Exhibit 10.1

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

CONFIDENTIAL

 

REGENERON PHARMACEUTICALS, INC.

INTELLIA THERAPEUTICS, INC.

777 Old Saw Mill River Road

40 Erie St., Suite 130

Tarrytown, New York 10591

Cambridge, Massachusetts 02139

 

 

July 20, 2018

 

On April 11, 2016, Regeneron Pharmaceuticals, Inc. (“Regeneron”) and Intellia
Therapeutics, Inc. (“Intellia”) entered into a License and Collaboration
Agreement (the “Collaboration Agreement”).  Under the Collaboration Agreement,
the Parties agreed to collaborate to research and develop improvements to
CRISPR-Cas technology and to engage in a research and development program in
which they will research and develop CRISPR Products Directed to certain
Targets.  In addition, each Party granted to the other Party certain options to
enter into a worldwide cost and profit share arrangement for the development and
commercialization of certain CRISPR Products and to enter into a Co-Co Agreement
related thereto.  Pursuant to Section 5.3 of the Collaboration Agreement, the
Parties agreed to negotiate the terms of a Form of Co-Co Agreement.  Having
agreed to the Form of Co-Co Agreement, the Parties desire to enter into this
letter agreement (this “Letter Agreement”), as of July 20, 2018 (the “Effective
Date”) regarding the Form of Co-Co Agreement.  Except as explicitly stated in
this Letter Agreement (excluding Exhibit A), capitalized terms used but not
defined in this Letter Agreement will have the meaning ascribed to them in the
Collaboration Agreement.

The Parties hereby agree that the Form of Co-Development and Co-Promotion
Agreement attached hereto as Exhibit A will be the Form of Co-Co Agreement for
all purposes contemplated by the Collaboration Agreement.  Promptly after the
Regeneron Option Exercise Notice or Intellia Option Exercise Notice, as
applicable, is delivered to the other Party in accordance with Section 5.1(e)(i)
or Section 5.2(c)(i) of the Collaboration Agreement, respectively, the Parties
will execute a Co-Development and Co-Promotion Agreement covering the applicable
Regeneron Target or Intellia Liver Target [***].

The Parties agree that, subject to the exceptions in Section 13.2 of the
Collaboration Agreement, this Letter Agreement (including Exhibit A) is
Confidential Information of both Parties under the Collaboration Agreement.  The
Parties do not intend to issue a press release announcing the execution of this
Letter Agreement.  Section 13.5(a) of the Collaboration Agreement, excluding the
first sentence, and Sections 13.5(b) and 13.5(c) of the Collaboration Agreement,
each applied mutatis mutandis, are hereby incorporated by reference into this
Letter Agreement.

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Each Party acknowledges that the other Party, as a publicly traded company, is
legally obligated to make timely disclosures of all material events relating to
its business.  Therefore, the Parties acknowledge that either or both Parties
may be obligated to file a copy of this Letter Agreement (including, for
clarity, the Form of Co-Development and Co-Promotion Agreement attached hereto
as Exhibit A) with the United States Securities and Exchange Commission or its
equivalent (the “SEC”).  The Parties agree that the form of the redacted version
of this Letter Agreement (the “Redacted Letter Agreement”), which shall be
mutually agreed by the Parties in good faith within [***], may be used as its
filing (or submission) of this Letter Agreement to the SEC, and the Parties
shall cooperate with one another and use reasonable efforts to obtain
confidential treatment of confidential information (including any information
that constitutes a trade secret or a sensitive commercial term), including with
respect to any comments received from the SEC with respect to the proposed
redactions.  The Parties further agree that, following the initial filing (or
submission) of the Redacted Letter Agreement, the filing Party will (i) promptly
deliver to the non-filing Party any written correspondence received by the
filing Party or its representatives from the SEC with respect to such
confidential treatment request and promptly advise the non-filing Party of any
other communications between the filing Party or its representatives with the
SEC with respect to such confidential treatment request, allowing a reasonable
time for the non-filing Party to review and comment; (ii) upon the written
request of the non-filing Party, request an appropriate extension of the term of
the confidential treatment period; and (iii) if the SEC requests any changes to
the redactions set forth in the Redacted Letter Agreement, to the extent
reasonably practicable, not agree to any changes to the Redacted Letter
Agreement without first discussing such changes with the non-filing Party and
taking the non-filing Party’s comments into consideration when deciding whether
to agree to such changes.  In addition, each Party will provide the other Party
with an advance copy of any securities filings in which the Letter Agreement is
discussed or disclosed, in each case only to the extent describing this Letter
Agreement or referencing the other Party, allowing a reasonable time for the
other Party to review and comment, and will reasonably consider and, to the
extent permitted by a Governmental Authority, or Applicable Law (including the
rules and regulations of any stock exchange or trading market on which a Party’s
(or its parent entity’s) securities are or will be traded), incorporate the
other Party’s timely comments thereon [***].

The Parties agree that the provisions of Article 17 of the Collaboration
Agreement, applied mutatis mutandis, are hereby incorporated by reference into
this Letter Agreement.  

[Remainder of page intentionally left blank.  Signature page follows.]

 

 

2

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

IN WITNESS WHEREOF, Regeneron and Intellia have caused this Letter Agreement to
be executed by their duly authorized representatives as of the Effective Date.

 

REGENERON PHARMACEUTICALS, INC.

 

 

 

By

 

/s/ Kerry K. Reinersten, Ph.D.

 

 

Name:  Kerry K. Reinertsen, Ph.D.

 

 

Title:  Vice President, Strategic Alliances

 

 

 

INTELLIA THERAPEUTICS, INC.

 

 

 

By

 

/s/ John Leonard

 

 

Name:  John Leonard

 

 

Title:  Chief Executive Officer

 

 

 

[Signature Page to Letter Agreement re: Form of Co-Development and Co-Promotion
Agreement]

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

EXHIBIT A

FORM OF CO-DEVELOPMENT AND CO-PROMOTION AGREEMENT

 

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

EXECUTION COPY

CONFIDENTIAL

 

 

FORM OF CO-DEVELOPMENT AND CO-PROMOTION AGREEMENT

By and Between

REGENERON PHARMACEUTICALS, INC.

and

INTELLIA THERAPEUTICS, INC.

