Document:

Exhibit

Exhibit 10.46 

CERTAIN INFORMATION IDENTIFIED BY BRACKETED ASTERISKS ([* * *]) HAS BEEN OMITTED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

EXECUTION COPY
Confidential

Collaboration and License Agreement

This Agreement, dated as of October 30, 2019, is entered into by and between

F. Hoffmann-La Roche Ltd
with an office and place of business at Grenzacherstrasse 124, 4070 Basel, Switzerland ("Roche Basel")
and
Hoffmann-La Roche Inc.
with an office and place of business at 150 Clove Road, Suite 8, Little Falls, New Jersey 07424, U.S.A. ("Roche US"; Roche Basel and Roche US together referred to as "Roche")
on the one hand
and
Dicerna Pharmaceuticals, Inc.
with an office and place of business at 33 Hayden Avenue, Lexington, Massachusetts 02421, U.S.A. ("Dicerna")
on the other hand.

Table of Contents
1.Definitions    1
1.1Accounting Standard    1
1.2Additional Dicerna Compound    1
1.3Affiliate    2
1.4Agreement    2
1.5Agreement Term    2
1.6Applicable Law    2
1.7Available Target    2
1.8Biosimilar Product    2
1.9Business Day    3
1.10Calendar Quarter    3
1.11Calendar Year    3
1.12cGLP    3
1.13Change of Control    3
1.14Change of Control Group    3
1.15Clinical Candidate    4
1.16Clinical Study    4
1.17Combination Product    4
1.18Commercialization    4
1.19Commercialization Plan    4
1.20Commercially Reasonable Efforts    4
1.21Committee    5
1.22Companion Diagnostic    5
1.23Competitor    5
1.24Complete or Completion    5
1.25Composition of Matter Claim    5
1.26Compound    6
1.27Compulsory Sublicense Compensation    6
1.28Confidential Information    6
1.29Continuation Election Notice    6
1.30Control    6
1.31Co-Promotion Exercise Period    7
1.32Co-Promotion Product    7
1.33Co-Promotion Territory    7
1.34Cost of Manufacture    7
1.35Cover    7
1.36CTA    7
1.37Detail    8
1.38Development    8
1.39Development Costs    8
1.40Development Plan    9
1.41Dicerna Base Patent Rights    9
1.42Dicerna Compound    9

1.43Dicerna GalXC Platform Patent Rights    9
1.44Dicerna Phase I Study    9
1.45Directed To    9
1.46Discontinued Target    10
1.47Effective Date    10
1.48EMA    10
1.49Encumbered Combination Agent    10
1.50Encumbered Combination Indication    10
1.51EU    10
1.52Excluded Claim    10
1.53Excluded Dicerna Patent Right    10
1.54Exclusivity Period    10
1.55Ex-Limited Licensee    11
1.56Expert    11
1.57Extraordinary Event    11
1.58FDA    11
1.59FDCA    11
1.60Field    11
1.61Filing    11
1.62Finalized    11
1.63First Commercial Sale    11
1.64FTE    12
1.65FTE Costs    12
1.66Gatekeeper    12
1.67Gatekeeper Process    12
1.68GalXC Molecule    12
1.69GalXC Platform    12
1.70GalXC Platform Improvements    12
1.71Genentech    12
1.72Genentech Patent Right    12
1.73Generic Product    13
1.74Handle    13
1.75HBV    13
1.76Host Cell Factor Target    13
1.77Hybrid Product    13
1.78IFRS    13
1.79Improvement    13
1.80Initiation    14
1.81Initiation of GLP Tox Study    14
1.82Insolvency Event    14
1.83Internal Revenue Code    14
1.84Invention    14
1.85Joint Know-How    14
1.86Joint Patent Rights    14
1.87JOT    14
1.88JRC    14
1.89JSC    14

1.90Know-How    15
1.91Lead Compound    15
1.92Lead Product    15
1.93Licensed IP    15
1.94Licensed Product    15
1.95Like-Substance Product    15
1.96Limited Field    15
1.97MAA    15
1.98Major Markets    15
1.99Marketing Study    15
1.100Materials    16
1.101Manufacture    16
1.102Medical Affairs Activities    16
1.103Method of Use Claim    16
1.104Net Sales    16
1.105Non-Compound Active Agent    17
1.106Not Available Target    17
1.107Party    17
1.108Patent Rights    17
1.109Pharmacovigilance Agreement    17
1.110Phase I Study    17
1.111Phase II Study    17
1.112Phase III Study    18
1.113Phase IV Study    18
1.114Pivotal Study    18
1.115PN Field Restriction    18
1.116Post-Approval Commitment Study    18
1.117Product    18
1.118Product Labeling or Product Label    18
1.119R&D Collaboration Term    18
1.120Regulatory Approval    18
1.121Regulatory Authority    19
1.122Regulatory Exclusivity    19
1.123Regulatory Expenses    19
1.124Regulatory Materials    19
1.125Research Plan    19
1.126Reserved Target    19
1.127Roche Background Improvements    20
1.128Roche Compound    20
1.129Roche Grant-Back Patent Rights    20
1.130Roche Group    20
1.131Roche Patent Rights    20
1.132Roche Product    20
1.133Royalty Term    20
1.134Sales    21
1.135Sales Representative    22
1.136Selected Target    22

1.137Selected Target Compound    22
1.138Selected Target Product    22
1.139Specific Patent Right    22
1.140Signature Date    22
1.141Sublicensee    22
1.142Target Nomination Deadline    22
1.143Target Term    23
1.144Territory    23
1.145Third Party    23
1.146Transfer Activities    23
1.147Transfer Compound    23
1.148Transfer Plan    23
1.149US    24
1.150US$    24
1.151Valid Claim    24
1.152Viral Target    24
1.153Additional Definitions    24
2.Grant of License    26
2.1Research Cross License    26
2.2Commercial License    26
2.3Non-Exclusive Roche License    27
2.4Sublicenses    27
2.5License Limitation    28
2.6Freedom-to-operate Licenses    28
3.R&D Collaboration    29
3.1Initiation    29
3.2Selected Target Nomination    29
3.3Scope    30
3.4Research Plans    30
3.5Information Exchange    30
3.6Replacement and Reserved Targets    31
3.7Gatekeeper Process    31
3.8Compound Progression    33
3.9Exclusivity    34
3.10Research Plan Costs of Performance    34
4.Diligence    34
5.Lead Transfer Activities    35
6.Development    35
6.1Development of Lead Product by Dicerna through Dicerna Phase I Study    35
6.2Development by Roche    36
6.3Dicerna Cost Share Option    36
6.4Updates    38
7.Governance    38
7.1Joint Research Committee    38
7.2Joint Steering Committee    39
7.3Members    39
7.4Meetings    39

7.5Minutes    39
7.6Responsibilities of the JRC    40
7.7JRC Decisions    41
7.8JSC Responsibilities and Decision Making for Shared Product Development    41
7.9JSC Responsibilities and Decision Making for Co-Promotion Products    42
7.10JSC Responsibilities for Roche Sole Development/Commercialization of Lead Product and Hybrid Product    43
7.11Joint Operational Teams    43
7.12Alliance Director    44
7.13Limitations of Authority    44
7.14Expenses    44
7.15Lifetime of JRC and JSC    44
8.Manufacture and Supply    44
8.1Dicerna Phase I Study    44
8.2R&D Collaboration    45
8.3Roche Responsibilities    45
8.4Transfer Activities for Manufacturing    45
9.Regulatory    46
9.1Dicerna Responsibility    46
9.2Transfer to Roche    47
9.3Roche Responsibility    47
9.4Reporting Adverse Events    47
10.Commercialization    48
10.1Generally    48
10.2Booking of Sales; Distribution    48
10.3Updates other than Co-Promotion Products in the Co-Promotion Territory    48
10.4Product Trademarks    48
10.5Product Labeling; Markings and Co-Branding    49
10.6Dicerna US Co-Promotion Option    49
10.7Medical Affairs    51
11.Payments to Dicerna    51
11.1Upfront License Fee for Lead Compound and Selected Targets    51
11.2Development and Regulatory Event Payments    51
11.3Sales Based Events    54
11.4Royalty Payments    54
11.5Disclosure of Payments    58
12.Accounting and reporting    59
12.1Timing of Payments    59
12.2Late Payment    59
12.3Method of Payment    59
12.4Currency Conversion    59
12.5Blocked Currency    59
12.6Reporting    59
13.Taxes    60
13.1Income Taxes    60
13.2Withholding Taxes    60
13.3Foreign-Derived Deduction Eligible Income Reporting    61

13.4No Partnership for Tax Purposes    61
13.5Value Added Tax    61
14.Auditing    61
14.1Dicerna Right to Audit    61
14.2Audit Reports    62
14.3Over-or Underpayment    62
15.Intellectual Property    62
15.1Ownership of Inventions    62
15.2Trademarks    63
15.3Prosecution    63
15.4Patent Coordination Team    64
15.5CREATE Act    64
15.6Infringement    64
15.7Defense    66
15.8Hatch-Waxman    66
15.9Patent Term Extensions    66
15.10Costs of Patent Challenge    67
16.Representations, Warranties and Covenants    67
16.1Dicerna Representations, Warranties and Covenants    67
16.2Roche Representations, Warranties and Covenants    69
16.3Mutual Representations and Warranties    71
16.4No Other Representations and Warranties    71
17.Indemnification    71
17.1Indemnification by Roche    71
17.2Indemnification by Dicerna    71
17.3Procedure    72
18.Liability    72
18.1Limitation of Liability    72
19.Obligation Not to Disclose Confidential Information    72
19.1Non-Use and Non-Disclosure    72
19.2Permitted Disclosure    72
19.3Press Releases    72
19.4Publications    73
19.5Commercial Considerations    73
19.6Injunctive Relief    74
20.Term and Termination    75
20.1Commencement and Term    75
20.2Termination    75
20.3Consequences of Termination    77
20.4Survival    84
21.Bankruptcy    84
22.Miscellaneous    84
22.1Governing Law; Excluded Claims    84
22.2Disputes    85
22.3Arbitration    85
22.4HSR    86
22.5Assignment    87

22.6Debarment    87
22.7Independent Contractor    87
22.8Unenforceable Provisions and Severability    87
22.9Waiver    87
22.10Interpretation    88
22.11Entire Understanding    88
22.12Amendments    88
22.13Invoices    89
22.14Notice    89
22.15Force Majeure    90
22.16Further Assurances    90
22.17Compliance with Laws    90
22.18Export    90
22.19No Third Party Beneficiary Rights    90
22.20Counterparts; Electronic Signatures    91

Collaboration and License Agreement

WHEREAS, Dicerna is the owner of a proprietary RNAi technology platform designated as GalXCTM which advances the development of next-generation RNAi-based therapies that act by silencing disease-driving genes in the liver;
WHEREAS, Dicerna has utilized the GalXCTM platform to create potential RNAi therapies for treating hepatitis B virus including a lead molecule currently in a Phase I clinical study;
WHEREAS, Roche has expertise in the research, development, manufacture and commercialization of pharmaceutical products and has an active program in the discovery and development of oligonucleotide therapeutics intended for the treatment of hepatitis B virus;
WHEREAS, Roche and Dicerna wish to collaborate in the research and development of oligonucleotide therapeutics for the treatment of hepatitis B virus;
WHEREAS, Roche desires to commercialize such therapeutics, with Dicerna retaining options for (i) the sharing of the costs of development, in exchange for increased royalty rates for Roche’s sales, of the lead molecule in the United States and (ii) the co-promotion of the lead compound in the United States; and,
WHEREAS, Dicerna is willing to grant to Roche rights to use certain of its intellectual property rights to make, use, offer for sale, sell and import and export Compounds and Products (as such terms are respectively defined below), as contemplated herein.
NOW, THEREFORE, in consideration of the mutual covenants and promises contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, do hereby agree as follows:

1

		
	1.
	Definitions

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

		
	1.1
	Accounting Standard

The term “Accounting Standards” shall mean: (i) with respect to Roche, its Affiliates or its Sublicensee, either IFRS or United States generally accepted accounting principles (GAAP), in either case, as currently used at the applicable time by, and as consistently applied by, such applicable entity; or (ii) with respect to Dicerna or its Affiliates, United States generally accepted accounting principles (GAAP), as currently used at the applicable time by, and as consistently applied by, such applicable entity.

		
	1.2
	Additional Dicerna Compound

The term “Additional Dicerna Compound” shall mean any GalXC Molecule (a) arising out of (or provided by either Party or its Affiliates into) the R&D Collaboration, or any derivative, modification or backup compound thereof, that is Directed To a Selected Target or (b) that is a derivative, modification or backup compound of the Lead Compound. If a Selected Target is terminated or becomes a Discontinued Target, Additional Dicerna Compounds Directed To such Selected Target shall only retain the status of Additional Dicerna Compounds for purposes of the provisions of Article 20 (however subject to Section 20.3.4 in the event of Compulsory Sublicense or Sublicensee rights).

		
	1.3
	Affiliate

The term “Affiliate” shall mean any individual, corporation, association or other business entity that directly or indirectly controls, is controlled by, or is under common control with the Party in question. As used in this definition of “Affiliate,” the term “control” shall mean the direct or indirect ownership of more than fifty percent (>50%) of the stock having the right to vote for directors thereof or the ability to otherwise control the management of the corporation or other business entity whether through the ownership of voting securities, by contract, resolution, regulation or otherwise. Anything to the contrary in this paragraph notwithstanding, Chugai Pharmaceutical Co., Ltd, a Japanese corporation (“Chugai”) and/or its subsidiaries (if any) shall not be deemed as Affiliates of Roche unless Roche provides written notice to Dicerna of its desire to include Chugai and/or its respective subsidiaries (as applicable) as Affiliate(s) of Roche.

		
	1.4
	Agreement

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

		
	1.5
	Agreement Term

The term “Agreement Term” shall mean the period of time commencing on the Effective Date and, unless this Agreement is terminated sooner as provided in Article 20, expiring on a Product-by-Product basis on the date when no royalty or other payment obligations under this Agreement are or will become due.

		
	1.6
	Applicable Law

The term “Applicable Law” shall mean any law, statute, ordinance, code, rule or regulation that has been enacted by a government authority (including any Regulatory Authority) and is in force as of the Effective Date or comes into force during the Agreement Term, in each case to the extent that the same is applicable to the performance by the Parties of their respective obligations or the Parties’ other activities under this Agreement.

		
	1.7
	Available Target

The term “Available Target” shall mean, with respect to a given target, the Gatekeeper’s good faith belief that a license to Roche is available under Patent Rights Controlled by Dicerna for compounds Directed To (i) a proposed Host Cell Factor Target because such proposed Host Cell Factor Target is not on the list of Not Available Targets and such license is available for the Limited Field or, (ii) a proposed Viral Target, because such proposed Viral Target is a Viral Target and such license is available in the Field.

		
	1.8
	Biosimilar Product

The term “Biosimilar Product” shall mean, with respect to a Product, a product that (i) is not produced, licensed or owned by the Roche Group, (ii) as determined by the relevant Regulatory Authority for the given country or jurisdiction, is highly similar with respect to such Product, notwithstanding minor differences in clinically inactive components, and with no clinically meaningful differences between the product and such Product in terms of the safety, purity and potency, and (iii) is approved through an abbreviated regulatory pathway.

For countries or jurisdictions where no explicit biosimilar regulations exist, a Biosimilar Product includes any product that (i) has been deemed to be biosimilar to such Product by a Regulatory Authority in another country or jurisdiction or (ii) have the same nucleic acid sequence as the Compound in such Product.

		
	1.9
	Business Day

The term “Business Day” shall mean 9.00am to 5.00pm local time on a day other than a Saturday, Sunday or other day on which commercial banking institutions in New York, New York and Boston, Massachusetts are authorized or permitted by law to be closed.

		
	1.10
	Calendar Quarter

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

		
	1.11
	Calendar Year

The term “Calendar Year” shall mean each period of twelve (12) months beginning on January 1 and ending December 31, except for the first year which shall begin on the Effective Date and end on December 31.

		
	1.12
	cGLP

The term “cGLP” shall mean the current Good Laboratory Practices, including, as applicable: (a) guidelines provided by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), (b) the requirements in Part 58 of Title 21 of the Code of Federal Regulations and all related guidance published by the FDA and (c) as required by other Applicable Law in applicable countries not subject to (a) and (b) where data from non-clinical studies conducted in other countries may be used to obtain Regulatory Approval, provided that to the extent applicable to Dicerna, such additional requirements not otherwise required under clauses (a) and (b) are set forth in an applicable Research Plan.

		
	1.13
	Change of Control

The term “Change of Control” shall mean, with respect to a Party: (a) the acquisition by any Third Party of beneficial ownership of fifty percent (50%) or more of the then outstanding common shares 

or voting power of such Party, other than acquisitions by employee benefit plans sponsored or maintained by such Party; (b) the consummation of a business combination involving such Party, unless, following such business combination, the stockholders of such Party immediately prior to such business combination beneficially own directly or indirectly more than fifty percent (50%) of the then outstanding common shares or voting power of the entity resulting from such business combination; or (c) the sale of all or substantially all of such Party’s assets or business relating to the subject matter of the Agreement.

		
	1.14
	Change of Control Group

The term “Change of Control Group” shall mean with respect to a Party, the person or entity, or group of persons or entities, that is the acquirer of, or a successor to, a Party in connection with a Change of Control, together with affiliates of such persons or entities that are not Affiliates of such Party immediately prior to the completion of such Change of Control of such Party.

		
	1.15
	Clinical Candidate

The term “Clinical Candidate” shall mean a Compound formally selected by the JRC during the Target Term, using criteria set forth in the applicable Research Plan, in preparation for cGLP toxicology and other studies that are required to be carried out in order to obtain Regulatory Approval for an initial Clinical Study for such Compound.

		
	1.16
	Clinical Study

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

		
	1.17
	Combination Product

The term “Combination Product” shall mean
		
	(a)
	a single pharmaceutical formulation containing as its active ingredients both a Compound and one or more Non-Compound Active Agents, or

		
	(b)
	a combination therapy comprised of a Compound and one or more Non-Compound Active Agents, priced and sold in a single package containing such multiple products or packaged separately but sold together for a single price,

in each case, including all dosage forms, formulations, presentations, line extensions, and package configurations. All references to Product in this Agreement shall be deemed to include Combination Product.

		
	1.18
	Commercialization

The term “Commercialization” shall mean any and all activities directed to the preparation for the sale of, offering for sale or sale of a Product, including activities relating to marketing, promoting, distributing and importing such Product. When used as a verb, to “Commercialize” and “Commercializing” means to engaged in Commercialization, and “Commercialized” has a corresponding meaning.  For clarity, “Commercialization” shall not include any research or Development activities.

		
	1.19
	Commercialization Plan

The term “Commercialization Plan” shall mean a commercialization plan and budget for the Co-Promotion Territory prepared by Roche and provided to Dicerna with respect to Shared Products that are subject to the Co-Promotion Option or are Co-Promotion Products that will include: (i) sales force and launch planning for Shared Products (to the extent applicable), (ii) marketing plans and budget. 

For Co-Promotion Products, the Parties (including through the JSC, as applicable) will review the Commercialization Plan from time to time as necessary for the purpose of considering appropriate amendments thereto; provided that (a) such review shall occur no less frequently than once every six (6) months, (b)  Roche shall make appropriate representatives available to discuss and answer questions concerning the Commercialization Plan with Dicerna at least twice annually upon Dicerna’s reasonable request in accordance with Section 7.12. In addition, either Party, through its representatives on the JSC (to the extent applicable), may propose amendments to the Commercialization Plan for Co-Promotion Products at any time.

		
	1.20
	Commercially Reasonable Efforts

[* * *]

		
	1.21
	Committee

The term “Committee” shall mean the JRC or the JSC.

		
	1.22
	Companion Diagnostic

The term “Companion Diagnostic” shall mean any product or service that:
		
	(a)
	identifies a person having a disease or condition, or a molecular genotype or phenotype that predisposes a person to such disease or condition, for which a Product could be used to treat and/or prevent such disease or condition;

		
	(b)
	defines the prognosis or monitors the progress of a disease or condition in a person for which a Product could be used to treat and/or prevent such disease or condition;

		
	(c)
	is used to select a therapeutic or prophylactic regimen, wherein at least [* * *] potential therapeutic or prophylactic regimen involves a Product, and where the selected regimen is determined, based on the use of such product or service, to likely be effective and/or to be safe for a person; and/or

		
	(d)
	is used to confirm a Product’s biological activity and/or to optimize dosing or the scheduled administration of a Product.

1.23    Competitor
[* * *]

		
	1.24
	Complete or Completion

The term “Complete” or “Completion” shall mean the availability of the final formal written report in relation to a Clinical Study setting out a final assessment of the results and conclusion of such Clinical Study.

		
	1.25
	Composition of Matter Claim

The term "Composition of Matter Claim" shall mean, for a given Product in a given country of the Territory, a Valid Claim that Covers the composition of matter of the Compound per se, or the composition of matter of the Product comprising the Compound plus unspecified pharmaceutically-acceptable excipients.  For clarity, a Compound may  include an oligonucleotide sequence capable of providing a guide strand that inhibits or prevents the expression or translation of viral or host cell factor genes in a human host.

		
	1.26
	Compound

The term “Compound” shall mean any Dicerna Compound or Roche Compound.

		
	1.27
	Compulsory Sublicense Compensation

The term “Compulsory Sublicense Compensation” shall mean, for a given country or region in the Territory, the compensation paid to Roche by a Third Party (a “Compulsory Sublicensee”) under a license or sublicense of applicable Licensed IP, Joint Patent Rights or Roche Patent Rights granted to the Compulsory Sublicensee (the “Compulsory Sublicense”) through the order, decree or grant of a governmental authority having competent jurisdiction in such country or region, authorizing such Third Party to manufacture, use, sell, offer for sale, import or export a Product in such country or region.

		
	1.28
	Confidential Information

The term “Confidential Information” shall mean any and all information, data or know-how (including Know-How), whether technical or non-technical, oral or written, that is disclosed by one Party or its Affiliates (“Disclosing Party”) to the other Party or its Affiliates (“Receiving Party”). Confidential Information shall not include any information, data or know-how that:
		
	(i)
	was generally available to the public at the time of disclosure, or becomes available to the public after disclosure by the Disclosing Party other than through fault (whether by action or inaction) of the Receiving Party or its Affiliates,

		
	(ii)
	can be evidenced by written records to have been already known to the Receiving Party or its Affiliates prior to its receipt from the Disclosing Party,

		
	(iii)
	is obtained at any time lawfully from a Third Party under circumstances permitting its use or disclosure,

		
	(iv)
	is developed independently by the Receiving Party or its Affiliates as evidenced by written records that evidence such development without the knowledge of the Confidential Information transferred hereunder, or

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

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

		
	1.29
	Continuation Election Notice

The term “Continuation Election Notice” shall mean the notice Dicerna provides to Roche under Section 20.3.2 or 20.3.3 describing (i) Dicerna’s bona fide intentions to continue ongoing Development and Commercialization of applicable Licensed Product(s) and (ii) Dicerna’s request for Roche’s continuation of activities during the termination period and/or transfer of the data, material and information relating to the applicable Licensed Product(s) in accordance with Section 20.3.2 or 20.3.3.

		
	1.30
	Control

The term “Control” shall mean (as an adjective or as a verb including conjugations and variations such as “Controls” “Controlled” or “Controlling”) (a) with respect to Patent Rights and/or Know-How, the possession by a Party of the ability to grant a license or sublicense of such Patent Rights and/or Know-How without violating the terms of any agreement or arrangement between such Party and any other party and (b) with respect to proprietary materials, the possession by a Party of the ability to supply such proprietary materials to the other Party as provided herein without violating the terms of any agreement or arrangement between such Party and any other party. Notwithstanding anything in this Agreement to the contrary, in the event of a Change of Control of a Party, such Party shall be deemed to not own or Control any intellectual property right that is owned or Controlled by the Change of Control Group except to the extent the Change of Control Group intermingles its intellectual property with the Party’s intellectual property.

		
	1.31
	Co-Promotion Exercise Period

The term “Co-Promotion Exercise Period” shall mean, with respect to a Shared Product, the period commencing upon Dicerna’s exercise of its Cost Share Option and ending upon the later of (i) [* * *] after Roche provides Dicerna with the Roche Estimate pursuant to Section 10.6.2(a) and (ii) [* * *] after the Roche Response Date (if Dicerna provides timely Shared Product Questions).

		
	1.32
	Co-Promotion Product

The terms “Co-Promotion Product” shall mean a Shared Product for which Dicerna has a Co-Promotion Right as of the applicable time.

		
	1.33
	Co-Promotion Territory

The terms “Co-Promotion Territory” shall mean the US.

		
	1.34
	Cost of Manufacture

The term “Cost of Manufacture” shall mean:
		
	(a)
	When a Party Manufactures directly, the sum of: (i) the cost (as defined in each such Party's Accounting Standards consistently applied) to Manufacture a Shared Product (or potential Shared Product), including items such as cost of materials, yield and waste levels, direct labor, etc.; (ii) any additional applicable overhead, including items such as costs that relate to such Party’s supervisory, occupancy, facility and equipment, etc., as calculated according to and consistent with such Party’s internal policies; (iii) other such costs burdened to the product due to Manufacturing (including inventory write-offs and excess capacity charges to the extent not exceeding [* * *]); and (iv) the actual costs associated with the technology transfer to a CMO to enable Manufacturing of that product, including any upfront and milestone based payments and startup costs allocable to the Shared Product that are associated therewith. All Cost of Manufacture shall be consistently applied to the product for ongoing clinical trials.

		
	(b)
	When a Party uses a CMO to Manufacture a Shared Product, the amount actually paid to (and not reimbursed by) each such CMO, including FTE costs associated with overseeing any CMO.

		
	1.35
	Cover

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

		
	1.36
	CTA

The term “CTA” shall mean a submission made to the applicable Regulatory Authority, the purpose of which is to gain necessary clearance, licensure or approval by such agency to lawfully distribute a product to perform a human clinical trial of such product that at the time of such submission is not otherwise lawfully able to be distributed or marketed under the Applicable Laws of the relevant jurisdiction. CTAs include the CTAs approved by the EMA or Health Canada, investigational new drug applications (“IND”) as defined in the FDCA and applicable regulations promulgated by the FDA, or the equivalent application to the equivalent agency in any other country or group of countries, the filing of which is necessary to commence clinical testing of the Products in humans.

		
	1.37
	Detail

The term “Detail” shall mean a one-on-one face-to-face contact in which a Sales Representative makes a presentation, including selling message and features and benefits of the Product to a professional having prescribing authority. E-details and presentations made at conventions or similar gatherings will not constitute a Detail. Sample drops (if applicable) and reminder details shall not constitute a Detail.  Attendance at group meetings or other group situations shall only be considered a single Detail regardless of the number of participants.  For the avoidance of doubt, Details may occur in group situations if the definition of a Detail is met. When used as a verb, “Detailing” shall mean to engage in the activities set forth herein.

		
	1.38
	Development

The term “Development” shall mean all activities undertaken by or on behalf of any Roche Group member on and after the Initiation of GLP Tox Study to develop a Compound or a Product including cGLP studies, manufacturing process and drug product (dosage form) development, conducting toxicology studies, clinical testing and all Clinical Studies (including approved investigator sponsored studies), statistical analysis and report writing, regulatory affairs and clinical regulatory activities. For further avoidance of doubt, Development does not include activities undertaken by or on behalf of a Party under the R&D Collaboration. When used as a verb, to “Develop” and “Developing” means to engage in Development, and “Developed” has a corresponding meaning.

		
	1.39
	Development Costs

The term “Development Costs” shall mean the global costs actually incurred, including FTE Costs and any direct out-of-pocket costs or expenses paid or accrued in accordance with Accounting Standards, by any Roche Group member for Development of a Shared Product (or potential Shared Product) including studies of the clinical aspects conducted internally or by individual investigators, or consultants necessary for the purpose of obtaining, maintaining and/or expanding marketing approval of such Shared Product, process development, process improvement and recovery costs, failed clinical lots, qualification lots, costs for preparing, submitting, reviewing or developing data or information for the purpose of submission to a governmental authority to obtain, maintain and/or expand marketing approval of such Shared Product. Development Costs shall not include costs associated with Companion Diagnostics. The Development Costs shall also include expenses for data management, CROs, statistical designs and studies, documentation preparation and other administration expenses associated with the clinical testing program or Post-Approval Commitment Studies and Cost of Manufacture for clinical supply of such Shared Product. By way of example, Development Costs may include costs in connection with the following activities:
		
	(a)
	Clinical Studies (for clarity including Post-Approval Commitment Studies but excluding Marketing Studies and Phase IV Studies) for such Shared Products, including (i) the preparation for and conduct of clinical trials (except clinical trials that are solely conducted for regulatory requirements specific to a particular country or territory outside the US); (ii) data collection, management and analysis and report writing; (iii) clinical laboratory work; (iv) advisory meetings in connection with such Shared Products; and (v) Regulatory Expenses in direct connection with Clinical Studies for such Shared Products;

		
	(b)
	CMC-related Development activities, including activities relating to the development and establishment of the clinical and commercial manufacturing process for such Shared Products and establishment of the supply chain; and

		
	(c)
	Cost of Manufacture for such Shared Products or other drug or product or other materials used for such Shared Products, including combination agents and comparators.

		
	1.40
	Development Plan

The term “Development Plan” shall mean Roche’s development plan for the Lead Product, the scope and level of detail of which shall be consistent with the standards Roche applies to its internal programs at a similar stage of development.

		
	1.41
	Dicerna Base Patent Rights

The term “Dicerna Base Patent Rights” shall mean the Patent Rights listed in Appendix 1.41 of this Agreement.

		
	1.42
	Dicerna Compound

The term “Dicerna Compound” shall mean
		
	(a)
	any Additional Dicerna Compounds, and

		
	(a)
	any GalXC Molecules owned or Controlled by Dicerna Directed To HBV other than Additional Dicerna Compounds, including

(i)    the Lead Compound, and
(ii)    any derivative, modification or backup compound to the Lead Compound.
in both cases excluding a Roche Compound.

		
	1.43
	Dicerna GalXC Platform Patent Rights

The term “Dicerna GalXC Platform Patent Rights” shall mean Patent Rights owned or Controlled (other than by license from the Roche Group under this Agreement) by Dicerna or its Affiliates, prior to or during the Agreement Term, that are reasonably necessary or useful to research, have researched, develop, have developed, make, have made, use, have used, register, have registered, sell, have sold, offer for sale, import or export GalXC Molecules and claim the GalXC Platform or the use or manufacture thereof, but however do not claim exclusively (i) Compounds, targets or associated sequences/constructs, in each case Directed To HBV or (ii) the use or manufacture of such Compounds or targets. Dicerna GalXC Platform Patent Rights as of the Effective Date are listed in Appendix 1.43 of this Agreement.

		
	1.44
	Dicerna Phase I Study

The term “Dicerna Phase I Study” shall mean the Phase I Study for the Lead Compound that Dicerna has commenced but not yet Completed as of the Signature Date, as well as the Optional Phase I Cohorts(s) if applicable.

		
	1.45
	Directed To

The term “Directed To” shall mean with regard to an RNAi product or oligonucleotide product and target, [* * *].  For clarity, if the defined term “Directed To” is separated, such as when required grammatically (e.g., when discussing targets “To which a product is Directed”), such separated term shall maintain the same meaning set forth in the previous sentence.

		
	1.46
	Discontinued Target

The term “Discontinued Target” shall mean a target that has been designated as such in accordance with Sections 3.8, 20.2.4 or 20.2.5.

		
	1.47
	Effective Date

The term “Effective Date” is defined in Section 22.4.

		
	1.48
	EMA

The term “EMA” shall mean the European Medicines Agency or any successor agency with responsibilities comparable to those of the European Medicines Agency.

		
	1.49
	Encumbered Combination Agent

The term “Encumbered Combination Agent” shall mean an active ingredient in a Combination Product that is not a Compound and that (i) is subject to Third Party rights or obligations granted from or to the Roche Group or (ii) directly competes with a product under clinical development or commercialization by Dicerna.

		
	1.50
	Encumbered Combination Indication

The term “Encumbered Combination Indication” shall mean, with respect to a Co-Promotion Product that is a Combination Product containing an active ingredient that is not a Compound, an indication for which Regulatory Approval is obtained with respect to which Roche has granted to a Third Party co-promotion or other rights.

		
	1.51
	EU

The term “EU” shall mean the European Union and all its then-current member countries but including in any case France, Germany, Italy, Spain and the United Kingdom regardless of whether they are then-current member countries.

		
	1.52
	Excluded Claim

The term “Excluded Claim” shall mean a dispute, controversy or claim between the Parties that concerns (a) the validity or infringement, scope, enforceability or inventorship of a patent, trademark or copyright, or (b) any antitrust, anti-monopoly or competition Applicable Law, whether or not statutory.

		
	1.53
	Excluded Dicerna Patent Right

The term “Excluded Dicerna Patent Right” shall mean a claim in a Patent Right owned or Controlled by Dicerna to the extent that such claim exclusively claims a Non-Compound Active Agent, alone or in combination with other molecular entities, none of which can be Compounds. For clarity, if a claim in a Patent Right Controlled by Dicerna lists a molecular entity that is a Compound, then such Patent Right is not an Excluded Dicerna Patent Right.

		
	1.54
	Exclusivity Period

The term “Exclusivity Period” shall mean the period of time commencing on the Effective Date and ending the earlier of the non-initiation, expiration or earlier termination of the R&D Collaboration. For clarity, if the R&D Collaboration does not commence, the Exclusivity Period for both Parties will end as of the earlier of date of the notice of termination of the Agreement or the date of Roche’s notice that Roche elects not to initiate the R&D Collaboration.

		
	1.55
	Ex-Limited Licensee

The term “Ex-Limited Licensee” shall mean Third Parties (and their respective sublicensees, successor or assigns) to whom Dicerna has granted as of the Signature Date rights imposing PN Field Restrictions.

		
	1.56
	Expert

The term “Expert” shall mean a person with no less than [* * *] of pharmaceutical industry experience and expertise having occupied at least one senior position within a large pharmaceutical company relating to product commercialization and/or licensing but excluding any current or former employee or consultant of either Party. Such person shall be fluent in the English language.

		
	1.57
	Extraordinary Event

The term “Extraordinary Event” shall mean Development Costs associated with any of the following activities that were not anticipated in a given Annual Budget and the then current Development Plan: (i) faster than planned Clinical Study enrollment, (ii) written guidance or requirements from a Regulatory Authority that would result in amendments to the Development Plan, (iii) technical issues affecting the ability to supply clinical material of Compound or Product or (iv) mutual agreement by the Parties to amend the Development Plan.

		
	1.58
	FDA

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

		
	1.59
	FDCA

The term “FDCA” shall mean the Food, Drug and Cosmetics Act.

		
	1.60
	Field

The term “Field” shall mean all uses.

		
	1.61
	Filing

The term “Filing” shall mean the filing of an application by the FDA as defined in the FDCA and applicable regulations, or the equivalent application to the equivalent agency in any other country or group of countries including MAA by the EMA, the official approval of which is required before any lawful commercial sale or marketing of Products.

		
	1.62
	Finalized

The term “Finalized” shall mean the applicable Clinical Study has been fully enrolled with the last enrolled patient receiving the last dose of Product pursuant to the study protocol and the draft clinical study report including listings and tables are available.

		
	1.63
	First Commercial Sale

The term “First Commercial Sale” shall mean, on a country-by-country basis, the first invoiced sale of a Product to a Third Party by the Roche Group following the receipt of any Regulatory Approval required for the sale of such Product, or if no such Regulatory Approval is required, the date of the first invoiced sale of a Product to a Third Party by the Roche Group in such country.

		
	1.64
	FTE

The term “FTE” shall mean with respect to a person, the equivalent of the work of [* * *] employee full time for [* * *] (consisting of [* * *] per Calendar year excluding vacations and holidays), or such other period as may be prescribed by Applicable Law, on a country-by-country basis. Overtime, work on weekends, holidays and the like will not be counted with any multiplier (e.g. time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution.

		
	1.65
	FTE Costs

The term “FTE Costs” shall mean Roche’s or Dicerna’s FTE rate, assessed consistent with internal Accounting Standards, multiplied by the applicable number of FTEs of Roche or its Affiliates or Dicerna or its Affiliates, as applicable, performing the applicable activities during such period multiplied by the applicable percentage of time such FTEs have performed the applicable activities during such period.

		
	1.66
	Gatekeeper

The term “Gatekeeper” shall mean an independent outside counsel appointed by Dicerna responsible for conducting the Gatekeeper Process, through which Roche may directly inquire as to whether any proposed target is an Available Target or Not Available Target.

		
	1.67
	Gatekeeper Process

The term “Gatekeeper Process” shall mean the processes described in Section 3.7 to be used for target nomination or target reservation.

		
	1.68
	GalXC Molecule

The term “GalXC Molecule” shall mean [* * *].

		
	1.69
	GalXC Platform

The term "GalXC Platform" shall mean [* * *].

		
	1.70
	GalXC Platform Improvements

The term “GalXC Platform Improvements” shall mean [* * *].

		
	1.71
	Genentech

The term “Genentech” shall mean Genentech, Inc. for so long as Genentech is an Affiliate of Roche.

		
	1.72
	Genentech Patent Right

The term “Genentech Patent Right” shall mean Patent Rights claiming inventions based on projects originating from the Genentech early development organization made by or on behalf of Genentech employees (with or without Third Parties). As of the Signature Date, as between the Roche Group Affiliates, Genentech Patent Rights are owned by Genentech in the US and Roche Basel outside the US.

		
	1.73
	Generic Product

The term “Generic Product” shall mean, with respect to a Product, a product that (i) is not produced, licensed or owned by the Roche Group, (ii) contains a pharmaceutically active ingredient that is the same as any Compound in such Product, (iii) has the same or substantially the same labelling as the applicable Product for at least one indication of such Product, and (iv) is approved through an abbreviated regulatory pathway, to the extent one exists in a given country.

		
	1.74
	Handle

The term “Handle” shall mean preparing, filing, prosecuting (including interferences, reissue, re-examination, post-grant reviews, inter-partes reviews, derivation proceedings and opposition proceedings) and maintaining.

		
	1.75
	HBV

The term “HBV” shall mean hepatitis B virus.

		
	1.76
	Host Cell Factor Target

The term “Host Cell Factor Target” shall mean [* * *]:
 

		
	1.77
	Hybrid Product

The term “Hybrid Product” shall mean a Product, on a country-by-country basis, that contains (i) a Lead Compound where such Lead Compound has already been included in a Lead Product that has achieved its First Commercial Sale in such country as a Product not containing a Selected Target Compound and (ii) at least one Selected Target Compound.

		
	1.78
	IFRS

The term “IFRS” shall mean International Financial Reporting Standards.

		
	1.79
	Improvement

The term “Improvement” shall mean, any Invention which is [* * *].

		
	1.80
	Initiation

The term “Initiation” shall mean the date that a human is first dosed with the Product in a Clinical Study approved by the respective Regulatory Authority.

		
	1.81
	Initiation of GLP Tox Study

The term “Initiation of GLP Tox Study” shall mean, with respect to a Compound or Product, the date that the first animal is first dosed with such Compound or Product in a study of the relationship between dose and its effects on the exposed animal, where (i) the study is conducted in accordance with cGLP standards and (ii) the study is intended to support establishment of a safe starting dose of the Compound or Product in human Clinical Studies.

		
	1.82
	Insolvency Event

The term “Insolvency Event” shall mean circumstances under which a Party (i) has a receiver or similar officer appointed over all or a material part of its assets or undertaking; (ii) passes a resolution for winding-up (other than a winding-up for the purpose of, or in connection with, any solvent amalgamation or reconstruction) or a court makes an order to that effect or a court makes an order for administration (or any equivalent order in any jurisdiction); (iii) enters into any composition or arrangement with its creditors (other than relating to a solvent restructuring); (iv) ceases to carry on business; (v) is unable to pay its debts as they become due in the ordinary course of business.

		
	1.83
	Internal Revenue Code

The term “Internal Revenue Code” shall mean the US Internal Revenue Code of 1986, as amended.

		
	1.84
	Invention

The term “Invention” shall mean an invention, whether or not patentable, that is conceived or reduced to practice in connection with any activity carried out pursuant to this Agreement. Under this definition, an Invention may be made by employees of Dicerna solely or jointly with a Third Party (a “Dicerna Invention”), by employees of the Roche Group solely or jointly with a Third Party (a “Roche Invention”), or jointly by employees of Dicerna and employees of the Roche Group with or without a Third Party (a “Joint Invention”).

		
	1.85
	Joint Know-How

The term “Joint Know-How” shall mean Know-How that is made jointly by employees of Dicerna and the Roche Group, with or without a Third Party in connection with any activity carried out pursuant to this Agreement.

		
	1.86
	Joint Patent Rights

The term “Joint Patent Rights” shall mean all Patent Rights Covering a Joint Invention other than GalXC Platform Improvements or Roche Background Improvements.

		
	1.87
	JOT

The term “JOT” shall mean a joint operating team (or Joint Project Team) described in Section 7.10.

		
	1.88
	JRC

The term “JRC” shall mean the joint research committee described in Section 7.1.

		
	1.89
	JSC

The term “JSC” shall mean the joint steering committee described in Section 7.2.

		
	1.90
	Know-How

The term “Know-How” shall mean data, knowledge and information, including materials, samples, chemical manufacturing data, toxicological data, pharmacological data, preclinical and clinical data, assays, platforms, formulations, specifications, quality control testing data, that are confidential and necessary or useful for the discovery, manufacture, development or commercialization of Products.

		
	1.91
	Lead Compound

The term “Lead Compound” shall mean the molecule designated as DCR-S219, the structure of which is listed in Appendix 1.91 of this Agreement.

		
	1.92
	Lead Product

The term “Lead Product” shall mean any Product containing the Lead Compound and does not include a Selected Target Compound.

		
	1.93
	Licensed IP

The term “Licensed IP” shall mean all Patent Rights and Know-How Controlled by Dicerna or its Affiliates (other than by license from the Roche Group under this Agreement), prior to or during the term of the Agreement, necessary or useful to research, have researched, develop, have developed, make, have made, use, have used, register, have registered, sell, have sold, offer for sale, import or export Compounds and/or Products in the Field, including Dicerna Base Patent Rights and Dicerna GalXC Platform Patent Rights, but excluding Excluded Dicerna Patent Rights.

		
	1.94
	Licensed Product

The term “Licensed Product” shall mean any product, including any Combination Product, containing a Dicerna Compound as a pharmaceutically active ingredient, regardless of their finished forms or formulations or dosages. One Licensed Product may be distinguished from another Licensed Product by the Dicerna Compound being a distinctive active pharmaceutical ingredient.

		
	1.95
	Like-Substance Product

The term “Like-Substance Product” shall mean a Generic Product or Biosimilar Product.

		
	1.96
	Limited Field

The term “Limited Field” shall mean [* * *].

		
	1.97
	MAA

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

		
	1.98
	Major Markets

The term “Major Markets” shall mean the [* * *].

		
	1.99
	 Marketing Study

The term “Marketing Study” shall mean any human clinical study for a Shared Product conducted following Initiation of a Pivotal Study for such Shared Product that is not required for receipt of Regulatory Approval (whether such human clinical study is conducted prior to or after receipt of such Regulatory Approval) and is not a Post-Approval Commitment Study, but that may be useful in support of the post-Regulatory Approval exploitation of such Shared Product.

		
	1.100
	 Materials

The term “Materials” shall mean any laboratory research materials that consist of the following substances (other than oligonucleotides): (i) organic or inorganic chemical or compound; (ii) gene; (iii) vector or construct, whether plasmid, phage, virus or any other type; (iv) host organism, including bacteria and eukaryotic cells; (v) eukaryotic or prokaryotic cell line or expression system; (vi) protein, including any peptide or amino acid sequence, enzyme, antibody or protein conferring targeting properties and any fragment of a protein or peptide or enzyme; (vii) genetic material, including any genetic control element (e.g., promoters); (viii) virus; or (ix) assay.

		
	1.101
	 Manufacture

The term “Manufacture” or “Manufacturing” shall mean all operations in the manufacture, receipt, incoming inspections, storage and handling of materials, manufacture, processing, formulation, filling, packaging, labeling, warehousing, quality control testing (including in-process release and stability testing), shipping and release of Shared Products.

		
	1.102
	 Medical Affairs Activities

The term “Medical Affairs Activities” shall mean the coordination of medical information requests and field based medical scientific liaisons with respect to Co-Promotion Products, including activities of medical scientific liaisons, activities involving key opinion leaders, and the provision of medical information services with respect to a Co-Promotion Product.

		
	1.103
	 Method of Use Claim

The term "Method of Use Claim" shall mean, for a given Product in a given country of the Territory, a Valid Claim of an issued patent that claims an approved indication in such country for the Product.

		
	1.104
	 Net Sales

[* * *].

		
	1.105
	 Non-Compound Active Agent

The term “Non-Compound Active Agent” shall mean a therapeutically or prophylactically active ingredient or compound that is not a Compound.

		
	1.106
	 Not Available Target

The term “Not Available Target” shall mean, [* * *].

		
	1.107
	 Party

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

		
	1.108
	 Patent Rights

The term “Patent Rights” shall mean all rights under any issued patent or pending patent application (which, for the purposes of this Agreement, includes certificates of invention, applications for certification of invention, and priority rights), in any country of the Territory, including any patents issuing on such patent application, and further including any and all provisional, substitution, extension (including pediatric exclusivity extension) or supplementary protection certificate, reissue, reexamination, restoration, renewal, confirmation, registration, revalidation, revisions and additions, divisional, continuation, continued prosecution (and requests therefor), or continuation-in-part of any of the foregoing.

		
	1.109
	 Pharmacovigilance Agreement

The term “Pharmacovigilance Agreement” shall mean an agreement entered into by the Parties to set forth the responsibilities and obligations of the Parties with respect to the procedures and timeframes for compliance with Applicable Laws pertaining to safety of the applicable Product and its related activities.

		
	1.110
	 Phase I Study

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

		
	1.111
	 Phase II Study

The term “Phase II Study” shall mean a human clinical trial, for which the primary endpoints include a determination of an effective dose range for Phase III Studies and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

		
	1.112
	 Phase III Study

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

		
	1.113
	 Phase IV Study

The term “Phase IV Study” shall mean a human clinical trial initiated post-approval of the Product to accumulate evidence about the efficacy and/or safety of the Product, which shall not include any Post-Approval Commitment Study.

		
	1.114
	 Pivotal Study

The term “Pivotal Study” shall mean, with respect to any Product, a Clinical Study that at the time of Initiation (or any later expansion of patient enrollment, if applicable), is expected to be the basis for Regulatory Approval of such Product.

		
	1.115
	 PN Field Restriction

The term “PN Field Restriction” shall mean, [* * *].

		
	1.116
	 Post-Approval Commitment Study

The term “Post-Approval Commitment Study” shall mean any human clinical study for a Shared Product conducted after marketing authorization of such Shared Product has been obtained from the FDA at the request of or requirement of the FDA.

		
	1.117
	 Product

The term “Product” shall mean any Licensed Product or Roche Product.

		
	1.118
	 Product Labeling or Product Label

The term “Product Labeling” or “Product Label” shall mean, with respect to a Product in a country in the Territory, (a) the Regulatory Authority-approved prescribing information for such Product for such country, including any required patient information, and (b) all labels and other written, printed or graphic matter upon a container, wrapper or any package insert utilized with or for such Product in such country, including any required patent marking.

		
	1.119
	 R&D Collaboration Term

The term “R&D Collaboration Term” shall mean the period of time commencing on the first individual Target Term and ending on the conclusion of the last individual Target Term.

		
	1.120
	 Regulatory Approval

The term “Regulatory Approval” shall mean any approvals (including supplements, amendments, pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations or authorizations (including marketing and labeling authorizations) by a Regulatory Authority, necessary for the research, Development, registration, Manufacture (including formulation), distribution, importation, exportation, use, sale or Commercialization of a pharmaceutical product (including a Compound or Product) in a regulatory jurisdiction in the Territory.

		
	1.121
	 Regulatory Authority

The term “Regulatory Authority” shall mean any national, supranational (e.g., the European Commission, the Council of the European Union, the EMA), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the FDA or any counterpart of the FDA outside the United States, in each country involved in the granting of regulatory approval for, or with authority over, the research, Development, registration, Manufacture (including formulation) and Commercialization of, a pharmaceutical product (including a Compound or Product), which may include the authority to grant the required reimbursement and pricing approvals for such sale.

		
	1.122
	 Regulatory Exclusivity

The term “Regulatory Exclusivity” shall mean any exclusive marketing rights or data exclusivity rights conferred by any governmental authority under Applicable Law with respect to a Product in a country or jurisdiction in the Territory to prevent Third Parties from selling such Product in such country or jurisdiction, other than a Patent Right, including orphan drug exclusivity, pediatric exclusivity, rights 

conferred in the U.S. under the FD&C Act, in the EU under Directive 2001/83/EC, or rights similar thereto in other countries or regulatory jurisdictions in the Territory.

		
	1.123
	 Regulatory Expenses

The term “Regulatory Expenses” shall mean those FTE Costs and any direct out-of-pocket costs (including filing, user, maintenance and other fees paid to Regulatory Authorities) paid or incurred as an expense in accordance with Accounting Standards by Roche or any of its Affiliates or Sublicensees after the Effective Date, that are specifically identifiable or reasonably allocable to the preparation of regulatory submissions for, and the obtaining and maintenance of Regulatory Approval, including compliance with Regulatory Approvals and requirements of such Regulatory Authorities, adverse event recordation and reporting and regulatory affairs activities.

		
	1.124
	 Regulatory Materials

The term “Regulatory Materials” shall mean any regulatory application, submission, notification, communication, correspondence, registration and other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop or Commercialize the applicable Lead Compound and Lead Product. Regulatory Materials include any CTAs.

		
	1.125
	 Research Plan

The term “Research Plan” shall mean the agreed upon plan of research for each Selected Target including the criteria to be used for selecting a Clinical Candidate. Updates to the Research Plan do not require an amendment to this Agreement and may be approved by unanimous consent of the JRC.

		
	1.126
	 Reserved Target

The term “Reserved Target” shall mean [* * *]. The number of Host Cell Factor Targets designated as either Reserved Targets, Selected Targets and Discontinued Targets at any given time cannot exceed five (5) in aggregate during the course of the collaboration (the “Host Cell Factor Target Limitation”).

		
	1.127
	    Roche Background Improvements

The term “Roche Background Improvements” shall mean [* * *].

		
	1.128
	 Roche Compound

The term “Roche Compound” shall mean an oligonucleotide compound Controlled by Roche and provided by Roche or its Affiliates into the R&D Collaboration that is Directed To a Selected Target and is not a GalXC Molecule.

		
	1.129
	 Roche Grant-Back Patent Rights

The term “Roche Grant-Back Patent Rights” shall mean Patent Rights Controlled by Roche that are reasonably necessary to develop, have developed, manufacture, have manufactured, use, offer to sell, sell, promote, export and import Dicerna Compounds or Licensed Products that are not Combination Products. For purposes of clarity, Genentech Patent Rights are specifically excluded from Roche Grant-Back Patent Rights.

		
	1.130
	 Roche Group

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

		
	1.131
	 Roche Patent Rights

The term “Roche Patent Rights” shall mean all Patent Rights that Roche Controls (other than by a license from Dicerna under this Agreement) during the Agreement Term other than Licensed IP and 

Joint Patent Rights. For purposes of clarity, Genentech Patent Rights are specifically excluded from Roche Patent Rights.

		
	1.132
	 Roche Product

The term “Roche Product” shall mean any product, including any Combination Product, containing a Roche Compound as a pharmaceutically active ingredient, regardless of their finished forms or formulations or dosages. One Roche Product may be distinguished from another Roche Product by the Roche Compound being a distinctive active pharmaceutical ingredient.

		
	1.133
	 Royalty Term

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

		
	(b)
	for Hybrid Products: on the later of the date that is [* * *] and

		
	(c)
	for Selected Target Products: on the later of the date that is [* * *]

		
	1.134
	 Sales

The term “Sales” shall mean, for a Product in a particular period, the sum of (i) and (ii):

[* * *].

By way of example, the gross-to-net deductions taken in accordance with IFRS as of the Effective Date include:

		
	(a)
	credits, reserves or allowances actually granted for (i) damaged, outdated, returned, rejected, withdrawn or recalled Product, (ii) wastage replacement and short-shipments; (iii) billing errors and (iv) indigent patient and similar programs (e.g., price capitation);

		
	(b)
	governmental price reductions and government mandated rebates;

		
	(c)
	chargebacks, including those actually granted to wholesalers, buying groups and retailers;

		
	(d)
	customer rebates, including cash sales incentives for prompt payment, cash and volume discounts; and

		
	(e)
	taxes and any other governmental charges or levies imposed upon or measured by the import, export, use, manufacture or sale of a Product (excluding income or franchise taxes).

For purposes of clarity, any such Sublicensee sales as reported to Roche in accordance with Compulsory Sublicense agreements shall be excluded from the sales amount.

When a Product is a Combination Product, and there are deductions under clauses (a)-(e), such deductions shall be allocated to such Combination Product as agreed or determined under Section 11.4.4. For purposes of clarity, sales by Roche and its Affiliates to any Sublicensee that is not a Roche Affiliate for resale shall be excluded from “Sales” under this clause (i).

		
	(i)
	for Sublicensees that are not Affiliates of Roche (and excluding Compulsory Sublicensees), the sales amounts reported to Roche and its Affiliates in accordance with their then-currently used accounting standards and Section 2.4. For the purpose of clarity, any such Sublicensee sales as 

reported to Roche in accordance with Compulsory Sublicense agreements shall be excluded from the Sales amount, and instead shall be addressed in accordance with Section 11.4.8.

		
	1.135
	 Sales Representative

The term “Sales Representative” shall mean a pharmaceutical sales representative or other persons engaged or employed by either Party to conduct Detailing and other promotional efforts or relevant activities with respect to the Products and consistent with the Commercialization Plan.

		
	1.136
	 Selected Target

The term “Selected Target” shall mean [* * *].

		
	1.137
	 Selected Target Compound

The term “Selected Target Compound” shall mean a Compound that is Directed To a Selected Target but is not the Lead Compound.

		
	1.138
	 Selected Target Product

The term “Selected Target Product” shall mean any Product that (i) includes a Selected Target Compound and (ii) if it includes the Lead Compound, is not a Hybrid Product.

		
	1.139
	 Specific Patent Right

The term “Specific Patent Right” shall mean any Licensed IP Patent Right (other than Dicerna GalXC Platform Patent Rights) exclusively directed to one or more Compound(s) or Licensed Product(s).

		
	1.140
	 Signature Date

The term “Signature Date” shall mean the date set forth on the cover page to this Agreement.

		
	1.141
	 Sublicensee

The term “Sublicensee” shall mean a Third Party to which Roche has licensed rights (through one or multiple tiers), other than through a Compulsory Sublicense, pursuant to this Agreement.

		
	1.142
	 Target Nomination Deadline

The term “Target Nomination Deadline” shall mean the earlier of [* * *] after Roche’s receipt of the following data from the Dicerna Phase I Study:
		
	1.
	[* * *] and

		
	2.
	all available patient data from [* * *], and

		
	(i)
	[* * *]

		
	(ii)
	[* * *]

In the event of either 2.(i) or 2.(ii) above, Roche will inform Dicerna in writing (which may be via email) prior to what would have otherwise been the applicable Target Nomination Deadline.

		
	1.143
	 Target Term

The term “Target Term” shall mean, for a given Selected Target, the period commencing on the date the JRC approves the corresponding Research Plan and ending on the earlier of (a) [* * *] thereafter and (b) the date on which a Clinical Candidate for such Selected Target is selected by the JRC. The Target Term may be (i) extended by Roche for up to [* * *] extensions upon written notice to Dicerna prior to the expiration of the initial [* * *] period, provided that no Compound Directed To such Selected 

Target meets the criteria for Clinical Candidate selection as set forth in the applicable Research Plan, or (ii) shortened (or lengthened beyond Roche’s unilateral [* * *] extension right) by unanimous decision of the JRC.

