to cooperate in the prosecution and maintenance of the Licensed Patent Rights.

 

3.4.                            Licensor acknowledges receipt of payment in full for any patent costs incurred prior to the execution of the Original License Agreement or the amendment thereto.  Licensee shall not have any obligation to pay for additional patent costs incurred prior to the execution of the this Agreement (for clarity, the Amended and Restated License Agreement) except to the extent that such costs incurred pursuant to a Prior Agreement for the prosecution or maintenance of patents and patent applications directed to ALK-1 Receptor Products and ALK-1 Antibody Products.

 

ARTICLE 4

 

PAYMENTS

 

4.1.                            Licensing Fees.  Licensee shall pay Licensor [* * *] within thirty (30) days after the execution of this Agreement.

 

4.2.                            Milestone Payments for ALK-1 Products.  Licensor acknowledges receipt of a milestone payment of $[* * *] for the first demonstration of in vivo efficacy for a Licensed ALK-1 Receptor Product and receipt of a milestone payment of $[* * *] for the

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

first administration of a Licensed ALK-1 Receptor Product to a human in a clinical trial.  Licensee shall pay the following milestone payments within thirty (30) days following the first achievement of the following events by Licensee:

 

Licensed ALK-1 Receptor Product

 

	
Completion   of a Phase II Clinical Study for a Licensed ALK-1 Receptor Product:
    	
 
    	
$
    	
[* * *]
    
	
 
    	
 
    	
 
    
	
Approval   of NDA for a Licensed ALK-1 Receptor Product:
    	
 
    	
$
    	
[* * *]
    

 

Licensed ALK-1 Antibody Product

 

	
First   Demonstration of In Vivo Efficacy for a Licensed ALK-1 Antibody Product:
    	
 
    	
$
    	
[* * *]
    
	
 
    	
 
    	
 
    
	
First   administration of a Licensed ALK-1 Antibody Product to humans in a clinical   trial:
    	
 
    	
$
    	
[* * *]
    
	
 
    	
 
    	
 
    
	
Completion   of a Phase II Clinical Study for a Licensed ALK-1 Antibody Product:
    	
 
    	
$
    	
[* * *]
    
	
 
    	
 
    	
 
    
	
Approval   of NDA for a Licensed ALK-1 Antibody Product:
    	
 
    	
$
    	
[* * *]
    

 

In no event shall Licensee be required to pay any of the foregoing milestones more than once.  Licensee shall notify Licensor promptly upon the first occurrence of any such milestone.

 

4.3.                            Milestones for Licensed Subsequent Products.  Licensee shall pay the following milestone payments within thirty (30) days following the first achievement of

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

the following events by Licensee for each Category of Licensed Subsequent Product set forth below:

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

	
 
    	
 
    	
Payment for Each Licensed Subsequent Product Category
    	
 
    
	
Milestone   Event
    	
 
    	
ALK-2
   Receptor
   Product
    	
 
    	
ALK-3
   Receptor
   Product
    	
 
    	
ALK-3
   Antibody
   Product
    	
 
    	
ALK-4
   Receptor
   Product
    	
 
    	
ALK-4
   Antibody
   Product
    	
 
    	
ALK-5
   Receptor
   Product
    	
 
    	
ALK-5
   Antibody
   Product
    	
 
    	
ALK-6
   Receptor
   Product
    	
 
    	
ALK-6
   Antibody
   Product
    	
 
    
	
First   Demonstration of In Vivo Efficacy
    	
 
    	
$
    	
[* * *]
    	
 
    	
-[* * *]-
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
First   administration to humans in a clinical trial
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
Completion   of a Phase II Clinical Study
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    
	
Approval   of NDA
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    	
$
    	
[* * *]
    	
 
    

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

For clarity, the milestone payments set forth in this Section 4.3 shall be paid only once for each Category of Licensed Product, regardless of how many Licensed Products in the same Category may achieve the milestone event and regardless of whether the same Licensed Product achieves the milestone event more than once.  By way of a nonlimiting example, if two separate products in the ALK-2 Receptor Product Category achieve the same milestone event, only one payment is due.  Furthermore, to the extent a particular product in a particular Category of Licensed Product fails and a replacement Licensed Product in the same Category is selected, any milestones previously paid for such failed Licensed Product shall not be paid a second time with respect to such replacement Licensed Product.  For clarity, the milestone payments set forth in this Section 4.3 are not payable if such milestone is achieved pursuant to a Sublicense.

 

4.4.                            Royalties for Licensed Product.  Licensee shall pay to Licensor a royalty of [* * *] on Net Revenues of Licensed Products, on a country-by-country and Licensed Product-by-Licensed Product basis through the Royalty Term; provided, however, that on a country-by-country and Licensed Product-by-Licensed Product basis, such royalty shall be reduced to [* * *] on Net Revenues of any Licensed Product the manufacture, use or sale of which is not covered by a Valid Claim of a Licensed Patent Right in such country.

 

4.5.                            Other Payments.  Licensee shall pay to Licensor a share of Sublicensing Revenue as follows:

 

(a)                                 [* * *] of the amount of Sublicensing Revenue received, in consideration of a sublicense related to a Sublicensed Product that is an ALK-1 Receptor Product or an ALK-1 Antibody Product, prior to the first filing with the FDA an IND for such Sublicensed Product;

 

(b)                                 [* * *] of the amount of Sublicensing Revenue received, in consideration of a sublicense related to a Sublicensed Product that is an ALK-1 Receptor Product or an ALK-1 Antibody Product, after the first filing with the FDA of an IND for such Sublicensed Product;

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

(c)                                  [* * *] of the amount of Sublicensing Revenue received, in consideration of a sublicense related to a Sublicensed Product that is an ALK-2 Receptor Product, an ALK-3 Receptor Product, an ALK-3 Antibody Product, an ALK-4 Receptor Product, an ALK-4 Antibody Product, an ALK-5 Receptor Product, an ALK-5 Antibody Product, an ALK-6 Receptor Product, or an ALK-6 Antibody Product.

 

4.6.                            Currency.  For the purpose of determining royalties payable under this Agreement, any royalties or other revenues Licensee receives from Sublicensees in currencies other than U.S. dollars and any Net Revenues denominated in currencies other than U.S. dollars shall be converted into U.S. dollars according to Licensee’s reasonable standard internal conversion procedures, including Licensee’s standard internal rates and conversion schedule.

 

4.7.                            Royalty Payment Period.  Royalties due under this ARTICLE 4 shall be payable on a country-by-country and Licensed Product-by-Licensed Product basis (X) until the expiration of the last to expire of the Valid Claims included in the Licensed Patent Rights covering such Licensed Product and (Y), with respect to each country in which such Licensed Product is or was covered by a Valid Claim of a Licensed Patent Right, until the later of: (a) the expiration of the last to expire of the Valid Claims included in the Licensed Patent Rights covering such Licensed Product in such country and (b) eight (8) years from the date of first commercial sale of such Licensed Product, on a country-by-country basis, in such country (in each such case, the “Royalty Term”).

 

4.8.                            Practice of Patents by U.S. Government.  Notwithstanding the provisions of this ARTICLE 4, no royalty shall be payable to Licensor with respect to any sales of Licensed Products on sales made solely to permit the U.S. Government to practice or have practiced or use on its behalf any invention or process covered by Licensed Patent Rights.

 

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4.9.                            Payment Terms.  Licensee shall deliver to Licensor, within forty five (45) days after each calendar quarter for which a payment is due hereunder, a report showing the information on which payments herein provided are calculated, including a breakdown of income from sales by country of each Licensed Product.  Each such report shall be accompanied by the payment shown to be due thereby.  Royalties based on Net Revenues shall be payable to Licensor in United States dollars.  Where royalties are due for Net Revenues in a country where, for reasons of currency, tax or other regulations, transfer of foreign currency out of such country is prohibited, Licensee has the right to place Licensor’s royalties in a bank account in such country in the name of and under the sole control of Licensor; provided, however, that the bank selected be reasonably acceptable to Licensor and that Licensee inform Licensor of the location, account number, amount and currency of money deposited therein.  After Licensor has been so notified, those monies shall be considered as royalties duly paid to Licensor and will be completely controlled by Licensor.  Licensee shall be responsible for any and all taxes that may be levied by a proper taxing authority on royalties or other payments accruing to Licensor under this Agreement other than income taxes.  Such taxes may not be deducted from royalties or other payments to be paid to Licensor hereunder.

 

4.10.                     Accounts.  All payments to be made under this Agreement to Licensee shall be made within thirty (30) days of receipt of an invoice from License and shall be made in US Dollars (“USD”) by bank wire transfer to Licensee’s bank account as follows:

 

	
Beneficiary/Payee   
    	
Ludwig   Institute for Cancer Research Ltd.
    
	
 
    	
 
    
	
Account   No:
    	
 
    
	
 
    	
 
    
	
With:
    	
 
    
	
 
    	
 
    
	
Clearing:
    	
 
    
	
 
    	
 
    
	
SWIFT:
    	
 
    
	
 
    	
 
    
	
IBAN
    	
 
    

 

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4.11.                     Late Interest.  If any payment is not made on or before the due date specified herein, Licensor will pay interest on the outstanding amount until paid in full if requested to do so by Licensee.  Interest will be charged at a rate equal to the “Intended Federal Funds Rate” or equivalent plus 2% as specified by the Federal Open Market Committee and currently published by the US Federal Reserve Board at www.federalreserve.gov/fomc/fundsrate.htm.

 

4.12.                     Audits.  During the Term of this Agreement and for a period of five (5) years thereafter, Licensee shall keep complete and accurate records pertaining to the development, manufacture, use, sale or other disposition of the Licensed Products, in sufficient detail to permit Licensor to confirm the accuracy of all payments due hereunder and compliance with the diligence obligations set forth in Section ARTICLE 11.  Licensee shall have the right to cause an independent, certified public accountant to audit such records.  Such audits may be exercised once each calendar year and only with respect to the then current calendar year and the immediately prior four calendar years, upon reasonable prior written notice to Licensee, and during normal business hours, and Licensee shall bear the full cost of such audit, unless such inspection leads to the discovery of a discrepancy of greater than the greater of ten percent (10%) in reporting to Licensor’s detriment, or of $50,000, for any calendar year.  In such instance, Licensee agrees to pay the reasonable cost of such audit plus interest as stipulated in Section 4.11 from and after the date the audit report is delivered to Licensee.  The terms of this Section 4.12 shall survive any termination or expiration of this Agreement for a period of five (5) years.

 

ARTICLE 5

 

INFRINGEMENT BY THIRD PARTY

 

5.1.                            A Party will notify the other Party if it becomes aware of activities of a Third Party that are believed to infringe any of the Licensed Patent Rights in the Field.  The Parties shall consult as to potential strategy or strategies to terminate such alleged

 

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infringement without litigation.  With respect to any alleged infringements relating to Licensed Products, Licensee (or its Sublicensee), at its sole discretion, may take reasonable actions to terminate such alleged infringement without litigation.  Licensee shall promptly notify Licensor in writing of its (or its Sublicensee’s) intention with regard to any such infringement.

 

5.2.                            Enforcement of Licensed Patent Rights.

 

(a)                                 The Parties agree that as between Licensor and Licensee, Licensee shall have the right, but not the obligation, to institute, prosecute and control any action or proceeding with respect to infringement or defense of any of the Patents within the Licensed Patent Rights in the Field by counsel of its own choice.  If Licensee commences any such action, Licensor agrees to execute all papers and to perform such other acts as may be reasonably required (including consent to be joined as party plaintiffs in such action).  Licensee shall reimburse Licensor for its out-of-pocket expenses incurred in performing such acts at the request of Licensee and Licensor may, at its option and expense, be represented by counsel of its choice.  If Licensee elects not to bring an action or proceeding with respect to such a Licensed Patent Right, or has not provided Licensor with evidence of bona fide negotiations with the alleged infringer, in each case within one hundred twenty (120) days of being notified of infringement, then Licensor shall have the right (but not the obligation) to bring such action and Licensee agrees, at Licensor’s expense, to execute all papers and perform such other acts as may be reasonably required (including consent to be joined as a party plaintiff in such action).  Neither party shall enter into any settlements, stipulated judgment or other arrangement which admits or concedes that any patent, or claims thereof, within the Licensed Patent Rights is invalid, unenforceable or limited in scope, without obtaining the other party’s prior written consent, which consent shall not be unreasonably withheld or delayed.