[_______] [__], [___]

 

 

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Article 1 DEFINITIONS

1

Article 2 AGREEMENT OVERVIEW AND COLLABORATION GOVERNANCE

21

 

2.1

Lead Party and Participating Party

21

 

2.2

Modification of the Collaboration Agreement by this Agreement, Conflicts,
Drafting Principles; Incorporation by Reference

22

 

2.3

Committees/Management

22

 

2.4

Joint Steering Committee

24

 

2.5

Joint Development Committee

25

 

2.6

Joint Commercialization Committee

26

 

2.7

Joint Finance Committee

27

 

2.8

Joint Manufacturing Committee

27

 

2.9

[See Annex 1.]

27

 

2.10

Resolution of Committee Disputes

27

 

2.11

Alliance Management

28

Article 3 DEVELOPMENT ACTIVITIES FOR CO-FUNDING PRODUCTS

28

 

3.1

Development of Co-Funding Products

28

 

3.2

Existing Product R&D Programs and Associated Product R&D Plans

28

 

3.3

New Product R&D Programs and Associated Product R&D Plans

28

 

3.4

[See Annex 1.]

28

 

3.5

Transition of Patent Prosecution Responsibilities.  [See Annex 1.]

28

 

3.6

Preparation, Updates and Approval of Global Development Plans

29

 

3.7

Global Development Budgets

29

 

3.8

[See Annex 1.]

29

Article 4 COMMERCIALIZATION OF CO-FUNDING PRODUCTS

29

 

4.1

Commercialization of Co-Funding Products

30

 

4.2

Preparation, Updates and Approval of Global Commercialization Plans

30

 

4.3

Global Commercialization Budget

30

 

4.4

Country/Region Commercialization Plans

31

 

4.5

Commercialization Efforts; Sharing of Commercial Information

31

 

4.6

Promotional Materials

31

i

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

 

4.7

Promotional Claims/Compliance

32

 

4.8

[***].

32

 

4.9

Market Exclusivity Extensions

32

 

4.10

Post Marketing Approval Obligations

32

 

4.11

The Participating Party’s Co-Promotion Option in the United States

32

Article 5 CLINICAL AND REGULATORY AFFAIRS

33

 

5.1

Regulatory Coordination

33

 

5.2

Labeling

33

 

5.3

Regulatory Events

34

 

5.4

Recalls and Other Corrective Actions

34

Article 6 LICENSES

34

 

6.1

Intellia License to Regeneron for Regeneron Co-Funding Products

34

 

6.2

Regeneron License to Intellia for Regeneron Co-Funding Products

35

 

6.3

Regeneron License to Intellia for Intellia Co-Funding Products

35

 

6.4

Unblocking License

35

 

6.5

Intellia License to Regeneron for Intellia Co-Funding Products

35

 

6.6

Mutual License to Materials

35

 

6.7

Ex-Vivo Field

35

 

6.8

[***].

35

 

6.9

[***].

35

Article 7 PERFORMANCE AND PERFORMANCE STANDARDS

36

 

7.1

Licenses Generally; No Implied License

36

 

7.2

Performance Standards

36

 

7.3

Third Party Agreements

37

 

7.4

Coordination of Third Party Intellectual Property Licensing

38

 

7.5

Third Party License Payments

38

 

7.6

Records

38

 

7.7

Materials for Development Plans

39

 

7.8

Debarment

39

ii

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

 

7.9

No Use of Non-Controlled IP in Performance of Activities under this Agreement

39

 

7.10

Further Assurances and Transaction Approvals

39

 

7.11

[See Annex 1.]

39

 

7.12

[See Annex 1.]

39

Article 8 CO-FUNDING PRODUCT MANUFACTURING

39

 

8.1

Non-GMP Manufacture of Co-Funding Products

39

 

8.2

Supply for Product R&D Program or its Equivalent

40

 

8.3

Supply Beyond Pre-Clinical

40

 

8.4

[See Annex 1.]

40

 

8.5

Clinical and Commercial Supply

40

 

8.6

Manufacturing Plans

40

 

8.7

[***].

40

Article 9 PAYMENTS

40

 

9.1

Reimbursement for Past Expenses

40

 

9.2

Sharing of Profits and Development Costs from Co-Funding Products

41

 

9.3

[***]

41

 

9.4

Periodic Reports

41

 

9.5

Adjustments to FTE Rates

42

 

9.6

Funds Flow

42

 

9.7

Invoices and Documentation

43

 

9.8

Payment Method and Currency

43

 

9.9

Taxes

43

 

9.10

Resolution of Payment Disputes

43

 

9.11

Late Fee

43

 

9.12

Effect of Intellia Option Exercise

43

 

9.13

[See Annex 1.]

43

 

9.14

[See Annex 1.]

43

Article 10 INTELLECTUAL PROPERTY

43

 

10.1

Newly Created Intellectual Property

43

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

 

10.2

Prosecution and Maintenance of Patent Rights

45

 

10.3

Administrative Patent Proceedings

46

 

10.4

Third Party Infringement Suits

47

 

10.5

BPCIA and Biosimilar Applications

48

 

10.6

Extensions and Other Protections

50

 

10.7

Patent Marking

50

 

10.8

Third Party Claims Related to [***]

50

 

10.9

Infringement of Third Party Patent Rights or Third Party Know-How

50

 

10.10

Product Trademarks

50

 

10.11

Use of Corporate Names

50

 

10.12

Third Party Rights

51

Article 11 BOOKS, RECORDS AND INSPECTIONS; AUDITS AND ADJUSTMENTS

51

 

11.1

Books and Records

51

 

11.2

Audits and Adjustments

51

 

11.3

GAAP

51

Article 12 REPRESENTATIONS, WARRANTIES AND COVENANTS

51

 

12.1

Joint Representations and Warranties

51

 

12.2

Additional Representations and Warranties of the Parties

52

 

12.3

Covenants

52

 

12.4

Compliance with Laws

52

 