		
	1.144
	 Territory

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

		
	1.145
	 Third Party

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

		
	1.146
	 Transfer Activities

The term “Transfer Activities” shall mean the transfer from Dicerna to Roche of the data, Materials, Know-How (including the GalXC Platform), documentation and other items in Dicerna’s possession (including through its Affiliates), and reasonable technical assistance, in each case, to the extent reasonably necessary or useful for Roche to continue Development of the Transfer Compounds, along with such other commercially reasonable actions which may be conducted by Dicerna to effectuate transfer of responsibilities and use good faith efforts to make relevant assignments (to the extent Dicerna has the right to do so) related to the Transfer Compounds, for example, with Regulatory Authorities, patent offices, Third Party contract manufacturing organizations (each a “CMO”), Third Party contract research organizations (each a “CRO”) and Clinical Study investigators. Transfer Activities are to be made at the appropriate time on or after the Effective Date with respect to the Lead Transfer Compounds (“Lead Transfer Activities”) and Selected Target Transfer Compounds (“Selected Target Transfer Activities”) and shall be made (i) as set forth in this Agreement, (ii) in accordance with the applicable Transfer Plans or (iii) as otherwise reasonably requested by Roche.

		
	1.147
	 Transfer Compound

The term “Transfer Compound” shall mean: (i) the Lead Compound with respect to the Dicerna Phase I Study and any existing derivative, modification or backup compound to the Lead Compound (each a “Lead Transfer Compound”); and (ii) at the point of a Clinical Candidate selection, all Additional Dicerna Compounds that are Directed To the Selected Target associated with such Clinical Candidate selected (each a “Selected Target Transfer Compound”).

		
	1.148
	 Transfer Plan

The term “Transfer Plan” shall mean (i) a plan for the Lead Transfer Activities (“Lead Transfer Plan”) or (ii) on a Selected Target-by-Selected Target basis, a plan for the Selected Target Transfer Activities (“Selected Target Transfer Plan”). Each Transfer Plan may consist of multiple sections applicable for relevant functions (e.g. regulatory, clinical, safety, manufacturing, clinical). The JRC will establish, implement and oversee the Parties’ activities under each Transfer Plan. The initial Lead Transfer Plan has been provided by Dicerna by letter dated October 30, 2019.

		
	1.149
	 US

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

		
	1.150
	 US$

The term “US$” shall mean US dollars.

		
	1.151
	 Valid Claim

The term “Valid Claim” shall mean, as applicable, a claim in any: (i) unexpired and issued patent within the applicable Patent Rights in any country of the Territory that has not been disclaimed, revoked or held invalid by a final nonappealable decision of a court of competent jurisdiction or government agency or (ii) pending patent application within the applicable Patent Rights in any country of the Territory that has been on file with the applicable patent office for no more than [* * *].

		
	1.152
	 Viral Target

The term “Viral Target” shall mean [* * *].

		
	1.153
	 Additional Definitions

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

	
		
	Definition
	Section

	Accounting Period
	12.1

	Acquired Party
	20.2.3

	Alliance Director
	7.12

	Annual Budget
	6.3.2(b)

	Bankruptcy Code
	21

	Breaching Party
	20.2.1

	CDA
	22.11

	Chairperson
	7.3

	Chemical Raw Materials
	8.4.1

	Chugai
	1.3

	CMO
	1.146

	Compulsory Profit Share Percentage
	11.4.8

	Compulsory Sublicense
	1.141

	Compulsory Sublicensee
	1.141

	Co-Promote, Co-Promoting, Co-Promotion
	10.6.4

	Co-Promotion Agreement
	10.6.3

	Co-Promotion Option
	10.6.1

	Co-Promotion Right
	10.6.1

	Cost Share Option
	6.3

	Cost Share Package
	6.3.1.1

	Cost Share Right
	6.3

	CRO
	1.146

	Debarred
	22.6

	Decision Period
	15.6.2

	Deduction Percentage
	1.104

	Defending Party
	15.7

	Dicerna
	cover page

	Dicerna Indemnitees
	17.1

	Dicerna Invention
	1.85

	Dicerna-Originated Transfer Activities
	20.3.5

	Disclosing Party
	1.28

	
		
	Definition
	Section

	Dispute
	22.2

	DOJ
	22.4

	Effective Date
	22.4

	Expert Committee
	11.4.4

	First Eligible Co-Promotion Indication
	(c)10.6.2(c)

	FTC
	22.4

	Full Review
	3.7(a)(iii)3.7(a)(iii)

	HSR Act
	22.4

	H-W Suit Notice
	15.8

	IND
	1.36

	Indemnified Party
	17.3

	Indemnifying Party
	17.3

	Initial Cost Share Payment
	6.3.2(a)

	Initiating Party
	15.6.2

	Joint Invention
	1.85

	JOT Co-Leader
	7.11

	Lead Transfer Activities
	1.146

	Lead Transfer Compound
	1.147

	Lead Transfer Plan
	1.148

	Members
	7.3

	Minimum Transfer Payment
	20.3.5.4

	Non-Acquired Party
	20.2.3

	Non-Breaching Party
	20.2.1

	Non-Defending Party
	15.7

	Non-Exclusive Conditions
	20.3.1

	Non-Exclusive Roche License
	2.3

	Non-Exclusive Trigger
	20.3.1

	Notice of Dispute
	22.2

	Optional Phase I Cohort(s)
	6.1.1

	Patent Challenge
	20.2.6

	Patent Challenge Notice
	15.10

	Patent Term Extensions
	15.9

	Payee
	13.2

	Payment Currency
	12.3

	Payor
	13.2

	Peremptory Notice Period
	20.2.1

	PII/Samples
	20.3.5.4

	pRED
	3.9

	Pre-Reserved Target
	3.7

	R&D Collaboration
	3.3

	Receiving Party
	1.28

	
		
	Definition
	Section

	Redacted Agreement
	19.5(d)

	Relative Commercial Value
	11.4.4

	Roche
	cover page

	Roche Basel
	cover page

	Roche Continuation Notice
	3.8

	Roche Estimate
	10.6.2(a)

	Roche Indemnitees
	17.2

	Roche Invention
	1.85

	Roche Response Date
	(a)10.6.2(a)

	Roche Transfer Activities
	(d)20.3.5.4(d)

	Roche US
	cover page

	Selected Target Transfer Activities
	1.146

	Selected Target Transfer Compound
	1.147

	Selected Target Transfer Plan
	1.148

	Sensitive Information
	20.2.3

	Settlement
	15.6

	Shared Product
	6.3.1.2

	Shared Product Questions
	(a)10.6.2(a)

	SPCs
	15.9

	Suit Notice
	15.6

	Target Nomination
	3.2

	VAT
	13.5

		
	2.
	Grant of License

		
	2.1
	Research Cross License

Subject to the terms and conditions of this Agreement, each Party grants to the other Party during the R&D Collaboration Term a non-exclusive right and license under Know-How and Patent Rights Controlled by such Party solely to enable the other Party to perform its activities contemplated under the Research Plan under this Agreement for each Selected Target.

		
	2.2
	Commercial License

		
	(a)
	Subject to the terms and conditions of this Agreement (including Section 2.2(b)), Dicerna hereby grants to Roche: (x) an exclusive (even as to Dicerna) right and license under Dicerna’s interest in the Licensed IP, to research, have researched, develop, have developed, register, have registered, make, have made, use, have used, register, have registered, sell, have sold, offer for sale, import, have imported, export and have exported, the below Compounds, Products and Companion Diagnostics which are solely with respect thereto in the Field (subject to (ii) below) in the Territory; and (y) non-exclusive right and license under Dicerna’s interest in the Licensed IP, to research, have researched, develop, have developed, register, have registered, make, have made, use, have used, register, have registered, sell, have sold, offer for sale, import, have imported, export and have exported, the below Companion Diagnostics (other 

than solely with respect to the below Compounds and Products) in the Field (subject to (ii) below) in the Territory.
		
	(i)
	If the Compound, Product or Companion Diagnostic is Directed To a Viral Target, then such license granted by Dicerna to Roche will be in the Field with respect to such Compound, Product or Companion Diagnostic.

		
	(ii)
	If the Compound, Product or Companion Diagnostic is Directed To a Host Cell Factor Target, then for so long as such Host Cell Factor Target is encumbered by rights granted to the Ex-Limited Licensee, such license granted by Dicerna to Roche will be in the Limited Field with respect to such Compound, Product or Companion Diagnostic. If at any time the Ex-Limited Licensee restrictions that keep Roche limited to such a Limited Field license no longer apply, then as of such time Dicerna hereby grants to Roche the full license under Section 2.2(a)(i) and Dicerna shall promptly notify Roche pursuant to Section 3.7(c)(ii).

		
	(b)
	The exclusivity of the above licenses is subject to the right of Dicerna and its respective Affiliates to Complete the Dicerna Phase I Study, conduct its activities under the Research Plans and perform its Co-Promotion Right obligations (if any) for the Co-Promotion Products in the US, to the extent expressly contemplated by this Agreement.

		
	2.3
	Non-Exclusive Roche License

In the event of a Non-Exclusive Trigger under Section 20.3.1, and with respect to a given Roche Compound, Roche Product or Companion Diagnostic relevant to such termination (either for Agreement termination as a whole or with respect to a given Selected Target for Selected Target termination), the non-exclusive license grant under Section 2.2(a)(y) shall continue as is and the exclusive license grant under Section 2.2(a)(x) shall continue as a non-exclusive license grant (collectively, the “Non-Exclusive Roche License”).

		
	2.4
	Sublicenses

		
	2.4.1
	Right to Sublicense to its Affiliates 

Roche shall have the right to grant sublicenses to its Affiliates (through multiple tiers), and to Chugai if Chugai is not an Affiliate under this Agreement, under its rights granted under Sections 2.1, 2.2 and 2.3 without prior approval of Dicerna. If Roche grants a sublicense permitted under this Section 2.4.1, Roche shall ensure that all of the applicable terms and conditions of this Agreement shall apply to the Affiliate (and Chugai as applicable) to the same extent as they apply to Roche for all purposes. Roche assumes full responsibility for the performance of all obligations and observance of all terms so imposed on such Affiliate (and Chugai as applicable) and shall itself account to Roche for all payments due under this Agreement by reason of such sublicense.
		
	2.4.2
	Right to Sublicense to Third Parties

Subject to the terms of this Agreement, Roche and its Affiliates shall have the right to grant written sublicenses to Third Parties (through multiple tiers) under its rights granted under Sections 2.2(a) and 2.3 without prior approval of Dicerna, with the proviso [* * *]. Roche shall inform Dicerna promptly after the signature of aa sublicense agreement under this Section 2.4.2 and provide a copy of each such agreement with a Third Party to Dicerna within [* * *] after execution thereof, which sublicense may be redacted to omit any terms not necessary to confirm Roche’s compliance with this Section 2.4.2. If Roche grants a sublicense permitted under this Section 2.4.2, Roche shall ensure that all of the applicable terms and conditions of this Agreement shall apply to the Sublicensee to the same extent as they apply to Roche for all purposes. Roche assumes full responsibility for the performance of all 

obligations and observance of all terms so imposed on such Sublicensee and shall itself account to Dicerna for all payments due under this Agreement by reason of such sublicense.

For clarity, without Dicerna’s prior written consent, Roche may not sublicense to non-Affiliate entities (i) its rights granted under Section 2.1 and (ii) its rights and obligations to conduct its activities under the R&D Collaboration.
		
	2.4.3
	Right to Subcontract

Both Parties shall have the right to subcontract the work performed under this Agreement (subject, in the case of Dicerna, to Section 10.6.4) without prior approval of the other Party, provided that (a) each Party will remain responsible for the work allocated to subcontractors to the same extent as if it had done such work itself, and (b) each Party’s applicable subcontracts shall be consistent with its obligations to the other Party under this Agreement and to the extent applicable fulfill such Party’s obligation to the other Party to comply with  obligations of confidentiality and non-use regarding Confidential Information  and to assign such Inventions required by this Agreement to be assigned to the other Party.

2.5    License Limitation
In consideration of the limitations of the Roche exclusivity covenant in Section 3.9(b)(b), Roche agrees that during the R&D Collaboration Term, the scope of the license rights (other than the Lead Compound) granted under Sections 2.1, 2.2, 2.3, and 2.4 to Roche are limited to [* * *].

		
	2.6
	Freedom-to-operate Licenses

		
	2.6.1
	Know-How

Roche hereby grants to Dicerna an irrevocable non-exclusive, worldwide, royalty-free license, with the right to sublicense, under such Roche Know-How as Roche may provide to Dicerna for use in research, development and commercialization of oligonucleotide compounds. Roche shall have no obligation to transfer or provide any information or materials to Dicerna as a result of this Section 2.6.1 unless otherwise expressly agreed by Roche.

Dicerna hereby grants to Roche an irrevocable non-exclusive, worldwide, royalty-free license, with the right to sublicense, under such Dicerna Know-How as Dicerna may provide to Roche for use in research, development and commercialization of oligonucleotide compounds. Dicerna shall have no obligation to transfer or provide any information or materials to Roche as a result of this Section 2.6.1 unless otherwise expressly agreed by Dicerna.
		
	2.6.2
	Mutual Use of Confidential Information

Subject to and without limiting any other license rights or exclusivity granted under this Agreement, Roche (and its Affiliates) and Dicerna (and its Affiliates) will have the right to use any Confidential Information disclosed by the other Party in connection with the R&D Collaboration and retained in the unaided memories of its employees after having access to such Confidential Information (without reference to tangible copies of such information), provided that this right to use does not constitute a license under any Patent Rights. [* * *]. 
		
	2.6.3
	GalXC Platform and Roche Background Patent Licenses 

Subject to Section 3.9(b)(b) and the license granted in Section 2.2, Roche hereby grants back to Dicerna a non-exclusive, worldwide, royalty-free license, with the right to sublicense through multiple 

tiers, under Patent Rights invented solely by Dicerna during the R&D Collaboration specifically claiming Roche Background Improvements, to research, have researched, develop, have developed, register, have registered, make, have made, use, have used, register, have registered, sell, have sold, offer for sale, import, have imported, export and have exported products.

Subject to Section 3.9(a)(a), Dicerna hereby grants back to Roche a non-exclusive, worldwide, royalty-free license, with the right to sublicense through multiple tiers, under Patent Rights invented solely by Roche during the R&D Collaboration specifically claiming GalXC Platform Improvements, to  research, have researched, develop, have developed, register, have registered, make, have made, use, have used, register, have registered, sell, have sold, offer for sale, import, have imported, export and have exported products.

		
	3.
	R&D Collaboration

		
	3.1
	Initiation

At any time after the Effective Date but in no case later than the Target Nomination Deadline, Roche will either
		
	(i)
	submit to Dicerna in writing the names of the [* * *] that Roche wants to nominate as the initial Selected Targets under the process described under Section 3.2,

		
	(ii)
	provide written notice to Dicerna that Roche elects not to initiate the R&D Collaboration, or

		
	(iii)
	provide written notice to Dicerna of termination of the Agreement without cause pursuant to Section 20.2.4.

In the event of either clause (ii) or (iii) above, the R&D Collaboration will not commence, the remainder of this Article 3 and all references to the R&D Collaboration in this Agreement will not apply, and Roche will receive no rights or licenses under Selected Target Products.

		
	3.2
	Selected Target Nomination

Roche may nominate prior to the Target Nomination Deadline [* * *] initial Selected Targets (or up to five (5) total Selected Targets as permitted under this Agreement) by utilizing the Gatekeeper Process designated as “Target Nomination”, with up to [* * *] of the Selected Targets being Host Cell Factor Targets.  Roche may replace up to [* * *] of the Selected Targets with a Reserved Target once utilizing the replacement processes described in Section 3.6, where up to [* * *] of the Reserved Targets may be Host Cell Factor Targets.

		
	3.3
	Scope

During the R&D Collaboration Term, Roche and Dicerna shall conduct a mutually agreed discovery, research and pre-clinical development collaboration (prior to Development) for HBV disease therapies (the “R&D Collaboration”) with the goal of advancing lead candidates from each of Dicerna’s and Roche’s proprietary technology platforms Directed To the Selected Targets from which one or more Additional Dicerna Compounds and/or Roche Compounds may be generated and advanced into Development and eventually translated into Products for Commercialization by Roche. The activities conducted in connection with the R&D Collaboration will be pursuant to individual Research Plans and will be overseen by the JRC.  The Parties shall not work on more than [* * *] Selected Target Research Plans at a given time without the written agreement of both Parties (which may include approved JRC minutes). For avoidance of doubt, if the Parties (or JRC) agree to suspend activities on a given Selected Target Research Plan, it shall not count as one of such [* * *]. 

		
	3.4
	Research Plans

Each Research Plan will outline the program and the work by the Parties to discover, research and pre-clinically develop (prior to Development) Additional Dicerna Compounds and Roche Compounds Directed To the applicable Selected Target up to the point of Clinical Candidate selection, as such plans may be updated from time to time as provided in this Agreement. Each Research Plan shall also include the plans for Roche at its own expense to either initiate or further pre-clinically develop (prior to Development) existing Roche Compounds Directed To the applicable Selected Target. Unless decided otherwise by the JRC, the Research Plan for each Selected Target will be updated annually by the JRC. Any changes shall be reflected in written amendments to the Research Plans approved by the JRC. Each Research Plan will set forth: (i) the scope of the R&D Collaboration for the applicable Selected Target broken down by activities for Dicerna Compounds and Roche Compounds, as applicable, and the resources that each Party will dedicate to the activities contemplated within the scope of the R&D Collaboration for such Dicerna Compounds and Roche Compounds, respectively; and (ii) specific objectives for each year, which objectives will be updated or amended, as appropriate, by the JRC as research progresses and based on the applicable criteria for selection of a Clinical Candidate. While each of the Dicerna and Roche teams shall primarily focus on the further research of compounds derived from their respective proprietary platforms, certain activities leveraging unique capabilities and expertise of a given Party may be applied to the Compounds generated by the other Party.

		
	3.5
	Information Exchange

		
	3.5.1
	Progress Reports

It is expected that the Research Plans shall be conducted as a joint team under the supervision of the JRC. Unless otherwise stated in the applicable Research Plan, each Party will only share data, information, results and output from in vitro and in vivo studies prior to the time a Compound is selected by the JRC to progress to non-human primate studies.  After such time , Dicerna shall provide Roche with the chemistry and sequence information on the GalXC Molecule. Unless the JRC determines otherwise, on at least a Calendar Quarter basis during the R&D Collaboration Term, each Party shall prepare and provide to the JRC a detailed written report consistent with each Party’s internal practices summarizing the progress of the work performed by each Party in the course of the R&D Collaboration during the preceding Calendar Quarter, and each Party will provide a final report to the JRC at the end of a given Research Plan with respect to its activities under the Research Plan.
		
	3.5.2
	Research Records

Each Party shall maintain records of the R&D Collaboration (or cause such records to be maintained) consistent with such Party’s internal practices that each Party determines in good faith records in sufficient detail and in good scientific manner the work done and results achieved by or on behalf of such Party in the performance of the R&D Collaboration. All laboratory notebooks shall be maintained for no less than is reasonably necessary to comply with Applicable Law or the term of any Patent Rights issuing therefrom.

		
	3.6
	Replacement and Reserved Targets

Roche may only replace Selected Targets with a Reserved Target no more than [* * *] times during the R&D Collaboration Term, as provided in this Section 3.6 and in Section 3.7 below.  During the Target Term for a Selected Target, if no Compounds Directed To such Selected Target are generated that meet the criteria for Clinical Candidate selection by the JRC as set forth in the applicable Research 

Plan for such Selected Target and Roche requests in writing to replace such Selected Target with a Reserved Target, then such Reserved Target shall be deemed a Selected Target in place of such prior Selected Target (and no longer a Reserved Target) and the JRC shall develop a Research Plan for such replacement Selected Target no later than [* * *] after Roche’s written request for replacement.

		
	3.7
	Gatekeeper Process

From the Effective Date until the end of the Target Nomination Deadline or last Target Term, whichever is later, Dicerna will keep Roche informed of the identity and contact information for the Gatekeeper. The Parties agree the initial Gatekeeper will [* * *].  The Parties will enter into a customary confidentiality agreement that includes confidentiality at least as stringent as the provisions set forth in Article 19 and prohibits the Gatekeeper from disclosing to Roche the Not Available Targets or from disclosing to either Dicerna or Roche the identity of a target that was the subject of inquiry by the other Party.

At the Effective Date, the Gatekeeper will have a list of Not Available Targets and from time to time thereafter (including at least [* * *] per Calendar Quarter, including in response to inquiries hereunder), Dicerna will provide the Gatekeeper with an update to the list of Not Available Targets, together with any applicable rights Dicerna can still grant hereunder with respect to such Not Available Targets, and any associated restrictions.

At the Effective Date, the Gatekeeper has confirmed [* * *] Host Cell Factor Target as a Reserved Target by letter dated October 28, 2019 (“Pre-Reserved Target”). Notwithstanding anything in this Agreement, including the right to select [* * *] initial Selected Targets under Section 3.2 such Pre-Reserved Target shall remain a Reserved Target until such time as Roche in its discretion nominates it as a Selected Target.  

The following are the Gatekeeper Processes to be followed with respect to target nomination (for Selected Targets) or for target nomination (for Reserved Targets), subject to the restrictions in Sections 1.136 and 1.127.
		
	(a)
	[* * *].

		
	(b)
	[* * *].

		
	(c)
	[* * *].

		
	(d)
	[* * *].

		
	3.8
	Compound Progression

Subject to JRC decisions to the contrary, Research Plan activities for each Selected Target shall continue until the selection of a Clinical Candidate from the overall pool of Roche Compounds and Additional Dicerna Compounds on a Selected Target-by-Selected Target basis. The periodic review by the JRC of the results of the Research Plans will inform which Compounds to further advance and whether to terminate development of certain Compounds and/or a Selected Target through appropriate amendments to the Research Plans. The JRC shall decide which Compound(s) will be advanced into Development to be conducted and funded by Roche with all remaining Compounds Directed To such Selected Target being reserved by Roche as backup Compounds and included within the licenses granted to Roche under Section 2.2.

During the Target Term, the JRC will make plans for the eventual Selected Target Transfer Activities with respect to Additional Dicerna Compounds (and if applicable, Roche Compounds) to Roche to enable Roche to timely continue advancement of Additional Dicerna Compounds, which Selected Target Transfer Activities will be conducted pursuant to a Selected Target Transfer Plan approved by the JSC and as otherwise reasonably requested by Roche. Selected Target Transfer Activities set forth in the given Selected Target Transfer Plan will be provided by or on behalf of Dicerna free of charge. For additional Selected Target Transfer Activities reasonably requested by Roche not set forth in the given Selected Target Transfer Plan, Dicerna shall provide up to [* * *] free of charge. Thereafter, additional hours will be provided at Roche’s expense based on Dicerna’s then current FTE Rate and Roche will reimburse Dicerna for all of Dicerna’s reasonable out of pocket expenses incurred in connection therewith.

If the JRC fails to select a Clinical Candidate for a given Selected Target prior to the expiration of the Target Term, Roche will either terminate its rights to Licensed Products under Section 20.2.5 (and such Selected Target will become a Discontinued Target) or will notify Dicerna of its intention (“Roche Continuation Notice”) to proceed with the further research and development of Licensed Products for such Selected Target in which case the JRC will promptly implement the associated Selected Target Transfer Plan.  If Roche has provided a Roche Continuation Notice and fails to progress a Clinical Candidate Directed To such Selected Target within [* * *], then Roche must terminate such Selected Target under Section 20.2.5 (and such Selected Target will become a Discontinued Target).  

		
	3.9
	Exclusivity

During the Exclusivity Period:
		
	(a)
	Dicerna will collaborate exclusively with Roche in the discovery, research, and development of GalXC Molecules Directed To Selected Targets in the Limited Field or if cleared pursuant to Section 3.7 the Field during the R&D Collaboration, other than as may be incidental to research activities outside the scope of this Agreement.

		
	(b)
	[* * *].

		
	3.10
	Research Plan Costs of Performance

Except as otherwise expressly set forth in this Agreement, in the applicable Research Plan or as otherwise agreed by the Parties in writing, each Party shall bear its expenses conducting R&D Collaboration activities for a Selected Target during the applicable Target Term as set forth in the applicable Research Plan.

		
	4.
	Diligence

Roche and Dicerna shall use Commercially Reasonable Efforts to perform their respective activities and fulfil their respective obligations contemplated by this Agreement or as may be agreed upon in any subsequent written agreements with respect to the subject matter hereof. Examples of the foregoing include:
		
	(a)
	Dicerna shall use Commercially Reasonable Efforts to Complete the Dicerna Phase I Study and to conduct the Lead Transfer Activities in accordance with the Lead Transfer Plan (including any timelines therein);

		
	(b)
	Roche shall use Commercially Reasonable Efforts to Develop and Commercialize at least one (1) Lead Product in the Territory;

		
	(c)
	on a Selected Target-by-Selected Target basis, and subject to the JRC deciding to stop work on a particular class of compounds for a given Selected Target, both Roche and Dicerna shall use Commercially Reasonable Efforts to (i) discover, research and pre-clinically develop (prior to Development) at least one (1) Roche Compound and Additional Dicerna Compound, respectively, as a Clinical Candidate, and (ii) perform their respective obligations under the applicable Research Plan; and

		
	(d)
	on a Selected Target-by-Selected Target basis, after the first Clinical Candidate selection, Roche shall use Commercially Reasonable Efforts to Develop and Commercialize at least one Selected Target Product or Hybrid Product. Roche’s efforts to Develop and Commercialize a Selected Target Product that includes a Lead Compound or Hybrid Product shall satisfy the obligations of subsection (b) above if at any time after the Completion of a Phase II Study for the Lead Product Roche in its good faith belief determines that continued Development and Commercialization of Product containing the Lead Compound as either the sole active agent (or in combination only with an active agent other than a Compound) is scientifically or medically unviable (or commercially unviable after First Commercial Sale of a Selected Target Product that includes a Lead Compound or Hybrid Product).

		
	5.
	Lead Transfer Activities

Lead Transfer Activities set forth in the Lead Transfer Plan will be provided by or on behalf of Dicerna free of charge. For all other Lead Transfer Activities reasonably requested by Roche not set forth in the Lead Transfer Plan, Dicerna shall provide up to [* * *] free of charge. Thereafter, additional hours for such Lead Transfer Activities not set forth in the Lead Transfer Plan will be provided at Roche’s expense based on Dicerna’s then current FTE Rate and Roche will reimburse Dicerna for all of Dicerna’s reasonable out of pocket expenses incurred in connection therewith.

		
	6.
	Development

		
	6.1
	Development of Lead Product by Dicerna through Dicerna Phase I Study

Dicerna shall, at its sole cost (other than the Optional Phase I Cohorts(s), if applicable), be responsible for Completion of the Dicerna Phase I Study, including, upon notification to the JRC, reasonable amendments to the existing protocols within the ordinary course of business that are not material deviations other than as required by Regulatory Authorities (with any such material deviation amendments proposed by Dicerna requiring approval of the JRC including via the applicable JOT). Dicerna shall promptly (i) disclose and make available to Roche through the JRC (including via the applicable JOT) the data and information reasonably requested by Roche about the Dicerna Phase I Study while on-going (for each time the data is analyzed, blinded or unblinded for SRC or for any interim analyses), (ii) upon Roche’s advance written request (which may be by email), permit Roche to join (in person or by teleconference) as a non-participating observer in meetings between Dicerna and the principal investigators involved in the Dicerna Phase I Study and meetings between Dicerna and the CRO(s) involved in the Dicerna Phase I Study, and (iii) if and to the extent provided in the Lead Transfer Plan, provide Roche with access to data generated in connection with the Dicerna Phase I Study prior to and after Completion, in each case, on or after the Effective Date.

Dicerna shall also be responsible, at its sole cost, for completing all ongoing preclinical or other studies for the Lead Compound. Dicerna shall disclose and make available to Roche through the JRC (or as otherwise requested by Roche) all data and information reasonably requested by Roche about such 

preclinical or other studies associated with the Lead Compound while on-going, including any safety review committee output, interim or preliminary results.

As reasonably necessary for Roche to continue Development of the Lead Compound, Dicerna shall conduct the Lead Transfer Activities. As part of the Lead Transfer Activities, Dicerna will cooperate with Roche and disclose and make available to Roche copies of all data and information in Dicerna’s possession and Control regarding the Lead Compound and Lead Product which is reasonably necessary for Roche’s Development of such Lead Product and in the timelines reasonably requested by Roche or as set forth in the Lead Transfer Plan.
		
	6.1.1
	Optional Phase I Cohort(s)

Dicerna will prepare and file a protocol amendment for the Dicerna Phase I Study for optional additional cohort(s) (“Optional Phase I Cohort(s)”) to explore different doses or dosing regimen. Such protocol amendments or Optional Phase I Cohort(s) may be used for IND Filing. Dicerna will conduct the Optional Phase I Cohort(s) at Roche’s expense, however the study design and cost will be mutually agreed by the Parties prior to initiation of the activities, otherwise Roche will have no obligation to fund and Dicerna will have no obligation to conduct the Optional Phase I Cohort(s).

		
	6.2
	Development by Roche

Other than Dicerna’s development responsibilities listed in Section 6.1, Roche, at its sole cost and discretion (subject to Article 4 and subject to discretion limitations and cost sharing under Dicerna’s Cost Share Option), shall be responsible for pursuing Development of Products.

Roche shall maintain records of its Development activities (or cause such records to be maintained) consistent with its internal practices. Roche shall be responsible for the correct use of Dicerna PII/Samples in line with Applicable Law and the informed consent forms.  Notwithstanding anything to the contrary in this Agreement but subject to Section 6.1 above (and except with respect to the Lead Compound and Lead Product if Dicerna exercises its Cost Share Option), Dicerna will not bear any costs or expenses in connection with Development of Compounds or Products.

		
	6.3
	Dicerna Cost Share Option

Dicerna shall have the option (the “Cost Share Option”) (unless earlier waived in accordance with this Section) to share in Development Costs and thereby receive increased royalties in the US for the Shared Products as described in this Agreement (the “Cost Share Right”). For so long as Dicerna has the Cost Share Option, Roche will provide to Dicerna through the JRC the current Development Plan and any updates and amendments thereto.
		
	6.3.1
	Option and Exercise

		
	6.3.1.1
	Roche Provision of Cost Share Package

Unless Dicerna earlier waives its Cost Share Option in writing, no later than at such time as Roche formally decides (based on Roche’s then current internal governance decision-making process and committees) to proceed into the first Pivotal Study for the Lead Product (or a Hybrid Product, as applicable), Roche shall provide to Dicerna a package (“Cost Share Package”) including (i) relevant data from the previous Clinical Studies conducted by or on behalf of Roche, if not already shared, (ii) an accounting of Roche’s actual Development Costs up to and including the previous Calendar Quarter, (iii) a copy of Roche’s then-existing proposed Development Plan for the Lead Product or Hybrid Product and (iv) for informational purposes only, Roche’s good faith, non-binding forecast, made in accordance with its regular internal forecasting procedures, of all then planned project 

Development Costs consistent with the Development Plan for the Lead Product or Hybrid Product (for clarity, the information that Roche provides to its internal decision-making committee for the purposes of deciding whether to proceed into the first Pivotal Study). Dicerna may ask reasonable questions concerning the contents of the Cost Share Package through the JRC and Roche will make appropriate representatives available to provide answers to Dicerna’s questions.
		
	6.3.1.2
	Cost Share Option Exercise

Dicerna may exercise its Cost Share Option by providing written notice at any time within [* * *] of Dicerna’s receipt of the Cost Share Package.  In the event that at the time Roche provides Dicerna with the Cost Share Package, Roche’s internal governance decision-making committee has not yet decided to proceed into the first Pivotal Study for the Lead Product, then such exercise by Dicerna shall not be effective unless, within the [* * *] after such exercise, Roche notifies Dicerna that such internal governance committee decision has been made and (a) such decision is consistent with the plan furnished to Dicerna in the Cost Share Package, and (b) Roche notifies Dicerna of any updates or changes to the Cost Share Package, including any deviations from the Development Plan. If such decision is then made by Roche but changes the plan furnished to Dicerna in the Cost Share Package, Roche shall revise the Cost Share Package and deliver it to Dicerna.  Dicerna may then exercise its Cost Share Option by providing written notice at any time during the period commencing upon Dicerna’s receipt of the revised Cost Share Package and ending thirty (30) days later.  Commencing upon Dicerna’s exercise of its Cost Share Option and continuing until the end of the Royalty Term unless and until Dicerna fails to meet its obligations under Section 6.3.2, (i) Dicerna shall have the Cost Share Right and (ii) any Lead Product shall also be deemed as a “Shared Product”. Provided that Dicerna exercises its Cost Share Option for the Lead Product, Dicerna shall also be granted a Cost Share Option for each subsequent Hybrid Product. The foregoing option exercise procedure for the Lead Product shall also be applied for eligible Hybrid Products. Any Hybrid Product for which Dicerna exercises its Cost Share Option shall be deemed a Shared Product.
		
	6.3.2
	Payments to Roche

If Dicerna exercises its Cost Share Option, then Dicerna will be responsible for [* * *] as follows:
		
	(a)
	Dicerna will pay Roche [* * *] of Roche’s actual global Development Costs up to and including the last Calendar Quarter prior to Dicerna’s exercise of the Cost Share Option (the “Initial Cost Share Payment”). Within [* * *] of Dicerna’s receipt of an invoice from Roche, Dicerna may notify Roche in writing of its election to set off the Initial Cost Share Payment against the payment from Roche to Dicerna for the Initiation of a Pivotal Study under Section 11.2.1, up to the full amount of the Initial Cost Share Payment. To the extent the Initial Cost Share Payment will not be set off against the Initiation of a Pivotal Study payment under Section 11.2.1, Dicerna will pay Roche such amount within [* * *] of Dicerna’s receipt of an invoice from Roche.

		
	(b)
	For such time as there are forecasted Development Costs, Roche shall in accordance with its regular internal forecasting processes and annual forecast cycle, provide Dicerna its forecast of all then planned project Development Costs for Shared Product(s), including the forecasted budget for a given Calendar Year (“Annual Budget”) in final form within [* * *].  For such time as there are Shared Product(s), Roche shall (a) within [* * *],  give Dicerna preliminary actual Development Costs for such Shared Product(s) for such Calendar Quarter and in the event of material changes, an updated Annual Budget for the remainder of the Calendar Year and (b) within [* * *], give Dicerna the final actual Development Costs for such Shared Product(s) for such Calendar Quarter.

		
	(c)
	For each Calendar Quarter (including the Calendar Quarter in which Dicerna exercised its Cost Share Option), within [* * *] after Dicerna’s receipt of an invoice from Roche, Dicerna will make a payment to Roche for (i) with respect to Lead Products, [* * *] of Roche’s actual Development Costs for the applicable previous [* * *] or (ii) with respect to Hybrid Products, [* * *] of Roche’s actual Development Costs for the applicable previous [* * *].

		
	(d)
	In the event that actual Development Costs for a Calendar Year exceed the Annual Budget, including due to Extraordinary Events, by more than [* * *], Dicerna’s portion of any such excess Development Costs  be deferred and payable to Roche in subsequent Calendar Years, with a maximum amount of such excess payable by Dicerna in a [* * *] not to exceed US dollars [* * *]. For the avoidance of doubt, the maximum amount of Development Costs to be paid by Dicerna after the end of a Calendar Year (but subject to additional deferred payments by Dicerna) shall be [* * *] of Dicerna’s portion of the Annual Budget. By way of example, if the Annual Budget for the year 2022 is [* * *] with Dicerna’s portion thereof equaling [* * *] and the FDA requires an additional arm be included in a Pivotal Study with the estimated costs for Calendar Year 2022 for such additional arm equaling [* * *] and actual Development Costs incurred by Roche for Calendar Year 2022 (including the additional arm) total [* * *] then Dicerna’s total Development Costs payable to Roche shall [* * *] of which [* * *] shall be payable by Dicerna within [* * *] after the end of 2022 and the remaining [* * *] shall be deferred and payable in [* * *] equal installments of [* * *] each after the end of [* * *], respectively.

		
	(e)
	Invoices submitted by Roche to Dicerna for Development Cost reimbursement will set forth in reasonable detail such costs and expenses to be reimbursed, which costs and expenses shall be specifically identifiable or reasonably allocable to the conduct of Shared Product Development Costs as determined in accordance with the applicable Accounting Standard, including any amounts that may be deferred into the following year.

		
	6.3.3
	Adjustment of Royalty Rate for Shared Product US Net Sales

If Dicerna exercises its Cost Share Option and maintains its Cost Share Right by payment of its portion of the Development Costs, then the royalty rate for the Shared Product shall be increased in accordance with Section 11.4.2.1.

		
	6.4
	Updates 

Roche shall provide an annual written report to Dicerna to update Dicerna with a summary based on information Roche provides to its internal management as to Development progress for each Licensed Product, including all preclinical and clinical development activities. Roche will provide notice and further information regarding changes to such annual reports with respect to such Licensed Products through the JSC (as applicable) in accordance with Section 7.10 and Roche’s Alliance Director in accordance with Section 7.12.

		
	7.
	Governance

		
	7.1
	Joint Research Committee

Within [* * *] after the Effective Date, the Parties shall establish a JRC to perform the functions described herein, including
		
	(i)
	monitor the Dicerna Phase I Study until Completion (which may be conducted by a JOT established by the Parties on behalf of the JRC prior to the first meeting of the JRC),

		
	(ii)
	develop, approve and update each Research Plan for each Selected Target,

		
	(iii)
	oversee the R&D Collaboration (upon start of the R&D Collaboration Term),

		
	(iv)
	establish, revise and implement the Transfer Plans, provided that all updates to the Lead Transfer Plan require Dicerna’s written approval or approved JRC minutes, and

		
	(v)
	share the results of Roche’s Development of the Lead Product or Hybrid Product until Dicerna either exercises or fails to exercise its Cost Share Option.

		
	7.2
	Joint Steering Committee

Within [* * *] of Dicerna’s receipt of the Cost Share Package, the Parties shall establish a JSC. If Dicerna exercises its Cost Share Option, the JSC shall oversee the global Development activities for Shared Products and, if Dicerna exercises its Co-Promotion Option, Co-Promotion activities in the US for Co-Promotion Products. If Dicerna does not exercise its Cost Share Option, the JSC and Roche’s Alliance Director shall be primarily responsible for information exchange between the Parties concerning Roche’s continued Development and Commercialization of the Lead Product as set forth herein.

		
	7.3
	Members

The JRC and JSC shall each be composed of [* * *] persons (“Members”). Roche and Dicerna each shall be entitled to appoint [* * *] Members with appropriate seniority and functional expertise. Each Party may replace any of its Members and appoint a person to fill the vacancy arising from each such replacement. A Party that replaces a Member shall notify the other Party at least [* * *] prior to the next scheduled meeting of the applicable Committee. Both Parties shall use reasonable efforts to keep an appropriate level of continuity in representation. Both Parties may invite a reasonable number of additional experts and/or advisors to attend part or the whole Committee meeting with prior notification to the applicable committee. Members may be represented at any meeting by another person designated by the absent Member. The JSC shall be chaired by a [* * *] Member (“Chairperson”).  The initial Chairperson of the JRC shall be a [* * *] Member and shall thereafter [* * *].

		
	7.4
	Meetings

The Chairperson for a given Committee or his/her delegate will be responsible for sending invitations and agendas for all such Committee meetings to all Members at least [* * *] before the next scheduled meeting of the Committee. The venue for the meetings shall be agreed by the Committee. Each Committee (after its formation in accordance with Section 7.1 or 7.2, as applicable) shall hold meetings at least [* * *] per Calendar Year, either in person or by tele-/video-conference, and in any case as frequently as the Members of the applicable Committee may agree shall be necessary, but not more than four times a year, provided that such limit shall not apply to meetings held following a material change to the Development or Commercialization of a Lead Product or Hybrid Product that occurs between planned annual updates at the JSC in accordance with Section 7.10. The Alliance Director of each Party may attend the JSC meetings as a permanent participant.

		
	7.5
	Minutes

The Chairperson of a given Committee will be responsible for designating a Member to record in reasonable detail and circulate draft minutes of the Committee meetings to all members of the Committee for comment and review within [* * *] after the relevant meeting. The Members of the Committee shall have [* * *] to provide comments. The Party preparing the minutes shall incorporate timely received comments and distribute finalized minutes to all Members of the Committee within [* * *] of the relevant meeting. The Chairperson approves the final version of the minutes before its distribution.

		
	7.6
	Responsibilities of the JRC

The JRC shall have the responsibility and authority to: [* * *]

The JRC shall have no responsibility and authority other than that expressly set forth in this Section such as to unilaterally impose financial or manpower obligations on either Party.

		
	7.7
	JRC Decisions

		
	7.7.1
	Decision Making Authority

The JRC shall decide matters within its responsibilities set forth in Section 7.6.
		
	7.7.2
	Consensus; Good Faith

The Members of the JRC shall act in good faith to cooperate with one another and seek agreement with respect to issues to be decided by the JRC. The Parties shall endeavor to make decisions by consensus with each Party having one (1) vote.
		
	7.7.3
	Failure to Reach Consensus

If the JRC is unable to decide a matter by consensus:
		
	(a)
	Dicerna shall be responsible for [* * *].

		
	(b)
	Roche shall have the final decision authority on [* * *].

Any such decision shall constitute a decision of the JRC.

		
	7.8
	JSC Responsibilities and Decision Making for Shared Product Development

		
	7.8.1
	JSC Responsibilities

With respect to Shared Product Development, the role of the JSC shall be to oversee and manage the global Development activities of Shared Products, which oversight and management shall be in alignment with Roche’s then current procedures as they would apply to an internal Roche development program at the equivalent stage of development having a similar commercial value, subject to the obligations set forth in this Agreement. The JSC may establish and oversee JOTs as applicable to Shared Product Development. In particular with regard to Shared Product Development, the JSC’s primary activities shall include: [* * *]
The JSC shall have no responsibility and authority other than that expressly set forth in this Section.
		
	7.8.2
	JSC Decision Making

The Members of the JSC shall act in good faith to cooperate with one another and seek agreement with respect to issues to be decided by the JSC concerning Shared Product Development. The Parties shall endeavor to make decisions by consensus with each Party having one (1) vote.
		
	7.8.3
	Failure to Reach Consensus

		
	(a)
	Subject to Section 7.8.3(b), if the JSC is unable to decide a matter, the resolution and/or course of conduct shall be determined by Roche, in its sole discretion; provided that, Roche shall not have the authority to make any decision without the consent of Dicerna that would result in an increase in Dicerna’s patent infringement risk under this Agreement.

		
	(b)
	If the JSC cannot resolve an issue which relates to:

		
	(i)
	continuing or discontinuing the [* * *];

		
	(ii)
	continuing or discontinuing any [* * *];

		
	(iii)
	a decision to [* * *]; or

		
	(iv)
	a decision to pursue or not to pursue a [* * *],

then the JSC (or either Party’s members thereof) may refer such dispute to [* * *]. Any such decision shall constitute a decision of the JSC.

		
	7.9
	JSC Responsibilities and Decision Making for Co-Promotion Products

The provisions of this Section 7.9 apply only with respect to Co-Promotion Products during such time as Dicerna has a Co-Promotion Right in the US for such Co-Promotion Products.
		
	7.9.1
	JSC Responsibilities

With respect to Co-Promotion activities, the role of the JSC shall be to oversee and coordinate the US Co-Promotion activities in the US for Co-Promotion Products in accordance with the Co-Promotion Agreement.  For Co-Promotion Products, the JSC will have responsibility for reviewing the Commercialization Plan from time to time as necessary for the purpose of considering appropriate amendments thereto.
		
	7.9.2
	JSC Decision Making

The Members of the JSC shall act in good faith to cooperate with one another and seek agreement with respect to issues to be decided by the JSC concerning Co-Promotion of Co-Promotion Products. The Parties shall endeavor to make decisions by consensus with each Party having one (1) vote.
		
	7.9.3
	Failure to Reach Consensus

If the JSC is unable to decide a matter regarding Co-Promotion of Co-Promotion Products, then the JSC (or either Party’s members thereof) may refer such dispute to [* * *], subject to the terms of this Agreement and the Co-Promotion Agreement.

		
	7.10
	JSC Responsibilities for Roche Sole Development/Commercialization of Lead Product and Hybrid Product

During the lifetime of the JSC pursuant to Section 7.15, the JSC shall be a forum for information exchange from Roche to Dicerna on the status of Development and Commercialization of the Lead Product and Hybrid Products if Dicerna does not exercise its Cost Share Option. Through the JSC, Roche shall provide updates regarding (i) Development of the Lead Product and Hybrid Product in accordance with Section 6.4 including progress since the last update and (ii) Commercialization of the Lead Product and Hybrid Product in accordance with Section 10.3. Such updates shall be consistent with the information Roche provides its internal management on Lead Products. In the event of a material change to the Development or Commercialization of a Lead Product or Hybrid Product that occurs between planned annual updates at the JSC, Roche’s Alliance Director shall timely inform Dicerna of such change after which the Parties may decide whether an ad hoc JSC meeting should be scheduled. Where there is no JSC, updates on the Lead Product will be provided through the Alliance Director in accordance with Section 7.12.

		
	7.11
	Joint Operational Teams

Each Committee may establish JOTs from time-to-time, with a defined scope and duration, to carry out the activities of such Committee. Each of the JOTs shall be composed of representatives designated by each Party and the Parties need not have the same number of representatives. The JOTs shall include individuals with expertise and responsibilities appropriate (in terms of their seniority, availability, function in their respective organizations, training and experience) for the tasks then being undertaken and the stage of the research, manufacture, development and commercialization of applicable Compounds and Products for which joint activities will be performed. Each Party shall designate one of its representatives as its primary contact for all JOT matters (such Party’s “JOT Co-Leader”). A Party may replace any or all of its representatives (and designated JOT Co-Leader) at any time by informing the other JOT Co-Leader in advance, in writing (which may be by email). Roche’s JOT Co-Leader for a given JOT shall be responsible for keeping minutes of any JOT meetings that record in writing all decisions made, action items assigned or completed, and other appropriate matters. Meeting minutes shall be sent to both Parties within [* * *] after a meeting for review, comment and approval by each Party.

		
	7.12
	Alliance Director

Each Party shall appoint one person to be its point of contact with responsibility for facilitating communication and collaboration between the Parties (each, an “Alliance Director”). The Alliance Directors shall be permanent participants of the Committee meetings (but not members of the Committee) and may attend JOT meetings as appropriate. The Alliance Directors shall facilitate resolution of potential and pending issues and potential disputes to enable the Committees to reach consensus and avert potential disputes. The Alliance Director will be the point of contact for communicating regular updates and shall provide such regular updates about Development and Commercialization for Licensed Products except where updates are otherwise handled by the JSC in accordance with this Agreement. Upon Dicerna’s request, the Alliance Director shall discuss and answer Dicerna’s reasonable questions regarding the information received from Roche under Sections 6.4 and 10.3.  In the event of a material change to the Development or Commercialization of a Licensed Product, Roche’s Alliance Director shall timely inform Dicerna of such change in accordance with Sections 6.4, 7.10, and 10.3, and to the extent the JSC does not meet to discuss such material change or there is no JSC, Roche’s Alliance Director shall discuss such change with Dicerna and provide further information as may be reasonably requested by Dicerna regarding such change.

		
	7.13
	Limitations of Authority

No Committee shall have the authority to amend or waive any terms of this Agreement.

		
	7.14
	Expenses

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

		
	7.15
	Lifetime of JRC and JSC

The JRC shall exist until the later of (i) the end of the R&D Collaboration Term unless terminated earlier (or if it does not come into existence), (ii) the expiration of Dicerna’s Cost Share Option without Dicerna exercising its Cost Share Option and (iii) if Dicerna exercises its Cost Share Option, the timely transfer of Cost Share Option activity oversight to the JSC. The JSC shall exist for such time as (x) there is a Shared Product that Dicerna is co-funding or Dicerna is Co-Promoting Co-Promotion Products under its Co-Promotion Right, and otherwise (y) until the earlier of the [* * *] anniversary of the First Commercial Sale of the Lead Product in the Territory or Roche’s termination of Development or Commercialization of the Lead Product. In addition, if Dicerna becomes an Acquired Party, Roche may restrict Dicerna’s participation in the JSC in accordance with and subject to the limitations in Section 20.2.3. Following any automatic cessation or earlier disbandment of a Committee, the Committee shall have no further obligations under this Agreement and shall perform no further functions hereunder unless and until relevant activities commence in the future (in which case the Committee shall be reconstituted).

		
	8.
	Manufacture and Supply

		
	8.1
	Dicerna Phase I Study

Dicerna shall have responsibility at its own expense for the clinical supply of the Lead Product for the Dicerna Phase I Study.

		
	8.2
	R&D Collaboration

During the Target Term with respect to Compounds Directed To a given Selected Target, except where otherwise set forth in the applicable Research Plan, Dicerna shall have responsibility at its own expense for the supply of Additional Dicerna Compounds for use in research activities conducted by Dicerna 

up to Initiation of GLP Tox Study for such Compound. Roche shall pay Dicerna’s fully burdened manufacturing costs for supply of Additional Dicerna Compounds as requested by Roche for use in activities that will occur after Initiation of GLP Tox Study, and otherwise Roche shall have responsibility at its own expense for the supply of all Compounds, in each case for use in the R&D Collaboration. For avoidance of doubt, any supply of Additional Dicerna Compounds by Dicerna to Roche prior to the Initiation of GLP Tox Study for use in or after the Initiation of GLP Tox Study (including manufacturing reservation and cancelation fees incurred under the Research Plan), shall be reimbursed to Dicerna by Roche. During the Target Term Dicerna shall provide Roche with reasonable access during Dicerna’s business hours to employees and Third Party CROs with relevant subject matter expertise to answer questions and assist Roche in potential preparation for Dicerna Selected Target Transfer Activities.

		
	8.3
	Roche Responsibilities

Other than Dicerna’s supply responsibilities under Sections 8.1 and 8.2 and Dicerna’s Transfer Activities (and subject to Section 6.3), (i) Roche shall otherwise be solely responsible at its own expense for the manufacture and supply of all pre-clinical and clinical supplies of Compounds and Products, either by itself or through Third Parties, and (ii) Roche shall be solely responsible at its own expense for the commercial manufacture and commercial supply of Lead Products for sale in the Territory, either by itself or through Third Parties. After the Effective Date, Roche will commence technical development in order to have established required processes and material for Roche’s Development needs.

		
	8.4
	Transfer Activities for Manufacturing

		
	8.4.1
	Lead Transfer Activities

As part of the Lead Transfer Activities for manufacturing, and in order to help establish the start of Roche’s production processes as soon as practicable, Dicerna shall supply Roche with [* * *] of the Lead Compound for solubility, stability testing, other technical development activities and non-clinical drug development activities and offer such other assistance as Roche reasonably requests after the Effective Date. Roche will not use such samples in humans. [* * *].

As soon as practicable after the Effective Date, Dicerna will provide Roche with the chemical raw materials (“Chemical Raw Materials”) identified in the Lead Transfer Plan or as otherwise reasonably requested by Roche, which are reasonably necessary for Roche’s technical development and manufacturing of Roche’s own material that will be used for Roche Development. Dicerna and Roche will timely liaise about the demand-supply setup for these Chemical Raw Materials for ensuring timely supply and availability of sufficient amounts in order to keep up with Roche Development timelines.

As soon as practicable after the Effective Date and if necessary as soon as practicable after Completion of the Dicerna Phase I Study (recognizing Dicerna’s responsibilities in Completion of the Dicerna Phase I Study), Dicerna shall initiate remaining Lead Transfer Activities associated with CMC and manufacturing, which may include providing reasonable assistance to enable Roche (or Roche’s designee(s)) to manufacture Lead Transfer Compounds and Lead Products and obtaining all necessary Regulatory Approvals or modifying existing Regulatory Approvals for the manufacture by Roche, including by reviewing and commenting on documents to be submitted by Roche to a Regulatory Authority, upon reasonable request from Roche. Dicerna shall use reasonable efforts to maintain in full force and effect agreements and relationships with Third Parties in effect as of the Effective Date so that Roche has access to non-clinical and clinical supply, as reasonably requested by Roche, prior to and during any manufacturing transition from Dicerna to Roche.

Unless otherwise specified in this Agreement or the Lead Transfer Plan or as agreed to by the Parties, the following shall apply: shipment of Chemical Raw Materials and any other Materials that Dicerna or Dicerna’s designees are to provide to Roche shall be shipped free of charge DAP Roche Basel or Roche’s designee (Incoterms 2010).
		
	8.4.2
	Selected Target Transfer Activities

Prior to selection of a presumed-to-be Clinical Candidate, the JRC may permit Dicerna to manufacture quantities of the applicable Additional Dicerna Compound, at Roche’s expense at Dicerna’s fully burdened Manufacturing cost, in preparation for or use in cGLP toxicology studies to commence after selection by the JRC of such Clinical Candidate, in which case Dicerna shall invoice Roche after each Calendar Quarter in which Dicerna supplies such Additional Dicerna Compounds with a description the amounts supplied in reasonable detail, and Roche shall pay each such invoice within [* * *] after receipt. Dicerna shall initiate the Selected Target Transfer Activities within [* * *] of the selection of a Clinical Candidate for a given Selected Target (or as otherwise may be set forth in an applicable Selected Target Transfer Plan) to enable Roche (or Roche’s designee(s)) to manufacture the Selected Target Transfer Compounds. Unless specifically requested by Roche or as otherwise stated in the applicable Selected Target Transfer Plan, Dicerna shall use reasonable efforts to maintain in full force and effect agreements and relationships with Third Parties in effect as of the Effective Date so that Roche has access to non-clinical supply prior to and during any manufacturing transition from Dicerna to Roche.

		
	9.
	Regulatory

		
	9.1
	Dicerna Responsibility

Prior to Completion of the Dicerna Phase I Study, [* * *].

During such time:
		
	(a)
	In consultation with Roche, Dicerna shall use Commercially Reasonable Efforts to make a submission for an IND in the US with the FDA by [* * *].

		
	(b)
	Roche shall have the right to reasonably attend regulatory interactions (including face-to-face meetings and phone calls) with Regulatory Authorities for the Lead Product to the extent permitted by Applicable Law. Dicerna shall give notice of any such meeting within [* * *] after Dicerna first receives notice of the scheduling of such meeting. In addition, Roche may participate in any preparatory pre-meetings held prior to a Regulatory Authority meeting.

		
	(c)
	Dicerna will coordinate with Roche on its material communications with and material Regulatory Materials submitted by Dicerna to any Regulatory Authority in connection with the Lead Product and Dicerna Phase I Study, including all CTA submissions, CTA amendments, Regulatory Authority meeting requests and Regulatory Authority advice (including scientific advisory packages). In particular Dicerna shall provide copies of draft Regulatory Authority meetings requests, Regulatory Authority advice (including scientific advisory packages) and any other material submissions and communications (including written summaries of material oral communications proposed or conducted by or on behalf of Dicerna) with any Regulatory Authority pertaining to the Lead Compound or Lead Product sufficiently in advance, where reasonable, for Roche to comment on any such Regulatory Materials or communications with any Regulatory Authority, and Dicerna shall give due consideration in good faith to any comments provided by Roche in relation to such Regulatory Materials or communications with any Regulatory Authority. As used in this 

Section 9.1(c), material communications include all formal communications or communications that impact the Dicerna Phase I Study.

		
	9.2
	Transfer to Roche

The following shall be part of the Lead Transfer Activities, specifically with respect to regulatory affairs. All such Lead Transfer Activities shall commence in accordance with the timeline in the Lead Transfer Plan or as otherwise reasonably practical (in view of the Dicerna Phase I Study) to facilitate Roche’s preparation for continued Development of the Lead Compound.