 

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(b)                                 Any damages or other monetary awards recovered pursuant to this Section 5.2(b) shall be allocated first to the reasonable costs and expenses of the enforcing party, then to the reasonable costs and expenses, if any, of the other party; and the balance of any recovery pursuant to any suit, proceeding or other legal action taken under this Section shall be treated as Net Revenues for the purposes of royalty calculations hereunder.

 

5.3.                            Defense of the Licensed Patent Rights.

 

(a)                                 In any challenges brought or declaratory judgment instituted against any of the Licensed Patent Rights, Licensor shall have the right, but not the obligation, to defend such action provided it shall keep (i) Licensee promptly and fully informed of the litigation; (ii) furnish to Licensee copies of all documents relevant thereto in advance of filing, to permit Licensee an opportunity to comment; and (iii) reasonably consider Licensee’s comments and not take positions adverse to or inconsistent with Licensee’s interests.  If Licensor commences such action, Licensee agrees to execute all papers and perform such other acts as may be reasonably required (including consent to be joined as a party plaintiff in such action).  Neither party shall enter into any settlements, stipulated judgment or other arrangement which admits or concedes that any patent, or claims thereof, within the Licensed Patent Rights is invalid, unenforceable or limited in scope, without obtaining the other party’s prior written consent, which consent shall not be unreasonably withheld or delayed.

 

(b)                                 Any damages or other monetary awards recovered pursuant to this Section 5.3 shall be allocated first to the reasonable costs and expenses of the enforcing party, then to the reasonable costs and expenses, if any, of the other party; and the balance of any recovery pursuant to any suit, proceeding or other legal action taken under this Section shall be allocated to Licensor.

 

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5.4.                            Patent Term Extension.  The Parties shall cooperate in selecting a patent within the Licensed Patent Rights to seek a term extension for or supplementary protection certificate under and in accordance with the applicable laws of any country.  Each party agrees to execute such documents and to take such additional actions as the other party may reasonably request in connection therewith.

 

ARTICLE 6

 

REPRESENTATIONS OF LICENSOR

 

6.1.                            Representations of Licensor.  Licensor hereby covenants, represents, and warrants to Licensee as follows:

 

(a)                                 There are no liens, mortgages, commitments, obligations and encumbrances of any kind or any nature whatsoever against the Licensed Patent Rights;

 

(b)                                 There are no outstanding options, licenses or agreements of any kind relating to the Licensed Patent Rights conflicting with the rights granted to Licensee under this Agreement.

 

(c)                                  Licensor has full power and authority to enter into this Agreement and to grant the rights, licenses and privileges granted herein and can perform as set forth in this Agreement without violating the terms of any agreement that Licensor has with any third party; and

 

6.2.                            Limitations of Representations and Warranties.  The parties agree that nothing in this Agreement shall be construed as:

 

(a)                                 A warranty or representation that anything made, used, sold, or otherwise disposed of hereunder is or will be free from infringement of rights of third parties; or

 

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(b)                                 An obligation by Licensor to bring or prosecute actions or suits against third parties for infringement of the Licensed Patent Rights; or

 

(c)                                  Conferring by implication, estoppel or otherwise, any license or rights under any patents of Licensor other than the Licensed Patent Rights, regardless of whether such other patents are dominant or subordinate to the Licensed Patent Rights.

 

(d)                                 THE PARTIES HEREBY AGREE THAT LICENSOR MAKES NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE LICENSED PATENT RIGHTS.

 

ARTICLE 7

 

TERM OF LICENSE

 

7.1.                            Term.  This Agreement and the rights and licenses hereunder shall be in effect beginning on the Effective Date and continuing on a Licensed Product-by-Licensed Product and country-by-country basis until the end of the applicable Royalty Term, as defined in Section 4.7.  Upon expiration of this Agreement, all licenses granted hereunder shall become fully-paid, perpetual and irrevocable.

 

7.2.                            Termination for Breach.  Subject to Sections 11.1 and 11.2, if this Agreement is materially breached by either party, including any monetary breach, the non-breaching party may elect to give the breaching party written notice describing the alleged breach, and, if the breaching party has not cured such breach within sixty (60) days, or thirty (30) days for any monetary breach, after receipt of such notice, the notifying party will be entitled, in addition to any other rights it may have under this Agreement, to terminate this Agreement in its entirety, or, in the event of a breach under Section 11.1, or 11.2, with respect to the applicable category or subcategory of Licensed Product only, effective immediately; provided, however, that if either party receives notification from the other of a material breach and if the party alleged to have breached 

 

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this Agreement notifies the other party in writing within thirty (30) days of receipt of such breach notice that it disputes the asserted breach, the matter will be submitted to arbitration as provided in ARTICLE 9 (Dispute Resolution) of this Agreement.  In such event, the non-breaching party shall not have the right to terminate this Agreement or any portion hereof until it has been determined in such arbitration proceeding that the other party materially breached this Agreement, and the breaching party fails to cure such breach within sixty (60) days after the conclusion of such arbitration proceeding or within thirty (30) days in the case of monetary breach.

 

7.3.                            Termination by Licensee.  Licensee may terminate this Agreement at any time upon thirty (30) days notice to Licensor.

 

7.4.                            Effect of Termination.  Termination of this Agreement for any reason shall not release any party hereto from any liability which, at the time of such termination, has already accrued to the other party or which is attributable to a period prior to such termination, nor preclude either party from pursuing any rights and remedies it may have hereunder or at law or in equity which accrued or are based upon any event occurring prior to such termination.  Upon any termination, Licensor will immediately return to Licensee its Licensee Confidential Information.  Any provision which, by its nature is intended to survive termination or expiration of this Agreement shall survive and continue to be enforceable, including without limitation, ARTICLE 1 (Definitions), Section 2.3 (Sublicenses), Section 6.2 (Limitations of Representations and Warranties), Section 7.4 (Effect of Termination), ARTICLE 8 (Confidentiality), ARTICLE 9 (Dispute Resolution) and ARTICLE 12 (Miscellaneous).

 

ARTICLE 8

 

CONFIDENTIALITY

 

8.1.                            General.  Licensor and Licensee agree that the Licensed Patent Rights and the existence of this Agreement shall be held in strict confidence and that no information concerning the same shall be disclosed by either party hereto to any third party without

 

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the prior written consent of the other party, except as may be required by law (including compulsory legal process).  Information shall not be considered confidential or subject to this ARTICLE 8 if it can be demonstrated to have been developed by Licensee without the use of such information furnished by Licensor, in the possession of Licensee prior to disclosure by Licensor or become part of the public domain by publication of a patent or by any other means except an unauthorized act or omission by a party to this Agreement.  Notwithstanding the foregoing, Licensee shall have the right, without Licensor’s consent, to disclose the Licensed Patent Rights and the terms and conditions of this Agreement to third parties in connection with the exercise of its rights and license hereunder and to potential investors and partners of Licensee.

 

8.2.                            Licensee Confidential Information.  Licensor will not publish or disclose to third parties any of the Licensee Confidential Information.  This confidentiality obligation does not apply to information which is lawfully and in good faith made available to Licensor from an independent source, is already published through no breach of this Agreement, or is/was known by Licensor independent of Licensee’s disclosure as evidenced by written records at the time of disclosure.  The provisions of this Section 8.2 are in addition to, and not in lieu of or in limitation to the obligations of the parties set forth in Section 8.1.

 

ARTICLE 9

 

DISPUTE RESOLUTION

 

9.1.                            Any and all disputes of whatever nature arising, between the parties of this Agreement or the underlying business relationship, including termination thereof, and which is not resolved between the parties themselves, shall be submitted to binding arbitration before a single arbitrator in accordance with the Commercial Arbitration Rules of the American Arbitration Association in effect as of the Effective Date.  Such arbitration shall take place in the Commonwealth of Massachusetts.  Judgment upon the award of the arbitrator may be entered in any court having jurisdiction thereof.  Arbitration hereunder shall be in lieu of all other remedies and procedures available to the 

 

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parties, except that either party may seek an injunction or other equitable remedy to the extent available.

 

ARTICLE 10

 

PRODUCT LIABILITY

 

10.1.                     Licensee agrees that Licensor shall have no liability to Licensee or to any purchasers or users of Licensed Products made or sold by Licensee for any claims, demands, losses, costs, or damages suffered by Licensee, or purchasers or users of Licensed Products, or any other party, which may result from personal injury, death, or property damage related to the manufacture, use, or sale of such Licensed Products, except to the extent the foregoing is the result of Licensor’s negligence, willful misconduct or a breach of this Agreement (“Claims”).  Licensee agrees to defend, indemnify, and hold harmless Licensor, their trustees, officers, agents, and employees from any such Claims, provided that (i) Licensee is notified promptly of any Claims, (ii) Licensee has the sole right to control and defend or settle any litigation within the scope of this indemnity, and (iii) all indemnified parties cooperate to the extent necessary in the defense of any Claims.

 

10.2.                     At such time as Licensee begins to sell or distribute Licensed Products (other than for the purpose of obtaining regulatory approvals), Licensee shall at its sole expense, procure and maintain policies of comprehensive general liability insurance comparable to those held by companies developing or selling similar products and in any case in amounts not less than $10,000,000 per incident and $50,000,000 in annual aggregate and naming Licensor as additional insureds.  Such comprehensive general liability insurance shall provide (i) product liability coverage and (ii) broad form contractual liability coverage for Licensee’s indemnification under Section 10.1.  In the event the aforesaid product liability coverage does not provide for occurrence liability, Licensee shall maintain such comprehensive general liability insurance for a reasonable period of not less than five (5) years after it has ceased commercial distribution or use of any Licensed Product.

 

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ARTICLE 11

 

DILIGENCE

 

11.1.                     Commercial Development Obligation.

 

(a)                                 ALK-1.  In order to maintain in force the license granted pursuant to Section 2.1(a) with respect to Licensed ALK-1 Receptor Products and Licensed ALK-1 Antibody Products, each separately, Licensee shall, either by itself or through its Sublicensees, use commercially reasonable efforts and diligence, commensurate with the state of development, market potential and strategic value of any Licensed Product, to develop a Licensed ALK-1 Receptor Product and a Licensed ALK-1 Antibody Product, and thereafter to produce and sell reasonable quantities of Licensed Product.  The parties hereto acknowledge and agree that achievement of the diligence milestones described in Sections 11.2(a) and 11.2(b) for Licensed ALK-1 Receptor Product and Licensed ALK-1 Antibody Product, respectively, on or before the dates set forth therein shall be evidence of compliance by Licensee with its commercial development obligations with respect to such Categories of Licensed Products hereunder for the time periods specified in Section 11.2. In the event that Licensor believes that Licensee has not met its diligence obligations as required hereunder for either a Licensed ALK-1 Receptor Product, a Licensed ALK-1 Antibody Product or a Licensed Subsequent Product, Licensor shall provide Licensee with a written notice that specifies the basis for such belief.  Upon such notice, Licensee shall have sixty (60) days to respond in writing with (a) proof of diligent efforts, and/or (b) a plan to meet such diligence milestones to Licensor’s satisfaction, and/or (c) a reasonable rationale as to why the milestone could not reasonably have been met, or cured, due to factors beyond Licensee’s control, and, in the case of clause (b) or (c), Licensee shall also provide to Licensor a revised reasonable diligence timeline, consistent with the revised development timeline of a Licensed ALK-1 Receptor Product, a Licensed ALK-1 Antibody Product or a Licensed Subsequent Product, as applicable.  In the event that Licensee does not provide responses that are reasonably satisfactory to 

 

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Licensor, Licensor shall have the right to terminate the Agreement in accordance with Section 7.2, but only for that category of Licensed Product, either Licensed ALK-1 Receptor Product, Licensed ALK-1 Antibody Product or Licensed Subsequent Product, for which Licensee is determined to have failed to meet its diligence obligations hereunder.  Otherwise, Licensor shall not have the right to terminate such license pursuant to this ARTICLE 11.  The termination of the license granted hereunder with respect to one category of Licensed Product shall not terminate or in any way affect the license granted hereunder with respect to any other category of Licensed Product.

