Document:

Exhibit 10.14

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

LICENSE AGREEMENT

 

This License Agreement is effective as of December 20, 2014 (the “Effective Date”), by and between THE SCRIPPS RESEARCH INSTITUTE, a California nonprofit public benefit corporation (“TSRI”), and Corvus Pharmaceuticals, Inc., a Delaware corporation (“Licensee”), each located at the respective address set forth in Section 12.16 below, with respect to the facts set forth below.

 

RECITALS

 

A.                                    TSRI is engaged in fundamental scientific biomedical and biochemical research including research relating to methods of antibody production.

 

B.                                    Licensee is engaged in research and development and commercialization of pharmaceuticals.

 

C.                                    TSRI has disclosed to Licensee certain technology and TSRI has the right to grant a license to the technology, subject to certain rights of the U.S. Government resulting from the receipt by TSRI of certain funding from the U.S. Government.

 

D.                                    TSRI desires to grant to Licensee, and Licensee wishes to acquire from TSRI, a non-exclusive license to certain biological materials of TSRI, all subject to the terms and conditions set forth herein.

 

NOW, THEREFORE, in consideration of the mutual covenants and conditions set forth herein, TSRI and Licensee hereby agree as follows:

 

1.                                      Definitions.  Capitalized terms shall have the meaning set forth herein.

 

1.1                               Affiliate.  The term “Affiliate” shall mean any entity which directly or indirectly controls, or is controlled by Licensee.  The term “control” as used herein means (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares entitled to vote for the election of directors; or (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interests with the power to direct the management and policies of such non-corporate entities.  The term “Licensee” as used throughout this Agreement also includes its Affiliates.

 

1.2                               Confidential Information.  The term “Confidential Information” shall mean any and all proprietary or confidential information of TSRI or Licensee that such party (the “Disclosing Party”) discloses to the other party (the “Receiving Party”) at any time and from time to time during the term of this Agreement.  The provisions of this Agreement shall be considered the Confidential Information of both parties.  Information shall not be considered confidential to the extent that the Receiving Party can establish by competent proof that such information:

 

(a)                                 is publicly available through no fault of the Receiving Party, either before or after it becomes known to the Receiving Party;

 

 

(b)                                 was known to the Receiving Party prior to the date of this Agreement, which knowledge was acquired independently and not from the Disclosing Party (or the Disclosing Party’s employees); or

 

(c)                                  is subsequently disclosed to the Receiving Party in good faith by a third party who is not under any obligation to maintain the confidentiality of such information, and without breach of this Agreement by the Receiving Party.

 

Specific Confidential Information disclosed to a Receiving Party shall not be deemed to be within any of the foregoing exceptions merely because it is (i) embraced by more general information in the public domain or in the Receiving Party’s possession; (ii) a combination of features or data that can be pieced together by combining individual features or data from multiple sources in the public domain or in the Receiving Party’s possession to reconstruct the Confidential Information, but none of which shows the entire combination; and/or (iii) a selection or part of a document or embodiment where other information in the same document or embodiment becomes part of the public domain or in the Receiving Party’s possession.

 

1.3                               Field.  The term “Field” shall mean all fields of use.

 

1.4                               Licensed Product.  The term “Licensed Product” shall mean any product (a) that comprises, utilizes or incorporates any of the Scripps Property, and/or (b) that is discovered, developed or made using any of the Scripps Property.  For clarification, a humanized version of the Scripps Property is considered a Licensed Product.

 

1.5                               Licensed Product Data.  The term “Licensed Product Data” shall mean any data, information or other materials exclusively controlled by Licensee, including without limitation pre-clinical, clinical and other regulatory data, generated or produced by or on behalf of Licensee directly relating to a Licensed Product and which is generated or produced after the Effective Date.

 

1.6                               Major Market Country.  The term “Major Market Country” shall mean any of the following countries:  the United States of America, the United Kingdom, France, Italy, Spain, Germany, Canada and Japan.

 

1.7                               Net Sales.  The term “Net Sales” shall mean the gross amounts invoiced by Licensee and its Sublicensees, or any of them, on all sales of Licensed Products, less the following items, to the extent directly applicable to such sales of Licensed Products (if not previously deducted from the amount invoiced):  (a) reasonable and customary trade, quantity and cash discounts actually granted; (b) reasonable and customary rebates and retroactive price reductions actually granted; (c) credits or allowances actually granted upon claims of nonconforming Licensed Products, rejections or returns of Licensed Products; (d) prepaid freight charges for the delivery of Licensed Products; and (e) sales, use or excise taxes imposed and actually paid on the with sale of Licensed Products (but excluding any value added taxes or taxes based on income or gross receipts).  Net Sales shall include all consideration charged by Licensee or Sublicensees in exchange for any Licensed Products including without limitation any

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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monetary payments or, with regard to any other property paid in exchange for any Licensed Products, an amount in cash equal to the fair market value of such property.  For purposes of determining Net Sales, a sale shall be deemed to have occurred [***].  Sales of Licensed Products by Licensee to a Sublicensee or Affiliate for resale or by a Sublicensee to an Affiliate of Licensee for resale shall be excluded, and only the subsequent sale of such Licensed Products by such Affiliates or Sublicensees to unrelated parties shall be deemed Net Sales hereunder.

 

The deductible items listed in sub-clauses (a) — (e) above shall be either (i) included as line items on the invoice, or (ii) documented as being specifically attributable to actual sales of Licensed Products in accordance with United States Generally Accepted Accounting Principles (“GAAP”) or International Financing Reporting Standards (“IFRS”), as applicable, consistently applied throughout the organization of the selling party, and provided that such amounts are included in [***] Royalty Reports that Licensee sends to TSRI pursuant to Section 5.4.  If Licensee or other selling party receives refunds or reimbursements of any amounts deducted as set forth herein, then such refunded or reimbursed amounts shall be considered Net Sales in the applicable reporting period in which such refunded or reimbursed amounts are received.

 

1.8                               Royalty Report.  The term “Royalty Report” shall have the meaning ascribed to such term as provided in Section 5.4.

 

1.9                               Scripps Property.  The term “Scripps Property” shall mean the materials identified in Exhibit A (which will be supplied by TSRI to Licensee), together with any progeny or mutants of such materials, or unmodified derivatives of such materials [***].

 

1.10                        Sublicensee.  The term “Sublicensee” shall mean any third party to whom Licensee grants a sublicense or similar rights with respect to the rights conferred upon Licensee under this Agreement, as contemplated by Section 2.3.  In addition, “Sublicensee” shall include any and all further third party Sublicensees that may be permitted under Section 2.3.

 

1.11                        Sublicense Revenues.  The term “Sublicense Revenue” shall mean all revenues and other consideration paid to Licensee or to an Affiliate in consideration of [***].  Without limiting the generality of the foregoing, Sublicense Revenues shall include without limitation [***] of Licensee or of an Affiliate, [***], and [***].  Sublicense Revenues include [***], whether set forth [***].  However, Sublicense Revenues shall exclude:  [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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[***] of Licensee or of an Affiliate that[***]; and (iii) [***] conducted after execution of such agreement and where [***] supported by reasonable written documentation.  Any non-cash Sublicense Revenues received by Licensee or by an Affiliate shall be valued at [***] by the parties.

 

2.                                      Grant of License.

 

2.1                               Grant of Non-Exclusive License for Scripps Property.  TSRI hereby grants and Licensee accepts, subject to the terms and conditions of this Agreement, a non-exclusive, worldwide, royalty-bearing license, with limited rights to sublicense pursuant to Section 2.3, to the Scripps Property to make, have made, use, have used, sell, have sold, offer to sell and import Licensed Products in the Field.  Licensee agrees not to practice or use the Scripps Property outside of the scope of the rights granted in this Section 2.1.

 

2.2                               No Additional License.  TSRI agrees that it shall not grant any additional licenses to the Scripps Property during the term of this Agreement except as contemplated by Sections 2.4 and 2.5.

 

2.3                               Sublicensing.  Licensee shall have the right to grant and authorize sublicenses to any party with respect to the rights conferred upon Licensee under this Agreement only with TSRI’s prior written consent, which will not be unreasonably withheld, except that no such prior written consent shall be required for any sublicense to a third party that is granted in conjunction with other proprietary rights of Licensee, or for any sublicense to a third party that is collaborating with Licensee on the development of Licensed Products or performing services for Licensee in connection with Licensed Products.  Sublicensees shall not have the right to further sublicense without TSRI’s prior written consent, which will not be unreasonably withheld, except that such Sublicensees shall have the right to grant further sublicenses to third parties performing services for such Sublicensees with respect to Licensed Products.  Any sublicense granted under this Section 2.3 shall be subject in all respects to the applicable provisions contained in this Agreement (including without limitation the provisions regarding governmental interest, reservation of rights, development efforts, reporting, audit rights, indemnity, insurance, challenges, warranty disclaimer, limitation of liability, confidentiality, and rights upon expiration or termination).  In the event of a conflict between this Agreement and the terms of any sublicense, the terms of this Agreement shall control.  Licensee shall forward to TSRI a copy of any and all fully executed sublicense agreements within thirty (30) days of execution.  Licensee shall at all times be and remain responsible for the compliance by Sublicensees with the terms and conditions of this Agreement, including without limitation the payment of all amounts that may become due hereunder as a result of any Sublicensees’ activities.

 

2.4                               No Other License.  This Agreement confers no license or rights by implication, estoppel or otherwise under any patent applications or patents or intellectual

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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property of TSRI other than the Scripps Property regardless of whether such patent applications, patents or intellectual property are dominant or subordinate to the Scripps Property.

 

2.5                               Governmental Interest.  Licensee and TSRI acknowledge that TSRI has received, and expects to continue to receive, funding from the United States Government in support of TSRI’s research activities.  Licensee and TSRI acknowledge and agree that their respective rights and obligations under this Agreement shall be subject to the rights of the United States Government, existing and as amended, which may arise or result from TSRI’s receipt of research support from the United States Government, including without limitation 37 C.F.R. Part 401, the National Institutes of Health (“NIH”) Grants Policy Statement and the NIH Guidelines for Obtaining and Disseminating Biomedical Research Resources.

 

2.6                               Reservation of Rights.  Notwithstanding Section 2.2, TSRI reserves the right to use for any internal research and educational purposes any Scripps Property licensed hereunder, without TSRI being obligated to pay Licensee any royalties or other compensation or to account to Licensee in any way.  In addition, TSRI reserves the right to grant non-exclusive licenses to use the Scripps Property for internal research and educational purposes to other nonprofit or academic institutions, without the other nonprofit or academic institution being obligated to pay Licensee any royalties or other compensation or to account to Licensee in any way.

 

3.                                      Royalties and Other Payments.

 

3.1                               License Issue Fee.  Licensee shall pay to TSRI a noncreditable, nonrefundable license issue fee in the amount of ten thousand U.S. Dollars (U.S. $10,000) [***] as follows.  TSRI shall transfer the Scripps Property [***].  Licensee shall have [***] from receipt of the Scripps Property to test and validate the Scripps Property.  Should the Scripps Property fail Licensee’s validation, Licensee shall notify TSRI of the test results and shall return Scripps Property received from TSRI.  No License Issue Fees shall be due to TSRI if the Scripps Property fails Licensee’s validation.  Failure of Licensee to make this payment shall render this Agreement null and void (ab initio).

 

3.2                               Annual Fee.  Licensee shall pay to TSRI [***] minimum annual fee in the amount of twenty five thousand Dollars ($25,000).  The first payment is due one year after the Effective Date and on the anniversary of the Effective Date of each subsequent calendar year during the remaining term of this Agreement.  The minimum annual fee shall be credited against running royalties due for that calendar year and Licensee’s Royalty Reports shall reflect such a credit.  The minimum annual fee [***].

 

3.3                               Running Royalties.  Licensee shall pay to TSRI running royalties on a Licensed Product-by-Licensed Product and country-by-country basis in the amount of (a) [***] of Net Sales of Licensed Products that are commercialized by the Licensee, its Affiliates or a Sublicensee.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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3.4                               Royalty Payments.  Licensee shall pay to TSRI all royalties required by this Section 3[***], based upon Net Sales during [***].  Licensee shall make all such royalty payments itself to TSRI, and/or cause its Affiliates or Sublicensees to pay to TSRI all royalties resulting from Net Sales by its Affiliates or Sublicensees, [***].

 

3.5                               Arm’s-Length Transactions.  On sales of Licensed Products which are made in other than an arm’s-length transaction, the value of the Net Sales attributed under this Section 3 to such a transaction shall be that which would have been received in an arm’s-length transaction, based on sales of like quality and quantity products on or about the time of such transaction.

 

3.6                               Duration of Royalty Obligations.  The royalty obligations of Licensee as to each Licensed Product shall [***] of such Licensed Product [***].

 

4.                                      Additional Consideration.

 

4.1                               Sublicense Payments.  All Sublicense Revenues shall be reported and Sublicense Payments (defined below) paid to TSRI by Licensee [***] of such Sublicense Revenues.  Licensee’s reports to TSRI regarding Sublicense Revenues shall contain an explanation and calculation of the amount of Sublicense Payments due to TSRI pursuant to the schedule below.  Licensee’s obligation to pay Sublicense Payments to TSRI shall continue for as long as royalties are due to TSRI pursuant to Section 3.6.  Licensee shall pay to TSRI a [***] percentage of Sublicense Revenues according to the following schedule (“Sublicense Payments”):

 

	
Date of Agreement With Third Party/Sublicensee
    	
 
    	
Percent of Sublicense
   Revenues Payable to TSRI
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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4.2                               Product Development Milestones.  Licensee shall pay to TSRI the following [***] amounts for the achievement of the following product development milestone events [***] for each Licensed Product to meet such milestone as follows:

 

	
Milestone
    	
 
    	
Payment
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    

 

For purposes of this Section 4.2, the following definitions shall apply:

 

(a)                                 The term “Initiation” means, with respect to a clinical trial, the first dosing of the first patient in such trial.

 

(b)                                 The term [***] means a human clinical trial that would satisfy the requirements for a [***] as defined in 21 C.F.R. §312.21(b) (or its successor regulation), or its foreign equivalent.

 

5.                                      Development and Commercialization Activities.

 

5.1                               Development Plan and Benchmarks.  Attached hereto as Exhibit B is Licensee’s development plan under which Licensee intends to bring the subject matter of the Licensed Product to the point of commercial use (“Commercial Development Plan”).  Pursuant to the Commercial Development Plan, Licensee shall achieve the Benchmarks specified in Exhibit C within the time periods set forth in Exhibit C (“Benchmarks”).  In addition, Licensee shall use commercially reasonable efforts, itself or through its Sublicensees, to develop and obtain regulatory approvals to market and sell Licensed Products in the Field as promptly as is reasonably and commercially feasible, and, subject to obtaining necessary regulatory approvals, to produce and sell reasonable quantities of Licensed Products sufficient to meet market demands.

 

5.2                               Progress Reports.  Licensee shall keep TSRI generally informed as to Licensee’s progress with respect to its development of Licensed Products, including without limitation its regulatory filings and approvals, marketing, production, sale and its efforts to sublicense the Licensed Product or Scripps Property.  Licensee shall also provide to TSRI written annual reports on its progress in the development and commercialization of Licensed Products in the Field [***].  These progress reports shall include without limitation:  [***].  Licensee agrees [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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[***].  Licensee shall also report to TSRI the dates that Licensee or its Sublicensees achieve the events described on Exhibit D attached hereto [***] of such occurrences.

 

5.3                               Failure of Diligence Efforts.  If Licensee does not achieve a Benchmark within the time provided in Exhibit C, TSRI has the right, at its option, to terminate this Agreement, terminate the licensed rights hereunder with respect to a particular Licensed Product, provided that, if Licensee can demonstrate that its failure to achieve said Benchmark occurred despite Licensee having used commercially reasonable efforts to develop and commercialize Licensed Products, then TSRI and Licensee agree to renegotiate said Benchmark and/or its associated deadline promptly and in good faith.  In addition, any time [***], TSRI has the right, at its option, to terminate this Agreement, or to terminate the licensed rights hereunder with respect to a particular Licensed Product, in the event TSRI has a reasonable basis to believe, based on Licensee’s annual and other reports to TSRI and other available information, that Licensee has not used commercially reasonable efforts to develop and commercialize Licensed Products as required hereunder, [***] to Licensee, if Licensee does not cure such failure [***].

 

5.4                               Royalty Reports.  Licensee shall submit to TSRI, [***], a royalty report (the “Royalty Report”) setting forth [***] the following information on a country-by-country and Licensed Product-by-Licensed Product basis:

 

(a)                                 [***];

 

(b)                                 [***];

 

(c)                                  [***].

 

Each Royalty Report shall be certified as correct by an officer of Licensee.

 

5.5                               Payments.  Licensee shall pay to TSRI [***] the amount of royalties due with respect [***].  All payments due under this Agreement shall be deemed received [***] and shall be payable by check or wire transfer in United States Dollars to an account designated by TSRI.