12.5

Disclaimer of Warranties

53

 

12.6

Exclusivity

53

Article 13 CONFIDENTIALITY

54

 

13.1

Confidential Information

54

 

13.2

Exceptions

55

 

13.3

Injunctive Relief

55

 

13.4

Publications

55

 

13.5

Disclosures Concerning this Agreement

56

Article 14 INDEMNITY

57

iv

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

 

14.1

Indemnity and Insurance

57

 

14.2

Indemnity Procedure

58

 

14.3

Insurance

59

Article 15 FORCE MAJEURE

60

Article 16 TERM AND TERMINATION

60

 

16.1

Term

60

 

16.2

Termination for Insolvency

60

 

16.3

Termination of Co-Funding Target for which a Party is the Lead Party for
Convenience

60

 

16.4

Termination of Co-Funding Target by the Participating Party for Convenience

61

 

16.5

Breach of the Agreement

61

 

16.6

Termination for IP Challenge

62

 

16.7

Termination for Suspension of Development or Commercialization

62

 

16.8

Effects of Termination of the Agreement where Regeneron is the Lead Party,
except if the Agreement is Terminated by Intellia pursuant to Section 16.4

62

 

16.9

Effects of Termination of the Agreement where Regeneron is the Lead Party if the
Agreement is Terminated by Intellia pursuant to Section 16.4

63

 

16.10

Effects of Termination of the Agreement where Intellia is the Lead Party, except
if the Agreement is Terminated by Intellia pursuant to Section 16.3 or Section
16.7 or the Agreement is Terminated by Regeneron pursuant to Section 16.4

63

 

16.11

Effects of Termination of the Agreement where Intellia is the Lead Party if this
Agreement is Terminated by Intellia pursuant to Section 16.3 or Section 16.7

64

 

16.12

Effects of Termination of the Agreement where Intellia is the Lead Party if this
Agreement is Terminated by Regeneron pursuant to Section 16.4

64

 

16.13

Participating Party’s Remedies in lieu of Termination

65

 

16.14

Change of Control of the Participating Party

66

 

16.15

Survival of Obligations

67

 

16.16

Return of Confidential Information

67

Article 17 MISCELLANEOUS

68

 

17.1

Governing Law; Dispute Resolution; Submission to Jurisdiction

68

 

17.2

Waiver

68

v

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

 

17.3

Notices

68

 

17.4

Entire Agreement

68

 

17.5

Amendments

68

 

17.6

Interpretation

68

 

17.7

Construction

68

 

17.8

Severability

68

 

17.9

Assignment

68

 

17.10

Successors and Assigns

68

 

17.11

Counterparts

68

 

17.12

Third Party Beneficiaries

68

 

17.13

Relationship of the Parties

69

 

17.14

Limitation of Damages

69

 

17.15

Injunctive or Other Equity Relief

69

 

17.16

Non-Exclusive Remedies

69

 

Schedules:

 

 

 

Schedule 1.18

Co-Funding Target

Schedule 1.102

[***]

Schedule 9.2

[***]

 

Annexes:1

ANNEX 1Provisions Specific to Categories of Products

 

 

 

1 

  NTD:  To be deleted prior to execution of the Agreement for the applicable
Co-Funding Target.

vi

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

FORM OF CO-DEVELOPMENT AND CO-PROMOTION AGREEMENT

THIS FORM OF CO-DEVELOPMENT AND CO-PROMOTION AGREEMENT (this “Agreement”), dated
as of [_______] [___], [___] (the “Effective Date”), is by and between REGENERON
PHARMACEUTICALS, INC., a corporation organized under the laws of New York and
having a principal place of business at 777 Old Saw Mill River Road, Tarrytown,
New York 10591 (“Regeneron”), and INTELLIA THERAPEUTICS, INC., a corporation
organized under the laws of Delaware and having a principal place of business at
40 Erie St., Suite 130, Cambridge, Massachusetts 02139 (“Intellia”) (with each
of Regeneron and Intellia referred to herein individually as a “Party” and
collectively as the “Parties”).

WHEREAS, the Parties have entered into that certain License and Collaboration
Agreement, dated April 11, 2016 (the “Collaboration Agreement”), whereby the
Parties agreed to collaborate to research and develop improvements to CRISPR-Cas
(as defined below) technology and to engage in a research and development
program in which they will research and develop CRISPR Products Directed to
certain Targets (as each such term is defined below);

WHEREAS, under the terms of the Collaboration Agreement, each Party granted to
the other Party certain options to enter into a worldwide cost and profit share
arrangement for the development and commercialization of certain CRISPR
Products;

WHEREAS, the Parties have entered into a Letter Agreement, dated July 20, 2018,
whereby the Parties agreed to a Form of Co-Development and Co-Promotion
Agreement (“Form of Co-Co Agreement”); and

WHEREAS, this Agreement shall govern the relationship between the Parties with
respect to the worldwide cost and profit share arrangement for the development
and commercialization of the applicable Co-Funding Products Directed to the
applicable Co-Funding Target that is the subject of a Party’s option exercised
under and in accordance with the Collaboration Agreement.

NOW, THEREFORE, in consideration for the following mutual promises and
obligations, and for other good and valuable consideration the adequacy and
sufficiency of which are hereby acknowledged, the Parties agree as follows:

Article 1
DEFINITIONS

Capitalized terms used in this Agreement, whether used in the singular or
plural, except as expressly set forth herein, shall have the meanings set forth
below:

1.1“Affiliate” shall have the meaning ascribed to such term in the Collaboration
Agreement.

1.2“Anti-Corruption Laws” shall have the meaning ascribed to such term in the
Collaboration Agreement.

\

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

1.3“Anticipated First Commercial Sale” shall mean, with respect to a Co-Funding
Product, the date agreed upon in advance by the JSC as the expected date of
First Commercial Sale of such Co-Funding Product in such country or Region (as
applicable) of the world if specified or, otherwise, any country in the
world.  [***].

1.4“API” shall have the meaning ascribed to such term in the Collaboration
Agreement.