After Roche’s reasonable request (unless not allowed by Applicable Law) or in accordance with the Lead Transfer Plan, Dicerna shall use reasonable efforts to transfer sponsorship of the existing CTAs to the Roche Affiliate designated by Roche, and the Parties will cooperate to draft and execute the necessary documents required to effect such transfer. Prior to the CTA transfer, Dicerna shall provide to Roche copies of all material correspondence with the Regulatory Authorities. For all completed study reports, Dicerna shall provide reasonably necessary documentation to confirm data reliability, as required by Article 43 of the Japanese Pharmaceutical Affairs Law Enforcement Regulations and related notifications, including original author signatures, raw data lists, cGLP and GCP compliance information. All documentation will be provided in English.

After Roche’s reasonable request or as in accordance with the Lead Transfer Plan, Dicerna shall transfer to Roche all relevant historical clinical safety data. Safety information on serious adverse events shall be provided in CIOMS format and safety information on non-serious adverse events shall be provided in English Line Listing format, inclusive of source documentation (e.g. lab data, discharge forms etc.).

		
	9.3
	Roche Responsibility

Other than Dicerna’s rights and obligations for regulatory activities set forth in this Article 9 (and subject to Section 6.3), Roche shall be solely responsible at its own expense for all regulatory affairs related to Compounds and Products in the Territory including the preparation and filing of applications for Regulatory Approval, as well as any or all governmental approvals required to develop, have developed, make, have made, use, have used, manufacture, have manufactured, import, have imported, sell and have sold Products. Roche shall be responsible for pursuing, compiling and submitting all regulatory filing documentation, and for interacting with regulatory agencies, for all Products in all countries in the Territory. Roche or its Affiliates shall own and file in their discretion all regulatory filings and Regulatory Approvals for all Products in all countries of the Territory.

		
	9.4
	Reporting Adverse Events

Each Party will promptly disclose to the other Party during the Agreement Term information in such Party’s possession and control concerning side effects, injury, toxicity or sensitivity reaction and incidents or severity thereof in humans with respect to any Licensed Product. 

After the transfer of historical clinical safety data from Dicerna (including adverse events, discontinuations, laboratory data, ECGs and vital signs), Roche or its designated Affiliate, at its sole cost, shall report to appropriate authorities in accordance with local requirements all adverse events related to use of the Products in the Territory.
		
	9.4.1
	Pharmacovigilance Agreement

If requested by a Party or as otherwise required by Applicable Law, the Parties shall execute one or more separate Pharmacovigilance Agreement(s) which set forth the responsibilities and obligations 

of the Parties with respect to the procedures and timeframes for compliance with all Applicable Laws pertaining to safety reporting and their related activities of the (i) applicable Product(s) in the Territory, (ii) responsibilities of Dicerna and Dicerna’s Third Party licensees with respect to other GalXC Molecules, and (iii) if Dicerna exercise its Co-Promotion Option, in connection with Dicerna’s Co-Promoting of the Co-Promotion Products in the US.

		
	10.
	Commercialization

		
	10.1
	Generally

Subject to Dicerna’s Co-Promotion Option and subject to Article 4, Roche, at its own expense, shall have sole responsibility and decision making authority for the marketing, promotion, sale and distribution of Products in the Territory.

		
	10.2
	Booking of Sales; Distribution

Roche shall have the sole right to (a) invoice and book sales of Products, establish all terms of sale (including pricing and discounts), warehouse and distribute Products in the Territory and to perform or cause to be performed all related services, (b) handle all order processing, invoicing, collection, distribution, reimbursement services and inventory management with respect to such Products in the Territory, (c) handle all returns, recalls or withdrawals with respect to any Product in the Territory, (d) handle all payer/distributor account management with respect to any Product in the Territory, and (e) manage all aspects of contracting with providers, distributors, managed care vendors or payers with respect to any Product in the Territory.

		
	10.3
	Updates other than Co-Promotion Products in the Co-Promotion Territory

Except as otherwise set forth in Section 7.10, upon request of Dicerna, Roche shall update Dicerna regarding the Commercialization of Products in the Territory (other than Co-Promotion Products in the Co-Promotion Territory) by Roche, its Affiliates and Sublicensees. If Dicerna requests an update, Roche shall provide a high-level summary, in writing and/or through a meeting (face to face/ tele-presence/videoconference or telephone). Dicerna shall not request an update more frequently than once per Calendar Year.

		
	10.4
	Product Trademarks

Roche shall have the sole right and responsibility to determine the Product trademarks to be used with the Products on a worldwide basis and to own such trademarks in accordance with Section 15.2, provided that if applicable Roche shall include in Co-Promotion Product labeling in the US appropriate reference to Dicerna’s company trademark(s). Neither Party shall, nor shall either Party permit its Affiliates or Sublicensees to (a) use in their respective businesses, any trademark that is confusingly similar to, misleading or deceptive with respect to or that dilutes any (or any part) of the Product trademarks, or (b) do any act which endangers, destroys or similarly affects, in any material respect, the value of the goodwill pertaining to the Product trademarks. Each Party agrees to conform (x) to the customary industry standards for the protection of Product trademarks for pharmaceutical products and such guidelines of Roche with respect to manner of use (as provided in writing by Roche) of the Product trademarks and (y) to maintain the quality standards of Roche with respect to the goods sold and services provided in connection with such Product trademarks. Neither Party shall do any act which endangers, destroys or similarly affects, in any material respect, the value of the goodwill pertaining to the Product trademarks.

		
	10.5
	Product Labeling; Markings and Co-Branding

Roche shall own and be responsible for all Product Labeling for all Products in accordance with the terms of this Agreement including, for Co-Promotion Products, Sections 10.4 and 15.2. Roche will comply with all Applicable Law relevant to patent marking and the Parties shall work together to include all relevant Patent Rights for such marking.

		
	10.6
	Dicerna US Co-Promotion Option

		
	10.6.1
	Option

If Dicerna exercises its Cost Share Option, then Dicerna also shall have the option (the “Co-Promotion Option”) to assume between [* * *] of the total sales force for each Shared Product measured in terms of Sales Representatives in the Co-Promotion Territory (the “Co-Promotion Right”). The Parties shall agree to a specific percentage within this range as part of the Co-Promotion Agreement. Notwithstanding the foregoing, Shared Products that are Combination Products containing an Encumbered Combination Agent are not subject to the Co-Promotion Option and Co-Promotion Right set forth herein.
		
	10.6.2
	Notice and Exercise

		
	(a)
	Approximately [* * *] before the anticipated filing of the first MAA for a given Shared Product, Roche will deliver and present to and discuss with the JSC the applicable Commercialization Plan, including Roche’s preliminary estimate of the number of Sales Representatives it anticipates for such Shared Product for such launch in the Co-Promotion Territory (the “Roche Estimate”). In addition to information received through the JSC, Dicerna may submit written questions to Roche about the Commercialization Plan for such Shared Product (“Shared Product Questions”) within [* * *] of the receipt of such Roche Estimate, in which case Roche will respond to such timely-delivered questions no later than [* * *] from receipt of Dicerna’s questions (the date of such delivery of all answers, the “Roche Response Date”). Dicerna may exercise its Co-Promotion Option by giving written notice thereof to Roche no later than the end of the Co-Promotion Exercise Period, all in accordance with Section 10.6.2(b).

		
	(b)
	As conditions precedent to exercising a Co-Promotion Option for a Shared Product and maintaining the Co-Promotion Right for such Co-Promotion Product, Dicerna must:

		
	(i)
	establish, by means of a presentation to Roche as of the time of exercise, that it has (A) an already established internal sales management organization and infrastructure to conduct Dicerna’s Co-Promotion activities for such Co-Promotion Product and (B) a plan to hire, retain or otherwise build a sales force consisting of direct employees of Dicerna that will be in place no later than [* * *] after the First Commercial Sale of such Co-Promotion Product with the number of Sales Representatives that Dicerna is required to use, each of whom has prior experience promoting pharmaceutical products to prescribing physicians in the Co-Promotion Territory and meets the qualifications set forth in Appendix 10.6.3; and

		
	(ii)
	as of the time of exercise, and for so long as Dicerna is Co-Promoting such Co-Promotion Product hereunder and under the Co-Promotion Agreement, not be developing or commercializing by itself or in collaboration with a Third Party, either (A) another product that treats HBV or that (B) is an Encumbered Combination Agent.

		
	(c)
	If Dicerna does not provide the election notice described in Section 10.6.2(a) prior to expiration of the applicable Co-Promotion Exercise Period or if Dicerna does not meet the requirements set forth in Section 10.6.2(b), Dicerna shall be deemed to have irrevocably waived its right to Co-Promote such Shared Product. Any election notice provided by Dicerna at a time when Dicerna 

does not meet the requirements set forth in Section 10.6.2(b) shall be void and have no effect. Following Dicerna’s exercise of its Co-Promotion with respect to a particular Co-Promotion Product, if that Co-Promotion Product subsequently attains Regulatory Approval in an Encumbered Combination Indication, Dicerna shall not engage in the Detailing or other Co-Promotion Activities for the Co-Promotion Product in the Encumbered Combination Indication, except as provided for in the Co-Promotion Agreement. If Dicerna does not exercise its Co-Promotion Option (or if it has been deemed to have waived its Co-Promote Right pursuant to this Section 10.6.2(c)) for a given Shared Product for the First Eligible Co-Promotion Indication, Dicerna shall not have the right to exercise its Co-Promotion Option with respect to any subsequent Regulatory Approvals or label expansion granted for such Shared Product. As used in this Section 10.6.2(c), the “First Eligible Co-Promotion Indication” for a Co-Promotion Product is the first indication for which Regulatory Approval in the Co-Promotion Territory is obtained that is not an Encumbered Combination Indication.
		
	10.6.3
	Co-Promotion Agreement

Promptly after Dicerna’s first exercise of a Co-Promotion Option for a Co-Promotion Product, and subject to Dicerna’s compliance with the requirements of Section 10.6.2(b)(b), the Parties shall negotiate in good faith and enter into a written agreement for Co-Promotion (the “Co-Promotion Agreement”) setting forth the terms of Dicerna’s and Roche’s Co-Promotion rights and obligations (including the specific percentage of the total sales force in the range permitted under Section 10.6.1) with regard to such Co-Promotion Product in accordance with the terms and conditions in this Agreement (including this Article 10, including Sections 10.6.2(b)(b), 10.6.4 and 10.6.5, and those set forth in Appendix 10.6.3). The Parties shall negotiate with such diligence as is required to enter into and execute the Co-Promotion Agreement within [* * *] following such exercise, or such other date as the Parties may agree in writing. The Parties shall promptly amend the Co-Promotion Agreement upon each subsequent exercise by Dicerna of a Co-Promotion Option with regard to a new Shared Product in accordance with the terms and conditions in this Article 10 and Appendix 10.6.3.  In addition to any other terms agreed to by the Parties, the Co-Promotion Agreement shall contain the terms set forth in Appendix 10.6.3 of this Agreement. Unless otherwise agreed to by the Parties, Dicerna may not commence Co-Promotion on Co-Promotion Products until such time as the Parties enter into the Co-Promotion Agreement.
		
	10.6.4
	General Requirements for Co-Promotion Activities

Dicerna’s Co-Promotion Rights shall only exist during such time as Dicerna has the Cost Share Right.

Dicerna may not use contract sales forces to fulfill its Co-Promote obligations for more than [* * *]  after the First Commercial Sale of the first Co-Promotional Product. Any Dicerna Sales Representatives involved in a sales call for one or more Co-Promotion Product(s) shall devote at least [* * *]  of its sales call time until the [* * *] anniversary of First Commercial Sale in the US and thereafter at least [* * *] of such call time to the Co-Promotion Product(s). Under the Co-Promotion Agreement, Roche shall have the sole right to control all decisions with respect to the co-promotion arrangement, including the call plans and assigned territories of Dicerna Sales Representatives, the promotional materials to be used, the training and testing applicable to such Sales Representatives, and restrictions with respect to the ability of such Sales Representatives to Detail other products. “Co-Promote”, “Co-Promoting” or “Co-Promotion” means the US Detailing activities assigned to Dicerna in the Co-Promotion Agreement, and shall not include any Medical Affairs Activities, sale or distribution of such Co-Promotion Product in the Co-Promotion Territory by Dicerna or its Affiliates. Dicerna shall have the right to terminate its Co-Promotion Rights for a Co-Promotion Product with [* * *] prior written notice 

to Roche, in which case, the Parties shall reasonably cooperate to transition to Roche, upon the effective date of such termination, all of Dicerna’s Co-Promotion activities to such Co-Promotion Product so as to minimize disruption to sales activity, the details of which shall be further set forth in the Co-Promotion Agreement. 
		
	10.6.5
	Change of Control

Section 20.2.3 shall apply in the event of a Dicerna Change of Control.

		
	10.7
	Medical Affairs

Roche shall have the sole right and responsibility to conduct and make decisions regarding Medical Affairs Activities with respect to any Product. For clarity, Roche shall retain such sole right and responsibility in the event that Dicerna exercises its Co-Promotion Option. For further clarity, Dicerna’s Sales Representatives shall be supported by Roche’s Medical Affairs personnel.

		
	11.
	Payments to Dicerna

		
	11.1
	Upfront License Fee for Lead Compound and Selected Targets

Within [* * *] after the Effective Date and receipt of an invoice from Dicerna, Roche shall pay to Dicerna a non-refundable, non-creditable upfront payment of Two Hundred Million US Dollars (US$ 200,000,000).  For the avoidance of doubt, upon the Effective Date, such payment is due and payable and is required to be paid as provided in this Section 11.1, notwithstanding any termination under this Agreement or failure to select any targets and/or to commence the R&D Collaboration.

		
	11.2
	Development and Regulatory Event Payments

		
	11.2.1
	Lead Products

Roche shall pay up to a total of [* * *] in relation to the achievements of events with respect to Lead Products. The development and regulatory event payments under this Section 11.2.1 shall be paid by Roche according to the following schedule of development and regulatory events.

	
		
	Development and Regulatory Event
	Dollars (in millions)

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

*The Initiation of Pivotal Study event payment will be reduced by [* * *], i.e. from [* * *], if Dicerna exercises its Cost Share Option.

Each development event payment shall be paid only once, the first time the first Lead Product reaches the applicable triggering event, regardless the number of times such events are reached and by how many Lead Products.  [* * *].  

For the avoidance of doubt, development event payments due on a Lead Product under this Section 11.2.1 shall continue to be due at the rate applicable to Lead Products (not Hybrid Products) until the applicable Lead Product has achieved its First Commercial Sale in such jurisdiction as a product not containing a Selected Target Compound. 

		
	11.2.2
	Selected Target Products and Hybrid Products

For each Selected Target Product and Hybrid Product, Roche shall pay up to a total of [* * *] in relation to the achievements of events with respect to Selected Target Products and Hybrid Products. The development and regulatory event payments under this Section 11.2.2 shall be paid by Roche according to the following schedule of development and regulatory events.

	
		
	Development and Regulatory Event
	Dollars (in millions)

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

* Payable upon the earlier of [* * *]. 

** [* * *]  

Each development and regulatory event payment shall be paid only once for each Selected Target Product or Hybrid Product, the first time each Selected Target Product or Hybrid Product reaches the applicable triggering event, regardless of the number of times such events are reached by such Selected Target Product. For purposes of this Section 11.2.2, with respect to events 1 through 4, [* * *] Selected Target Products are considered the same Selected Target Product if they contain different Selected Target Compounds that target the same Selected Target. If any of events 5 through 7 above are achieved by a Selected Target Product, any of events 1 through 4 not previously achieved by such Selected Target Product shall be deemed to have been achieved at the time of achievement of events 5 through 7, as applicable, and the corresponding milestone payment shall be owed.
		
	11.2.3
	Development and Regulatory Event Payment Invoicing and Timing

Upon occurrence of each development and regulatory event in this Section 11.2, Roche shall notify Dicerna within [* * *] of the event and pay the corresponding development and regulatory event payment to Dicerna within [* * *] of the event and receipt of an invoice from Dicerna. Each such payment shall be non-refundable and non-creditable.

		
	11.3
	Sales Based Events

Roche shall pay to Dicerna up to a total of [* * *] based on the Calendar Year Net Sales of the Lead Product and Hybrid Product in the Territory:

	
				
	Sales Based Events for Net Sales
	Dollars (in millions)

	No.
	Lead Product
	Hybrid Product

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

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

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

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

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

	[* * *]
	[* * *]

Each of the sales based event payments 1-5 shall be paid no more than once each, irrespective of whether or not the previous sales based event payment was triggered by a Lead Product or a Hybrid Product, and whether or not the previous sales based event payment was triggered by the same or by a different applicable Product, and shall be non-refundable and non-creditable. Roche will notify Dicerna of the achievement of sales based events within [* * *] after the end of the Calendar Quarter in which the event first occurs for the Lead Product or Hybrid Product in the Territory first reaching the respective Net Sales Threshold, and will pay Dicerna the corresponding milestone within [* * *] of receipt of an invoice. For the avoidance of doubt, if more than one sales based event occurs in any Calendar Year, all such sales based event payments shall be payable for such Calendar Year.

		
	11.4
	Royalty Payments

		
	11.4.1
	Royalty Term

On a Product-by-Product basis, Roche shall pay to Dicerna royalties on Net Sales of such Product during the applicable Royalty Term. Thereafter upon expiration of the applicable Royalty Term, the licenses granted to Roche for a given Product shall be fully paid up, irrevocable and royalty-free.
		
	11.4.2
	Royalty Rates

		
	11.4.2.1
	Lead Product

The following royalty rates shall apply to the respective tiers of aggregate Calendar Year Net Sales of a Lead Product per area of the Territory, on an incremental basis, as follows:

		
	(a)
	For the [* * *]

Royalty rates depend if the Lead Product is a Shared Product or is not a Shared Product.

	
			
	Tier of Calendar Year
Net Sales in million US$
	Percent (%) of Net Sales

	Shared Product
	Not a Shared Product

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

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

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

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

		
	(b)
	For aggregate countries of the Territory other than US:

	
		
	Tier of Calendar Year
Net Sales in million US$
	Percent (%) of Net Sales

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

For example, if Net Sales of a Lead Product [* * *]that is not a Shared Product, for a given Calendar Year, are [* * *], then royalties owed to Dicerna on such Net Sales of such Product for that Calendar Year shall equal * * *]calculated as follows:

[* * *]

For the avoidance of doubt, royalty payments on a Lead Product in a given country will not be affected because a Hybrid Product is also being sold in the same or another country.

		
	11.4.2.2
	Selected Target Product

The following royalty rates shall apply to the respective tiers of aggregate Calendar Year Net Sales of a Selected Target Product per area of the Territory, on an incremental basis, as follows:

		
	(a)
	For [* * *]

	
		
	Tier of Calendar Year
Net Sales in million US$
	Percent (%) of Net Sales

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

		
	(b)
	For aggregate countries of the Territory other than [* * *]

	
		
	Tier of Calendar Year
Net Sales in million US$
	Percent (%) of Net Sales

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

For example, if Net Sales of a Selected Target Product [* * *], for a given Calendar Year, are [* * *], then royalties owed to Dicerna on such Net Sales of such Product for that Calendar Year shall equal [* * *] calculated as follows:

[* * *] royalty payment

		
	11.4.3
	Hybrid Product

The following royalty rates shall apply to the respective tiers of aggregate Calendar Year Net Sales of a Hybrid Product per area of the Territory, on an incremental basis, as follows:
		
	(a)
	For [* * *]:

Royalty rates depend if the Hybrid Product is a Shared Product or is not a Shared Product.

	
			
	Tier of Calendar Year
Net Sales in million US$
	Percent (%) of Net Sales

	Shared Product
	Not a Shared Product

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

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

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

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

		
	(b)
	For aggregate countries of the Territory other than [* * *]:

	
		
	Tier of Calendar Year
Net Sales in million US$
	Percent (%) of Net Sales

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

The above royalty rates in Section 11.4.3 shall apply to a Hybrid Product until the later of [* * *].
		
	11.4.3.2
	Royalty Adjustments

For the purpose of calculating royalties of a given Product under this Section 11.4.2, Calendar Year Net Sales and the royalty rates shall be subject, as applicable, to the following adjustments in this Section 11.4.
		
	11.4.4
	Combination Product

If Roche or its Affiliates intend to sell a Combination Product, then the Parties shall meet approximately [* * *] prior to the anticipated First Commercial Sale of such Combination Product in the Territory to negotiate in good faith and agree to an appropriate adjustment to Net Sales to reflect the relative commercial value contributed by the components of the Combination Product (the “Relative Commercial Value”). If, after such good faith negotiations not to exceed [* * *], the Parties cannot agree to an appropriate adjustment, the dispute shall be initially referred to the executive officers of the Parties in accordance with Section 22.2.

If the Parties are unable to agree on the Relative Commercial Value within [* * *] of such referral, then the Relative Commercial Value shall be determined by the following procedure. Roche will select one (1) individual who would qualify as an Expert, Dicerna will select (1) individual who would qualify as an Expert, and those two (2) individuals shall select one (1) individual who would qualify as an Expert and who shall be chairman of a committee of the three Experts (the “Expert Committee”), each with a single deciding vote. The Expert Committee will promptly hold a meeting to review the issue under review, at which it will consider memoranda submitted by each Party at least [* * *] before the meeting, as well as reasonable presentations that each Party may present at the meeting. As part of the Expert Committee’s consideration, the Parties agree that the Relative Commercial Value of the Lead Product within a Combination Product shall not be less than (a) [* * *] if the first Filing for Regulatory Approval is (or is planned to be, as applicable) for use with one additional Non-Compound Active Agent Controlled by Roche where such compound has a Valid Claim of the composition of matter with at least [* * *]remaining patent life in one or more countries in the Territory or (b) [* * *] if the condition in part (a) is not met. The determination of the Expert Committee as to the issue under review will be binding on both Parties. The Parties will share equally in the costs of the Expert Committee. Unless otherwise agreed to by the Parties, the Expert Committee may not decide on issues outside the scope mandated under terms of this Agreement.

A Hybrid Product shall not be treated as a Combination Product under this Section 11.4.4 with respect to the Lead Compound and Selected Target Compound, however the Relative Commercial Value will be determined if there are other Combination Product components other than the Lead Compound and Selected Target Compound.
		
	11.4.5
	No Composition of Matter Claim or Regulatory Exclusivity; Generic Competition

For a given Product, and subject to Section 11.4.7, if in a given country within the Territory there is:
		
	(a)
	no Composition of Matter Claim of a Party that Covers such Product and no applicable Regulatory Exclusivity for such Product remains in such country; or

		
	(b)
	entry of a Like-Substance Product has occurred, provided that after such entry there has been a decline of quarterly Net Sales of such Product in such country greater than [* * *] of the average level of the quarterly Net Sales of such Product achieved in the [* * *] immediately prior to such entry;

then the royalty payments due to Dicerna for such Product in such country shall be reduced for the remainder of the Royalty Term by (i) [* * *] for the Major Markets other than [* * *], or (ii) [* * *].

		
	11.4.6
	Third Party Payments

Other than for the Existing Third Party In-License Agreement listed in Appendix 16.1.5 (for which Dicerna shall be responsible), Roche shall be responsible for and pay or have paid any consideration owed to any Third Party in relation to Third Party intellectual property rights necessary or useful to make, use or sell Products. With respect to such Third Party Patent Rights that are reasonably necessary for the sale of a given Product in a given country, Roche shall have the right to deduct (x) a maximum of [* * *] of royalties actually paid by Roche to such Third Party with respect to such arrangement from (y) royalty payments otherwise due and payable by Roche to Dicerna for such Product in such country under this Agreement. Any such deduction shall be made only on a Product-by-Product and country-by-country basis. Prior to entering into such arrangement, Roche will notify and discuss with Dicerna unless Roche will not deduct payments under such arrangement. 
		
	11.4.7
	Maximum Deductions

In no event shall the royalty paid to Dicerna for Net Sales of Products hereunder, as reduced by Sections 11.4.5 and 11.4.6, be reduced from the applicable royalty rates set forth in Section 11.4.2 above by more than an amount equal to (i) [* * *] of the royalties otherwise due for Net Sales of such Products for the Major Markets other than [* * *], or (ii)  [* * *].
		
	11.4.8
	Apportionment of Compulsory Sublicensee Consideration

Compulsory Sublicense Compensation received by the Roche Group from a Compulsory Sublicensee during the Royalty Term shall be shared with Dicerna on an equivalent profit share percentage (the “Compulsory Profit Share Percentage”) calculated for the respective Calendar Year for the relevant country as follows:

	
		
	[* * *]
	[* * *]

	[* * *]

At the end of the Calendar Year, Roche shall pay to Dicerna the Compulsory Sublicense Compensation under a given country multiplied by the Compulsory Profit Share Percentage for such country. For clarity, any sales or payments by Compulsory Sublicensees under a Compulsory Sublicense shall not be considered as Net Sales and shall not give rise to any royalty payment under Section 11.4.2 of this Agreement.

		
	11.5
	Disclosure of Payments

Each Party acknowledges that that the other Party may be obligated to disclose this financial arrangement, including all fees, payments and transfers of value made pursuant to this Agreement, as may be advisable or required under Applicable Law, including certain payments by a Party to health care providers the US Sunshine Act.

		
	12.
	Accounting and reporting

		
	12.1
	Timing of Payments

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

		
	12.2
	Late Payment

Any payment under this Agreement by either Roche or Dicerna that is not paid on or before the date such payment is due shall bear interest, to the extent permitted by Applicable Law, at [* * *] as reported by Reuters from time to time, calculated on the number of days such payment is overdue.

		
	12.3
	Method of Payment

Royalties on Net Sales and all other amounts payable by Roche hereunder shall be paid by Roche in US Dollars (the “Payment Currency”) to account(s) designated by Dicerna.

		
	12.4
	Currency Conversion

When calculating the Sales of any Product that occur in currencies other than the Payment Currency, Roche shall convert the amount of such sales into Swiss Francs and then into the Payment Currency using Roche’s then-current internal foreign currency translation method actually used on a consistent basis in preparing its audited financial statements (at the Effective Date, YTD average rate as reported by Reuters).

		
	12.5
	Blocked Currency

In a given country, if by reason of Applicable Law (for example governmental restrictions on foreign exchange trade) the local currency is blocked and cannot be removed from such country, Roche will notify Dicerna in writing and
		
	(a)
	Dicerna will have the right to receive the applicable royalties of Net Sales in such country in local currency by deposit in a local bank designated by Dicerna, or

		
	(b)
	if such local currency payment is not allowed by reason of Applicable Law or if otherwise requested by Dicerna, then the royalties related to such Net Sales in such country shall continue to be accrued and shall continue to be reported, but such royalties will not be paid until the sales proceeds related to such Net Sales may be removed from such country. At such time as Roche, its Affiliates or their Sublicensees, as the case may be, is able to remove the sales proceeds related to such Net Sales from such country, Roche shall also pay such accrued royalties in Payment Currency using the actual exchange rate which is used to remove such sales proceeds from such country.

		
	12.6
	Reporting

With each royalty payment, Roche shall provide Dicerna in writing for the relevant Calendar Quarter on a Product-by-Product basis the following information:

		
	(a)
	Sales in Swiss Francs;

		
	(b)
	Net Sales in Swiss Francs and itemized adjustments to arrive at Net Sales;

		
	(c)
	adjustments made pursuant to Section 11.4.4 (Combination Product);

		
	(d)
	Net Sales in Swiss Francs after adjustments made pursuant to Section 11.4.4 in Swiss Francs;

		
	(e)
	exchange rate used for the conversion of Net Sales from Swiss Francs to the Payment Currency pursuant to Section 12.4 (Currency Conversion);

		
	(f)
	Net Sales after adjustments made pursuant to Section 11.4.4 in the Payment Currency;

		
	(g)
	royalty rate pursuant to Section 11.4.2;

		
	(h)
	adjustments made pursuant to Sections 11.4.5 - 11.4.7; and

		
	(i)
	total royalty payable in the Payment Currency after adjustments made pursuant to Sections 11.4.5 - 11.4.7.

Roche shall provide an estimate of the Net Sales in the Payment Currency to Dicerna in writing for the relevant Calendar Quarter on a Product-by-Product basis within [* * *] after the end of each Calendar Quarter.

		
	13.
	Taxes

		
	13.1
	Income Taxes

Except as provided in this Section 13.1, each  Party shall pay all income and other taxes (including interest) imposed on or measured with respect to its own income accruing or paid to it under this Agreement. Notwithstanding anything in this Agreement to the contrary, if Roche’s assignment of this Agreement leads to the imposition of income tax liability on Dicerna that would not have been imposed in the absence of such action or in an increase in such liability above the liability that would have been imposed in the absence of such action, Roche will indemnify and hold harmless Dicerna from any such additional or increased income tax liability (except to the extent that Dicerna or any of its Affiliates can obtain a refund or credit for such amounts, provided that Dicerna will be reimbursed for any reasonable out of pocket costs incurred in obtaining such a refund or credit).

		
	13.2
	Withholding Taxes

If provision is made in law or regulation of any country for withholding of taxes of any type, levies or other charges with respect to any royalty or other amounts payable under this Agreement to a Party (the “Payee”), then the other Party (the “Payor”) shall timely pay such tax, levy or charge for and on behalf of the Payee to the proper governmental authority, and shall promptly furnish Payee with appropriate proof of payment of the withheld taxes as well as the official receipts sufficient to enable the Payee to claim credits for such payments of taxes; provided, however, that notwithstanding anything in this Agreement to the contrary, if Roche’s assignment of this Agreement leads to the imposition of  withholding tax liability on Dicerna that would not have been imposed in the absence of such action or in an increase in such liability above the liability that would have been imposed in the absence of such action, Roche will indemnify and hold harmless Dicerna from any such additional or increased withholding tax liability (except to the extent that Dicerna or any of its Affiliates can reclaim it, provided that Dicerna will be reimbursed for any reasonable out of pocket costs incurred in the reclaim).  The Parties shall cooperate and exercise their reasonable best efforts to ensure that any such withholding taxes are mitigated or reduced to the extent possible under the provisions of any Applicable Law, and shall provide the Payee reasonable assistance (including the provision of any tax forms and other information) in order to allow the Payee to obtain the benefit of any present or future treaty against double taxation or exemption from, refund or reduction in taxes which may apply to such payments.  To the extent that a Party is required to deduct and withhold taxes on any such payment pursuant to this Section 13.2, such Party will provide the Payee with written notice of the required withholding as promptly as reasonably practical (and in any event, no later than [* * *] prior to making such payment.  To the extent such amounts are so deducted and withheld and timely remitted to the relevant tax authorities, such amounts shall be treated for all purposes under this Agreement as having been paid to the Party to whom such amounts would otherwise have been paid.

		
	13.3
	Foreign-Derived Deduction Eligible Income Reporting

Roche shall obtain and deliver to Dicerna, on an annual basis and within [* * *] of Dicerna’s request to provide, information as reasonably requested by Dicerna and in Roche’s possession to meet any documentation requirements imposed by regulations issued under Section 250 of the Internal Revenue Code for the treatment of an appropriate portion of such amounts as “foreign-derived deduction eligible income” within the meaning of Section 250 of the Internal Revenue Code and the regulations thereunder.

		
	13.4
	No Partnership for Tax Purposes

As of the Signature Date, the Parties expect that this Agreement will not be treated as a partnership or joint venture for United States federal and state tax purposes.

		
	13.5
	Value Added Tax

It is understood and agreed between the Parties that any payments made by any Party under this Agreement are exclusive of any value added tax (“VAT”) or similar tax imposed upon such payments.  Where VAT is properly chargeable in respect of any supply of goods or services made under this Agreement, the Party paying the consideration for that supply will pay the amount of VAT subject to receipt of a valid tax invoice issued in accordance with Applicable Law.

		
	14.
	Auditing

		
	14.1
	Dicerna Right to Audit

Roche shall keep, and shall require its Affiliates and Sublicensees to keep, full, true and accurate books of account containing all particulars that may be necessary for the purpose of calculating all royalties payable under this Agreement. Such books of accounts shall be kept at their principal place of business. At the expense of Dicerna, Dicerna shall have the right to engage an internationally recognized independent public accountant reasonably acceptable to Roche to perform, on behalf of Dicerna, an audit of such books and records of Roche and its Affiliates and Sublicensees that are deemed necessary by the independent public accountant to report on Net Sales of Product for the period or periods requested by Dicerna and the correctness of any financial report or payments made under this Agreement.

Upon timely request and at least [* * *] prior written notice from Dicerna, such audit shall be conducted for those countries Dicerna has specifically requested, during regular business hours in such a manner as to not unnecessarily interfere with Roche's normal business activities. Such audit shall be limited to results in the [* * *] prior to audit notification, and if Dicerna requests an audit for a given Calendar Year, no additional audits may be conducted for such Calendar Year, unless such audit is for cause based on a material finding identified in the initial annual audit. If Dicerna does not request an audit of a given Calendar Year on or before the [* * *] of the end of such Calendar Year, then Dicerna will be deemed to have accepted the royalty payments and reports in such Calendar Year.

Such audit shall not be performed more frequently than [* * *] nor more frequently than [* * *] with respect to records covering any specific period of time unless there are adverse findings that the independent public accountant determines requires further examination or review of records.

All information, data documents and abstracts herein referred to shall be used only for the purpose of verifying royalty statements, shall be treated as Roche’s Confidential Information subject to the obligations of this Agreement and need neither be retained more than [* * *] after completion of an audit hereof, if an audit has been requested; nor more than [* * *] from the end of the Calendar Year to which each shall pertain; nor more than [* * *] after the date of termination of this Agreement.

		
	14.2
	Audit Reports

The auditors shall only state factual findings in the audit reports and shall not interpret this Agreement. The auditors shall first discuss their draft audit findings with Roche before sharing such findings with Dicerna and before preparing its draft or final audit report. The final audit report shall be shared with Roche at the same time it is shared with Dicerna.

		
	14.3
	Over-or Underpayment

If the audit reveals an overpayment of royalties, Dicerna shall reimburse Roche for the amount of the overpayment within [* * *]. If the audit reveals an underpayment of royalties, Roche shall make up such underpayment of royalties within [* * *]. Roche shall pay for the audit costs if the underpayment 

of Roche exceeds [* * *] of the aggregate amount of royalty payments owed with regard to the royalty statements subject of the audit. Section 12.2 shall apply to this Section 14.3.

		
	15.
	Intellectual Property

		
	15.1
	Ownership of Inventions

All GalXC Platform Improvements shall be owned by Dicerna. Roche shall promptly notify Dicerna of any GalXC Platform Improvements invented by Roche solely or jointly with Dicerna. Roche hereby assigns and agrees to assign to Dicerna all right, title and interest in such GalXC Platform Improvements and to execute and deliver all documents, instruments and other papers and take all actions necessary to perfect such assignment and for Dicerna to Handle Patent Rights in such GalXC Platform Improvements.

All Roche Background Improvements shall be owned by Roche. Dicerna shall promptly notify Roche of Roche Background Improvements invented by Dicerna solely or jointly with Roche. Dicerna hereby assigns and agrees to assign to Roche all right, title and interest in such Roche Background Improvements and to execute and deliver all documents, instruments and other papers and take all actions necessary to perfect such assignment and for Roche to Handle Patent Rights in such Roche Background Improvements.

Other than GalXC Platform Improvements and Roche Background Improvements, Dicerna shall own all Dicerna Inventions, Roche shall own all Roche Inventions, and Dicerna and Roche shall jointly own all Joint Inventions. Dicerna and Roche each shall require all of its employees to assign all Inventions made by them to Roche and Dicerna, as the case may be.
The determination of inventorship for Inventions shall be in accordance with US inventorship laws as if such Inventions were made in the US.

Subject to the licenses granted under this Agreement, Dicerna and Roche will each have an equal undivided share in the Joint Patent Rights, without obligation to account to the other for exploitation thereof, or to seek consent of the other Party for the grant of any license thereunder.

Except as specifically set forth herein, this Agreement shall not be construed as: (i) giving any of the Parties any license, right, title, interest in or ownership to (a) the Confidential Information of the other Party or (b) any materials, Know-How, Patent Rights or other intellectual property rights Controlled by the other Party or its Affiliates; (ii) granting any license or right under any intellectual property rights; or (iii) representing any commitment by either Party to enter into any additional agreement, by implication or otherwise.

With respect to Know-How (other than patentable Inventions) made in connection with any activity carried out pursuant to this Agreement, Dicerna shall own such Know-How made by employees of Dicerna solely or jointly with a Third Party, Roche shall own such Know-How made by employees of the Roche Group solely or jointly with a Third Party, and the Parties shall jointly own Joint Know-How, subject to Section 2.6.1.

		
	15.2
	Trademarks

Roche shall own all trademarks used on or in connection with Products and shall, at its sole cost, be responsible for procurement, maintenance, enforcement and defense of all trademarks used on or in connection with Products, provided that if applicable Roche shall include in US Co-Promotion Product 

labeling appropriate reference to Dicerna’s company trademark(s). Roche shall not use any trademarks owned by Dicerna without Dicerna’s prior written consent.

Roche shall have the right to obtain the International Non-proprietary Name (INN) from the World Health Organization and the US Adopted Name (USAN) from the US adopted Names Council (USANC) as the generic name(s) for the Products.

Dicerna shall use the Co-Promotion Product trademarks in accordance with Section 10.4, the Co-Promotion Agreement and sound trademark and trade name usage principles and in accordance with all Applicable Law as reasonably necessary to maintain the validity and enforceability of the Co-Promotion Product Trademarks. Dicerna recognizes that the Co-Promotion Product trademarks owned by Roche or Roche’s Affiliates represent a valuable asset of Roche, and that substantial recognition and goodwill are associated with such name, logo and trademarks.

		
	15.3
	Prosecution

		
	15.3.1
	GalXC Platform Patent Rights

Dicerna shall be responsible for Handling, at its own expense and discretion, Dicerna GalXC Platform Patent Rights.
		
	15.3.2
	Specific Patent Rights

Roche shall, at its own expense and discretion: (i) Handle all Specific Patent Rights, (ii) consult with Dicerna as to the Handling of such Specific Patent Rights, and (iii) furnish to Dicerna copies of all documents relevant to any such Handling. Roche shall furnish such documents and consult with Dicerna in sufficient time before any action by Roche is due to allow Dicerna to provide comments thereon, which comments Roche must reasonably consider. At Roche’s expense and reasonable request, Dicerna shall cooperate, in all reasonable ways, with the Handling of all such Specific Patent Rights. Should Roche decide that it wishes to abandon or does not desire to Handle a given Specific Patent Right, it shall promptly advise Dicerna thereof. At the written request of Dicerna, Dicerna may thereafter Handle the same at Dicerna’s own cost, to the extent that Dicerna desires to do so.  An outside law firm shall be used to Handle such Specific Patent Right; Roche and Dicerna shall consult and agree upon the law firm(s).  Roche shall ensure that the Handling of such Specific Patent Rights are as protective of and uses a similar level of diligence that Roche would devote to similar Patent Rights Covering other similarly-situated products of Roche.
		
	15.3.3
	Other Patent Rights

For any Patent Rights other than the foregoing Patent Rights in Sections 15.3.1 and 15.3.2: (i) each party shall, at its own expense and discretion, Handle Patent Rights claiming Inventions that are owned solely by such Party or its Affiliates (alone or with a Third Party) at its own expense and discretion, and (ii) the Parties will jointly cooperate in the Handling of Joint Patent Rights.

		
	15.4
	Patent Coordination Team

Where the Parties need to consult with each other on the Handling of Patent Rights, the Parties shall establish a patent coordination team and shall adopt procedures for interacting on patent matters.

		
	15.5
	CREATE Act

It is the intention of the Parties that this Agreement is a “joint research agreement” as that phrase is defined in 35 USC §103(c)(3).

		
	15.6
	Infringement

Each Party shall promptly provide written notice to the other Party during the Agreement Term of any (i) known infringement or suspected infringement by a Third Party of any Licensed IP Patent Rights or Joint Patent Rights, or (ii) known or suspected unauthorized use or misappropriation by a Third Party of any Licensed IP Know-How or Joint Know-How, and shall provide the other Party with all evidence in its possession supporting such infringement or unauthorized use or misappropriation.
		
	15.6.1
	[* * *]

[* * *]
		
	15.6.2
	[* * *]

[* * *]

		
	15.6.3
	[* * *]

[* * *]

		
	15.7
	Defense

[* * *]  

		
	15.8
	Hatch-Waxman

Notwithstanding anything herein to the contrary, should a Party receive a certification for a Generic Product pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417, known as the Hatch-Waxman Act), as amended, or its equivalent in a country other than the US, then such Party shall immediately provide the other Party with a copy of such certification. Upon receipt of such a certification Roche shall (i) promptly seek to obtain a copy of the regulatory filing for such Generic Product (as contemplated in the Hatch-Waxman Act), (ii) promptly determine whether Roche will, within a [* * *] period from the date of such certification, bring suit at its expense, and provide written notice to Dicerna of such decision (“H-W Suit Notice”), and (iii) in any event provide Dicerna a H-W Suit Notice within [* * *] from the date on which Roche first received a copy of such certification. Should such [* * *] period expire without Roche bringing suit or providing such H-W Suit Notice, then Dicerna shall be free to immediately bring suit in its name.

		
	15.9
	Patent Term Extensions

The Parties shall use Commercially Reasonable Efforts to obtain all available patent term extensions, adjustments or restorations, or supplementary protection certificates (“SPCs”, and together with patent term extensions, adjustments and restorations, “Patent Term Extensions”) in the Territory. Dicerna shall execute such authorizations and other documents and take such other actions as may be reasonably requested by Roche to obtain such Patent Term Extensions for relevant Specific Patent Rights, including designating Roche as its agent for such purpose as provided in 35 USC § 156. All filings for such Patent Term Extensions shall be made by Roche; provided, that in the event that Roche elects not to file for a Patent Term Extension, Roche shall (a) promptly inform Dicerna of its intention not to file and (b) grant Dicerna the right to file for such Patent Term Extension. Each Party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain such extensions. The Parties shall cooperate with each other in gaining patent term restorations, extensions and/or SPCs wherever applicable to such Dicerna 

Patent Rights; provided, however, that notwithstanding anything to the contrary herein, Dicerna shall have the sole right to decide on Patent Term Extensions of the GalXC Platform Patent Rights.

		
	15.10
	Costs of Patent Challenge

[* * *]

		
	16.
	Representations, Warranties and Covenants

Each Party makes the following representations and warranties to the other Party as of the Signature Date or the Effective Date, as applicable, and covenants after the Effective Date.

		
	16.1
	Dicerna Representations, Warranties and Covenants 

		
	16.1.1
	Data and Safety Information Disclosure

To the knowledge of Dicerna, it has disclosed to Roche: (i) the relevant and material results of all preclinical testing and human clinical testing of Products in its possession or control; and, (ii) the relevant and material information in its possession or control concerning side effects, injury, toxicity or sensitivity reaction and incidents or severity thereof with respect to Product. Dicerna and its Affiliates are, and at all times have been to its knowledge, in compliance with all adverse event reporting requirements applicable to the Lead Product. To Dicerna’s knowledge, Dicerna has disclosed to Roche as of the Signature Date an accurate in all material aspects list of (i) adverse drug experience information (adverse events and lab abnormalities/cohort in the Dicerna Phase I Study, the severity of each, grading and outcomes), (ii) material events and matters concerning or affecting safety or lack of efficacy, and (iii) medical inquiries and complaints, in each case, relating to the Lead Product. Neither Dicerna nor any of its Affiliates is aware of anything that could materially adversely affect the acceptance, or the subsequent approval, of any Product by any Regulatory Authority of any filing, application or request for Regulatory Authority.
		
	16.1.2
	Regulatory Documentation and No Misrepresentations to Regulatory Authorities

Dicerna and its Affiliates have, to their knowledge, with respect to Lead Product, generated, prepared, maintained and retained all material regulatory documentation that is required to be maintained or retained pursuant to and in accordance with cGLPs and cGCPs and in compliance with Applicable Law, and to the best of their knowledge and ability all such information is true, complete, accurate in all material respects and what it purports to be. Neither Dicerna nor any of its Affiliates, nor any of its or their respective officers, employees or agents, to the best of their knowledge, has made an untrue statement of material fact or fraudulent statement to any Regulatory Authority with respect to the development or manufacture of the Lead Product, failed to disclose a material fact required to be disclosed to any Regulatory Authority with respect to the development or manufacture of the Lead Product, or committed an act, made a statement, or failed to make a statement with respect to the development or manufacture of the Lead Product that could reasonably be expected to provide a basis for the FDA to invoke its policy concerning “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any analogous laws or policies in the Territory.
		
	16.1.3
	Third Party Patent Rights

As of the Signature Date, Dicerna has no knowledge of the existence of any patent or patent application owned by or licensed to any Third Party that could prevent Roche from making, having made, using, offering for sale, selling or importing Product in the Territory.
		
	16.1.4
	Ownership of Patent Rights

Dicerna is the exclusive owner of all right, title and interest in the Dicerna Base Patent Rights. Appendix 1.43 of this Agreement contains a complete and accurate list of all Patent Rights in the Dicerna GalXC Platform Patent Rights as of the Signature Date. No other parties have any right, title or interest in or to the Dicerna Base Patent Rights. Except for rights granted herein, the  Dicerna Base Patent Rights are free and clear of all liens, claims, security interests and other encumbrances of any kind or nature for Viral Targets. Dicerna has not granted any licenses to the Dicerna Base Patent Rights to any Third Party, nor has Dicerna effectuated any prior transfer, sale or assignment of any part of the Dicerna Base Patent Rights, except to Affiliates.
		
	16.1.5
	Existing Third Party In-License Agreements

Except as set forth in Appendix 16.1.5 and permitted hereunder, there are no agreements between Dicerna and any of its Affiliates with any Third Parties (i) pursuant to which Dicerna or its Affiliates has obtained, or has a right to obtain, a license under or rights to use Dicerna Patent Rights in HBV or (ii) pursuant to which Dicerna or its Affiliates otherwise owes, or would otherwise owe, payments to a Third Party as a result of the exploitation of the Lead Compound and Lead Product based upon the Dicerna Patent Rights (whether by Dicerna or Roche or their respective sublicensees), including the grant of rights to Roche.
		
	16.1.6
	Inventors

The inventors of the inventions disclosed and/or claimed in the Licensed IP have transferred (or will have transferred for Licensed IP Patent Rights filed after the Signature Date) to Dicerna full ownership of the Licensed IP. All of Dicerna’s employees, officers and consultants have executed agreements requiring assignment to Dicerna of all Inventions made by such individuals during the course of and as a result of their association with Dicerna.
		
	16.1.7
	Authorization

The execution, delivery and performance of this Agreement by Dicerna and all instruments and documents to be delivered by Dicerna hereunder, and assuming that no filing is required under the HSR Act: (i) are within the corporate power of Dicerna; (ii) have been duly authorized by all necessary or proper corporate action; (iii) to the knowledge of Dicerna, will not violate any law or regulation or any order or decree of any court of governmental instrumentality; (iv) will not violate the terms of any indenture, mortgage, deed of trust, lease, agreement, or other instrument to which Dicerna is a party or by which Dicerna or any of its property is bound, which violation would have an adverse effect on the financial condition of Dicerna or on the ability of Dicerna to perform its obligations hereunder; and (v) do not require any filing or registration with, or the consent or approval of, any governmental body, agency, authority or any other person, which has not been made or obtained previously (other than approvals required under the HSR Act, Regulatory Approvals required for the sale of Products and filings with Regulatory Authorities required in connection with Products).
		
	16.1.8
	No Conflict

Neither Dicerna nor any of its Affiliates is or will be under any obligation to any person, contractual or otherwise, that is conflicting with the terms of this Agreement or that would impede the fulfillment of Dicerna’s obligations hereunder.

		
	16.1.9
	Target Exclusion

Dicerna has and will continue to ensure that its Third-Party agreements appropriately exclude licenses to compounds Directed To Viral Targets, until such compounds become available to Third Parties by early termination of such rights under this Agreement. Dicerna will ensure that its Third Party agreements entered into on or after a given Host Cell Factor Target becomes a Selected Target or Reserved Target appropriately exclude licenses to compounds Directed To such Host Cell Factor Target until either (i) after the R&D Collaboration Term, the target of such compounds are not Selected Targets or (ii) such compounds become available to Third Parties by early termination of such rights under this Agreement. 
		
	16.1.10
	Validity of Patent Rights

As of the Signature Date, Dicerna is not in possession of information that could render invalid and/or unenforceable any claims that are in any of the Licensed IP. As of the Signature Date, Dicerna has no knowledge of any inventorship disputes concerning any Licensed IP.
		
	16.1.11
	Ownership and Validity of Know-How

Dicerna’s Know-How is legitimately in the possession of Dicerna and has not been misappropriated from any Third Party. Dicerna has taken reasonable measures to protect the confidentiality of its Know-How.
		
	16.1.12
	Effective Date

During the period from the Signature Date until the Effective Date, Dicerna shall promptly inform Roche in writing if and when Dicerna or any of its Affiliates becomes aware that the representations and warranties made by Dicerna as of the Signature Date are no longer true and correct in any material respects if made on and as of the date of such notice, except where such failure to be true and correct would not have any material adverse effect on Roche. Upon receipt of such notice, Roche shall have the right, on written notice to Dicerna, to terminate the Agreement, and upon receipt of such notice by Dicerna, this Agreement shall be null and void and have no further force and effect.

		
	16.2
	Roche Representations, Warranties and Covenants

		
	16.2.1
	Authorization

The execution, delivery and performance of this Agreement by Roche and all instruments and documents to be delivered by Roche hereunder, and assuming that no filing is required under the HSR Act: (i) are within the corporate power of Roche; (ii) have been duly authorized by all necessary or proper corporate action; (iii) are not in contravention of any provision of the certificate of formation or limited liability company agreement of Roche; (iv) to the knowledge of Roche, will not violate any law or regulation or any order or decree of any court of governmental instrumentality; (v) will not violate the terms of any indenture, mortgage, deed of trust, lease, agreement, or other instrument to which Roche is a party or by which Roche or any of its property is bound, which violation would have an adverse effect on the financial condition of Roche or on the ability of Roche to perform its obligations hereunder; and (vi) do not require any filing or registration with, or the consent or approval of, any governmental body, agency, authority or any other person, which has not been made or obtained previously (other than approvals required under the HSR Act, Regulatory Approvals required for the sale of Products and filings with Regulatory Authorities required in connection with Products).
		
	16.2.2
	Inventors

All Roche employees and officers have executed agreements requiring assignment to Roche or Roche Affiliates of all Inventions made by such individuals.  All consultants performing services by or on behalf of Roche under this Agreement shall have entered into agreements with Roche in accordance with Section 2.4.3.
		
	16.2.3
	No Conflict

Neither Roche nor any of its Affiliates is or will be under any obligation to any person, contractual or otherwise, that is conflicting with the terms of this Agreement or that would impede the fulfillment of Roche’s obligations hereunder.
		
	16.2.4
	Regulatory Documentation and No Misrepresentations to Regulatory Authorities

Roche and its Affiliates shall, to their knowledge, with respect to Lead Product, generate, prepare, maintain and retain all material regulatory documentation that is required to be maintained or retained pursuant to and in accordance with cGLPs and cGCPs and in compliance with Applicable Law, and to the best of their knowledge and ability all such information shall be true, complete, accurate in all material respects and what it purports to be. Neither Roche nor any of its Affiliates, nor any of its or their respective officers, employees or agents, to the best of their knowledge, shall make an untrue statement of material fact or fraudulent statement to any Regulatory Authority with respect to the development or manufacture of the Lead Product, fail to disclose a material fact required to be disclosed to any Regulatory Authority with respect to the development or manufacture of the Lead Product, or commit an act, make a statement, or fail to make a statement with respect to the development or manufacture of the Lead Product that could reasonably be expected to provide a basis for the FDA to invoke its policy concerning “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any analogous laws or policies in the Territory.
		
	16.2.5
	Ownership and Validity of Know-How

The Know-How that Roche contributes to the R&D Collaboration is legitimately in the possession of Roche and has not been misappropriated from any Third Party. Roche has taken reasonable measures to protect the confidentiality of such Know-How.
		
	16.2.6
	Effective Date

During the period from the Signature Date until the Effective Date, Roche shall promptly inform Dicerna in writing if and when Roche or any of its Affiliates becomes aware that the representations and warranties made by Roche as of the Signature Date are no longer true and correct in any material respects if made on and as of the date of such notice, except where such failure to be true and correct would not have any material adverse effect on Dicerna.

		
	16.3
	Mutual Representations and Warranties

Each Party hereby represents and warrants to the other Party as follows:
		
	16.3.1
	Grants

To the best of such Party’s knowledge and belief, such Party has the lawful right to grant the other Party and its Affiliates the rights and licenses described in this Agreement.
		
	16.3.2
	No Claims

As of the Signature Date, there are no claims or investigations to such Party’s knowledge, (other than with respect to the Parties’ HSR filings), pending or threatened against such Party or any of its Affiliates, 

at law or in equity, or before or by any governmental authority relating to the matters contemplated under this Agreement or that would materially adversely affect such Party’s ability to perform its obligations hereunder.

		
	16.4
	No Other Representations and Warranties

EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT, THE FOREGOING REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF PRODUCTS.

		
	17.
	Indemnification

		
	17.1
	Indemnification by Roche

Roche shall indemnify, hold harmless and defend Dicerna, Dicerna’s Affiliates and their directors, officers, employees and agents (“Dicerna Indemnitees”) from and against any and all liabilities, losses, expenses, cost of defense (including reasonable attorneys' fees, witness fees, damages, judgments, fines and amounts paid in settlement) and any amounts Dicerna Indemnitees become legally obligated to pay because of the breach of the Agreement by Roche or any claim or claims against it to the extent that such claim or claims arise out of activities related to the Compounds or Products (e.g., product liability claims or Roche’s R&D Collaboration activities or its Development or Commercialization of Compounds or Products) conducted by or on behalf of Roche, except to the extent such losses, expenses, costs and amounts are due to the breach of the Agreement by Dicerna or the gross negligence or willful misconduct or failure to act of Dicerna Indemnitees.

		
	17.2
	Indemnification by Dicerna

Dicerna shall indemnify, hold harmless and defend Roche, Roche’s Affiliates and their directors, officers, employees and agents (“Roche Indemnitees”) from and against any and all liabilities, losses, expenses, cost of defense (including reasonable attorneys' fees, witness fees, damages, judgments, fines and amounts paid in settlement) and any amounts Roche Indemnitees become legally obligated to pay because the breach of the Agreement by Dicerna or of any claim or claims against it to the extent that such claim or claims arise out of activities related to the Compounds or Products (e.g., product liability claims or Dicerna’s R&D Collaboration activities or its Co-Promotion of Lead Products) conducted by or on behalf of Dicerna or its Affiliates, except to the extent such losses, expenses, costs and amounts are due to the breach of the Agreement by Roche or the gross negligence or willful misconduct or failure to act of Roche Indemnitees.

		
	17.3
	Procedure

In the event of a claim by a Third Party against a Party entitled to indemnification under this Agreement ("Indemnified Party"), the Indemnified Party shall promptly notify the other Party ("Indemnifying Party") in writing of the claim and the Indemnifying Party shall undertake and solely manage and control, at its sole expense, the defense of the claim and its settlement. The Indemnified Party shall cooperate with the Indemnifying Party and may, at its option and expense, be represented in any such action or proceeding by counsel of its choice. The Indemnifying Party shall not be liable for any litigation costs or expenses incurred by the Indemnified Party without the Indemnifying Party’s written consent. The Indemnifying Party shall not settle any such claim unless such settlement fully and unconditionally releases the Indemnified Party from all liability relating thereto, unless the Indemnified Party otherwise agrees in writing.