 

11.2.                     Diligence Milestones for ALK-1.  Prior to signing this Agreement, Licensee shall have provided to Licensor the Research and Development Plan attached hereto as Exhibit B, under which Licensee intends to bring the subject matter of the Licensed Patent Rights to the point of commercial use.  This Research and Development Plan is hereby incorporated by reference into this Agreement and is the basis for the following performance milestones:

 

(a)                                 Diligence Milestones for a Licensed ALK-1 Receptor Product:

 

(1)                                 by six (6) years after the Original License Date, Initiation of Phase II Clinical Study with a Licensed ALK-1 Receptor Product.

 

(b)                                 Diligence Milestones for a Licensed ALK-1 Antibody Product:

 

(1)                                 by six (6) years after the First Amendment Date, Initiation of Phase I Clinical Study with a Licensed ALK-1 Antibody Product;

 

(2)                                 by nine (9) years after the First Amendment Date, Initiation of Phase II Clinical Study with a Licensed ALK-1 Antibody Product.

 

(c)                                  Diligence Milestones for a Licensed Subsequent Product:

 

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(1)                                 by three (3) years after the Effective Date, have tested a Licensed Subsequent Product for in vivo activity.

 

(d)                                 Licensor acknowledges that the identification, isolation and production of clinically useful antibodies that bind to ALK-1 is an unpredictable process requiring substantial investment on the part of Licensee.  Therefore, Licensor agrees that if, after generating and characterizing anti-ALK-1 antibodies in accordance with the Research and Development Plan as set forth in Exhibit B, Licensee requires additional time to accomplish any of milestones (1), (2) or (3) of Section 11.2(b) as a result of difficulties in obtaining a sufficiently potent antibody, Licensee shall, upon delivery of a written statement to Licensor describing such difficulties and describing the activities proposed to be undertaken by Licensee to address such difficulties, be entitled to amend Section 11.2(b) to extend the time for performance of milestones (1), (2) and (3) by up to twenty-four (24) months in order to allow Licensee to accomplish the milestone in question.

 

11.3.                     Other Categories.  In order to maintain in force the license granted pursuant to Section 2.1(a) with respect to the following groupings of Categories of Licensed Products: (i) ALK-2 Receptor Product, (ii) ALK-3 Receptor Product and ALK-3 Antibody Product, (iii) ALK-4 Receptor Product and ALK-4 Antibody Product, (iv) ALK-5 Receptor Product and ALK-5 Antibody Product, and (v) ALK-6 Receptor Product and ALK-6 Antibody Product, each grouping separately, Licensee shall, either by itself or through its Sublicensees, use commercially reasonable efforts and diligence, commensurate with the state of development, market potential and strategic value of any of the Licensed Products listed above (i-v), to develop such a Licensed Product, and thereafter to produce and sell reasonable quantities of such Licensed Product.  In addition, upon request by Licensor, Licensee shall use commercially reasonable efforts and diligence, on an as-available basis, to supply Licensor with reasonable amounts of at least one antibody or receptor-Fc fusion for each such grouping, and such materials shall 

 

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be provided to Licensor subject to terms and conditions of a separate material transfer agreement.  The supply of the first such reagent shall be available to Licensor within one (1) year of the Effective Date and the supply of reagent with respect to all remaining groupings shall be made within three (3) years of the Effective Date.  Following the initial supply of reagent for each grouping, Licensee shall have no obligation to manufacture or have manufactured reagent solely to satisfy the requests of Licensor, but if Licensee continues to manufacture or have manufactured such reagents, it will use commercially reasonable efforts and diligence, on an as-available basis, to supply Licensee with reasonable amounts such reagents for non-clinical research use, provided that Licensee shall have no obligation to supply Licensor with any Licensed Product in development for human use and may substitute a non-human cognate for any such clinical Licensed Product.  In the event that Licensor believes that Licensee has not met its diligence obligations as required hereunder for any grouping, Licensor shall provide Licensee with a written notice that specifies the basis for such belief.  Upon such notice, Licensee shall have sixty (60) days to respond in writing with (a) proof of diligent efforts, and/or (b) a plan to meet provide such reagent to Licensor’s satisfaction, and/or (c) a reasonable rationale as to why the reagent could not reasonably be supplied on the timeline set forth here, due to factors beyond Licensee’s control, and, in the case of clause (b) or (c), Licensee shall also provide to Licensor a revised reasonable diligence timeline, consistent with the revised development timeline of such grouping, as applicable.  In the event that Licensee does not provide responses that are reasonably satisfactory to Licensor, Licensor shall have the right to terminate the Agreement in accordance with Section 7.2, but only for the Category or Categories of Licensed Products within the grouping for which Licensee has failed to timely provide the requisite reagent.  Otherwise, Licensor shall not have the right to terminate such license pursuant to this ARTICLE 11.  The termination of the license granted hereunder with respect to one or more Categories of Licensed Products shall not terminate or in any way affect the license granted hereunder with respect to any other Category of Licensed Product.

 

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11.4.                     Reports and Clinical Development.  Licensee will provide Licensor with an annual report on the progress of the development of all Licensed Products, such report shall be due upon the anniversary of the Effective Date and shall be treated as Licensee’s Confidential Information.  In addition, Licensee shall consider Licensor, or any of its affiliated clinical sites, for participation in clinical trials for any Licensed Products in the oncology field.

 

ARTICLE 12

 

MISCELLANEOUS

 

12.1.                     Notices.  All notice, requests, demands and other communications hereunder shall be in English and shall be given in writing and shall be: (a) personally delivered; (b) sent by telecopier, facsimile transmission or other electronic means of transmitting written documents with confirmation of receipt; or (c) sent to the parties at their respective addresses indicated herein by registered or certified mail, return receipt requested and postage prepaid, or by private overnight mail courier services with confirmation of receipt.  The respective addresses to be used for all such notices, demands or requests are as follows:

 

(a)                                 If to LICENSOR, to:

 

Ludwig Institute for Cancer Research

605 Third Avenue/33rd Floor

New York, NY 10158

ATTN:  Jonathan C.A. Skipper, Ph.D.

Phone No.:  212-450-1539
 Fax No.:  212-450-1555

 

Or to such other person or address as Licensor shall furnish to Licensee in writing.

 

(b)                                 If to LICENSEE, to:

 

Acceleron Pharma Inc.
 128 Sidney St.

 

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Cambridge, Massachusetts 02139
 ATTN: Chief Executive Officer
 Phone No.:  617-649-9200
 Fax No.:  617-576-2224

 

With a copy to:

 

Marc A. Rubenstein, Esq.

Ropes & Gray LLP

One International Place

Boston, Massachusetts 02110

Phone No.: 617-951-7826

Fax No.: 617-951-7050

 

If personally delivered, such communication shall be deemed delivered upon actual receipt by the “attention” addressee or a person authorized to accept for such addressee; if transmitted by facsimile pursuant to this Section, such communication shall be deemed delivered the next business day after transmission (and sender shall bear the burden of proof of delivery); if sent by overnight courier pursuant to this Section, such communication shall be deemed delivered upon receipt by the “attention” addressee or a person authorized to accept for such addressee; and if sent by mail pursuant to this Section, such communication shall be deemed delivered as of the date of delivery indicated on the receipt issued by the relevant postal service, or, if the addressee fails or refuses to accept delivery, as of the date of such failure or refusal.  Any party to this Agreement may change its address for the purposes of this Agreement by giving notice thereof in accordance with this Section 12.1

 

12.2.       Severability.  Each provision contained in this Agreement is declared to constitute a separate and distinct covenant and provision and to be severable from all other separate, distinct covenants and provisions.  It is agreed that should any clause, condition or term, or any part thereof, contained in this Agreement be unenforceable or prohibited by law or by any present or future legislation then such clause, condition, term or part thereof, shall be amended, and is hereby amended, so as to be in compliance with the said legislation or law but, if such clause, condition or term, or part thereof, cannot be amended so as to be in compliance with the said legislation or law, then such clause, condition, term or part thereof is severable from this Agreement and the rest of the 

 

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clauses, terms and conditions or parts thereof contained in this Agreement shall remain unimpaired.

 

12.3.       No Amendment.  This Agreement may not be amended or modified otherwise than by a written agreement executed by Licensor and Licensee or their respective successors and legal representatives.

 

12.4.       Governing Law.  This Agreement, the legal relations between the parties and any action, whether contractual or non-contractual, instituted by any party with respect to matters arising under or growing out of or in connection with or in respect of this Agreement or the Prior Agreements shall be governed by and construed in accordance with the internal laws of the State of New York, excluding any choice of law rules that may direct the application of the laws of another jurisdiction.

 

12.5.       Waiver.  No waiver of a breach of any provision of this Agreement shall be deemed to be, or shall constitute, a waiver of a breach of any other provision of this Agreement, whether or not similar, nor shall such waiver constitute a continuing waiver of such breach unless otherwise expressly provided in such waiver.

 

12.6.       Headings.  The headings in this Agreement are inserted for convenience only and shall not constitute a part hereof.

 

12.7.       Counterparts/Facsimiles.  This Agreement may be executed in one or more counterparts, all of which taken together shall be deemed one original.  Facsimile signatures shall be deemed original.

 

12.8.       Recitals.  The recitals to this Agreement are true and correct and are made a part of this Agreement.

 

12.9.       No Endorsement.  Licensee agrees that it shall not make any form of representation or statement which would constitute an express or implied endorsement by Licensor of any Licensed Product, and that it shall not authorize others to do so, without 

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

first having obtained written approval from Licensor, except as may be required by governmental law, rule or regulation.  Licensor agrees, however, that Licensee may identify Licensor as the inventor of the Licensed Patent Rights in any advertising or publicity material.

 

12.10.     Entire Agreement.  This Agreement sets forth the complete agreement of the parties concerning the subject matter hereof.  No claimed oral agreement in respect thereto shall be considered as any part hereof.  No waiver of or change in any of the terms hereof subsequent to the execution hereof claimed to have been made by any representative of either party shall have any force or effect unless in writing, signed by duly authorized representatives of the parties.  Upon the effectiveness of this Agreement, the Prior Agreements shall be deemed amended and restated and superseded and replaced in their entirety by this Agreement, and shall be of no further force or effect.

 

12.11.     Assignment.  This Agreement shall be binding upon and inure to the benefit of any successor or assignee of Licensor.  This Agreement is not assignable by Licensee without the prior written consent of Licensor (not to be unreasonably withheld or delayed), except that Licensee may assign this Agreement without the prior written consent of Licensor to any Affiliate or any successor of, or purchaser of a substantial part of, the assets of its business to which this Agreement pertains or services utilizing the methods within the Licensed Patent Rights.  Any permitted assignee shall succeed to all of the rights and obligations of Licensee under this Agreement.

 

12.12.     Third-Party Technology.  Nothing in this Agreement will impair Licensee’s right to independently acquire, license, develop for itself, or have others develop for it, intellectual property and technology performing similar functions as the technology described in the Licensed Patent Rights or to market and distribute products other than Licensed Products based on such other intellectual property and technology.

 

12.13.     Certain Damages.  NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, OR 

 

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INDIRECT DAMAGES ARISING OUT OF THIS AGREEMENT, HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY.

 

12.14.     Force Majeure.  Neither party shall lose any rights hereunder or be liable to the other party for damages or losses (except for payment obligations) on account of failure of performance by the defaulting party if the failure is occasioned by war, strike, fire, Act of God, earthquake, flood, lockout, embargo, governmental acts or orders or restrictions, failure of suppliers, or any other reason where failure to perform is beyond the reasonable control and not caused by the negligence or intentional conduct or misconduct of the nonperforming party, and such party has exerted all reasonable efforts to avoid or remedy such force majeure; provided, however, that in no event shall a party be required to settle any labor dispute or disturbance.

 

12.15.     Consents and Approvals.  Whenever provision is made in this Agreement for either party to secure the consent or approval of the other, that consent or approval shall not unreasonably be withheld or delayed, and whenever in this Agreement provisions are made for one party to object to or disapprove a matter, such objection or disapproval shall not unreasonably be exercised.

 

12.16.     Further Assurances.  Each party hereto agrees to execute, acknowledge and deliver such further instruments, and to do all other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

 

[remainder of page intentionally left blank]

 

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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed:

 

	
 
    	
 
    	
(Licensor) 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
LUDWIG   INSTITUTE FOR CANCER RESEARCH LTD
    
	
 
    	
 
    	
 
    	
 
    
	
Date:   
    	
August 17,   2010
    	
 
    	
By:   
    	
/s/   Edward A. McDermott, Jr.
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
Name:   
    	
Edward   A. McDermott, Jr.
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
Title:   
    	
President
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:   
    	
August 17,   2010
    	
 
    	
By:   
    	
/s/   Jonathan Skipper 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
Name:   
    	
Jonathan   Skipper 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
Title:   
    	
Executive   Director, IP + Licensing
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:   
    	
 
    	
 
    	
By:
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
Name:
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
Title:
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:   
    	
 
    	
 
    	
(Licensee)  
    
	
 
    	
 
    	
 
    
	
 
    	
ACCELERON   PHARMA INC.
    