1.5“Applicable Law” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.6“Approval” shall mean, with respect to each Co-Funding Product, any approval,
registration, license or authorization from an applicable Regulatory Authority
required for the Development, Manufacture or Commercialization of such
Co-Funding Product in a regulatory jurisdiction, and shall include any such
approval, registration, license or authorization granted for any Marketing
Approval.

1.7“Biosimilar Application” shall mean an application or submission filed with a
Regulatory Authority for Marketing Approval of a pharmaceutical or biological
product claimed to be biosimilar or interchangeable to any Co-Funding Product or
otherwise relying on the approval of such Co-Funding Product, including, for
example, an application filed under 42 U.S.C. §262(k).

1.8 “BPCIA” shall have the meaning ascribed to such term in the Collaboration
Agreement.

1.9“Business Day” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.10“Caribou-Intellia License Agreement” shall have the meaning ascribed to such
term in the Collaboration Agreement.

1.11“Change of Control” shall mean, with respect to a Party, (a) a merger or
consolidation of such Party with a Third Party that results in the voting
securities of such Party outstanding immediately prior thereto, or any
securities into which such voting securities have been converted or exchanged,
ceasing to represent more than fifty percent (50%) of the combined voting power
of the surviving entity or the parent of the surviving entity immediately after
such merger or consolidation; (b) a transaction or series of related
transactions in which a Third Party, together with its Affiliates, (i) becomes
the direct or indirect beneficial owner of more than fifty percent (50%) of the
combined voting power of the outstanding securities, and (ii) acquires the
ability to appoint a majority of the board of directors, of such Party; or (c)
the sale or other transfer to a Third Party of all or substantially all of such
Party’s and its Affiliates’ assets.

2

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

1.12“Claim Date” shall mean the date on which any claim or assertion covered by
Section 10.9 or any Claim covered by Section 14.1 is filed or threatened in
writing.

1.13“Clinical Supply Costs” shall mean, the Manufacturing Costs for Clinical
Supply Requirements, [***].

1.14“Clinical Supply Requirements” shall mean, with respect to a Co-Funding
Product, (a) the quantities of such Co-Funding Product (or placebo or comparator
agent, as the case may be) required by a Party or the Parties for Development in
the Field under this Agreement in connection with the Global Development Plan
and (b) quantities of the Co-Funding Product that are required by a Party for
submission to a Regulatory Authority, including in connection with any
Registration Filing or Approval in the Field in any regulatory jurisdiction in
the world or in connection with any request by such Regulatory Authority.

1.15“Co-Funding Percentage” shall mean, with respect to the Co-Funding Target
and all Co-Funding Products, the [***] share of financial investment, expenses,
costs, profit and loss as between the Parties on a world-wide basis [***].

1.16“Co-Funding Product Invention” shall mean [***].

1.17“Co-Funding Product” [See Annex 1.]

1.18“Co-Funding Target” shall mean the Target that is the subject of the
Exercised Option as set forth on Schedule 1.18.

1.19“Combination Product” shall mean a Co-Funding Product incorporating or
comprising at least [***] CP that is developed under this Agreement and at least
[***].

1.20“Commercialize” or “Commercialization” shall mean, with respect to a
Co-Funding Product, the following activities undertaken or performed for such
Co-Funding Product from and after the Option Exercise Date:  [***].

1.21“Commercially Reasonable Efforts” shall mean, with respect to the efforts to
be expended by a Party or its Affiliate with respect to any objective, activity
or decision to be undertaken hereunder, those reasonable, good faith efforts and
resources to accomplish such objective, activity or decision consistent with
those efforts and resources the relevant Party would normally use to accomplish
a similar objective, activity or decision under similar circumstances, it being
understood and agreed that with respect to the research, Development,
Manufacture, seeking and obtaining Marketing Approval, or Commercialization of a
product, such efforts and resources shall be consistent with the usual practices
of such [***].

1.22“Commercial Overhead Charge” shall mean, [***].

1.23“Commercial Supply Costs” shall mean the Manufacturing Costs for Commercial
Supply Requirements of the applicable Co-Funding Products.  [***].

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

1.24“Commercial Supply Requirements” shall mean, with respect to a Co-Funding
Product, the quantities of such Co-Funding Product as are required to fulfill
requirements for [***] in the world as approved by the JSC.

1.25“Contract Year” shall mean the period beginning on the Effective Date and
ending on December 31, 2017, and each succeeding twelve (12) month period
thereafter during the Term (except that the last Contract Year shall end on the
effective date of any termination or expiration of the Term).

1.26“Control” shall mean, with respect to any Material, Confidential
Information, Intellectual Property right, or trademark that a Party (a) owns
such Material, Confidential Information, Intellectual Property right, or
trademark, or (b) has a license or right to use to such Material, Confidential
Information, Intellectual Property right, or trademark, in each case of (a) or
(b), with the ability to grant to the other Party access to, or a license or a
sublicense (as applicable) of such rights to such Material, Confidential
Information, Intellectual Property right, or trademark on the terms and
conditions set forth herein, without (i) violating the terms of any agreement
with any Third Party in existence as of the Effective Date or (ii) with respect
to any such Material, Confidential Information, Intellectual Property right, or
trademark that Intellia (or its Affiliate) in-licenses pursuant to an in-license
agreement entered into by Intellia (or its Affiliate) with a Third Party after
the Effective Date, having an obligation to pay any royalties or other
consideration or being subject to additional conditions that are applicable to a
sublicensee under such in-license, and with respect to a Regeneron Co-Funding
Product unless included pursuant to the procedures set forth in Section 7.3, as
applicable, or (iii) with respect to any such Material, Confidential
Information, Intellectual Property Right, or trademark that Intellia (or its
Affiliate) comes to own after the Effective Date that was invented [***] or (iv)
with respect to any such Material, Confidential Information, Intellectual
Property right, or trademark that Regeneron (or its Affiliate) in-licenses
pursuant to an in-license agreement entered into by Regeneron (or its Affiliate)
with a Third Party after the Effective Date, having an obligation to pay any
royalties or other consideration or being subject to additional conditions that
are applicable to a sublicensee under such in-license, and with respect to an
Intellia Co-Funding Product unless Intellia agrees to assume the applicable
obligations under such in-licenses, as applicable, or (v) with respect to any
such Material, Confidential Information, Intellectual Property Right, or
trademark that Regeneron (or its Affiliate) comes to own after the Effective
Date, [***], in each of (i), (ii), (iii),(iv) and (v), as of the time such Party
or its Affiliates would first be required hereunder to grant the other Party
such access, license or (sub)license; provided that, for clarity, Intellia will
be deemed to Control such Intellectual Property as is licensed to it under the
Intellia Existing Third Party Agreements (but subject to the terms and
conditions of the Intellia Existing Third Party Agreements and with respect to
Regeneron Co-Funding Products as and to the extent set forth in Section 7.3(e)
and 10.12 of this Agreement with respect to such Intellia Existing Third Party
Agreements).  Notwithstanding anything in this Agreement to the contrary, in the
event of a Change of Control of a Party, a Party will be deemed not to Control
any Material, Confidential Information, Intellectual Property right, or
trademark that are owned or in-licensed by a Third Party described in the
definition of “Change of Control” or such Third Party’s Affiliates (other than
such Party or