		
	18.
	Liability

		
	18.1
	Limitation of Liability

Subject to the Parties’ obligations hereunder to use Commercially Reasonable Efforts including in Article 4 (Diligence), neither Party shall be liable to the other Party as a result of failure or delay to develop and/or commercialize the Compound or the Product, as applicable, including a) a delay in timelines, or b) delay or failure to recruit patients, or c) a change in its respective study protocols, or d) failure to obtain regulatory approval for the Compound or the Product, as applicable.

EXCEPT FOR EITHER PARTY’S INDEMNIFICATION OBLIGATIONS UNDER ARTICLE 17 OR BREACH OF ARTICLE 19, NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER.

		
	19.
	Obligation Not to Disclose Confidential Information

		
	19.1
	Non-Use and Non-Disclosure

During the Agreement Term and for [* * *] thereafter, a Receiving Party shall (i) treat Confidential Information provided by Disclosing Party as it would treat its own information of a similar nature, (ii) take all reasonable precautions not to disclose such Confidential Information to Third Parties, without the Disclosing Party’s prior written consent, and (iii) not use such Confidential Information other than for fulfilling its obligations and exercising its rights under this Agreement.

		
	19.2
	Permitted Disclosure

Notwithstanding the obligation of non-use and non-disclosure set forth in Section 19.1, the Parties recognize the need for certain exceptions to this obligation, specifically set forth below, with respect to press releases, patent rights, publications, securities law requirements, and certain commercial considerations.

		
	19.3
	Press Releases

The Parties may issue a press release announcing the existence and selected key terms of this Agreement, in a form substantially similar to the template attached as Appendix 18.3 of this Agreement.

Roche may issue press releases in accordance with its internal policy that typically does not issue a second press release until proof of concept has been achieved for a Compound. Roche shall provide Dicerna with a copy of any draft press release related to the activities contemplated by this Agreement at least [* * *] prior to its intended publication for Dicerna's review. Dicerna may provide Roche with suggested modifications to the draft press release. Roche shall in good faith consider Dicerna's suggestions prior to issuing its press release.

Dicerna shall only issue press releases related to the activities contemplated by this Agreement that either (i) have been approved by Roche or (ii) are required to be issued by Dicerna as a matter of law and Dicerna has been advised by counsel to that effect. In all circumstances, Dicerna shall endeavor to provide Roche with a draft press release at least [* * *] prior to its intended publication (or as soon as practicable with good faith) for Roche's review. During such period, Roche shall (i) approve the draft press release and permit Dicerna to issue the press release, (ii) contact Dicerna to discuss modification to the draft press release, or (iii) contact Dicerna and disapprove the press release. If Roche asks for modification, then Dicerna shall either make such modification or work with Roche to arrive at a press release that Roche approves. If Dicerna issues a press release without Roche's 

approval, then such release must be made by Dicerna in consultation with counsel that the release was required to be issued by Dicerna as a matter of law.

To ensure communication alignment, responses (if any) to inquiries by media or other Third Parties after issuance of a permitted press release by Dicerna (solely or jointly with Roche) shall consist solely of the press release language or shall follow the response guidelines that may be mutually developed by the Parties (or as deemed necessary by Dicerna’s counsel).

		
	19.4
	Publications

During the Agreement Term, the following restrictions shall apply with respect to disclosure by any Party of Confidential Information relating to the Product in any scientific publication or presentation (provided that, for avoidance of doubt, such restrictions shall not apply to information contained in patent applications):
		
	(a)
	Both Parties acknowledge that it is their policy for studies and results thereof to be registered and published in accordance with their internal guidelines. Roche, in accordance with its internal policies and procedures, shall have the right to publish all studies, clinical trials and results thereof on the clinical trial registries that are maintained by or on behalf of Roche. Other than with respect to the Dicerna Phase I Study, Dicerna shall not publish any studies, clinical trials or results thereof on its clinical trial registry, provided however, that Roche’s clinical trial registry can be accessed via a link from Dicerna’s clinical trial registry.

		
	(b)
	Dicerna may not publish such information about Licensed Products without the prior written consent of Roche.

		
	19.5
	Commercial Considerations

		
	(a)
	Nothing in this Agreement shall prevent Dicerna or its Affiliates from disclosing Confidential Information of Roche to (i) Third Parties acting on behalf of Dicerna, to the extent reasonably necessary and as permitted for the development, manufacture or Co-Promotion of Lead Product in the Territory, (ii) Third Parties requesting Dicerna Phase I Study clinical trial data information (in accordance with Dicerna’s then-current data sharing policy), or (iii) actual and potential partners and investors subject to commercially reasonable confidentiality obligations.

		
	(b)
	Nothing in this Agreement shall prevent Roche or its Affiliates from disclosing Confidential Information of Dicerna to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacture or sale of Product in the Territory, (ii) Third Parties acting on behalf of Roche, to the extent reasonably necessary for the development, manufacture or sale of Product in the Territory, (iii) Third Parties requesting clinical trial data information (in accordance with the applicable Party’s then-current data sharing policy), (iv) Third Parties to the extent reasonably necessary to market the Product in the Territory, or (iv) actual and potential partners and investors subject to commercially reasonable confidentiality obligations.

		
	(c)
	The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such Confidential Information is required to be disclosed by the Receiving Party to comply with Applicable Law, to defend or prosecute litigation or to comply with governmental regulations, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party and, to the extent practicable, takes reasonable and lawful actions to minimize the degree of such disclosure.

		
	(d)
	The Parties acknowledge that either or both Parties may be obligated to make one or more filings (including to file a copy of this Agreement) with the U.S. Securities and Exchange Commission 

(or equivalent foreign agency) or a governmental authority. Each Party will be entitled to make such a required filing, provided that if such filing includes a copy of this Agreement it will (i) submit in connection with such filing a copy of this Agreement in a form mutually agreed by the Parties in advance or, if despite the reasonable efforts of Dicerna a form mutually agreed by the Parties cannot be agreed in advance, redacted to the extent permitted by Applicable Law (the “Redacted Agreement”), (ii) request, and use reasonable efforts consistent with Applicable Laws to obtain, confidential treatment of all terms redacted from this Agreement, as reflected in the Redacted Agreement, for a period of at least [* * *], (iii) to the extent consistent with Applicable Law, promptly deliver to the other Party any written correspondence received by it or its representatives from the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request and promptly advise the other Party of any other material communications between it or its representatives with the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority with respect to such confidential treatment request, (iv) upon the written request of the other Party, if legally justifiable, request an appropriate extension of the term of the confidential treatment period, and (v) if the U.S. Securities and Exchange Commission (or equivalent foreign agency) or a governmental authority requests any changes to the redactions set forth in the Redacted Agreement, use reasonable efforts consistent with Applicable Laws to maintain the redactions in the Redacted Agreement as originally filed and not agree to any changes to the Redacted Agreement without, to the extent practical, first discussing such changes with the other Party and taking the other Party’s comments into consideration when deciding whether to agree to such changes (provided that a Party will only be required to make such efforts to support such redactions once). For clarity, following a request from a governmental authority to change the redactions requested by a Party, a Party will not be required pursuant to the provisions of this Section 19.5(d) to again request the redactions rejected by the applicable governmental authority.  Each Party will be responsible for its own legal and other external costs in connection with any such filing, registration or notification.

		
	19.6
	Injunctive Relief

The Parties agree that a breach of Article 19 may cause irrevocable harm for which monetary damages might not provide a sufficient remedy. In case of an actual or threatened material breach of Article 19, in addition to any other remedy available under this Agreement or under applicable Laws or equity, the non-breaching Party will be entitled to seek and obtain equitable relief (including temporary or permanent restraining orders, specific performance or other injunctive relief) from any court of competent jurisdiction, without the necessity of posting any bond or of any undertaking (other than with respect to enjoining a product launch), and without any requirement to submit to any dispute resolution procedures contained herein.

		
	20.
	Term and Termination

		
	20.1
	Commencement and Term

This Agreement shall commence upon the Effective Date and continue for the Agreement Term.

		
	20.2
	Termination

		
	20.2.1
	Termination for Material Breach

After the Effective Date, a Party (“Non-Breaching Party”) shall have the right to terminate this Agreement in its entirety or on a Product-by-Product basis in the event the other Party (“Breaching 

Party”) is in material breach (which shall include any breach of Section 3.9 (Exclusivity), Section 4 (Diligence) and Section 22.17 (Compliance with Laws)) of its obligations under this Agreement. The non-Breaching Party shall provide written notice to the Breaching Party, which notice shall identify the material breach. The Breaching Party shall have a period of [* * *] after such written notice is provided (“Peremptory Notice Period”) to cure such material breach. If the Breaching Party has a dispute as to whether such material breach occurred or has been cured, it will so notify the Non-Breaching Party within the Peremptory Notice Period and the Agreement shall not terminate until such dispute is resolved pursuant to Section 22.2 and 22.3. Upon a determination of material breach and failure to cure, the Breaching Party shall have the Peremptory Notice Period to cure such material breach. If such material breach is not cured within the Peremptory Notice Period, then absent withdrawal of the Non-Breaching Party’s request for termination, this Agreement shall terminate in its entirety or with respect to such Product effective as of the expiration of the Peremptory Notice Period.
		
	20.2.2
	Insolvency

Either Party shall have the right to terminate this Agreement, if the other Party incurs an Insolvency Event; provided, however, in the case of any involuntary bankruptcy proceeding, such right to terminate shall only become effective if the Party that incurs the Insolvency Event consents to the involuntary bankruptcy or such proceeding is not dismissed within [* * *] after the filing thereof.
		
	20.2.3
	Effects of Change of Control

If there is a Change of Control, then the Party experiencing such Change of Control (“Acquired Party”) shall provide written notice to the other Party (“Non-Acquired Party”) at least [* * *] prior to completion of such Change of Control, subject to any confidentiality obligations of the Acquired Party then in effect (but in any event shall notify the Non-Acquired Party within [* * *] after completion of such Change of Control).

The Change of Control Group in connection with such Change of Control shall not have the right to utilize any of the Non-Acquired Party’s Know-How (excluding information generally applicable to other products or retained in the unaided memory of Dicerna employees), Patent Rights, Inventions, Materials or Confidential Information (collectively, “Sensitive Information”) for the research, development or commercialization of any product for the treatment of any indication or patient population for which a Product may be developed or commercialized.

Following consummation of the Change of Control, the Non-Acquired Party and the Change of Control Group shall adopt in writing reasonable procedures to prevent the disclosure of Sensitive Information beyond the Acquired Party’s personnel who need to know the Sensitive Information solely for the purpose of fulfilling the Acquired Party’s obligations under this Agreement or for lawful reporting obligations. [* * *].
		
	20.2.4
	Termination by Roche without a Cause

After the Effective Date, Roche shall have the right to terminate a given Research Plan under the R&D Collaboration (i.e. on a Selected Target-by-Selected Target basis) or the R&D Collaboration in its entirety upon [* * *] prior written notice, and such Selected Target shall become a Discontinued Target.

In addition to the foregoing, at any time after the Effective Date, Roche shall have the right to terminate this Agreement as a whole or on a Licensed Product-by-Licensed Product basis upon [* * *] prior written notice before First Commercial Sale of a Licensed Product or upon [* * *] prior written notice after the First Commercial Sale of a Licensed Product. The effective date of termination under this Section 20.2.4 

paragraph 2 shall be the date [* * *] as the case may be) after Roche provides such written notice to Dicerna.
		
	20.2.5
	Termination of Selected Targets

After the Effective Date, at the end of the R&D Collaboration Term (or earlier termination thereof), if across all Selected Targets Roche does not select any Additional Dicerna Compounds as a Clinical Candidate, Roche shall have the right, but not the obligation, to terminate all rights to all Additional Dicerna Compounds generated under the R&D Collaboration upon [* * *] written notice. After a Clinical Candidate is selected for a given Selected Target or after the Target Term if Roche provides a Roche Continuation Notice, Roche shall have the right to (or where required by Section 3.8, the obligation to) terminate with respect to all Licensed Products for such Selected Target upon [* * *] prior written notice. Upon such termination, such Selected Target shall become a Discontinued Target.
		
	20.2.6
	Termination for Patent Challenge

[* * *].

		
	20.3
	Consequences of Termination

		
	20.3.1
	Roche Compound License

In the event of a (i) termination of the Agreement as a whole by Roche pursuant to Section 20.2.1 (for Material Breach by Dicerna), Section 20.2.2 (for Dicerna’s Insolvency) or Section 20.2.4 (Without a Cause) or (ii) termination pursuant to Section 20.2.5 (Termination of Selected Targets) or pursuant to Section 20.2.6 (for Patent Challenge) (a “Non-Exclusive Trigger”) then
		
	(a)
	Roche shall retain the Non-Exclusive Roche License for (i) all applicable Roche Compounds (for Agreement termination) or (ii) all applicable Roche Compounds Directed To the given Selected Target being terminated (for Selected Target termination),

		
	(b)
	Article 4 notwithstanding, Roche shall not continue to have diligence obligations related to any such Roche Compounds, and,

		
	(c)
	the financial compensation owed to Dicerna for Roche Compounds under Sections 11.2.2 and 11.4.2.2 and shall remain, but subject to the following reductions:

		
	(i)
	[* * *]

		
	(ii)
	[* * *]

		
	(iii)
	[* * *].

[* * *].

Notwithstanding the foregoing, if Roche terminates the R&D Collaboration in its entirety on or before Initiation of the first Phase II Study for the Lead Product, the financial compensation owed to Dicerna for Roche Compounds shall be eliminated in its entirety.

(collectively, the “Non-Exclusive Conditions”).
		
	20.3.2
	Termination by Dicerna pursuant to Section 20.2.1 (Material Breach by Roche) or Section 20.2.2 (Insolvency) 

Upon any termination by Dicerna pursuant to Section 20.2.1 (Material Breach by Roche) or Section 20.2.2 (Insolvency) all rights and licenses granted by Dicerna to Roche under this Agreement shall terminate in their entirety or on a Product-by-Product basis, as applicable, on the effective date of termination. If the alleged material breach by Roche is of its obligations under Article 4, then termination shall only be on a Product-by-Product basis.

If Dicerna desires to continue Development and/or Commercialization of Licensed Product(s), Dicerna shall give a Continuation Election Notice to Roche within [* * *] of Dicerna’s notice of such termination. If Roche receives such a timely Continuation Election Notice, then with respect to applicable Licensed Product(s) and to the extent reasonably requested by Dicerna:
		
	(a)
	Roche hereby grants to Dicerna [* * *] license to Roche Grant-Back Patent Rights and (if such Licensed Product has achieved First Commercial Sale) the applicable Product Trademarks (in each case with the right to sublicense through multiple tiers), and a [* * *] license to Roche Know-How, solely to the extent necessary [* * *].

		
	(b)
	After the effective date of termination Roche shall (or shall cause such other Roche Group member to), to the extent Roche has the right to do so, assign and transfer to Dicerna all regulatory filings and approvals, all final pre-clinical and clinical study reports and clinical study protocols, and all data, including clinical data, in Roche’s possession and control related to applicable Licensed Product(s) in the country reasonably necessary for Dicerna to continue to Develop and Commercialize the Licensed Product(s). To the extent Roche does not have the right to make such assignment and/or transfer, Roche shall, to the extent possible, provide a license, right of reference, or other right or access to such regulatory filings and approvals, pre-clinical and clinical study reports and protocols, and data. All data shall be transferred in the form and format in which it is maintained by Roche. Original paper copies shall only be transferred, if legally required. Roche shall not be required to prepare or finalize any new data, reports or information solely for purposes of transfer to Dicerna.

		
	(c)
	Roche shall assign all clinical trial agreements for applicable Licensed Product(s), to the extent such agreements have not been cancelled in good faith and are assignable without Roche breaching such agreement (any required consideration to be paid by Roche).  In any event, Roche shall cooperate and make all reasonable efforts to provide an orderly transition of clinical activities and continue such agreements to support such transition.

		
	(d)
	Dicerna shall, upon transfer, have the right to disclose such filings, approvals and data to (i) governmental agencies of the country to the extent required or desirable to secure government approval for the development, manufacture or sale of Licensed Product(s) in the country, (ii) Third Parties acting on behalf of Dicerna, its Affiliates or licensees, to the extent reasonably necessary for the development, manufacture, or sale of Licensed Product(s) in the country, and (iii) Third Parties to the extent reasonably necessary to market Licensed Product(s) in the country.

		
	(e)
	In consideration for the above license and transfers, and Roche’s work on applicable Licensed Product(s), Dicerna shall pay Roche a royalty on all net sales (as determined by reasonable accounting methods) of Licensed Product(s) by Dicerna, its Affiliates or licensees, mutatis mutandis, with the royalty rate as follows:

	
			
	Status of Product at termination effective date
	Royalty rate for Lead Product
	Royalty rate for other Licensed Products

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

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

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

Notwithstanding the foregoing, Dicerna shall pay a [* * *] royalty on net sales for Licensed Products (other than with the Lead Product) that are Combination Products and where Roche has at least Completed a Phase I Study if Roche elects to not provide transfer and license access to the other therapeutically active ingredients contained in such Combination Product.

		
	20.3.3
	Termination by Roche without Cause or for Material Breach by Dicerna or Dicerna’s Insolvency, or Termination for Patent Challenge 

Subject to the Non-Exclusive Conditions, upon any termination by Roche without cause (under Section 20.2.4 or Section 20.2.5), for Dicerna’s Insolvency,  for material breach by Dicerna or for Patent Challenge (under Section 20.2.6), the rights and licenses granted by Dicerna to Roche under this Agreement shall terminate in their entirety or with respect to the R&D Collaboration or all Dicerna Compounds, or on a Licensed Product-by-Licensed Product, Selected Target-by-Selected Target or Research Plan-by-Research Plan basis, as applicable, on the effective date of termination.

If Dicerna desires to continue Development and/or Commercialization of Licensed Product(s), Dicerna shall give a Continuation Election Notice to Roche within [* * *] of receipt of Roche’s notice of termination without cause. If Roche receives such a timely Continuation Election Notice, then with respect to applicable Licensed Product(s) and to the extent reasonably requested by Dicerna:
		
	(a)
	Roche hereby grants to Dicerna an exclusive, royalty-bearing, worldwide license to Roche Grant-Back Patent Rights and (if such Licensed Product has achieved First Commercial Sale) the applicable Product Trademarks (in each case with the right to sublicense through multiple tiers), and a non-exclusive, royalty-free, worldwide license to Roche Know-How, solely to the extent reasonably necessary to allow Dicerna, its Affiliates or licensees to develop, have developed, manufacture, have manufactured, use, offer to sell, sell, promote, export and import the applicable Licensed Product(s) in the applicable country(ies). For clarity, the licenses under this Section 20.3.3(a) shall not include any licenses that Roche has with a Third Party for which such grant would be prohibited or under which a member of the Roche Group would incur financial obligations to such Third Party.

		
	(b)
	After the effective date of termination Roche shall, to the extent Roche has the right to do so, assign and transfer to Dicerna all regulatory filings and approvals, all final pre-clinical and clinical study reports and clinical study protocols, and all data, including clinical data, in Roche’s possession and control related to applicable Licensed Product(s) in the country reasonably necessary for Dicerna to continue to Develop and Commercialize the Licensed Product(s). To the extent Roche does not have the right to make such assignment and/or transfer, Roche shall, to the extent possible, provide a license, right of reference, or other right or access to such regulatory filings and approvals, pre-clinical and clinical study reports and protocols, and data. All data shall be transferred in the form and format in which it is maintained by Roche. Original paper copies shall only be transferred, if legally required. Roche shall not be required to prepare or finalize any new data, reports or information solely for purposes of transfer to Dicerna. 

		
	(c)
	Roche shall assign all clinical trial agreements for the applicable Licensed Product(s), to the extent such agreements have not been cancelled in good faith and are assignable without Roche paying any consideration or commencing litigation in order to effect an assignment of any such agreement, provided that Roche has agreed to such consideration in good faith and has given Dicerna notice of the requisite amount of consideration and affording Dicerna the opportunity to provide such consideration.  In any event, Roche shall cooperate and make all reasonable efforts to provide an orderly transition of clinical activities and continue such agreements to support such transition.

		
	(d)
	Dicerna shall, upon transfer, have the right to disclose such filings, approvals and data to (i) governmental agencies of the country to the extent required or desirable to secure government approval for the development, manufacture or sale of Licensed Product(s) in the country; (ii) Third Parties acting on behalf of Dicerna, its Affiliates or licensees, to the extent reasonably necessary for the development, manufacture, or sale of Licensed Product(s) in the country, and (iii) Third Parties to the extent reasonably necessary to market Licensed Product(s) in the country.

		
	(e)
	In consideration for the above license and transfers, and Roche’s work on applicable Licensed Product(s), Dicerna shall pay Roche a royalty on all net sales (as determined by reasonable accounting methods) of Licensed Product(s) by Dicerna, its Affiliates or licensees, mutatis mutandis, with the royalty rate as follows:

	
			
	Status of Product at termination effective date
	Royalty rate for Lead Product
	Royalty rate for other Licensed Products

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

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

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

Notwithstanding anything to the contrary herein, if Roche terminates an individual Selected Target without replacing it with another under the procedures set forth in Section 3.6, then all Additional Dicerna Compounds related to such Selected Target shall revert to Dicerna free of charge.
		
	20.3.4
	Direct License

Irrespective of anything to the contrary in this Agreement,
		
	(a)
	any Compulsory Sublicense shall remain in full force and effect as may be required by Applicable Law, and

		
	(b)
	any existing sublicense granted by Roche (and any further sublicenses thereunder) in accordance with Section 2.4.2 shall, upon the written request of Roche, remain in full force and effect, provided that (i) such Sublicensee is not then in breach of its sublicense agreement (and, in the case of termination by Dicerna for breach by Roche, that such Sublicensee and any further sublicensees did not cause the breach that gave rise to the termination by Dicerna); (ii) Dicerna continues to receive the amounts for development and regulatory event payments and sales based events as set forth in Sections 11.2 and 11.3; (iii) the royalty rates in such sublicense agreement are equal to the royalty rates set forth in Section 11.4 and are received by Dicerna; and (iv) such Sublicensee agrees in writing to be bound to Dicerna under the terms and conditions of such sublicense agreement and the applicable terms of this Agreement.

		
	20.3.5
	Other Obligations

		
	20.3.5.1
	Obligations Related to Ongoing Activities

If Dicerna does not provide timely Continuation Election Notice, then Roche (a) shall have the right to cancel all ongoing non-financial obligations with respect to the applicable Licensed Product(s) and (b) shall complete all non-cancellable obligations at its own expense.

If Dicerna provides such timely Continuation Election Notice, then from the date of notice of termination until the effective date of termination, Roche shall continue activities for the applicable Licensed Product(s), including preparatory activities, ongoing as of the date of notice of termination. Additionally, for Third Party CMO and CRO service providers in use by Roche for the applicable Licensed Product(s) of Roche, upon request of Dicerna Roche will facilitate an introduction to, cooperate in good faith, and allow Dicerna to contract directly with, such contractual party, if possible. Roche shall not be obliged to initiate any new activities not ongoing at the date of notice of termination.

After the effective date of termination, Roche shall have no obligation to perform and/or complete any activities or to make any payments for performing or completing any Development activities under this Agreement, except as expressly stated in the Agreement.  Roche shall promptly transfer back to Dicerna all patent prosecution files relating to Licensed IP and patent prosecution activities to Dicerna’s control.

Notwithstanding the foregoing, in case of termination by Dicerna under Section 20.2.1 or 20.2.2 or by Roche under Section 20.2.4, upon the request of Dicerna, Roche shall complete any Clinical Studies related to the applicable Licensed Product(s) that are being conducted under its CTAs for the Licensed Product(s) and are ongoing as of the effective date of termination; provided, however, that:
		
	(i)
	both Dicerna and Roche in their reasonable judgment have concluded that completing any such Clinical Studies does not present an unreasonable risk to patient safety;

		
	(ii)
	Roche shall have no obligation to recruit or enroll any additional patients after the date of termination; and

		
	(iii)
	Dicerna shall be responsible for all Development Costs that arise after the effective date of termination in completing such Clinical Studies.

Either Party shall have the right to complete on-going pre-clinical animal studies if the early termination thereof would raise potential ethical concerns concerning animal rights issues.
		
	20.3.5.2
	Obligations Related to Manufacturing

		
	(a)
	Clinical Supplies

In the case of termination by Dicerna according to Section 20.2.1 or 20.2.2 or by Roche under Section 20.2.4, if Dicerna elects to Develop the applicable Licensed Product(s), Roche shall transfer all existing and available clinical material to Dicerna at Roche’s fully burdened manufacturing cost. Dicerna shall assume all liability for the use of such material.

		
	(b)
	Commercial Supplies

In the case of termination by Dicerna according to Section 20.2.1 or 20.2.2 or by Roche under Section 20.2.4, if a Licensed Product is marketed in any country of Territory on the date of the notice of termination of this Agreement, upon the request of Dicerna, Roche shall manufacture and supply reasonable amounts of such Licensed Product to Dicerna under a manufacturing transfer and transition plan for a period that shall not exceed [* * *] from the effective date of the termination of this Agreement at a price to be agreed by the Parties in good faith, but in no event 

exceeding (i) Roche‘s fully burdened manufacturing cost, if the Licensed Product is manufactured tor Roche through a Third Party contract, or (ii) Roche‘s fully burdened manufacturing cost plus a mark-up of [* * *]‚ if Roche manufactures the Licensed Product itself, as calculated on a consistent basis according to its then current accounting procedures. Dicerna shall use Commercially Reasonable Efforts to take over such manufacturing as soon as possible after the effective date of termination. If, despite using Commercially Reasonable Efforts, Dicerna has not secured commercial supply of the Product within the [* * *] period, then the Parties shall use Commercially Reasonable Efforts to ensure an uninterrupted commercial supply for up to a maximum additional [* * *] period, in quantities sufficient to satisfy Dicerna‘s requirements and for Dicerna to assume all development and commercialization activities, at a price which shall be at (i) Roche‘s fully burdened manufacturing cost plus a mark-up of [* * *] if Product is manufactured for Roche through a Third Party contract, or (ii) Roche‘s fully burdened manufacturing cost plus a mark-up of [* * *] if Roche manufactures Product itself, under terms to be negotiated in good faith.
		
	20.3.5.3
	Ancillary Agreements

Unless otherwise agreed by the Parties, the termination of this Agreement shall cause the automatic termination of all ancillary agreements related hereto, including the Pharmacovigilance Agreement and the Co-Promotion Agreement, if any.
		
	20.3.5.4
	Limitations on Grant-Backs; Transfer Expenses; Damages and Other Relief

For purposes of clarity, irrespective of anything to the contrary in this Agreement:

		
	(a)
	Dicerna may not give a Continuation Election Notice to Roche for Licensed Products (other than the Lead Product) that have not advanced into Development by or on behalf of Roche as of the effective date of termination.

		
	(b)
	All transfers and licenses from Roche to Dicerna (or other obligations of Roche) under Section 20.3 are solely (i) where the Licensed Product contains both the Lead Compound and a Selected Target Compound, only with respect to the applicable Dicerna Compound(s) that have been previously terminated or are subject to the termination, (ii) with respect to Licensed Product(s) that are not (A) Combination Product(s) containing a compound that is proprietary to Roche or subject to Third Party rights or (B) Companion Diagnostics, and (iii) for the applicable Licensed Product that is being Developed or Commercialized by or on behalf of Roche as it exists on the effective date of termination. Such transfers, licenses and obligations do not extend to other therapeutically active ingredients or products, even if physically mixed, combined or packaged together with a Licensed Product, and even if a Licensed Product is intended (according to the investigation plan, proposed labeling or actual labeling, as applicable) for use with such other therapeutically active ingredients or products.

		
	(c)
	In connection with research studies, clinical trials or other activities associated with the Development and Commercialization of Licensed Products, Roche may have collected (i) personally identifiable information about individual human subjects and/or (ii) human biological samples (collectively, “PII/Samples”). Legal and contractual restrictions may apply to such PII/Samples. Roche shall have no obligation to transfer such PII/Samples unless reasonably necessary or useful for the continued Development of the Licensed Product, in which case Roche shall not be obliged to transfer any PII/Samples that Roche in good faith believes would be prohibited or would subject Roche to potential liability by reason of Applicable Law, insufficient patient consent or contractual restrictions (however for contractual restrictions, upon request of Dicerna Roche 

will facilitate an introduction to the applicable contractual party and allow Dicerna to contract directly with such contractual party, if possible). If Roche transfers any such PII/Samples, Dicerna shall use for the sole purpose of Developing and Commercializing the Licensed Product, and Dicerna shall be responsible for the correct use of the PII/Samples in line with Applicable Law and the informed consent forms (including but not limited to potential re-consenting of the patients at Dicerna’s costs).

		
	(d)
	Dicerna shall promptly reimburse Roche for all reasonable out-of-pocket costs and expenses (including FTE charges) incurred by or on behalf of Roche for transfer activities from Roche to Dicerna under Sections 20.3.2 and 20.3.3 (“Roche Transfer Activities”); however transfer activities corresponding to the return of materials, data, reports, records, documents, Regulatory Filings and Regulatory Approvals originally provided by Dicerna to Roche no less than [* * *] from the effective date of termination (“Dicerna-Originated Transfer Activities”) shall be returned to Dicerna (if readily available) free of charge. If Dicerna desires Roche Transfer Activities other than Dicerna-Originated Transfer Activities, Dicerna shall make a payment to Roche of [* * *] (“Minimum Transfer Payment”). The Minimum Transfer Payment shall be non-refundable, but shall be fully creditable against Dicerna’s reimbursement for the Roche Transfer Activities. Roche shall be under no obligation to provide Roche Transfer Activities (beyond than Dicerna-Originated Transfer Activities) prior to receipt of the Minimum Transfer Payment or if the Minimum Transfer Payment is received after the effective date of the termination.

		
	(e)
	Unless otherwise agreed to by the Parties, transfer of physical materials that are required under Roche Transfer Activities (except in conjunction with such future toll manufacturing obligations as may apply under Section (b), if applicable) shall be delivered CPT Dicerna or Dicerna’s designee to the location designated by Dicerna (Incoterms 2010).

		
	(f)
	Neither Party may use any documents or materials provided by the other Party as part of any license or transfer under this Section 20.3 as evidence in any legal proceedings against the providing Party, however this exception will not apply to documents or materials exchanged pursuant to discovery requests or other litigation processes.

		
	(g)
	Termination of this Agreement and exercise of the rights and remedies set forth herein (or failure to terminate or exercise such rights and remedies) shall not preclude either Party from claiming any other damages, compensation or relief to which it may be entitled.

		
	20.3.5.5
	Royalty and Payment Obligations; Return of Information and Technology

Termination of this Agreement by a Party, for any reason, shall not release Roche from any obligation to pay royalties or make any payments to Dicerna that accrued prior to the effective date of termination. Termination of this Agreement by a Party, for any reason, will release Roche from any obligation to pay royalties or make any payments to Dicerna that would otherwise accrue on or after the effective date of termination. To the extent practicable, upon expiration or termination of this Agreement, each Party shall return to the other Party, or destroy, the other Party’s Confidential Information and all copies thereof, except to the extent and for so long as such Confidential Information is included within the scope of any surviving license, and provided that each Party may keep [* * *] copy of the other Party’s Confidential Information in its confidential files solely for records purposes. Without limiting the foregoing, upon termination of this Agreement or a Product is returned to Dicerna, Roche shall return to Dicerna the information and materials solely with respect to such Licensed Product which shall become Dicerna’s Confidential Information.

		
	20.4
	Survival

Article 1 (Definitions, to the extent necessary to interpret this Agreement), Section 2.3 (Non-Exclusive Roche License), Section 2.4.2 (last sentence of first paragraph), Section 2.4.3 (Right to Subcontract, for purpose of continuing obligations under Article 20), Section 2.6 (Freedom-to-operate Licenses), Section 3.5.2 (Research Records, for purpose of continuing obligations under Article 20), Articles 11 and 12 (Payment to Dicerna, and Accounting and Reporting, each to the extent payment obligations exist at the time of termination), Article 13 (Taxes, to the extent such were incurred at the time of termination), Article 14 (Auditing, for [* * *], Section 15.1 (Ownership of Inventions), Sections 15.6, 15.7, and 15.8 (Infringement, Defense, and Hatch-Waxman, for purpose of accrued obligations), Section 15.10 (Costs of Patent Challenge), Section 16.4 (No Other Representations and Warranties), Article 17 (Indemnification), Article 18 (Liability), Article 19 (Obligation Not to Disclose Confidential Information), Article 20 (Term and Termination), Article 21 (Bankruptcy), and Article 22 (Miscellaneous, but excluding Sections 22.4, 22.6, 22.17 and 22.18), and such sections as are relevant for the mutatis mutandis provisions under Sections 20.3.2(e) and 20.3.3(e) shall survive any expiration or termination of this Agreement for any reason. 

		
	21.
	Bankruptcy

All licenses (and to the extent applicable rights) granted under or pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11, US Code (the “Bankruptcy Code”) licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code. Unless a Party elects to terminate this Agreement, the Parties agree that such Party, as a licensee or sublicensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code, subject to the continued performance of its obligations under this Agreement.

		
	22.
	Miscellaneous

		
	22.1
	Governing Law; Excluded Claims

This Agreement shall be governed by and construed in accordance with the laws of the US state of Delaware, without reference to its conflict of laws principles.

Notwithstanding anything to the contrary in this Agreement, Excluded Claims shall be determined in a court of competent jurisdiction over such Excluded Claim.  With respect to Excluded Claims, each Party consents to the jurisdiction of the state and federal courts located in the State of New York and waives any objection to such courts on grounds of personal jurisdiction, venue, or forum non conveniens.

		
	22.2
	Disputes

Unless otherwise set forth in this Agreement, in the event of any dispute between the Parties arising out of or relating to this Agreement (each, a “Dispute”) and the Parties cannot resolve such Dispute (through their respective Alliance Directors or the JRC or JSC, if and as applicable) within [* * *] of a written request by either Party to the other Party (“Notice of Dispute”), and such Dispute is not one for which a Party has final decision-making as expressly set forth in this Agreement, such Dispute shall be referred to the respective executive officers of the Parties designated below or their designees, for good faith negotiations attempting to resolve the Dispute. The designated executive officers are as follows:

For Dicerna:    CEO
For Roche:    Head of Pharma Partnering

		
	22.3
	Arbitration

Except for an Excluded Claim, should the Parties fail to resolve a Dispute within [* * *] after delivery of a Notice of Dispute, then such Dispute shall be finally resolved by binding arbitration by [* * *] arbitrators experienced in the business of pharmaceuticals in accordance with the commercial arbitration rules of the International Chamber of Commerce (ICC) as in force at the time when initiating the arbitration applying the substantive law specified in Section 22.1. The right and obligation to arbitrate under this Section 22.3 shall extend to any claims by or against the Parties and their respective Affiliates and any agents, principals, officers, directors or employees of either of the Parties or their respective Affiliates.

Each Party shall nominate one arbitrator. Should the claimant fail to appoint an arbitrator in the request for arbitration within [* * *] of being requested to do so, or if the respondent should fail to appoint an arbitrator in its answer to the request for arbitration within [* * *] of being requested to do so, the other Party shall request the ICC Court to make such appointment.

The arbitrators nominated by the Parties shall, within [* * *] from the appointment of the arbitrator nominated in the answer to the request for arbitration, and after consultation with the Parties, agree and appoint a third arbitrator, who will act as a chairman of the Arbitral Tribunal. Should such procedure not result in an appointment within the [* * *] time limit, either Party shall be free to request the ICC Court to appoint the third arbitrator.

Where there is more than one claimant and/or more than one respondent, the multiple claimants or respondents shall jointly appoint one arbitrator.

If any Party-appointed arbitrator or the third arbitrator resigns or ceases to be able to act, a replacement shall be appointed in accordance with the arrangements provided for in this Section.

The place of arbitration shall be [* * *]. The language to be used shall be English.

Either Party, without waiving any remedy under this Agreement, may seek from any court having jurisdiction any temporary injunctive or provisional relief necessary to protect the rights or property of that Party.  Once the arbitrators are in place, either Party may also apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved, and either Party may apply to a court of competent jurisdiction to enforce interim injunctive relief granted by the arbitrators.  Any final award by the arbitrators may be entered by either Party in any court having appropriate jurisdiction for a judicial recognition of the decision and applicable orders of enforcement.  The arbitrators may render early or summary disposition of any or some issues after the Parties have had a reasonable opportunity to make submissions on such issues.  The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damages.  Each Party shall bear its own costs and expenses and attorneys’ fees and an equal share of the arbitrators’ fees and any administrative fees of arbitration, unless the arbitrators determine otherwise.

Except to the extent necessary to confirm an award or as may be required by law, neither a Party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties.  In no event shall an arbitration be initiated after the date when commencement 

of a legal or equitable proceeding based on the dispute, controversy or claim would be barred by the applicable [* * *] statute of limitations.

		
	22.4
	HSR

As soon as is reasonably practicable following the Signature Date and in any event within [* * *] of the Signature Date, each of Dicerna (or its Affiliate, as appropriate) and Roche (or its Affiliate, as appropriate) shall prepare and submit appropriate filings under the United States Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”) and the rules promulgated thereunder, and request early termination of the waiting period under the HSR Act. The Parties shall furnish, or cause their respective Affiliates to furnish, as the case may be, promptly to the United States Federal Trade Commission (the “FTC”) and the Antitrust Division of the United States Department of Justice (the “DOJ”) any additional information reasonably requested within their authority under the HSR Act, use reasonable efforts to obtain antitrust clearance for the transactions contemplated hereunder as soon as practicable, and otherwise cooperate with each other in the United States governmental antitrust clearance process. Subject to Applicable Law relating to the exchange of information, each of Roche and Dicerna shall consult and cooperate with one another, and consider in good faith the views of one another, in connection with any analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any Party hereto in connection with proceedings under or relating to the HSR Act. Roche and Dicerna shall cooperate fully with each other in connection with the making of all such filings or responses. Each Party shall bear its own fees in connection with its respective filing under this Section 22.4 and each Party shall bear their respective attorneys’ fees in connection therewith. This Agreement shall bind the Parties upon execution and continue in full force and effect unless and until the termination or expiration of the Agreement by its terms; provided, however, that this Agreement (including Dicerna’s grant of license rights hereunder, Roche’s obligation to make the payments hereunder, and each Party’s performance of discovery, research, transfer development, communications with regulatory authorities and other activities, and other rights and obligations hereunder in connection with the Compounds and Products), other than this Section 22.4, shall not become effective or binding unless and until each of the following conditions are met: (i) the waiting period provided by the HSR Act shall have expired or been terminated, (ii) no court or administrative challenges to the transactions commenced by the FTC or DOJ are pending, and (iii) no court or administrative orders commenced by the FTC or DOJ are outstanding blocking the completion of the transactions, (the date of such, the “Effective Date”).  Nothing in this Agreement shall require or be deemed to require either Party (or their Affiliates) to commit to any divestitures or licenses or agree to hold separate any assets or agree to any similar arrangements or commit to conduct its business in a specified manner, or to submit and respond to a formal discovery procedure initiated by the FTC or DOJ (i.e., a “Request for Additional Information and Documentary Materials” also known as a “second request”, or Civil Investigative Demand if a filing is not required under the HSR Act), in each case as a condition to obtaining antitrust clearance for the transactions contemplated hereunder.  If antitrust clearance is not received on or before [* * *] after the date on which both Parties have submitted to the FTC and DOJ their respective initial filings to request antitrust clearance of the transactions hereunder, then either Party shall have the right to terminate this Agreement, but prior to receipt of antitrust clearance of the transactions contemplated hereunder, by written notice to the other Party.

		
	22.5
	Assignment

Neither Party shall have the right to assign the present Agreement or any part thereof to any Third Party (other than Affiliates ) without the prior written approval of the other Party; provided that, either Party may, without the prior written approval of the other Party, assign this Agreement and its rights and obligations hereunder (or under a transaction under which this Agreement is assumed) to the 

acquirer of or successor to such Party in connection with a Change of Control (and shall so assign in connection with a sale of all or substantially all of the assets of such Party as further described in Section 20.2.3).

		
	22.6
	Debarment

Each Party represents and warrants that neither it nor its employees have been debarred under 21 U.S.C. §335a, disqualified under 21 C.F.R. §312.70 or §812.119, sanctioned by a Federal Health Care Program (as defined in 42 U.S.C §1320 a-7b(f)), including the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar Federal or state agency or program (“Debarred”). In the event a Party or an employee of such Party receives notice of debarment, suspension, sanction, exclusion, ineligibility or disqualification under the above-referenced statutes, such Party shall immediately notify the other Party in writing. Each Party and its Affiliates will not knowingly allow any Debarred employee to conduct activities under this Agreement.

		
	22.7
	Independent Contractor

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

		
	22.8
	Unenforceable Provisions and Severability

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

		
	22.9
	Waiver

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

		
	22.10
	 Interpretation

Except where the context expressly requires otherwise:
		
	(a)
	the use of any gender herein shall be deemed to encompass references to either or both genders, and the use of the singular shall be deemed to include the plural (and vice versa),

		
	(b)
	the words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation”,

		
	(c)
	any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time 

amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein),
		
	(d)
	any reference herein to any Party or Third Party or person shall be construed to include the Party’s or Third Party’s or person’s permitted successors and assigns,

		
	(e)
	the words “herein”, “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof,

		
	(f)
	all references herein to Articles, Sections or Appendices shall be construed to refer to Articles, Sections or Appendices of this Agreement, and references to this Agreement include all Appendices hereto,

		
	(g)
	references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof, and

		
	(h)
	the term “or” shall be interpreted in the inclusive sense commonly associated with the term “and/or”.

		
	22.11
	 Entire Understanding

This Agreement contains the entire agreement and understanding between the Parties hereto with respect to the within subject matter and supersedes any and all prior agreements, understandings and arrangements, whether written or oral, and all other communications between the Parties with respect to such subject matter.  In case of inconsistencies between this Agreement and any Appendix hereof, the terms of this Agreement shall prevail unless agreed to explicitly that the Appendix should prevail. This Agreement shall be binding upon and inure to the benefit of the Parties and their respective legal representatives, successors and permitted assigns.  The Parties acknowledge and agree that, as of the Effective Date, all Confidential Information disclosed pursuant to the CDA by a Party or its Affiliates shall be included in the Confidential Information subject to this Agreement and the Confidentiality Agreement is hereby superseded in its entirety; provided, that the foregoing shall not relieve any Person of any right or obligation accruing under the Confidentiality Agreement prior to the Effective Date.  “CDA” means the Non-Disclosure Agreement between Dicerna and Roche US dated February 5, 2019.

		
	22.12
	 Amendments

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

		
	22.13
	 Invoices

		
	22.13.1
	Invoices to Roche

All invoices for payments to Dicerna that are required or permitted hereunder shall be in writing (or via email if directed by Roche) and sent by Dicerna to Roche at the following address or such other address (including email) as Roche may later provide:

F. Hoffmann-La Roche Ltd
Kreditorenbuchhaltung
Grenzacherstrasse 124
4070 Basel
Switzerland
Attn: (name of a Roche Alliance Director at the time)
		
	22.13.2
	Invoices to Dicerna

All invoices for payments to Roche that are required or permitted hereunder shall be in writing and sent by Roche to Dicerna via e-mail to the following addresses or such other address as Dicerna may later provide:

Accounts Payable: [* * *]
David Miller: [* * *]

		
	22.14
	 Notice

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

	
		
	if to Dicerna, to:

	Dicerna Pharmaceuticals, Inc.
33 Hayden Avenue
Lexington, MA 02421
U.S.A.
Attn:  Dicerna CEO

	and:
	Dicerna Pharmaceuticals, Inc.
33 Hayden Avenue
Lexington, MA 02421
U.S.A.
Attn: Dicerna Legal Department
Email: [* * *]

	if to Roche, to:
	F. Hoffmann-La Roche Ltd
Grenzacherstrasse 124
4070 Basel
Switzerland
Attn:  Legal Department

	and:
	Hoffmann-La Roche Inc.
150 Clove Road
Suite 8
Little Falls, New Jersey 07424
U.S.A.
Attn.  Corporate Secretary

or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith.

		
	22.15
	 Force Majeure

Neither Party shall be responsible to the other for any failure or delay in performing any of its obligations under this Agreement or for other nonperformance hereunder (excluding, in each case, the obligation to make payments when due) if such delay or nonperformance is caused by strike, fire, flood, earthquake, accident, war, act of terrorism, act of God or of the government of any country or of any local government, or by any other cause unavoidable or beyond the control of any Party hereto.  In such event, such affected Party shall use Commercially Reasonable Efforts to resume performance of its obligations and will keep the other Party informed of actions related thereto.

		
	22.16
	 Further Assurances

Roche and Dicerna hereby covenant and agree without the necessity of any further consideration, to execute, acknowledge and deliver any and all documents and take any action as may be reasonably necessary to carry out the intent and purposes of this Agreement.

		
	22.17
	 Compliance with Laws

Each Party shall, or shall cause its Affiliates, sublicensees or Third Party contractors to, perform its obligations under this Agreement in accordance with all Applicable Laws, including (i) all applicable local, state, federal and national data security and privacy laws, rules and implementing regulations, including the Health Insurance Portability and Accountability Act (HIPAA) and General Data Protection Regulation (2016/679), (ii) all applicable laws relating to anti-corruption, anti-kickbacks and anti-money laundering, including U.S. Foreign Corrupt Practices Act of 1977 and the UK Bribery Act of 2010, (iii) any GCPs, cGLPs, GMPs or GRPs (iv) Internal Compliance Codes, as applicable and (v) applicable securities laws. No Party shall, or shall be required to, undertake any activity under or in connection with this Agreement which violates, or which it believes, in good faith, may violate, any Applicable Laws.

		
	22.18
	 Export

Laws and regulations of the United States may restrict the export and re-export of commodities and technical data of United States origin.   Neither Party shall export or re-export restricted commodities or the technical data of the other Party in any form without appropriate United States and foreign government licenses.

		
	22.19
	 No Third Party Beneficiary Rights

This Agreement is not intended to and shall not be construed to give any Third Party any interest or rights (including any Third Party beneficiary rights) with respect to or in connection with any agreement or provision contained herein or contemplated hereby, except as otherwise expressly provided for in this Agreement.

		
	22.20
	 Counterparts; Electronic Signatures

This Agreement may be executed in one or more counterparts, each of which will be deemed an original, and all of which together will be deemed to be one and the same instrument.

[Signature Page Follows]

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

	
		
	Dicerna Pharmaceuticals, Inc.

___/s/ Douglas Fambrough_____________
Name: Douglas Fambrough
Title:    CEO
	

	
		
	F. Hoffmann-La Roche Ltd

____/s/ Vikes Kabra___________________
Name: Vikes Kabra
Title:   Head of Transaction Excellence
	

_______/s/ Stefan Arnold________________
Name: Stefan Arnold
Title:    Head of Legal Pharma

	
	
	Hoffmann-La Roche Inc.

_____/s/ John P. Parise_________________
Name: John. P Parise
Title:    Authorized Signatory

Appendix 1.41

Dicerna Base Patent Rights

[* * *]

83

Appendix 1.43

Dicerna GalXC Platform Patent Rights
as of the Effective Date

	
			
	Priority Applications
	Title
	National Applications

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

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

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

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

[* * *]

	
			
	Priority Applications
	Title
	National Applications

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

84

Appendix 1.91

 [* * *]

85

Appendix 2.4.2

[* * *]

86

Appendix 10.6.3

[* * *]

87

Appendix 16.1.5

Existing Third Party In-License Agreement

[* * *]

88

Appendix 19.3

Form of Press Release

Dicerna Enters Agreement with Roche to Develop and Commercialize  
DCR-HBVS for the Treatment of Chronic Hepatitis B Virus (HBV) Infection

– Roche to gain worldwide license to Dicerna’s novel RNAi therapy currently in Phase 1 –
– Dicerna to receive $200 million upfront plus up to $1.47 billion in potential milestone payments related to DCR-HBVS –
– Dicerna to retain option to co-fund pivotal development of DCR-HBVS worldwide and  
co-promote in U.S. with enhanced royalties –
– Collaboration includes discovery and development of additional therapies targeting multiple additional gene targets implicated in chronic HBV infection –

CAMBRIDGE, Mass., November 1, 2019 – DicernaTM Pharmaceuticals, Inc. (Nasdaq: DRNA) today announced a research collaboration and licensing agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) to develop novel therapies for the treatment of chronic hepatitis B virus (HBV) infection using Dicerna’s proprietary GalXCTM RNAi platform technology. The collaboration will focus on worldwide development and commercialization of DCR-HBVS, Dicerna’s investigational therapy in Phase 1 clinical development. The collaboration also includes the discovery and development of therapies targeting multiple additional human and viral genes associated with HBV infection using the technology platforms of both companies.

“Dicerna is excited to collaborate with Roche to realize the full potential of DCR-HBVS and leverage our GalXC platform to target and silence specific genes that contribute to chronic hepatitis B virus infection,” said Douglas M. Fambrough, Ph.D., president and chief executive officer of Dicerna. “With its deep expertise in HBV and established global infrastructure, Roche is ideally suited to help us accelerate the development and commercialization of DCR-HBVS, pursue a cure for chronic HBV infection, and address this serious global threat to public health.”

"We are excited to engage in a clinical partnership and research collaboration with Dicerna,” said John Young, global head of Infectious Diseases at Roche Pharma Early Research & Development. “This partnership builds upon our existing portfolio and internal expertise and positions us well to develop a best-in-disease therapy to cure chronic HBV infection."   

89

 

Under the terms of the agreement, Dicerna will receive $200 million in an initial upfront payment and may be eligible to receive up to an additional $1.47 billion over time for the achievement of specified development, regulatory and commercial milestones. In addition, Dicerna may be eligible to receive royalties based on potential product sales of DCR-HBVS. Dicerna retains an option to co-fund pivotal development of DCR-HBVS worldwide, which if exercised, entitles Dicerna to receive enhanced royalties and co-promote products including DCR-HBVS in the U.S.

Dicerna and Roche also agreed to collaborate on the research and development of additional therapies targeting multiple human and viral genes implicated in chronic HBV infection, using technology from both companies, for which Dicerna is eligible to receive additional milestones and royalties on any potential products.  

The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions.

About Chronic Hepatitis B Virus (HBV) Infection
Hepatitis B virus (HBV) is the world’s most common serious liver infection, with more than 292 million patients chronically infected, according to the World Health Organization. Chronic HBV infection, a condition characterized by the presence of the HBV surface antigen (HBsAg) for six months or more, claims more than 800,000 lives annually. HBV is also the primary cause of liver cancer (also known as hepatocellular carcinoma or HCC), which is the second-leading cause of cancer deaths in the world.1 

About DCR-HBVS and the DCR-HBVS-101 Clinical Trial
DCR-HBVS is an investigational drug in development for the treatment of chronic hepatitis B virus (HBV) infection. Current therapies for HBV, such as nucleoside analogs, can provide long-term viral suppression if taken continuously, but they rarely lead to long-term functional cures, as measured by the clearance of HBV surface antigen (HBsAg) and sustained HBV deoxyribonucleic acid (DNA) suppression in patient plasma or blood. By contrast, DCR-HBVS employs RNA interference to selectively knock down specific genes involved in the creation of HBV messenger RNA (mRNA) and the entry of the virus into liver cells. This approach leads to greater than 99.9% reduction in circulating HBsAg, as observed in mouse models of HBV infection. These data suggest that DCR-HBVS may induce clearance of HBsAg and contribute meaningfully to a functional cure for HBV.

Dicerna is conducting a Phase 1, randomized, placebo-controlled study designed to evaluate the safety and tolerability of DCR-HBVS in healthy volunteers (HVs) and in patients with non-cirrhotic chronic HBV infection. 

About Dicerna's GalXCTM RNAi Technology Platform
Dicerna’s proprietary RNA interference (RNAi) technology platform, called GalXCTM, aims to advance the development of next-generation RNAi-based therapies designed to silence disease-driving genes in the liver and other body systems. Liver-targeted GalXC-based compounds enable subcutaneous delivery of RNAi therapies that are designed to specifically bind to receptors on liver cells, leading to internalization and access to the RNAi machinery within the cells. The GalXC approach seeks to optimize the activity of the RNAi pathway so that it operates in the most specific and potent fashion. Compounds produced via GalXC are intended to be broadly applicable across multiple therapeutic areas, including both liver and non-liver indications.
About DicernaTM Pharmaceuticals, Inc.
DicernaTM Pharmaceuticals, Inc., is a biopharmaceutical company using ribonucleic acid (RNA) interference (RNAi) to develop medicines that silence genes that cause disease. The Company’s proprietary GalXCTM technology is being applied to develop potent, selective, and safe RNAi therapies for treatment of rare diseases, chronic liver diseases, cardiovascular diseases, neurodegenerative diseases, pain, and viral infectious disease. Dicerna aims to treat disease by addressing the underlying causes of illness with capabilities that extend beyond the liver to address a broad range of diseases, focusing on target genes where connections between gene and disease are well understood and documented. Dicerna intends to discover, develop, and commercialize novel therapies either on its own or in collaboration with pharmaceutical partners. Dicerna has strategic collaborations with Roche, Eli Lilly and Company (Lilly), Alexion Pharmaceuticals, Inc. (Alexion), and Boehringer Ingelheim International GmbH (BI). For more information, please visit www.dicerna.com.

Dicerna Forward-Looking Statement
This press release includes forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Examples of forward-looking statements include, among others, statements we make regarding: (i) the full potential of DCR-HBVS and to leverage our GalXC platform to target and silence specific genes that contribute to HBV cures; (ii) the potential to earn revenue from royalties and milestone payments under the collaboration with Roche; (ii) research and development plans related to GalXC and its utility in silencing genes that contribute to HBV; (iii) the potential of RNAi therapies for the treatment of chronic HBV infection; and (iv) the potential for the collaboration between Roche and Dicerna. The process by which an early-stage platform such as GalXC could potentially lead to an approved 

product is long and subject to highly significant risks, particularly with respect to a preclinical research collaboration. Applicable risks and uncertainties include those relating to preclinical research and other risks identified under the heading "Risk Factors" included in Dicerna's most recent Form 10-Q filings and in other future filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Dicerna's current views with respect to future events, and Dicerna does not undertake and specifically disclaims any obligation to update any forward-looking statements, except as required by law.

DicernaTM and GalXCTM are trademarks of Dicerna Pharmaceuticals, Inc.

Reference
1. Hepatitis B Foundation. Facts and Figures. 2019. Available at: http://www.hepb.org/what-is-hepatitis-b/what-is-hepb/facts-and-figures/. Accessed on October 25, 2019.

Contacts
Investors:
Stern Investor Relations, Inc. 
Lauren Stival, 212-698-8646 
Lauren.stival@sternir.com 

Media:
SmithSolve
Alex Van Rees, 973-442-1555 ext. 111
alex.vanrees@smithsolve.comExhibit

Exhibit 10.47
 

CERTAIN INFORMATION IDENTIFIED BY BRACKETED ASTERISKS ([* * *]) HAS BEEN OMITTED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
COLLABORATION AND LICENSE AGREEMENT

between

NOVO NORDISK A/S

and

DICERNA PHARMACEUTICALS, INC.