	
 
    	
 
    	
 
    
	
 
    	
By:   
    	
/s/   John Knopf 
    
	
 
    	
 
    	
 
    
	
 
    	
Name:   
    	
John   Knopf, Ph.D.
    
	
 
    	
 
    	
 
    
	
 
    	
Title:   
    	
Chief   Executive Officer
    

 

	
 
    	
APPRROVED   AS TO

LEGAL   FORM

Initials:  /s/ JDQ

Date:   6-Aug-2010

Acceleron   Pharma

Legal   Department
    

 

[Signature Page to Amended and Restated License Agreement]

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Exhibit A

 

[***]

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Exhibit B

 

Research and Development Plan for Licensed ALK-1 Receptor Product

 

[***]

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Research and Development Plan for Licensed ALK-1 Antibody Product

 

[***]

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Research and Development Plan for Licensed Subsequent Product

 

[***]Exhibit 10.8

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

EXCLUSIVE LICENSE AGREEMENT

BETWEEN

ACCELERON PHARMA, INC.

AND

BETH ISRAEL DEACONESS MEDICAL CENTER

 

This License Agreement (“Agreement”) is made as of the date immediately above the signatures of the Parties below (“Effective Date”) between Beth Israel Deaconess Medical Center, a not-for-profit Massachusetts corporation, with a principal place of operation at 330 Brookline Avenue, Boston, Massachusetts 02215 (“BIDMC”), and Acceleron Pharma, Inc., a for-profit corporation, having a principal place of business at 128 Sidney Street, Cambridge, MA  02139 (“Licensee”), each referred to individually as a “Party” and collectively as the “Parties”.

 

RECITALS

 

WHEREAS, BIDMC, as a center for patient care, research and education, owns certain Patent Rights (defined below) through assignment and desires to benefit the public by disseminating the results of its research through the grant of a license of those Patent Rights to Licensee for the commercial development, manufacture, distribution and use of Patented Products (defined below); and

 

WHEREAS, Licensee has the capability to commercially develop, manufacture, distribute and use Patented Products for public use and benefit and desires to receive a license to such Patent Rights; and

 

WHEREAS, Licensee enjoys certain rights under the terms and provisions of the Material Transfer Agreement between the Parties effective September 27, 2010 (“MTA”);

 

NOW THEREFORE, for good and valuable consideration, the sufficiency of which the Parties acknowledge, the Parties agree as follows:

 

1.                                      DEFINITIONS

 

The following terms have the following meanings:

 

1.1                               “ALK1 Product” means: (i) an ALK1 (activin receptor-like kinase 1) polypeptide comprising a ligand binding portion of the extracellular domain of a vertebrate ALK1, particularly human ALK1 (e.g. a fusion protein including the ALK1 ligand binding domain fused to an Fc portion of an IgG); (ii) an antibody that binds to the extracellular domain of human ALK1; (iii) an antibody that binds to human BMP9; or (iv) an antibody that binds to human BMP10.  For clarity, proteins that include the amino acid sequence described as SEQ ID NO: 3 or SEQ ID NO:5 in U.S. Patent No. 8,158,584 are included in the term “ALK1 Product”.

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1.2                               “Affiliate” with respect to either Party, means any corporation or other legal entity other than that Party, in whatever country organized, controlled by, controlling, or under common control with that Party.  For the purposes of this definition, the term “control” means (a) for Licensee, (i) beneficial ownership of at least fifty percent (50%) of the voting securities of a corporation or other business organization with voting securities or (ii) a fifty percent (50%) or greater interest in the net assets or profits of a partnership or other business organization without voting securities; and (b) for BIDMC, the power, direct or indirect, to elect or appoint fifty percent (50%) or more of the directors or trustees, or to cause direction of management and policies, whether through the ownership of voting securities, by contract or otherwise.

 

1.3                               “Claim” means any pending or issued claim of any Patent Right that has not been permanently revoked, nor held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction that is unappealable or unappealed in the time allowed for appeal, provided that, on a country-by-country and Product-by-Product basis, a patent application pending for more than five (5) years from the priority date of such patent application shall not be considered to be a Claim for purposes of this Agreement from and after such five (5) year date unless and until a patent with respect to such patent application issues.

 

1.4                               “First Commercial Sale” means, on a country-by-country basis, the initial Sale to a non-Affiliate third party in a country of a Patented Product following receipt of all regulatory approvals necessary to commence regular commercial scale Sales in such country.

 

1.5                               “Field” means all fields of use.

 

1.6                               “mTOR-targeted inhibitor” means a direct inhibitor of the protein called the mammalian target of rapamycin.  Each of the following compounds is a non-limiting example of an mTOR-targeted inhibitor: everolimus and temsirolimus.

 

1.7                               “Net Sales” means:

 

(a)                                 the gross amount billed by Licensee, its Affiliates, and Sublicensees for or on account of Sales of Patented Products, and, for clarity, to the extent that a Patented Product is labeled for a Patented Use and one or more additional uses that are not Patented Uses, only the gross amount billed for or on account of Sales of the Patented Product for the Patented Use shall be deemed to be Net Sales, and, for clarity, Sales for the one or more additional uses shall not be included in Net Sales;

 

less the following amounts (to the extent appropriately documented) actually paid or otherwise recognized as a revenue reduction by Licensee, its Affiliates, and Sublicensees in effecting such Sale:

 

(i)                                     amounts repaid or credited by reason of rejection or return of applicable Patented Products;

 

2

 

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(ii)                                  reasonable and customary trade, quantity or cash rebates or discounts to the extent allowed and taken;

 

(iii)                               amounts for outbound transportation, insurance, handling and shipping, but only to the extent separately invoiced in a manner that clearly specifies the charges applicable to the Patented Products;

 

(iv)                              taxes, customs duties and other governmental charges levied on or measured by Sales of Patented Products, to the extent separately invoiced, whether paid by or on behalf of Licensee, its Affiliates and Sublicensees so long as Licensee’s, its Affiliates and Sublicensee’s price is reduced thereby, but not franchise or income taxes, or any other tax of any kind whatsoever; and

 

(b)                                 Specifically excluded from the definition of “Net Sales” are the following:

 

(i)                                     any amounts billed, invoiced or received attributable to any Sale of any Patented Product between or among Licensee and any Licensee Affiliate and/or Sublicensee, unless the recipient of such transfer is the final purchaser, user or consumer of such Patented Product; and

 

(ii)                                  any Sublicense Income.

 

(c)                                  No deductions shall be made for any commissions paid to any individuals or for any costs or expenses of collections.

 

(d)                                 Net Sales shall occur, and the applicable Patented Product shall be deemed to have been Sold, on the billing date.

 

(e)                                  If Licensee, a Licensee Affiliate, or a Sublicensee Sells any Patented Product for non-cash consideration, Net Sales shall be calculated based on the cash amount charged to an independent third party for the Patented Product during the same Reporting Period or, in the absence of such transaction, on the fair market value of the Patented Product.

 

1.8                               “Patent Costs” means all out-of-pocket costs and expenses of any kind, including attorneys’ fees, associated with the preparation, filing, prosecution and maintenance of all Patent Rights.

 

1.9                               “Patent Challenge” means a challenge to the validity, patentability, enforceability and/or non-infringement of any of the Patent Rights or otherwise opposing any of the Patent Rights.

 

1.10                        “Patent Rights” means (i) the United States provisional applications listed on Appendix A, and (ii) patent applications that embody additional inventions made by BIDMC pursuant to the MTA which are within the scope of the applications or issued patents at the time included in the Patent Rights and are requested by Licensee at any time to be included as Patent Rights

 

3

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

hereunder, and in each case the patents resulting from any of the foregoing applications; any divisions, continuations, and continuations-in-part (but only to the extent the claims are directed to subject matter specifically described in the foregoing patent applications listed in Appendix A and the named inventors are identical to such applications), including foreign patent applications or patents that are equivalent to the foregoing; and any reissues, reexaminations or extensions of any of the foregoing.

 

1.11                        “Patented Use” means the use of an ALK1 Product and (i) an RTKI or (ii) an mTOR-targeted inhibitor, for the treatment of patients with renal cell carcinoma.  “Patented Use” shall include without limitation the sequential, overlapping or simultaneous dosing of patients with an ALK1 Product and the RTKI or mTOR-targeted inhibitor.  “Patented Use” shall also include any additional uses of ALK1 Products that are the subject of a valid Claim of the Licensed Patents.

 

1.12                        “Patented Product” means any product (including any apparatus or kit) that

 

(a)                                 in whole or through a component part thereof, the manufacture, use, or sale of which, in the absence of a license from BIDMC, would infringe one or more Claims of the Patent Rights; and

 

(b)                                 is labeled for a Patented Use, as such label is approved by an applicable regulatory authority.

 

For clarity, the determination of whether a product is considered a Patented Product shall be made on a country-by-country basis in relation to the status of the Patent Rights and any approved label in each country.

 

1.13                        “Phase 3 Clinical Trial” means a pivotal clinical trial performed to gain evidence with statistical significance of the efficacy of an ALK1 Product in a target patient population, and to obtain expanded evidence of safety that is needed to evaluate the overall benefit-risk relationship of such ALK1 Product, to form the basis for approval of a New Drug Application or equivalent regulatory approval.  In a clinical trial composed of multiple stages (e.g. a phase 2b/3 clinical trial), only that portion of the clinical trial that is named as “phase 3” in the protocol and provides for the enrollment of sufficient numbers of patients to meet the criteria of this definition shall be considered a Phase 3 Clinical Trial.

 

1.14                        “Reporting Period” means each three month period ending March 31, June 30, September 30 and December 31.

 

1.15                        “RTKI” means a small-molecule receptor tyrosine kinase inhibitor that binds to and inhibits signaling of VEGFR1, VEGFR2, or VEGFR3.  An RTKI may, but need not, bind to and inhibit receptor tyrosine kinases in addition to a VEGFR, such as PDGFRa, PDGFRb, RET and c-Met.  Likewise, an RTKI may, but need not, inhibit a different class of kinases that are not cell surface receptors, such as the serine kinases B-raf and c-raf kinase.  Each of the following

 

4

 

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compounds is a non-limiting example of an RTKI: sorafenib, pazopanib, axitinib, tivozanib, sunitinib, vandetanib, motesanib, vatalanib and samaxanib.

 

1.16                        “Sale” (and “Sell” and “Sold” as the case may be) shall mean to sell or have sold, to lease or have leased, to import or have imported or otherwise to transfer or have transferred a Patented Product for consideration (in the form of cash or otherwise), following receipt of regulatory approval to market such Patented Product or for compassionate use (also referred to as a single-patient IND).

 

1.17                        “Sublicense Income” means any payments that Licensee and its Affiliates receive in consideration of the sublicense of, or the grant of an option to receive a sublicense of, the rights granted under Section 2.1, including payments received from entities granted the right to advertise and offer for sale any Patented Products.  Such payments include, license fees, milestone payments, and license maintenance fees, but specifically exclude royalties on Net Sales.

 

1.18                        “Sublicensee” means any sublicensee of the rights granted to Licensee pursuant to Section 2.1(a).

 

1.19                        “Territory” means worldwide.

 

1.20                        “Term” means the term of this Agreement, on a country-by-country and Product-by-Product basis, which shall commence on the Effective Date and shall remain in effect until the date on which all claims within the Patent Rights in such country claiming such Patented Product have expired or been abandoned, unless this Agreement is terminated earlier as provided herein.

 

2.                                      LICENSE

 

2.1                               Grant of License.

 

(a)                                 Subject to the terms of this Agreement, BIDMC hereby grants to Licensee and its Affiliates in the Field in the Territory for the Term, an exclusive, royalty-bearing license under BIDMC’s rights in the Patent Rights to make, have made, use, have used, Sell, have Sold, import and have imported Patented Products and Patented Uses.