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

such Party’s Affiliates immediately prior to the closing of such Change of
Control) (y) prior to the closing of such Change of Control, except to the
extent that any such Patent Rights, Know-How or Materials were Controlled by
such Party or any of its Affiliates prior to such Change of Control, or (z)
after such Change of Control to the extent that such Patent Rights, Know-How or
Materials are invented or created by such Third Party or its Affiliates (other
than such Party or such Party’s Affiliates immediately prior to the closing of
such Change of Control) after such Change of Control without using or
incorporating any Patent Rights, Know-How or Materials licensed hereunder,
provided that, notwithstanding the foregoing, following such Change of Control,
such Party shall in all cases be deemed to Control all Patent Rights, Know-How
and Materials (1) arising from the performance of activities under this
Agreement or performance of activities under the Collaboration Agreement,
including the Technology Collaboration, Regeneron Target Evaluation Programs,
Intellia Target Evaluation Programs or Product R&D Programs on the terms as set
forth in the Collaboration Agreement, or (2) that are improvements to, or
derivatives of, or are otherwise based on or incorporates, any Patent Rights,
Know-How or Materials Controlled by such Party or any of its Affiliates prior to
such Change of Control or (3) that such Party or its Affiliates chooses to make
available for the conduct of activities under this Agreement or actually uses in
the conduct of activities under this Agreement.

1.27“Converted CFP Inventions” [See Annex 1.]

1.28“Co-Promote” or “Co-Promotion” shall mean the joint Detailing of Co-Funding
Product(s) by the Parties (or their respective Affiliates) under the same
trademark in the United States pursuant to the U.S. Co-Promotion Agreement.

1.29“Country/Region Commercialization Budget” shall mean the budget(s) for a
particular Contract Year developed by the Lead Party, reviewed by the JCC and
JSC, and approved by the JSC for the applicable Country/Region Commercialization
Plan.

1.30“Country/Region Commercialization Plan” shall mean for a Co-Funding Product,
[***].  The JCC shall propose and the JSC shall approve the number of
Country/Region Commercialization Plans for each Co-Funding Product and the
geographic scope of each such Plan.

1.31“Cost of Goods Sold” shall mean, with respect to a given Quarter, the
aggregate Manufacturing Costs (calculated in accordance with GAAP and Schedule
1.102) for all Co-Funding Products sold worldwide during such Quarter.

1.32“CPI” shall have the meaning ascribed to such term in the Collaboration
Agreement.

1.33“CPI Adjustment” shall mean the percentage increase or decrease, if any, in
the CPI applicable to the applicable personnel for the [***] of the Contract
Year prior to the Contract Year for which the adjustment is being made.

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

1.34“CRISPR-Cas” and “CRISPR-Cas Materials” shall have the meaning ascribed to
such term in the Collaboration Agreement.

1.35“CRISPR Product” or “CP” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.36“Detail” shall mean, with respect to each Co-Funding Product, [***].

1.37“Develop” or “Development” shall mean, with respect to a Co-Funding Product,
the following activities undertaken or performed for such Co-Funding Product
from and after the Option Exercise Date:  [***]; and (b) any other research and
development activities with respect to such Co-Funding Product, including,
activities to [***].

1.38“Development Costs” shall mean, with respect to a Co-Funding Product, those
costs incurred by a Party for the Development of such Co-Funding Product in
accordance with this Agreement and the applicable Global Development Plan [***]
for the following items:

(a)Out-of-Pocket Costs [***] under this Agreement;

(b)Development FTE Costs;

(c)Clinical Supply Costs;

(d)Out-of-Pocket Costs incurred for [***];

(e)[***];

(f)Out-of-Pocket Costs and Development FTE Costs incurred pursuant to Section
3.7; and

(g)any other costs or expenses for such Co-Funding Product [***] or included as
Development Costs under this Agreement.

[***]:

 

1.

[***].  

 

 

2.

[***].

 

 

3.

[***].  

 

 

4.

[***].

 

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

 

5.

In no event shall a Party charge the other Party more than once for the same
Development Costs under this Agreement, even if such costs are of benefit to
multiple Co-Funding Products.

1.39“Development Cost Forecast” shall mean the [***].

1.40“Development FTE Cost” shall mean, for a given period, the number of FTEs
for such period multiplied by the applicable Development FTE Rate.

1.41“Development FTE Rate” shall mean (a) for each FTE based in the US, $[***]
per FTE per Contract Year, adjusted each Contract Year on January 1 (commencing
on January 1, 2019) in accordance with any CPI Adjustment, and (b) for each FTE
based outside the U.S., such amount as the Parties shall agree to, in writing,
in the local currency in the country where such FTE is based (which shall be
converted into United States Dollars in accordance with Section 9.8).  [***].  

1.42“Development Payment Report” on a Co-Funding Product-by-Co-Funding Product
basis, shall mean the [***] report prepared by the Lead Party in accordance with
Section 9.2 which sets forth in reasonable detail, for each Co-Funding Product
individually (a) the Development Costs incurred by the Parties for such [***]
and (b) the [***] Development True-Up calculated in accordance with Schedule
9.2.