NOVEMBER 15, 2019

 

		
	1.
	DEFINITIONS AND INTERPRETATIONS    1

		
	2.
	TARGET SELECTION AND VALIDATION    24

		
	2.1
	Target Selection, Validation, and Development Candidates.    24

		
	2.2
	Development Candidates.    25

		
	2.3
	Reserved and Option Targets.    26

		
	2.4
	Gatekeeper Process.    29

		
	2.5
	Scope of Blocked Targets    31

		
	2.6
	Encumbered Targets    31

		
	3.
	EXCLUSIVITY    31

		
	3.1
	Hepatocyte Target Exclusivity – R&D Collaboration Term.    31

		
	3.2
	Development Candidate and Product Exclusivity – Term of Agreement,    32

		
	3.3
	Novo Options for Dicerna Reserved Orphan Liver Target.    32

		
	3.4
	Limited Novo Exclusivity.    33

		
	3.5
	Blocked Targets and Third Party Agreements.    34

		
	4.
	RESEARCH AND PRODUCT DEVELOPMENT    34

		
	4.1
	Research and Development Program.    34

		
	4.2
	Research and Development Activities.    35

		
	4.3
	Clinical Development Activities.    35

		
	4.4
	Costs of Performance.    35

		
	4.5
	IND Filing    37

		
	4.6
	Records, Reports and Audits.    37

		
	4.7
	Certain Standards Applicable to Work    38

		
	4.8
	Right to Subcontract    39

		
	5.
	MANUFACTURING AND COMMERCIALIZATION    40

		
	5.1
	Compound and Product Manufacturing Generally.    40

		
	5.2
	Product Quality Generally    41

		
	5.3
	Commercialization by Novo    41

		
	5.4
	Co-Development Payments    41

		
	6.
	GOVERNANCE AND JOINT STEERING COMMITTEE    43

		
	6.1
	Project Leader    43

		
	6.2
	Program Leader    44

		
	6.3
	Alliance Leader    44

i

 

		
	6.4
	Working Groups    44

		
	6.5
	Joint Steering Committee.    45

		
	7.
	LICENSES    47

		
	7.1
	License Grant to Novo    47

		
	7.2
	Sublicenses    47

		
	7.3
	License Grants to Dicerna    47

		
	7.4
	Know-How Transfer; Availability of Employees    47

		
	7.5
	Covenants    48

		
	7.6
	Mutual Use of Confidential Information    48

		
	7.7
	No Implied Licenses    48

		
	7.8
	Third Party IP Agreements.    49

		
	8.
	FINANCIAL PROVISIONS    50

		
	8.1
	Upfront Payment; Escrow    50

		
	8.2
	Annual Fee    50

		
	8.3
	Pre-Clinical Milestones; DC Milestones    51

		
	8.4
	Development and Regulatory Milestones    51

		
	8.5
	Commercialization Milestones    53

		
	8.6
	Royalties.    53

		
	8.7
	Co-Development Programs.    56

		
	9.
	REPORTS AND PAYMENT TERMS    56

		
	9.1
	Net Sales Reports and Royalties Due    56

		
	9.2
	Payment Currency / Exchange Rate    56

		
	9.3
	Novo Nordisk Invoicing Instructions    56

		
	9.4
	Taxes    57

		
	9.5
	Audit Rights (Financial).    58

		
	10.
	INTELLECTUAL PROPERTY RIGHTS    59

		
	10.1
	Disclosure of Inventions    59

		
	10.2
	Notification of Issuance    59

		
	10.3
	Novo Background IP    59

		
	10.4
	Dicerna Background IP    59

		
	10.5
	Program Inventions; Joint Inventions.    60

		
	10.6
	Cooperation    61

ii

 

		
	10.7
	Filing, Prosecution, Enforcement and Defense.    61

		
	10.8
	Management of Novo Background Patents    64

		
	10.9
	Product Infringement    64

		
	10.10
	Product Trademarks    65

		
	10.11
	Inventorship and Title    65

		
	10.12
	Invention Disclosure and Recordkeeping    65

		
	10.13
	Consultation on Program Inventions    66

		
	11.
	CONFIDENTIALITY    66

		
	11.1
	Duty of Confidence    66

		
	11.2
	Exceptions    66

		
	11.3
	Authorized Disclosures    66

		
	11.4
	Performance; Regulatory Approvals    67

		
	11.5
	Disclosure of Agreement    68

		
	11.6
	Breaches of Confidentiality; Assistance in Respect of Same    69

		
	11.7
	Security    69

		
	12.
	PUBLICATIONS AND PUBLICITY    69

		
	12.1
	Publications    69

		
	12.2
	Publicity    70

		
	13.
	HSR FILINGS AND CLOSING    70

		
	13.1
	HSR Filings    70

		
	13.2
	Conduct Pending HSR Clearance Date    71

		
	14.
	TERM AND TERMINATION    71

		
	14.1
	Term    71

		
	14.2
	Voluntary Termination    71

		
	14.3
	Termination for Cause.    72

		
	14.4
	Alternative to Termination    73

		
	15.
	EFFECTS OF TERMINATION    73

		
	15.1
	Termination of Agreement    73

		
	15.2
	Target/Product Return.    74

		
	15.3
	Survival    76

		
	15.4
	Termination Not Sole Remedy    76

		
	15.5
	Bankruptcy Code    77

iii

 

		
	16.
	REPRESENTATIONS AND WARRANTIES    77

		
	16.1
	Representations and Warranties by Each Party    77

		
	16.2
	Representations, Warranties and Covenants by Dicerna    79

		
	16.3
	No Other Warranties    81

		
	17.
	INDEMNIFICATION AND LIABILITY    81

		
	17.1
	Indemnification by Dicerna    81

		
	17.2
	Indemnification by Novo    81

		
	17.3
	Indemnification Procedure.    82

		
	17.4
	SPECIAL, INDIRECT, AND OTHER LOSSES    83

		
	17.5
	Insurance    83

		
	18.
	COMPLIANCE    83

		
	18.1
	Compliance with this Agreement    83

		
	18.2
	Compliance with Party Specific Regulations    83

		
	18.3
	Compliance with Internal Compliance Codes    83

		
	18.4
	Compliance with Anti-Corruption Laws    84

		
	18.5
	Prohibited Conduct    84

		
	18.6
	Responsible Business    84

		
	19.
	GENERAL PROVISIONS    84

		
	19.1
	Assignment    84

		
	19.2
	Effects of Assignment, Change of Control    85

		
	19.4
	Severability    86

		
	19.5
	Governing Law; English Language    86

		
	19.6
	Dispute Resolution.    86

		
	19.7
	Continued Performance During Pendency of Arbitral Matters    88

		
	19.8
	Consent to Non-Exclusive Jurisdiction; Service of Process    88

		
	19.9
	Force Majeure    88

		
	19.10
	Waivers and Amendments    88

		
	19.11
	Relationship of the Parties    88

		
	19.12
	Notices    88

		
	19.13
	Further Assurances    89

		
	19.14
	Compliance with Law    90

		
	19.15
	No Third Party Beneficiary Rights    90

iv

 

		
	19.16
	Entire Agreement    90

		
	19.17
	Counterparts    90

		
	19.18
	Expenses    90

		
	19.19
	Binding Effect    90

		
	19.20
	Construction    90

		
	19.21
	Interpretation    90

		
	19.22
	Cumulative Remedies    91

		
	19.23
	Export    91

List of Exhibits:

Exhibit A –     Work Flow Plan
Exhibit B –     Initial Research Plan
Exhibit C –     Novo Nordisk A/S’s Invoicing Instructions 
Exhibit D –     Press Release
Exhibit E –     Existing Patents
Exhibit F –     Co-Development Programs Profit Sharing 
Exhibit G –     Co-Promotion Principles 
Exhibit H –    Dicerna Competitors
Exhibit I –     Dicerna Contract Manufacturers
Exhibit J –      Patent Prosecution: Default Countries & Territories
Exhibit K –      [Intentionally Omitted]
Exhibit L –     Use of Human Biosamples and Informed Consent
Exhibit M –     NOVO Principles for the Use of Animals

v

COLLABORATION AND LICENSE AGREEMENT
THIS COLLABORATION AND LICENSE AGREEMENT (the “Agreement”), entered into as of November 15, 2019 (the “Signing Date”) is by and between NOVO NORDISK A/S, a corporation organized and existing under the laws of Denmark, having an address at Novo Allé, 2880 Bagsvaerd, Denmark, CVR No. 24 25 67 90 (“Novo”), on the one hand, and DICERNA PHARMACEUTICALS, INC., a corporation organized and existing under the laws of Delaware, with its principal place of business at 33 Hayden Avenue, Lexington, Massachusetts 02421, U.S.A. (“Dicerna”), on the other hand.  Dicerna and Novo are each referred to individually as a “Party” and together as the “Parties”.  
BACKGROUND
A.Novo is a leading global health care company engaged in the research, development and commercialization of pharmaceutical products.
B.    Dicerna has developed a RNAi platform technology targeting hepatocytes in the liver using GalXC Molecules (as defined below) to silence mRNA molecules, which may lead to therapeutic uses of such GalXC Molecules in patients with unmet medical needs. 
C.    Novo and Dicerna desire to enter into this Agreement to allow the Parties to collaborate using Dicerna’s GalXC Platform in selecting hepatocyte gene targets and identifying GalXC Molecules from which one or more Products could be developed to treat liver-associated cardiometabolic diseases, including non-alcoholic steatohepatitis, and potentially other diseases in each case, on terms set forth in this Agreement.
D.    Novo desires to obtain exclusive and nonexclusive licenses from Dicerna to support the activities conducted pursuant to the research and development program and to enable Novo to Commercialize Products derived from or containing compounds developed pursuant to this Agreement, and Dicerna is willing to grant such rights to Novo subject to the terms and conditions as set forth below.
E.    The Parties desire to jointly participate in the Development and Commercialization of certain Products.
F.    Concurrently with the entering into of this Agreement, Dicerna and Novo are entering into a Share Issuance Agreement, pursuant to which Novo will purchase certain shares of Dicerna’s Common Stock on the terms and conditions set forth therein.
NOW THEREFORE, in consideration of the mutual covenants and agreements contained herein, the sufficiency which is acknowledged by both Parties, the Parties agree as follows:

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1.DEFINITIONS AND INTERPRETATIONS
Capitalized terms used in this Agreement shall have the meanings specified in this Article 1, or as defined elsewhere in this Agreement.
1.1    “Acceptance for Filing” means, following the submission of an application for Marketing Authorization made to a Regulatory Authority, the expiration of any applicable waiting period during which the Regulatory Authority has authority to issue a refusal to file, if any, as to such application.
1.2    “Accounting Firm” has the meaning set forth in Section 9.5.1.
1.3    “Accounting Standards” means accounting determinations made according to (i) U.S. Generally Accepted Accounting Principles, with respect to Dicerna and its Affiliates, and (ii) International Financial Reporting Standards, with respect to Novo and its Affiliates.
1.4    “Acquirer” has the meaning set forth in Section 1.24.
1.5    “Act” means, as applicable, the United States Federal Food, Drug, and Cosmetic Act, 44 U.S.C. §§ 301 et seq., or the Public Health Service Act, 42 U.S.C. §§ 262 et seq., as such may be amended from time to time.
1.6    “Action” has the meaning set forth in Section 10.7.5. 
1.7    “Affiliate” means, with respect to a Party, a person, corporation, company, partnership, joint venture or other entity, which Controls, is Controlled by, or is under common Control with such Party. For the purpose of this definition, “Control” of an entity means the ownership, directly or indirectly, of more than fifty percent (50%) of the outstanding voting securities or capital stock of such entity, or the legal power to direct or cause the direction of the general management and policies of the entity in question.  An entity will be deemed to be an Affiliate for so long as such Control exists. Novo Holdings A/S, the Novo Nordisk Foundation, and Novozymes A/S and their respective Excluded Affiliates (other than Novo and its subsidiaries) are not considered Affiliates of Novo.  “Excluded Affiliates” means with respect to Novo Holdings A/S, the Novo Nordisk Foundation, and Novozymes A/S and any person, corporation, company, partnership, joint venture or other entity, which Controls, is Controlled by, or is under common Control with such entities.
1.8    “Alexion” has the meaning set forth in Section 1.18.
1.9    “Alexion Agreement” has the meaning set forth in Section 1.18.
1.10    “Alliance Leader” has the meaning set forth in Section 6.3.
1.11    “Annual Net Sales” means, on a Product-by-Product basis, for a given Calendar Year, all Net Sales of such Product throughout the Territory during such Calendar Year.

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1.12    “Applicable Laws” means all federal, state, local, national and supra-national laws, statutes, rules and regulations, including any rules, regulations, guidelines or requirements of Regulatory Authorities, taxing authorities, national securities exchanges or securities listing organizations that may be in effect from time to time during the Term and applicable to a particular activity hereunder.
1.13    “Audited Party” has the meaning set forth in Section 9.5.1.
1.14    “Auditing Party” has the meaning set forth in Section 9.5.1.
1.15    “BI” has the meaning set forth in Section 1.18.  
1.16    “BI Agreement” means that certain Collaborative Research and License Agreement between BI and Dicerna dated October 27, 2017, as (subject to Section 2.5) amended and in effect from time to time.  
1.17    “Bioinformatics Package and Mapping Plan” has the meaning set forth in Section 8.1.2.
1.18    “Blocked Target” means targets [* * *].
1.19    “Blocked Target List” has the meaning set forth in Section 2.4.2.
1.20    “Business Day” means a day on which commercial banking institutions are open for business in each of Boston, Massachusetts, New York, New York, U.S. and Copenhagen, Denmark. 
1.21    “Calendar Day” means any day of the Calendar Year.
1.22    “Calendar Quarter” means any respective period of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31 of any Calendar Year.
1.23    “Calendar Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31.
1.24    “Change of Control” means:
(a)     with respect to either Party: (i) the acquisition by a Third Party or group of Third Parties acting in concert, in one transaction or a series of related transactions, of direct or indirect beneficial ownership of more than fifty percent (50%) of the outstanding voting equity securities of such Party; (ii) a merger, transfer of control or consolidation involving such Party, as a result of which a Third Party or group of Third Parties acting in concert acquires direct or indirect beneficial ownership of more than fifty percent (50%) of the voting power of the surviving entity immediately after such merger, reorganization or consolidation; or (iii) a sale, transfer or disposition of all or substantially all of the assets of such Party in one transaction or a series of related transactions to a Third Party or group of Third Parties acting in concert, but in any event, excluding any consolidation or merger 

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effected exclusively to change the domicile of a Party where the ultimate indirect share ownership of the Party as a result of such consolidation or merger does not change.  The acquiring or combining Third Party in any of (i), (ii) or (iii), and any of such Third Party’s Affiliates (other than the acquired Party and its Affiliates as in existence prior to the applicable transaction) are referred to collectively herein as the “Acquirer”; or
(b)    with respect to Dicerna: (i) the acquisition by a Novo Competitor (and/or Affiliates of such Novo Competitor) or group of Third Parties (of which at least one is a Novo Competitor) acting in concert, whether in one transaction or a series of related transactions, of: (1) majority control of the board of directors or equivalent governing body of Dicerna; (2) direct or indirect beneficial ownership of more than forty percent (40%) of the outstanding voting equity securities of Dicerna; or (ii) a merger, transfer of control or consolidation involving Dicerna, as a result of which a Novo Competitor (and/or Affiliates of such Novo Competitor) or group of Third Parties (of which at least one is a Novo Competitor) acting in concert acquires direct or indirect beneficial ownership of more than forty percent (40%) of the voting power of the surviving entity immediately after such merger, reorganization or consolidation; or (iii) a sale, transfer or disposition of all or substantially all of the assets of Dicerna related to the transactions contemplated by this Agreement.  In any such case, such Novo Competitor and its Affiliates (other than Dicerna and its Affiliates in existence prior to the applicable transaction) shall also be considered an Acquirer of Dicerna. 
1.25    “Claims” has the meaning set forth in Section 17.1.
1.26    “Clinical Trial” means a Phase 1 Clinical Trial, Phase 2 Clinical Trial or Phase 3 Clinical Trial, or any post-approval human clinical trial, as applicable.
1.27    “CMC Activities” means chemistry, manufacturing and controls activities.
1.28    “CMC Working Group” has the meaning set forth in Section 6.4.
1.1    “Co-Development Budget” has the meaning set forth in Section 5.4.1.
1.2    “Co-Development Percentage” means a percentage representing a designating Party’s economic stake in a Co-Development Program.  Novo as the designating Party under Section 3.3 will designate the percentage of at least [* * *] and not greater than [* * *] as X percent (X%) and Dicerna will be [* * *] minus X percent ([* * *]-X%).  Dicerna as the designating Party under Sections 2.3.2(c) or 2.3.3 will designate the percentage of at [* * *] and not greater than [* * *] as X percent (X%) and Novo will be [* * *] minus X percent ([* * *]-X%).  
1.3    “Co-Development Post-Option Expenses” means, with respect to a given Co-Development Program, the Co-Development Percentage multiplied by the portion of Development Expenses incurred after designation as a Co-Development Program.

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1.4    “Co-Development Pre-Option Expenses” means with respect to a given Co-Development Program, the Co-Development Percentage multiplied by the portion of Development Expenses incurred [* * *] until designation as a Co-Development Program.
1.5    “Co-Development Product” means a Compound Directed To a Co-Development Target.
1.6    “Co-Development Profit Share” has the meaning set forth in Section 5.4.2.  
1.7    “Co-Development Program” means Research of a Co-Development Target, or Development and Commercialization of a Co-Development Product.
1.8    “Co-Development Target” means a Target that either Dicerna or Novo has designated under Sections 2.3.2, 2.3.3, or 3.3 for co-development and co-commercialization.
1.9    “Code” has the meaning set forth in Section 15.5.
1.10    “Collaboration Targets” has the meaning set forth in Section 2.1.1, including Validated, Continuation and Co-Development Targets, but not Discontinued Targets.
1.11    “Combination Product” has the meaning set forth in Section 1.142.
1.12    “Commercial Milestone Event” has the meaning set forth in Section 8.5.
1.13    “Commercial Milestone Payment” has the meaning set forth in Section 8.5.
1.14    “Commercialization” or “Commercialize” means any and all activities directed to the offering for sale and sale of a Compound, Product, or other compound, product or therapy including: (a) activities directed to storing, marketing, promoting, detailing, distributing, importing, exporting, selling and offering to sell that Compound, Product, or other compound, product or therapy; (b) conducting Clinical Trials after Marketing Authorization of a Compound, Product, or other compound, product or therapy with respect to such Compound, Product, or other compound, product or therapy; (c) interacting with Regulatory Authorities regarding the foregoing; and (d) seeking pricing approvals and reimbursement approvals (as applicable) for that Compound, Product or other compound, product or therapy in the Field in the Territory.  When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization and “Commercialized” has a corresponding meaning. For clarity, “Commercialization” shall not include any Research or Development activities.
1.15    “Commercially Reasonable Efforts” [* * *]. 
1.16    “Competing GalXC Product” means any product that contains a GalXC Molecule Directed To a Collaboration Target that is being researched, developed, used, made (including formulated) or commercialized by a Third Party.
1.17    “Complement Pathway” [* * *].

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1.18    “Compound” [* * *].  
1.19    “Confidential Information” means all Know-How or other information or materials of a Party, in any form (written, oral, electronic, photographic, or otherwise) that is confidential or proprietary, including:
(a)    all Know-How which is generated by or on behalf of a Party under this Agreement or which one Party or any of its Affiliates or representatives has provided or otherwise made available to the other Party, including such Know-How comprising or relating to concepts, discoveries, Inventions, data, designs or formulae arising from this Agreement;
(b)    all such information or materials regarding or concerning any Collaboration Target, Compound, Product, or any other technical or business information;
(c)    all communications between the Parties or information of whatever kind whether recorded or not and, if recorded, in whatever medium, relating to or arising out of this Agreement, whether disclosed prior to or after entering into this Agreement;
(d)    any information that the Party indicates in writing is information of a confidential nature or which is marked “confidential”; and,
(e)    all copies and excerpts of the communications, information, notes, reports and documents in whatever form referred to in subclauses (a) through (d) of this definition.
For purposes of the confidentiality obligations set forth herein and subject to Section 7.6 and for so long as they continue as Confidential Information under Article 11: (i)  Know-How owned or Controlled by Novo (other than Joint Know-How) shall be deemed Confidential Information of Novo; (ii) Know-How owned or Controlled by Dicerna (other than Joint Know-How) shall be deemed Confidential Information of Dicerna; (iii) the terms and conditions of this Agreement shall be deemed Confidential Information of both Parties; (iv) any disclosed information which is not publicly available relating to the Blocked Targets and is not otherwise possessed by Novo (and does not otherwise come into Novo’s possession), including the identity of Dicerna Excluded Programs, or Discontinued Targets shall be deemed Confidential Information of Dicerna; (v) any of Novo’s Confidential Information on Novo’s Own Targets prior to selection of such Novo’s Own Targets as Collaboration Targets shall continue to be Confidential Information of Novo even after such Novo’s Own Targets become Discontinued Targets; (vi) for purposes of the restriction on disclosure, non-public information concerning Collaboration Targets, Compounds and Products (including the identity, structure and/or properties, in each case, specific to the Collaboration Targets, Compounds and Products in the Field, except for the GalXC Platform) and information contained in the Research Plans shall be deemed Confidential Information of both Parties; and (vii) for purposes of the restriction on disclosure, Joint Know-How shall be deemed Confidential Information of both Parties and kept confidential per the terms of Article 11, unless subsequently assigned to the other Party as set forth in Article 10, in which case, such Know-How shall become the Confidential Information of the assignee.  For clarity, nothing in the foregoing shall limit Sections 3.1 through 3.3 or the exclusive licenses granted to Novo pursuant to Section 7.1). Product-Specific Know-How shall be used by the Parties only in accordance with the terms of this Agreement.

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1.20    “Confidentiality Agreement” has the meaning set forth in Section 19.16.
1.21    “Continuation Targets” has the meaning set forth in Section 2.3.4.
1.22    “Control” or “Controlled” means, with respect to any Know-How, or intellectual property right (including any Patent Right), that a Party owns, or has a license to, such Know-How or intellectual property right, in each case to the extent such Party has the power to grant to the other Party access, a license, or a sublicense (as applicable) to the same on the terms and conditions set forth in this Agreement; provided that, as to Know-How or Patent Rights first licensed or acquired by Dicerna from a Third Party after the Effective Date, such Know-How or Patent Right will be included as “Controlled” by Dicerna only if Novo elects to accept a sublicense or license in accordance with Section 7.8.1.  Notwithstanding anything in this Agreement to the contrary, in the event of a Change of Control of a Party, the Party shall be deemed to not Control any intellectual property right that is owned or controlled by the Acquirer or its Affiliates prior to or after the Change of Control, other than Know-How and intellectual property rights Controlled by such Party prior to the Change of Control.  
1.23    “Co-Promotion Agreement” means a co-promotion agreement for a Co-Development Program for which the Parties have agreed to co-promote according to Sections 2.3.2(c), 2.3.3(b) (in the US for Dicerna’s option) or 3.3 and to be negotiated by the Parties based on the co-promotion principles as set forth in Exhibit G.  
1.24    “Cover”, “Covering”, or “Covered” means, with respect to Patent Rights, where the use, Manufacture, sale, offer for sale, import or export of subject matter (including, but not limited to, goods and services such as Products), absent ownership or a license, would infringe at least one issued and unexpired claim (or a pending claim, if such pending claim were to issue without modification from a claim in the application as filed) of such Patent Rights which has not been declared invalid or unenforceable by a patent office or a court of competent jurisdiction in a decision that is unappealable or unappealed.
1.25    “CRO” has the meaning set forth in Section 4.4.2.
1.26    “Data Package” means, with respect to a given Collaboration Target, a data package that includes each of the following: (a) relevant data related to such Collaboration Target, including design and synthesis of the Compound(s) Directed To the Collaboration Target, and any in vitro and in vivo validation and other related research and preclinical data and information relating to such Compound(s) and Collaboration Target; (b) a reasonably detailed analysis of the data related to such Collaboration Target; and (c) such other information regarding such Collaboration Target as Novo may otherwise reasonably request that is in Dicerna’s possession and control.  
1.27    “DCR-HBVS” means the GalXC Molecule known as DCR-S219 that is identified in clinicaltrials.gov with the clinical trial identifier NCT03772249.
1.28    “Default Countries” means, with respect to Program Inventions and/or Product-Specific Patents Covering Compounds and Products advanced to at least a Phase 1 Clinical Trial, each patent application shall at least be filed in the countries identified in Exhibit J.

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1.29    “Development” or “Develop” means, with respect to a Compound or Product, any activities after nomination as a Development Candidate for such Compound or Product, including research, preclinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, Manufacture, process development, clinical studies (including manufacturing in support thereof, but excluding any commercial manufacturing), statistical analysis and report writing, the preparation and filing of regulatory filings and all regulatory affairs related to the foregoing.  When used as a verb, “Developing” means to engage in Development and “Developed” has a corresponding meaning.  For clarity, “Development” shall not include any Research or Commercialization activities.
1.30    “Development and Regulatory Milestone Event” has the meaning set forth in Section 8.4.
1.31    “Development and Regulatory Milestone Payment” has the meaning set forth in Section 8.4.
1.32    “Development Budget” means, with respect to a Compound, projection of expected total Development Expenses through Marketing Authorization from nomination as a Development Candidate.
1.33    “Development Candidate” or “DC” has the meaning set forth in Section 2.2.
1.34    “Development Expenses” means all expenses incurred in accordance with the Accounting Standards, directly or indirectly, in connection with the Development activities hereunder, including without limitation expenses incurred in connection with: (i) obtaining, maintaining and/or expanding Regulatory Approval and/or the ability to Manufacture, formulate, use, fill, ship and/or sell a Product; (ii) data management, statistical designs and studies, document preparation, and other expenses associated with clinical testing programs; (iii) costs of process development or improvement, Manufacturing Expenses (including Manufacturing activities occurring prior to nomination of a Development Candidate approved by Novo for use in future Development activities and Manufacturing Expenses incurred in Manufacturing Product inventory in preparation for commercial sales), scale-up, validation and recovery (including plant costs), in each case including all FTE Expenses for FTEs who perform activities in furtherance of the foregoing.
1.35    “Development Plan” means, with respect to a Development Candidate, an outline of Development activities to be conducted and corresponding objectives to be achieved up until Commercialization.
1.36    “Dicerna Background IP” has the meaning set forth in Section 10.4.
1.37    “Dicerna Excluded Programs” means the research and development of compounds or products by Dicerna and its Affiliates Directed To the Targets identified in subsection (i) of the definition of “Blocked Targets” in Section 1.18 above.
1.38    “Dicerna Indemnified Party” has the meaning set forth in Section 17.2.

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1.39    “Dicerna Orphan Product” has the meaning set forth in Section 3.3.
1.40    “Dicerna Reserved Orphan Liver Target” has the meaning set forth in Section 2.3.2.
1.1    “Direct Manufacturing Costs” means all direct manufacturing costs and charges for a given Compound or Product, including: (a) direct manufacturing charges reasonably allocable to Compounds or Products, such as purchase of materials, (b) storage and insurance, packaging and shipment thereof, and (c) FTE Expenses (e.g., quality, manufacturing, and chemistry) used therefor and equipment purchased for Compounds or Products and excluding: (y) amortization of property or equipment not specifically related to manufacturing of Products and (z) allocation of general corporate overhead.    
1.2    “Directed To” means, with regard to an RNAi product or oligonucleotide product and Target, [* * *].  For clarity, if the defined term “Directed To” is separated, such as when required grammatically (e.g., when discussing Targets “To which a product is Directed”), such separated term shall maintain the same meaning set forth in the previous sentence.
1.3    “Discontinued Target” means a Target with [* * *] pursuant to Section 2.3.5 or as to which Novo has exercised a right of termination under Section 14.2.  In case of termination of this Agreement in its entirety under Section 14.2 or under Section 14.3 then all Collaboration Targets shall be Discontinued Targets.
1.4    “Discovery Period” has the meaning set forth in Section 2.1.1.
1.5    “Dispute” has the meaning set forth in Section 19.6.1.
1.6    “Distribution Expenses” means all expenses incurred in accordance with the Accounting Standards, directly or indirectly, in connection with the distribution of Products, including, without limitation, expenses for customer services, order entry, billing, shipping, insurance, tariffs, customs, duties and similar taxes, credit and collection and other such activities, in each case: (i) except to the extent deducted in the calculation of Net Sales and (ii) including all FTE Expenses for FTEs who perform activities in furtherance of the foregoing.
1.7    “DOJ” has the meaning set forth in Section 13.1.
1.8    “Dollar” means the United States of America dollar, and “$” and “USD” will be interpreted accordingly.
1.9    “Effective Date” means the HSR Clearance Date.
1.10    “Effective Patent Claim” means any Valid Claim of: (a) a patent; or (b) a pending patent application; in each case claiming a method of use of a Compound or Product for an approved use of a Product or the composition of matter (including formulations) of a Compound or Product and included within the Licensed Patent Rights (including Product-Specific Patents).
1.11    “EMA” means the European Medicines Agency and any successor thereto.

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1.12    “Escrow Agent” means Silicon Valley Bank or such other bank or other entity selected by the Parties as the escrow agent under the Escrow Agreement.
1.13    “Escrow Agreement” means the Escrow Agreement entered into as of the Signing Date by and among the Escrow Agent, Novo and Dicerna to effectuate the intent and purposes of Section 8.1.
1.14    “Excluded Claim” has the meaning set forth in Section 19.6.5.
1.15    “Excluded Field” means any and all uses of the GalXC Platform, including any and all use of the GalXC Molecules generated by the GalXC Platform, for diagnostic, therapeutic, or prophylactic uses in humans, in an indication whose [* * *].
1.16    “Existing Patents” has the meaning set forth in Section 16.2.3(a).
1.17    “Expenses and Payments” has the meaning set forth in Section 9.5.1.
1.18    “FDA” means the United States Food and Drug Administration and any successor thereto.
1.19    “FFDCA” has the meaning set forth in Section 16.1.5.
1.20    “Field” means any and all diagnostic, therapeutic or prophylactic uses in humans for indications which achieve their beneficial effect using a [* * *] except [* * *].
1.21    “First Commercial Sale” means, in a country, the first sale of a Product by Novo or Dicerna or their respective Affiliates or their sublicensees, to an unaffiliated Third Party in that country after receipt of all Marketing Authorizations required to market and sell the Product have been obtained in the country in which such Product is sold.  Sales for purposes of testing the Product and sample purposes shall not be deemed a First Commercial Sale.  Furthermore, for purposes of clarity, the term “First Commercial Sale” as used in this Agreement shall not include: (i) any distribution or other sale solely for so-called treatment investigational new drug sales, named patient sales, compassionate or emergency use sales or pre-license sales, in each case provided that such Product is distributed without charge or sold at or below cost; (ii) intercompany transfers to Affiliates of a Party or between such entities and a sublicensee of a Party or an Affiliate, provided a subsequent sale to an unaffiliated Third Party by such Affiliate of a Party or sublicensee is not considered an intercompany transfer; nor (iii) other similar non-commercial sales.
1.22    “FTC” has the meaning set forth in Section 13.1.
1.23    “FTE” means, with respect to a person, the equivalent of the work of one (1) employee full time for [* * *] (consisting of at least [* * *] per year (with no further reductions for vacations and holidays)).  Overtime, and work on weekends, holidays and the like will not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution.  The portion or multiple of an FTE billable by the applicable Party for one (1) individual during a given accounting period shall be determined by dividing the number of hours worked by said individual on the work to be conducted under the Agreement during 

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such accounting period and the number of FTE hours applicable for such accounting period based on [* * *] per Calendar Year, applied consistently throughout the Calendar Year.  For clarity, no individual person can ever constitute more than a single FTE.
1.24    “FTE Expenses” means the FTE Rate multiplied by the applicable number of FTEs.
1.25    “FTE Rate” means, for the period commencing on the Effective Date until such time as the Parties agree otherwise, [* * *] per year, subject to annual increases or decreases beginning on January 1, 2021 to reflect the percentage increase or decrease in the Consumer Price Index – All Urban Consumers, US City Average, All Items (as quoted by the U.S. Department of Labor, Bureau of Labor Statistics), and similarly calculated year to year increases each subsequent Calendar Year.  The FTE Rate shall be deemed to encompass compensation for expenses of salaries, benefits, supplies, other employee expenses, and supporting overhead and general and administration allocations.
1.26    “GalXC Molecule” means an RNAi molecule conjugated to one or more N-acetylgalactosamine (GalNAc) ligands and designed to be Directed To a Target. 
1.27    “GalXC Patents” has the meaning set forth in Section 10.7.1.
1.28    “GalXC Platform” means the RNAi technology platform Controlled by Dicerna, generating and using GalXC Molecules to silence one or more mRNA molecules.
1.29    “GalXC Platform IP” means [* * *].  
1.30    “Gatekeeper” has the meaning set forth in Section 2.4.1.
1.31    “Generic Product” means, as to a given Product, a product whose sale is not authorized by Novo or its Affiliates or sublicensees that is (a) approved by a Regulatory Authority as therapeutically equivalent to such Product in a country for at least one approved indication of the Product in such country, or (b) is approved by a Regulatory Authority by making cross-reference to and relying on the safety and effectiveness data provided to such Regulatory Authority for the Product on the basis that it demonstrates bioequivalence or biosimilarity or interchangeability to such Product.
1.32    “Global Profits” means, as to a given Product, Net Sales less the following items: Manufacturing Expenses, Marketing Expenses, Sales Expenses, Patent Expenses, Distribution Expenses, and Development Expenses, for a given period.  For the avoidance of doubt, Co-Development Pre-Option Expenses will not be used to calculate Global Profits.
1.33    “Good Clinical Practices” or “GCP” means all applicable current Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trials, including, as applicable, (a) as set forth in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the 

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Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) US Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws in any relevant country, each as may be amended and applicable from time to time.
1.34    “Good Laboratory Practices” or “GLPs” means all applicable Good Laboratory Practice standards, including, as applicable: (a) as set forth in the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 44 C.F.R. Part 58; and (b) the equivalent Applicable Laws in any relevant country, each as may be amended and applicable from time to time.
1.35    “Good Manufacturing Practices” or “GMPs” means all applicable Good Manufacturing Practices including, as applicable: (a) the principles detailed in the US Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820; (b) European Directive 2003/94/EC and Eudralex 4; (c) the principles detailed in the WHO TRS 986 Annex 2, TRS 961 Annex 6 and TRS 957 Annex 2; (d) ICH Q7 guidelines and (e) the equivalent Applicable Laws in any relevant country, each as may be amended and applicable from time to time.
1.36    “Good Research Practices” or “GRP” means research practices consistent with the Research Quality Association (RQA), 2014 Quality in Research Guidelines for Working in Non-Regulated Research.
1.37    “Governmental Authority” means any court, commission, authority, department, ministry, official or other instrumentality of, or being vested with public authority under any law of, any country, state or local authority or any political subdivision thereof, or any association of countries.
1.38    “Hepatocyte Target” means any Target [* * *]. 
1.39    “HSR Act” has the meaning set forth in Section 13.1.
1.40    “HSR Clearance Date” has the meaning set forth in Section 13.1.
1.41    “Improvement” means any (a) modification, enhancement or change to the Patent Rights or Know-How Controlled by a Party and its Affiliates and existing as of or after the Signing Date and (b) Patent Rights claiming priority to the Patent Rights included in Dicerna’s Background IP, with respect to Dicerna, or Novo’s Background IP, with respect to Novo.
1.42    “IND” means an investigational new drug application filed with the FDA with respect to a Compound or a Product, or an equivalent application filed with a Regulatory Authority in a country other than the United States required to commence clinical trials of a pharmaceutical product.

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1.43    “IND Approval” of a Product means that an IND for such Product has been submitted to the FDA or equivalent Regulatory Authority and not rejected (including placed on clinical hold) by the FDA or equivalent Regulatory Authority within [* * *] after such submission.
1.44    “Indemnified Party” has the meaning set forth in Section 17.3.1.
1.45    “Indemnifying Party” has the meaning set forth in Section 17.3.1.
1.1    “Initial Discovery Period” has the meaning set forth in Section 2.1.1. 
1.2    “Initial Party” has the meaning set forth in Section 10.7.6.
1.3    “Initial R&D Collaboration Term” has the meaning set forth in Section 4.1.2.
1.4    “Initial Targets” has the meaning set forth in Section 8.1.2. 
1.5    “Initiation of GLP Tox Studies” means the first toxicology testing of a Compound under GLP conditions.  
1.6    “Internal Compliance Codes” means a Party’s internal policies and procedures intended to ensure that a Party complies with Applicable Laws, Party Specific Regulations, and such Party’s internal ethical, medical and similar standards.
1.7    “Internal Revenue Code” has the meaning set forth in Section 9.4.2.
1.8    “Invention” means any invention, composition of matter, formulation, article of manufacture, method of manufacture, method of use or other subject matter, whether patentable or not.
1.9    “Joint Intellectual Property” means Joint Patent Rights and Joint Know-How.
1.10    “Joint Inventions” has the meaning set forth in Section 10.5.1.
1.11    “Joint Know-How” has the meaning set forth in Section 10.5.1.
1.12    “Joint Patent Right” has the meaning set forth in Section 10.5.1.
1.13    “JSC” has the meaning set forth in Section 6.5.1.
1.14    “JSC Chair” has the meaning set forth in Section 6.5.1.
1.15    “Know-How” means all technical, scientific, and other information, know-how, data, Inventions, discoveries, trade secrets, specifications, instructions, techniques, processes, designs, drawings, formulae, methods, practices, protocols, expertise and other information and technology applicable to formulations, compositions or products or to their Manufacture, development, registration, use, marketing or sale or to methods of assaying or testing them, and all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical and analytical, safety, quality control, manufacturing, preclinical and clinical data relevant to any of the 

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foregoing.  For clarity, Know-How includes any such information comprised or embodied in any applicable physical materials, and excludes Patent Rights. 
1.1    “Licensed Know-How” means all Know-How, including Know-How within the GalXC Platform IP, that is Controlled by Dicerna (or one of its Affiliates) and that is: (a), necessary or reasonably useful for the Research, Development, registration, Manufacture (including formulation), use or Commercialization of a Compound or Product in the Field (which would include all Know-How relating to targeting of Hepatocyte Targets using the GalXC Platform, excluding Know-How exclusively relating to Dicerna Reserved Orphan Liver Targets that are not designated by Novo as Collaboration Targets under Section 2.3.2 or exclusively relating to Discontinued Targets); or (b) acquired (subject to Section 7.8.1), licensed (subject to Section 7.8.1), conceived, developed, created, made or reduced to practice, whether in the course of performing the R&D Program during the Term or otherwise, including Dicerna’s rights in any Joint Know-How and any Improvements to the foregoing Know-How described in subclause (a).
1.2    “Licensed Patent Rights” means any and all Patent Rights, including Patent Rights within the GalXC Platform IP, that are Controlled by Dicerna (or one of its Affiliates) and that are: (a) listed in Exhibit E, (b) necessary or reasonably useful for the Research, Development, registration, Manufacture (including formulation), use or Commercialization of a Compound or Product in the Field (which would include all Patent Rights directed to Targets using the GalXC Platform excluding Patent Rights directed exclusively to Dicerna Reserved Orphan Liver Targets that are not designated by Novo as Collaboration Targets under Section 2.3.2 or exclusively relating to Discontinued Targets), (c) acquired (subject to Section 7.8.1), licensed (subject to Section 7.8.1), conceived, developed, created, made or reduced to practice, whether in the course of performing the R&D Program during the Term or otherwise, including Dicerna’s rights in any Joint Patent Rights, or (d) directed to Know-How described in subclause (b) of the definition of “Licensed Know-How,” including Dicerna’s rights in any Joint Patent Rights.
1.3    “Licensed Technology” means, individually or collectively, the Licensed Patent Rights and the Licensed Know-How.
1.4    “Lilly” has the meaning set forth in Section 1.133.
1.5    “Lilly Agreement” means that certain Collaboration and License Agreement between Eli Lilly and Company or its permitted successors and assigns (“Lilly”) and Dicerna Pharmaceuticals, Inc. together with Dicerna Cayman dated October 25, 2018, as (subject to Section 2.5) amended and in effect from time to time.
1.6    “Losses” has the meaning set forth in Section 17.1.
1.7    “Major European Market” means any of [* * *].
1.8    “Major Territory” means: [* * *].
1.9    “Manufacturing” or “Manufacture” means any and all activities directed to manufacturing, processing, packaging, labeling, filing, finishing, assembly, shipping, storage, or 

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freight of any pharmaceutical product (or any components or process steps involving any product or any companion diagnostic), placebo, or comparator agent, as the case may be, including quality assurance and stability testing, characterization testing, quality control release testing of drug substance and drug product, quality assurance batch record review and release of product, process development, qualification, and validation, scale-up, pre-clinical, clinical, and commercial manufacture and analytic development, and product characterization.
1.10    “Manufacturing Expenses” means all expenses incurred in accordance with the Accounting Standards, directly or indirectly, in connection with Manufacturing a pharmaceutical product, including without limitation the costs incurred for all materials (including devices sold as part of a Product for a single sales price, or included as part of a Product under Development), labor, access and use of a portion of a Manufacturing facility, reasonably allocable Manufacturing overhead and out-of-pocket costs paid to Third Parties, in each case including all FTE Expenses for FTEs who perform activities in furtherance of the foregoing, but in any event excluding any unreserved, allocated idle capacity costs and charges that exceed in the aggregate [* * *] of a manufacturing facility relating to or occasioned by unused manufacturing capacity not otherwise committed to Products.
1.11    “Mapped Target” means a Collaboration Target for which design and generation of [* * *] or more distinct Compounds Directed To such Target has occurred and that such Compounds Directed To such Target induce an inhibition, disruption or modulation of Target-derived mRNA resulting in reduced expression of the Target-derived mRNA.
1.12    “Marketing Authorization” means, collectively, all Regulatory Approvals (including any applicable pricing, reimbursement or access approvals) from the relevant Regulatory Authority (including FDA and EMA) necessary to initiate marketing and selling a Product in such country or jurisdiction.
1.13    “Marketing Expenses” means all expenses incurred in accordance with the Accounting Standards, directly or indirectly, in connection with the marketing, promotion and advertising of Products, including, without limitation, expenses for preparing and reproducing detailing aids, promotional materials, expenses of professional education, product related public relations, relationships with opinion leaders and professional societies, market research and market studies (before and after Regulatory Approval), healthcare economics studies, promotional events, attendance of professional conferences and trade shows, and other similar activities directly related to the Products, in each case including all FTE Expenses for FTEs who perform activities in furtherance of the foregoing. 
1.14    “Net Sales” [* * *]: 
1.15    “New Chemical Entity Regulatory Exclusivity” means the exclusivity granted to a drug that contains no active moiety that has been previously approved by FDA under Section 505(b) of the FFDCA (or any successor statutory provision or treaty that provides for an extension of such exclusivity) or equivalent exclusivity in countries outside the United States, which exclusivity shall be deemed, for purposes of Section 8.6.2(b), not to extend beyond [* * *] following the grant of such exclusivity for the applicable Product in the applicable country.

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1.16    “Notice of Dispute” has the meaning set forth in Section 19.6.1.
1.17    “Novo Background IP” has the meaning set forth in Section 10.3.
1.18     “Novo Competitor” means [* * *]. 
1.19    “Novo Indemnified Party” has the meaning set forth in Section 17.1.
1.20    “Novo Intellectual Property” means, individually or collectively, Novo Background IP, Novo Product Inventions, Novo Patents and Novo Know-How.
1.21    “Novo Know-How” means any and all Know-How Controlled by Novo (or one of its Affiliates) that is: (a) existing as of the Signing Date or generated or acquired outside the scope of the R&D Program and this Agreement, including any Improvements to any of the foregoing that is necessary or reasonably useful for the Research, Development, registration, Manufacture (including formulation), use or Commercialization of a Product in the Field; or (b) conceived, Developed, created, made or reduced to practice in the course of performing the R&D Program during the Term, subject to Section 10.4, but including Novo’s rights in any Joint Know-How.
1.22    “Novo’s Own Target” means any Collaboration Target which Novo has identified, and for which it has generated Confidential Information or has independently conducted research or development, prior to the Signing Date or during the R&D Collaboration Term and prior to its designation as a Collaboration Target.  
1.23    “Novo Patents” means any and all Patent Rights Controlled by Novo and its Affiliates that are: (a) existing as of the Signing Date or generated or acquired outside the scope of the R&D Program and this Agreement, including any improvements to any of the foregoing that is necessary or reasonably useful for the Research, Development, registration, Manufacture (including formulation), use or Commercialization of a Product in the Field; or (b) directed to Know-How described in subclause (b) of the definition of “Novo Know-How,” subject to Section 10.4, but including Novo’s rights in any Joint Patent Rights.  Novo Patents shall be disclosed in writing, which disclosures shall be updated from time to time, in accordance with Section 10.1.
1.24    “Novo Product Inventions” means any Invention discovered or conceived during the Term solely by or on behalf of Novo or Affiliates of Novo (and not by Dicerna, its Affiliates or sublicensees) arising in connection with the Research Plan, Development Plan or any other activities in connection with the R&D Program or this Agreement, that is Directed To a Compound, Product, or Collaboration Target(s).  For the avoidance of doubt, Novo Product Inventions do not include any Dicerna Background IP (including GalXC Platform IP), any Product-Specific Patents owned solely or jointly by Dicerna or any and Product-Specific Know-How owned solely or jointly by Dicerna.  
1.25    “Novo Product Patent” means any Patent Right Covering a Novo Product Invention. 
1.26    “Novo Review Period” has the meaning set forth in Section 2.1.4.

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1.27    “Orphan Liver Indication” means an indication for use of a drug to treat a rare disease or condition of the liver where the number of people affected by the disease or condition is less than 200,000 persons or where the indication for use otherwise meets the criteria for orphan drug designation under section 526(a) of the FFDCA and 21 C.F.R. 316.21.
1.28    “Party Specific Regulations” means all judgments, decrees, orders or similar decisions issued by any Governmental Authority specific to a Party, and all consent decrees, corporate integrity agreements, or other agreements or undertakings of any kind by a Party with any Governmental Authority, in each case as the same may be in effect from time to time and applicable to a Party’s activities contemplated by this Agreement.
1.29    “Patent Expenses” means any expenses incurred by either Party in connection with the drafting, filing, prosecution, maintenance, enforcement or defense of Patent Rights under Article 10.
1.30    “Patent Rights” means the rights and interests in and to issued patents and pending patent applications (which, for purposes of this Agreement, include certificates of invention, applications for certificates of invention and priority rights) in any country or region where filed, including all provisional applications, substitutions, continuations, supplementary protection certificates, continuations-in-part, continued prosecution applications including requests for continued examination, divisional applications and renewals, and all letters patent or certificates of invention granted thereon, and all reissues, reexaminations, extensions (including pediatric exclusivity patent extensions), term restorations, renewals, substitutions, confirmations, registrations, revalidations, revisions and additions of or to any of the foregoing, and all foreign counterparts of any of the foregoing.
1.31    “Patent Working Group” has the meaning set forth in Section 6.4.
1.32    “Payee” has the meaning set forth in Section 9.4.1.
1.33    “Payor” has the meaning set forth in Section 9.4.1.
1.34    “Permitted Subcontractors” has the meaning set forth in Section 4.8.
1.35    “Person” means any individual, corporation, partnership, association, joint-stock company, trust, unincorporated organization or government or political subdivision thereof.
1.36    “Phase 1 Clinical Trial” means a clinical trial of a Product generally consistent with 21 C.F.R. §312.21(a) or equivalent trial outside of the United States, or a phase 1/2 clinical trial where a subsequent Phase 2 Clinical Trial will be required.
1.37     “Phase 2 Clinical Trial” means a clinical trial of a Product generally consistent with 21 C.F.R. §312.21(b) or equivalent trial outside of the United States.
1.38    “Phase 3 Clinical Trial” means a clinical trial of a Product generally consistent with 21 C.F.R. §312.21(c) or equivalent trial outside of the United States.

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1.39    “Pivotal Study” means a human clinical trial that demonstrates the statistical efficacy and safety of a Product and that is the final stage of clinical testing prior to and in support of the filing of an NDA or MAA for a Marketing Authorization, whether constituting a Phase 2 Clinical Trial or Phase 3 Clinical Trial in the United States or a similar trial in other jurisdictions.
1.40    “PMDA” means the Japanese Pharmaceutical and Medical Device Association and any successor thereto.
1.41    “Pre-Clinical Milestone Event” has the meaning set forth in Section 8.3.1.
1.42    “Pre-Clinical Milestone Payment” has the meaning set forth in Section 8.3.1.
1.43    “Pre-Reserved Targets” means the up to [* * *] Targets that have been or may be pre-cleared by the Gatekeeper prior to the Effective Date and, following such clearance, will be reserved for designation by Novo or the JSC as Collaboration Targets hereunder following the Effective Date.
1.44    “Product” means any Compound formulated for use in the Field.
1.45    “Product-Specific Know-How” means Know-How directed to a Compound, Product, or Collaboration Target(s) but not directed to the GalXC Platform. 
1.46    “Product-Specific Patents” has the meaning set forth in Section 10.7.2. 
1.47    “Program Inventions” has the meaning set forth in Section 10.5.1.
1.48    “Program Leader” has the meaning set forth in Section 6.2.
1.49    “Project Leader” has the meaning set forth in Section 6.1.
1.50    “Proof of Concept Study” means [* * *].  
1.51    “Proof of Principle” means [* * *].
1.52    “R&D Collaboration Term” has the meaning set forth in Section 4.1.2.
1.53    “R&D Program” has the meaning set forth in Section 4.1.1.
1.54    “Records” has the meaning set forth in Section 4.6.1.
1.55    “Regulatory Approval” means, collectively, any and all approvals (including supplements, amendments, pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations or authorizations (including marketing and labeling authorizations) of any Regulatory Authority that are necessary for the Research, Development, registration, Manufacture (including formulation), distribution, importation, exportation, use, and Commercialization of a pharmaceutical product (including a Compound or Product) in a given jurisdiction.

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1.56    “Regulatory Authority” means the FDA or any counterpart of the FDA outside the United States, or other Governmental Authority with authority over the Research, Development, registration, Manufacture (including formulation), and Commercialization of a pharmaceutical product (including a Compound or Product), which may include the authority to grant the required reimbursement and pricing approvals for such sale.
1.57    “Regulatory Documentation” has the meaning set forth in Section 16.1.6.
1.58    “Research” means all activities related to the research, identification, generation, formatting, screening, testing (including in silico, in vitro, ex vivo human validation systems and animal models, but not in human subjects), stability testing, toxicology and formulation of Collaboration Targets or Compounds up until nomination as a Development Candidate.  When used as a verb, “to Research” and “Researching” means to engage or engaging in Research.
1.59    “Research Plan” has the meaning set forth in Section 4.1.4.
1.60     “Returned Compounds and Products” has the meaning set forth in Section 15.2.1.
1.61    “RNAi” means a double-stranded RNA molecule that silences or inhibits the expression of a Target. 
1.62    “Roche” has the meaning set forth in Section 1.18.  
1.63    “Roche Agreement” has the meaning set forth in Section 1.18.  
1.64    “Royalty” has the meaning set forth in Section 8.6.1.
1.65    “Royalty Term” has the meaning set forth in Section 8.6.2.
1.66    “Sales Expenses” means all expenses incurred in accordance with the Accounting Standards, directly or indirectly, in connection with the sales of Products, including pre-launch expenses, to all markets in the Territory including the managed care market, including without limitation sales operations, account managers, district managers, regional managers, fleet, travel and entertainment, supervision, training, sales meetings, and other sales expenses, in each case including all FTE Expenses for FTEs who perform activities in furtherance of the foregoing.  For the avoidance of doubt, Sales Expenses will include the start-up expenses associated with a Party’s sales force, including recruiting, relocation and other similar expenses.
1.67    “Senior Representative” means, with respect to a Party, an executive officer of such Party having greater seniority than such Party’s JSC representatives, which executive officer such Party designates for the escalation of a disagreement within the JSC.  
1.68    “Target” means: [* * *].
1.69    “Taxes” has the meaning set forth in Section 9.4.
1.70    “Term” has the meaning set forth in Section 14.1.

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1.71    “Territory” means all of the countries and territories in the world.
1.72    “Third Party” means any Person other than Novo or Dicerna or an Affiliate of Novo or Dicerna.
1.73    “United States” or “U.S.” means the United States of America and its territories and possessions.
1.74    “Upfront Payment” has the meaning set forth in Section 8.1.1.
1.75    “Valid Claim” means (a) a claim of an issued and unexpired patent that has not been (i) held permanently revoked, unenforceable, unpatentable or invalid by a decision of a court or governmental body of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, (ii) disclaimed or rendered unenforceable through disclaimer or otherwise, or (iii) abandoned, or (b) a pending claim of a pending patent application, which claim does not remain pending later than the [* * *] anniversary of the First Commercial Sale of the relevant Product, and has not been abandoned or finally rejected without the possibility of appeal or refiling or without such appeal having been taken or refiling having been made within the applicable time periods.  
1.76    “Validated Target” has the meaning forth in Section 2.1.3.
1.77    “Validated Target Criteria” means [* * *].
1.78    “VAT” has the meaning set forth in Section 9.4.4.
1.79    “Working Group” has the meaning set forth in Section 6.4.
1.80    “Work Flow Plan” has the meaning set forth in Section 2.1.3.

2.    TARGET SELECTION AND VALIDATION

2.1    Target Selection, Validation, and Development Candidates.
2.1.1    Collaboration Targets. For the initial [* * *] period of the R&D Collaboration Term (“Initial Discovery Period”), the Parties will engage in a collaborative effort to identify approximately thirty (30) or more Hepatocyte Targets which are confirmed available through the Gatekeeper process described in Section 2.4 in the Field that the Parties wish to further Research and Develop, pursuant to the R&D Program (such Targets individually and collectively referred to as “Collaboration Targets”), provided that such time period will be extended for up to [* * *] additional [* * *] terms if Dicerna is materially delayed with respect to generating at least [* * *] (or, if fewer, such number of Collaboration Targets designated by the Parties) Mapped Targets per [* * *] period over the course of the Initial Discovery Period or if the Parties agree in writing that additional time is needed to identify Collaboration Targets and Mapped Targets (the Initial Discovery Period plus any such extensions, the “Discovery Period”).  For clarity, if Dicerna generates more than the minimum number of Mapped Targets in any such [* * *] period, such excess shall count toward the minimum for the subsequent [* * *] period(s).  Any Hepatocyte Target to be 

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included as a Collaboration Target will be subject to confirmation of its availability to Novo through the Gatekeeper process described in Section 2.4.  Notwithstanding anything else in this Agreement, the Parties agree that on a Collaboration Target-by-Collaboration Target basis, Dicerna’s Research obligations end on achievement of the Proof of Principle for a Compound Directed To such Collaboration Target.
2.1.1    Mapped Targets.  During the Discovery Period, on a per [* * *] basis, Dicerna will deliver Mapped Targets for [* * *] or more Collaboration Targets selected by Novo or the JSC to be Mapped Targets.  For the avoidance of doubt, once a Collaboration Target becomes a Mapped Target, it is still considered to be a Collaboration Target. 
2.1.2    Validated Targets and Proof of Principle.  During the R&D Collaboration Period, Dicerna will use Commercially Reasonable Efforts to perform Research of Compounds and Novo will use Commercially Reasonable Efforts to conduct the Research activities it has agreed to undertake, both as set forth in Exhibit A (as may be amended by the JSC from time to time, the “Work Flow Plan”) and the applicable Research Plans, with the objective for the JSC to nominate at least [* * *] “Validated Targets” achieving the applicable Validated Target Criteria, provided that Novo shall have the right to designate any Collaboration Target as a Validated Target at any time in its discretion, whether or not such Collaboration Target has achieved the applicable Validated Target Criteria.  For the avoidance of doubt, the reference to [* * *] Validated Targets is not intended in any way to limit or guarantee the total number of Collaboration Targets which may be designated as Validated Targets.  Dicerna shall, as determined by the JSC, engage in further evaluation and testing of Collaboration Targets, Validated Targets and Compounds, including, but not limited to, evaluation and testing of in vivo efficacy, and evaluation and testing of preclinical pharmacology of Compounds, in order to achieve Proof of Principle for at least [* * *] Compounds to the extent feasible.  For the avoidance of doubt, even when a Collaboration Target is nominated as a Validated Target or a Compound Directed To a Collaboration Target has achieved Proof of Principle, it is still considered a Collaboration Target. For clarity, Research results are inherently uncertain and the Parties acknowledge that there is no assurance such results can be achieved.
2.1.1    Data Packages and Access to Tissue Samples.  From time to time at the reasonable request of Novo, and in any case promptly upon the end of the R&D Collaboration Term, Dicerna shall promptly provide to Novo an accurate and reasonably detailed copy of the Data Packages for each Collaboration Target, which Data Packages may be used by Novo for purposes of determining whether to designate a Collaboration Target as a Validated Target and/ or having achieved Proof of Principle.  Following Dicerna’s provision of each Data Package for each Collaboration Target at the end of the R&D Collaboration Term: (i) Novo shall review such Data Package, and Novo shall notify Dicerna, no later than [* * *] after receiving such Data Package, of any reasonable requests for additional information and records for the applicable Collaboration Target that is within Dicerna’s possession and control, and Dicerna shall respond to such requests within [* * *] thereof; and (ii) Novo shall have at least [* * *] following the receipt of such Data Package or additional information and records to decide whether to designate the applicable Collaboration Target as a Validated Target and/ or having achieved Proof of Principle, provided that such [* * *] time period shall be extended by the number of Calendar Days equal to the number of Calendar Days after such [* * *] period during which Dicerna failed to provide such reasonably 

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requested additional information, if any (each such time period following receipt of a Data Package at the end of the R&D Collaboration Term, a “Novo Review Period”).  Further, as agreed in the applicable Research Plan, Dicerna shall, in the conduct of pharmacology studies during the R&D Collaboration Term and as reasonably requested by Novo, provide to Novo at Novo’s expense for shipping thereof reasonable samples, such as blood and certain organs (e.g. liver, testes and accessory sex glands) for early safety assessment of the relevant Compounds.