 

5.6                               Foreign Sales.  The remittance of royalties payable on sales outside the United States shall be payable to TSRI in United States Dollar equivalents at the official rate of exchange of the currency of the country from which the royalties are payable, as quoted in The Wall Street Journal for the last business day of [***].  If the transfer of or the conversion into the United States Dollar equivalents of any such remittance in any such instance is not lawful or possible, the payment of such part of the

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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royalties as is necessary shall be made by the deposit thereof, in the currency of the country where the sale was made on which the royalty was based, to the credit and account of TSRI or its nominee in any commercial bank or trust company designated by TSRI and located in that country, prompt written notice of which shall be given by Licensee to TSRI.

 

6.                                      Record Keeping.  Licensee shall keep, and shall require its Affiliates and Sublicensees to keep, accurate records (together with supporting documentation) of all Licensed Products made, used and sold under this Agreement, as appropriate to determine the amount of royalties (including the calculations of royalty credits), product development milestone payments and other monies due to TSRI hereunder, as well as records regarding Sublicense Revenues, Sublicense Payments and Licensee’s compliance with this Agreement.  Such records shall be retained for [***] to which such records relate.  Such records shall be available, upon prior written notice to Licensee, during normal business hours for examination and copying by TSRI and/or its designated certified public accountant for the purpose of verifying the accuracy of Licensee’s reports and payments hereunder and its compliance with this Agreement.  In conducting examinations pursuant to this Section, [***].  These examinations shall be at TSRI’s expense, except that if an examination shows an underreporting or underpayment of [***], then Licensee shall pay the cost of such examination [***], plus interest on such amounts at the rate of [***].  All payments due hereunder shall be made [***].  TSRI may exercise its audit rights under this Section 6 no more frequently than once in any calendar year.

 

7.                                      Indemnity and Insurance.

 

7.1                               Indemnity. Licensee hereby agrees to indemnify, defend (by counsel reasonably acceptable to TSRI) and hold harmless TSRI and any parent, subsidiary or other affiliated entity of TSRI and their respective trustees, directors, officers, employees, scientists, agents, students, successors, assigns and other representatives (collectively, the “Indemnitees”) from and against all damages, liabilities, losses and other expenses, including without limitation reasonable attorney’s fees, expert witness fees and costs incurred by the Indemnitees, with respect to any third party claim, suit or action asserted against any of the Indemnitees, whether or not a lawsuit or other proceeding is filed (collectively “Claims”), that arise out of or relate to (a) Licensee’s or any of its Sublicensees’ practice of any invention claimed by the use of Licensed Products, (b) alleged defects or other problems with any of the Licensed Products manufactured, sold, distributed or rendered by or on behalf of Licensee or any Sublicensee, including without limitation any personal injuries, death or property damages related thereto, (c) the research, development, manufacture, use, marketing, advertising, distribution, sale or importation of any Licensed Product by or on behalf of Licensee or any of its Sublicensees, (d) the negligent or willful acts or omissions of Licensee or any of its Sublicensees, (e) any allegations that the

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Licensed Products developed, manufactured, sold, distributed or rendered by or on behalf of Licensee or any Sublicensee and/or any trademarks, service marks, logos, symbols, slogans or other materials used in connection with or to market Licensed Products violate or infringe upon the trademarks, service marks, trade dress, trade names, copyrights, patents, works of authorship, inventorship rights, trade secrets, database rights, rights under unfair competition laws, rights of publicity, privacy or defamation, or any other intellectual or industrial property right of any third party, (f) Licensee’s or any Sublicensee’s failure to comply with any applicable laws, rules or regulations, and/or (g) the labeling, packaging or patent marking of any Licensed Product or containers thereof by or on behalf of Licensee or any Sublicensee.  Licensee shall not enter into any settlement, stipulated judgment or other arrangement with respect to such Claims that [***], without TSRI’s prior written consent.  Notwithstanding the above, Indemnitees, at their expense, shall have the right to retain separate independent counsel to assist in defending any such Claims.  In the event Licensee fails to promptly indemnify and defend such Claims and/or pay Indemnitees’ expenses as provided above, Indemnitees shall have the right, but not the obligation, to defend themselves, and in that case, [***].  This indemnity shall [***] of Licensee to Indemnitees.

 

7.2                               Insurance.

 

7.2.1                     [***].  [***].

 

7.2.2                     Coverages.  Beginning at the time any Licensed Product or Scripps Property is being commercially distributed or sold (other than for the purpose of obtaining regulatory approvals) by Licensee or a Sublicensee, Licensee shall, at its sole expense, procure and maintain commercial general liability insurance with reputable insurers in amounts not less [***] per occurrence and [***] annual aggregate.  Prior to the initiation of the first clinical trial and continuing throughout the clinical trials involving any Licensed Product or Scripps Property, Licensee shall, at its sole expense, procure and maintain commercial general liability insurance with reputable insurers in the same amounts as specified above.  Such commercial general liability insurance shall provide coverage for:  [***].  If Licensee desires to self-insure all or part of the limits described above, such self-insurance program must be approved in advance by TSRI in its sole discretion.  The insurance coverage amounts specified herein or the maintenance of such insurance policies shall not in any way limit Licensee’s indemnity or other liability under this Agreement.

 

7.2.3                     [***].  Licensee, on behalf of itself and its insurance carriers, [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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[***], with respect to [***] or for [***].  Licensee’s commercial general liability insurance policy [***].  Licensee shall [***].  Licensee’s insurance policies [***].  At the time when Licensee sends its annual progress report to TSRI under Section 5.2 and upon TSRI’s additional request, Licensee shall [***].

 

7.2.4                     Cancellation/Changes in Coverages.  Licensee shall provide TSRI with written notice [***] prior to the cancellation, non-renewal or material change in any insurance required by this Section 7.2.  If Licensee does not obtain replacement insurance providing comparable coverage within [***], TSRI shall have the right to immediately terminate this Agreement by providing written notice to Licensee and without providing any additional cure period.

 

7.2.5                     Continuation of Coverage.  Licensee shall maintain such commercial general liability and product liability insurance beyond the expiration or termination of this Agreement during [***].

 

8.                                      Disclaimer and Limitation of Liability.

 

8.1                               Disclaimer.  TSRI MAKES NO WARRANTIES OR REPRESENTATIONS CONCERNING SCRIPPS PROPERTY OR ANY OTHER MATTER WHATSOEVER, INCLUDING WITHOUT LIMITATION ANY EXPRESS, IMPLIED OR STATUTORY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF THIRD PARTY RIGHTS, TITLE, ACCURACY OR ARISING OUT OF COURSE OF CONDUCT OR TRADE CUSTOM OR USAGE, AND DISCLAIMS ALL SUCH EXPRESS, IMPLIED OR STATUTORY WARRANTIES.  TSRI MAKES NO WARRANTY OR REPRESENTATION AS TO THE VALIDITY, SCOPE OR ENFORCEABILITY OF ANY OF SCRIPPS PROPERTY, OR THAT ANY LICENSED PRODUCT OR SCRIPPS PROPERTY WILL NOT INFRINGE ANY THIRD PARTY RIGHTS, OR THAT NO THIRD PARTY IS IN ANY WAY INFRINGING UPON OR MAY INFRINGE UPON ANY SCRIPPS PROPERTY COVERED BY THIS AGREEMENT.  FURTHER, TSRI HAS MADE NO INVESTIGATION AND MAKES NO REPRESENTATION OR WARRANTY THAT THE SCRIPPS PROPERTY ARE SUITABLE FOR LICENSEE’S PURPOSES.

 

8.2                               Limitation of Liability.  IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION DAMAGES FOR LOST PROFITS OR EXPECTED SAVINGS) ARISING OUT OF OR IN CONNECTION

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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WITH THIS AGREEMENT OR ITS SUBJECT MATTER, EXCEPT WITH RESPECT TO LICENSEE’S INDEMNITY OBLIGATIONS UNDER SECTION 7.1.  TSRI’S AGGREGATE LIABILITY, IF ANY, FOR ALL DAMAGES OF ANY KIND RELATING TO THIS AGREEMENT OR ITS SUBJECT MATTER SHALL NOT EXCEED THE AMOUNT PAID BY LICENSEE TO TSRI UNDER THIS AGREEMENT.  THE FOREGOING EXCLUSIONS AND LIMITATIONS SHALL APPLY TO ALL CLAIMS AND ACTIONS OF ANY KIND AND ON ANY THEORY OF LIABILITY, WHETHER BASED ON CONTRACT, TORT (INCLUDING WITHOUT LIMITATION NEGLIGENCE OR STRICT LIABILITY), OR ANY OTHER GROUNDS, AND REGARDLESS OF WHETHER A PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.  THE PARTIES FURTHER AGREE THAT EACH WARRANTY DISCLAIMER, EXCLUSION OF DAMAGES OR OTHER LIMITATION OF LIABILITY HEREIN IS INTENDED TO BE SEVERABLE AND INDEPENDENT OF THE OTHER PROVISIONS BECAUSE THEY EACH REPRESENT SEPARATE ELEMENTS OF RISK ALLOCATION BETWEEN THE PARTIES.

 

9.                                      Confidentiality and Publicity.

 

9.1                               Treatment of Confidential Information.  The parties agree that during the term of this Agreement, and for a period of [***] after this Agreement terminates, a party receiving Confidential Information of the other party will (a) maintain in confidence such Confidential Information to the same extent such party maintains its own proprietary information, but with no less than a reasonable degree of care; (b) not disclose such Confidential Information to any third party without the other party’s prior written consent; and (c) not use such Confidential Information for any purpose except those permitted by this Agreement.  Notwithstanding the foregoing, if a party is required by law, regulation or court order or rules of a securities exchange to disclose Confidential Information of the other party, the party required to make such disclosure shall (i) promptly send a copy of the order or notice to the other party [***] before the proposed disclosure (or such shorter period of time as may be reasonably practical under the circumstances); (ii) reasonably cooperate with the other party if the other party wishes to object or condition such disclosure through a protective order or otherwise; (iii) limit the extent of such disclosure to the minimum required to comply with the order or notice; and (iv) use reasonable efforts to seek confidential treatment (i.e., filing “under seal”) for that disclosure.  In addition, a party may disclose Confidential Information of the other party to its Affiliates and employees, to Sublicensees and potential Sublicensees, to investors or potential investors of a party in connection with due diligence or similar investigations or in confidential financing documents, to an organization to whom TSRI intends to assign or transfer or does assign or transfer this Agreement or the payment obligations due hereunder to TSRI provided, in each case, that any such agrees in writing to be bound by terms of confidentiality and non-use at least as stringent as those set forth in this Section 9.1, but with no further right to disclose or otherwise distribute the other party’s Confidential Information.

 

9.2                               Publications.  Licensee agrees that TSRI shall have the right to publish in accordance with its general policies, and that this Agreement shall not restrict, in any fashion, TSRI’s right to publish.

 

9.3                               Publicity.  Except as otherwise required by law,

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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no party shall originate or distribute any publication, news release or other public announcement, written or oral, whether in the public press, stockholders’ reports or otherwise, relating to this Agreement, or to the performance hereunder, without the prior written approval of the other party, which approval shall not be unreasonably withheld.  [***] shall not be construed as publicity governed by this Section 9.3.

 

10.                               Term and Termination.

 

10.1                        Term.  Unless terminated sooner in accordance with the terms set forth herein, this Agreement shall expire upon such time that no further royalties are due to TSRI pursuant to Section 3.6.

 

10.2                        Termination Upon Mutual Agreement.  This Agreement may be terminated by mutual written consent of both parties.

 

10.3                        Termination by TSRI.  TSRI has the right to immediately terminate this Agreement as follows (unless a further cure period is provided below):

 

(a)                                 If Licensee does not make a payment due hereunder and fails to cure such non-payment (including the payment of interest in accordance with Section 12.2) within thirty (30) days after the date of TSRI’s written notice of such non-payment;

 

(b)                                 If Licensee defaults upon its indemnification or insurance obligations under Section 7;

 

(c)                                  As provided in Section 5.3;

 

(d)                                 Upon TSRI’s written notice to Licensee in the event Licensee becomes insolvent, has a petition in bankruptcy filed for or against it, has a receiver appointed over any of Licensee’s assets, makes an assignment for the benefit of creditors, or has any other proceedings filed against Licensee under any bankruptcy or insolvency laws;

 

(e)                                  If Licensee is convicted of a felony relating to the development, manufacture, use, marketing, distribution or sale of Licensed Products or Scripps Property;

 

(f)                                   If an audit pursuant to Section 6 shows an underreporting or underpayment by Licensee or any Sublicensee of [***]or more for [***] and fails to make full payment (including the payment of interest in accordance with Section 12.2) of such underpayment within thirty (30) days after the date of such audit; or

 

(g)                                  Except as provided in subparagraphs (a) — (f) above, if Licensee defaults in the performance of any other obligations under this Agreement and the default has not been remedied within thirty (30) days after the date of TSRI’s written notice of such default.

 

10.4                        Termination by Licensee.  Licensee may terminate this Agreement

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

13

 

by giving ninety (90) days’ advance written notice of termination to TSRI.

 

10.5                        Rights Upon Expiration.  Upon the expiration of this Agreement, neither party shall have any further rights or obligations, other than the obligation of Licensee to make any and all reports and payments due under Sections 3, 4 and 10.8 with respect to events that occurred prior to such expiration in accordance with Sections 3.4, 4, 5.4, 5.5 and 5.6 (all of which Sections referenced in this sentence shall survive such expiration for such purposes).  Notwithstanding the above, Sections 1, 2.2, 2.3, 2.4, 6, 7 (as to activities conducted during the term of this Agreement), 8, 9, 10.5, 10.7, 10.8, 11.1, 11.2 and 12 shall also survive the expiration of this Agreement.

 

10.6                        Rights Upon Termination.  Notwithstanding any other provision of this Agreement, upon any termination of this Agreement prior to the regularly scheduled expiration date of this Agreement, the licenses granted hereunder shall terminate and revert to TSRI, and all sublicenses granted by Licensee shall also automatically terminate; provided that TSRI agrees that upon termination of this Agreement, any then-existing Sublicensees who are in compliance with this Agreement and the relevant sublicense agreement shall have the right to obtain a direct license from TSRI on the same terms and conditions as are provided in this Agreement, upon written request by such Sublicensee within thirty (30) days after such termination becomes effective.  Except as otherwise provided in Section 10.7 of this Agreement with respect to work-in-progress, upon such termination, Licensee and its Sublicensees shall have no further right to develop, manufacture, market, distribute or sell any Licensed Product or Scripps Property.  Upon any such termination, Licensee shall promptly return or destroy all materials, samples, documents, information and other items which embody or disclose any Scripps Property.

 

Any such termination shall not relieve either party from any obligations accrued to the date of such termination, including without limitation the obligation of Licensee to make any and all reports and payments due under Sections 3, 4 and 10.8 with respect to events that occurred prior to such termination or as provided in Section 10.7, in accordance with Sections 3.4, 4, 5.4, 5.5 and 5.6 (all of which Sections referenced in this sentence shall survive such termination for such purposes).  In addition, Sections 1, 2.2, 2.3, 2.4, 6, 7, 8, 9, 10.6, 10.7, 11.1, 11.2 and 12 shall also survive the termination of this Agreement.

 

10.7                        Work-in-Progress.  Upon any early termination of the licenses granted hereunder, Licensee shall be entitled to finish any work-in-progress and to sell any completed inventory of Licensed Products which remain on hand as of the termination date, so long as Licensee sells such inventory in the normal course of business and at regular selling prices and pays to TSRI the royalties applicable to such subsequent sales in accordance with the provisions of this Agreement, provided that no such sales shall be permitted following the date that is six (6) months after the termination date.

 

10.8                        Final Royalty Report.  Upon termination or expiration of this Agreement, Licensee shall promptly submit a final report to TSRI, and any payments due to TSRI under this Agreement that accrued prior to such termination or expiration shall be paid by Licensee to TSRI at the time of delivery of the final report.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

14

 

11.                               Assignment; Successors.

 

11.1                        Assignment.  Licensee shall neither assign nor transfer this Agreement or any interest herein without the prior written consent of TSRI.  Notwithstanding the foregoing, Licensee may assign its rights and delegate its duties under the Agreement in connection with the transfer or sale to an Affiliate or to a third party of all or substantially all of the business of Licensee, whether by merger, sale of stock, sale of assets or otherwise, provided the assignee agrees in writing to be bound by all the terms and conditions of this Agreement.  Licensee will notify TSRI of any such permitted assignment [***] after the effective date thereof.

 

11.2                        Binding Upon Successors and Assigns.  Subject to the limitations on assignment in Section 11.1, this Agreement shall be binding upon and inure to the benefit of any successors in interest and assigns of TSRI and Licensee.  Any successor or assignee of Licensee’s interest shall expressly assume in writing the performance of all the terms and conditions of this Agreement to be performed by Licensee and such written assumption shall be delivered to TSRI as a condition to TSRI’s agreement to consent to any such assignment.