1.43“Directed to” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.44“Exercised Option” [See Annex 1.]

1.45“Executive Officers” shall mean the [***] of Regeneron and the [***] of
Intellia, or their respective designees with equivalent decision-making
authority with respect to matters under this Agreement.

1.46“Ex-Vivo Field” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.47“FCPA” shall have the meaning ascribed to such term in the Collaboration
Agreement.

1.48“FDA” shall have the meaning ascribed to such term in the Collaboration
Agreement.

1.49“Field” shall mean [***]; provided that, for clarity, the Field shall
include [***].  The Field shall specifically [***].

1.50“Field Force Cost” shall mean, for a given Co-Funding Product in the
applicable country or Region, the product of (a) a percentage of the number of
Lead Party’s FTEs [***] and

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(b) the applicable Field Force FTE Rate(s), in each case, with respect to such
country or Region, as applicable.  [***].

1.51“Field Force FTE Rates” shall mean, on a country-by-country or
Region-by-Region (as proposed by JCC and reviewed and approved by the JSC) basis
(determined based on the location of the field force representative), a rate or
rates proposed by the JCC and reviewed and approved by the JSC [***], as
applicable, based upon the [***].

1.52“Financial Dispute” shall mean any dispute related to [***].

1.53“First Commercial Sale” shall mean, with respect to a given Co-Funding
Product and a given country, the first commercial sale [***].

1.54“FTE” shall mean a full time equivalent employee [***] employed by Party (or
its Affiliate) who performs activities under a Plan, with such commitment of
time and effort to constitute [***] employee performing such work on a full-time
basis, which for purposes hereof shall be [***] per Contract Year (pro-rated for
any Contract Year that is less than twelve (12) months).

1.55“GAAP” shall have the meaning ascribed to such term in the Collaboration
Agreement.

1.56“Gene” shall have the meaning ascribed to such term in the Collaboration
Agreement.

1.57“Global Commercialization Budget” shall mean the budget(s) for a particular
Contract Year developed by the Lead Party, reviewed by the JCC and JSC, and
approved by the JSC for the applicable Global Commercialization Plan.

1.58“Global Commercialization Plan” shall mean, with respect to a Co-Funding
Product, the [***], and approved by the JSC for the worldwide Commercialization
of such Co-Funding Products in the Field and shall include the following:

(a)[***];

(b)[***];

(c)[***];

(d)[***];

(e)[***];

(f)[***];

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(g)[***];

(h)[***]; and

(i)[***].

1.59“Global Development Budget” shall mean the budget(s) for a particular
Calendar Year [***] developed by the Lead Party, reviewed by the JDC and JSC,
and approved by the JSC pursuant to Section 3.7(a) for the applicable Global
Development Plan.

1.60“Global Development Plan” shall mean, with respect to a Co-Funding Product,
the [***], reviewed by the JDC and JSC, and approved by the JSC for the
worldwide Development of such Co-Funding Product, which shall include the
following:

(a)[***];

(b)[***];

(c)[***];

(d)[***];

(e)[***]; and

(f)[***].

1.61“GLP Toxicology Study” shall mean a toxicology study, in a species that
satisfies applicable requirements of a Regulatory Authority, using applicable
Good Laboratory Practices (“GLP”), which meets the standard necessary for
submission as part of an IND filing with the applicable Regulatory Authority.

1.62“Good Practices” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.63“Governmental Authority” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.64“HSC” shall have the meaning ascribed to such term in the Collaboration
Agreement.

1.65“ICH” shall have the meaning ascribed to such term in the Collaboration
Agreement.

1.66“IND” shall have the meaning ascribed to such term in the Collaboration
Agreement.

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

1.67“IND Acceptance” shall mean, with respect to a particular Co-Funding
Product, that the particular IND for such Co-Funding Product was accepted by the
FDA (or other applicable Regulatory Authority outside the United States if the
IND was submitted to such Regulatory Authority outside the United States), as
evidenced by no objection by the FDA (or such other applicable Regulatory
Authority outside the United States) within [***].

1.68“Initiation of GLP Toxicology Batch” shall mean, with respect to a
particular Co-Funding Product, commencement of Manufacturing activities for an
initial batch of Co-Funding Product intended to be used in a GLP Toxicology
Study for such Co-Funding Product.  For purposes of this paragraph,
“commencement” means the start of any Manufacturing activities directly or via a
Third Party manufacturer.

1.69“Intellectual Property” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.70“Intellia Background Patent Rights” shall mean those Patent Rights that (a)
are Controlled by Intellia or any of its Affiliates (i) as of the Effective Date
or (ii) during the Term [***], or (iii) during the IP Term, [***], or (iv) any
(A) Patent Rights claiming priority to the Patent Rights, or (B) foreign
equivalents of the Patent Rights, in each case of (A) and (B), in subclauses
(i), (ii), or (iii), but in each of (i), (ii), (iii), and (iv) excluding Patent
Rights to the extent within the [***], Intellia Materials Improvements, Intellia
CRISPR-Cas IP, [***] Co-Funding Product Inventions (including Intellia Liver
Product Inventions that become Co-Funding Product Inventions), Regeneron
Materials Improvements, [***] and (b) are necessary or useful for the research,
Development, Manufacturing, using, Commercialization, exploitation or selling of
(i) a Co-Funding Product or (ii) CRISPR-Cas.  The Intellia Background Patent
Rights as of the Effective Date include those set forth on Schedule 1.47 of the
Collaboration Agreement.

1.71“Intellia Co-Funding Product” shall mean [***].

1.72“Intellia Co-Funding Product Invention” shall mean a Co-Funding Product
Invention that relates to or covers an Intellia Co-Funding Product.

1.73“Intellia Co-Funding Target” shall mean with respect to an Intellia
Co-Funding Product, [***].