2.2    Development Candidates.  During the R&D Collaboration Term, the JSC or Novo may nominate one or more Compound(s) Directed To one or more Validated Target(s) (each a “Development Candidate” or “DC”) which have achieved Proof of Principle.  If more than [* * *] DCs are nominated, it shall be deemed an increase in the scope of the Agreement and any DCs in excess of [* * *] shall be subject to the additional payment requirements set forth in Section 8.3.2.  For the avoidance of doubt, either the JSC or Novo, in its discretion, is free to cause such increase in scope.  From time to time at the reasonable request of Novo, and in any case promptly upon the end of the R&D Collaboration Term, Dicerna shall promptly provide to Novo a report including all material data generated by Dicerna regarding Validated Targets and such other information reasonably requested by Novo regarding evaluation and testing of Compounds Directed To one or more Validated Targets.  Following Dicerna’s provision of such report at the end of the R&D Collaboration Term: (i) Novo shall review such report, and Novo shall notify Dicerna, no later than [* * *] after receiving such report, of any reasonable requests for additional information and records related to Compounds that is within Dicerna’s possession or control, and Dicerna shall respond to such requests within [* * *] thereof; and (ii) Novo shall have at least [* * *] following the receipt of such report to decide whether to nominate any Development Candidates, provided that such [* * *] time period shall be extended by the number of Calendar Days equal to the number of [* * *] after such [* * *] period during which Dicerna failed to provide such reasonably requested additional information, if any.  Novo shall have final decision on the selection and prioritization for further testing of Development Candidates.  The Parties shall collaborate in the conduct of all Research activities to DC nomination as specified in the Research Plans and Work Flow Plan, leveraging the capabilities and expertise of each Party.  
2.2.1    IND Activities.  For each DC, Novo will lead IND-enabling and clinical development activities to IND filing, except for the first DC, for which Dicerna will lead all activities to IND filing at Novo’s expense after achievement of Proof of Principle, provided that the JSC shall establish a Working Group consisting of [* * *] representatives from each Party through which Dicerna will regularly inform Novo regarding the progress of activities prior to IND filing and through which Novo shall be able to provide reasonable feedback and guidance to Dicerna.  Dicerna shall reasonably consider and the Parties will mutually implement all such feedback and guidance.  During the period when Dicerna is entitled to exercise its co-development options under Section 2.3.3, on a DC-by-DC basis, within [* * *] of the end of each Calendar Year and until expiration of such co-development option, Novo will submit a report to the JSC (and send a copy to Dicerna) for its Development Expenses.  
2.2.2    Development Budget and Development Plan.  On a DC-by-DC basis, prior to the first dosing of the first patient in the first Clinical Trial, the Parties will also negotiate in good faith (and submit to the JSC) a Development Budget and Development Plan for Development 

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activities to be performed by Dicerna.  If the Parties cannot agree upon a Development Budget or a Development Plan, each Party will submit a separate report to the JSC of a proposed Development Budget or Development Plan for the DC and the JSC will determine a Development Budget or Development Plan.  If the JSC is unable to agree on a Development Budget or Development Plan, the Parties shall escalate the issue to Senior Representatives of each Party for resolution. If such Senior Representatives have not succeeded in agreeing upon a Development Budget and Development Plan within [* * *], Novo shall be free to perform or have performed such IND-enabling and clinical development activities without Dicerna’s involvement.  

2.3    Reserved and Option Targets.
2.3.1    Dicerna Targets.  Dicerna represents and warrants that the identity of the Blocked Targets which are the subject of Dicerna Excluded Programs as of the Signing Date are as set forth in the letter dated as of November 14, 2019 from Dicerna to Novo listing the Blocked Targets that are the subject of the Dicerna Excluded Programs.
2.3.2    Dicerna Orphan Liver Target Reservation. At any time during the R&D Collaboration Term, Dicerna shall have the option to designate up to [* * *] Targets that are not designated as Collaboration Targets for worldwide research, development, and commercialization of GalXC Molecules, in each case that is relevant for the treatment of a single Orphan Liver Indication (which can be worldwide) and provided that such Orphan Liver Indication (which can be worldwide) is the sole disease for which Dicerna intends to research, develop and commercialize GalXC Molecules (“Dicerna Reserved Orphan Liver Target”).  Before Dicerna (by itself or with any Third Party) or its Affiliates, or any Third Party authorized by Dicerna or its Affiliates, initiates research, development or commercialization of a proposed Dicerna Reserved Orphan Liver Target, Dicerna shall notify Novo in writing of its intention to designate a Target as a Dicerna Reserved Orphan Liver Target and of the Orphan Liver Indication for the proposed Dicerna Reserved Orphan Liver Target and provide Novo sufficient documentation for Novo to assess whether such Orphan Liver Indication is validly proposed as an Orphan Liver Indication for which the proposed Dicerna Reserved Orphan Liver Target could be relevant.  
(a)    After such notification and provision of documentation, Novo shall have [* * *] to notify Dicerna that it either (i) challenges the status of such proposed Dicerna Reserved Orphan Liver Target as one for which there is an Orphan Liver Indication for which Dicerna intends to research, develop and commercialize GalXC Molecules, or (ii) designates the proposed Dicerna Reserved Orphan Liver Target as a Collaboration Target.  
(b)    If Novo does not provide any such notice: (i) the proposed Target shall become a Dicerna Reserved Orphan Liver Target which Dicerna can Develop and Commercialize for the Orphan Liver Indication; (ii) subject to Section 3.3, the Dicerna Reserved Orphan Liver Target shall be reserved exclusively to Dicerna worldwide and will be promptly reported to the Gatekeeper pursuant to Section 2.4; and (iii) Dicerna shall have the sole and final decision at its sole expense, subject to Novo’s subsequent option set forth in Section 3.3, as to the selection and 

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prioritization of Research activities for each GalXC Molecule Directed To a Dicerna Reserved Orphan Liver Target.
(c)    If Novo designates the proposed Dicerna Reserved Orphan Liver Target as a Collaboration Target as contemplated in Section 2.3.2(a)(ii) above, the proposed Dicerna Reserved Orphan Liver Target will become a Collaboration Target and automatically be eligible for designation by Dicerna as a Co-Development Target for co-promotion for the same percentage of details as its designated Co-Development Percentage, subject to Dicerna’s written notification to Novo specifying a Co-Development Percentage in accordance with Section 1.30 provided within [* * *] of Novo’s designation.  Promptly after Dicerna designates the proposed Dicerna Reserved Orphan Liver Target as a Co-Development Product, the Parties shall negotiate in good faith and enter into a written agreement for co-promotion setting forth the terms of Dicerna’s and Novo’s rights and obligations with regard to such co-promotion in accordance with Exhibit G and the terms and conditions in this Agreement.  This election by Dicerna shall be in addition to Dicerna’s rights to designate two Co-Development Products in Section 2.3.3.
(d)    If Novo challenges the status of such proposed Dicerna Reserved Orphan Liver Target as one for which an Orphan Liver Indication is the sole disease in the Field for which the proposed Dicerna Reserved Orphan Liver Target could be relevant in accordance with the foregoing Section 2.3.2(a)(i), such dispute shall be resolved in accordance with the procedures set forth in Section 19.5.  If such dispute resolution procedures result in a determination that the proposed Orphan Liver Indication was validly proposed by Dicerna, Section 2.3.2(b) shall apply (inclusive of Novo’s ongoing option under Section 3.3) as if Novo never provided notice challenging the designation.  If such dispute resolution procedures result in a determination that the proposed Dicerna Reserved Orphan Liver Target was not validly proposed by Dicerna, such proposed Target shall remain a Target available for designation as a Collaboration Target hereunder.
(e)    If Dicerna is researching, developing and commercializing a compound or product Directed To a Dicerna Reserved Orphan Liver Target under Section 2.3.2(b), and if there is any indication other than an Orphan Liver Indication that is relevant for the Dicerna Reserved Orphan Liver Target, then neither Dicerna nor its Affiliates, licensees and transferees shall, unless otherwise agreed to in writing by Novo in its sole discretion, Research, Develop or Commercialize any compound or product Directed To the Dicerna Reserved Orphan Liver Target for such other non-Orphan Liver Indication.  In such event, Dicerna shall notify Novo and the Parties will discuss research, development and commercialization of such non-Orphan Liver Indication and consider adding it to the Agreement as a Collaboration Target and Co-Development Target.
2.3.3    Dicerna Options for Co-Development and Co-Promotion. 

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(a)    During the R&D Collaboration Term of this Agreement, Dicerna shall have an option to designate a total of [* * *] Products as Co-Development Products that, upon such designation, will become subject to Section 5.4.  For purposes of clarity, any such designation shall apply to all indications for the applicable Product.  Dicerna has an option to select [* * *] Product as a Co-Development Product upon availability of top-line data from the first Phase 1 Clinical Trial (referred to in this Section 2.3.3 as “completion” of the first Phase 1 Clinical Trial) for such Product and one (1) Product as a Co-Development Product upon availability of top-line data from the first Phase 2 Clinical Trial (referred to in this Section 2.3.3 as “completion” of a Phase 2 Clinical Trial) for such Product, in each case provided that Dicerna exercises such option within the time period specified in Section 2.3.3(b) below.  For purposes of clarity, the first Product chosen by Dicerna as a Co-Development Product may be designated as such upon either such completion, but the second Product chosen by Dicerna as a Co-Development Product may only be designated as such at the point in time not used by Dicerna to choose the [* * *] Product (i.e., [* * *] Product may be designated as a Co-Development Product following completion of the first Phase 1 Clinical Trial and [* * *] Product may be designated as a Co-Development Product upon completion of the first Phase 2 Clinical Trial).  During the R&D Collaboration Term, for each Product, Novo will deliver to Dicerna within [* * *] of completion of the first Phase 1 Clinical Trial and the first Phase 2 Clinical Trial, in each case only if Dicerna retains a designation option at such point in time: (a) a reasonably detailed and complete report and analysis of the Phase 1 Clinical Trial or Phase 2 Clinical Trial, as applicable; and (b) a proposed budget detailing projected expenses for the remainder of the Development of such Product through the first Marketing Authorization thereof in the first Major Territory.  Dicerna may select such Product as a Co-Development Product until [* * *] from Dicerna’s receipt from Novo of the foregoing by providing a written notice stating that it wishes to designate such Product as a Co-Development Product and specifying a Co-Development Percentage in accordance with Section 1.30.  
(b)    If Dicerna exercises its option to designate a Co-Development Product, then Dicerna also shall have the option to co-promote the Co-Development Product in the United States for the same percentage of details as its designated Co-Development Percentage.  Approximately [* * *] before the anticipated filing of the first Marketing Authorization for a given Co-Development Product, Novo shall deliver and discuss with the JSC the applicable Commercialization Plan.  In addition to information received through the JSC, Dicerna may submit written questions to Novo about the Commercialization Plan for such Co-Development Product within [* * *] of the receipt of such information, in which case Novo will respond to such questions no later than [* * *] from receipt of Dicerna’s questions. Dicerna may exercise its option by giving written notice thereof to Novo no later than [* * *] following Novo’s delivery to the JSC of the applicable Commercialization Plan.  If Dicerna fails to provide such written notice within such time period, Dicerna’s option is of no further force or effect.  Promptly after Dicerna exercises a co-promotion option for a Co-Development Product, the Parties shall negotiate in good faith and 

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enter into a written agreement for co-promotion setting forth the terms of Dicerna’s and Novo’s rights and obligations with regard to such co-promotion in accordance with Exhibit G and the terms and conditions in this Agreement.  For the avoidance of doubt, the contents of each Commercialization Plan for each Co-Development Product designated by Dicerna, and any amendments to each such Commercialization Plan, are at all times within the sole discretion of Novo, and neither the JSC nor Dicerna has any right to approve or amend any such Commercialization Plan, regardless of whether Dicerna exercises its option to co-promote. 
2.3.4    Continuation Targets. During the R&D Collaboration Term, Novo may provide written notice to the JSC and Dicerna designating up to [* * *] Targets among the Collaboration Targets (including Validated Targets) as “Continuation Targets” which will remain available to Novo and subject to the exclusivity provisions of Sections 3.1 and 3.2 for a period ending on the earlier of [* * *] after the completion of the R&D Collaboration Term or [* * *] after the Effective Date.  For the avoidance of doubt, once a Collaboration Target is designated as a Continuation Target, it is still considered a Collaboration Target subject to this Section 2.3.4.
2.3.5    Discontinued Targets.  On a Collaboration Target-by-Collaboration Target basis, upon the later of the end of all Novo Review Periods or the end of the R&D Collaboration Term, the remaining Collaboration Targets that are not (i) Validated Targets for which a Development Candidate has been nominated or (ii) Continuation Targets, shall become Discontinued Targets, subject to Section 15.2.  At the end of the period ending on the earlier of [* * *] after the completion of the R&D Collaboration Term or [* * *] after the Effective Date, any Continuation Target for which a Development Candidate has not been nominated shall become a Discontinued Target.  

2.4    Gatekeeper Process.
2.4.1    Gatekeeper.  The Parties have agreed to use an independent attorney to act as an information gatekeeper (the “Gatekeeper”) through which Novo may directly inquire as to whether any Target that Novo intends to designate as a Collaboration Target (whether pursuant to Section 2.1 or Section 2.4) is a Blocked Target at that time; Dicerna may inquire as to whether any Hepatocyte Target is available to be a Dicerna Reserved Orphan Liver Target or a Blocked Target pursuant to Section 1.18(iv) and Dicerna’s third party partners (i.e., Alexion, Lilly, Roche and BI) may inquire as to whether any Target is available to be designated as a Blocked Target at that time.  Dicerna and Novo will cause the Gatekeeper to enter into a customary confidentiality agreement that includes confidentiality obligations at least as stringent as the provisions set forth in Article 10 and prohibits the Gatekeeper from disclosing to Novo the Blocked Targets List or from disclosing to either Dicerna or Novo the identity of a Target that was the subject of any inquiry by the other Party.  Nothing in this Section 2.4.1 will preclude Novo from contacting Dicerna directly regarding the availability of Targets or otherwise, to which Dicerna will respond in its discretion, or preclude Dicerna from contacting Novo directly regarding whether a particular Target is a Collaboration Target.  The initial Gatekeeper will be [* * *], whom the Parties have acknowledged and agreed is independent and which law firm shall enter into an agreement regarding the continued independence 

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of such Gatekeeper.  As of the Effective Date, the Gatekeeper has confirmed and reserved certain Pre-Reserved Targets for designation as Collaboration Targets hereunder.
2.4.2    Gatekeeper Procedures.  At the Signing Date Dicerna shall provide to the Gatekeeper the list of Blocked Targets for the Dicerna Excluded Programs and from time to time thereafter (including at least [* * *], including in response to inquiries hereunder), (a) Dicerna will provide the Gatekeeper with a current list adding up to [* * *] Dicerna Reserved Orphan Liver Targets which shall be Blocked Targets (where it is understood that [* * *] such Targets is all Dicerna may designate during the R&D Collaboration Term pursuant to this Agreement) (the “Blocked Target List”), and (b) Novo will be entitled, acting in good faith as reasonably necessary to identify Hepatocyte Targets as permitted under Section 2.1.1, to submit inquiries to the Gatekeeper as to whether or not a proposed Target is a Blocked Target.  Upon receipt of an inquiry, the Gatekeeper will notify Dicerna of such inquiry by Novo without disclosing the proposed Target, after which Dicerna will have [* * *] to provide the Gatekeeper with any updates on requests made to Dicerna for reservations, substitutions or eliminations to the Blocked Target List with supporting evidence of such changes having been requested in writing prior to the Novo inquiry.  The Gatekeeper will inform Novo in writing whether the proposed Target is a Blocked Target within [* * *] of receipt of the associated inquiry and, if the proposed Target is a Target as to which Dicerna can still grant rights to Novo, the Gatekeeper will inform Novo of the availability of such Target and what rights Dicerna can grant and any associated restrictions.  Upon the Effective Date, the Pre-Reserved Targets will automatically be designated as Collaboration Targets and after the Effective Date upon notification of Novo by the Gatekeeper of availability, each subsequent proposed Target will be automatically designated as Collaboration Targets.  If the Gatekeeper notifies Novo in response to an inquiry (or Dicerna notifies Novo, in the case of direct contact between the Parties) that a proposed Target is a Blocked Target, Novo will not have exhausted any of its rights to reserve or select Targets as a result of the inquiry, and if the status of any Blocked Target changes and it is no longer a Blocked Target, Dicerna shall promptly notify the Gatekeeper; and if such a change relates to a Target which was previously submitted by Novo and rejected by the Gatekeeper, the Gatekeeper shall be under an obligation to notify Novo of such change as soon as practicable.  Dicerna may from time to time inquire as to whether any Hepatocyte Target with respect to which Dicerna intends to engage in activities that may be restricted under Sections 3.1 and 3.2 is a Collaboration Target.  Upon receipt of such an inquiry from Dicerna, the Gatekeeper will inform Dicerna in writing whether the proposed Target is a Collaboration Target within [* * *] of receipt of the associated inquiry.

2.5    Scope of Blocked Targets.  [* * *].

2.6    Encumbered Targets [* * *].

3.    EXCLUSIVITY

3.1    Hepatocyte Target Exclusivity – [* * *]. [* * *], with respect to each Hepatocyte Target that is not a Blocked Target, except as agreed in the Research Plan or as mutually agreed to by the Parties, Novo shall have exclusive and, as applicable, co-exclusive worldwide rights to Research, Develop and Commercialize Compounds and Products in the Field, and Dicerna shall be exclusive to and work exclusively with Novo on Researching, Developing or Commercializing Compounds or Products Directed To any such Hepatocyte Target in the Field.  In connection with 

27

the foregoing, other than as may be incidental to research activities for Blocked Targets, and except as may be permitted under Section 19.1 or as Dicerna may be permitted to delegate its obligations to a Permitted Subcontractor pursuant to Section 4.8, Dicerna shall not (by itself nor with any Third Party) and shall cause its Affiliates not to (by themselves nor with any Third Party) and shall not grant rights to any other Third Parties, carry out Research, Development or Commercialization, of any Hepatocyte Target that is not a Blocked Target, nor sell, assign, transfer, convey, license, sublicense, covenant not to assert or otherwise grant or transfer, to any Third Party (other than to an assignee pursuant to Section 19.1), any rights or immunities to or under any Licensed Patent Rights to carry out any of the foregoing activities. In addition, during the [* * *], with respect to each Collaboration Target, subject to Dicerna’s rights under Sections 2.3.2 and 2.3.3, Dicerna shall not enter into any agreement or take any action that would adversely affect its ability to extend Novo the rights granted hereunder and otherwise perform should such Collaboration Target be selected as a Validated Target.

3.2    Development Candidate and Product Exclusivity - Term of Agreement, During the Term of this Agreement, with respect to each Development Candidate or Product, except as agreed in the Development Plan or as mutually agreed to by the Parties in writing, Novo shall have exclusive and, as applicable, co-exclusive worldwide rights to Develop and Commercialize Development Candidates and Products in the Field, and Dicerna shall be exclusive to and work exclusively with Novo on the Research, Development and Commercialization of all such Development Candidates or Products Directed To a Collaboration Target in the Field while Novo is researching or developing any Development Candidates or Products Directed to such Collaboration Target and Dicerna shall be exclusive to and work exclusively with Novo on any Commercialization of all such Development Candidates or Products Directed to a Collaboration Target in the Field while Novo is commercializing a Development Candidate or Product Directed to such Collaboration Target.  In connection with the foregoing, other than as may be incidental to research activities for Third Party products not Directed To the applicable Collaboration Target, and except as may be permitted under Section 19.1 or as Dicerna may be permitted to delegate its obligations to a Permitted Subcontractor pursuant to Section 4.8, Dicerna shall not (by itself nor with any Third Party) and shall cause its Affiliates not to (by themselves nor with any Third Party) and shall not grant rights to any other Third Parties, to (i) during such Development by Novo, carry out Development or Commercialization, and (ii) during such Commercialization by Novo, carry out Commercialization in the case of each (i) and (ii), of any compound, product, or therapy containing anything that binds to, or is intended to bind to, the same Validated Target in the Field to which such Development Candidate or Product is Directed To, nor sell, assign, transfer, convey, license, sublicense, covenant not to assert or otherwise grant or transfer, to any Third Party (other than to an assignee pursuant to Section 19.1), any rights or immunities to or under any Licensed Patent Rights to carry out any of the foregoing activities.

3.3    [* * *].  

3.4    Limited Novo Exclusivity. If during the Discovery Period, Novo wishes to Research, Develop or Commercialize, by itself or any Affiliate or Third Party, any compound, product or therapy using siRNA conjugated to GalNAc that is Directed To a Collaboration Target in the Field and Novo had not already commenced any such research prior to the Signing Date, 

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such Research, Development or Commercialization shall be done in collaboration with Dicerna under this Agreement and subject to the confirmation of availability through the Gatekeeper process described in Section 2.5.  Otherwise, nothing in this Agreement shall restrict the ability of Novo or its Affiliates to research, develop or commercialize any compounds, products or therapies, it being understood that this Section 3.4 shall not be deemed to expand the scope of any licenses to Licensed Technology or ownership or Control of intellectual property granted hereunder.

3.5    Blocked Targets and Third Party Agreements.  [* * *].

4.    RESEARCH AND PRODUCT DEVELOPMENT

4.1    Research and Development Program.
4.1.1    Purpose.  During the R&D Collaboration Term, Dicerna and Novo shall engage in a research and development program with the goal of Researching and Developing one or more Compounds from which one or more Development Candidates would be nominated by the JSC or Novo for further Development as Compounds or Products based on the specified activities, timelines and criteria set forth in the Work Flow Plan and/or an applicable Research Plan or Development Plan (such research and development program, the “R&D Program”). Each of the Parties shall expend at least the resources specified in the Work Flow Plan in the performance of its Research and Development activities during R&D Collaboration Term.
4.1.2    R&D Collaboration Term.  The R&D Program shall be conducted over a term commencing on the Effective Date and continuing for a period of [* * *] thereafter (the “Initial R&D Collaboration Term”), provided that with respect to any particular Collaboration Target that is the subject of active Development at the end of the Initial R&D Collaboration Term, the term shall be extended for an additional [* * *] period(s) if Proof of Principle has not been achieved by the Parties on at least [* * *] Compounds following designation of at least [* * *] Collaboration Targets and provided that such lack of achievement has not been caused by Novo’s failure to perform its obligations under the Research Plan, if any, or if the Parties mutually agree in writing that additional time is needed to complete Research and Development toward the nomination of Development Candidates (the Initial R&D Collaboration Term plus any such extensions, the “R&D Collaboration Term”).
4.1.1    Work Flow Plan.  All Research and Development activities of each Party occurring during the R&D Collaboration Term and the timelines for all Collaboration Targets and Products therefor shall be set forth in the Work Flow Plan set forth in Exhibit A attached hereto. 
4.1.2    Research and Development Plans.  All Research and Development activities occurring during the R&D Collaboration Term and the timelines and budget for all Collaboration Targets and Products therefor shall be set forth in one or more mutually agreed upon research plans (each, a “Research Plan”) or Development Plans, copies of which will be signed and furnished to each Party, subject to Section 4.1.3, as may be amended from time to time in accordance with the terms of this Agreement.  Once agreed upon, the first Research Plan hereunder shall be attached hereto as Exhibit B.  For clarity, subject to Section 4.1.3, the budgets to be set forth in the Research Plan(s) shall be construed only as guidelines and shall not in any way limit a 

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Party’s obligations to use Commercially Reasonable Efforts to perform all activities specified in the Research Plan, subject to the rights of reimbursement and any limitations on responsibilities or their costs as expressly set forth in this Article 4.  Each Target and Compound shall have a separate Research Plan and Development Plan associated with it unless otherwise agreed to by the Parties (e.g. because a Target is dual or Targets are interdependent).  For the avoidance of doubt, Novo’s Research and Development activities shall not be constrained by the contents of any Research Plan or Development Plan.  

4.2    Research and Development Activities.
4.2.1    Activities until Achievement of Proof of Principle.  For each Validated Target, Dicerna shall use Commercially Reasonable Efforts to conduct activities specified in the Research Plan directed toward the achievement of Proof of Principle of a Compound Directed To that Validated Target Each Party is responsible for its own expenses in conducting activities specified in the Research Plan and intended for achieving Proof of Principle, which in Dicerna’s case, may include rodent and non-human primate studies before Proof of Principle but no other in vivo studies, unless otherwise discussed and agreed by the JSC.  Notwithstanding the foregoing, subject to Novo’s prior written approval regarding the costs thereof, Novo shall be responsible for reimbursing reasonable, out-of-pocket costs paid by Dicerna to Third Party contract manufacturers for CMC Activities to support animal studies that are reasonably necessary to achieve Proof of Principle.  
4.2.2    Activities from DC Nomination through IND Submission.  For the first Development Candidate nominated by the JSC or Novo, Dicerna shall use Commercially Reasonable Efforts to conduct all activities specified in the Development Plan that are not expressly indicated as being Novo’s responsibility in a manner reasonably requested by Novo toward the preparation and submission of an IND for the Development Candidate with Novo having the sole obligation for payment of related expenses after nomination as a Development Candidate for the applicable Validated Target, provided further that Novo will only be responsible for payment of expenses incurred in accordance with a Development Budget that has been approved in writing by Novo, including Dicerna’s Direct Manufacturing Costs from and after achievement of Proof of Principle that have been so approved.  Novo shall use Commercially Reasonable Efforts to perform such activities specified in the Development Plan that are expressly indicated as Novo’s responsibility.  For all subsequent Development Candidates nominated by the JSC, unless otherwise agreed to by the Parties, Novo shall use Commercially Reasonable Efforts to conduct activities it deems reasonably appropriate in furtherance of the preparation and submission of an IND for each subsequent Development Candidate.  

4.3    Clinical Development Activities.  Subject to Section 3.1, Novo shall use Commercially Reasonable Efforts to conduct all Development activities from IND Approval through Commercialization on at least [* * *] Development Candidates, provided that at least [* * *] Development Candidates are selected for Development Candidate nomination.  If more than [* * *] Development Candidates are selected, then Novo shall, subject to the immediately preceding sentence, have the right to prioritize its Development efforts among such Development Candidates.

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4.1    Costs of Performance.
4.1.1    Responsibilities of Parties.  
(a)    Except as otherwise expressly set forth in this Agreement or in a Research Plan, during the Term, each Party shall bear its expenses conducting Research activities until nomination as a Development Candidate for a Compound Directed To a Validated Target.  
(b)    [* * *].  
(c)    [* * *].  
(d)    Except as otherwise set forth in herein, unless the Parties mutually agree or subject to Sections 2.3.2, 2.3.3, 3.3 or 5.4, [* * *] will not bear any expenses after nomination as a Development Candidate for a Compound or Product and [* * *] shall bear all other expenses incurred under this Agreement, including for Development and Commercialization, other than for a Co-Development Program.  
4.1.2    Cost Calculation Mechanism.  Where this Agreement expressly requires that Novo reimburse or be responsible for Dicerna’s expenses incurred under a Research Plan or Development Plan or otherwise directed by Novo under Section 4.2.2, such expenses shall be calculated in accordance with the following mechanism: Novo shall compensate Dicerna for FTEs performing activities under and in accordance with the Research Plan or Development Plan at the FTE Rate, provided that the nature and scope of the work performed by Dicerna has been approved in advance in writing by Novo and that Dicerna uses at least the same level of efforts and efficiency to perform such work as Dicerna uses for similar work performed for its own account (but in no event less than Commercially Reasonable Efforts).  For the avoidance of doubt, the FTE Rates are payable solely for activities for which this Agreement expressly specifies that Novo is to reimburse or be responsible for Dicerna’s expenses and are not payable for any other activities that Dicerna undertakes.  In addition to the FTE Rates, Novo shall reimburse any out of pocket expenses incurred by Dicerna in accordance with the Research Plan or Development Plan that are specified as being Novo’s responsibility.  The compensation is to be paid by Novo to Dicerna on a [* * *] basis with respect to each [* * *].  Payment shall be made in arrears and within [* * *] after receipt of an invoice, with supportive documentation detailing the FTE hours and out of pocket expenses applicable to Dicerna’s efforts for such applicable [* * *] period, such information to include the work packages of the Development Plan items worked on the number of FTEs assigned to each work package and the out-of-pocket expenses.  Notwithstanding the foregoing, contract research organization (“CRO”) expenses incurred by Dicerna in accordance with the Development Plan shall be invoiced separately by Dicerna upon Dicerna’s receipt of such CRO’s invoice, and irrespective of whether such payments are made in advance or in arrears, such invoice to be due and payable within [* * *] upon receipt of such invoice by Novo; provided, that, if Novo reimburses Dicerna for advance payments made by Dicerna to CROs, Dicerna shall provide the final actual cost per invoiced period and a true up of actual cost compared to advance payment (planned cost) to Novo.  If the advance payment(s) turn out to be higher than the actual cost incurred by Dicerna, 

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Dicerna shall credit the respective amount of the advance payment to the next invoice or invoices payable by Novo, and in the event there are no further invoices anticipated, reimburse Novo within [* * *] of such true up.  As long as Dicerna provides Development support to Novo and for a period of [* * *] thereafter, Dicerna shall maintain complete and accurate books and records regarding the FTEs and all out-of-pocket expenses (including CRO expenses) invoiced to Novo and Novo shall have the right to have an Accounting Firm inspect Dicerna’s records solely for purposes of determining the accuracy of the FTEs passed through to Novo in accordance with Section 9.5 of this Agreement applied mutatis mutandis (subject only to replacing references to “Novo” with references to “Dicerna,” and vice versa, and other analogous changes, including changes related to the subject matter of the audit).  Unless mutually agreed to by the parties, Dicerna shall invoice Novo for such expenses according to the Novo Nordisk A/S Invoicing Instructions attached hereto as Exhibit C.

4.2    IND Filing.  For all Products Developed and Commercialized under Section 4.2 or Section 4.3, [* * *], Novo shall be responsible for the preparation and submission of the IND filing and for seeking IND Approval and shall have control over all interactions with the applicable Regulatory Authority.  [* * *], the Parties shall be jointly responsible for the preparation and submission of the IND filing, including responses to any questions from the Regulatory Authorities during review, at Novo’s expense, but Novo will otherwise be responsible for seeking IND Approval and shall have control over all interactions with the applicable Regulatory Authority. Novo shall own all Regulatory Approvals and be responsible for all decisions in connection therewith for Regulatory Approvals of Products in the Field; provided, that Dicerna shall reasonably cooperate in these efforts as reasonably requested by Novo at Novo’s expense.

4.3    Records, Reports and Audits.
4.3.1    Records of Activities under R&D Program.  Dicerna and Novo shall maintain complete, current and accurate records (paper and/or electronic) for so long as necessary to comply with Applicable Laws, or reasonably necessary to support the prosecution, maintenance and enforcement of intellectual property rights (including Patent Rights), regarding its conduct of the R&D Program after the applicable activity, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall fully and properly reflect the work done and results achieved by each Party in the performance of the R&D Program; and sufficient to confirm the accuracy and contents of the Blocked Target List (the “Records”).  Electronic Records shall be stored by each Party in accordance with the system for electronic data storage and exchange specified by the JSC (which specification the JSC shall agree upon during the first JSC meeting).  
4.3.2    Prioritization and Resource Allocation Planning. At the Effective Date and at least [* * *] thereafter, Dicerna will present to the JSC for approval a proposed project prioritization and timeline for the next [* * *] period, including a suggested allocation of FTE resources to each identified Collaboration Target; provided that, if the JSC is unable to agree on such project prioritization, timeline and/or allocation of resources, including FTEs, such issue(s) shall be finally decided as set forth in Section 19.6.  Dicerna shall provide to Novo a draft of the above project prioritization and timeline at least [* * *] in advance of the JSC meeting at which such project prioritization and timeline is to be discussed. 

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4.3.3    Resource Allocation. During the R&D Collaboration Term, Dicerna and Novo agree that each will assign to the Collaboration Targets resources substantially in accordance with the budgets set forth in the Research Plans, including appropriate personnel resources comprising skills and levels of experience consistent with such budgets set forth in the Work Flow Plan.  
4.3.4    Copies and Inspection of Records.  [* * *].

4.4    Certain Standards Applicable to Work.  
4.4.1    All Research and Development done by either Party for non-regulated work under this Agreement will be conducted in accordance with the Research Plan or Development Plan, all applicable data privacy and security laws and regulations and other Applicable Laws.  [* * *]. 
4.4.2    [* * *]. [* * *]. Each Party represents and warrants that, during the R&D Collaboration Term, it shall adhere to and comply with its respective obligations related to the use of [* * *] set forth in Exhibit L and shall use Commercially Reasonable Efforts to ensure that all future subcontractors and CROs adhere to and comply with these obligations. The decision to use [* * *] in the activities to be conducted pursuant to the Research Plan or Development Plan shall be made by the JSC.
4.4.3    Use of Animals. The Parties agree to ensure high welfare standards for experimental animals used in any activities to be conducted pursuant to the Research Plan or Development Plan. Dicerna acknowledges that it has read and understood Novo’s Principles for the Use of Animals attached hereto as Exhibit M and agrees to adhere to and comply with these obligations. Dicerna must promptly notify Novo in the event of any material unexpected issues in relation to animal welfare or bioethical concerns that occur under the Research Plan or Development Plan and Dicerna must report to Novo the number of experimental animals having been used by Dicerna under the Research Plan or Development Plan in a [* * *] within [* * *] after the end of such [* * *]. The Parties agree to reasonably collaborate to address any such issues and concerns to the extent such issues and concerns relate to more than local legal requirements. Dicerna acknowledges that Novo may require a single on-site animal welfare inspection prior to initiation of the activities to be conducted pursuant to the Research Plan or Development Plan. If Novo wishes to perform such animal welfare inspection during the R&D Collaboration Term, Dicerna shall give Novo access to the relevant areas of its site upon reasonable notice of no less than [* * *]; provided, that any such audit shall comply with Dicerna’s SPF protocols, shall not be conducted more than [* * *] (except in the event that an audit identifies any issues, in which case Novo shall be permitted to undertake a follow-up audit) and shall be conducted during normal business hours and in a manner intended to minimize any disruptions to Dicerna’s day-to-day business.

4.5    Right to Subcontract.  Subject to the terms of this Section 4.8 and Section 5.1.2, each Party shall have the right to engage permitted Third Party contractors working on its behalf (the “Permitted Subcontractors”) to perform such portions of its Research and Development obligations under this Agreement that it customarily engages for its other similar research and Development activities, except that: (a) any use of Permitted Subcontractors by Dicerna is subject 

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to the prior written approval of Novo, except for the contract manufacturers listed on Exhibit I; and (b) under no circumstance can such Permitted Subcontractor be debarred or disqualified by a regulatory authority.  Any Permitted Subcontractor to be engaged by a Party to perform its obligations under this Agreement shall meet the qualifications typically required by such Party for the performance of work similar in scope and complexity to the subcontracted activities. Furthermore, notwithstanding the foregoing, each Party shall be responsible for ensuring that, prior to engaging any Permitted Subcontractor that such Permitted Subcontractor is subject to written agreements containing terms and conditions: (i) consistent with and which provides a substantially similar degree of protection as the relevant terms and conditions of this Agreement protecting the rights of the Parties under this Agreement including imposing obligations of confidentiality on each such Permitted Subcontractor; (ii) that vests ownership in such Party of any and all Inventions developed by such Permitted Subcontractor in the course of performing such subcontracted work; (iii) that does not under any circumstance impose any payment obligations or liability on the other Party, and (iv) that is otherwise consistent with the terms of this Agreement.  Dicerna shall obtain the right for Novo to once annually and at its own expense to audit Permitted Subcontractors of Dicerna in accordance with Section 4.6.4.  Each Party shall remain directly responsible for all of its obligations under this Agreement that have been subcontracted or sublicensed to any Permitted Subcontractor.

5.    MANUFACTURING AND COMMERCIALIZATION

5.1    Compound and Product Manufacturing Generally.
5.1.1    Generally.  Dicerna shall supply Compounds through nomination as a Development Candidate in accordance with Section 5.1.2, either itself or through a contract manufacturer disclosed pursuant to Section 5.1.2.  Subject to the Parties’ respective rights and obligations with respect to filing applications for and obtaining IND Approvals as set forth in Sections 4.2.2 and 4.5, Dicerna has the right to perform and manage the CMC Activities through IND Approval, and the obligation to do so, [* * *].  On a Development Candidate-by-Development Candidate basis, the Parties, in consultation with the JSC, shall decide on the transfer of responsibilities and obligations related to CMC.  The Parties will specify in the relevant Research Plan or Development Plan the source of manufacture and supply of all other pre-clinical and clinical Products. For the avoidance of doubt, unless the Parties mutually agree to other terms, Dicerna will have no obligation to Manufacture any Compounds or Products for Clinical Trials and will not be responsible for any Manufacturing Expenses after nomination as a Development Candidate. If the Parties mutually agree that Dicerna will supply Products for Clinical Trials, the Parties will negotiate in good faith a future Supply Agreement for submission to the JSC for approval.
5.1.2    Manufacturing Standards.  A list of the contract manufacturers that Dicerna has engaged with the ability to Manufacture the Products for Research and Development until at least IND-submission (on a Product-by-Product basis) is attached as Exhibit I, which contract manufacturers shall be considered Permitted Subcontractors in accordance with Section 4.8.  Without limiting the foregoing, but subject to the terms and conditions of this Agreement, the Parties will negotiate in good faith to come to a mutual agreement related to Product supply by Dicerna under GMP during the R&D Collaboration Term for each Product up until nomination as a Development Candidate and, with the respect the first Product that is the subject of an IND filing, 

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up until such IND filing; it being understood that unless the Parties agree otherwise, Dicerna has the right to use the contract manufacturers in Exhibit I to fulfill its manufacturing obligations.  The Parties shall enter into a quality agreement if Novo determines that such an agreement is relevant to the conduct of manufacturing activities.  When Dicerna uses a contract manufacturer or other subcontracted element of the supply chain, Novo will have the right to audit such contract manufacturer and to approve (or reject) in advance any new contract manufacturer that is not listed on Exhibit I, provided that such approval shall not be unreasonably withheld, delayed or conditioned.  The Parties agree that the manufacturers for each Product shall be listed in the Research Plan or Development Plan.  Except as set forth in this Section 5.1.2, Novo shall have the right to perform or have performed Product manufacturing in its discretion.  
5.1.1    Visits to Facilities.  Novo may conduct ongoing and routine audits of Dicerna or its subcontractors (including its contract manufacturers) in accordance with Section 4.6.4 (including the expense reimbursement provisions thereof) to ensure compliance with applicable GMPs and Exhibit M during normal business hours no more than once annually and upon reasonable advance notice by Novo and the mutual agreement of the Parties as to the specific date and time for such audit, provided, however, that in the case of audits for cause, Novo will have the right to conduct, or cause Dicerna to conduct, compliance audits more than once annually at the time of the event giving rise to a for cause audit, upon at least [* * *] advance written notice, provided that such audit does not unreasonably interfere with Dicerna’s operations.  Dicerna shall ensure that all of its agreements with is contract manufacturers and other subcontractors provide for Novo to directly conduct such audits.
5.1.1    Notice of Inspections.  If legally permissible, Dicerna shall provide notice to Novo within [* * *] of becoming aware of any requested or commenced governmental or regulatory review, audit or inspection of its or its contractor’s facility, processes, Compounds or Products that directly relate to this Agreement.  Dicerna shall provide Novo with the results of any such review, audit or inspection and be given the opportunity to provide assistance in responding to any such review, audit or inspection.

5.2    Product Quality Generally.  An applicable quality agreement will determine, in accordance with applicable regulatory requirements, all Product quality standards for Product to be used in Clinical Trials including: stability; process validation and pre-approval inspection preparation; specifications; assay methodology and storage conditions.  Novo will determine in accordance with applicable Regulatory Requirements such Product quality standards that must be included in any manufacturing requirements for Product and Novo will in all circumstances have the sole right to make the final release determinations for the Products, as the Parties shall set forth greater detail in the applicable quality agreement.

5.3    Commercialization by Novo.  Subject to Sections 2.3.2, 2.3.3, 3.3 and 5.4, Novo shall have the sole right and be responsible for Commercialization of the Products in the Territory, and shall use Commercially Reasonable Efforts to achieve a First Commercial Sale of at least [* * *] Products, provided that all necessary Regulatory Approvals are obtained.  

5.4    Co-Development Payments.  A Co-Development Program will not be subject to any future Development and Regulatory Milestone Payments, Commercial Milestone Payments or 

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Royalties due under Sections 8.4, 8.5 and 8.6.  Upon Dicerna’s designation of a Product as a Co-Development Product, all Development and Regulatory Milestone Payments and Commercial Milestone Payments previously paid by Novo to Dicerna with respect to such Product and the relevant Collaboration Target shall constitute Pre-Option Development Expenses of Novo and be subject to Section 5.4.2 below.  
5.4.1    Budget. On a Co-Development Program-by-Co-Development Program basis, and as further detailed in Exhibit F, the Parties will promptly agree upon a budget for expected Development Expenses for the Co-Development Program (“Co-Development Budget”) unless the Parties have already agreed upon or the JSC has determined a Development Budget, which will be used to calculate the Co-Development Budget.  [* * *]. 
5.4.2    Payment of Shared Costs and Profits.  Subject to Section 5.4.1 and as further detailed in Exhibit F, the designating Party will be responsible for: (i) paying the other Party for all Co-Development Pre-Option Expenses within [* * *] of the receipt of an invoice from the non-designating Party issued on or after the designation date; and (ii) payment of Co-Development Post-Option Expenses as they are incurred for a given Co-Development Program within [* * *] after receipt of a report of Co-Development Post-Option Expenses incurred by the other Party, which report shall be submitted following the end of each [* * *] beginning with the [* * *] of opt-in.  Each Party will be entitled to a respective percentage of Global Profits for the Co-Development Product, with the designating Party receiving an amount equal to Co-Development Percentage multiplied by Global Profits (“Co-Development Profit Share”) and the Party responsible for Commercialization activities receiving the remainder of Global Profits, as further detailed in Exhibit F.  In the event that actual Co-Development Post-Option Expenses for a [* * *] exceed the Co-Development Budget in effect as of the first day of such [* * *] by more than [* * *]: 
(a)    Dicerna may (but is not required to) elect, upon written notice to Novo delivered within [* * *] of the date on which Novo notifies Dicerna of such budget excess, to continue to pay the budgeted Co-Development Post-Option Expenses and adjust the future Co-Development Percentage to reflect the relative share paid by each Party of the Co-Development Post-Option Expenses for the Product.  By way of example, if (i) Dicerna’s Co-Development Percentage is [* * *], (ii) in prior [* * *], the aggregate Co-Development Post-Option Expenses were [* * *]  (of which Dicerna paid [* * *]), (iii) the Co-Development Budget for the Product in the current [* * *] is $[* * *] (of which Dicerna’s share would be ([* * *]), and (iv) FDA requires an additional arm be included in a Pivotal Study and, as a result, the actual Co-Development Post-Option Expenses incurred during such [* * *]  (including the additional Co-Development Post-Option Expenses for such additional arm) totaled [* * *], Dicerna could elect to pay only [* * *]  (i.e.,  [* * *] of its budged share) and to decrease its Co-Development Percentage going forward to [* * *] (calculated as [* * *] (i.e., the aggregate Co-Development Post-Option Expenses funded by Dicerna through such [* * *])) divided by [* * *] (i.e., the total Co-Development Post-Option Expenses through such [* * *])).  Once Dicerna makes such an election, Dicerna may not thereafter increase its Co-Development Percentage; or

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(b)    Dicerna may (but is not required to) elect, which election Dicerna may make only once during the Term, upon written notice to Novo delivered within [* * *]  of the date on which Novo notifies Dicerna of such budget excess, to defer its portion of such excess Co-Development Post-Option Expenses over [* * *]  of the budgeted Co-Development Budget for the Product in the current [* * *], with the amount of such deferral not to exceed a total [* * *].  For example, in the circumstances described in the example in Section 5.4.2(a) above, Dicerna could elect to defer [* * *]  (i.e., [* * *] of the portion of the budget excess ([* * *]) over [* * *] of the Co-Development Budget for the Product in the current Calendar Year).  The deferred amount must be repaid within the following [* * *] immediately subsequent [* * *] with an interest rate of [* * *].    
5.4.3    Co-Development Product Payments.  Subject to this Section 5.4, with respect to each Co-Development Product, Global Profits accrued during the Term shall be shared between the Parties according to the Co-Development Profit Share, except as subject to Section 5.4.4.  Within [* * *] after the end of each [* * *], the Party responsible for such Commercialization shall submit a report to the other Party, including a calculation of Net Sales during such Calendar Quarter, a breakdown of the calculation of Global Profits, and a proposed division between the Parties, including the calculation of Co-Development Profit Share, in accordance with Section 5.4.2.  Concurrently with the submission of such report, the Party responsible for such Commercialization shall make a payment to the other Party in an amount calculated according to the Co-Development Profit Share included in such report; provided, however, that in the event such calculated payment amount is negative (including all previous calculated payment amounts that were negative), the Party responsible for such Commercialization shall invoice the other Party for such amount and the other Party shall pay on such invoice within [* * *] of the date thereof.  In the event of any disagreement with respect to the calculation of such payment, any undisputed portion of such payment shall be paid in accordance with the foregoing timetable and the remaining, disputed portion shall be paid within [* * *] after the date on which the Parties, using good faith efforts, resolve the dispute.
5.4.4    Failure to Pay and Early Termination. If a designating Party fails to make timely and complete payment of the Co-Development Pre-Option Expenses or any Co-Development Post-Option Expenses, the other Party may provide written notice of termination of the relevant Co-Development Program to the designating Party, which notice shall be effective [* * *] after the date of the notice unless the failure to pay is cured within such time period.  If a Co-Development Program is terminated, the underlying Co-Development Target will become a Collaboration Target.  In the event of any such termination with respect to a Co-Development Program that had been designated by Dicerna, Dicerna shall not be eligible to receive any payments under Sections 8.2 or 8.3 with respect to any applicable Products.  For the avoidance of doubt, no payments are due under Sections 8.2 or 8.3 with respect to Co-Development Products.  

6.    GOVERNANCE AND JOINT STEERING COMMITTEE

6.1    Project Leader.  Within [* * *]  after a Collaboration Target has been selected, Novo and Dicerna shall [* * *] to serve as the primary point of contact between the Parties with respect 

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to each Collaboration Target being Researched and Developed under the R&D Program (each, a “Project Leader”).  The Project Leaders shall regularly communicate with each other to address R&D Program-related issues, needs and updates and facilitate communications and organization of Working Groups associated with each active Research Plan or Development Plan with respect to each Target.  Either Party, upon prior notice to the other Party, may change its Project Leader.  Additionally, the Parties may assign different Project Leaders for different Projects.  Except for those Disputes that are subject to the purview of the JSC, prior to submitting any Dispute to the Program Leaders or dispute resolution mechanism set forth in Section 19.6, the Project Leaders shall attempt, for a period of [* * *], to resolve such Dispute.

6.2    Program Leader.  Within [* * *]  of the Effective Date, Novo and Dicerna shall [* * *]  to serve as the primary point of contact between the Parties with respect to all Collaboration Targets being Researched and Developed under the R&D Program (each, a “Program Leader”).  The Program Leader will be responsible for overseeing the list of Collaboration Targets, the Discontinued Targets and the Continuation Targets. The Program Leaders shall regularly communicate with each other to address R&D Program-related issues, needs and updates and facilitate communications and organization of Project Leaders, Working Groups associated with all active Research Plan or Development Plan with respect to all Targets.  Either Party, upon prior notice to the other Party, may change its Program Leader.  If the Project Leaders cannot agree under Section 6.1 on the Dispute, then, except for those Disputes that are subject to the purview of the JSC, prior to submitting any Dispute to the dispute resolution mechanism set forth in Section 19.6, the Program Leaders shall attempt, for a period of [* * *], to resolve such Dispute.

6.3    Alliance Leader.  Within [* * *]  of the Effective Date, each Party shall also appoint an individual to act as the Alliance Leader at director level or above for such Party (each, an “Alliance Leader”).  Each Alliance Leader shall thereafter be permitted to attend meetings of the JSC and any sub-committee as a nonvoting observer.  The Alliance Leaders shall be the primary point of contact for the Parties regarding the collaboration activities contemplated by this Agreement (other than the activities/responsibilities of the Project Leader outlined in Section 6.1 and the activities/responsibilities of the Program Leader outlined in Section 6.2) and shall help facilitate all such activities hereunder.  For avoidance of doubt, the individual appointed by a Party to act as an Alliance Leader may, but need not, be the same individual appointed by such Party as the Program Leader or as a Project Leader.

6.4    Working Groups.  The Parties may establish working groups (each, a “Working Group”) to oversee the activities of the Research Plan or Development Plan.  In addition, from time to time, the Parties may establish a Working Group to oversee particular additional projects or activities.  Each Working Group shall undertake the activities delegated to it by the JSC.  During the process of establishing each Working Group, such Working Group and the JSC shall agree regarding which matters such Working Group will resolve on its own and which matters such Working Group will advise the JSC (and with respect to which such advice-specific matters the JSC will resolve).  In addition to the Target-specific Working Groups overseen by the respective Project Leaders, the Parties shall, at a minimum, establish [* * *] additional Working Groups to oversee, respectively, (i) technology transfer pursuant to Section 7.4, (ii) the manufacturing supply chain for the Products, (iii) disclosure of Program Inventions and strategy for prosecution and 

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maintenance of Joint Inventions (the “Patent Working Group”); and (iv) with respect to work conducted through Proof of Principle and, with respect to the first Development Candidate, through the first IND filing, matters relating to chemistry, manufacturing and controls (the “CMC Working Group”).

6.5    Joint Steering Committee.
6.5.1    Establishment.  As soon as practicable after the Effective Date, the Parties shall establish a Joint Steering Committee (the “JSC”) to oversee and coordinate the activities of the Parties under the R&D Program.  The Parties will either continue the JSC or establish additional committees to oversee and coordinate the activities of the Parties during the R&D Collaboration Term and the Development and Commercialization of Products.  The JSC shall be comprised of [* * *] from Novo and [* * *] from Dicerna, which the JSC may increase as its discretion.  Subject to the foregoing, each Party shall appoint its respective representatives to the JSC from time to time, and may change its representatives, in its sole discretion, effective upon notice to the other Party designating such change.  Representatives from each Party shall have appropriate technical credentials, experience and knowledge pertaining to and ongoing familiarity with the R&D Program.  [* * *] of the JSC appointed by [* * *] shall be designated the JSC Chair (the “JSC Chair”).  The JSC Chair will be responsible for calling meetings of the JSC, circulating agendas and performing administrative tasks required to assure efficient operation of the JSC but shall not have any extra or additional vote.  
6.5.2    JSC Meetings.  The JSC shall meet in accordance with a schedule established by mutual written agreement of the Parties, and no less frequently than [* * *] until expiration of the R&D Collaboration Term or as mutually agreed.  The JSC may meet by means of teleconference, videoconference or other similar means.  As appropriate, additional employees or consultants may from time to time attend the JSC meetings as nonvoting observers, provided that any such consultant shall agree in writing to comply with the confidentiality obligations under this Agreement; and provided further that no Third Party personnel may attend unless otherwise agreed by both Parties.  Each Party shall bear its own expenses related to the attendance of the JSC meetings by its representatives.  Each Party may also call for special meetings to resolve particular matters requested by such Party.  The JSC Chair or his/her designee shall keep minutes of each JSC meeting that records in writing all decisions made, action items assigned or completed and other appropriate matters.  Novo shall send meeting minutes to all members of the JSC promptly after a meeting for review.  Each member shall have [* * *] from receipt in which to comment on and to approve/provide comments to the minutes (such approval not to be unreasonably withheld, conditioned or delayed).  If a member, within such time period, does not notify Novo that s/he does not approve of the minutes, the minutes shall be deemed to have been approved by such member.
6.5.3    JSC Functions.  The JSC’s responsibilities with respect to the R&D Program are as follows:
(a)    Overseeing and coordinating the activities of the Parties under the R&D Program;

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(b)    Facilitating the exchange of Know-How and materials as required hereunder;
(a)    Approving plans and budgets for Development and Commercialization of Co-Development Products (with all such plans and budgets to be initially proposed by Novo other than Co-Development Products designated by Novo pursuant to Section 2.3.2 or Section 3.3);
(b)    Periodically reviewing the progress of the R&D Program; 
(c)    Coordinating the Parties’ documentation of Research Plans and Development Plans, suggesting updates to and modifications of each Research Plan and Development Plan and establishing the Validated Target Criteria for each Collaboration Target.  For clarification, any update or modification to the Research Plan prior to Proof of Principle with respect to the relevant Compound shall require the consent of each Party and is subject to reaching an agreement between the Parties with regards to any potential implications of such modification or update; and
(d)    Amending the Work Flow Plan.
6.5.4    JSC Disputes; Authority.  The JSC will endeavor to make decisions by consensus, with each of Novo and Dicerna having [* * *].  If consensus is not reached by the Parties’ representatives pursuant to such vote, then the matter may be escalated by either Party to designated officers of both Novo and Dicerna with appropriate decision-making authority.  In the event the designated officers are unable to resolve the issue within [* * *], then: [* * *].  Notwithstanding the foregoing, neither Party may exercise decision making authority to unilaterally amend this Agreement, or to cause the other Party to perform any activities or incur any material expenses that are not contemplated in this Agreement or the Work Flow Plan, Research Plan or Development Plan, provided that during the pendency of any escalation or dispute resolution in accordance with this Section 6.5.4: [* * *].
6.5.5    Rights and Powers.  For clarity and notwithstanding the creation of the JSC, each Party shall retain the rights, powers and discretion granted to it hereunder, and the JSC shall not be delegated or vested with such rights, powers or discretion unless such delegation or vesting is expressly provided herein, or the Parties expressly so agree in writing.  The JSC shall not have the power to amend, waive or modify any term of this Agreement, and no decision of the JSC shall be in contravention of any terms and conditions of this Agreement.  It is understood and agreed that issues to be formally decided by the JSC are limited to those specific issues that are expressly provided in this Agreement to be decided by the JSC.  The JSC shall cease to operate, on a Product-by-Product basis, once Dicerna’s option with respect to such Product under Section 2.3.3 has lapsed without being exercised, and any obligations of either Party to provide any information to the JSC with respect to such Product shall be deemed to be an obligation to provide such information directly to the other Party instead of through the JSC.  