 

12.                               General Provisions.

 

12.1                        Independent Contractors.  The relationship between TSRI and Licensee is that of independent contractors.  TSRI and Licensee are not joint venturers, partners, principal and agent, master and servant, employer and employee, and have no other relationship other than independent contracting parties.  TSRI and Licensee shall have no power to bind or obligate each other in any manner, other than as is expressly set forth in this Agreement.

 

12.2                        Late Payments.  Late payments of any and all amounts due hereunder shall bear interest from the due date until the date paid at a rate of [***], whichever is [***].

 

12.3                        Governmental Approvals and Compliance.  Licensee shall, at its expense, be responsible for obtaining all necessary governmental approvals for the development, production, distribution, performance, sale and use of any Licensed Product, and shall comply with all applicable laws, rules and regulations in conducting its activities under this Agreement.  Licensee shall, at its expense, also be responsible for any warning labels, packaging and instructions produced or distributed with respect to the use of Licensed Products and for the quality control for any Licensed Products.

 

12.4                        No Use of Name.  The use of the name “The Scripps Research Institute”, “Scripps”, “TSRI” or any variation thereof in connection with the marketing, advertising, distribution, sale or performance of Licensed Products is expressly prohibited.

 

12.5                        U.S. Manufacture.  If applicable, Licensee agrees that it and its Sublicensees will abide by the Preference for United States Industry as set forth in 37 C.F.R. Section 401.14(I), which requires that any Licensed Product sold in the United States shall be

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

15

 

manufactured substantially in the United States.

 

12.6                        Foreign Registration.  Licensee agrees, at its expense, to register this Agreement with any foreign governmental agency which requires such registration.

 

12.7                        Use of Scripps Property.  Licensee agrees that its and its Sublicensees’ use of any Scripps Property shall comply with all applicable laws, rules, regulations and guidelines.  Licensee agrees that the Scripps Property will not be used for research involving human subjects or clinical trials in the United States without complying with 21 C.F.R. Part 50 and 45 C.F.R. Part 46.  Licensee agrees that the Scripps Property will not be used for research involving human subjects or clinical trials outside of the United States without complying with the applicable foreign laws, rules and regulations.

 

12.8                        Dispute Resolution.  Any dispute or claim between the parties arising out of or relating to this Agreement, including without limitation the breach thereof, shall be resolved according to the following dispute resolution procedures:

 

(a)                                 Such dispute shall be first addressed by the representatives of TSRI and Licensee who have primary responsibility for managing this Agreement.

 

(b)                                 If the dispute is not resolved by such representatives within fifteen (15) days after the date either party gives written notice that such dispute exists, then the dispute shall be referred to and addressed by the senior management of each party.

 

(c)                                  If such dispute is not resolved by the parties’ senior management within thirty (30) days after the date the dispute is referred to them, then the dispute shall be submitted to mediation.  The mediator shall be a retired judge or other neutral third party mutually selected by TSRI and Licensee who has at least ten (10) years experience in mediating or arbitrating cases in the bio-pharmaceutical industry and regarding the same or substantially similar subject matter as the dispute between Licensee and TSRI.  If the parties are unable to agree on such mediator within twenty (20) days after they exchange initial lists of potential mediators, a mediator with the same qualifications will be selected by the JAMS office in San Diego located at 401 B Street, San Diego, CA  92101 (after consultation with the parties).

 

(d)                                 The location of the mediation shall be in the County of San Diego, California.  TSRI and Licensee hereby irrevocably submit to the exclusive jurisdiction and venue of the mediator mutually selected by the parties or to the neutral mediator selected by JAMS of San Diego for purposes of the mediation, and to the exclusive jurisdiction and venue of the federal and state courts located in San Diego County, California for any action or proceeding regarding this Agreement in the event mediation is unsuccessful as provided in sub-clause (e) below, or as provided in sub-clause (f) below, and waive any right to contest or otherwise object to such exclusive jurisdiction or venue, including without limitation any claim that such exclusive venue is not a convenient forum.

 

(e)                                  If the dispute is not resolved through mediation, either party may refer the dispute to a court of competent jurisdiction in San Diego County, California.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

16

 

(f)                                   Notwithstanding anything to the contrary in this Agreement, prior to or while a mediation proceeding is pending, either party has the right to seek and obtain injunctive and other equitable relief from a court of competent jurisdiction to enforce that party’s rights hereunder.

 

12.9                        Entire Agreement; Modification.  This Agreement and all of the attached Exhibits (which are incorporated herein) set forth the entire agreement between the parties as to the subject matter hereof, and supersede all prior or contemporaneous agreements or understandings, whether oral or written, regarding this subject matter.  This Agreement cannot be amended except by a written instrument signed by both parties.

 

12.10                 California Law.  This Agreement shall be construed and enforced according to the laws of the State of California without regard to its conflicts or choice of law rules.

 

12.11                 Headings.  The headings for each Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Section.

 

12.12                 Severability.  If any provision of this Agreement is judicially determined to be invalid, void or unenforceable, the remaining provisions shall remain in full force and effect, and the stricken provision shall be revised in a manner that best reflects the original intent of the parties.

 

12.13                 No Waiver.  The failure of a party to enforce any of its rights hereunder or at law or in equity shall not be deemed a waiver or a continuing waiver of any of its rights or remedies against the other party, unless such waiver is in writing and signed by the waiving party.

 

12.14                 Name.  Whenever there has been an assignment by Licensee as permitted by this Agreement, the term “Licensee” as used in this Agreement shall also include and refer to, if appropriate, such assignee.

 

12.15                 Attorneys’ Fees.  In the event of a dispute between the parties or any default hereunder, the party prevailing in the resolution of such dispute or default shall be entitled to recover its reasonable attorneys’ fees and other costs incurred in connection with resolving such dispute or default, in addition to any other relief to which it is entitled.  TSRI and Licensee each represent that it has been represented by its own counsel in the negotiation and execution of this Agreement.  Each party further represents that it has relied solely on the advice and representation of its respective counsel in agreeing to this Section 12.15 and all of the other provisions of this Agreement.

 

12.16                 Notices.  Any notices required or permitted by this Agreement shall be in writing and shall be delivered as follows, with notice deemed given as indicated:  (a) by personal delivery, when received; (b) by overnight courier guaranteeing next-day delivery, upon the next business day immediately following delivery to such overnight courier; or (c) by

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

17

 

registered or certified mail, return receipt requested and postage prepaid, upon verification of receipt.  Notices shall be sent to the respective addresses set forth below, unless subsequently changed by written notice to the other party:

 

	
For TSRI:
    	
The Scripps Research Institute
    
	
 
    	
10550 North Torrey Pines Road, TPC-9
    
	
 
    	
La Jolla, California 92037
    
	
 
    	
Attention: Vice President, Business Development
    
	
 
    	
 
    
	
with a copy to:
    	
The Scripps Research Institute
    
	
 
    	
10550 North Torrey Pines Road, TPC-8
    
	
 
    	
La Jolla, California 92037
    
	
 
    	
Attention: Chief Business Counsel
    
	
 
    	
 
    
	
For Licensee:
    	
Corvus Pharmaceuticals, Inc.
    
	
 
    	
250 Golden Hills Drive
    
	
 
    	
Portola Valley, CA 94028
    
	
 
    	
Attention: Richard A. Miller, M.D., CEO
    
	
 
    	
 
    
	
With a copy to:
    	
Latham & Watkins
    
	
 
    	
140 Scott Drive
    
	
 
    	
Menlo Park CA 94028
    
	
 
    	
Attention: Alan C. Mendelson
    

 

12.17                 Counterparts.  This Agreement may be executed in several counterparts that together shall constitute originals and one and the same instrument.

 

12.18                 Cumulative Remedies.  The rights and remedies stated in this Agreement shall be cumulative and in addition to any other rights and remedies the parties may have at law or in equity.

 

IN WITNESS WHEREOF, the parties have executed this Agreement by their duly authorized representatives as of the Effective Date.

 

	
TSRI:
    	
 
    	
LICENSEE:
    
	
 
    	
 
    	
 
    
	
THE   SCRIPPS RESEARCH INSTITUTE
    	
 
    	
CORVUS   PHARMACEUTICALS, INC.
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Scott   Forrest
    	
 
    	
By:
    	
/s/ Richard A.   Miller
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
Business   Development, VP
    	
 
    	
Title:
    	
CEO
    

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

18

 

EXHIBIT A

 

SCRIPPS PROPERTY

 

Hybridoma expressing anti-CD73 antibody clone [***] and any antibodies expressed by such hybridoma.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

19

 

EXHIBIT B

 

LICENSEE’S COMMERCIAL DEVELOPMENT PLAN

 

Company will evaluate and test [***] murine antibody for various preclinical characteristics.  If acceptable properties are found, [***].  If successful, [***].  If acceptable features are confirmed [***].  The [***] will also be evaluated in [***] for potential [***].

 

Once these steps are successfully met, [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

20

 

EXHIBIT C

 

BENCHMARKS

 

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

21

 

EXHIBIT D

 

REPORTING EVENTS

 

Licensee shall notify TSRI in writing of each of the following events with respect to each Licensed Product in a Major Market Country [***] of such occurrence:

 

[***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

22Exhibit 10.15

 

Execution Copy

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

PHASE I/IB COMBINATION STUDY AGREEMENT

 

BY AND BETWEEN

 

GENENTECH, INC.

 

AND

 

CORVUS PHARMACEUTICALS, INC.

 

 

TABLE OF CONTENTS

 

	
 
    	
 
    	
Page
    
	
 
    	
 
    	
 
    
	
ARTICLE 1 DEFINITIONS
    	
1
    
	
 
    	
 
    
	
1.1
    	
“Affiliate”
    	
1
    
	
1.2
    	
“Ancillary Agreements”
    	
2
    
	
1.3
    	
“Applicable Law”
    	
2
    
	
1.4
    	
“Business Day”
    	
2
    
	
1.5
    	
“Case Report Form”
    	
2
    
	
1.6
    	
“CFR”
    	
2
    
	
1.7
    	
“Collaboration IND”
    	
2
    
	
1.8
    	
“Collaboration   Invention”
    	
2
    
	
1.9
    	
“Combination”
    	
3
    
	
1.10
    	
Competitive Product”
    	
3
    
	
1.11
    	
“Confidential   Information”
    	
3
    
	
1.12
    	
“Corvus Molecule”
    	
3
    
	
1.13
    	
“CRO”
    	
3
    
	
1.14
    	
“Database Lock”
    	
3
    
	
1.15
    	
“Data Review Committee”
    	
3
    
	
1.16
    	
“EMA”
    	
3
    
	
1.17
    	
“FDA”
    	
3
    
	
1.18
    	
“Final Study Report”
    	
3
    
	
1.19
    	
“GCP”
    	
3
    
	
1.20
    	
“Genentech Molecule”
    	
4
    
	
1.21
    	
“GLP”
    	
4
    
	
1.22
    	
“GMP”
    	
4
    
	
1.23
    	
“HIPAA”
    	
4
    
	
1.24
    	
“IND”
    	
4
    
	
1.25
    	
“Investigator”
    	
4
    
	
1.26
    	
“IRB”
    	
4
    
	
1.27
    	
“JDC Chair”
    	
4
    
	
1.28
    	
“JDC Co-Leader”
    	
4
    
	
1.29
    	
“Joint Development   Committee”
    	
4
    
	
1.30
    	
“Joint Patent”
    	
4
    
	
1.31
    	
“Know-How”
    	
4
    
	
1.32
    	
“Molecules”
    	
5
    
	
1.33
    	
“Molecule Supply Plan”
    	
5
    
	
1.34
    	
“NDA”
    	
5
    
	
1.35
    	
“Participating Site”
    	
5
    
	
1.36
    	
“Patents”
    	
5
    
	
1.37
    	
“PD-1 Antagonist”
    	
5
    
	
1.38
    	
“PD-L1 Antagonist”
    	
5
    
	
1.39
    	
“Project Participants”
    	
5
    
	
1.40
    	
“Prosecution and   Maintenance”
    	
5
    

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

i

 

	
1.41
    	
“Protocol”
    	
5
    
	
1.42
    	
“PV Agreement”
    	
5
    
	
1.43
    	
“Quality Agreement”
    	
5
    
	
1.44
    	
“Regulatory Authority”
    	
6
    
	
1.45
    	
“Regulatory   Documentation”
    	
6
    
	
1.46
    	
“Roche Group”
    	
6
    
	
1.47
    	
“Sample Analyses”
    	
6
    
	
1.48
    	
“Sample Analysis Plan”
    	
6
    
	
1.49
    	
“Sample Data”
    	
6
    
	
1.50
    	
“Samples”
    	
6
    
	
1.51
    	
“Specifications”
    	
6
    
	
1.52
    	
“Sponsor”
    	
6
    
	
1.53
    	
“Study”
    	
6
    
	
1.54
    	
“Study Completion”
    	
6
    
	
1.55
    	
“Study Data”
    	
6
    
	
1.56
    	
“Subinvestigator”
    	
6
    
	
1.57
    	
“Subject”
    	
6
    
	
1.58
    	
“Third Party”
    	
7
    
	
 
    	
 
    
	
ARTICLE 2 CONDUCT OF THE STUDY; REGULATORY   MATTERS
    	
7
    
	
 
    	
 
    
	
2.1
    	
Overview
    	
7
    
	
2.2
    	
Sponsor
    	
7
    
	
2.3
    	
Collaboration IND;   Protocol
    	
7
    
	
2.4
    	
Enrollment
    	
7
    
	
2.5
    	
Project Participants
    	
7
    
	
2.6
    	
Regulatory Matters
    	
8
    
	
2.7
    	
Adverse Experience   Reporting
    	
8
    
	
2.8
    	
Documentation, Updates   and Final Study Report
    	
9
    
	
2.9
    	
Genentech Study   Responsibilities
    	
9
    
	
2.10
    	
Costs
    	
9
    
	
2.11
    	
Additional Studies
    	
10
    
	
2.12
    	
Right of First Negotiation
    	
10
    
	
 
    	
 
    
	
ARTICLE 3 GOVERNANCE
    	
11
    
	
 
    	
 
    
	
3.1
    	
Joint Development   Committee
    	
11
    
	
3.2
    	
Data Review Committee
    	
12
    
	
 
    	
 
    
	
ARTICLE 4 SUPPLY OF STUDY DRUGS
    	
13
    
	
 
    	
 
    
	
4.1
    	
Corvus Molecule
    	
13
    
	
4.2
    	
Genentech Molecule
    	
13
    
	
4.3
    	
Insufficient Quantities
    	
14
    
	
4.4
    	
Quality Agreement
    	
14
    
	
4.5
    	
Mutual Obligations
    	
14
    
	
 
    	
 
    
	
ARTICLE 5 STUDY DATA; SAMPLE ANALYSES AND   SAMPLE DATA
    	
15
    
	
 
    	
 
    
	
5.1
    	
Study Data
    	
15
    

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

ii

 

	
5.2
    	
Samples and Sample   Analyses
    	
15
    
	
5.3
    	
Sample Data
    	
15
    
	
 
    	
 
    
	
ARTICLE 6 INTELLECTUAL PROPERTY
    	
16
    
	
 
    	
 
    
	
6.1
    	
Inventorship; Ownership   and Use; Definitions
    	
16
    
	
6.2
    	
Licenses
    	
17
    
	
6.3
    	
Patent Prosecution and   Maintenance of Solely Owned Inventions
    	
18
    
	
6.4
    	
Patent Prosecution and   Maintenance of Jointly Owned Inventions
    	
18
    
	
6.5
    	
Third Party   Infringement, Third Party Challenges and Third Party Allegations of   Infringement
    	
19
    
	
 
    	
 
    
	
ARTICLE 7 CONFIDENTIALITY
    	
20
    
	
 
    	
 
    
	
7.1
    	
Disclosure and Use of   Confidential Information
    	
20
    
	
7.2
    	
Authorized Disclosures
    	
21
    
	
7.3
    	
Continuing Obligation
    	
22
    
	
7.4
    	
Termination of Prior   Agreements
    	
22
    
	
 
    	
 
    
	
ARTICLE 8 PUBLIC DISCLOSURES; USE OF NAMES
    	
23
    
	
 
    	
 
    
	
8.1
    	
Clinical Trials   Registries
    	
23
    
	
8.2
    	
Publications and   Presentations
    	
23
    
	
8.3
    	
Press Releases and   Other Public Disclosures
    	
23
    
	
8.4
    	
Use of Names
    	
24
    
	
 
    	
 
    
	
ARTICLE 9 HUMAN SUBJECTS
    	
24
    
	
 
    	
 
    
	
9.1
    	
Informed Consent
    	
24
    
	
9.2
    	
IRB Approval
    	
25
    
	
9.3
    	
Patient Privacy and   Data Protection
    	
25
    
	
 
    	
 
    
	