 

(b)                                 Subject to the terms of this Agreement and specifically with regards to Section 2.2, BIDMC grants Licensee the right to grant sublicenses under the rights granted in Section 2.1(a), provided that in each case Licensee shall be responsible for the performance of any obligations of Sublicensees relevant to this Agreement as if such performance were carried out by Licensee itself, including, without limitation, the payment of any royalties or other payments provided for hereunder, regardless of whether the terms of any sublicense provide for such amounts to be paid by the Sublicensee directly to BIDMC.  For clarity, Licensee shall not be required to pay BIDMC any share of Sublicense Income.

 

5

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

(c)                                  The foregoing license grants to Licensee Affiliates are subject to each such Affiliate assuming the same obligations as those of Licensee and becoming subject to the same terms and conditions under this Agreement; and further provided that Licensee shall be responsible for the performance of all of such obligations and for compliance with all of such terms and conditions by Affiliate.  Licensee shall provide to BIDMC a written list of all Affiliates of Licensee within thirty (30) days of request by BIDMC.  Licensee shall cause each of its Affiliates to comply with the provisions and obligations under this Agreement as if such Affiliates were the Licensee.

 

2.2                               Sublicenses.  Each sublicense granted hereunder shall be consistent with and comply with all applicable terms of this Agreement and shall incorporate terms and conditions sufficient to enable Licensee to comply with this Agreement.  Licensee shall provide to BIDMC a fully signed copy of all sublicense agreements and amendments thereto, including all exhibits, attachments and related documents, within thirty (30) days of executing the same; provided that any such copy may be redacted by Licensee to the extent that any such redaction does not impair BIDMC’s ability to ensure compliance with this Agreement.  Any sublicense which is not in accordance with the forgoing provisions, and is not able to be cured to conform with this Agreement within a commercially reasonable period of time, shall be null and void.

 

Upon any termination of this Agreement, BIDMC shall automatically be deemed to have entered into a license agreement directly with each Sublicensee on substantially the same terms and conditions under which such sublicenses granted to each Sublicensee by Licensee, provided that (i) such Sublicensee is in material compliance with the Sublicense terms;  (ii) such Sublicensee agrees in writing with BIDMC to be bound by the terms, conditions and limitation relating to the licensed Patented Product and Patented Use; and (iii) the terms of any such agreement shall automatically be amended so as not to include obligations upon BIDMC that exceed the obligations of BIDMC under this Agreement.

 

2.3                               Retained Rights; Requirements.  Any and all licenses granted hereunder are subject to:

 

(a)                                 the royalty-free right of BIDMC and BIDMC’s Affiliates and of academic, government and not-for-profit institutions to make, use and/or practice the technology or method described and/or claimed in the Patent Rights for non-commercial, research purposes only; and

 

(b)                                 for Patent Rights supported by federal funding, the rights, conditions and limitations imposed by U.S. law (see 35 U.S.C. § 202 et seq. and regulations pertaining thereto), including without limitation:

 

(i)                                     the royalty-free non-exclusive license granted to the U.S. government; and

 

(ii)                                  the requirement that any Patented Products used or sold in the United States shall be manufactured substantially in the United States to the extent required by law, provided that, at Licensee’s written request and at Licensee’s expense, BIDMC will promptly seek a waiver from the U.S.

 

6

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

government with respect to the requirements addressed in this Section 2.3(b)(ii).

 

2.4                               No Additional Rights.  Nothing in this Agreement shall be construed to grant Licensee an express or implied license under any patent, technology or intellectual property right owned solely or jointly by BIDMC, other than the Patent Rights and Related Information expressly licensed hereunder.

 

3.                                      DUE DILIGENCE OBLIGATIONS

 

3.1                               Diligence Requirements.  Licensee shall itself use, or shall cause its Affiliates or Sublicensees, as applicable, to use, commercially reasonable efforts to develop and make available to the public Patented Products throughout the Territory in the Field.  Such efforts shall include achieving the following objectives within the time periods designated below following the Effective Date:

 

(a)                                 Pre-Sales Requirements.

 

(i)                                     Within six (6) months after the Effective Date, Licensee shall furnish BIDMC with a written research and development plan, which research and development plan may thereafter be amended by Licensee in its discretion as necessary, describing the major tasks to be achieved in order to bring to market a Patented Product.

 

(ii)                                  By the third (3rd) anniversary of the Effective Date, Licensee (or an Affiliate or Sublicensee) shall initiate a clinical trial for an ALK1 Product in a Patented Use.

 

(iii)                               By the seventh (7th) anniversary of the Effective Date, Licensee (or an Affiliate or Sublicensee) shall initiate a Phase 3 Clinical Trial for an ALK1 Product in a Patented Use.

 

(iv)                              By the twelfth (12th) anniversary of the Effective Date, Licensee (or an Affiliate or Sublicensee) shall file for regulatory approval to market a Patented Product.

 

(b)                                 Post-Sales Requirements. Following the First Commercial Sale in any country in the Territory, Licensee shall itself or through its Affiliates and/or Sublicensees make continuing Sales in such country without any elapsed time period of one (1) year or more in which such Sales do not occur.

 

(c)                                  Satisfaction of Diligence Obligations; Adjustment of Diligence Obligations. Achievement of the objectives set forth in Sections 3.1(a) and 3.1(b) shall be deemed to satisfy Licensee’s obligations to use commercially reasonable efforts under this Section 3.1.  The diligence requirements established in Sections 3.1(a)

 

7

 

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and 3.1(b) may be adjusted from time to time by written mutual agreement signed by both parties, for example as the case where a regulatory action or requirement causes time to elapse without continuing sales after the First Commercial Sale. In addition, in the event that circumstances beyond Licensee’s reasonable control prevent Licensee from meeting its obligations set forth in this Section 3.1, Licensee may so notify BIDMC, and the Parties shall negotiate in good faith an adjustment to the requirements set forth in Section 3.1.

 

3.2                               Diligence Failures.  If BIDMC determines that any of the obligations under Section 3.1 have not been fulfilled, then BIDMC may treat such failure as a default and may terminate this Agreement in accordance with the terms set forth in Section 10.4.

 

3.3                               Diligence Reports.  Licensee shall provide all reports with respect to its obligations under Section 3.1 as set forth in Article 5.

 

4.                                      PAYMENTS AND ROYALTIES

 

4.1                               License Issue Fee.  Licensee shall pay BIDMC a non-refundable, non-creditable license issue fee in the sum of [* * *] within fifteen (15) days of execution of this Agreement.

 

4.2                               Annual License Maintenance Fee.  Licensee shall pay to BIDMC the following non-refundable and non-creditable amounts as an annual license maintenance fee within thirty (30) days after each of the following anniversaries of the Effective Date:

 

(a)                                 the first anniversary of the Effective Date: [* * *]; and

 

(b)                                 the second anniversary and on each subsequent anniversary of the Effective Date thereafter: [* * *].

 

The annual license maintenance fee shall not be due at the end of any year in which a milestone or royalty payment (including minimum annual royalties) is made.

 

4.3                               Milestone Payments.  In addition to the payments set forth in Sections 4.1 and 4.2 above, within forty-five (45) days after the date of achievement by Licensee, a Licensee Affiliate or a Sublicensee of the milestones below, Licensee shall pay BIDMC the non-refundable milestone payments indicated.  Payments will only be due in respect of the first achievement of the milestone events below for each Patented Product or, as applicable, for an ALK1 Product for a Patented Use.  Each such milestone payment shall be payable only one time per Patented Product or, as applicable, per ALK1 Product, and shall not be creditable against any royalties due in the same year.

 

8

 

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Pre-Market Milestones
    	
 
    	
Payments
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Enrollment of first patient in the first clinical   trial initiated after the Effective Date with an ALK1 Product for a Patented   Use:
    	
 
    	
$
    	
[* * *]
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Enrollment of first patient in the second clinical   Trial initiated after the Effective Date with an ALK1 Product for a Patented   Use:
    	
 
    	
$
    	
[* * *]
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Enrollment of first patient in the first Phase 3   Clinical Trial with an ALK1 Product for a Patented Use:
    	
 
    	
$
    	
[* * *]
    	
 
    

 

	
Post-Market Milestones
    	
 
    	
Payments
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
First commercial sale of a Patented Product:
    	
 
    	
$
    	
[* * *]
    	
 
    
					

 

In the event that BIDMC 1569 inventors Rupal Bhatt or James Mier participate in research directly relating to the subject matter of the Patent Rights during the term of the Agreement, Licensor shall so inform Licensee and pre-market milestone payments thereafter due shall be waived from that timepoint forward, and the post-market milestone payment due upon first commercial sale of a Patented Product shall change from $[* * *] to the sum of $[* * *] plus any waived milestone payments.

 

4.4                               Royalties.

 

(a)                                 Beginning with the First Commercial Sale in any country in the Territory, Licensee shall pay BIDMC a royalty of [* * *] on Net Sales in such country.

 

(b)                                 Within thirty (30) days after the first anniversary of the first event of a First Commercial Sale in any country and on each subsequent anniversary of such First Commercial Sale thereafter, Licensee shall pay to BIDMC [* * *] as a non-refundable minimum annual royalty, payable only once per year, regardless of the number of countries in which the Product is sold; such annual minimum royalty shall be credited against royalties subsequently due on Net Sales, if any, made during the same calendar year, but shall not be credited against royalties due on Net Sales, if any, made in any other year.

 

(c)                                  All payments due to BIDMC under this Section 4 shall be due and payable by Licensee within sixty (60) days after the end of each Reporting Period, and shall be accompanied by a report as set forth in Section 5.3.

 

4.5                               Form of Payment.  All payments due under this Agreement shall be drawn on a United States bank and shall be payable in United States dollars.  Each payment shall reference this Agreement and identify the obligation under this Agreement that the payment satisfies.  Conversion of foreign currency to U.S. dollars shall be made at the conversion rate existing in the United States, as reported in The Wall Street Journal, on the last working day of the applicable Reporting Period.  To the extent that Licensee is required to deduct and withhold taxes

 

9

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

on any payments to BIDMC, Licensee shall pay the amounts of such taxes to the proper governmental authority in a timely manner and transmit to BIDMC in a timely manner an official tax certificate or other evidence of such withholding sufficient to enable BIDMC to claim such payments of taxes. BIDMC shall provide to Licensee any tax forms that may be reasonably necessary in order for Licensee not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. Each Party shall provide the other Party with reasonable assistance to enable the recovery, as permitted by law, of withholding taxes, VAT, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the party bearing such withholding tax or VAT.  Checks for all payments due to BIDMC under this Agreement shall be made payable to BIDMC and addressed as set forth in Section 13.2.

 

4.6                               Overdue Payments.  The payments due under this Agreement shall, if overdue, bear interest at two percentage points above the Prime Rate of interest as reported in the Wall Street Journal on the date payment is due until payment thereof, not to exceed the maximum permitted by law.  Any such overdue payments when made shall be accompanied by all interest so accrued.  Payment and acceptance, in whole or in part, of interest and the overdue payment shall not preclude BIDMC from exercising any other rights it may have as a consequence of the lateness of any payment.  Any payment that is subject to a bona fide dispute shall not be subject to this Section 4.6 for the time that the parties are attempting, in good faith, to resolve such dispute.

 

4.7                               Consequences of a Patent Challenge.  In the event that (a) Licensee, any of its Affiliates, or any Sublicensee brings a Patent Challenge against BIDMC, or (b) Licensee, any of its Affiliates, or any Sublicensee assists another party in bringing a Patent Challenge against BIDMC (except as required under a court order or subpoena), and, in either such case, BIDMC does not choose to exercise its rights to terminate this Agreement pursuant to Section 10.5, then if such a Patent Challenge is successful, Licensee will have no right to recoup any monies paid during the period of challenge.

 

5.                                      REPORTS AND RECORDS

 

5.1                               Diligence Reports.  Within thirty (30) days after the end of each calendar year, Licensee shall report in writing to BIDMC on progress made toward the due diligence obligations set forth in Section 3.1 during such preceding 12 month period, including, without limitation, progress on research and development, status of applications for regulatory approvals, manufacturing, sublicensing and the number of sublicenses entered into and marketing.

 

5.2                               Milestone Achievement Notification.  Licensee shall report to BIDMC the dates on which it achieves the milestones set forth in Section 4.3 within forty-five (45) days of each such occurrence.