7.    LICENSES

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7.1    License Grant to Novo.  Subject to the terms and conditions of this Agreement, Dicerna hereby grants to Novo: (a) an exclusive (even as to Dicerna), royalty bearing, sub-licensable (through multiple tiers) (subject to Section 7.2), worldwide, license under the Licensed Technology to Develop, register, make (including formulate), have made, use, and Commercialize Compounds and Products in the Field; and (b) a non-exclusive, non-royalty bearing, fully paid-up, sub-licensable (through multiple tiers) (subject to Section 7.2), worldwide license under Licensed Technology to carry out Novo’s obligations under the R&D Program, including Research and Development work required to select Targets and related Compounds and Products for purposes of this Agreement.  To the extent Dicerna is no longer subject to the exclusivity obligations granted under the Lilly Agreement (whether through the clearance process discussed in Section 2.6, termination of the Lilly Agreement, or otherwise), then, on a Collaboration Target-by-Collaboration Target basis, such license granted by Dicerna to Novo in this Section 7.1 will also extend to the Excluded Field with respect to all applicable Compounds and Products and Dicerna shall promptly notify Novo to such effect.

7.2    Sublicenses.  [* * *].

7.3    License Grants to Dicerna.  Novo hereby grants to Dicerna during the Term a non-exclusive, non-royalty bearing, fully paid-up, non-sub-licensable (except to Affiliates and Permitted Subcontractors of Dicerna solely as needed to perform services for Dicerna under this Agreement), worldwide license under Novo Intellectual Property, solely to the extent necessary for Dicerna to perform its duties and obligations according to the R&D Program.

7.4    Know-How Transfer; Availability of Employees.  Within [* * *] following Novo’s assumption of responsibility for Development or Commercialization of a Product under Article 4 or Novo’s election to retain rights under Section 15.2, Dicerna shall disclose and/or deliver to Novo, to the extent not previously provided, copies of all data and information in Dicerna’s possession relating to the Licensed Know-How which is reasonably necessary for Novo’s Development or Commercialization of such Product (including for regulatory purposes).  In addition, upon Novo’s reasonable request, Dicerna shall disclose and/or deliver to Novo, to the extent not previously provided, copies of all data and information in Dicerna’s possession that would be reasonably useful to Novo in manufacturing or having manufactured the Products, as well as authorization letters sufficient for Novo to be able to place Product orders directly with Dicerna’s contract manufacturers pursuant to the terms of the applicable agreement between Dicerna and such manufacturers. Upon Novo’s reasonable request, Dicerna will: (a) provide reasonable technical assistance to Novo during such disclosure or delivery set forth in the preceding two sentences; and (b) make its employees and non-employee consultants reasonably available at their respective places of employment to consult with Novo on issues arising in the course of Novo’s Research, Development, Manufacturing or Commercialization and in connection with any request related to a Product from any Regulatory Agency, including regulatory, scientific, technical and clinical testing issues.  The technology transfer to be undertaken under this Section 7.4 shall be overseen by the JSC or a Working Group established for such purposes, and the JSC or such Working Group may put in place a technology transfer plan expressly identifying Know-How Controlled by Dicerna to be transferred and the timing for such transfer.

41

7.5    Covenants.  Dicerna covenants that it will not: (a) take any action that (i) would impose or result in a lien, charge or encumbrance of the Licensed Technology that would prevent or limit Novo’s exercise of its licensed rights to such Licensed Technology, or (ii) adversely affects the license rights granted to Novo under this Agreement; or (b) assign, transfer, convey or otherwise grant to any Person any rights to any Licensed Technology, Joint Know-How or Joint Patent Rights or any Compounds or Products, in any manner that conflicts with the exclusive licenses granted to Novo pursuant to Section 7.1.

7.6    Mutual Use of Confidential Information.  Subject to and without limiting any license rights or exclusivity granted to Novo under this Agreement, each Party and its Affiliates will have the right to use any Confidential Information disclosed by the other Party in connection with the R&D Program and retained in the unaided memories of its employees after having access to such Confidential Information (without reference to tangible copies of such information), provided that this right to use does not constitute a license under any Patent Rights or copyrights.  An individual’s memory will be considered to be unaided if [* * *].  Notwithstanding anything to the contrary under this Section 7.6 and except as expressly authorized in this Agreement (including as to generally applicable information), the foregoing does not permit any disclosure by either Party of any of the other Party’s Confidential Information regarding the Collaboration Targets, Compounds or Products or disclosure by either Party of any of the other Party’s Confidential Information in any unpublished patent application owned (either solely or jointly) by the other Party.  

7.7    No Implied Licenses.  Except as expressly set forth in this Agreement, neither Novo, on the one hand, or Dicerna, on the other hand, by virtue of this Agreement, shall acquire any license or other interest, by implication or otherwise, in any materials, Know-How, Patent Rights or other intellectual property rights Controlled by the other Party or its Affiliates not expressly granted under this Agreement.  Furthermore, notwithstanding anything to the contrary in this Agreement, by entering into this Agreement with Dicerna, Novo is not forfeiting any rights that Novo may have, including its rights to perform research activities in compliance with 35 U.S.C. § 271(e)(1) or any experimental or research use exemption that may apply in any country.

7.8    Third Party IP Agreements.
7.8.1    Notwithstanding anything to the contrary in this Agreement, if after the Signing Date, Dicerna enters into any agreement with a Third Party under which Dicerna acquires Control of any Patent Rights or Know-How that would be necessary or reasonably useful for the Development or Commercialization of Collaboration Targets, Compounds, or Products, then Dicerna shall so notify Novo and Novo shall have the option to include such Patent Rights and Know-How in the rights and licenses granted to Novo under this Agreement.  If Novo elects to include such rights and licenses, Novo shall (a) to the extent the Third Party agreement is a license agreement, be bound by the terms of such Third Party agreement applicable to a sublicensee thereunder, and (b) reimburse Dicerna for the portion of any amounts that become owing to such Third Party by reason of the grant to, or exercise by or under the authority of, Novo of such rights; provided, that, any amounts owing to such Third Party shall not be disproportionately allocated to the Collaboration Targets, Compounds, Products or Novo’s rights hereunder (e.g., the upfront payments, milestone payments, royalty for Product sales and other payments shall be fairly allocated 

42

based on the extent to which such amounts are attributable to the applicable Collaboration Target, Compound or Product and taking into account exploitation of the Patent Rights and Know-How by Dicerna for other purposes).  In such event, the amounts reimbursed by Novo shall be deductible as contemplated under Section 8.6.3(b) from all amounts owed to Dicerna under Sections 8.3 through 8.6.  Upon request by Novo, Dicerna shall disclose to Novo a true and correct written description of the payment and other relevant obligations.  In the event Novo does not agree in writing to reimburse Dicerna for such amounts upon request, and (if applicable) to be bound by the terms of such Third Party agreement applicable to a sublicensee thereunder, then the rights licensed under such Third Party agreement shall thereafter be deemed excluded from the Licensed Patent Rights and/or Licensed Know-How, as applicable, hereunder.  Dicerna is solely responsible for, and shall make, all payments due to any Third Party licensors and assignors of rights included in the Licensed Technology pursuant to its agreements relevant to such rights, and Dicerna shall otherwise take all actions necessary to ensure that all such agreements remain in full force and effect.  
7.8.2    If, after the Effective Date, Dicerna identifies Patent Rights or Know-How Covering or relating to RNAi or oligonucleotide platform technologies Controlled by a Third Party that would be necessary or reasonably useful for inhibition, disruption or modulation of mRNA in Collaboration Targets, then Dicerna shall so notify Novo and the Parties shall coordinate in good faith the negotiation of [* * *] agreements in order to facilitate Novo having access to such technology, which may be through an agreement directly between Novo and such Third Party.  Any payments made by Novo to obtain such access shall be deductible as contemplated under Section 8.6.3(b).  

8.    FINANCIAL PROVISIONS

8.1    Upfront Payment; Escrow.  
8.1.1    In consideration for the rights granted to Novo pursuant to this Agreement and Dicerna’s performance of its obligations hereunder, including but not limited to, license grants under the Licensed Technology and Research and Development services, Dicerna shall invoice Novo and Novo shall deposit with the Escrow Agent in a non-interest bearing account a one-time upfront payment of One Hundred Seventy-Five Million U.S. Dollars (USD $175,000,000) (the “Upfront Payment”). Novo shall make such deposit to the Escrow Agent within [* * *] following the Effective Date, the payment of which to Dicerna shall be governed by this Section 8.1.  Dicerna has provided an estimate for Research and Development services of [* * *] per Collaboration Target to achieve Proof of Principle and the Parties estimate that approximately [* * *] Collaboration Targets will be the subject to this Agreement.  Within [* * *] after the Effective Date, Novo shall identify in writing [* * *] (the “Initial Targets”).  Dicerna shall prepare and deliver to Novo a bioinformatics package and mapping plan for at least one of the Initial Targets which if not identified by Novo in such [* * *] period shall be one of the [* * *]  Hepatocyte Targets previously cleared by Dicerna by the Gatekeeper (the “Bioinformatics Package and Mapping Plan”).  Upon delivery to Novo of the Bioinformatics Package and Mapping Plan, Dicerna shall certify to the Escrow Agent such delivery, whereupon the Escrow Agent shall pay to Dicerna the Upfront Payment, which shall be non-refundable and non-creditable, within [* * *] of such certification.  Novo shall execute, acknowledge and deliver any and all documents and take any action as may be reasonably necessary 

43

to assist Dicerna under the foregoing or to otherwise carry out the intent and purposes of this Section 8.1.  
8.1.2    In the event the Bioinformatics Package and Mapping Plan is not delivered within [* * *] after the Effective Date, as will be extended for factors outside Dicerna’s reasonable control, the Escrow Agent shall return the Upfront Payment.  All costs and expenses associated with the Escrow Agent and Escrow Agreement shall be borne by Dicerna.  In the event that the Escrow Agent fails to return the Upfront Payment to Novo as required by this Section 8.1.4, Dicerna shall immediately repay such amount to Novo upon Novo’s demand, and in the event that the Escrow Agent fails to release the Upfront Payment to Dicerna as required by Section 8.1.3, Dicerna shall hold harmless Novo from such failure and the payment of the Upfront Payment to Dicerna shall be deemed to have been made in full by Novo.  

8.2    Annual Fee.  As additional consideration for the rights granted to Novo pursuant to this Agreement, including license grants under the Licensed Technology, and for Dicerna’s performance of certain obligations hereunder, Novo shall pay to Dicerna Seventy-Five Million U.S. Dollars (USD $75,000,000) to be split into three non-refundable, non-creditable annual payments of Twenty-Five Million U.S. Dollars (USD $25,000,000), provided that Dicerna meets the requirements to deliver the minimum number of Mapped Targets as set forth below.  Dicerna shall invoice Novo and Novo shall pay the annual payments within [* * *] of (1) the first anniversary of the Effective Date, if Dicerna has delivered to Novo at least [* * *] Mapped Targets or, if fewer Collaboration Targets are selected by Novo to be Mapped Targets, such fewer number of Mapped Targets, (2) the second anniversary of the Effective Date, if Dicerna has delivered another at least [* * *] (or such fewer additional Collaboration Targets selected by Novo to be Mapped Targets) Mapped Targets in addition to the initial minimum number of Mapped Targets delivered under clause (1) of this Section 8.2 and (3) the third anniversary of the Effective Date, if Dicerna has delivered another at least [* * *] (or such fewer additional Collaboration Targets selected by Novo to be Mapped Targets) Mapped Targets in addition to the initial minimum number of Mapped Targets delivered under clauses (1) and (2) of this Section 8.2.  In the event Novo terminates pursuant to Section 14.2 or Dicerna terminates pursuant to Section 14.3, prior to the third anniversary of the Effective Date, then [* * *] of the outstanding, unearned annual payments will become due and payable by Novo to Dicerna.  

8.3    Pre-Clinical Milestones; DC Milestones.  
8.3.1    Pre-Clinical Milestones.  Except for Co-Development Products, which shall not be eligible for milestone payments under this Section 8.3, on a Collaboration Target-by-Collaboration Target (other than Dicerna Orphan Liver Targets) basis, with respect to a Product Directed To the applicable Collaboration Target, within [* * *] after first achievement of either (1) Proof of Principle for the first Product Directed To the first applicable Collaboration Target or (2) Initiation of GLP Tox Studies for the first Product Directed To all subsequent applicable Collaboration Targets (each, a “Pre-Clinical Milestone Event”), Novo shall notify Dicerna and make a [* * *]  milestone payment to Dicerna (each, a “Pre-Clinical Milestone Payment”).  Such payment shall be non-refundable and non-creditable and due only once for the first Product Directed To the applicable Collaboration Target to achieve the Pre-Clinical Milestone Event regardless of 

44

the repeated achievement of the Pre-Clinical Milestone Event by the same Product, irrespective of how many indications for which the Product is Developed or Commercialized.  For the avoidance of doubt, if any Pre-Clinical Milestone Payment is made with respect to a particular Product, such Pre-Clinical Milestone Payment will not be due for any other Product hereunder that is Directed To the same Target as such Product.
8.3.2    DC Milestones.  If at least [* * *]  Compounds achieve Proof of Principle and are nominated as Development Candidates as contemplated under Section 2.2, then for each subsequent Compounds that achieves Proof of Principle and is nominated as a Development Candidate (i.e., for the [* * *]  and subsequent such Compounds), Novo shall make a first [* * *]) milestone payment to Dicerna upon such achievement and nomination and a second [* * *] milestone payment to Dicerna upon the first dosing of a patient in a Phase 1 Clinical Trial with such Compound.  Such payments shall be non-refundable and non-creditable. 

8.4    Development and Regulatory Milestones.  Except for Co-Development Products, which shall not be eligible for milestone payments under this Section 8.4, on a Collaboration Target-by-Collaboration Target (other than Dicerna Orphan Liver Targets) basis, within [* * *] after first achievement of each milestone set forth in the table below by Novo, its Affiliate or sublicensee of Novo’s rights with respect to the first Product Directed To the applicable Collaboration Target (each, a “Development and Regulatory Milestone Event”), Novo shall notify Dicerna and make the corresponding milestone payment to Dicerna (each, a “Development and Regulatory Milestone Payment”).  Such payment shall be non-refundable and non-creditable and [* * *].

	
			
	 
	Development and Regulatory Milestone Events
	Development and Regulatory Milestone Payments

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

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

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

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

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

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

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

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

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

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

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8.5    Commercialization Milestones.  Subject to Sections 2.3.2 and 5.4, except for Co-Development Products, which shall not be eligible for milestone payments under this Section 8.5 if such Products are designated as Co-Development Products, on a Collaboration Target-by-Collaboration Target basis, within [* * *] after the end of the [* * *]  in which each milestone event set forth in the table below is first achieved by Novo, its Affiliate or its sublicensee (unless Dicerna or its Affiliate is the sublicensee) of Novo’s rights with respect to the first Product Directed To the applicable Collaboration Target (each, a “Commercial Milestone Event”), Novo shall notify Dicerna and make the corresponding, non-refundable (except as set forth in Section 5.4), non-creditable milestone payment to Dicerna (each, a “Commercial Milestone Payment”):
	
			
	 
	Commercial Milestone Events
	Commercial Milestone Payments

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

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

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

	 
	[* * *]
	[* * *]

The Commercial Milestone Payment shall be payable only once, irrespective of how many indications for which the first Product is Developed or Commercialized.  For the avoidance of doubt, if any Commercial Milestone Payment is made with respect to a particular Product, such Commercial Milestone Payment shall be payable for any other Product hereunder that is Directed To the same Target as such Product.

8.6    Royalties.
8.6.1    Royalty Payments.  Subject to Sections 2.3.2, 2.3.3, 3.3 and 5.4, except for Co-Development Products, which shall not be eligible for royalties under this Section 8.6 if such Products are designated as Co-Development Products, on a Product-by-Product basis, within [* * *] after the end of each Calendar Year during the Royalty Term, Novo shall pay Dicerna a royalty on only that portion of Net Sales of a Product as designated below and at the rates set forth below (each such royalty payment, a “Royalty”):
	
		
	Annual Worldwide Net Sales on a Product-by-Product basis
	   Royalty Rate

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

	[* * *]
	[* * *]

8.6.2    Royalty Term.  The Royalty will be payable on a country-by-country and Product-by-Product basis from First Commercial Sale of the Product in such country and shall terminate upon the latest of: (a) such Product no longer being Covered by at least one Effective 

46

Patent Claim in such country that is either (1) Controlled by Dicerna or one of its Affiliates as of the Signing Date or (2) Controlled by Dicerna or one of its Affiliates only after the Signing Date and claiming an Invention conceived by Dicerna or one of its Affiliates that is a GalXC Patent or a Product-Specific Patent; (b) the expiration of New Chemical Entity Regulatory Exclusivity granted to such Product, but no longer than [* * *] from such grant; and (c) [* * *] after the First Commercial Sale of such Product in such country (the “Royalty Term”), in each case subject to Section 8.6.3.  For the avoidance of doubt, any Patent Rights Covering Improvements to GalXC Platform IP that are discovered, conceived or otherwise generated solely by Novo and assigned to Dicerna under Section 10.4 are not within the scope of the Effective Patent Claims described in the foregoing Section 8.6.2(a), and no Royalties will be payable by Novo with respect to any such Patent Rights. 
8.6.3    Royalty Step-Downs.  The Royalties under Section 8.6.1 shall be reduced by the following step-down provisions:
(a)    Effective Patent Claims.  
(i)    Notwithstanding Section 8.6.1, on a country-by-country and Product-by-Product basis, if at the time of or after the First Commercial Sale of a particular Product in a country or anytime thereafter, such Product is not Covered by one or more Effective Patent Claims in such country, then the Royalty at which Novo is required to pay during the Royalty Term to Dicerna on the Net Sales of such Product in such country shall be reduced by [* * *] of the Royalty rate set forth in Section 8.6.1 for the rest of the Royalty Term.
(ii)    Notwithstanding Section 8.6.1, on a country-by-country and Product-by-Product basis, if at the time of or after the First Commercial Sale of a particular Product in a country or anytime thereafter, either (A) such Product is not Covered by one or more Effective Patent Claims of Product-Specific Patents but is Covered by one or more Effective Patent Claims in other Licensed Patent Rights in such country or (B) such Product is not Covered by any issued Effective Patent Claim but is Covered by a pending Effective Patent Claim, then the Royalty at which Novo is required to pay during the Royalty Term to Dicerna on the Net Sales of such Product in such country shall be reduced by [* * *]  to [* * *]  of the Royalty rate set forth in Section 8.6.1 for the rest of the Royalty Term.
(b)    Third Party Payments – Anti-Stacking.  If Novo reasonably determines that Novo and/or its Affiliates or sublicensees need to acquire a Third Party’s Patent Rights (excluding Patent Rights solely claiming methods of Manufacture) or obtain a license under a Third Party’s Patent Rights in order to avoid infringement of such Patent Rights (including a patent of an Acquirer that is not part of the Licensed Patents) in order to Research, Develop or Commercialize a Compound or Product in a particular country or in the event that Novo makes any payments to Dicerna or a Third Party as contemplated under Sections 7.8, then Novo shall have the right to deduct [* * *] of all payments due from Novo and/or its 

47

Affiliates or sublicensees under the applicable agreement with the Third Party and all such payments as contemplated under Section 7.8 from the payments owed to Dicerna under Sections 8.3 through 8.5 and the Royalty owing to Dicerna during the applicable period for the such Product under Section 8.6.1, as applicable, subject to the Royalty reduction floor as set forth in Section 8.6.3(d).
(c)    Generic Competition.  On a country-by-country and Product-by-Product basis, if Generic Products reach a market share, on a unit basis, equal to or higher than [* * *] of the aggregate units of such Generic Products and a Product containing a GalXC Molecule Directed To the same Collaboration Target as such Generic Products sold in any country during any [* * *], then Novo’s obligation to pay Royalties to Dicerna for the applicable Product in the applicable country under Section ‎8.6.1 shall be reduced by [* * *] beginning with such [* * *].  On a country-by-country and Product-by-Product basis, if Generic Products reach a market share, on a unit basis, equal to or higher than [* * *] of the aggregate units of such Generic GalXC Products and a Product containing a GalXC Molecule Directed To the same Collaboration Target as such Generic GalXC Products sold in any country during any [* * *], then Novo’s obligation to pay Royalties to Dicerna for the applicable Product in the applicable country shall terminate and be of no further force or effect for and after such [* * *], at which point the Royalty Term for that Product shall also be considered terminated in that country.  For purposes of the foregoing royalty reductions, unit sales shall be determined by reference to applicable sales data obtained from IQVIA or from such other source for such sales data as may be agreed by the Parties; provided that if applicable sales data is not available from IQVIA and the Parties are unable to agree on an alternative data source, Novo may determine a reasonable alternative data source after consultation with the JSC, which reasonable alternative shall be a well-established data source widely used in the pharmaceutical industry.
(a)    Limit on Royalty Reductions.  In no event shall the Royalties owed under Section 8.6.1, with respect to a Product in a country, be reduced by operation of Sections 8.6.3(a) or 8.6.3(b) by more than an aggregate of [* * *] of what would otherwise be owed under the table set forth in Section 8.6.1 with respect to such Product in such country.  To the extent that the reductions under Sections 8.6.3(a) or 8.6.3(b) would, but for the limitation in the foregoing sentence, result in a Royalty that would be less than [* * *]  of what would otherwise be owed, the difference between such lower Royalty and the Royalty payable due to the forgoing limitation shall be carried forward and deducted against any and all subsequent payments due to Dicerna from Novo hereunder until the end of the Royalty Term.  For the avoidance of doubt, the foregoing limitation on reductions does not affect Section 8.6.3(c), and any reduction under Section 8.6.3(c) shall be made net of any reductions made pursuant to Sections 8.6.3(a) and 8.6.3(b) (e.g., if the maximum reduction of [* * *] is reached under Sections 8.6.3(a) and 8.6.3(b) and the reduction of [* * *] in Section 8.6.3(c) is also reached, the net Royalty will be [* * *] of what would otherwise be owed). 

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8.1    Co-Development Programs.  With respect to Co-Development Products, the Parties shall share in costs, profits and losses as described under Section 5.4 and Exhibit F.  

9.    REPORTS AND PAYMENT TERMS

9.1    Net Sales Reports and Royalties Due.  During the Royalty Term, Novo shall furnish to Dicerna a written report for each [* * *] showing the global Net Sales by Product, except for Co-Development Products, sold by Novo, its Affiliate or sublicensee during the reporting [* * *], the Royalties payable under this Agreement and whether a Commercial Milestone Event has been achieved in sufficient detail to allow Dicerna to verify the amount of Royalties or Commercial Milestone Payments paid by Novo with respect to such Calendar Quarter, including on a Product-by-Product basis, the Net Sales of each Product, and the Royalties (in USD) payable and in total for all Products.  Reports shall be due no later than [* * *] following the end of each Calendar Quarter.  Royalties shown to have accrued by each report provided under this Section 9.1 and any Commercial Milestone Payment achieved in such Calendar Quarter shall be due and payable on the date such report is due.

9.1    Payment Currency / Exchange Rate.  All payments to be made by Novo to Dicerna under this Agreement shall be made in USD.  Payments to Dicerna shall be made by electronic wire transfer of immediately available funds to the account of Dicerna, as designated in writing to Novo.  If any currency conversion is required in connection with the calculation of amounts payable hereunder, such conversion shall be made in accordance with Section V of Exhibit F.  

9.1    Novo Nordisk Invoicing Instructions.  Any payment payable by Novo under this Agreement, including payments under Sections 4.4.2, 5.4.2, 5.4.3, 8.1, 8.2, 8.3, 8.4, 8.5 and 8.6, is subject to receipt by Novo of an invoice prepared in accordance with the Novo Nordisk Invoicing Instructions set forth in Exhibit C.

9.1    Taxes. 
Each Party shall be responsible for the payment of all income and other taxes (including interest) (“Taxes”) imposed on its own income arising under this Agreement.  
9.1.1    If Applicable Laws require the withholding of Taxes by either Party or its Affiliates, such Taxes shall be retained by the Party making such payment (the “Payor”) as required by such Applicable Law from such remittable royalty or other payment and shall be timely remitted by the Payor to the proper tax authorities on behalf of the Party with respect to which such deduction and withholding was made (the “Payee”); provided, however, that notwithstanding anything in this Agreement to the contrary, if Novo’s assignment of this Agreement leads to the imposition of any additional withholding Tax liability on Dicerna that would not have been imposed in the absence of such action or in an increase in such liability above the liability that would have been imposed in the absence of such action, Novo will indemnify and hold harmless Dicerna from any such additional or increased withholding Tax liability (except to the extent that Dicerna or any of its Affiliates can reclaim it, provided that Dicerna will be reimbursed for any reasonable out of pocket costs incurred in the reclaim).  If Dicerna’s assignment of this Agreement leads to a requirement for Novo to withhold any additional Tax, the imposition of any additional withholding Tax liability that would not have been imposed in the absence of such action or in an increase in such liability above the liability that would have been imposed in the absence of such action, Dicerna will be 

49

liable for such additional or increased withholding Tax and indemnify and hold Novo harmless from any such additional or increased withholding tax liability (except to the extent that Novo or any of its Affiliates can reclaim it, provided that Novo will be reimbursed for any reasonable out of pocket costs incurred in the reclaim).  The Parties shall cooperate and exercise their reasonable best efforts to ensure that any such withholding Taxes are mitigated or reduced to the extent possible under the provisions of any Applicable Law, and shall provide Payee reasonable assistance (including the provision of any Tax forms and other information) in order to allow Payee to obtain the benefit of any present or future treaty against double taxation or exemption from refund or reduction in Taxes which may apply to such payments.  To the extent that a Party is required to deduct and withhold Taxes on any such payment pursuant to this Section 9.4, such Party will provide the Payee with written notice of the required withholding as promptly as reasonably practical (and in any event, no later than [* * *]) prior to making such payment.  To the extent such amounts are so deducted and withheld and timely remitted to the relevant tax authorities, such amounts shall be treated for all purposes under this Agreement as having been paid to the Person to whom such amounts would otherwise have been paid.  The Payor shall promptly (as available) submit to the Payee appropriate proof of payment of the withheld Taxes as well as the official receipts sufficient to enable the Payee to claim credits for such payments of Taxes.
9.1.2    Novo shall use reasonable efforts to obtain and deliver to Dicerna on an annual basis and within [* * *] of Dicerna’s request to provide, information as reasonably requested by Dicerna that is sufficient to meet any documentation requirements imposed by regulations issued under Section 250 of the Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”), for the treatment of an appropriate portion of such amounts as “foreign-derived deduction eligible income” within the meaning of Section 250 of the Internal Revenue Code and the regulations thereunder.  Novo shall not be required to deliver such information which Novo reasonably deems sensitive or which would be unlawful according to Danish or U.S. law.  Dicerna shall compensate Novo for any internal and external costs associated with obtaining and delivering the information to Dicerna.
9.1.3    The Parties intend that this Agreement will not be treated as a partnership or joint venture for United States federal and state tax purposes, and each Party will file all tax returns and will otherwise take all tax reporting positions in a manner consistent with such treatment.
9.1.4    It is understood and agreed between the Parties that any payments made by any Party under this Agreement are exclusive of any value added tax (“VAT”) or similar Tax imposed upon such payments.  Where VAT is properly added to a payment made under this Agreement, the paying Party will pay the amount of VAT only on receipt of a valid Tax invoice issued in accordance with Applicable Law.

9.2    Audit Rights (Financial).
9.2.1    [* * *].
9.2.2    [* * *].

1.    INTELLECTUAL PROPERTY RIGHTS

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1.1    Disclosure of Inventions.  [* * *].

1.2    Notification of Issuance.  Novo and Dicerna shall each promptly notify the other in writing of any issuance of each patent included in the Licensed Patent Rights or Joint Patent Rights of which they become aware via the Patent Working Group.

1.3    Novo Background IP.  [* * *]. 

1.4    Dicerna Background IP.  As between the Parties, Dicerna shall own and Control all right, title and interest in and to all Patent Rights or Know-How Controlled by Dicerna and existing as of or before the Effective Date, including any GalXC Platform IP, or generated or acquired outside the scope of the R&D Program and this Agreement, and shall own any Improvements to any of the foregoing made by Dicerna or an Affiliate of Dicerna and any Improvements to GalXC Platform IP made by Novo or an Affiliate of Novo generated in connection with this Agreement, but excluding Novo Product Patents, Product-Specific Patents and Product-Specific Know-How (“Dicerna Background IP”).  Novo hereby assigns and agrees to assign to Dicerna all right, title and interest in and to any Improvements to GalXC Platform IP, that are discovered, conceived or otherwise generated by Novo in connection with the R&D Program or otherwise under the Agreement.  For purposes of clarity, (1) Improvements to GalXC Platform IP do not constitute Joint Patent Rights and (2) Joint Patent Rights do not constitute Improvements to GalXC Platform IP.  If the Parties determine by mutual agreement that any Novo Know-How shall necessarily be contributed to the development of the GalXC Platform, the Parties shall develop a mutually acceptable strategy for prosecution of any Patent Rights directed to such Novo Know-How through a joint patent process via the Patent Working Group, prior to contributing such Novo Know-How to the GalXC Platform.  

1.5    Program Inventions; Joint Inventions.
1.5.1    Ownership.  [* * *]. 
1.5.2    Exploitation[* * *].
1.5.3    Assignment and Transfer of Interests in Joint Inventions.  [* * *].

1.6    Cooperation.  Each Party represents and covenants that all of such Party’s employee(s), contractor(s) and agent(s) are or will be obligated under a binding written agreement or otherwise to assign to such Party all Program Inventions made or conceived by such employee(s), contractor(s) or other agent(s) in connection with this Agreement.  The Parties shall cooperate to file, prosecute, and maintain Joint Inventions and Joint Patent Rights as may reasonably be needed.

1.7    Filing, Prosecution, Enforcement and Defense.
1.7.1    GalXC Patents and Dicerna Background IP.  [* * *].
1.7.2    Product-Specific Patents.  [* * *].
1.7.1    Joint Patent Rights. [* * *].

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1.7.2    Abandonment of Patent Rights.  If either Party elects to cease the filing, prosecution, maintenance and/or defense of a Patent Right for which Dicerna or Novo, as applicable, is in control of the filing, prosecution, maintenance and/or defense of Product-Specific Patents pursuant to Section 10.7.2 or Joint Patent Rights pursuant to Section 10.7.3 in any country of the Territory, the abandoning Party shall provide the other Party with written notice promptly following its decision to abandon the filing, prosecution, maintenance and/or defense of such Patent Right, but in no event later than [* * *] before the next relevant deadline relating to or any public disclosure of the relevant Patent Right.  In such event, the abandoning Party shall permit the other Party, at such other Party’s sole discretion, to take over or continue, as the case may be, the filing, prosecution, maintenance and defense of such abandoned Patent Right on behalf of and in the name of the abandoning Party, but at the other Party’s own expense.  If the other Party elects to take over and continue such filing, prosecution, maintenance or defense, the abandoning Party shall execute such documents and perform such acts, at the other Party’s expense, as may be reasonably necessary to permit the other Party to take over and continue the filing, prosecution, maintenance and/or defense of such abandoned Patent Right on behalf and in the name of the abandoning Party and at the other Party’s own expense.  For the avoidance of doubt, the abandoning Party shall remain the owner of the abandoned Patent Right(s) but shall have no further say in the filing, prosecution, maintenance and defense of such abandoned Patent Right(s); provided, however, that the other Party shall timely inform the abandoning Party if it too decides to finally abandon the respective Patent Right, in which event the abandoning Party shall have the right to re-assume sole responsibility for ongoing prosecution, maintenance and defense of such abandoned Patent Right in accordance with this Section 10.7.4.  Notwithstanding the foregoing, if Novo determines, in its sole discretion following good faith discussions with Dicerna, that any such abandonment is necessary to avoid detrimental effect to any Product-Specific Patent or Joint Patent Right, then, subject to Sections 10.7.2 and 10.7.3, Dicerna shall have no right pursuant to this Section 10.7.4 to elect to take over and continue the filing, prosecution, maintenance or defense of such Product-Specific Patent or Joint Patent Right.
1.7.3    Notification of Infringement.  Novo and Dicerna shall each promptly notify the other in writing of any alleged or threatened infringement of the Licensed Patent Rights or Joint Patent Rights of which they become aware (each, an “Action”), and the prosecution and enforcement of such alleged or threatened infringement of the Licensed Patent Rights or Joint Patent Rights shall be done in accordance with this Section 10.7.
1.7.4    Control of Enforcement Actions.  The Party specified in this Section 10.7 as having control over enforcement of particular Patent Rights alleged or threatened to be infringed in an Action (the “Initial Party”) may commence litigation with respect to the alleged or threatened infringement at its own expense or otherwise seek to handle such Action.  If the Initial Party elects, in its sole discretion, to handle such an Action, the Initial Party shall control such Action, and the Initial Party may enter into settlements, stipulated judgments or other arrangements respecting such infringement; provided, however, the Initial Party shall not take any action, including legal action, settle or make any agreement that adversely affects the other Party’s rights or interests, including any settlement or agreement which admits or concedes that any aspect of any of the Joint Patent Rights or Licensed Technology is invalid or unenforceable or which adversely affects the scope of any of the Joint Patent Rights or Licensed Technology (in cases where Dicerna is the Initial Party) or Licensed Technology (in cases where Novo is the Initial Party), without the prior written consent 

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of the other Party.  The Initial Party shall keep the other Party reasonably apprised of the progress of any such Action.  The other Party may, at its option and sole expense, be represented by counsel of its choice, but all other expenses associated with any such Action shall be at the sole expense of the Initial Party.  In the event that the Initial Party does not commence litigation or otherwise address an Action within [* * *] following the date on which Novo or Dicerna (as applicable) notifies the other Party of any alleged or threatened infringement of the Licensed Patent Rights or Joint Patent Rights of which they become aware pursuant to Section 10.7.5, the other Party may do so, at the other Party’s expense; provided, however, that: [* * *].  Notwithstanding the foregoing, if an Action involves Product-Specific Patents, Novo may determine whether or not to enforce such Product-Specific Patents in its sole discretion; provided that Novo shall not enforce such Product-Specific Patents except against infringing Competing GalXC Products.  In any Action, (a) the Party not in control of enforcing such Action will reasonably cooperate with the enforcing Party, including, if required to bring such action, the furnishing of a power of attorney, and (b) any damages or other recovery, including compensatory and other non-compensatory damages or recovery actually received from a Third Party, shall first be used to reimburse the Parties for their respective reasonable costs and expenses incurred in connection with such Action.  Any remaining recovery shall be paid to Novo and [* * *].
1.7.5    Patent Term Extension.  The Parties shall consult with and cooperate and coordinate with each other in obtaining patent term extensions or supplemental protection certificates and the like with respect to the Licensed Patent Rights, in each country and region where it is possible to do so.  Novo will elect whether to pursue patent term extensions or supplemental protection certificates [* * *] and Dicerna agrees to abide by such election.  Any request by Novo to pursue patent term extensions or supplemental protection certificates [* * *] shall not unreasonably be refused by Dicerna.  Dicerna shall provide prompt and reasonable assistance, as requested by Novo, at Novo’s reasonable, pre-approved expense, including by taking such action as may be required of the patent holder under any Applicable Laws to obtain such patent extension or supplementary protection certificate.
1.7.1    Patent Listing. Novo will promptly, accurately and completely list, with the applicable Regulatory Authorities during the Term, all applicable [* * *] for a Product. Prior to such listings, the Parties will meet, through the JSC, to evaluate and identify all applicable Patent Rights. Notwithstanding the preceding sentence, Novo will retain final decision-making authority as to the listing of all applicable [* * *].
1.7.2    Filing Countries.  [* * *].  

1.8    Management of Novo Background Patents.  Novo shall have sole responsibility for and control over the filing, prosecution, maintenance and enforcement of the Novo Patents (other than the Joint Patent Rights), at Novo’s sole expense.

1.9    Product Infringement.  [* * *].

1.10    Product Trademarks.  Novo will be free, in its sole discretion, to use and to register in any trademark office in the Territory any trademark for use with a Product; provided, that nothing herein shall grant Novo any right to use any trademark Controlled by Dicerna and/or its Affiliates.  

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Subject to the foregoing, Novo shall have the right to select, and shall own all right, title and interest in and to, any such trademark relating to a Product that it selects during and after the Term.  Upon Dicerna’s request, Novo shall recognize Dicerna in a press release associated with the Regulatory Approval of any Product.

1.1    Inventorship and Title.  Inventorship of inventions shall be determined in accordance with the patent laws of the United States. 

1.2    Invention Disclosure and Recordkeeping.  Each Party shall use its established policies to ensure that all inventions shall be documented by employees and consultants conducting research subject to this Agreement, in a way that makes clear: (a) the identity of each individual involved in any particular experimental result and the identity of each individual creating any document concerning the research; (b) the date that each particular experiment was executed; and, (c) the date each experimental result was recorded.

1.3    Consultation on Program Inventions.  Neither Party will knowingly and intentionally take an action that could reasonably be expected to give rise to a declaratory judgment action seeking nullity of a Program Invention without consulting the other Party.  However, if any Program Invention, other than a Product-Specific Patent, becomes the subject of a legal action or claim seeking declaratory relief, revocation or nullity of Program Invention, or is subject to an interference, inter partes re-examination, opposition or similar proceeding with regard to a Program Invention, the Parties shall promptly consult with one another concerning the defense of such action, claim or proceeding.

2.    CONFIDENTIALITY

2.1    Duty of Confidence.  During the Term and for [* * *] thereafter, all Confidential Information disclosed by one Party to the other Party hereunder shall be maintained in confidence by the receiving Party and shall not be disclosed to any Third Party or used for any purpose, except as set forth herein, without the prior written consent of the disclosing Party.  The recipient Party may only use Confidential Information of the other Party for purposes of exercising its rights and fulfilling its obligations under this Agreement and may disclose Confidential Information of the other Party and its Affiliates to employees, agents, contractors, consultants and advisers of the recipient Party and its Affiliates, licensees and actual and potential sublicensees to the extent reasonably necessary for such purposes; provided that such persons and entities are bound by confidentiality and non-use of the Confidential Information substantially as protective as the confidentiality provisions of this Agreement as they apply to the recipient Party.

2.2    Exceptions.  The obligations under this Article 11 shall not apply to any information to the extent the recipient Party can demonstrate by competent written evidence that such information:
(a)    is (at the time of disclosure) or becomes (after the time of disclosure) known to the public or part of the public domain through no breach of this Agreement by the recipient Party or its Affiliates;

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(b)    was known to, or was otherwise in the possession of, the recipient Party or its Affiliates prior to the time of disclosure by the disclosing Party;
(c)    is disclosed to the recipient Party or an Affiliate by a Third Party on a non-confidential basis that is entitled to disclose it without breaching any confidentiality obligation with respect to such information; or
(d)    is independently developed by or on behalf of the recipient Party or its Affiliates, as evidenced by its written records, without use of or reference to the Confidential Information disclosed by the disclosing Party or its Affiliates under this Agreement.

2.3    Authorized Disclosures.  Subject to this Section 11.3, the recipient Party may disclose Confidential Information (including the Agreement) belonging to the other Party as follows:
2.3.1    if such disclosure is deemed necessary by counsel to the recipient Party to be disclosed to such Party’s attorneys, independent accountants or financial advisors for the sole purpose of enabling such attorneys, independent accountants or financial advisors to provide advice to the receiving Party, on the condition that such attorneys, independent accountants and financial advisors are bound by confidentiality and non-use obligations substantially as protective as the confidentiality provisions of this Agreement as they apply to the recipient Party.
2.3.2    to governmental or other regulatory agencies in order to obtain and maintain Patent Rights consistent with Article 10, but provided that such disclosure may be only to the extent reasonably necessary to obtain and maintain Patent Rights.
2.3.3    to governmental or other regulatory agencies by (a) Novo or a Novo Affiliate, licensee or sublicensee to gain or maintain approval to conduct Clinical Trials for a Product, to obtain and maintain Marketing Authorization or to otherwise Research, Develop and Commercialize Products, or (b) Dicerna or a Dicerna Affiliate, licensee or sublicensee to gain or maintain approval to conduct Clinical Trials for a Returned Compound or Product, to obtain and maintain Marketing Authorization or to otherwise Research Develop and Commercialize Returned Compounds and Products, but provided, in each case, that such disclosure may be only to the extent reasonably necessary to obtain or maintain Marketing Authorizations.
2.3.4    to the extent required in connection with any judicial or administrative process relating to or arising from this Agreement (including any enforcement hereof) or to comply with applicable court orders or governmental regulations.
2.3.5    if the recipient Party is required by judicial or administrative process to disclose Confidential Information that is subject to the non-disclosure provisions of this Article 11, in which case such Party shall promptly inform the other Party of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations.  Confidential Information that is disclosed as permitted by this Section 11.3 shall, provided that such disclosure to the extent possible does not cause such Confidential Information to become known to the public or become part of the public domain, remain otherwise subject to the confidentiality 

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and non-use provisions of this Article 11, and the Party disclosing Confidential Information as permitted by this Section 11.3 shall take all steps reasonably necessary, including obtaining an order of confidentiality and otherwise cooperating with the other Party, to ensure the continued confidential treatment of such Confidential Information. For matters subject to this Section 11.3.5 and Section 11.5, Section 11.5 shall control.
2.3.6    if the recipient Party is required to make a disclosure by Law, regulation or legal process, including by the rules or regulations of any tax authority, the United States Securities and Exchange Commission, or any other similar regulatory agencies in a country other than the United States or of any stock exchange or other securities trading institution.  In such event, a Party disclosing Confidential Information of the other Party under this Section 11.3.6 shall disclose only such Confidential Information of such other Party as is required to be disclosed.

2.4    Performance; Regulatory Approvals.  The Parties expressly agree that Novo shall have access to, and may submit, Confidential Information of Dicerna to any Regulatory Authority to the extent necessary for obtaining Regulatory Approvals for Products in the Field, and otherwise disclose Confidential Information concerning Collaboration Targets, Compounds and Products as it reasonably deems necessary or desirable in connection with Novo’s exercise of its rights and performance of its obligations under this Agreement consistent with Novo’s usual practices for protecting and disclosing confidential information relating to its products.  The Parties expressly agree that Dicerna may submit Confidential Information of Novo to any Regulatory Authority to the extent necessary for obtaining Regulatory Approvals for Returned Compounds and Products in the Field.  Confidential Information that is disclosed as permitted by this Section 11.4 shall, provided that such disclosure to the extent possible does not cause such Confidential Information to become known to the public or become part of the public domain, remain otherwise subject to the confidentiality and non-use provisions of Article 11, and the Party disclosing Confidential Information as permitted by this Section 11.4 shall take all steps reasonably necessary, including obtaining an order of confidentiality and otherwise cooperating with the other Party, to ensure the continued confidential treatment of such Confidential Information.

2.5    Disclosure of Agreement.  This Agreement and the terms herein shall be considered the Confidential Information of each of the Parties and shall be treated confidentially by each of the Parties, except that either Party or its Affiliates may disclose the terms of this Agreement: 
(a) to the extent required or advisable to comply with the rules and regulations promulgated by the United States Securities and Exchange Commission or any equivalent governmental agency in any country in the Territory, provided that such Party shall submit a confidential treatment request in connection with such disclosure and shall submit with such confidential treatment request only such redacted form of this Agreement as may be mutually agreed in writing by the Parties; 
(b) to external counsel to bona fide prospective Acquirers who would only have access on a need-to-know basis, in a secure data room (which would contain documents that are water-marked and accessible on a time-stamped basis) following agreement on all material terms of the prospective transaction and would be restricted from sharing the terms with such counsel’s client, provided that, either Party may disclose an unredacted form of this Agreement (including the foregoing information regarding Targets and payments) to the senior management of such prospective Acquirers, but only 

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at such time as (x) the Party wishing to so disclose such information certifies in writing to the other Party that such Party reasonably and in good faith believes, that it has reached agreement on all substantial economic terms and that it will execute a definitive agreement with respect to the proposed transaction within the following [* * *] and (y) the prospective Acquirer has executed a non-disclosure agreement restricting it to use such terms solely for purposes of evaluating the potential acquisition, restricting access to such individuals as may need to know the information for such evaluation, and strictly prohibiting disclosure of such terms by the prospective Acquirer; 
(c) upon request from a Governmental Authority (such as tax authorities), provided the disclosing Party uses reasonable efforts to ensure the Governmental Authority maintains such terms as confidential; 
(d) to applicable licensors, to the extent necessary to comply with the terms of any Third Party license agreement, the rights under which are sublicensed to the other Party under this Agreement; and, 
(e) to the extent necessary to perform obligations or exercise rights under this Agreement, any sublicensee, collaborator or potential sublicensee or potential collaborator of such Party, provided that (i) any sublicensee, collaborator or potential sublicensee or collaborator agree in writing to be bound by obligations of confidentiality and non-use no less protective of the disclosing Party than those set forth in this Agreement; and (ii) the financial terms of this Agreement shall be redacted from any such disclosure of the terms of this Agreement.

2.6    Breaches of Confidentiality; Assistance in Respect of Same.  The recipient Party shall promptly notify the disclosing Party if the recipient Party becomes aware of any breach of confidence or unauthorized use by any Person to whom the recipient Party has disclosed any Confidential Information. The recipient Party shall give the disclosing Party all reasonable assistance in connection with any action, demand, claim or proceeding that the disclosing Party may institute against any such person in respect of such disclosure.

2.7    Security.  Each Party will make reasonable efforts concerning collection, use, analysis, retention, storage, protection, security, transfer, disclosure, disposal, and other processing of Novo Confidential Information will comply with, and will not violate, any (i) contractual obligation of the Party, (ii) any applicable laws, rules or regulations, including those relating to privacy and best practice (based on the size and scope of the applicable Party) data security, and/or (iii) internal or external written policy or privacy statement of such Party.  Each Party has made Commercially Reasonable Efforts to implement and maintain reasonable administrative, physical, organizational, and technical safeguards sufficient to protect the Confidential Information processed by it, and such safeguards take into account the state of the art, are sufficient for the risks posed to the other Party’s’ Confidential Information.  Each Party will notify the other Party as soon as possible after discovery of any unauthorized access to, or unpermitted or inappropriate use or disclosure of, the other Party’s Confidential Information.  Dicerna shall permit Novo to audit on reasonable notice and no more often than [* * *], under customary confidentiality obligations, of its compliance with the foregoing industry standard information technology requirements, to be conducted by Novo or Third Party experts appointed by Novo. 

3.    PUBLICATIONS AND PUBLICITY

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3.1    Publications.  Notwithstanding anything to the contrary in this Agreement, Novo shall have the right to publish the results of the R&D Program with respect to the Products, provided that any such publication shall be subject to the prior review of Dicerna and shall be provided at least [* * *] prior to its submission for publication.  Dicerna will use diligent efforts to complete its review at least [* * *] prior to the intended publication date.  Novo shall: (a) delete from such publication any of Dicerna’s Confidential Information; or, (b) upon a determination that such publication includes patentable material, delay the submission of such publication or presentation for an additional period of up to [* * *] in order to allow the appropriate Party to pursue patent protection.

3.2    Publicity.  The Parties have mutually approved a press release attached hereto as Exhibit D with respect to this Agreement and either Party may make subsequent public disclosure of the contents of such press release.  Subject to the foregoing, each Party agrees not to issue any press release or other public statement, whether oral or written, disclosing the terms hereof or any of the activities under the R&D Program conducted hereunder without the prior written consent of the other Party; provided however, that neither Party will be prevented from complying with any duty of disclosure it may have pursuant to Applicable Laws or pursuant to the rules of any recognized stock exchange or quotation system subject to the restrictions set forth in Sections 11.3 and 11.5.  In the event that Dicerna desires to make a public announcement regarding the achievement of any milestone event under Section 8.4 or Section 8.5, to the extent reasonably practicable, Dicerna will provide Novo with no less than [* * *] in which to review and approve such announcement, such approval not to be unreasonably withheld, conditioned or delayed.

4.    HSR FILINGS AND CLOSING

4.1    HSR Filings.  Promptly after the execution of this Agreement, both Parties shall file the appropriate notices with respect to the transactions contemplated hereby as promptly as reasonably practicable with the United States Federal Trade Commission (“FTC”) and Department of Justice (“DOJ”) under the Hart Scott Rodino Antitrust Improvements Act of 1976, as amended (“HSR Act”).  Each of the Parties shall promptly supply the other with any information that may reasonably be required in order to effectuate the filings under the HSR Act.  Each of the Parties shall notify the other promptly upon receipt from the FTC or DOJ in connection with any filing made under the HSR Act and of any request for amendments or supplements to any such filings or of any communications with, and any other inquiries or requests for additional information from, the FTC and DOJ.  Each Party shall comply promptly, in accordance with advice received from counsel, as appropriate, with any such inquiry or request, provided, however, that neither Party shall be required to consent to the divestiture or other disposition of any of its assets or the assets of its Affiliates or to consent to any other structural or conduct remedy, and each Party and its Affiliates shall have no obligation to contest, administratively or in court, any ruling, order or other action of the FTC or DOJ or any Third Party with respect to the transactions contemplated by this Agreement.  Each Party shall be responsible for paying its own costs and expenses (including legal and consultants’ fees) incurred in connection with obtaining clearance of the transactions contemplated hereby from the FTC and the DOJ, except that Novo will pay the filing fees incurred by both Parties in connection with the filings required pursuant to the HSR Act.  The Effective Date shall not be deemed to have occurred and this Agreement (other than this Article 13 and Articles 1, 11, 16 and 

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19 and Sections 2.4, 2.5 and 17.4) shall not be effective until the HSR Clearance Date.  As used herein, the “HSR Clearance Date” means the earlier of (i) the date on which the FTC or DOJ shall notify the Parties of early termination of the waiting period under the HSR Act or (ii) the date on which the applicable waiting period under the HSR Act expires; provided, however, that if the FTC or DOJ commences any investigation by means of a second request or otherwise, HSR Clearance Date means the date on which any investigation opened by the FTC or DOJ has been terminated, without action to prevent the Parties from implementing the transactions contemplated by this Agreement with respect to the United States.  Notwithstanding any other provisions of this Agreement to the contrary, either Party may terminate this Agreement effective upon Notice to the other Party if the HSR Clearance Date has not occurred on or before the date that is [* * *] after the Parties make their respective HSR filings.

4.2    Conduct Pending HSR Clearance Date.  Between the date of execution of this Agreement and the earlier of the Effective Date or the date of termination, each Party shall conduct its business with respect to the intellectual property rights granted hereunder in the ordinary course, and it will refrain from taking any action or omitting to take any action that would have the effect of restricting or impairing the rights to be granted to either Party hereunder or preventing either Party’s ability to perform its obligations under this Agreement.

5.    TERM AND TERMINATION

5.1    Term.  Subject to Article 13, the term of this Agreement (the “Term”) will commence on the Signing Date (provided that this Agreement shall not become effective until the Effective Date, except as otherwise set forth in Section 13.1) and (subject to earlier termination in accordance with Section 14.3 or Section 14.2) will expire on a Product-by-Product (other than a Co-Development Product) basis upon the expiration of the Royalty Term for such Product.  Upon expiration (but not earlier termination) of this Agreement with respect to a Product (other than a Co-Development Product), all rights and licenses granted to Novo hereunder shall become fully paid-up, royalty-free, perpetual and irrevocable with respect to such Product.  The Term of this Agreement shall terminate on a Co-Development Product-by-Co-Development Product basis as set forth in Section 14.2.2.

5.2    Voluntary Termination.  
5.2.1    Novo has the right to terminate the Agreement in its entirety or on a Collaboration Target-by-Collaboration Target, Compound-by-Compound, Product-by Product, or (with respect to Co-Development Products Directed to Collaboration Targets pursuant to Novo’s exercise of its option under Section 2.3.2 or Section 3.3) Co-Development Product-by-Co-Development Product basis, without cause and in its sole discretion upon [* * *] prior written notice to Dicerna.  
5.2.2    On or after the expiration of the Royalty Term that would have been applicable to a Co-Development Product if it had continued as a Royalty-bearing Product, either Party may terminate this Agreement with respect to such Co-Development Product upon written notice to the other Party.  In such event, rights to such Co-Development Product shall revert to the non-terminating Party such that (1) if the non-terminating Party is Dicerna, the Co-Development Product shall 

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constitute a Returned Compound and Product under Sections 15.2.2 and 15.2.3, and (2) if the non-terminating Party is Novo, the provisions of Sections 15.2.2 and 15.2.3 shall apply to the benefit of Novo to the same extent that they are specified to apply to the benefit of Dicerna and Dicerna shall have the same obligations that Novo is specified as having, mutatis mutandis, provided that the exclusive license Novo receives under Section 15.2.3 shall be under all of the Licensed Technology and no negotiation is required in order for Novo to receive such license. Notwithstanding the foregoing, the royalties specified under Section 15.2.4 shall not apply to such reverted Co-Development Product.  The Parties shall negotiate in good faith the royalties that will be payable by the non-terminating Party with respect to the reverted Co-Development Product.  If the Parties are unable to agree on such royalties within [* * *] of the termination, then, at the request of either Party, the dispute shall be decided by binding arbitration as specified in Section 19.6 with the following modifications: there shall be only a single arbitrator, and within [* * *] after selection of the arbitrator, each Party shall submit to the arbitrator, and exchange with the other Party in accordance with a procedure to be established by the arbitrator, its case and proposal for a post-termination royalty structure applicable to the reverted Co-Development Product.  Within [* * *] after receiving each Party’s case and proposal, the arbitrators shall select, in its entirety and without modification, solely [* * *] of the [* * *] proposals submitted by the Parties.  

5.3    Termination for Cause.
5.3.1    If a Party materially breaches this Agreement, the non-breaching Party may provide the breaching Party with a written notice specifying the nature of the breach and stating its intention to terminate this Agreement with respect to the Target(s), Compound(s) and/or Product(s) (as applicable) to which such breach directly relates if such breach is not cured as provided for in this Section 14.3.1.  If the material breach is not cured by the allegedly breaching Party within [* * *] in the event of an undisputed payment default) after the receipt of such notice or if such other breach is curable but cannot be cured within the [* * *] period (which inability shall not apply to undisputed payment defaults) and the allegedly breaching Party fails to use diligent efforts to promptly cure such breach, or the allegedly breaching Party fails to dispute the alleged breach, within such [* * *] period, then in each case the non-breaching Party shall be entitled, without prejudice to any of its other rights under this Agreement, and in addition to any other remedies available to it by law or in equity, to terminate this Agreement with respect to the Target(s), Collaboration Targets, Compound(s) and/or Product(s) (as applicable) to which such breach directly relates by providing written notice to the other Party.  If the allegedly breaching Party in good faith disputes such material breach or the failure to cure or remedy such material breach such Party shall, within [* * *] of receipt of written notice from the other Party of its intention to terminate: (x) provide written notice of that dispute putting forward in reasonable detail the rationale for disputing the alleged breach to the notifying Party and (y) initiate expedited arbitration procedures in accordance with Section 19.6, in which case, such termination shall not be effective until [* * *] after the arbitration award determining that the conditions for termination of this Section 14.2 are met; provided further that the breach is not cured within such [* * *] period.  During the pendency of any such arbitration the Parties shall continue performing their respective obligations, and exercising their respective rights, under this Agreement.  The Parties hereby agree to take such steps as may be reasonably necessary to complete such arbitration process as expeditiously as possible given the circumstances.