ARTICLE 10 SUBCONTRACTING; RECORDS
    	
25
    
	
 
    	
 
    
	
10.1
    	
Subcontracting
    	
25
    
	
10.2
    	
Records
    	
25
    
	
 
    	
 
    
	
ARTICLE 11 COMPLIANCE WITH LAWS
    	
26
    
	
 
    	
 
    
	
11.1
    	
Compliance with Laws   and Policies
    	
26
    
	
11.2
    	
Debarment
    	
26
    
	
 
    	
 
    
	
ARTICLE 12 TERM; TERMINATION
    	
26
    
	
 
    	
 
    
	
12.1
    	
Term
    	
26
    
	
12.2
    	
Termination for   Material Breach
    	
26
    
	
12.3
    	
Termination for Other   Reasons
    	
27
    
	
12.4
    	
Effects of Termination   or Expiration
    	
27
    
	
 
    	
 
    
	
ARTICLE 13 REPRESENTATIONS AND WARRANTIES
    	
28
    
	
 
    	
 
    
	
13.1
    	
Mutual Representations   and Warranties
    	
28
    
	
13.2
    	
Disclaimers
    	
28
    

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

iii

 

	
ARTICLE 14 INDEMNIFICATION; LIMITATION ON   LIABILITY; INSURANCE
    	
28
    
	
 
    	
 
    
	
14.1
    	
Indemnification
    	
28
    
	
14.2
    	
Limitation on Liability
    	
30
    
	
14.3
    	
Insurance
    	
30
    
	
 
    	
 
    
	
ARTICLE 15 DISPUTE RESOLUTION
    	
31
    
	
 
    	
 
    
	
15.1
    	
Internal Resolution
    	
31
    
	
15.2
    	
Arbitration
    	
31
    
	
15.3
    	
Subject Matter   Exclusions
    	
32
    
	
15.4
    	
Continued Performance
    	
32
    
	
 
    	
 
    
	
ARTICLE 16 MISCELLANEOUS
    	
33
    
	
 
    	
 
    
	
16.1
    	
Notices
    	
33
    
	
16.2
    	
Governing Law
    	
34
    
	
16.3
    	
Assignment
    	
34
    
	
16.4
    	
Force Majeure
    	
35
    
	
16.5
    	
Relationship of the   Parties
    	
35
    
	
16.6
    	
Amendment; Waiver
    	
35
    
	
16.7
    	
Construction; Captions
    	
35
    
	
16.8
    	
Severability
    	
35
    
	
16.9
    	
Entire Agreement
    	
35
    
	
16.10
    	
Counterparts;   Facsimiles
    	
36
    

 

	
Exhibits
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Exhibit A
    	
Protocol
    	
 
    
	
 
    	
 
    	
 
    
	
Exhibit B
    	
Sample Analysis Plan
    	
 
    
	
 
    	
 
    	
 
    
	
Exhibit C
    	
Molecule Supply Plan
    	
 
    

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

iv

 

PHASE I/IB COMBINATION STUDY AGREEMENT

 

THIS PHASE I/IB COMBINATION STUDY AGREEMENT (“Agreement”) is made and entered into, effective as of October 5, 2015 (“Effective Date”), by and between Genentech, Inc., a Delaware corporation, having a principal place of business at 1 DNA Way, South San Francisco, California 94080 (“Genentech”) and Corvus Pharmaceuticals, Inc., a Delaware corporation, having a principal place of business at 863 Mitten Road, Suite 102, Burlingame, CA 94010 (“Corvus”).  Genentech and Corvus are each referred to herein individually as a “Party” and collectively as the “Parties.”

 

RECITALS

 

A.                                    Genentech is developing the Genentech Molecule (defined below) for the treatment of certain tumor types;

 

B.                                    Corvus is developing the Corvus Molecule (defined below) for the treatment of certain tumor types.

 

C.                                    Corvus wishes to conduct a Phase I/Ib clinical study evaluating the safety and tolerability of the Corvus Molecule, in patients with selected incurable cancers, as a single agent and in combination with the Genentech Molecule.

 

D.                                    Genentech and Corvus, consistent with the terms of this Agreement, desire to collaborate as more fully described herein, including by providing the Genentech Molecule and the Corvus Molecule for the Study.

 

E.                                     Corvus is willing to provide to Genentech the Study Data, Samples and Final Study Report (each, defined below).

 

AGREEMENT

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Genentech and Corvus agree as follows:

 

ARTICLE 1
 DEFINITIONS

 

Capitalized terms used in this Agreement shall have the meanings set forth below, unless otherwise specifically indicated.

 

1.1                               “Affiliate” of a Party means any corporation or other business entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with such Party.  For purposes of this definition, the term “control” (including, the correlative meanings, “controlled by” and “under common control with”) means (a) the direct or indirect ownership of more than fifty percent (50%) of the stock having the right to vote for

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

1

 

directors thereof (or general partnership interests) or (b) the ability to otherwise control the decisions of the board of directors or equivalent governing body thereof.  Notwithstanding the foregoing, for purposes of this Agreement, Chugai Pharmaceutical Co., Ltd (for purposes of this definition, “Chugai”) and FMI Medicine, Inc. (for purposes of this definition, “FMI”), and all business entities controlled by Chugai or FMI, shall not be considered Genentech’s Affiliates, unless and until Genentech elects to include one or more of such business entities as its Affiliate, by providing written notice to Corvus of such election.

 

1.2                               “Ancillary Agreements” means the Quality Agreement and the PV Agreement.

 

1.3                               “Applicable Law” means all (a) federal, state, local, national and regional statutes, laws, rules, regulations and directives applicable to a particular activity under this Agreement (including the performance of clinical trials and medical treatment) that may be in effect from time to time (including GCP, GLP, GMP and other laws promulgated by Regulatory Authorities); (b) applicable data protection and patient privacy laws and requirements (including those specified in the EU Data Protection Directive and the regulations issued under HIPAA); (c) export control and economic sanctions regulations that prohibit the shipment of United States-originated products and technology to certain restricted countries, entities and individuals; (d) anti-bribery and anti-corruption laws pertaining to interactions with government agents, officials and representatives (including the United States Foreign Corrupt Practices Act); (e) laws and regulations governing payments to healthcare providers; (f) laws and requirements governing ineligibility to participate in federal, state or other healthcare programs (including debarment under 21 USC § 335a, disqualification under 21 CFR §312.70 or § 812.119, sanctions by a Federal Health Care Program (as defined in 42 USC § 1320a-7b(f)), including the federal Medicare or a state Medicaid program); and (g) successor or replacement statutes, laws, rules, regulations and directives relating to the foregoing.

 

1.4                               “Business Day” means a day, other than a Saturday, Sunday or day on which commercial banks located in San Francisco, California are authorized or required by law or regulation to close.

 

1.5                               “Case Report Form” means the form (whether paper or electronic) for collecting certain data about each Subject, including the data collected for such Subject.

 

1.6                               “CFR” means the United States Code of Federal Regulations.

 

1.7                               “Collaboration IND” means the IND that includes the Protocol.

 

1.8                               “Collaboration Invention” means any invention, discovery or creation (including materials and Know-How but excluding Study Data and Sample Data) that is first conceived or reduced to practice by a Party (directly or by a Third Party on its behalf) or jointly by the Parties, in each case, (1) [***]; (2)[***]; or (3) [***].  Collaboration Inventions may include new uses, compositions or formulations [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2

 

[***].

 

1.9                               “Combination” means the Genentech Molecule and the Corvus Molecule used in combination, but not co-formulated together.

 

1.10                        “Competitive Product” means any compound or molecule that is [***].

 

1.11                        “Confidential Information” means nonpublic information (including Know-How) (i) that is disclosed by or on behalf of one Party to the other or its designee in connection with this Agreement (whether orally, electronically, visually or in writing) and/or (ii) Joint Confidential Information.

 

1.12                        “Corvus Molecule” means the investigational medicinal product identified as CPI-444 in final form for administration to Subjects in the Study.  CPI-444 is an investigational adenosine-2A (A2A) receptor antagonist that has the following chemical formula: [***].

 

1.13                        “CRO” means a Third Party service provider (e.g., a person or organization) that assumes one or more obligations of the Sponsor, in accordance with Title 21 of the CFR, or the equivalent assumption of obligations in a jurisdiction other than the United States.

 

1.14                        “Database Lock” means the database lock of the Study Data after Study Completion.

 

1.15                        “Data Review Committee” or “DRC” is defined in Section 3.2(a).

 

1.16                        “EMA” means, collectively, the European Medicines Agency and the European Commission (with respect to its functions related to marketing authorizations for medicinal products), or any successor entity thereto performing similar functions.

 

1.17                        “FDA” means the United States Food and Drug Administration, or any successor entity thereto performing similar functions.

 

1.18                        “Final Study Report” is defined in Section 1.1(c).

 

1.19                        “GCP” means, as to the United States and the European Union, applicable good clinical practices (for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected) in effect in the United States and the European Union, respectively, during the term of the Agreement and, with respect to any other jurisdiction, clinical practices equivalent to good clinical practices then in effect in the United States or the European Union.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

3

 

1.20                        “Genentech Molecule” means atezolizumab in final form for administration to Subjects in the Study.  Atezolizumab is an investigational monoclonal antibody that targets PD-L1 (programmed death-ligand 1) and is also identified as an anti-PD-L1 antibody (MPDL3280A and RG7446).

 

1.21                        “GLP” means, as to the United States and the European Union, applicable good laboratory practices in effect in the United States and the European Union, respectively, during the term of the Agreement and, with respect to any other jurisdiction, laboratory practices equivalent to good laboratory practices then in effect in the United States or the European Union.

 

1.22                        “GMP” means, as to the United States and the European Union, applicable good manufacturing practices in effect in the United States and the European Union, respectively, during the term of the Agreement and, with respect to any other jurisdiction, manufacturing practices equivalent to good manufacturing practices then in effect in the United States or the European Union.

 

1.23                        “HIPAA” means, collectively, the United States Health Insurance Portability and Accountability Act of 1996, and the regulations promulgated thereunder, as amended from time to time.

 

1.24                        “IND” means an investigational new drug application filed or to be filed with the FDA as described in 21 CFR Part 312, or the equivalent filing with a relevant Regulatory Authority in any jurisdiction (including an investigational medicinal product dossier filed or to be filed with the EMA or a clinical trial application filed or to be filed with Health Canada), together with any amendments, supplements or other additions or deletions thereto.

 

1.25                        “Investigator” is defined in 21 CFR § 312.3(b) and, under this Agreement, means an individual who conducts the Study at a Participating Site in any jurisdiction.

 

1.26                        “IRB” means an institutional review board as described in 45 CFR Part 46, or the equivalent entity (such as an independent ethics committee) in any jurisdiction.

 

1.27                        “JDC Chair” is defined in Section 3.1(a).

 

1.28                        “JDC Co-Leader” is defined in Section 3.1(a).

 

1.29                        “Joint Development Committee” or “JDC” is defined in Section 3.1(a).

 

1.30                        “Joint Patent” is defined in Section 6.4(a).

 

1.31                        “Know-How” means all information, unpatented inventions (whether or not patentable), improvements, practices, formula, trade secrets, techniques, methods, procedures, knowledge, results, test data (including pharmacological, toxicological, pharmacokinetic and pre-clinical and clinical information and test data, related reports, structure-activity relationship data and statistical analysis), analytical and quality control data, protocols, processes, models, designs,

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

4

 

and other information regarding research, discovery, development, marketing, pricing, distribution, cost, sales and manufacturing.  Know-How shall not include any Patents.

 

1.32                        “Molecules” means the Genentech Molecule and the Corvus Molecule.  A “Molecule” means either the Genentech Molecule or the Corvus Molecule, as applicable.

 

1.33                        “Molecule Supply Plan” means the plan for supplying the Genentech Molecule for the Study attached hereto as Exhibit C.

 

1.34                         “NDA” means a new drug application filed or to be filed with the FDA as described in 21 CFR Part 314, or the equivalent filing with a relevant Regulatory Authority in any jurisdiction (including a marketing authorization application filed or to be filed with the EMA or Health Canada), together with any amendments, supplements or other additions or deletions thereto.

 

1.35                        “Participating Site” means a hospital or other institution participating in the Study.

 

1.36                        “Patents” means all patents and patent applications and any patents issuing therefrom or claiming priority to, in any country, including any reissues, extensions, supplementary protection certificates, registrations, divisions, continuations, continuations-in-part, reexaminations, substitutions or renewals thereof.

 

1.37                        “PD-1 Antagonist” means any molecule that [***].

 

1.38                        “PD-L1 Antagonist” means any molecule that [***].

 

1.39                         “Project Participants” means Investigators, Subinvestigators, Participating Sites, CROs, drug distributors, vendors and subcontractors or agents of Corvus (or its Affiliates), who conduct or assist in conducting the Study or provide related services.

 

1.40                        “Prosecution and Maintenance” or “Prosecute and Maintain” with regard to a given Patent, means the preparation, filing, prosecution and maintenance of such Patent, as well as any ex parte and inter partes proceedings, including reexaminations, reissues, applications for patent term extensions, interferences, derivation proceedings, post-grant review proceedings, oppositions and other similar administrative proceedings with respect to such Patent.

 

1.41                        “Protocol” means the mutually agreed protocol by the Parties attached hereto as Exhibit A, titled “A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose Selection Study of CPI-444 as Single Agent and in Combination with Atezolizumab in Patients with Selected Incurable Cancers,” which may be amended by the JDC in accordance with this Agreement.

 

1.42                        “PV Agreement” is defined in Section 2.7(a).

 

1.43                        “Quality Agreement” is defined in Section 4.3.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

5

 

1.44                        “Regulatory Authority” means (a) the FDA; (b) the EMA; or (c) any regulatory authority or body performing similar functions in any jurisdiction anywhere in the world.

 

1.45                        “Regulatory Documentation” means any document submitted to a Regulatory Authority, including all INDs, NDAs, drug master files, correspondence with Regulatory Authorities, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records.

 

1.46                        “Roche Group” means Genentech and its Affiliates.

 

1.47                        “Sample Analyses” is defined in Section 5.2.

 

1.48                        “Sample Analysis Plan” means the plan, attached as Exhibit B, that outlines the Sample Analyses to be performed by Corvus or Genentech and the priority for performing such Sample Analysis.

 

1.49                        “Sample Data” is defined in Section 5.3(a).

 

1.50                        “Samples” is defined in Section 5.2(a).

 

1.51                        “Specifications” means, with respect to a Molecule, the set of requirements for such Molecule set forth in the Quality Agreement.

 

1.52                        “Sponsor” is defined in 21 CFR § 312.3(b) and, under this Agreement, means the entity that takes responsibility for and initiates the Study in any jurisdiction.

 

1.53                        “Study” means the Phase I/Ib clinical study to be sponsored and conducted by Corvus as set forth in the Protocol.  The principal purpose of the Study is a preliminary determination of the safety of Corvus Molecule as a single agent and in combination with Genentech Molecule, consistent with the requirements further described in 21 CFR § 312.21(a) (as may be amended) or foreign counterpart thereto, or a similar clinical study in a country other than the United States. [***].

 

1.54                        “Study Completion” means the last Subject visit specified in the Protocol for primary endpoint evaluation.

 

1.55                        “Study Data” means all data (including raw data), Case Report Forms, findings, conclusions and other results, in all cases, from the single agent arm and Combination arm of the Study and the Final Study Report, including investigator reports (both preliminary and final), statistical analyses and expert opinions and reports.  Study Data excludes Sample Data.

 

1.56                        “Subinvestigator” is defined in 21 CFR § 312.3(b) and, in the event the Study is conducted by a team at a Participating Site, means an individual designated by the Investigator to be the responsible leader of such team.

 

1.57                        “Subject” is defined in 21 CFR § 312.3(b) and, under this Agreement, means a human who participates in the Study in any jurisdiction.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

6

 

1.58                        “Third Party” means any person or entity other than a Party or its Affiliates.

 

ARTICLE 2
 CONDUCT OF THE STUDY; REGULATORY MATTERS

 

2.1                               Overview.  The Parties wish to collaborate regarding the Study to be conducted under this Agreement.  Each Party shall use commercially reasonable efforts to perform its obligations hereunder.

 

2.2                               Sponsor.  Corvus shall be the Sponsor of the Study.  Corvus shall conduct, and use commercially reasonable efforts to cause all Project Participants to conduct, the Study in accordance with this Agreement, the Protocol and Applicable Law.  Corvus shall be responsible for obtaining all approvals and clearances necessary to conduct the Study, including approvals from Regulatory Authorities and IRBs and customs clearances.  In no event shall Genentech or any member of the Roche Group be deemed a Sponsor of the Study.

 

2.3       Collaboration IND; Protocol.  

 

(a)         Collaboration IND.  Corvus shall prepare and file IND #126559 for the Study (“Collaboration IND”).  Subject to the ownership provisions of Sections 5.1, 5.3 and 6.1, Corvus shall own all right, title and interest in and to the Collaboration IND and related Regulatory Documentation.