 

5.3                               Sales Reports.  Licensee shall report to BIDMC the date on which it achieves the First Commercial Sale in each country of the Territory within thirty (30) days of each such occurrence.  Following the First Commercial Sale, Licensee shall deliver reports to BIDMC

 

10

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

within sixty (60) days after the end of each Reporting Period.  Each report under this Section 5.3 shall have substantially the format outlined in Appendix B, shall be certified as correct by an officer of Licensee and shall contain at least the following information as may be pertinent to a royalty accounting hereunder for the immediately preceding Reporting Period:

 

(a)                                 the number of Patented Products Sold by Licensee, its Affiliates, and Sublicensees in each country;

 

(b)                                 the amounts billed, invoiced and received by Licensee, its Affiliates, and Sublicensees for each Patented Product, in each country, and total billings or payments due or made for all Patented Products;

 

(c)                                  calculation of Net Sales for the applicable Reporting Period in each country, including an itemized listing of permitted offsets and deductions;

 

(d)                                 total royalties payable on Net Sales in U.S. dollars, together with the exchange rates used for conversion; and

 

(e)                                  any other payments due to BIDMC under this Agreement.

 

If no amounts are due to BIDMC for any Reporting Period, the report shall so state.

 

5.4                               Audit Rights.  Licensee shall maintain, and shall cause each of its Affiliates and Sublicensees to maintain, complete and accurate records relating to the rights and obligations under this Agreement and any amounts payable to BIDMC in relation to this Agreement, which records shall contain sufficient information to permit BIDMC and its representatives to confirm the accuracy of any payments and reports delivered to BIDMC and compliance in all other respects with this Agreement.  Licensee shall retain and make available, and shall cause each of its Affiliates and Sublicensees to retain and make available, such records for at least five (5) years following the end of the calendar year to which they pertain, to BIDMC and/or its representatives, at BIDMC’s expense and upon at least fifteen (15) days’ advance written notice, for inspection during normal business hours.  If any examination conducted by BIDMC or its representatives pursuant to the provisions of this Section show an underreporting or underpayment of five percent (5%) or more, Licensee shall bear the full cost of such audit and shall remit any amounts due to BIDMC (including interest due in accordance with Section 4.6) within thirty (30) days of receiving notice thereof from BIDMC.

 

6.                                      PATENT PROSECUTION AND MAINTENANCE

 

6.1                               Prosecution.  Provided that Licensee seeks and maintains the strongest and broadest reasonable patent claims in the best interests of all owners of the Patent Rights and uses patent attorneys acceptable to BIDMC, such acceptance not to be unreasonably withheld, BIDMC appoints Licensee as its agent to prepare, file, prosecute, and maintain all of the Patent Rights during the Term.  Licensee shall pay Licensee’s patent counsel directly for any invoiced Patent Costs and agrees to indemnify, defend and hold BIDMC harmless from and against any and all

 

11

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

liabilities, damages, costs and expenses incurred by or imposed upon BIDMC in connection with any third party claim arising from the failure of Licensee to timely pay such invoices.  Licensee shall instruct patent counsel to provide copies to BIDMC for BIDMC’s administrative files of all invoices detailing Patent Costs which are sent directly to Licensee and inform patent counsel that in no case shall BIDMC be liable for any Patent Costs incurred at the instruction of Licensee.  Licensee shall copy BIDMC on all patent prosecution documents and give BIDMC reasonable opportunities to advise Licensee on such filing, prosecution and maintenance.

 

In the event Licensee desires to abandon any patent, patent application, or any patent claims within the Patent Rights, Licensee shall provide BIDMC with reasonable prior written notice of such intended abandonment.  If Licensee determines to abandon such patent or patent application without filing a divisional or continuing application directed to similar subject matter, then, at its sole discretion, BIDMC may assume the right to prepare, file, prosecute and maintain the relevant Patent Rights at BIDMC’s expense.  In such event, if such abandonment is in the European Union., United States or Japan, such BIDMC paid-for rights shall be removed from the definition of Patent Rights under this Agreement, the licenses granted to Licensee and its Affiliates as to such rights under this Agreement shall terminate, except that, for the avoidance of doubt, Licensee shall retain the rights as set forth in the MTA, and BIDMC shall have the right to abandon or maintain and license its interest in such Patent Rights in its discretion.  In the event Licensee (i) fails to maintain any of the Patent Rights and has not complied with the last sentence of the first paragraph of this Section 6.1, or (ii) fails to notify BIDMC of its intent to abandon such Patent Rights, in accordance with this Section, Licensee shall indemnify, defend and hold BIDMC harmless from and against costs and liabilities to any third parties that are associated with the recovery of or loss of any such Patent Rights.

 

In the event that License is obligated to indemnify BIDMC pursuant to this Section 6.1, such indemnification obligation shall be on the term set forth in Section 8.1.

 

6.2                               Copies of Documents.  With respect to any Patent Right licensed hereunder, Licensee shall instruct the patent counsel prosecuting such Patent Right to (i) copy BIDMC on patent prosecution documents that are received from or filed with the United States Patent and Trademark Office and foreign equivalent, as applicable; (ii) if requested by BIDMC, provide BIDMC with copies of draft submissions to the USPTO prior to filing; and (iii) give consideration to the comments and requests of BIDMC or its patent counsel.

 

6.3                               Licensee’s Election Not to Proceed.  Licensee may elect to surrender any patent or patent application, on a country-by-country or Patent-by-Patent basis, in Patent Rights in any country upon sixty (60) days advance written notice to BIDMC.  Notwithstanding such election to surrender any such patent or patent application, for the avoidance of doubt, Licensee shall retain all rights under the MTA. Such notice shall relieve Licensee from the obligation to pay for future Patent Costs but shall not relieve Licensee from responsibility to pay Patent Costs incurred prior to the expiration of the sixty (60) day notice period.  Such U.S. or foreign patent application or patent shall thereupon cease to be a Patent Right hereunder and BIDMC shall be free to license its rights to that particular U.S. or foreign patent application or patent to any other party on any

 

12

 

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terms.  For the avoidance of doubt, nothing in this Article 6 shall be interpreted as abrogating any rights Licensee may have with regard to the Patent Rights by virtue of joint ownership therein.

 

6.4                               Confidentiality of Prosecution and Maintenance Information.  Each Party agrees to treat all information related to prosecution and maintenance of Patent Rights as Confidential Information in accordance with the provisions of Appendix C.

 

7.                                      THIRD PARTY INFRINGEMENT AND LEGAL ACTIONS

 

7.1                               Licensee Right to Prosecute.  Licensee shall have the first right, but not the obligation, to initiate legal proceedings to protect the Patent Rights from infringement, with respect to a claim of a Patent Right in the Field in the Territory, and prosecute infringers at Licensee’s expense.  Before commencing such action, Licensee and, as applicable, any Affiliate, shall consult with BIDMC concerning the advisability of bringing suit, the selection of counsel and the jurisdiction for such action (provided Licensee must have BIDMC’s prior written consent, such consent to not be unreasonably withheld, conditioned or delayed, with respect to selection of jurisdiction for any action in which BIDMC may be joined as a party-plaintiff) and shall consider the views of BIDMC regarding the proposed action, especially but without limitation with respect to potential effects on the public interest.

 

7.2                               BIDMC Right to Prosecute.  In the event that Licensee elects not to take action pursuant to this Section 7.1, Licensee shall so notify BIDMC promptly in writing of its intention in good time to enable BIDMC to meet any deadlines by which an action must be taken to establish or preserve any enforcement rights, and BIDMC shall have the right to take steps to protect the Patent Rights from infringement, with respect to a claim of a Patent Right in the Field in the Territory, and prosecute infringers at BIDMC’s expense.  If BIDMC notifies Licensee that it intends to so prosecute, BIDMC shall use reasonable efforts, within three (3) months of its notice to Licensee, to (i) cause such infringement to terminate; (ii) reach a settlement with infringer; or (iii) initiate legal proceedings against the infringer. Nothing in this Section 7.2 shall be construed to prevent Licensee from initiating legal proceedings, in accordance with their independent judgment of the merits of an infringement action, as provided in Section 7.1.

 

7.3                               BIDMC Joining as a Party-Plaintiff.  If Licensee elects to commence an action as described in Section 7.1 above, BIDMC shall have, in its sole discretion and at its own expense, the option to voluntarily join such action as a party-plaintiff.

 

7.4                               Notice of Actions; Settlement.  Licensee shall promptly inform BIDMC of any action or suit relating to Patent Rights and shall not enter into any settlement, consent judgment or other voluntary final disposition of any action relating to Patent Rights, including but not limited to appeals, that imposes any liability on BIDMC or binds BIDMC to any contractual relationship or admits the invalidity or unenforceability of any Patent Rights, without the prior written consent of BIDMC, which shall not be unreasonably withheld or delayed.

 

7.5                               Cooperation.  If necessary to enable any enforcement action undertaken by either Party, the Parties agree to be joined as parties to such enforcement action.  Each Party agrees to

 

13

 

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cooperate reasonably in any action under this Article 7 which is controlled by the other Party, provided that the controlling party reimburses the cooperating party for any costs and expenses incurred by the cooperating party in connection with providing such assistance, except for the expense of any independent counsel retained by BIDMC in accordance with Section 7.3.  Such controlling party shall keep the cooperating party informed of the progress of such proceedings and shall make its counsel available to the cooperating party.  The cooperating party shall also be entitled to independent counsel in such proceedings but at its own expense, said expense to be offset against any damages received by the Party bringing suit in accordance with Section 7.6.

 

7.6                               Recovery.  Any award paid by third parties as the result of such proceedings (whether by way of settlement or otherwise) shall first be applied to reimbursement of any legal fees and expenses incurred by both Parties, in proportion to their expenditures, and then the remainder, if any, shall be distributed between the Parties as follows [provided however that in any award paid by third parties as a result of a settlement or other dispute resolution that does not result in a finding of infringement and damages calculated in a manner described in part (a)(i) below, all payments shall be deemed to be of the type described in part (a)(i) below and BIDMC shall receive only the amount provided in part (a)(ii) below]:

 

(a)                                 (i)                                     Licensee shall receive an amount equal to its lost profits or a reasonable royalty on the infringing sales, or whichever measure of damages the court shall have applied; and

 

(ii)                                  BIDMC shall receive an amount equal to the royalties and other amounts that Licensee would have paid to BIDMC if Licensee had Sold the infringing Patented Products rather than the infringer; and

 

(b)                                 only in the case of a decision of patent infringement in which damages are calculated in a manner described in Part(a)(i) above, the balance, if any, remaining after Licensee and BIDMC have been compensated under Section 7.6(a), shall be shared pro rata. To determine BIDMC’s pro rata distribution, the balance will be multiplied by the following fractions:

 

(i)                                     the number of patents within the Patent Rights found to be enforceable and infringed divided by the total number of patents in suit found to be enforceable and infringed; and

 

(ii)                                  the number of BIDMC inventors divided by all inventors named in the relevant Licensed Patents.

 

14

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

8.                                      INDEMNIFICATION AND INSURANCE

 

8.1                               Indemnification.

 

(a)                                 Licensee shall indemnify, defend and hold harmless BIDMC and its Affiliates and their respective trustees, directors, officers, medical and professional staff, employees, and agents and their respective successors, heirs and assigns (the “Indemnitees”), against any liability, damage, loss or expense (including reasonable attorney’s fees and expenses of litigation) incurred by or imposed upon the Indemnitees or any one of them in connection with any third party claims, suits, actions, demands or judgments arising out of any theory of liability, including without limitation, any theory of product liability (including, but not limited to, actions in the form of contract, tort, warranty, or strict liability) concerning any product, process, or service made, used or sold pursuant to any right or license granted under this Agreement.

 

(b)                                 BIDMC shall endeavor to promptly notify Licensee in writing for any claim of indemnification hereunder.  Licensee agrees, at its own expense, to provide attorneys reasonably acceptable to the BIDMC to defend against any actions brought or filed against any party indemnified hereunder with respect to the subject of indemnity contained herein, whether or not such actions are rightfully brought; provided, however, that any Indemnitee shall have the right to retain its own counsel, at the expense of Licensee, if Licensee’s defense of such claim by counsel retained by Licensee would create an actual or potential conflict of interest.  Licensee agrees to keep BIDMC informed of the progress in the defense and disposition of such claim and to consult with BIDMC prior to any proposed settlement.  For purposes of clarity, Licensee shall manage the defense it underwrites for the claim of indemnification hereunder and shall be relieved of its indemnification obligation to the extent a delay by BIDMC in notifying Licensee materially impairs the Licensee’s ability to defend such a claim.