1.74“Intellia CRISPR-Cas IP” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.75“Intellia Existing Third Party Agreements” shall mean the Caribou-Intellia
License Agreement, including any amendments or restatements thereto as of the
Effective Date or amendments following the Effective Date in accordance with
Section 12.3, and the Invention Management Agreement under which Intellia is
granted rights which are then sublicensed to Regeneron hereunder as Intellia
Patent Rights, Intellia Know-How or Intellia Materials.

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

1.76“Intellia Intellectual Property” shall mean the Intellia Patent Rights and
the Intellia Know-How.

1.77“Intellia Know-How” shall mean any and all Know-How that (a) is Controlled
by Intellia or any of its Affiliates (i) as of the Effective Date or (ii) during
the Term [***], and (b) is necessary or useful for the research, Development,
Manufacturing, using Commercialization, exploitation or selling of (A) a
Co-Funding Product or (B) CRISPR-Cas.  Intellia Know-How shall include Know-How
created during the Term in or related to Intellia Materials, Intellia Materials
Improvements or Intellia CRISPR-Cas IP, Intellia Co-Funding Product Inventions
as well as Intellia’s interests in any [***].

1.78“Intellia Liver Product” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.79“Intellia Liver Product Invention” shall mean (a) all Intellectual Property
that is invented by or on behalf of either Party (or by the Parties jointly) in
the performance of Development, Manufacture or Commercialization of any Intellia
Liver Product Directed to an Intellia Liver Target for which Regeneron exercised
the Exercised Option and such invention is made prior to the Option Exercise
Date, in each case that solely relates to or covers one or more Intellia Liver
Products or components thereof (provided any such component is specific to such
Intellia Liver Product), including (i) composition of matter or other chemical
structure of such Intellia Liver Product(s), (ii) a method of making or using
such Intellia Liver Product(s), or (iii) any gRNAs and crRNAs for one or more
Intellia Liver Products, and (b) Patent Rights within any of the foregoing
Intellectual Property.  For clarity, an Intellia Liver Product Invention may
constitute or comprise the combination of Intellia Materials and Regeneron
Materials.

1.80“Intellia Liver Target” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.81“Intellia Materials” shall mean Intellia’s (or its Affiliate’s) proprietary
[***] that are used in the performance of this Agreement or the Collaboration
Agreement or otherwise licensed to Regeneron hereunder.  [***].

1.82“Intellia Materials Improvement” shall mean (a) any Intellectual Property
that is invented by or on behalf of either Party (solely or jointly with the
other) under this Agreement during the Term that constitutes or comprises an
improvement, enhancement or other modification to any Intellia Materials [***]
including any such Intellectual Property that comprises a composition of, or any
method of using or making, Intellia Materials [***], (b) any Patent Rights to
the extent within the Intellectual Property in the foregoing clause (a), in each
case of (a) and (b) other than Co-Funding Product Inventions, Regeneron
Materials Improvements, [***], Intellia CRISPR-Cas IP or [***] and (c) any
Intellectual Property or Patents Rights that are covered by the definition of
Intellia Materials Improvement in the Collaboration Agreement.

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

1.83“Intellia Option” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.84“Intellia Option Exercise Notice” shall have the meaning ascribed to such
term in the Collaboration Agreement.

1.85“Intellia Patent Rights” shall mean the Intellia Background Patent Rights,
Patent Rights to the extent within the Intellia Co-Funding Product Inventions
and Intellia’s interest in Patent Rights to the extent within the
[***].  Intellia Patent Rights shall include the Patent Rights listed on
Schedule 1.47 of the Collaboration Agreement as and to the extent pertaining to
the Co-Funding Target and Co-Funding Products hereunder.

1.86“Intellia Platform In-License” shall have the meaning ascribed to such term
in the Collaboration Agreement.

1.87[***].

1.88“Invention Management Agreement” shall mean that certain Consent to
Assignments, Licensing and Common Ownership and Invention Management Agreement
for a Programmable DNA Restriction Enzyme for Genome Editing, by and among Dr.
Emmanuelle Charpentier, The Regents of the University of California, University
of Vienna, CRISPR Therapeutics AG, ERS Genomics Ltd., TRACR Hematology Ltd.,
Caribou Biosciences, Inc. and Intellia dated December 15, 2016, including any
amendments or restatements thereto as of the Effective Date or amendments
following the Effective Date.

1.89“IP Term” [See Annex 1.]

1.90“Joint Improvement” shall mean, in each case of the following clauses (a)
and (b) [***]:

(a)[***]; and

(b)[***].

1.91“Joint Steering Committee” or “JSC” shall have the meaning ascribed to such
term in the Collaboration Agreement.

1.92“Key Components” means, with respect to a Co-Funding Product: [***].

1.93“Know-How” shall have the meaning ascribed to such term in the Collaboration
Agreement.

1.94“Lead Party” [See Annex 1.]

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

1.95“Legal Dispute” shall mean any dispute related to a Party’s alleged material
breach of this Agreement or the validity, breach, termination or interpretation
of this Agreement, or Intellectual Property-related disputes.

1.96“Liver Cell” shall have the meaning ascribed to such term in the
Collaboration Agreement

1.97“Liver Product” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.98“Liver Target” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.99“MAA Acceptance” shall mean, with respect to a particular Co-Funding
Product, that the particular biologics application, new drug application, or its
equivalent for such Co-Funding Product was accepted by the FDA (or other
applicable Regulatory Authority outside the United States if the particular
biologics application, new drug application, or its equivalent was submitted to
such Regulatory Authority outside the United States).

1.100“Major Market Country” shall mean any of the following:  [***] and, with
respect to any Co-Funding Product, [***].

1.101“Manufacture” or “Manufacturing” shall mean activities directed to [***]
Co-Funding Product [***], as the case may be.

1.102“Manufacturing Cost” shall mean the fully burdened cost [***] of
Manufacturing a Co-Funding Product [***].

1.103“Manufacturing Plan” shall mean, with respect to a Co-Funding Product, the
plan developed by the Lead Party, in consultation with the JMC, and reviewed and
approved by the JSC as described in Section 8.6 for the Manufacture of such
Co-Funding Product.

1.104“Marketing Approval” shall mean all approvals of the applicable Regulatory
Authority necessary for the marketing and sale of a Co-Funding Product in a
given country (or other jurisdiction).