 

(b)         Protocol.  The Protocol for such Collaboration IND is set forth in Exhibit A. Any amendments to the Protocol shall be reviewed and approved by Genentech in accordance with Section 3.1.  Subject to the terms of this Agreement, Corvus shall be responsible for preparing and filing all necessary Regulatory Documentation for the Collaboration IND and the Study.

 

(c)          Investigator’s Brochure for the Combination.  Corvus shall prepare an investigator’s brochure for the Combination.  Genentech shall provide to Corvus those portions of the investigator’s brochure (and any updates) for the Genentech Molecule that pertain to safety matters and other information that may be required by Corvus to prepare the investigator’s brochure for the Combination.  Corvus shall provide a draft of the Combination investigator’s brochure to Genentech and shall duly consider Genentech’s comments.

 

2.4       Enrollment.  Commencing on or after the date the PV Agreement is executed by the Parties, Corvus may begin enrolling Subjects in the Study in compliance with Applicable Law.  Corvus shall be responsible for tracking enrollment at Participating Sites which shall not exceed the maximum number of Subjects specified in the Protocol, unless such number is increased by an amendment to the Protocol.

 

2.5       Project Participants.  Corvus shall be solely responsible for the performance and conduct of the Project Participants, including monitoring the conduct of the Study at the Participating Sites.  Corvus shall be solely responsible for negotiating and executing the necessary agreements with all Project Participants.  Corvus shall ensure that (a) all such

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

7

 

agreements include terms and conditions that are necessary for Corvus to comply with the terms and conditions of this Agreement (including the confidentiality provisions in Article 7); (b) all Project Participants are appropriately qualified and satisfy the requirements of Section Article 1; and (c) the compensation being paid to a Project Participant under its agreement with Corvus for the Study constitutes the fair market value of the services to be provided.  In no event shall any agreement with a Project Participant represent that any member of the Roche Group is a Sponsor or is otherwise responsible for the Study.

 

2.6       Regulatory Matters. 

 

(a)         Generally.  Corvus shall comply with all guidance and direction provided by Regulatory Authorities and IRBs with jurisdiction over the Study.  Corvus shall perform all regulatory obligations related to the Study, including preparation and submission of Regulatory Documentation for the Study, in accordance with the Protocol and Applicable Law.

 

(b)         Interactions with Regulatory Authorities.  Corvus shall promptly provide Genentech with a copy of any material notice, inquiry or correspondence that Corvus (or a Project Participant) receives from a Regulatory Authority regarding the Study (“Material Regulatory Notice”), including any serious safety matter related to a Party’s Molecule or the Combination and any inspection or investigation by a Regulatory Authority.  Genentech shall have the right (but not the obligation) to provide comments to any response to such Material Regulatory Notice and to participate in any discussions with a Regulatory Authority to the extent permitted by such Regulatory Authority. Without limiting Genentech’s obligations under Section 2.9, Genentech shall promptly provide Corvus with a copy of any [***].

 

(c)          Letter of Cross-Reference.  Promptly, but no later than [***], after the Effective Date, Genentech shall provide to Corvus a letter of cross-reference authorizing Corvus to reference certain information previously provided by Genentech in its INDs for the Genentech Molecule as support for the Combination portion of the Study in accordance with 21 CFR § 312.23(b).  Such letter of cross-reference shall remain in full force and effect unless it is withdrawn by Genentech due to termination of this Agreement by a Party.

 

2.7                               Adverse Experience Reporting.

 

(a)         Prior to enrollment of Subjects in the Study, the Parties shall enter into a pharmacovigilance agreement setting forth the Parties’ responsibilities and obligations with respect to the procedures and timeframes for compliance with Applicable Law pertaining to safety reporting of the respective Molecules and the Combination (“PV Agreement”).

 

(b)         The Parties shall cooperate in determining how to respond to adverse experience reports under the Study.  For adverse experience reports solely related to the Corvus Molecule, Corvus shall have final decision making authority.  For adverse experience reports solely related to the Genentech Molecule, Genentech shall have final decision making authority.  For adverse experience reports solely related to the Combination, [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

8

 

[***].  Notwithstanding the foregoing, Corvus may submit a response to Regulatory Authorities if required by a regulatory deadline.

 

(c)          Corvus shall be responsible for reporting adverse events from the Study to Regulatory Authorities in accordance with Applicable Law, including 21 CFR § 312.32.

 

2.8       Documentation, Updates and Final Study Report.

 

(a)         Documentation.  Each Party shall maintain reports and documentation arising in connection with the Study in good scientific manner and in compliance with Applicable Law.  Each Party shall provide to the other Party all such reports and documentation arising from the Study (including reports of interim analyses, if applicable) reasonably requested to enable each Party to comply with any of its legal, regulatory and/or contractual obligations, or in response to any request by a Regulatory Authority.

 

(b)         Updates.  Corvus shall provide written updates regarding the status of the Study (including enrollment status, project timelines, Genentech Molecule inventory and Genentech Molecule forecasting) to Genentech on a quarterly basis within [***] of the end of each calendar quarter or such other time as reasonably requested by Genentech.  Following receipt of such written update, Genentech may request that Corvus make available personnel and/or Project Participants (if requested by Genentech) responsible for the Study on a reasonable basis to address Genentech’s questions regarding such written update, either in person or by telephone.  Genentech shall provide a list of questions and/or topics for discussion in advance of such meeting.

 

(c)          Final Study Report.  Corvus shall complete the Study as outlined in the Protocol.  Corvus shall summarize the findings of the Study in a Final Study Report.  Corvus shall provide the Final Study Report to Genentech within [***] after Database Lock.  “Final Study Report” means a formal clinical study report documenting and summarizing the results and interpretation of the Study, including the trial design, trial objectives, patient assessment, data analysis, results, risk/benefit analysis, safety and effectiveness, in accordance with the requirements of then-existing Regulatory Authority rules, regulations and guidance on the structure and content of clinical study reports.

 

2.9       Genentech Study Responsibilities.  In addition to Genentech’s obligations to supply the Genentech Molecule under Section 4.2, Genentech shall provide and make available to Corvus any necessary information about the Genentech Molecule to support Corvus in conducting the Study.  Further, Genentech shall provide reasonable assistance to Corvus’ to support Corvus’ interactions with Regulatory Authorities and IRBs in connection with the Study.

 

2.10                                                Costs.  [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

9

 

2.11                                                Additional Studies.  During the Term and continuing [***], Corvus agrees to negotiate exclusively with Genentech for a period of [***] prior to entering into any clinical study or clinical development agreement with a Third Party involving the combination of Corvus Molecule and any PD-L1 Antagonist or PD-1 Antagonist.  During such [***], the Parties shall discuss in good faith the terms and conditions for collaborating with each other to conduct further clinical studies of the Combination, including terms [***].

 

2.12                                                Right of First Negotiation.  During the Term and continuing through [***] (“RFN Period”), Corvus shall negotiate exclusively with Genentech for a period of up to [***] prior to entering into any agreement with a Third Party for a license relating to the development and commercialization of the Corvus Molecule (a “Corvus License”).  Notwithstanding the foregoing, if Genentech enters into a license with or acquires a Third Party with a Competitive Product during the RFN Period, Genentech will notify Corvus and all of Corvus’ obligations under this Section 2.12(a) will expire on the effective date of such transaction.  Further, Genentech will thereafter adopt reasonable procedures to prevent any disclosure and/or use of Confidential Information of Corvus or Joint Confidential Information, as the case may be, to such Third Party and provide notice to Corvus describing such procedures as soon as practicable.  For clarity, the obligations and covenants set forth in this Section 2.12(a) expressly exclude and shall not limit the separate activities of Genentech’s Affiliates, including the Roche pRED (Research and Early Development) organization.

 

(b)         If Corvus is interested in negotiating with Genentech and/or a Third Party the terms of a Corvus License during the RFN Period, it shall so notify Genentech in writing.  Thereafter, the Parties shall negotiate, on an exclusive basis, the terms and conditions of a potential Corvus License for a period of [***] after Genentech receives such notice from Corvus, or such longer time period as the Parties may mutually agree in writing (the “Exclusive Negotiation Term”). If Corvus and Genentech do not reach mutually agreeable terms and conditions of a Corvus License during the Exclusive Negotiation Term, then Corvus shall be free to negotiate and enter into a Corvus License with a Third Party; provided that Corvus shall not, during the [***] period following the end of the Exclusive Negotiation Term, enter into any Corvus License with a Third Party on terms more favorable to such Third Party than those last proposed by Genentech.  If Corvus enters into a Corvus License with a Third Party during the [***] following the end of the Exclusive Negotiation Term, Corvus shall so notify Genentech.  Genentech shall have the right, within [***] days after Corvus enters into such Corvus License, [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

10

 

ARTICLE 3
 GOVERNANCE

 

3.1       Joint Development Committee.

 

(a)         Establishment of the JDC.  Within thirty (30) days after the Effective Date, the Parties shall establish a Joint Development Committee (“Joint Development Committee” or “JDC”) to oversee the Study.  The JDC shall be composed of [***] representatives designated by each Party (and the Parties need not have the same number of representatives).  The representatives shall be appropriate (in terms of their seniority, availability, function in their respective organizations, training and experience) for the activities then being undertaken.  Each Party shall designate one of its representatives as its primary JDC contact for JDC matters (each, a Party’s “JDC Co-Leader”).  Corvus’ JDC Co-Leader shall chair the Joint Development Committee (“JDC Chair”), including scheduling JDC meetings (at the request of either Party) and setting meeting agendas.  A Party may replace any or all of its representatives (and designated JDC Co-Leader) at any time by informing the other Party’s JDC Co-Leader in advance, in writing (which may be by email).  The JDC shall exist during the Term, unless otherwise mutually agreed by the Parties in writing.

 

(b)         Responsibilities of the JDC.  The Joint Development Committee shall be responsible for the following activities:

 

(i)                                    reviewing and approving amendments to the Protocol;

 

(ii)                                approving Participating Sites and Investigators;

 

(iii)                            reviewing the progress of the Study and making necessary joint decisions;

 

(iv)                             establishing the Data Review Committee (as described in Section Article 2) and deciding whether and how address its recommendations;

 

(v)                                 evaluating and determining how to address any safety matters related to the Combination;

 

(vi)                             reviewing the progress of the Sample Analysis Plan and making necessary joint decisions, including subsequent amendments to the Sample Analysis Plan and determining the timing for Sample Analysis to be performed by a Party and the transfer of results to the other Party;

 

(vii)                         coordinating the transfer of materials and information between the Parties, including the Study Data, the Final Study Report, the Samples and the Sample Data;

 

(viii)                     addressing any issues that may arise in the event of a shortage of supply of Corvus Molecule or Genentech Molecule for the Study, subject to Section 4.3;

 

(ix)                             attempting to resolve any Disputes related to the Study; and

 

(x)                                 performing such other functions as appropriate to further the purposes of the Study, or as otherwise specified in this Agreement.

 

(c)                                  Unanimous Decisions.  Actions and decisions to be taken by the JDC shall be made only following a unanimous vote, with each Party’s representatives on the JDC

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 

 

11

 

having collectively one (1) vote.  If the JDC cannot reach unanimous agreement within [***] of a matter being brought to a vote, either Party may refer the dispute to the Parties’ executives for resolution in accordance with Section 15.1 and the other provisions of Article 15.  The JDC has no authority to amend, or to waive compliance with, any provisions of this Agreement.

 

(d)         Meetings; Attendees; Decisions.  Once established, the Joint Development Committee shall meet at least once each calendar quarter and at such other times as deemed appropriate by the JDC.  The JDC may meet in person or via teleconference, video conference or the like, provided that at least one (1) meeting per calendar year shall be held in person (unless otherwise agreed by the Parties).  Each Party shall bear the expense of its respective representatives’ participation in JDC meetings.  If a Party’s representative is unable to attend a given meeting, such Party may designate a knowledgeable alternate to attend such meeting and perform the functions of such representative.  Each Party may invite a reasonable number of non-voting employees, consultants or scientific advisors to attend JDC meetings, provided that such invitees are bound by appropriate confidentiality obligations.  The JDC shall maintain written minutes of each JDC meeting, including all decisions made, action items assigned or completed and other appropriate matters.  The JDC Chair shall prepare the initial draft minutes and provide the Genentech Co-Leader with ten (10) business days for Genentech to review and approve such minutes.

 

(e)          Sub-Teams; Designees.  From time to time, the Joint Development Committee may establish sub-teams to oversee particular projects or activities, and such sub-teams will be constituted and operate as determined by the JDC.  From time to time, the JDC may designate individuals (by name or function) to oversee activities, and such designees will perform such activities as determined by the JDC.

 

3.2       Data Review Committee.

 

(a)         Establishment of the DRC; Meetings.  Under the direction of the Joint Development Committee, the Parties shall establish a Data Review Committee (“Data Review Committee” or “DRC”) to monitor the safety of the Molecules being used in the Study.  The DRC shall be composed of [***].  The DRC shall [***] during the Study.

 

(b)         Responsibilities of the DRC.  The Data Review Committee shall be responsible for performing the following functions:

 

(i)                                    evaluating suspected dose-limiting toxicities (using criteria defined in the Protocol, if applicable) and adjudicating treatment related adverse events, based on clinical experience with the Molecules;

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

12

 

(ii)                                making recommendations to the JDC to hold dosing or enrollment, if safety data require further evaluation;

 

(iii)                            making recommendations to the JDC to end dosing or enrollment; and

 

(iv)                             performing such other functions as directed by the JDC.

 

(c)          Advisory Body.  The Data Review Committee shall be solely an advisory body to the JDC and shall not have any power to make decisions that bind either Party.

 

ARTICLE 4
 SUPPLY OF STUDY DRUGS

 

4.1       Corvus Molecule.  Corvus shall use commercially reasonable efforts to supply for use in the Study, at its expense, sufficient quantities of the Corvus Molecule to conduct the Study.  Corvus represents and warrants to Genentech that the Corvus Molecule used in the Study shall be manufactured in compliance with the Specifications for the Corvus Molecule and Applicable Law.

 

4.2       Genentech Molecule.

 

(a)         Manufacture and Supply.  Genentech shall use commercially reasonable efforts to supply for use in the, at its expense, the quantities of the Genentech Molecule specified in the Molecule Supply Plan attached hereto as Exhibit C.  Genentech represents and warrants to Corvus that such Genentech Molecule shall be manufactured in compliance with: the Specifications for the Genentech Molecule, Applicable Law and the Quality Agreement.  Genentech or its designee will deliver Genentech Molecule to (i) Corvus or (ii) a Project Participant as designated by Corvus or the Joint Development Committee (for purposes of Section 4.2, “Delivery Locations”).

 

(b)         Delivery.  Genentech shall deliver the Genentech Molecule to the Delivery Locations in accordance with the Quality Agreement and the timelines specified in the Molecule Supply Plan or determined by the Joint Development Committee.  Corvus shall require the Project Participants to (i) maintain accurate records of all Genentech Molecule received and dispensed in the conduct of the Study and (ii) properly store all Genentech Molecule, in accordance with any written instructions provided by Genentech and Applicable Law, in a secure and locked location to prevent theft or misuse.

 

(c)          Remaining Molecule.  Upon completion or termination of the Study, Corvus shall ensure that all unused quantities of Genentech Molecule, as well as all used vials and bottles containing the Genentech Molecule, are destroyed in accordance with Corvus’ standard operating procedures and documented accordingly (including certifying such destruction in writing to Genentech), or returned to Genentech or its designated agent if requested by Genentech.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

13

 

(d)         Use of Genentech Molecule.  From the Effective Date until the first to occur of Study Completion or any earlier termination of the Study, Corvus (i) has the right to use the Genentech Molecule for the purpose of conducting the Study and shall use the Genentech Molecule solely for such purpose.  Corvus shall use, store, transport, handle and dispose of the Genentech Molecule in compliance with Applicable Law, the Quality Agreement and all instructions from Genentech.  Corvus shall not use the Genentech Molecule for any research, development or commercial purpose; Corvus shall not attempt to derive or reverse engineer the composition or underlying information or structure of the Genentech Molecule, and in particular shall not analyze the Genentech Molecule by physical, chemical or biochemical means, except as necessary to perform its obligations under the Quality Agreement.  [***].  The provisions of this Section 4.2(d) shall apply to any Third Party performing Study-related activities on behalf of Corvus mutatis mutandis.

 

4.3       Insufficient Quantities.  In the event that a Party determines that there are insufficient quantities of the Corvus Molecule or the Genentech Molecule to reach Study Completion, such Party shall promptly provide written notice to the other Party, including what quantities of its Molecule, if any, are available for the Study.  The JDC will promptly discuss how to address the shortage and allocate the available amounts of Corvus Molecule or Genentech Molecule, as applicable.  Notwithstanding the foregoing, [***].