 

(c)                                  This Section 8.1 shall survive expiration or termination of this Agreement.

 

8.2                               Insurance.

 

(a)                                 Beginning at such time as any such product, process or service is being commercially distributed, sold, leased or otherwise transferred, or performed or used (other than for the purpose of obtaining regulatory approvals), by Licensee, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in amounts not less than $2,000,000 per incident and $2,000,000 annual aggregate and naming the Indemnitees as additional insureds.  Such commercial general liability insurance shall provide (i) product liability coverage and (ii) broad form contractual liability coverage for the indemnification obligations under Section 8.1 of this Agreement.  Licensee may not elect to self-insure without (a) providing to BIDMC certification of adequate insurance and (b) securing BIDMC’s written approval, such approval not to be unreasonably withheld.  The minimum amounts of insurance coverage required under this Section 8.2 shall not be construed to create a limit of liability with respect to the indemnification obligations under Section 8.1 of this Agreement.

 

(b)                                 Licensee shall provide BIDMC with written evidence of such insurance upon request of BIDMC.  Licensee shall provide BIDMC with written notice at least fifteen

 

15

 

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(15) days prior to the cancellation, non-renewal or material change in such insurance; if Licensee does not obtain replacement insurance providing comparable coverage prior to the expiration of such fifteen (15) day period, BIDMC shall have the right to terminate this Agreement effective at the end of such fifteen (15) day period without notice or any additional waiting periods.

 

(c)                                  Licensee shall maintain such commercial general liability insurance beyond the expiration or termination of this Agreement during (i) the period that any such product, process or service is being commercially distributed, sold, leased or otherwise transferred, or performed or used (other than for the purpose of obtaining regulatory approvals), by Licensee or by a licensee, affiliate or agent of Licensee and (ii) a reasonable period after the period referred to in (c) (i) above which in no event shall be less than ten (10) years.

 

(d)                                 This Section 8.2 shall survive expiration of termination of this Agreement.

 

8.3                               Affiliates and Sublicensees.  Licensee shall require all its Affiliates and Sublicensees to comply with the provisions and obligations under this Article 8 as if such entity were the Licensee.

 

9.                                      DISCLAIMER OF WARRANTIES; LIMITATION OF LIABILITY

 

9.1                               No Warranties.  BIDMC HEREBY DISCLAIMS AND MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, CONCERNING THE PATENT RIGHTS AND ANY OF THE RIGHTS GRANTED HEREUNDER, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, VALIDITY OF PATENT RIGHTS CLAIMS, WHETHER ISSUED OR PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE.  SPECIFICALLY, AND NOT TO LIMIT THE FOREGOING, BIDMC MAKES NO WARRANTY OR REPRESENTATION (i) REGARDING THE VALIDITY OR SCOPE OF ANY OF THE CLAIM(S), WHETHER ISSUED OR PENDING, OF ANY OF THE PATENT RIGHTS, AND (ii) THAT THE EXPLOITATION OF THE PATENT RIGHTS OR ANY PATENTED PRODUCT OR PROCESS WILL NOT INFRINGE ANY PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF BIDMC OR OF ANY THIRD PARTY.

 

9.2                               Limitation of Liability.  IN NO EVENT SHALL EITHER PARTY OR ANY OF THEIR AFFILIATES OR ANY OF THEIR RESPECTIVE TRUSTEES, DIRECTORS, OFFICERS, MEDICAL AND PROFESSIONAL STAFF, EMPLOYEES AND AGENTS BE LIABLE TO THE OTHER PARTY OR ANY OF THEIR AFFILIATES OR SUBLICENSEES FOR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND ARISING IN ANY WAY OUT OF THIS AGREEMENT OR THE LICENSE RIGHTS GRANTED HEREUNDER, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, INCLUDING WITHOUT LIMITATION ECONOMIC DAMAGES OR INJURY TO PROPERTY OR LOST PROFITS, REGARDLESS OF WHETHER THE APPLICABLE PARTY

 

16

 

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SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING.

 

10.                               TERM AND TERMINATION

 

10.1                        Expiration of Agreement. This Agreement shall expire on a country-by-country and Patented Product-by-Patented Product basis at the end of the applicable Term, at which time the License in such country with respect to such Patented Product shall be fully paid, irrevocable and perpetual.

 

10.2                        Termination for Failure to Pay.  If Licensee fails to make any payment due hereunder, BIDMC shall have the right to terminate this Agreement upon fifteen (15) business days written notice, unless Licensee makes such payments plus any interest due, as set forth in Section 4.6, within said fifteen (15) day notice period.  If payments are not made, BIDMC may immediately terminate this Agreement at the end of said fifteen (15) day period.

 

10.3                        Termination for Insurance and Insolvency.  BIDMC may terminate this Agreement immediately upon written notice with no further notice obligation or opportunity to cure if Licensee fails to maintain or replace the insurance required by Section 8.2 or if Licensee shall become insolvent, shall make an assignment for the benefit of creditors, or shall have a petition in bankruptcy filed for or against it.

 

10.4                        Termination for Non-Financial Default.  If Licensee, any of its Affiliates, or any Sublicensee shall default in the performance of any of its obligations under this Agreement (excluding as provided for in Sections 10.2 and 10.3), including but not limited to its obligations under Section 3.1(b), and if such default has not been cured within sixty (60) days after notice by BIDMC in writing of such default, then at the end of such cure period, BIDMC may, at its option, in its sole discretion, either (i) terminate any licenses granted hereunder with respect to the country or countries in which such default has occurred, or (ii) terminate the Agreement in its entirety; provided that, if such default is a default of Licensee’s obligations under Section 3.1(b), then BIDMC may only terminate the licenses granted hereunder pursuant to clause (i) with respect to the country or countries in which such default has occurred. Notwithstanding the foregoing, if any default by Licensee cannot reasonably be cured within the sixty (60) day period described in the preceding sentence, and Licensee within such sixty (60) day period provides BIDMC with a plan to cure such default, BIDMC may not terminate all or any portion of this Agreement as a result of such default so long as Licensee continues to use commercially reasonable efforts to cure such default in accordance with such plan. All cure periods arising under this Section 10.4 shall be tolled during the pendency of any bona fide dispute regarding the occurrence of a default by Licensee.

 

10.5                        Patent Challenge.  During the Term:

 

(a)                                 If Licensee or any of its Affiliates brings a Patent Challenge against BIDMC, or assists others in bringing a Patent Challenge against BIDMC (except as required under a

 

17

 

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court order or subpoena), then BIDMC may immediately terminate this Agreement and/or the license granted hereunder.

 

(b)                                 If a Sublicensee brings a Patent Challenge or assists another party in bringing a Patent Challenge (except as required under a court order or subpoena), then BIDMC may send a written demand to Licensee to terminate such sublicense agreement.  If Licensee fails to so terminate such sublicense within thirty (30) days after BIDMC’s demand, or cause Sublicensee to terminate such Patent Challenge, BIDMC may immediately terminate this Agreement and/or any licenses granted hereunder.

 

10.6                        Termination by Licensee.  Licensee shall have the right to terminate this Agreement by giving ninety (90) days advance written notice to BIDMC.

 

10.7                        Effects of Termination of Agreement.

 

(a)                                 General.  Upon termination of this Agreement or any of the licenses hereunder for any reason, final reports in accordance with Article 5 shall be submitted to BIDMC and all royalties and other payments, including without limitation any unreimbursed Patent Costs, accrued or due to BIDMC as of the termination date shall become immediately payable.  The termination or expiration of this Agreement or any licenses granted hereunder shall not relieve Licensee, its Affiliates or Sublicensees of obligations arising before such termination or expiration.  The terms of the MTA shall survive any termination of this Agreement, including all licenses granted by BIDMC to Licensee thereunder.  For the avoidance of doubt, no termination of this Agreement shall abrogate any rights Licensee may have with regard to the Patent Rights by virtue of joint ownership therein.

 

(b)                                 Survival.  The following provisions shall survive the expiration or termination of this Agreement:  Articles 1, 4 (to the extent relevant to final Sales), 5, 8, 9 and 12 and Section 10.7.

 

11.                               COMPLIANCE WITH LAW

 

11.1                        Compliance.  Licensee shall have the sole obligation for compliance with, and shall ensure that any Affiliates and Sublicensees comply with, all government statutes and regulations that relate to Patented Products, including, but not limited to, those of the Food and Drug Administration and the Export Administration, and any applicable laws and regulations of any other country in the Territory.  Licensee agrees that it shall be solely responsible for obtaining any necessary licenses to export, re-export, or import Patented Products covered by Patent Rights and/or Confidential Information and that it will indemnify, defend, and hold BIDMC harmless (in accordance with Section 8.1) for the consequences of any violation by Licensee, its Affiliates or Sublicensees of any such laws or regulations.

 

18

 

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12.                               ASSIGNMENT

 

12.1                        Assignment.  This Agreement is personal to Licensee and no rights or obligations may be assigned by Licensee without the prior written consent of BIDMC, except that Licensee may assign its rights and obligations under this Agreement to an Affiliate or to a successor in connection with the merger, consolidation, or sale of all or substantially all of its assets or equity or that portion of its business to which this Agreement relates (“Assignment”); provided, however, that (i) this Agreement shall immediately terminate if the proposed assignee fails to agree in writing to be bound by the terms and conditions of this Agreement on or before the effective date of the Assignment; and (ii) Licensee shall pay to BIDMC on or before the effective date of the Assignment a fee in the amount of ten thousand U.S. dollars ($10,000).  Licensee shall provide a copy of all assignment documents and related agreements to BIDMC within thirty (30) days of such Assignment.

 

13.                               MISCELLANEOUS

 

13.1                        Entire Agreement.  This Agreement and the MTA constitutes the entire understanding between the Parties with respect to the subject matter hereof.

 

13.2                        Notices.  Any notice, communication or payment required or permitted to be given or made hereunder shall be in writing and, except as otherwise expressly provided in this Agreement, shall be deemed given or made and effective (i) when delivered personally; or (ii) when delivered by telex or telecopy(if not a payment); or (iii) when received if sent by overnight express or mailed by certified, registered or regular mail, postage prepaid, addressed to parties at their address stated below, or to such other address as such party may designate by written notice in accordance with the provisions of this Agreement.

 

	
BIDMC:
    	
Attn:   Mark Chalek
    
	
 
    	
Chief, Business Ventures
    
	
 
    	
Beth Israel Deaconess Medical Center
    
	
 
    	
330 Brookline Avenue, FN2
    
	
 
    	
Boston, MA 02215
    
	
 
    	
Fax # 617-667-0537
    
	
 
    	
 
    
	
With a copy to:
    	
General   Counsel
    
	
 
    	
Legal Department
    
	
 
    	
CareGroup, Inc.
    
	
 
    	
109 Brookline Avenue, Suite 300
    
	
 
    	
Boston, MA 02215
    
	
 
    	
 
    
	
LICENSEE:
    	
Acceleron Pharma, Inc.
    
	
 
    	
Attn: Dr. John Knopf
    
	
 
    	
Chief Executive Officer
    
	
 
    	
128 Sidney Street
    
	
 
    	
Cambridge, MA 02139
    

 

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Fax # 617-649-9988
    
	
 
    	
 
    
	
With a copy to:
    	
Ropes &   Gray LLP
    
	
 
    	
Attn: Marc Rubenstein
    
	
 
    	
800 Boylston St., Prudential Tower
    
	
 
    	
Boston, MA 02199
    
	
 
    	
Fax # 617-235-0706
    

 

13.3                        Amendment; Waiver.  This Agreement may be amended and any of its terms or conditions may be waived only by a written instrument executed by an authorized signatory of the Parties or, in the case of a waiver, by the Party waiving compliance.  The failure of either Party at any time or times to require performance of any provision hereof shall in no manner affect its rights at a later time to enforce the same.  No waiver by either Party of any condition or term shall be deemed as a further or continuing waiver of such condition or term or of any other condition or term.  Notwithstanding the foregoing, except for disputes relating to errors of fact of the type that may be discovered in an audit pursuant to Section 5.4, neither Party may dispute a payment made hereunder more than six (6) months after the date such payment is accepted by the payee.

 

13.4                        Binding Effect.  This Agreement shall be binding upon and inure to the benefit of and be enforceable by the Parties hereto and their respective permitted successors and assigns.