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5.3.2    In the event that Dicerna or any of its Affiliates commences a declaratory judgment action, inter partes review, post-grant review, opposition or similar proceeding to challenge the validity or enforceability of any Product-Specific Patents, other than in response to a threat of an infringement claim or as necessary to secure allowance of a Novo-owned patent claim, such Patent Right shall no longer be a royalty-bearing Product-Specific Patent (but shall otherwise remain a Licensed Patent Right).
5.3.3    In the event that Novo or any of its Affiliates commences a declaratory judgment action, inter partes review, post-grant review, opposition or similar proceeding to challenge the validity or enforceability of any Licensed Patent Right, other than in response to a threat of an infringement claim or as necessary to secure allowance of a Dicerna-owned patent claim, and such action does not result in a declaration or ruling that the challenged Licensed Patent Right is invalid or unenforceable, Novo shall reimburse Dicerna for its out-of-pocket costs of defending such action and the Royalty rate on Products Covered by the challenged Licensed Patent Right shall be increased by [* * *] of the otherwise applicable Royalty rate set forth in Section 8.6.
5.3.4    In the event of any failure to make timely and complete payments by either Party under Section 5.4, including for Dicerna any adjustments of the Co-Development Percentage, the other Party shall have the right to terminate the relevant Co-Development Program.

5.4    Alternative to Termination.  To the extent either Party acquires any right to terminate this Agreement with respect to any Target, Collaboration Target, Compound or Product (including Co-Development Targets and Co-Development Products) or Product-Specific Patent under Section 14.3.1, the non-breaching Party may, in lieu of such termination and without limiting any other rights and remedies, elect for this Agreement to continue in full force and effect with respect to such Target, Collaboration Target, Compound, Product or Product-Specific Patent (as applicable); provided, however, that in the event Novo acquires such termination right due to Dicerna’s breach of any of its obligations under Sections 3.1 and 3.2, Novo shall have the additional right, at its election upon notice to Dicerna, to either (a) have any and all amounts thereafter payable by Novo hereunder relating to or in any way connected with the applicable Target, Collaboration Target, Compound or Product, or the Product(s) Covered by the applicable Product-Specific Patent, for which Novo made such election under this Section 14.4 reduced by [* * *] or (b) seek damages through dispute resolution in accordance with Section 19.6.  With respect to any such reduction relating to a Co-Development Product, Dicerna’s obligation to pay Post-Option Development Expenses shall also be reduced by [* * *].  For the avoidance of doubt, the non-breaching Party acquiring a right to terminate is not required to choose between exercising such termination right and such reduction right, and if the non-breaching Party elects to terminate this Agreement it may also seek damages through dispute resolution in accordance with Section 19.6.

6.    EFFECTS OF TERMINATION

6.1    Termination of Agreement.  If this Agreement terminates in full for any reason other than expiration, then no later than [* * *] after the effective date of such termination, Novo shall pay all amounts then due and owing (except that Novo shall have the right to offset any undisputed monies owed to Novo by Dicerna, if any) as of the termination date and each Party shall return or cause to be returned to the other Party, or destroy, the other Party’s Confidential Information and all copies thereof unless such Confidential Information are included within the scope of any ongoing license under Section 15.2.3; provided, however, that each Party may keep [* * *] copy of the other Party’s Confidential Information in its confidential files for record purposes and such copy shall remain subject to Article 11 of this Agreement.  In the event of termination of this Agreement, except as expressly set forth otherwise in this Agreement (including under the surviving provisions set forth in Section 15.3), the rights and obligations (including the licenses granted under Article 7, except for the mutual use of Confidential Information under Section 7.6, which shall survive) of the Parties hereunder shall terminate as of the date of such termination.

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6.2    Target/Product Return.
6.2.1    Upon any Target becoming a Discontinued Target, voluntary termination of this Agreement in its entirety under Section 14.2 or with respect to particular Compounds, Products or Collaboration Targets under Section 14.2 or Section 14.3, any license rights granted by Dicerna to Novo to the Discontinued Target or affected Products, as applicable, (or rights to all Collaboration Targets in the event of the termination of this Agreement as a whole) shall cease and revert to the respective Parties.  For purposes of this Section 15.2, “Returned Compounds and Products” shall mean, in the case of a Collaboration Target or Co-Development Target becoming a Discontinued Target, all Product(s) and Compound(s) then being Developed under this Agreement that are Directed To such Discontinued Target(s). Discontinued Targets and Returned Compounds and Products will no longer be subject to Sections 3.1 and 3.2.  If this Agreement is terminated by either Party pursuant to Section 13.1, the Parties acknowledge and agree that (a) no Target shall ever have been deemed to be a Collaboration Target, (b) the licenses herein shall be deemed to have never granted and (c) neither Party shall have been subject to any exclusivity obligations.
6.2.2    Novo shall, at Dicerna’s request, transfer to Dicerna the following items with respect to Returned Compounds and Products, to the extent necessary and to the extent used by Novo (as of the date of termination) for the Development, registration, Manufacture (including formulation), use, or Commercialization of the Returned Compounds and Products: all clinical and regulatory correspondence; all Regulatory Approvals held by Novo or its Affiliates; all data and results arising from Novo’s Development or Commercialization of the Compounds and Products corresponding to the Returned Compounds and Products, including the trial master file, the clinical database and the safety database; and solely related to the Compounds and Products that are transferable by Novo or its Affiliates to Dicerna; provided, however, that Novo shall have the right to retain copies of the foregoing information and documentation and information and documentation generally.  Dicerna shall (i) reimburse Novo for its reasonable out-of-pocket costs associated with such transfer, as defined in an invoice to be provided by Novo to Dicerna promptly following the effective date of termination in the event of a termination by Novo for Dicerna’s material breach pursuant to Section 14.3; and (ii) assume financial responsibility for such items from the date of transfer to Dicerna.  All Confidential Information of Novo relating to the items transferred pursuant hereto shall become joint Confidential Information following such transfer; provided that Dicerna shall have the right to use and disclose such Confidential Information as it reasonably deems necessary or desirable in connection with research, development and commercialization of Returned Compounds and Products incorporating such Confidential Information consistent with Dicerna’s usual practices for protecting and disclosing confidential information relating to its products.
6.2.3    [* * *].  The Parties will agree in good faith regarding a technology transfer plan to facilitate Dicerna’s practice of the foregoing licenses, which plan will provide for reasonable reimbursement to Novo for Novo’s actual internal and out-of-pocket costs and expenses, except in the event Dicerna terminates pursuant to Section 14.3 (in which case the costs and expenses of such transfer shall be borne by Novo), and Dicerna shall be solely responsible, in its discretion, for the prosecution, maintenance, defense and enforcement or all Product-Specific Patents and Novo Product Patents.  Any sublicense granted by Novo or its Affiliate to a Third Party under the license granted under Section 7.1 shall survive the termination of this Agreement, provided that, in the case 

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where termination of this Agreement for Novo’s uncured material breach pursuant to Section 14.3, such sublicensee did not cause such uncured material breach.  If permitted under such a surviving sublicense, effective upon termination of this Agreement, such sublicense shall become a direct license from Dicerna to such sublicensee; provided, that, if assignment of the sublicense or such conversion of the sublicense to a direct license is not permitted under the applicable sublicense, Novo shall be entitled to retain its right to payment thereunder and shall remain liable for Royalties under Section 8.6 of this Agreement with respect to sales by such sublicensee. If Novo will be required to pay a Third Party licensing fees based on the grant of a sublicense to Dicerna of the applicable intellectual property, Novo shall notify Dicerna of such requirement in advance and Dicerna shall have the option of either not receiving such sublicense or of receiving such sublicense and becoming responsible for the licensing fees and other payments that become payable as a result of such sublicense to Dicerna.  In addition, if Dicerna reasonably believes that Dicerna requires a license under Novo Background IP in order to Develop or Commercialize Returned Compounds and Products and requests that Novo negotiate with Dicerna a license under such Novo Background IP for such Development and Commercialization, Novo shall negotiate in good faith with Dicerna with respect to such requested license.  
6.2.4    [* * *]. 
6.2.5    For clarity, with the exception of applicable obligations under this Section 15.2 and without limiting Section 15.4 and unless expressly agreed otherwise, all obligations of the Parties with respect to the Research, Development and Commercialization of the Collaboration Targets, Compounds, and Products shall terminate on the date of notice of termination of this Agreement.

6.3    Survival.  Termination or expiration of this Agreement shall not relieve Novo or Dicerna of any obligation accruing prior to such termination/expiration, nor affect in any way the survival of any other right, duty or obligation of Novo or Dicerna which is expressly stated elsewhere in this Agreement to survive such termination.  Without limiting the foregoing and except as expressly set forth otherwise in this Agreement, Article 1 (for definitional purposes), Articles 8 and 9 (to the extent that any amounts payable accrued prior to the effective date of such expiration/termination and remain unpaid), Article 11, Article 15 and Article 17 (to the extent and with respect to claims accruing or arising prior to the effective date of such termination), Article 18 (to the extent arising prior to the effective date of termination) and Section 2.4 (but only with respect to information disclosed prior to the notice of termination), Section 8.6 (but only applicable with respect to sublicenses surviving termination (not an expiration) as described in Section 15.2.3 and further, only after First Commercial Sale of a Product and to the extent such sublicensee continues to Develop or Commercialize a Product that triggers such payment obligations during the Royalty Term), Sections 10.1, 10.3 through 10.6, 10.7.3, 10.8, 10.11, and 10.12 (but only to the extent and with respect to intellectual property generated/developed prior to the effective date of such termination), and Sections 2.3.5, 3.4 (to the extent any Compounds, Products, Collaboration Targets or Co-Development Products are still being Researched, Developed or Commercialized), 4.6.1, 7.6, 7.7, 7.8, 9.4, 9.5, 10.7.1, 10.13, 12.2, 14.1, 14.2.2, 15.2, and 16.3 shall survive termination, and Sections 19.1, 19.3 through 19.23 shall survive to the extent applicable.  Except as otherwise expressly 

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provided herein, all other rights and obligations of the Parties under this Agreement shall terminate upon termination/expiration of this Agreement.

6.4    Termination Not Sole Remedy.  Termination of this Agreement is not the sole remedy under this Agreement and, whether or not termination is effected, all other remedies will remain available (except as Novo and Dicerna have expressly agreed to otherwise herein) and such termination shall not preclude Novo and Dicerna from claiming any other damages, compensation or relief that it may be entitled to upon such termination.

6.5    Bankruptcy Code.  If this Agreement is rejected by a Party as a debtor under Section 365 of the United States Bankruptcy Code or similar provision in the bankruptcy laws of another jurisdiction (the “Code”), then, notwithstanding anything else in this Agreement to the contrary, all licenses and rights to licenses granted under or pursuant to this Agreement by the Party in bankruptcy to the other Party are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the Code (or similar provision in the bankruptcy laws of the jurisdiction), licenses of rights to “intellectual property” as defined under Section 101(35A) of the Code (or similar provision in the bankruptcy laws of another applicable jurisdiction).  The Parties agree that a Party that is a licensee of rights under this Agreement shall retain and may fully exercise all of its rights and elections under the Code, and that upon commencement of a bankruptcy proceeding by or against a Party under the Code, the other Party shall be entitled to a complete duplicate of, or complete access to (as such other Party deems appropriate), any such intellectual property and all embodiments of such intellectual property, if not already in such other Party’s possession, shall be promptly delivered to such other Party (a) upon any such commencement of a bankruptcy proceeding upon written request therefor by such other Party, unless the bankrupt Party elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under the foregoing subclause (a), upon the rejection of this Agreement by or on behalf of the bankrupt Party upon written request therefor by the other Party.  The foregoing provisions of this Section 15.5 are without prejudice to any rights a Party may have arising under the Code.

7.    REPRESENTATIONS AND WARRANTIES

7.1    Representations and Warranties by Each Party.  Each Party represents and warrants to the other as of the Signing Date that:
7.1.1    Good Standing.  It is a corporation duly organized, validly existing under the laws of the jurisdiction of its incorporation, and in good standing under the laws of its jurisdiction of formation;
7.1.2    Authority and Capabilities.  It has: (a) full corporate power and authority to execute, deliver, and perform this Agreement; (b) taken all corporate action(s) required by Applicable Laws and its organizational documents to authorize the execution and delivery of this Agreement, and the consummation of the transactions and performance of its obligations contemplated by this Agreement; and, (c) sufficient facilities, experienced personnel or other capabilities (including via Affiliates and/or Third Parties) to enable it to perform its obligations under this Agreement;

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7.1.3    Valid and Binding.  This Agreement constitutes a legal, valid and binding agreement enforceable against it in accordance with its terms (except as the enforceability thereof may be limited by bankruptcy, bank moratorium or similar laws affecting creditors’ rights generally and laws restricting the availability of equitable remedies and may be subject to general principles of equity whether or not such enforceability is considered in a proceeding at law or in equity);
7.1.4    No Conflict.  The execution and delivery of this Agreement and all other instruments and documents required to be executed pursuant to this Agreement, and the consummation of the transactions contemplated hereby do not and shall not: (a) conflict with or result in a breach of any provision of its organizational documents; (b) result in a breach of any agreement to which it is a party; or, (c) violate any Applicable Laws;
7.1.5    Absence of Debarment.  Neither Party, its officers, employees, agents, consultants or any other person used by such Party in the performance of the respective Research and Development activities under the R&D Program has been or is: (a) debarred, convicted, or is subject to a pending debarment or conviction, pursuant to section 306 of the United States Federal Food, Drug, and Cosmetic Act (“FFDCA”), 44 U.S.C. § 335a; (b) listed by any government or regulatory agencies as ineligible to participate in any government healthcare programs or government procurement or non-procurement programs (as that term is defined in 42 U.S.C. 1320a-7b(f)), or excluded, debarred, suspended or otherwise made ineligible to participate in any such program; or, (c) convicted of a criminal offense related to the provision of healthcare items or services, or is subject to any such pending action.  A Party agrees to inform the other Party in writing promptly if a Party or any person who is performing activities under the R&D Program is subject to the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best of such Party’s knowledge, is threatened.
7.1.6    Regulatory Documentation. With respect to the Product(s), each Party and its Affiliates shall generate, prepare, maintain and retain all Regulatory Documentation that is required to be maintained or retained by such Party and its Affiliates pursuant to and in accordance with, to the extent applicable, good laboratory and clinical practice and Applicable Law and all such information shall be true, complete and correct in all material respects and what it purports to be.  “Regulatory Documentation” means: all (i) applications (including all INDs and applications for Regulatory Approval), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (ii) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; (iii) supplements or changes to any of the foregoing following Regulatory Approval; and (iv) clinical and other data, including Clinical Trial data, contained or relied upon in any of the foregoing; in each case ((i), (ii), (iii) and (iv)) relating to the Product(s) Directed To a Collaboration Target.
7.1.7    Assignment by Employees, Agents and Consultants.  All employees and agents of, and consultants to, each Party or its Affiliates are obligated to assign to such Party or its Affiliate their rights in and to any inventions arising out of their work at such Party or its Affiliate either pursuant to written agreement or by operation of law.

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7.1.8    Actions Regarding Regulatory Authorities.  Neither Party nor any of its Affiliates, nor any of its or their respective officers, employees or agents has: (i) committed (or after the Signing Date, will commit) an act, (ii) made (or after the Signing Date, will make) a statement or (iii) failed (or after the Signing Date, will fail) to act or make a statement that, in any case ((i), (ii) (iii)), that (x) would be or create an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the Commercialization of Products or (y) could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities”, set forth in 56 Fed.  Reg. 46191 (September 10, 1991) and any amendments thereto or any analogous laws or policies in the Territory, with respect the Commercialization of Compounds or Products.
7.1.9    Limitation.  Neither Party nor its Affiliates makes any representation or warranty, either express or implied, that any of the R&D Program, Research, Development and/or Commercialization efforts with regard to any Compound or Product will be successful.

7.2    Representations, Warranties and Covenants by Dicerna.  Dicerna represents, warrants and, as applicable, covenants, to Novo as follows:
7.2.1    No Targets Encumbered.  As of the Signing Date, the Blocked Target List is comprised of only the Blocked Targets disclosed pursuant to Section 2.3.1.
7.2.2    No Conflict with this Agreement.  Neither Dicerna nor any of its Affiliates has granted, nor will Dicerna or its Affiliates grant during the Term, any rights (or other encumbrances) to any Third Party to Licensed Technology that conflict with the rights assigned and/or granted to Novo hereunder.  Dicerna has Control over all Know-How and Patent Rights owned by it or its Affiliates as of the Signing Date that are necessary or reasonably useful to the Research, Development, registration, manufacturing (including formulation) or Commercialization of the Compounds and Products as known to be contemplated by this Agreement as of the Signing Date.  Dicerna shall ensure that: (a) all Know-How relating to, and Patent Rights directed to (i) the GalXC Platform or (ii) Compounds and Products, necessary or reasonably useful to Research, Develop, register, Manufacture (including formulate), use or Commercialize Compounds or Products in the Field in the Territory; and (b) all Improvements to Licensed Technology; in each case of (a) and (b) solely conceived, developed, created, made or reduced to practice by Dicerna or its Affiliates and not subject to Third Party rights under existing agreements, except for the Blocked Targets and Targets subject to the Excluded Field due to exclusivity obligations granted under the Lilly Agreement consistent with this Section 16.2.2, are upon creation and remain thereafter Controlled by Dicerna.  Neither Dicerna, nor any of its Affiliates, will enter into any agreement after the date of execution of this Agreement conflicting with the foregoing. Neither Dicerna nor any of its Affiliates will assign, divest or otherwise transfer any of the Licensed Technology in a manner that would adversely affect Novo’s rights hereunder.  Neither Dicerna nor any of its Affiliates has, in anticipation of this Agreement or one of a similar nature, participated in, or agreed or planned to participate in, any transaction or series of transactions where the intent or result of such transaction(s) is (or was) to avoid extending to Novo or its Affiliates any benefits of this Agreement that Novo and its Affiliates otherwise would have enjoyed, and Dicerna shall 

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not, and shall cause its Affiliates not to, participate in, or agree or plan to participate in, any such transaction following the Signing Date.  
7.2.3    Existing Patent Rights.
(a)    All Patent Rights contained in the Licensed Technology existing as of the Signing Date that are issued or subject to a pending application for issuance (the “Existing Patents”) are listed on Exhibit E and all such Existing Patents are, as of the Signing Date: (i) to the extent issued (unless otherwise indicated on Exhibit E), subsisting and, to Dicerna’s knowledge, not invalid or unenforceable; (ii) except for the Blocked Targets or Targets subject to the Excluded Field due to the exclusivity obligations granted under the Lilly Agreement, solely and exclusively owned or exclusively licensed to Dicerna in the Field in the Territory, free of any encumbrance, lien or claim of ownership by any Third Party; (iii) to the extent subject to a pending application for issuance, being prosecuted in the respective patent offices in which such applications have been filed in accordance with Applicable Law and Dicerna’s ordinary patent prosecution practices and Dicerna and its Affiliates have presented all relevant references, documents and information of which it and the inventors are aware and which is advisable based on advice from patent counsel to the relevant patent examiner at the relevant patent office; and (iv) filed and maintained properly and all applicable fees applicable thereto have been paid on or before the due date for payment.
(b)    As of the Signing Date, to Dicerna’s Knowledge, neither Dicerna nor any of its Affiliates have taken any action that would render any Invention claimed in the issued Existing Patents unpatentable.
(c)    The Existing Patents represent all Patent Rights Controlled by Dicerna or their Affiliates as of the Signing Date that are necessary or reasonably useful for the Research, Development, or Commercialization of the Compounds and Products as known to be contemplated by this Agreement as of the Signing Date.  To Dicerna’s knowledge, as of the Signing Date, no rights or licenses are required under any Third Party Patent Rights or Know-How for Novo to Research, Develop, Manufacture (including to formulate) or Commercialize the Products as contemplated herein as of the Signing Date other than those granted under Section 7.1.
(d)    There is no license or other right granted by Dicerna or any of its Affiliates to any Third Party, or any agreement with a Third Party to which Dicerna or any of its Affiliates is a party, that would cause any Patent Right or Know-How generated by or on behalf of Dicerna or any of its Affiliates in the conduct of activities under this Agreement to fail to be Licensed Technology by depriving Dicerna of Control of such Patent Right or Know-How in the Field.  
7.2.4    Litigation and Actions Relating to Intellectual Property.  As of the Signing Date: (a) Dicerna has not received any written notice of any threatened claims or litigation seeking 

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to invalidate or otherwise challenge the Licensed Technology, including the Licensed Patent Rights, or Dicerna’s or its Affiliates’ rights, therein; and (b) Dicerna is not aware of any pending or threatened action, suit, proceeding or claim by a Third Party asserting that Dicerna or its Affiliates is infringing or has misappropriated or otherwise is violating any Patent Right, trade secret or other proprietary right of any Third Party as would reasonably be expected to impair in any material respect the ability of it or its Affiliates to fulfill any of its obligations under this Agreement.
7.2.5    Other Material Claims and Actions.  As of the Signing Date, there are no claims, actions, or proceedings pending or, to Dicerna’s of its Affiliates’ knowledge, threatened; nor, to Dicerna’s or its Affiliates’ knowledge, are there any formal inquiries initiated or written notices received for any such legal proceedings, in each case (or in aggregate) against Dicerna or its Affiliates or their properties, assets or businesses, which if adversely decided, would, individually or in the aggregate, have a material adverse effect on, or prevent Dicerna’s or its Affiliates’ ability to conduct the R&D Program or to grant the licenses or rights granted under this Agreement.
7.2.6    No Government Funding.  The Inventions claimed by the Existing Patents as of the Signing Date: (i) were not conceived, discovered, developed or otherwise made in connection with any research activities funded, in whole or in part, by the federal government of the United States of America or any agency thereof and (ii) are not a “subject invention” as that term is described in 35 U.S.C. Section 201(e) and (iii) are not otherwise subject to the provisions of the Patent and Trademark Law Amendments Act of 1980, as amended, codified at 35 U.S.C. §§ 200-212, as amended, as well as any regulations promulgated pursuant thereto, including in 37 C.F.R. Part 401.

7.3    No Other Warranties.  Except as otherwise expressly set forth in this Agreement, each Party and its Affiliates expressly disclaim any and all representations or warranties of any kind with respect to the subject matter of this Agreement, whether express or implied, including any warranties of non‐infringement, merchantability or fitness for a particular purpose.

8.    INDEMNIFICATION AND LIABILITY

8.1    Indemnification by Dicerna.  Dicerna shall indemnify, defend and hold Novo and its Affiliates, and their respective officers, directors, employees and agents (each, a “Novo Indemnified Party”), harmless from and against losses, settlements, penalties, fines, costs or expenses, damages and liability, including reasonable legal expense and attorneys’ fees, (collectively, “Losses”) to which any Novo Indemnified Party may become subject as a result of any Third Party demands, suits, claims or actions (“Claims”) against any Novo Indemnified Party (including product liability claims) arising or resulting from: (a) the Research, Development, Manufacture (including formulation), Commercialization or other exploitation of the Dicerna Orphan Products and Returned Compounds and Products pursuant to this Agreement by or on behalf of Dicerna or its Affiliates; (b) the negligence or willful misconduct of Dicerna or its Affiliates pursuant to this Agreement; (c) the breach of any term in or the covenants, warranties, representations made by Dicerna to Novo under this Agreement; (d) misappropriation of a Third Party’s Know-How to the extent such misappropriation arises from Novo’s, its Affiliate’s or its or their sublicensees’ use hereunder of materials provided by a Dicerna Indemnified Party hereunder.  Dicerna is only obliged to so indemnify and hold the Novo Indemnified Parties harmless to the extent that such 

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Claims: (i) do not arise from any breach of this Agreement or the negligence or willful misconduct of a Novo Indemnified Party and/or (ii) are not subject to indemnification by Novo under Section 17.2.

8.2    Indemnification by Novo.  Novo shall indemnify, defend and hold Dicerna and its Affiliates, and their respective officers, directors, employees and agents (each, a “Dicerna Indemnified Party”), harmless from and against Losses incurred by any Dicerna Indemnified Party as a result of any Third Party Claims against any Dicerna Indemnified Party (including product liability claims) arising or resulting from: (a) the Research, Development, Manufacture (including formulation), Commercialization or other exploitation of the Compounds and Products (but not the Co-Development Products) pursuant to this Agreement by or on behalf of Novo or its Affiliates (other than to the extent Dicerna or its Affiliates are carrying out work on behalf of Novo, but subject to subclause (d)), (b) the negligence or willful misconduct of Novo or its Affiliates pursuant to this Agreement; (c) the breach of any term in or the covenants, warranties, representations made by Novo to Dicerna under this Agreement or (d) misappropriation of a Third Party’s Know-How to the extent such misappropriation arises from Dicerna’s, its Affiliate’s or its or their sublicensees’ use hereunder of materials provided by a Novo Indemnified Party hereunder.  Novo is only obliged to so indemnify and hold the Dicerna Indemnified Parties harmless to the extent that such Claims: (i) do not arise from any breach of this Agreement or the negligence or willful misconduct of a Dicerna Indemnified Party and/or (ii) are not subject to indemnification by Dicerna under Section 17.1.

8.3    Indemnification Procedure.
8.3.1    Any Novo Indemnified Party or Dicerna Indemnified Party seeking indemnification hereunder (“Indemnified Party”) shall notify the Party against whom indemnification is sought (“Indemnifying Party”) in writing reasonably promptly after the assertion against the Indemnified Party of any Claim in respect of which the Indemnified Party intends to base a claim for indemnification hereunder, but the failure or delay so to notify the Indemnifying Party shall not relieve the Indemnifying Party of any obligation or liability that it may have to the Indemnified Party except to the extent that the Indemnifying Party demonstrates that its ability to defend or resolve such Claim is adversely affected thereby.
8.3.2    Subject to the provisions of Section 17.3.3, the Indemnifying Party shall have the right, upon providing notice to the Indemnified Party of its intent to do so within [* * *] after receipt of the notice from the Indemnified Party of any Claim, to assume the defense and handling of such Claim, at the Indemnifying Party’s sole expense.  If the Indemnifying Party does not assume control of such defense, or does not comply with its obligations under Section 17.3.3, the Indemnified Party shall be entitled to control the defense and handling of the Claim at the Indemnifying Party’s sole expense.  
8.3.3    If the Indemnifying Party elects to assume the defense and handling of the Claim: (a) the Indemnifying Party shall select competent counsel in connection with conducting the defense and handling of such Claim, and the Indemnifying Party shall defend or handle the same in consultation with the Indemnified Party, and shall keep the Indemnified Party timely apprised of the status of such Claim; (b) the Indemnifying Party shall not, without the prior written consent 

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of the Indemnified Party, agree to a settlement of any Claim which could lead to liability or create any financial or other obligation on the part of the Indemnified Party for which the Indemnified Party is not entitled to indemnification hereunder, or would involve any admission of wrongdoing on the part of the Indemnified Party; and (c) the Indemnified Party shall cooperate with the Indemnifying Party, at the request and expense of the Indemnifying Party, shall be entitled to participate in the defense and handling of such Claim with its own counsel and at its own expense, and shall not agree to any settlement of the Claim without the prior written consent of the Indemnifying Party if there is any liability or any financial or other obligation on the part of the Indemnifying Party or if it would adversely affect the Indemnifying Party.

8.4    SPECIAL, INDIRECT, AND OTHER LOSSES.  NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE UNDER THIS AGREEMENT FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES, INCLUDING LOSS OF PROFITS SUFFERED BY THE OTHER PARTY, EXCEPT FOR: (A) LIABILITY FOR BREACH OF ARTICLE 7; (B) DAMAGES REQUIRED TO BE PAID TO (I) A THIRD PARTY PURSUANT TO A NON-APPEALABLE ORDER OF A COURT OF COMPETENT JURISDICTION IN CONNECTION WITH A THIRD PARTY CLAIM FOR WHICH THE INDEMNIFIED PARTY IS ENTITLED TO INDEMNIFICATION HEREUNDER OR (II) A PARTY PURSUANT TO A NON-APPEALABLE ORDER OF A COURT OF COMPETENT JURISDICTION IN CONNECTION WITH A VIOLATION OF PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS; (C) SUCH DAMAGES ARISING OUT OF ANY BREACH OF SECTIONS 3.1 OR 3.2 OR 3.4 OR ARTICLE 11 OF THIS AGREEMENT BY A PARTY, ITS AFFILIATES OR SUBLICENSEES; OR (D) SUCH DAMAGES ARISING OUT OF THE GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF THE LIABLE PARTY.

8.1    Insurance.  [* * *].

9.    COMPLIANCE

9.1    Compliance with this Agreement.  Each of the Parties shall, and shall (to the extent applicable) cause their respective Affiliates to, comply in all material respects with the terms of this Agreement. 

9.1    Compliance with Party Specific Regulations.  In carrying out their respective obligations under this Agreement, the Parties agree to cooperate with each other as may reasonably be required to help ensure that each is able to fully meet its obligations with respect to the Party Specific Regulations applicable to it.  Neither Party shall be obligated to pursue any course of conduct that would result in such Party being in material breach of any Party Specific Regulation applicable to it; provided that in the event that a Party refuses or is unable to fulfill its obligations under this Agreement in any material respect on such basis, the other Party shall (without derogation to any other available rights and remedies) have the right to terminate this Agreement in accordance with Section 14.3.  All Party Specific Regulations are binding only in accordance with their terms and only upon the Party to which they relate.

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9.2    Compliance with Internal Compliance Codes.  Except as expressly set forth in this Agreement, all Internal Compliance Codes shall apply only to the Party to which they relate.  The Parties agree to cooperate with each other to help insure that each Party is able to comply with the substance of its respective Internal Compliance Codes and, to the extent practicable, each Party shall operate in a manner consistent with its Internal Compliance Codes applicable to its performance under this Agreement.

9.3    Compliance with Anti-Corruption Laws.  In connection with this Agreement, the Parties shall comply with all applicable local, national, and international laws, regulations, and industry codes dealing with government procurement, conflicts of interest, corruption or bribery, including, if applicable, the US Foreign Corrupt Practices Act of 1977, as amended, and any laws enacted to implement the Organization of Economic Cooperation and Development Convention on Combating Bribery of Foreign Officials in International Business Transactions. 

9.4    Prohibited Conduct.  Without limiting the other obligations of the Parties set forth in this Article 18, in connection with any activities of the Parties under this Agreement, the Parties confirm that they have not made, offered, given, promised to give, or authorized, and will not make, offer, give, promise to give, or authorize, any bribe, kickback, payment or transfer of anything of value, directly or indirectly, to any person or to any Government Official for the purpose of:  (i) improperly influencing any act or decision of the person or Government Official; (ii) inducing the person or Government Official to do or omit to do an act in violation of a lawful or otherwise required duty; (iii) securing any improper advantage; or, (iv) inducing the person or Government Official to improperly influence the act or decision of any organization, including any government or government instrumentality, to assist any Party in obtaining or retaining business.  For the purposes of this Section “Government Official” means:  (i) any officer or employee of: (a) a government, or any department or agency thereof; (b) a government-owned or controlled company, institution, or other entity, including a government-owned hospital or university; or (c) a public international organization (such as the United Nations, the International Monetary Fund, the International Committee of the Red Cross, and the World Health Organization), or any department or agency thereof; (ii) any political party or party official or candidate for public or political party office; and/or (iii) any person acting in an official capacity on behalf of any of the foregoing.

9.5    Responsible Business.  Each Party will work to improve its social, environmental and ethical procedures, policies and performance and will support the principles set out in the United Nations’ Universal Declaration of Human Rights of 1948, the International Labour Organization Conventions and the ICC Business Charter for Sustainable Developments (hereinafter jointly referred to as “Responsible Business Practices”). Each Party undertakes to promptly notify the other Party if it encounters difficulties in supporting Responsible Business Practices. Upon request and within a reasonable period of time, each Party will discuss with the other Party information on its social, environmental and ethical procedures, policies and performance in order to reasonably substantiate that Responsible Business Practices are being followed. If, based on such discussion, a Party appears to face difficulties in supporting Responsible Business Practices, the Parties agree to collaborate in good faith to address any such difficulties as the exclusive remedy therefor.

10.    GENERAL PROVISIONS

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10.1    Assignment.  Except as provided in this Section 19.1, [* * *].

10.1    Effects of Assignment, Change of Control.  In the event of any assignment of this Agreement by Dicerna or upon a Change of Control of Dicerna: 
10.1.1    Dicerna’s rights subsequent to a Change of Control to designate Products as Co-Development Products under Sections 2.3.2 and 2.3.3 shall [* * *];
10.1.2    Novo may terminate Dicerna’s rights to participate in any Commercialization (including co-promotion) activities with respect to any Co-Development Products; 
10.1.3    Novo shall have no obligations under this Agreement to provide to Dicerna any sensitive information or materials, including information or materials relating to sales, marketing, development or strategic matters; 
10.1.4    Dicerna’s rights as an Auditing Party under Section 9.5 shall be limited to auditing Novo’s books and records to determine the accuracy of Net Sales and Operating Profit or Loss calculations;
10.1.5    [* * *];
10.1.6    Novo shall have the right to terminate the JSC and/or any of its Working Groups, in which case all authority granted to the JSC and any such Working Groups shall vest in Novo; and
10.1.7    If Dicerna owes any deferred amount under Section 5.4.2(b), Dicerna shall repay to Novo such deferred amount prior to or on the date of such assignment or Change of Control of Dicerna.
10.2    Extension to Affiliates.  Except as expressly set forth otherwise in this Agreement, each Party shall have the right to extend the rights and immunities granted in this Agreement to one or more of its Affiliates.  All applicable terms and provisions of this Agreement, except this right to extend, shall apply to any such Affiliate to which this Agreement has been extended to the same extent as such terms and provisions apply to the Party extending such rights and immunities.  For clarity, the Party extending the rights and immunities granted hereunder shall remain primarily liable for any acts or omissions of its Affiliates.

10.3    Severability.  Should one or more of the provisions of this Agreement become void or unenforceable, or be determined to be void or unenforceable, as a matter of Applicable Laws, then this Agreement shall be construed as if such provision were not contained herein and the remainder of this Agreement shall be in full force and effect, and the Parties will use their best efforts to substitute for the invalid or unenforceable provision a valid and enforceable provision which conforms as nearly as possible with the original intent of the Parties.

10.4    Governing Law; English Language.  This Agreement shall be governed by and construed in accordance with the laws of the State of New York and the patent laws of the United States without giving effect to any law that would result in the application of a different body of 

72

law than as set forth in this Section 19.5.  This Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this Agreement.

10.5    Dispute Resolution.
10.5.1    If any dispute, claim or controversy of any nature arising out of or relating to this Agreement, including any action or claim based on tort, contract or statute, or concerning the interpretation, effect, termination, validity, performance or breach of this Agreement (each, a “Dispute”), arises between the Parties and the Parties cannot resolve such Dispute through their respective Project Leaders, Program Leaders or JSC, if and as applicable, within [* * *] of a written request by either Party to the other Party (“Notice of Dispute”), and such Dispute is not one for which a Party has final decision-making as expressly set forth in Section 6.5.4 of this Agreement, either Party may refer the Dispute to Senior Representatives of each Party for resolution.  Each Party, within [* * *] after a Party has received such written request from the other Party to so refer such Dispute, shall notify the other Party in writing of the Senior Representative to whom such dispute is referred.  If, after an additional [* * *] after the Notice of Dispute, such Senior Representatives have not succeeded in negotiating a resolution of the Dispute, and a Party wishes to pursue the matter, each such Dispute, controversy or claim that is not an “Excluded Claim” (defined in Section 19.6.5) shall be finally resolved by binding arbitration by the International Chamber of Commerce (“ICC”) administered in accordance with Rules of ICC in effect on the date of this Agreement and applying the substantive law specified in Section 19.5.  Judgment on the arbitration award may be entered in any court having jurisdiction thereof.  The obligation to arbitrate under this Section 19.6 shall extend to any claims by or against the Parties and their respective Affiliates and any agents, principals, officers, directors, or employees of either of the Parties or their respective Affiliates.
10.5.2    The arbitration shall be conducted by: [* * *]  experienced in the business of pharmaceuticals.  If the issues in dispute involve scientific, technical or commercial matters, the arbitrators chosen hereunder shall engage experts that have educational training or industry experience sufficient to demonstrate a reasonable level of relevant scientific, medical and industry knowledge, as necessary to resolve the dispute.  Within [* * *] after initiation of arbitration, the Parties shall select the arbitrators. Novo, on the one hand, shall select [* * *] arbitrator and Dicerna, on the other hand, shall select [* * *] arbitrator (or, if either Party fails to make a choice, the ICC shall select [* * *] arbitrator on behalf of such Party) and the [* * *] arbitrators selected by the Parties will mutually select a [* * *] arbitrator (or, if they fail to make a choice, the ICC shall select a [* * *] arbitrator). In making their determination, the arbitrators shall not have the authority to modify any term or provision of this Agreement. A consensus decision of any [* * *] of the arbitrators shall be final, conclusive and binding on the Parties.  The place of arbitration shall be v, and all proceedings and communications shall be in English.
10.5.3    Prior to the arbitrators being selected, either Party, without waiving any remedy under this Agreement, may seek from any court having jurisdiction any temporary injunctive or provisional relief necessary to protect the rights or property of that Party until final resolution of the issue by the arbitrators or other resolution of the controversy between the Parties.  Once the 

73

arbitrators are in place, either Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved, and either Party may apply to a court of competent jurisdiction to enforce interim injunctive relief granted by the arbitrators.  Any final award by the arbitrators may be entered by either Party in any court having appropriate jurisdiction for a judicial recognition of the decision and applicable orders of enforcement.  The arbitrators may render early or summary disposition of some or all issues, after the Parties have had a reasonable opportunity to make submissions on those issues.  The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damages.  The arbitrators may award the costs and expenses of the arbitration, including reasonable attorneys’ fees, disbursements, arbitration expenses, arbitrators’ fees and the administrative fee of the ICC, to the prevailing Party, which award shall be in such manner as the arbitrators deem appropriate, based on the determination of the arbitrators on the merits.
10.5.4    Except to the extent necessary to confirm an award or as may be required by law, neither a Party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties.  In no event shall an arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy or claim would be barred by the applicable [* * *] statute of limitations.
10.5.5    As used in this Section 19.6, the term “Excluded Claim” means any dispute, controversy or claim that concerns: (a) the validity, enforceability or infringement of any patent, trademark or copyright; or (b) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory.  Any Excluded Claim may be submitted by either Party to any court of competent jurisdiction over such Excluded Claim.

10.6    Continued Performance During Pendency of Arbitral Matters.  Unless and until this Agreement has terminated in accordance with its terms, the Parties shall continue to proceed with and be bound by all rights and obligations hereunder notwithstanding the issue of a Notice of Dispute or the pendency of an Arbitral Matter, litigation involving a patent issue pursuant to this Agreement, or any applicable Cure Period.

10.7    Consent to Non-Exclusive Jurisdiction; Service of Process.  As may be permitted under this Agreement, any legal action or proceeding that may be brought, in a [* * *] and, by execution and delivery of this Agreement, each Party hereby consents for itself and in respect of its property, generally and unconditionally, to the non-exclusive jurisdiction of such courts.  The Parties irrevocably waive any objection, including any objection to the laying of venue or based on the grounds of forum non conveniens, which either Party may now or hereafter have to the bringing of any such action of proceeding in such respective courts.  Each Party irrevocably consents to the service of process of any such courts in any such action or proceeding by the mailing of copies thereof by registered or certified mail, postage prepaid, to the other Party at its address provided herein, such service to become effective [* * *] after such mailing.

10.8    Force Majeure.  Neither Party shall be responsible to the other for any failure or delay in performing any of its obligations under this Agreement or for other nonperformance hereunder (excluding, in each case, the obligation to make payments when due) if such delay or nonperformance is caused by strike, fire, flood, earthquake, accident, war, act of terrorism, act of 

74

God or of the government of any country or of any local government, or by any other cause unavoidable or beyond the control of any Party hereto.  In such event, such affected Party shall use Commercially Reasonable Efforts to resume performance of its obligations and will keep the other Party informed of actions related thereto.

10.9    Waivers and Amendments.  The failure of any Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other Party.  No waiver shall be effective unless it has been given in writing and signed by the Party giving such waiver.  No provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives of each Party.

10.10    Relationship of the Parties.  Nothing contained in this Agreement shall be deemed to constitute a partnership, joint venture, or legal entity of any type between Dicerna and Novo, or to constitute one as the agent of the other.  Each Party shall act solely as an independent contractor, and nothing in this Agreement shall be construed to give any Party the power or authority to act for, bind, or commit the other to any contract, agreement or undertaking with any third Party.

10.11    Notices.  All notices, consents or waivers under this Agreement shall be in writing and will be deemed to have been duly given when: (a) scanned and converted into a portable document format file (i.e., pdf file), and sent as an attachment to an e-mail message, where, when such message is received, a read receipt e-mail is received by the sender (and such read receipt e-mail is preserved by the Party sending the notice), provided further that a copy is promptly sent by an internationally recognized overnight delivery service (receipt requested) (although the sending of the e-mail message shall be when the notice is deemed to have been given); or (b) the earlier of when received by the addressee or [* * *] after it was sent, if sent by registered letter or overnight courier by an internationally recognized overnight delivery service (receipt requested), in each case to the appropriate addresses and e-mail addresses set forth below (or to such other addresses and e-mail addresses as a Party may designate by notice):
If to Dicerna:
Dicerna Pharmaceuticals, Inc.
33 Hayden Avenue
 
Lexington, Massachusetts 02421
 
Attention: President and Chief Executive Officer
 
Fax: [* * *]
 
E-mail: [* * *] 

75

and
 

 
Dicerna Pharmaceuticals, Inc.
 
33 Hayden Avenue
 
Lexington, Massachusetts 02421
 
Attention: Legal Department
If to Novo:    

Novo Nordisk A/S
Novo Alle 1
2880 Bagsvaerd
Denmark
Attention: CVP of Global Business Development

with a copy (which shall not constitute notice) to:

Novo Nordisk A/S
Novo Alle 1
2880 Bagsvaerd
Denmark
Attention: General Counsel

Dicerna shall also provide a copy of any notice (via e-mail if available) to Novo.

10.12    Further Assurances.  Novo and Dicerna hereby covenant and agree without the necessity of any further consideration, to execute, acknowledge and deliver any and all documents and take any action as may be reasonably necessary to carry out the intent and purposes of this Agreement.

10.13    Compliance with Law.  Each Party shall, or shall cause, its Affiliates, sublicensees or Third Party contractors to, perform its obligations under this Agreement in accordance with all Applicable Laws, including any GCPs, GLPs, GMPs or GRPs and Internal Compliance Codes, as applicable.  No Party shall, or shall be required to, undertake any activity under or in connection 

76

with this Agreement which violates, or which it believes, in good faith, may violate, any Applicable Laws. 

10.14    No Third Party Beneficiary Rights.  This Agreement is not intended to and shall not be construed to give any Third Party any interest or rights (including any Third Party beneficiary rights) with respect to or in connection with any agreement or provision contained herein or contemplated hereby, except as otherwise expressly provided for in this Agreement.

10.15    Entire Agreement.  This Agreement sets forth the entire agreement and understanding of the Parties as to the subject matter hereof and supersedes all proposals, oral or written, and all other communications between the Parties with respect to such subject matter.  The Parties acknowledge and agree that, as of the Effective Date, all Confidential Information disclosed pursuant to the Confidentiality Agreement by a Party or its Affiliates shall be included in the Confidential Information subject to this Agreement and the Confidentiality Agreement is hereby superseded in its entirety; provided, that the foregoing shall not relieve any Person of any right or obligation accruing under the Confidentiality Agreement prior to the Effective Date.  “Confidentiality Agreement” means the Mutual Confidentiality Agreement between Dicerna and Novo dated August 14th, 2018, as amended on August 14, 2019, and further amended with respect to exclusivity disclosure on October 9, 2019.

10.16    Counterparts.  This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.  Counterpart signature pages may be validly delivered by facsimile or by electronic mail in PDF format and such signature pages shall have the same effect as originals.

10.17    Expenses.  Each Party shall pay its own costs, charges and expenses incurred in connection with the negotiation, preparation and execution of this Agreement.

10.18    Binding Effect.  This Agreement shall be binding upon and inure to the benefit of the Parties and their respective legal representatives, successors and permitted assigns.

10.19    Construction.  The Parties hereto acknowledge and agree that: (a) each Party and its counsel reviewed and negotiated the terms and provisions of this Agreement and have contributed to its revision; (b) the rule of construction to the effect that any ambiguities are resolved against the drafting Party shall not be employed in the interpretation of this Agreement; and (c) the terms and provisions of this Agreement shall be construed fairly as to all Parties hereto and not in a favor of or against any Party, regardless of which Party was generally responsible for the preparation of this Agreement.

10.20    Interpretation.  The captions and headings to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement.  Unless specified to the contrary, references to Articles, Sections, Schedules or Exhibits mean the particular Articles, Sections, Schedules or Exhibits to this Agreement and references to this Agreement include all Exhibits hereto.  In the event of any conflict between the main body of this Agreement and any Exhibit hereto, the main body of this Agreement shall prevail.  Unless context otherwise clearly requires, whenever used in this Agreement:  (a) the words “include” or 

77

“including” shall be construed as incorporating, also, “but not limited to” or “without limitation”; (b) the word “day” or “year” means a Calendar Day or year unless otherwise specified; (c) the word “notice” shall mean notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement; (d) the words “hereof,” “herein,” “hereby” and derivative or similar words refer to this Agreement as a whole and not merely to the particular provision in which such words appear; (e)  the words “shall” and “will” have interchangeable meanings for purposes of this Agreement; (f) provisions that require that a Party, the Parties or a committee hereunder “agree,” “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise; (g) words of any gender include the other gender; (h) words using the singular or plural number also include the plural or singular number, respectively; (i) references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement law, rule or regulation thereof; (j) the phrase “non-refundable” shall not prohibit, limit or restrict either Party’s right to obtain damages in connection with a breach of this Agreement; and (k) neither Party shall be deemed to be acting on behalf of the other Party.

10.21    Cumulative Remedies.  No remedy referred to in this Agreement is intended to be exclusive unless explicitly stated to be so, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

10.22    Export.  Each Party acknowledges that the laws and regulations of the United States restrict the export and re-export of commodities and technical data of United States origin.  Each Party agrees that it will not export or re-export restricted commodities or the technical data of the other Party in any form without appropriate United States and foreign government licenses.

[Remainder of page left blank intentionally; signature page follows.]

78

 

IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives.

DICERNA PHARMACEUTICALS, INC.

By:    /s/ Douglas Fambrough    
Name: Douglas Fambrough
Title:   CEO

NOVO NORDISK A/S

By:      /s/ Karsten Munk Knudsen    
Name: Karsten Munk Knudsen
Title:    Executive Vice President

NOVO NORDISK A/S

By:    /s/ Mads Krogsgaard Thomsen    
Name:    Mads Krogsgaard Thomsen
Title:    Executive Vice President

[Signature Page to Collaboration and License Agreement]

 

Exhibit A
Work Flow Plan

[* * *]

    

A-1

 

Exhibit B

Initial Research Plan

To be attached hereto by the Parties as set forth in Section 4.1.4.  

 

Exhibit C

Novo Nordisk A/S’s Invoicing Instructions 
 
In order to ensure timely settlement of invoices, you are kindly requested to observe the below guidelines when sending invoices or credit notes to Novo Nordisk. 
 
All invoices should be sent via email by attaching the invoice as a PDF file, email address: [* * *]. Novo Nordisk is unable to process invoices sent by telefax. 
 
All invoices must include the following information: 
•Full name and Novo Nordisk initials of the Project Director for Novo Nordisk:  
•It must be clearly stated that the document is an invoice   
 
•A reference to the Novo Nordisk agreement ID ________  
 
•Value Added Tax number or Federal ID/registration number   
 
•Bank information:  
1. International Bank Account Number 
2. Bank Name: The name of beneficiary’s bank 
3. Bank Address: The address of beneficiary’s bank 
4. Bank Key #: ABA/Routing/Fedwire/Transit number/Sort Number  
5. Swift: Swift code 
6. Account Name: Under what name beneficiary’s bank account is open 
7. Account Number: Number of beneficiary’s bank account and/or IBAN code, which is applicable in all EU countries. 

 

Exhibit D

Press Release

Dicerna and Novo Nordisk enter agreement to discover and develop RNAi therapies for liver-related cardio-metabolic diseases 

		
	•
	Collaboration to explore liver cell targets using Dicerna’s GalXCTM technology with the potential to deliver a significant number of clinical candidates 

		
	•
	Each company to retain rights to co-develop and co-commercialise product candidates 

		
	•
	Dicerna to receive upfront payment of USD 175 million and equity investment of USD 50 million 

		
	•
	Dicerna is eligible to receive an additional USD 75 million over the first three years, plus up to USD 357.5 million per target in potential milestone payments, and royalties on product sales 

		
	•
	[* * *]

Lexington, Massachusetts, US, and Bagsværd, Denmark, 18 November 2019 – DicernaTM Pharmaceuticals, Inc. (Nasdaq: DRNA) and Novo Nordisk A/S today announced an agreement to discover and develop novel therapies for the treatment of liver-related cardio-metabolic diseases using Dicerna’s proprietary GalXCTM RNAi platform technology. The collaboration plans to explore more than 30 liver cell targets and may deliver multiple clinical candidates for disorders including chronic liver disease, non-alcoholic steatohepatitis (NASH), type 2 diabetes, obesity, and rare diseases. Dicerna will conduct and fund discovery and preclinical development to clinical candidate selection for each liver cell target, and Novo Nordisk will be responsible for all further development.

The agreement represents a significant investment by Novo Nordisk to secure access to Dicerna’s proprietary GalXC RNAi platform, which complements its existing technology base. The collaboration provides Novo Nordisk with the capability to inhibit hepatocyte targets involved in disease regulation and has the potential to generate a number of clinical development candidates. 

“We are excited to collaborate with Novo Nordisk on this broad research and development effort that extends the reach of our GalXC platform to a wide range of liver cell targets and maximises our opportunities in serious liver diseases,” said Douglas M Fambrough, PhD, president and chief executive officer of Dicerna. “Our efforts will benefit from Novo Nordisk’s expertise in cardio-metabolic diseases and years of experience developing and commercialising innovative therapies worldwide, which will help us advance novel RNAi treatments for underserved patient populations.”

The agreement enables each company to co-develop and co-commercialise product candidates discovered under the collaboration. Novo Nordisk will lead programmes targeting cardio-metabolic disorders and other indications with Dicerna having the option to opt into two programmes during clinical development. Dicerna retains rights to initiate two new orphan liver disease programmes for which Novo Nordisk can opt in. For all co-development programmes, 

D-1

 

the companies will share in the profit/loss of net sales of products consistent with each company’s contribution to co-development costs. 

“Through this important collaboration with Dicerna, we gain access to an innovative technology and deep expertise in RNA interference,” said Marcus Schindler, senior vice president of Global Drug Discovery in Novo Nordisk. “Dicerna is the ideal partner to discover and develop molecules for targets that may yield multiple potential treatments across disease areas such as diabetes, obesity, cardiovascular and NASH. We will work closely together to unlock the true potential of treating a range of diseases using RNAi therapies, for the benefit of patients.”

Under the terms of the agreement, Dicerna will receive: 
		
	•
	An upfront payment of USD 175 million.

		
	•
	A USD 50 million equity investment in Dicerna at a premium.

		
	•
	USD 25 million annually during each of the first three years of the collaboration, contingent on Dicerna delivering RNAi molecules for a defined number of targets.

		
	•
	Up to USD 357.5 million per target in development, regulatory and commercialisation milestone payments, plus tiered royalties on product sales ranging from the mid-single-digits to mid-teens.

The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions.

[* * *]

About Dicerna's GalXCTM RNAi technology platform
Dicerna’s proprietary RNA interference (RNAi) technology platform, called GalXCTM, aims to advance the development of next-generation RNAi-based therapies designed to silence disease-driving genes in the liver and other tissues. Liver-targeted GalXC-based compounds enable subcutaneous delivery of RNAi therapies that are designed to bind specifically to receptors on liver cells, leading to internalisation and access to the RNAi machinery within the cells. The GalXC approach seeks to optimise the activity of the RNAi pathway so that it operates in the most specific and potent fashion. Compounds produced via GalXC are intended to be broadly applicable across multiple therapeutic areas, including both liver and non-liver indications.

About DicernaTM Pharmaceuticals, Inc.
DicernaTM Pharmaceuticals, Inc., is a biopharmaceutical company using ribonucleic acid (RNA) interference (RNAi) to develop medicines that silence genes that cause disease. The company is applying its proprietary GalXCTM technology to develop potent, selective, and safe RNAi therapies for treatment of rare diseases, chronic liver diseases, cardiovascular diseases, neurodegenerative diseases, pain and viral infectious disease. Dicerna aims to treat disease by addressing the underlying causes of illness with capabilities that extend beyond the liver to address a broad range of diseases, focusing on target genes where connections between gene and disease are well understood and documented. Dicerna intends to discover, develop and commercialise novel therapies either on its own or in collaboration with pharmaceutical partners. Dicerna has strategic collaborations with Novo Nordisk A/S, Roche, Eli Lilly and Company, Alexion Pharmaceuticals, Inc. and Boehringer Ingelheim International GmbH. For more information, please visit www.dicerna.com.

Dicerna Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. 

D-2 

 

Examples of forward-looking statements include, among others, statements we make regarding: (i) the full potential to leverage our GalXC platform to target and silence specific genes that contribute to cardio-metabolic diseases; (ii) the potential to earn revenue from royalties and milestone payments under the collaboration with Novo Nordisk; (iii) research and development plans related to GalXC and its utility in silencing genes that contribute to cardio-metabolic diseases; (iv) the potential of RNAi therapies for the treatment of cardio-metabolic diseases; and (v) the potential for the collaboration and co-commercialization of products by Novo Nordisk and Dicerna. The process by which an early-stage platform such as GalXC could potentially lead to an approved product is long and subject to highly significant risks, particularly with respect to a preclinical research collaboration. Applicable risks and uncertainties include those relating to preclinical research and other risks identified under the heading "Risk Factors" included in Dicerna's most recent quarterly report on Form 10-Q and in other filings made by the company with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Dicerna's current views with respect to future events, and Dicerna does not undertake and specifically disclaims any obligation to update any forward-looking statements, except as required by law.

* Novo Nordisk A/S and Roche transactions are subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary closing conditions.

DicernaTM and GalXCTM are trademarks of Dicerna Pharmaceuticals, Inc.

Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately 42,200 people in 80 countries and markets its products in more than 170 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

Further information
	
			
	Media Dicerna:
	 
	 

	Amy Trevvett
	1 617-612-6253
	atrevvett@dicerna.com 

	Alex Van Rees, SmithSolve
	+1 973-442-1555  
ext. 111
	alex.vanrees@smithsolve.com

	Media Novo Nordisk:
	 
	 

	Mette Kruse Danielsen
	45 3079 3883
	mkd@novonordisk.com

	Ken Inchausti (US)
	1 609 240 9429
	kiau@novonordisk.com

	 
	 
	 

	Investors Dicerna:
	 
	 

	Lauren Stival, Stern Investor Relations, Inc.
	1 212-362-1200
	lauren.stival@sternir.com 

	 
	 
	 

	Investors Novo Nordisk:
	 
	 

	Peter Hugreffe Ankersen
	45 3075 9085
	phak@novonordisk.com

	Valdemar Borum Svarrer
	45 3079 0301
	jvls@novonordisk.com

	Ann Søndermølle Rendbæk
	45 3075 2253
	arnd@novonordisk.com

	Mark Joseph Root
	45 3079 4211
	mjhr@novonordisk.com

	Kristoffer Due Berg (US)
	1 609 235 2989
	krdb@novonordisk.com

D-3 

 

#    #    #

D-4 

 

Exhibit E

Existing Patents 

 [* * *]

E-1

 

Exhibit F

Co-Development Programs Profit Sharing

[* * *]

E-1

 

Exhibit G

Co-Promotion Principles

[* * *]

G-1

Exhibit H

Dicerna Competitors

[* * *]

Exhibit I

Dicerna Contract Manufacturers

[* * *]

Exhibit J

Patent Prosecution: Default Countries & Territories

[* * *]

Exhibit K

[Intentionally Omitted]

Exhibit L

Use of Human Biosamples and Informed Consent
[* * *]

L-1
5028265.7B

Exhibit M

NOVO Principles for the Use of Animals
[* * *]

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