 

4.4       Quality Agreement.  Within [***] of executing this Agreement, the Parties shall enter into a quality agreement establishing the quality requirements for Genentech Molecule (“Quality Agreement”).  In the event of a conflict between the Quality Agreement and this Agreement, this Agreement shall govern and control, unless otherwise expressly provided in the Quality Agreement.

 

4.5       Mutual Obligations.  Each Party shall obtain and maintain all regulatory approvals (including facility licenses) required to manufacture its respective Molecule in compliance with Applicable Law.

 

(b)         Each Party shall notify the other Party as promptly as possible in the event any manufacturing delay (or other event) is likely to adversely affect its ability to fulfill its obligations to supply its Molecule under this Agreement.

 

(c)          Each Party hereby agrees that it shall not disclose to the other Party information related to the identity (including chemical identity), chemical structure, or sequence (amino acid or nucleic acid) of its proprietary Molecule.  [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

14

 

[***].

 

(d)         For clarity, this Agreement does not create any obligation on the part of either Party to provide its Molecule for any activities or purposes other than to conduct the Study.

 

ARTICLE 5
 STUDY DATA; SAMPLE ANALYSES AND SAMPLE DATA

 

5.1       Study Data.

 

(a)         Database.  Corvus shall maintain all Study Data in its database in accordance with Applicable Law.  [***], Corvus shall timely provide such Study Data to Genentech via electronic data transfer, in SAS format or as otherwise agreed by the Parties.

 

(b)         Ownership of Study Data.  Corvus shall own all right, title and interest in and to Study Data from the single agent arm of the Study and such Study Data shall be deemed Corvus Confidential Information.  Corvus and Genentech shall [***].  Genentech has the right to [***].

 

5.2       Samples and Sample Analyses.

 

(a)         Samples.  During the Study, Corvus will direct the collection of certain biologic samples from Subjects in both the single agent arm and Combination arm (“Samples”), as set forth in the Protocol.

 

(b)         Sample Analysis.  Each Party, [***], shall perform (directly or through an Affiliate or Third Party acting on its behalf) the testing procedures and analyses of the Samples (together “Sample Analysis”) pursuant to the sample analysis plan attached hereto as Exhibit B (“Sample Analysis Plan”).  The Sample Analysis shall be performed by a Party within [***] of receipt of the Samples or such other timeline as determined by the JDC.  Neither Party shall use the Samples for any purpose other than to perform the Sample Analyses for which it is responsible, without the prior written consent of the other Party.  Corvus shall provide to Genentech the Samples necessary for Genentech to perform the Sample Analyses.

 

5.3       Sample Data.

 

(a)         Corvus and Genentech will each generate data [***].  Each Party shall

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

15

 

provide to the other Party the results and/or analysis generated in the course of performing Sample Analyses for both the single agent arm and the Combination arm via electronic data transfer or other format/media determined by the JDC.  Such results and/or analysis shall be provided to the other Party within [***] of completion of the assay or as otherwise agreed by the JDC.

 

(b)         Corvus shall own all right, title and interest in and to [***] shall be deemed Corvus Confidential Information.

 

(c)          Corvus and Genentech shall [***] (collectively “[***] Sample Data”).  [***] Sample Data shall be deemed Joint Confidential Information.

 

ARTICLE 6
 INTELLECTUAL PROPERTY

 

6.1       Inventorship; Ownership and Use; Definitions.

 

(a)         Inventorship.  The inventorship of any Collaboration Invention shall be determined in accordance with United States patent laws.

 

(b)         Sole Ownership and Use of Molecule-Specific Inventions

 

(i)                                    Corvus shall solely own all right, title and interest in and to any Collaboration Invention that [***] (“Corvus Owned Invention”).  For the avoidance of doubt, any Collaboration Invention generically encompassing [***], is a Corvus Owned Invention.  Corvus shall have the right to use and exploit any Corvus Owned Invention for any and all purposes.  Further, Corvus shall be obligated to disclose any such Corvus Owned Invention [***].

 

(ii)                                Genentech shall solely own all right, title and interest in and to any Collaboration Invention that [***] (“Genentech Owned Invention”).  For the avoidance of doubt, any Collaboration Invention generically encompassing [***], is a Genentech Owned Collaboration Invention.  Genentech shall have the right to use and exploit any Genentech Owned Invention for any and all purposes.  Further, Genentech shall be obligated to disclose any such Genentech Owned Invention [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

16

 

(c)          Joint Ownership and Use of Jointly Owned Inventions.  Genentech and Corvus shall jointly own all right, title and interest in and to the any Collaboration Invention that relates to [***] (in both cases, a “Jointly Owned Invention”) and any Patent that claims or covers a Jointly Owned Invention (each, a “Joint Patent”).  Each Party shall promptly disclose to the other Party any Jointly Owned Invention.  During and after the Term, Genentech and Corvus shall use Joint Confidential Information solely in connection with [***].  After the Term, with respect to Joint Patents only, Genentech and Corvus shall [***].

 

(d)         Assignments and Cooperation.  Each Party hereby assigns to the other Party any joint or sole ownership interest in the Collaboration Inventions as necessary to effectuate ownership of the Collaboration Inventions as set forth in this Section 6.1.  Each Party shall require its employees and Third Parties acting on a Party’s behalf to assign to such Party any Collaboration Inventions conceived, reduced to practice or otherwise created by such employees or Third Parties, and to cooperate with such Party in connection with obtaining patent protection therefor.  The Parties agree to cooperate with each other to effectuate ownership of the Collaboration Inventions as set forth in Section 6.1, including by executing and recording documents.

 

6.2       Licenses.

 

(a)         License to Corvus.  Genentech hereby grants to Corvus a non-exclusive, [***], sublicensable (as described in Section 6.2(c)) license, under Genentech’s right, title and interest in and to [***], solely for the purpose of performing [***] for use in the Combination.

 

(b)         License to Genentech.  Corvus hereby grants to Genentech a non-exclusive, [***], sublicensable (as described in Section 6.2(c)) license, under Corvus’ right, title and interest in and to [***], solely for the purpose of performing [***] for use in the Combination.

 

(c)          Sublicenses; Exercise of Licensed Rights by Third Parties.  Each Party may sublicense the rights granted to such Party under this Section 6.2, [***].

 

(d)         No Implied Licenses.  Except as otherwise expressly provided in this Agreement, this Agreement does not grant any right or license to either Party under any of the

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

17

 

other Party’s intellectual property rights (including pre-existing or independently developed intellectual property rights), and no other right or license is to be implied or inferred from any provision of this Agreement or by the conduct of the Parties.

 

6.3       Patent Prosecution and Maintenance of Solely Owned Inventions.  Each Party, [***], has the right (but not the obligation) to Prosecute and Maintain any Patents for Collaboration Inventions that such Party solely owns, including the right to use Study Data and Sample Data in such Prosecution and Maintenance.

 

6.4       Patent Prosecution and Maintenance of Jointly Owned Inventions.

 

(a)         Prosecution and Maintenance of Joint Patents.  At [***] sole cost and expense, [***] shall be responsible for the Prosecution and Maintenance of any Joint Patent through mutually agreed outside counsel (“Outside Patent Counsel”); provided that [***] consults with [***] on the Prosecution and Maintenance of any such Joint Patents as set forth in this Section 6.4.  [***] shall instruct Outside Patent Counsel to provide each of Genentech and Corvus with copies of any and all papers associated with such Prosecution and Maintenance, including all filings, submissions and correspondence to and from a patent office pertaining to such Prosecution and Maintenance so as to give [***] reasonable opportunities to provide comments in connection with such Prosecution and Maintenance.  Genentech and Corvus shall consult with each other after receiving any substantive action or after any material development in such Prosecution and Maintenance (including issues regarding the scope of, the allowance of or the rejection of any claims and any proposed or actual response to any correspondence from a patent office in connection with any such patent applications or patents).  [***] shall consider and incorporate [***] reasonable comments with respect to such Prosecution and Maintenance.

 

(b)         Selection of Outside Patent Counsel.  Outside Patent Counsel shall be selected by [***], following consultation with [***], within [***] of the Effective Date or such other date as mutually agreed by the Parties.  During the Term, [***] may, in its sole discretion, change the selected outside counsel to new patent counsel, provided that [***] consults with [***] prior to make such change.  Following any such change of patent counsel in accordance with this Section 6.4, the new patent counsel shall be deemed “Outside Patent Counsel” for purposes of this Section 6.4.

 

(c)          Step-in Rights.  In the event that [***] declines to Prosecute and Maintain a Patent for a Jointly Owned Invention or wishes to discontinue the Prosecution and Maintenance of a Joint Patent in any countries or in particular countries, [***], at its sole option, may continue such Prosecution and Maintenance, [***].

 

(d)         Limitations on Filing of Joint Patents.  Each Party [***].  In the event [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

18

 

(e)          Joint Research Agreement.  This Agreement shall be deemed a joint research agreement under 35 U.S.C. §102(c) and any foreign counterparts entered into for the purpose of developing the combination of Corvus Molecule and Genentech Molecule.

 

(f)                                   European Patent Court. At any time prior to the end of the “transitional period” as such term is used in Article 83 of the Agreement on a Unified Patent Court between the participating Member States of the European Union, for a given relevant EU Patent, [***].  [***] as a result of taking the requested action.

 

6.5       Third Party Infringement, Third Party Challenges and Third Party Allegations of Infringement.

 

(a)         Notice.  Each Party shall promptly provide the other Party with written notice reasonably detailing any known or alleged infringement by a Third Party of any Joint Patent, including Third Party submissions and post-grant reviews, unenforceability, or non-infringement of any such Joint Patent (collectively “Third-Party Infringement”).  Within [***] after receipt of such notice, the Parties shall consult with each other to determine the response to any Third Party Infringement.

 

(b)         Enforcement or Defense.

 

(i)                                    Subject to consultation with [***] as set forth in Section 6.4(a), [***] will have the initial right to determine and control a course of action designed to curtail or address such Third Party Infringement, [***], in connection with such Third Party Infringement, against such Third Party which is infringing the Joint Patent or challenging the validity, patentability, or enforceability of the Joint Patent, at its own expense, as it reasonably determines appropriate.

 

(ii)                                [***] shall keep [***] reasonably informed as to any legal or other courses of action it pursues pursuant to this subsection (i).  [***] shall provide reasonable assistance to [***] in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery and joining as a party to the action.

 

(iii)                            In connection with any such proceeding, [***] shall not enter into any settlement admitting the invalidity of, or otherwise impairing the Joint Patent without the prior written consent of [***], such consent not to be unreasonably withheld.  Any recoveries received from such an action arising from Third Party Infringement shall be applied as follows:

 

(A)                               First, [***]; and

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

19

 

(B)                               Second, any remainder shall be paid [***] to Genentech and [***] to Corvus.

 

(iv)                             If, within [***] after [***] receipt of a notice of a Third Party Infringement, [***] does not take or decides not to take any action as described in subsection (i) against a Third Party (who is infringing such Joint Patent or is challenging the validity, patentability, or enforceability of any Joint Patent), [***] may, subject to the following sentence, in its sole discretion, bring and control any legal action in connection therewith at its sole expense.  If [***] intends to bring any such legal action, it shall first notify [***] in writing of such intent and the reasons therefor and provide [***] with an opportunity to indicate to [***] its reasons for not bringing such legal action.  If [***] provides either [***].  [***] shall keep [***] reasonably informed as to any legal or commercial courses of action it pursues pursuant to this subsection (ii).  At the request [***] of [***], [***] shall provide reasonable assistance to [***] in connection therewith, including by executing reasonably appropriate documents, and cooperating in discovery; provided, however, that nothing herein shall require [***] to join as a party or otherwise participate in such legal action unless required by law or regulation, if in [***] reasonable opinion such participation will [***]. [***] may choose, at its own expense, to be represented in any such action by counsel of its own choice; provided, however, that if [***] is required as a necessary party to such action, [***]. In connection with any such proceeding, [***] shall not enter into any settlement admitting the invalidity of or otherwise impairing any Joint Patent without the prior written consent of [***], which consent shall not be unreasonably withheld.  [***].

 

ARTICLE 7
 CONFIDENTIALITY

 

7.1       Disclosure and Use of Confidential Information.  Corvus Confidential Information and Genentech Confidential Information.  Except to the extent expressly authorized by this Agreement or otherwise agreed to in writing, each Party (the “Receiving Party”) in possession of the Confidential Information of the other Party (the “Disclosing Party”) shall: (i) hold in confidence and not disclose the Disclosing Party’s Confidential Information to any Third Party, (ii) take all reasonable precautions to protect the Confidential Information of the other Party (including all precautions a Party employs with respect to its own confidential information of a similar nature and taking reasonable precautions to assure that no unauthorized use or disclosure is made by others to whom access to the Confidential Information of the Party is granted) and (iii) only use the Disclosing Party’s Confidential Information in connection with activities contemplated by, the exercise of rights permitted by or in order to further the purposes of this Agreement.  The foregoing obligations of the Receiving Party shall

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

20

 

not apply to the Disclosing Party’s Confidential Information to the extent that the Receiving Party establishes by written evidence that such Confidential Information:

 

(i)                                    was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of its disclosure by the Disclosing Party;

 

(ii)                                was generally available to the public or otherwise part of the public domain at the time of its disclosure by the Disclosing Party;

 

(iii)                            became generally available to the public or otherwise part of the public domain, other than through any act or omission of the Receiving Party in breach of this Agreement, after its disclosure by the Disclosing Party;

 

(iv)                             was disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others;

 

(v)                                 was subsequently developed by or on behalf of the Receiving Party without use of the Disclosing Party’s Confidential Information or Joint Confidential Information, as the case may be; or

 

(vi)                             is no longer subject to the provisions of Section 7.1 by the prior written consent of the Disclosing Party.

 

(b)         Joint Confidential Information.  Except to the extent expressly authorized by this Agreement (including Section 6.1(c)) or otherwise agreed to in writing, each Party shall, with regard to Joint Confidential Information, (i) hold in confidence and not disclose Joint Confidential Information to any Third Party, (ii) take all reasonable precautions to protect Joint Confidential Information (including all precautions a Party employs with respect to its own confidential information of a similar nature and taking reasonable precautions to assure that no unauthorized use or disclosure is made by others to whom access to the Confidential Information of the Party is granted) and (iii) subject to Section 6.1(c), only use Joint Confidential Information in connection with activities contemplated by, the exercise of rights permitted by or in order to further the purposes of this Agreement.

 

7.2       Authorized Disclosures.

 

(a)         Legal Compliance.  A Party may disclose the other Party’s Confidential Information or Joint Confidential Information, as the case may be, if such disclosure is required by law, rule or regulation (including to comply with the order of a court or governmental regulations , and any disclosure requirements of the Securities and Exchange Commission or the securities exchange or other stock market on which such Party’s securities are traded), but only to the extent such disclosure is reasonably necessary for such compliance; provided, however, except for disclosures otherwise permitted under Section Article 3, or as otherwise required or necessitated by law, such Party shall where practicable provide prompt notice of such disclosure requirement to the other Party and provide reasonable assistance to enable such other Party to seek a protective order or otherwise prevent such disclosure (in each case, to the extent it is legally permitted to do so).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

21

 

(b)         Regulatory Authorities.  A Party may disclose the other Party’s Confidential Information or Joint Confidential Information, as the case may be, to Regulatory Authorities to the extent such disclosure is required to comply with applicable governmental regulations or is in connection with such Party’s filings, submissions and communications with Regulatory Authorities regarding such Party’s Molecule.

 

(c)          Subcontractors.  A Party may disclose the other Party’s Confidential Information or Joint Confidential Information, as the case may be, to subcontractors to the extent such disclosure is required to conduct the Study or perform the Sample Analysis; provided that any such subcontractors are contractually bound in writing by obligations reasonably similar to those set forth in Section 7.1.

 

(d)         Affiliates; Professional Advisors; Other Third Parties.  A Party may disclose the terms of this Agreement (or a summary thereof) or the other Party’s Confidential Information or Joint Confidential Information, as the case may be, on a confidential basis and to the extent reasonably necessary, to its Affiliates, board members, accountants, attorneys, auditors or other professional advisors; provided that any such board members, accountants, attorneys, auditors or other professional advisors are contractually bound in writing by obligations reasonably similar to those set forth in Section 7.1.  [***].  Notwithstanding the foregoing, [***], to a potential or actual licensee or corporate partner, provided that (i) such disclosure is [***]; (ii) such [***]; (iii) any such disclosure is not [***]; and (iv) Corvus provides written notice to Genentech prior to [***].

 

7.3       Continuing Obligation.  Article 7 shall survive the expiration or termination of this Agreement for a period of [***].