 

13.5                        Force Majeure.  Neither Party shall be responsible for delays resulting from fire, explosion, flood, war, sabotage, strike or riot, or similar causes beyond the reasonable control of such Party, provided that the nonperforming Party uses commercially reasonable efforts to avoid or remove such causes of nonperformance and continues performance under this Agreement with reasonable dispatch whenever such causes are removed.

 

13.6                        Use of Name.  Neither Party shall use the name of the other Party or of any trustee, director, officer, staff member, employee, student or agent of the other Party or any adaptation thereof in connection with the activities contemplated under this Agreement in any advertising, promotional or sales literature, publicity or in any document employed publicly to obtain funds or financing without the prior written approval of the Party or individual whose name is to be used.  Nothing in this Section 13.6 shall prevent either Party from providing appropriate scientific citation in any public document.

 

13.7                        Governing Law.  This Agreement shall be governed by and construed and interpreted in accordance with the laws of the Commonwealth of Massachusetts, excluding with respect to conflict of laws, except that questions affecting the construction and effect of any patent shall be determined by the law of the country in which the patent shall have been granted.  Each Party agrees to submit to the exclusive jurisdiction of the Superior Court for Suffolk County, Massachusetts, and the United States District Court for the District of Massachusetts with respect to any claim, suit or action in law or equity arising in any way out of this Agreement or the subject matter hereof.

 

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13.8                        BIDMC Policies.  Licensee acknowledges that BIDMC’s employees and medical and professional staff members and the employees and staff members of BIDMC’s Affiliates are subject to the applicable policies of BIDMC and such Affiliates, including, without limitation, policies regarding conflicts of interest, intellectual property and other matters.  BIDMC shall provide Licensee, at Licensee’s request, with copies of any such policies applicable to any such employee or staff member.

 

13.9                        Severability.  If any provision(s) of this Agreement are or become invalid, are ruled illegal by any court of competent jurisdiction or are deemed unenforceable under then current applicable law from time to time in effect during the term hereof, it is the intention of the parties that the remainder of this agreement shall not be effected thereby.  It is further the intention of the parties that in lieu of each such provision which is invalid, illegal or unenforceable, there be substituted or added as part of this Agreement a provision which shall be as similar as possible in economic and business objectives as intended by the parties to such invalid, illegal or enforceable provision, but shall be valid, legal and enforceable.

 

13.10                 Interpretation.  The parties hereto are sophisticated, have had the opportunity to consult legal counsel with respect to this transaction and hereby waive any presumptions of any statutory or common law rule relating to the interpretation of contracts against the drafter.

 

13.11                 Headings.  All headings are for convenience only and shall not affect the meaning of any provision of this Agreement.

 

13.12                 Dispute Resolution.

 

(a)                                 Subject to Section 13.3 and 13.12(b) below, if a dispute arises between the Parties relating to the interpretation or performance of this Agreement or the grounds for the termination thereof, the Parties agree to hold a meeting, attended by individuals with decision-making authority regarding the dispute, to attempt in good faith to negotiate a resolution of the dispute prior to pursuing other available remedies.  If the dispute remains unresolved sixty (60) days after the above-mentioned meeting, then each party shall have the right to pursue other remedies legally available to resolve the dispute.

 

(b)                                 Subject to Section 13.3, in the event that the BIDMC disputes Licensee’s calculation of Net Sales for a Patented Product that is labeled for a Patented Use and one or more additional uses that are not Patented Uses, BIDMC shall promptly notify Licensee in writing and shall provide Licensee with an alternative calculation of Net Sales.  The Parties shall negotiate in good faith to resolve the dispute for a period of sixty (60) days from the date on which Licensee provides its alternative calculation.  If the dispute remains unresolved at the end of the negotiation period, then the Parties agree to resolve the dispute as follows:  each Party will select a qualified expert with experience in the valuation of pharmaceutical products, and the two experts selected in this manner will select a third qualified expert, provided that the third expert shall have no conflicts of

 

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interest regarding either Party.  After consideration of available information that is reasonably pertinent to the dispute, such information to be kept confidential by the experts and the Parties, the three experts will determine the appropriate calculation of the disputed Net Sales and the Parties will abide by this determination.  The three experts will also determine an appropriate methodology for the calculation of future Net Sales to the extent any subsequent dispute regarding Net Sales involves similar issues as the previously resolved dispute. The Parties will share equally the costs incurred in connection with the valuation experts.

 

(c)                                  Subject to Section 13.3, in the event that a dispute involves a claim of breach or default under Section 10.2 or Section 10.4, then the applicable cure period under such Section shall be tolled during the pendency of any dispute in accordance with this Section 13.12.

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the date first written above.

 

The Effective Date of this License Agreement is Jun 21, 2012.

 

 

	
ACCELERON   PHARMA, INC.
    	
BETH ISRAEL DEACONESS MEDICAL CENTER
    
	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
BY:
    	
/s/   John Knopf
    	
 
    	
BY:
    	
/s/   Mark Chalek
    
	
 
    	
Name:
    	
 
    	
 
    	
Name:
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
TITLE:
    	
CEO
    	
 
    	
TITLE:
    	
Chief,   Technology Ventures
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
DATE:
    	
11/21/12
    	
 
    	
DATE:
    	
11/5/12
    

 

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Appendix A

 

DESCRIPTION OF PATENT RIGHTS

 

Provisional patent applications associated with BIDMC case [* * *]

 

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Appendix B

 

COMMERCIAL SALES REPORTS

 

	
AGREEMENT   INCOME REPORT
    	
Fees, Milestones and Sublicense Income
    
	
 
    	
 
    
	
Agreement # -
    	
 
    
	
Licensee -
    	
 
    
	
Sub-Licensee -
    	
 
    
	
 
    
	
Separate   reports must be filed for Payments associated with each Patented Product:
    
	
 
    
	
Product Name:
    	
 
    
	
 
    	
 
    
	
Report Time Period:
    	
 
    
	
 
    
	
 
    	
From
    	
mm/dd/yyyy
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
To
    	
mm/dd/yyyy
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
PLEASE ATTACH DETAIL AS REQUIRED
    
								

 

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AGREEMENT   INCOME REPORT
    	
Royalty Income
    
	
 
    	
 
    
	
Agreement # -
    
	
Licensee -
    
	
Sub-Licensee -
    
	
 
    	
 
    	
 
    
	
 
    	
Separate reports must be filed for:
    	
 
    
	
 
    	
 
    	
 
    
	
1.
    	
Each Product sold.
    
	
2.
    	
Each country of sale, if different   deductions or royalty rates apply.
    
	
 
    	
 
    
	
Product Name:
    
	
 
    
	
Report Time Period:
    
	
 
    	
 
    
	
 
    	
From
    	
mm/dd/yyyy
    
	
 
    	
 
    	
 
    
	
 
    	
To
    	
mm/dd/yyyy
    
	
 
    
	
Country of Sale
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Quantity Sold
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Net Sales (USD)
    	
$
    	
$
    	
$
    
	
 
    	
 
    	
 
    	
 
    
	
Exchange Rate
    	
 
    	
 
    	
 
    
	
 
    
	
Deductions and   Credits (Itemize)
    
	
 
    	
Please list each deduction and credit   separately.
    
	
 
    	
 
    
	
 
    	
Use same definition as appears in Agreement   and include the contract paragraph as a reference.
    
	
 
    
	
Royalty   Percentage
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Royalty Due
    	
$
    	
$
    	
$
    
								

 

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PLEASE ATTACH DETAIL SALES REPORTS AS REQUIRED

 

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APPENDIX C

 

CONFIDENTIALITY TERMS AND CONDITIONS

 

The following provisions under this Appendix C shall only apply to the Patent Prosecution and Maintenance Information requirements under Section 6,

 

1.                                      Definition of Confidential Information.  “Confidential Information” shall mean any information, including but not limited to data, techniques, protocols or results, or business, financial, commercial or technical information, disclosed by one Party (each a “Discloser” as applicable) to the other Party (each a “Recipient” as applicable) in connection with the terms of that certain Exclusive License Agreement effective as of the Effective Date (the “License Agreement”) and identified as confidential at the time of disclosure (the “Purpose”).  BIDMC’s Confidential Information shall also include all information disclosed by BIDMC to Licensee in connection with the Patent Rights.  Capitalized terms used in this Appendix that are not otherwise defined herein have the meanings ascribed in the License Agreement to which this Appendix is attached and made a part thereof.

 

2.                                      Exclusions.  “Confidential Information” under this Agreement shall not include any information that (i) is or becomes publicly available through no wrongful act of Recipient; (ii) was known by Recipient prior to disclosure by Discloser, as evidenced by tangible records; (iii) becomes known to Recipient after disclosure from a third party having an apparent bona fide right to disclose it; (iv) is independently developed or discovered by Recipient without use of Discloser’s Confidential Information, as evidenced by tangible records; or (v) is disclosed to another party by Discloser without restriction on further disclosure.  The obligations of confidentiality and non-use set forth in this Agreement shall not apply with respect to any information that Recipient is required to disclose or produce pursuant to applicable law, court order or other valid legal process provided that Recipient promptly notifies Discloser prior to such required disclosure, discloses such information only to the extent so required and cooperates reasonably with Discloser’s efforts to contest or limit the scope of such disclosure.

 

3.                                      Permitted Purpose.  Recipient shall have the right to, and agrees that it will, use Discloser’s Confidential Information solely for the Purpose as described in the License Agreement, except that Acceleron shall be permitted to share the Confidential Information with investors, potential investors, lenders, potential lendors, licensees, potential licensees, Sublicensees and potential Sublicensees provided that each third party to whom the Confidential Information is disclosed shall have entered into a written obligation of confidentiality and non-use with Acceleron that is at least as stringent as the obligations set forth in this Appendix C.

 

4.                                      Restrictions.  For the term of the License Agreement and a period of three (3) years thereafter (and indefinitely with respect to any individually identifiable health information disclosed by BIDMC to Licensee, if any), each Recipient agrees that: (i) it will not use such Confidential Information for any purpose other than as specified herein, including without limitation for its own benefit or the benefit of any other person or entity; and (ii) it will use

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

reasonable efforts (but no less than the efforts used to protect its own confidential and/or proprietary information of a similar nature) not to disclose such Confidential Information to any other person or entity except as expressly permitted hereunder.  Recipient may, however, disclose Discloser’s Confidential Information only on a need-to-know basis to its and its Affiliates employees, staff members and agents (“Receiving Individuals”) who are directly participating in the Purpose and who are informed of the confidential nature of such information, provided Recipient shall be responsible for compliance by Receiving Individuals with the terms of this Agreement and any breach thereof.  Each party further agrees not to use the name of the other party or any of its Affiliates or any of their respective trustees, directors, officers, staff members, employees, students or agents in any advertising, promotional or sales literature, publicity or in any document employed to obtain funds or financing without the prior written approval of the party or individual whose name is to be used, in the case of BIDMC such approval to be given by the Public Affairs Department.  This Section 4 shall survive termination or expiration of this Agreement.

 

5.                                      Right to Disclose.  Discloser represents that to the best of its knowledge it has the right to disclose to each Recipient all of Discloser’s Confidential Information that will be disclosed hereunder.

 

6.                                      Ownership.  All Confidential Information disclosed pursuant to this Agreement, including without limitation all written and tangible forms thereof, shall be and remain the property of the Discloser.  Upon termination of this Agreement, if requested by Discloser, Recipient shall return or destroy at Discloser’s discretion all of Discloser’s Confidential Information, provided that Recipient shall be entitled to keep one copy of such Confidential Information in a secure location solely for the purpose of determining Recipient’s legal obligations hereunder.

 

7.                                      No License.  Nothing in this Agreement shall be construed as granting or conferring, expressly or impliedly, any rights by license or otherwise, under any patent, copyright, or other intellectual property rights owned or controlled by Discloser relating to Confidential Information, except as specifically set forth in the License Agreement.

 

8.                                      Remedies.  Each party acknowledges that any breach of this Agreement by it may cause irreparable harm to the other party and that each party is entitled to seek injunctive relief and any other remedy available at law or in equity.

 

9.                                      General.  These Confidentiality Terms and Conditions, along with the License Agreement, contain the entire understanding of the parties with respect to the subject matter hereof, and supersede any prior oral or written understandings between the parties relating to confidential treatment of information.  Sections 1, 2, 4, 7, 10 and 11 of these Confidentiality Terms and Conditions shall survive any expiration or termination of the License Agreement.

 

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