 

7.4       Termination of Prior Agreements.  As of the Effective Date, this Agreement supersedes the Non-Disclosure Agreement between Corvus and Hoffman-La Roche Inc. (covering the Roche Group, including Genentech) effective as of [***].  All “Information” (as defined in such non-disclosure agreement) exchanged between the Parties thereunder shall be deemed Confidential Information of the Disclosing Party hereunder and shall be subject to the provisions of Article 7.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

22

 

ARTICLE 8
 PUBLIC DISCLOSURES; USE OF NAMES

 

8.1       Clinical Trials Registries.  Corvus agrees that it is the “responsible party” as that term is used in Title VIII Section 801 of the Food Drug Administration Amendments Act 2007 (known as FDAAA 801) and, as such, agrees to timely post the required Study information on ClinicalTrials.gov, and on other clinical trials registries as required by Applicable Law.

 

8.2       Publications and Presentations.

 

(a)         Corvus may publish or present the final results of the Study (in accordance with this Section 8.2); provided that Corvus gives Genentech an opportunity to review and provide comments in accordance with subsection (b).

 

(b)         In the event that either Party (for purposes of this Section, the “Publishing Party”) wishes to publish or present any Study Data or Sample Data, the Publishing Party shall submit to the other Party (for purposes of this Section, the “Reviewing Party”) all materials related to the proposed publication or presentation (including posters, abstracts, manuscripts and written descriptions of oral presentations) at least [***] days (or [***], in the case of abstracts) prior to the date of submission for publication or the date of presentation, whichever is earlier, of any of such submitted materials.  The Reviewing Party shall review such submitted materials and respond to the Publishing Party as soon as reasonably possible, but in any case within [***] (or [***], in the case of abstracts) of receipt thereof.  The Publishing Party will be permitted to publish or present such Study Data or Sample Data, but shall give reasonable consideration to any request by the Reviewing Party; provided, however, at the request of the Reviewing Party, the Publishing Party shall (i) delete from such proposed publication or presentation Confidential Information of the Reviewing Party (including Sample Data), provided that the Publishing Party shall have no obligation to delete any Study Data; and/or (ii) if such proposed publication or presentation contains patentable subject matter owned solely or jointly by the Reviewing Party, delay such proposed publication or presentation, for [***], to permit the Reviewing Party to prepare and file a patent application.  The Publishing Party shall comply with all applicable requirements regarding disclosure of industry support (financial or otherwise) in connection with any publications and presentations.  For clarity, the provisions of this Section 8.2 only apply to publications or presentations of Study Data or Sample Data and do not apply to any other publications or presentations by a Party, including with respect to results from such Party’s development activities outside of the Study.

 

(c)          Authorship of publications or presentations of final results of the Study and/or any Study Data or Sample Data shall be determined in accordance with appropriate scientific and academic standards and customs.

 

8.3       Press Releases and Other Public Disclosures.

 

(a)         Generally.  For purposes of Section 8.3, a “Disclosure” means a press release or other public disclosure concerning this Agreement or the subject matter hereof, including the terms and conditions of this Agreement and the Protocol.  The provisions of Section 8.3 are in addition to the provisions of Article 7.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

23

 

(b)         Review and Approval.  Each Party agrees that the other Party shall have no less than [***] (before the date of a proposed Disclosure) to review and provide comments regarding any proposed Disclosure (subject to Section 8.3(d)), unless a shorter review time is agreed to by both Parties.  Except for Disclosures covered by other provisions of Section 8.3, if a Party desires to make a Disclosure, it shall obtain the other Party’s prior written approval for the proposed Disclosure.  Disclosures include public communications that contain previously disclosed information; provided, however, neither Party shall be required to obtain the other Party’s approval to repeat any information regarding the terms of this Agreement that has already been publicly disclosed by such Party, or by the other Party, in accordance with Section 8.3, provided such information remains accurate at such time.

 

(c)          Disclosure Required by Law.  In the event that one Party reasonably concludes, based on the opinion of legal counsel, that a Disclosure is required by law, rule or regulation (including the disclosure requirements of the Securities and Exchange Commission or the securities exchange or other stock market on which such Party’s securities are traded (for purposes of Section 8.3, collectively, an “Exchange”)), such Party shall provide the other Party with such advance notice of this Disclosure as it reasonably can, but shall not be required to obtain approval therefor.  Each Party agrees that it shall obtain its own legal advice with regard to its compliance with securities laws, rules and regulations, and will not rely on any statements made by the other Party relating to such securities laws, rules and regulations.

 

(d)         Filing of Agreement.  The Parties acknowledge that either or both Parties may be obligated under the disclosure requirements of an Exchange to file a copy of this Agreement with such Exchange.  Each Party shall be entitled to make such a required filing, provided that it uses reasonable efforts to request confidential treatment of the commercial terms and sensitive technical terms of this Agreement, to the extent such confidential treatment is reasonably available to such Party.  The filing Party shall provide to the other Party a copy of this Agreement marked to show the provisions for which the filing Party intends to seek confidential treatment no less than [***] before the date of the proposed filing, for such other Party’s review and comment, [***].

 

8.4       Use of Names.  Each Party agrees to identify the other Party and acknowledge its support in any press release and any publication or presentation of the Study Data or Sample Data (which shall be in accordance with other provisions of this Agreement, including Section 8.2).  Except as otherwise expressly provided in this Agreement, no right, express or implied, is granted by the Agreement to use in any manner the name of “Corvus,” “Genentech”, “Roche” or any other trade name or trademark of the other Party (or its Affiliates) in any public statement or for commercial, marketing or other promotional purpose, without the other Party’s prior written consent.

 

ARTICLE 9
 HUMAN SUBJECTS

 

9.1       Informed Consent.  Corvus shall obtain the informed written consent of all Subjects participating in the Study, in accordance with Applicable Law.  [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

24

 

[***].  Corvus shall provide copies of such informed written consents upon Genentech’s request.  Corvus further represents and warrants that the Samples may be used as contemplated in this Agreement [***].

 

9.2       IRB Approval.  Corvus shall obtain IRB review and approval of the Protocol and the informed consent form to be used in the Study in accordance with Applicable Law.

 

9.3       Patient Privacy and Data Protection.  Each Party shall comply with Applicable Law relating to patient privacy and data protection.  Such compliance includes [***] for the purposes of [***].  Each Party agrees that [***].

 

ARTICLE 10
 SUBCONTRACTING; RECORDS

 

10.1                                                Subcontracting.  Each Party shall have the right to delegate any portion of its obligations under this Agreement to a subcontractor, provided that such Party shall remain solely and fully liable for the performance of such subcontractors.  Each Party shall ensure that each of its subcontractors performs its obligations pursuant to the terms of this Agreement, including the Exhibits.  Each Party shall use reasonable efforts to obtain and maintain copies of documents relating to the obligations performed by such subcontractors that are held by or under the control of such subcontractors and that are required to be provided to the other Party under this Agreement.

 

10.2                                                Records.

 

(a)         In addition to providing Study Data to Genentech under Section 5.1(a), [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

25

 

[***].

 

(b)         Corvus (or its designee) shall maintain such records for at least the period of time required by Applicable Law, but for no less than [***] following the completion or termination of the Study.

 

ARTICLE 11
 COMPLIANCE WITH LAWS

 

11.1                                                Compliance with Laws and Policies.  Each Party shall perform activities under this Agreement in compliance with Applicable Law and in accordance with good business ethics and the ethics and other corporate policies applicable to such Party.  Specifically, each Party covenants that it, its directors, employees, officers, and anyone acting on its behalf, shall not, in connection with the performance of this Agreement, directly or indirectly, make, promise, authorize, ratify or offer to make, or take any act in furtherance of any payment or transfer of anything of value for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an improper advantage; or improperly assisting it in obtaining or retaining business for it or the other Party, or in any way with the purpose or effect of public or commercial bribery.  Other provisions of the Agreement require compliance with specified areas of Applicable Law and such other provisions do not limit the scope of compliance required of the Parties under this Section.

 

11.2                                                Debarment.  Corvus shall require each Project Participant to represent and warrant that neither the Project Participant nor anyone employed by such Project Participant has been debarred under 21 USC § 335a, disqualified under 21 CFR § 312.70 or § 812.119, sanctioned by a Federal Health Care Program (as defined in 42 USC § 1320a-7b(f)), including the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar regional, national, federal or state agency or program.  If a Project Participant receives notice of debarment, suspension, sanction, exclusion, ineligibility or disqualification under the foregoing-referenced statutes, Corvus shall promptly notify Genentech, and the Parties shall agree upon appropriate action to address the matter.

 

ARTICLE 12
 TERM; TERMINATION

 

12.1                                                Term.  Unless sooner terminated as provided in Article 12, this Agreement shall expire on the one year anniversary of the date that Corvus provides the Final Study Report to Genentech or termination of the Study (in either case, “Term”).

 

12.2                                                Termination for Material Breach.  Either Party may terminate this Agreement, by notice to the other Party, for any material breach of this Agreement by the other Party, if such breach is not cured within [***] after the allegedly breaching Party receives notice of such breach from the non-breaching Party; provided, however, if such breach is not capable of being cured within such [***] period, the cure period shall be extended for such amount

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

26

 

of time that the Parties agree to in writing is reasonably necessary to cure such breach, so long as the allegedly breaching Party is using diligent efforts to do so.

 

12.3                                                Termination for Other Reasons.  Either Party may terminate this Agreement immediately, by notice to the other Party, if: (a) based on a review of Study Data or other Study-related information, such Party determines that the Study may unreasonably affect patient safety; (b) any Regulatory Authority or IRB withdraws the authorization and/or approval to conduct the Study; (c) any Regulatory Authority takes any action, or raises any objection, that prevents such Party from supplying its Molecule for purposes of the Study; (d) the other Party breaches the representation and warranty under Section 13.1(c); or (e) such Party determines, in its sole discretion, to discontinue all development of its Molecule, for medical, scientific, business or legal reasons, [***].

 

12.4                                                Effects of Termination or Expiration.

 

(a)         Study Wind-Down.  Following termination of this Agreement under Section 12.2 or Section 12.3, the Parties shall cooperate to ensure the orderly wind-down of Study activities, taking into consideration the safety and welfare of Subjects.

 

(b)         Accrued Rights and Obligations.  Except as otherwise expressly provided in this Agreement, termination of this Agreement shall not affect the rights and obligations of the Parties that accrued prior to the effective date of such termination.  Any right that a Party has to terminate this Agreement, and any rights that such Party has under Article 12, shall be in addition to and not in lieu of all other rights or remedies that such Party may have at law or in equity or otherwise.

 

(c)          Survival.  Except as otherwise expressly provided in this Agreement, the following shall survive this Agreement’s expiration or termination for any reason:  Article 1 (Definitions), Section 2.6 (Regulatory Matters), Section 1.1(a) (Documentation), Section 2.11 (Additional Studies), Section 2.12 (Right of First Negotiation), Section 5.1(b) (Ownership of Study Data), Sections 5.3(b) and (c) (Sample Data), Article 6 (Intellectual Property and Licenses), Article 7 (Confidentiality), Article 8 (Public Disclosures; Use of Names), Section 9.3 (Patient Privacy and Data Protection), Section 10.2(a) (Records), Section 12.4 (Effects of Termination), Section 13.2 (Disclaimers), Section 14.1 (Indemnification), Section 14.2 (Limitation on Liability), Article 15 (Dispute Resolution) and Article 16 (Miscellaneous).  To the extent applicable to a Section or Article that survives the expiration or termination of this Agreement, any other Sections and Articles that are (directly or indirectly) referenced in, or refer to, such surviving Section or Article shall survive.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

27

 

ARTICLE 13
 REPRESENTATIONS AND WARRANTIES

 

13.1                                                Mutual Representations and Warranties.  Each Party represents and warrants to the other Party the following:

 

(a)         Such Party has the full right, power and authority, and has obtained all approvals, permits or consents necessary, to enter into this Agreement, to perform all of its obligations hereunder.

 

(b)         Such Party has not entered into prior to the Effective Date, and shall not enter into during the Term, any agreement that conflicts with a Party’s obligations hereunder.

 

(c)          Neither Party nor anyone employed by it has been debarred under 21 USC § 335a, disqualified under 21 USC § 312.70 or § 812.119, sanctioned by a Federal Health Care Program (as defined in 42 USC § 1320a-7b(f)), including the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar regional, national, federal or state agency or program.  If such Party receives notice of debarment, suspension, sanction, exclusion, ineligibility or disqualification under the foregoing-referenced statutes, such Party shall promptly notify the other Party, and the Parties shall agree upon appropriate action to address the matter.

 

13.2                                                Disclaimers.  NEITHER PARTY REPRESENTS OR WARRANTS THAT THE STUDY WILL BE SUCCESSFUL OR LEAD TO ANY PARTICULAR RESULT.  EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO ITS RESPECTIVE MOLECULE, MATERIALS OR INFORMATION SUPPLIED BY IT TO THE OTHER PARTY HEREUNDER, AND EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.

 

ARTICLE 14
 INDEMNIFICATION; LIMITATION ON LIABILITY; INSURANCE

 

14.1                                                Indemnification.

 

(a)         Definitions.  The following definitions are for purposes of Section 14.1:

 

(i)                                    “Claims” means claims, suits, actions, demands or other proceedings by any Third Party arising out of this Agreement or the Study, including product liability claims.

 

(ii)                                “Indemnitee” means, as applicable, a Corvus Indemnitee (as defined in Section 14.1(b)(i)) or a Genentech Indemnitee (as defined in Section 14.1(c)(i)).

 

(iii)                            “Losses” means any and all liabilities, damages, settlements, penalties, fines, costs or expenses (including, reasonable attorneys’ fees and other expenses of litigation).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

28

 

(b)         Indemnification by Genentech.

 

(i)                                    Indemnification Scope.  Genentech hereby agrees to indemnify, defend and hold harmless each of Corvus, its Affiliates and its and their officers, directors, employees, subcontractors and agents (for purposes of Section 14.1, each, a “Corvus Indemnitee”) from and against Losses incurred in connection with Claims, to the extent such Losses (A) arise out of or in connection with (1) the negligence or willful misconduct of any Genentech Indemnitees; (2) Genentech’s breach of any of its representations, warranties, covenants or obligations under this Agreement; or (3) Genentech’s breach of any Applicable Law pertaining to activities it performs under this Agreement or (B) are directly caused by the Genentech Molecule.

 

(ii)                                Procedures.  Corvus shall (A) notify Genentech of any Claim for which it seeks to exercise its rights under Section 14.1(b)(i) as soon as reasonably possible after it receives notice of such Claim; (B) permit Genentech to assume the sole control of the defense thereof, including the right to settle or conclude such defense; (C) cooperate as reasonably requested (at the expense of Genentech) in the defense of such Claim; and (D) not settle such Claim without the express, prior written consent of Genentech.  Genentech’s obligations under Section 14.1(b)(i) shall not apply (A) to amounts paid in settlement of any Claims if such settlement is effected without Genentech’s consent or (B) to the extent any Losses arise out of or in connection with (1) the negligence or willful misconduct of any Corvus Indemnitees; (2) Corvus’ breach of any of its representations, warranties, covenants or obligations under this Agreement; or (3) Corvus’ breach of any Applicable Law pertaining to activities it performs under this Agreement.

 

(c)          Indemnification by Corvus.

 

(i)                                    Indemnification Scope.  Corvus hereby agrees to indemnify, defend (if requested by Genentech) and hold harmless each of Genentech, its Affiliates and its and their officers, directors, employees, subcontractors and agents (for purposes of Section 14.1, each, a “Genentech Indemnitee”) from and against Losses incurred in connection with Claims, to the extent such Losses (A) arise out of or in connection with (1) the negligence or willful misconduct of any Corvus Indemnitees; (2) Corvus’ breach of any of its representations, warranties, covenants or obligations under this Agreement; or (3) Corvus’ breach of any Applicable Law pertaining to activities it performs under this Agreement or (B) are directly caused by the Corvus Molecule.

 

(ii)                                Procedures.  Genentech shall notify Corvus of any Claim for which it seeks to exercise its rights under Section 14.1(c)(i) as soon as reasonably possible after it receives notice of such Claim.  If requested by Genentech, Corvus shall assume control of the defense thereof, with counsel mutually satisfactory to the Parties, including the right to settle or conclude such defense.  In the event that Genentech requests that Corvus assume such control, Genentech shall (A) cooperate as reasonably requested (at the expense of Corvus) in the defense of such Claim and (B) not settle such Claim without the express, prior written consent of Corvus.  Corvus’ obligations under Section 14.1(c)(i) shall not apply (A) to amounts paid in settlement of any Claims if such settlement is effected without Corvus’ consent or (B) to the extent any Losses arise out of or in connection with (1) the negligence or willful misconduct of any Genentech Indemnitees; (2) Genentech’s breach of any of its representations, warranties, covenants or

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

29

 

obligations under this Agreement; or (3) Genentech’s breach of any Applicable Law pertaining to activities it performs under this Agreement.

 

(d)         Limitations.  The failure of an Indemnitee to deliver notice to the other Party (for purposes of this Section 14.1(d), the “Indemnitor”) within a reasonable time after the commencement of any Claim for which such Indemnitee seeks to exercise its rights under Section 14.1, to the extent prejudicial to the Indemnitor’s ability to defend such Claim, shall relieve the Indemnitor of its obligation to the Indemnitees under Section 14.1.  The Parties agree that only Corvus or Genentech may seek to exercise the rights under Section 14.1 (on its own behalf or on behalf of its Indemnitees), and other Indemnitees may not directly seek to exercise such rights.

 

(e)                                  Study Subjects.  [***]

 

14.2                                                Limitation on Liability.  IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL, PUNITIVE OR EXEMPLARY DAMAGES, HOWEVER CAUSED; PROVIDED HOWEVER, NOTHING IN THIS SECTION 14.2 IS INTENDED TO LIMIT THE RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER SECTION 14.1.

 

14.3                                                Insurance.

 

(a)         General.  Each Party shall maintain insurance coverage as set forth in Section 14.3; provided, however, Genentech has the right, in its sole discretion, to self-insure, in part or in whole, for any such coverage.  Insurance coverage shall be primary insurance with respect to each Party’s own participation under this Agreement and shall be maintained with an insurance company or companies having an A.M. Best’s rating (or its equivalent) of A-VII or better.  On request, each Party shall provide to the other Party certificates of insurance evidencing the insurance coverage required under Section 14.3.  Each Party shall provide to the other Party at least [***] notice of any cancellation, nonrenewal or material change in any of the required insurance coverages.  The limits of any required insurance coverage shall not limit the Parties’ liability under the indemnification provisions of this Agreement.

 

(b)         Genentech Coverage.  Genentech shall maintain product liability insurance relating to the Genentech Molecule provided by Genentech under this Agreement, for limits no less than [***] per occurrence and [***] in the aggregate.

 

(c)          Corvus Coverage.  Corvus shall maintain in full force and effect through the term of this Agreement, sufficient insurance, including (i) commercial general liability (including contractual liability) insurance covering bodily injury and property damage arising out of Corvus’ obligations under this Agreement, for limits no less than [***] per occurrence and [***] in the aggregate and (ii) product liability insurance relating to the Corvus Molecule provided by Corvus under this Agreement, for limits of no less than [***] per occurrence and [***] in the aggregate.  For claims-made type coverage, product liability

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

30

 

insurance shall be maintained for a minimum of [***] after the last Subject receives treatment in connection with the Study (which may be achieved, without limitation, by way of an extended reporting period endorsement), including any treatment received after Study Completion, but not less than the statute of limitations in the state or location where the Study is being conducted.  Corvus shall ensure prior to the enrollment of any Subjects that the insurance policies required by this Section cover injuries that may arise in connection with the Study.

 

ARTICLE 15
 DISPUTE RESOLUTION

 

15.1                                                Internal Resolution.  Corvus and Genentech recognize that a dispute, controversy or claim of any nature whatsoever arising out of or relating to this Agreement (each, a “Dispute”) may from time to time arise during the Term.  In the event of the occurrence of such a Dispute, the Parties shall first refer such Dispute to the JDC pursuant to Section 3.1(c).  If the JDC cannot resolve such Dispute, the Party bringing the Dispute shall provide written notice, including a description of the Dispute and the steps taken to resolve such Dispute, to the other Party.  Upon receipt of such notice, the Dispute shall be referred to [***] and [***] for resolution, prior to proceeding under the other provisions of Article 15.  In the event that such Dispute is not resolved within [***] of such other Party’s receipt of such notice, [***].  For all other Disputes not subject to final decision making authority of a Party, either Party may commence an arbitration to resolve such Dispute in accordance with Section 15.2.

 

15.2                                                Arbitration.  Except as otherwise expressly provided in this Agreement, the Parties agree that any Dispute not resolved internally by the Parties pursuant to Section 15.1 shall be resolved through binding arbitration conducted by the American Arbitration Association in accordance with the then prevailing Commercial Arbitration Rules of the American Arbitration Association (for purposes of Article 15, the “Rules”), except as modified in this Agreement, applying the substantive law specified in Section 16.2.

 

(a)         Arbitrators; Location.  Each Party shall select one (1) arbitrator, and the two (2) arbitrators so selected shall choose a third arbitrator.  All three (3) arbitrators shall serve as neutrals and have at least ten (10) years of both (i) dispute resolution experience (which may include judicial experience) and (ii) legal or business experience in the biotech or pharmaceutical industry.  If a Party fails to nominate its arbitrator, or if the Parties’ arbitrators cannot agree on

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

31

 

the third arbitrator, the necessary appointments shall be made in accordance with the Rules.  Once appointed by a Party, such Party shall have no ex parte communication with its appointed arbitrator.  The arbitration proceedings shall be conducted in [***].

 

(b)         Procedures; Awards.  Each Party agrees to use reasonable efforts to make all of its then current employees available, if reasonably needed, and agrees that the arbitrators may deem any employee or person as necessary to the arbitration.  The arbitrators shall be instructed and required to render a written, binding, non-appealable resolution and award on each issue that clearly states the basis upon which such resolution and award is made.  The written resolution and award shall be delivered to the Parties as expeditiously as possible, but in no event more than ninety (90) days after conclusion of the hearing, unless otherwise agreed by the Parties.  Judgment upon such award may be entered in any competent court or application may be made to any competent court for judicial acceptance of such an award and order for enforcement.  Each Party agrees that, notwithstanding any provision of applicable law or of this Agreement, it will not request, and the arbitrators shall have no authority to award punitive or exemplary damages against any Party.

 

(c)          Interim Equitable Relief.  Notwithstanding anything to the contrary in Article 15, in the event that a Party reasonably requires relief on a more expedited basis than would be possible pursuant to the procedure set forth in Article 15, such Party may seek a temporary injunction or other interim equitable relief in a court of competent jurisdiction pending the opportunity of the arbitrators to review the decision under Article 15.  Such court shall have no jurisdiction or ability to resolve disputes beyond the specific issue of temporary injunction or other interim equitable relief.

 

(d)         Protective Orders; Arbitrability.  At the request of either Party, the arbitrators shall enter an appropriate protective order to maintain the confidentiality of information produced or exchanged in the course of the arbitration proceedings.  The arbitrators shall have the power to decide all questions of arbitrability.

 

15.3                        Subject Matter Exclusions.  Notwithstanding the provisions of Section 15.2, any Dispute not resolved internally by the Parties pursuant to Section 15.1 that involves the scope, enforceability, validity or infringement of any Corvus Patent, Genentech Patent or Joint Patent (a) that is issued in the United States shall be subject to actions before the United States Patent and Trademark Office and/or submitted exclusively to the federal court located in the jurisdiction of the district where any of the defendants resides; and (b) that is issued in any other country shall be brought before an appropriate regulatory or administrative body or court in that country, and the Parties hereby consent to the jurisdiction and venue of such courts and bodies.

 

15.4                        Continued Performance.  Provided that this Agreement has not terminated, the Parties agree to continue performing under this Agreement in accordance with its provisions, pending the final resolution of any Dispute.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

32

 

ARTICLE 16
 MISCELLANEOUS

 

16.1                Notices.  Except as otherwise expressly provided in this Agreement, any notice required under this Agreement shall be in writing, shall specifically refer to this Agreement and shall be sent in accordance with the provisions of this Section 16.1.  Notices shall be sent via one of the following means and will be effective (a) on the date of delivery, if delivered in person; (b) on the date of receipt, if sent by a facsimile (with delivery confirmed); or (c) on the date of receipt, if sent by private express courier or by first class certified mail, return receipt requested (or its equivalent).  Any notice sent via facsimile shall be followed by a copy of such notice by private express courier or by first class mail.  Notices shall be sent to the other Party at the addresses set forth below.  Either Party may change its addresses for purposes of this Section 16.1 by sending written notice to the other Party.

 

If to Corvus:

 

Corvus Pharmaceuticals, Inc.

863 Mitten Road

Suite 102

Burlingame, CA 94010

Attn:  Richard Miller, M.D.

Telephone: (650) 900-4520

Facsimile:  N/A

 

with a required copy to:

 

Latham & Watkins

140 Scott Drive

Menlo Park, CA 94025

Attn: Alan C. Mendelson, Esq.

Telephone:  (650) 328-4600

Facsimile:  (650) 463-3000

 

If to Genentech:

 

Genentech, Inc.

1 DNA Way

South San Francisco, CA 94080

Attn:  Corporate Secretary

Telephone:  (650) 225-1000

Facsimile:  (650) 467-9146

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

33

 

with a required copy to:

 

F Hoffmann-La Roche Ltd

Grenzacherstrasse 124

CH-4070 Basel

Switzerland

Attn:  Head of Oncology, Business Development, Roche Partnering

Telephone:  +41 61 688 06 29

 

16.2                Governing Law.  This Agreement shall be governed by and construed under the laws of the State of Delaware, without regard to conflict of laws principles.  The Parties hereby exclude from this Agreement the application of the United Nations Convention on Contracts for the International Sale of Goods.

 

16.3                Assignment.

 

(a)   General.  Except as otherwise expressly provided in this Agreement, neither Party may assign any of its rights or delegate any of its obligations under this Agreement without the prior written consent of the other Party, such consent not to be unreasonably withheld.  Subject to the other provisions of Section 16.3, either Party may assign this Agreement, in part or in its entirety, to (a) an Affiliate; (b) an acquirer of all its capital stock (by reverse triangular merger or otherwise) or all or substantially all its assets; or [***] (for purposes of Section 16.3, any of the foregoing, a “Change of Control”), provided that in the event of any Change of Control, the Third Party to which this Agreement is assigned expressly agrees in writing to assume and be bound by the obligations of the assigning Party under this Agreement.  A copy of such writing shall be provided to the non-assigning Party within thirty (30) days of the assignment.  Subject to the foregoing and other applicable provisions of Section 16.3, this Agreement will inure to the benefit of and bind the Parties’ successors and assigns.  Any assignment or delegation in contravention of any such applicable provisions shall be null and void.  Notwithstanding any other provision of Section 16.3, this Agreement may only be assigned together with the Ancillary Agreements.

 

(b)   Assignment by Corvus; Acquisitions.  In the case of a Change of Control of Corvus, Corvus shall notify Genentech promptly upon completing such Change of Control if the acquiring party (i) [***] or (ii) [***] (directly or indirectly) or the like.  Corvus, including its acquiring party, shall (i) [***] and (ii) provide [***].  The foregoing obligations shall also apply if Corvus or a Corvus Affiliate [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

34

 

16.4                Force Majeure.  Neither Party shall be deemed to have breached this Agreement for failure to perform its obligations under this Agreement to the extent such failure results from causes beyond the reasonable control of the affected Party, such causes including acts of God, earthquakes, fires, floods, embargoes, wars, acts of terrorism, insurrections, riots, civil commotions, omissions or delays in action by any governmental authority, acts of a government or agency thereof and judicial orders or decrees.  If a force majeure event occurs, the Party unable to perform shall promptly notify the other Party of the occurrence of such event, and the Parties shall meet (in person or telephonically) promptly thereafter to discuss the circumstances relating thereto.  The Party unable to perform shall (a) provide reasonable status updates to the other Party from time to time; (b) use commercially reasonable efforts to mitigate any adverse consequences arising out of its failure to perform; and (c) resume performance as promptly as possible.

 

16.5                Relationship of the Parties.  The Parties to this Agreement are independent contractors, and nothing contained in this Agreement shall be deemed or construed to create a partnership, joint venture, employment, franchise, agency or fiduciary relationship between the Parties.

 

16.6                Amendment; Waiver.  Except as otherwise expressly provided in this Agreement, no amendment to this Agreement shall be effective unless made in writing and executed by an authorized representative of each Party.  A Party’s failure to exercise, or delay in exercising, any right, power, privilege or remedy under this Agreement shall not (a) operate as a waiver thereof or (b) operate as a waiver of any other right, power, privilege or remedy.  A waiver will be effective only upon the written consent of the Party granting such waiver.

 

16.7                Construction; Captions.  Each Party acknowledges that it participated in the negotiation and preparation of this Agreement and that it had the opportunity to consult with an attorney of its choice in connection therewith.  Ambiguities, if any, in this Agreement shall not be construed against either Party, irrespective of which Party may be deemed to have drafted the Agreement or authorized the ambiguous provision.  Capitalized terms defined in the singular shall include the plural and vice versa.  The terms “includes” and “including” mean “includes, without limitation,” and “including, without limitation,” respectively.  Titles, headings and other captions are for convenience only and shall not affect the meaning or interpretation of this Agreement.

 

16.8                Severability.  If any of the provisions of this Agreement are held to be illegal, invalid or unenforceable, such illegal, invalid or unenforceable provisions shall be replaced by legal, valid and enforceable provisions that will achieve to the maximum extent possible the intent of the Parties, and the other provisions of this Agreement shall remain in full force and effect.

 

16.9                Entire Agreement.  This Agreement, together with the Ancillary Agreements and the exhibits hereto, contain the entire understanding between the Parties with respect to the subject matter hereof and thereof and supersede and terminate all prior agreements, understandings and arrangements between the Parties with respect to such subject matter, whether written or oral.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

35

 

16.10              Counterparts; Facsimiles.  This Agreement may be executed in two (2) or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument.  A facsimile (including a PDF image delivered via email) of this Agreement, including the signature pages hereto, will be deemed to be an original.  Notwithstanding the foregoing, the Parties shall deliver original execution copies of this Agreement to one another as soon as practicable following execution thereof.

 

[Signature page follows]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

36

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective duly authorized representatives as set forth below.

 

 

	
CORVUS PHARMACEUTICALS, INC.
    	
 
    	
GENENTECH, INC.
    
	
 
    	
 
    	
 
    
	
Signed:
    	
/s/   Richard Miller 
    	
 
    	
Signed:
    	
/s/   Mark Davis
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Richard   A. Miller 
    	
 
    	
Name:
    	
Mark   Davis 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
CEO
    	
 
    	
Title:
    	
Lifecycle   Leader
    

 

[Signature page to PhI/Ib Combination Study Agreement]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

CONFIDENTIAL

 

EXHIBIT A

 

 

PROTOCOL FOR THE STUDY

 

[see separate attachment]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Exhibit A-1

 

CONFIDENTIAL

 

EXHIBIT B

 

SAMPLE ANALYSIS PLAN

 

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Exhibit B-1

 

CONFIDENTIAL

 

EXHIBIT C

 

GENENTECH MOLECULE SUPPLY PLAN

 

Schedule of Deliveries for the Genentech Molecule

 

Genentech will supply the quantities of Genentech Molecule set forth below. [***].

 

The delivery dates below are based on the [***].

 

[***]

 

Genentech Molecule Information

 

	
[***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Exhibit C-1

 

	
[***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Exhibit C-2

 

CONFIDENTIAL

 

CLINICAL STUDY PROTOCOL

 

Adenosine-2A Receptor Antagonist CPI-444

 

 

863 Mitten Road, Suite 102

Burlingame, CA 94010-1311

Telephone: +1 (650) 900-4520

email: Admin@CorvusPharma.com

 

	
Study Title
    	
A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection   Study of CPI-444 as Single Agent and in Combination with Atezolizumab in   Patients with Selected Incurable Cancers
    
	
 
    	
 
    
	
Protocol Number
    	
CPI-444-001
    
	
 
    	
 
    
	
Development Phase
    	
Phase 1
    
	
 
    	
 
    
	
IND Number
    	
126,559
    
	
 
    	
 
    
	
Drug Substance
    	
Adenosine-2A (A2A) Receptor Antagonist CPI-444

 

[***]
    
	
 
    	
 
    
	
Indication
    	
Treatment of patients with selected incurable cancers
    
	
 
    	
 
    
	
Medical Monitor
    	
[***]
   Vice President of Clinical Development
   Corvus Pharmaceuticals, Inc.
   Phone: [***]
   Email:   [***]
    
	
 
    	
 
    
	
Sponsor
    	
Corvus Pharmaceuticals, Inc.
   863 Mitten Road, Suite 102
   Burlingame, CA 94010
    
	
 
    	
 
    
	
Protocol Version: Date
    	
Original: September 24, 2015
    

 

The information contained in this document, particularly unpublished data, is the property or under control of Corvus Pharmaceuticals, Inc. (Corvus) and is provided to you in confidence as an investigator, potential investigator, or consultant, for review by you, your staff, and an applicable Institutional Review Board or Independent Ethics Committee. The information is only to be used by you in connection with authorized clinical studies of the investigational drug described in the protocol. Your acceptance and use of this document is subject to the condition that no information contained herein will be published or disclosed without first obtaining written approval from Corvus Pharmaceuticals, Inc., except to the extent necessary to obtain informed consent from those persons to whom the drug may be administered. If you do not agree to this condition, please return the document to Corvus at the above address.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

	
CONFIDENTIAL

24   September 2015

Phase   1/1b Clinical Study Protocol
    	
Corvus Pharmaceuticals, Inc.

CPI-444

IND 126,559
    

 

[***]

 

[***] 105 Pages of Exhibit A constituting the Relevant Clinical Study Protocol have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted pages.

 

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