1.105“Modulate” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.106“Net Sales” shall mean, with respect to a Co-Funding Product, the gross
amount invoiced for bona fide arms’ length sales of all units of such Co-Funding
Product in the Field by or on behalf of the Lead Party or its Affiliates or
sublicensees (but excluding distributors) to the first Third Party (including
distributors), less the following deductions, consistently applied:

(a)[***];

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(b)[***];

(c)[***];

(d)[***];

(e)[***];

(f)[***];

(g)[***];

(h)[***];

(i)[***];

(j)[***]; and

(k)[***].

Such amounts will be determined from the books and records of a Lead Party, its
Affiliates and sublicensees, maintained in accordance with GAAP.  Net Sales in
currency other than United States Dollars shall be converted into United States
Dollars according to the provisions of Section 9.8 of this Agreement.

Sales between the Lead Party and its Affiliates or sublicensees, for resale,
shall be disregarded for purposes of calculating Net Sales.  Any of the items
set forth above that would otherwise be deducted from the invoice price in the
calculation of Net Sales but which are separately charged to and paid by Third
Parties shall not be deducted from the invoice price in the calculation of Net
Sales.  In the case of any sale of a Co-Funding Product for consideration other
than cash, such as barter or countertrade, Net Sales shall be calculated based
[***].

Solely for purposes of calculating Net Sales, if the Lead Party or any of its
Affiliates or sublicensees sells any Co-Funding Product in the form of a
Combination Product, then [***].

1.107“Non-Approval Trials” shall mean any surveys, registries and clinical
trials, each of which are not intended to gain additional labeled indications.

1.108[***].

1.109[***].

1.110“Option Exercise Date” shall mean, with respect to the Exercised Option,
the date the Regeneron Option Exercise Notice or Intellia Option Exercise
Notice, as applicable, is delivered to the other Party in accordance with
Section 5.1(e)(i) or Section 5.2(c)(i) of the Collaboration Agreement,
respectively.

1.111“Option Package” shall have the meaning ascribed to such term in the
Collaboration Agreement.

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

1.112“Other Co-Funding Agreement Inventions” shall mean (a) all Intellectual
Property that is invented [***].

1.113“Other Shared Expenses” shall mean, with respect to a Co-Funding Product,
those costs and expenses incurred by a Party that are specifically referred to
in Sections 5.4, 7.11, 8.4, 10.2(b), 10.3(c), 10.4(c), 10.5(b), 10.9, 10.10, and
14.1(c) and other costs agreed between the Parties to be included therein, to
the extent that such costs and expenses do not include any costs and expenses
included in Development Costs or Shared Commercial Expenses.  [***].

1.114“Out-of-Pocket Costs” shall mean costs and expenses paid to Third Parties
(or payable to Third Parties and accrued in accordance with GAAP) by Regeneron
(or its Affiliate) or Intellia (or its Affiliate) [***].

1.115“Participating Party” [See Annex 1.]

1.116“Patent Application” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.117“Patent Rights” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.118“Patents” shall have the meaning ascribed to such term in the Collaboration
Agreement.

1.119“Person” shall have the meaning ascribed to such term in the Collaboration
Agreement.

1.120“Phase I Trial” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.121“Phase II Trial” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.122“Phase III Trial” shall mean a human clinical trial that would satisfy the
requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof),
including, to the extent satisfying the foregoing requirements (a) a human
clinical trial that becomes a registration trial sufficient for filing an
application for a Marketing Approval for such product in the United States or
(b) an equivalent clinical trial in conducted in a country other than the United
States.

1.123“Plan” shall mean any Country/Region Commercialization Plan, U.S.
Commercialization Plan, Global Commercialization Plan, Global Development Plan,
Manufacturing Plan or other plan approved through the Committee process relating
to the Development, Manufacture or Commercialization of any Co-Funding Product
under this Agreement.

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

1.124“Pricing Approval” shall mean such [***].

1.125“Product R&D Plan” shall mean a written plan and [***] budget associated
with the discovery, research, pre-clinical Development, and Manufacture of a
Regeneron Co-Funding Product as originally agreed to under the Collaboration
Agreement (that was formerly referred to as a Regeneron Product under the
Collaboration Agreement), which plans shall be incorporated and made a part of
the Global Development Plan for the relevant Regeneron Co-Funding Product in
accordance with Section 3.2.

1.126“Product R&D Program” shall mean collectively, or individually, as
applicable, the research and development program(s) to be performed under the
Collaboration Agreement that was intended to discover, research, Manufacture and
Develop Regeneron Co-Funding Products Directed to a Regeneron Target that is a
Liver Target as originally agreed to under the Collaboration Agreement (that was
formerly referred to as a Regeneron Product under the Collaboration Agreement),
as set forth in the applicable Product R&D Plan(s) which program shall be
incorporated and made a part of the Development for the relevant Regeneron
Co-Funding Product in accordance with Section 3.2.

1.127“Product Trademark” shall mean, with respect to each Co-Funding Product,
the trademark(s) proposed by the Lead Party, reviewed by the JCC and JSC, and
approved by the JSC for use on such Co-Funding Product throughout the world
and/or accompanying logos, slogans, trade names, trade dress and/or other
indicia of origin, in each case as selected by the Lead Party, reviewed by the
JCC and JSC, and approved by the JSC.

1.128“Profit Payment Report” shall mean a consolidated [***] report prepared by
the Lead Party (based on information reported under Section 9.4) setting forth
in reasonable detail, for each Major Market Country, and in the aggregate,
worldwide as a whole, [***].  If an item is included in one [***] report, in no
event shall the same item be included in a subsequent [***] Report.

1.129“Promotional Materials” shall mean, with respect to each Co-Funding Product
and country in which such Co-Funding Product is or will be sold, promotional,
advertising, communication and educational materials relating to such Co-Funding
Product for use in connection with the marketing, promotion and sale of such
Co-Funding Product in such country, and the content thereof, and shall include
promotional literature, product support materials and promotional giveaways.

1.130“Quarter” or “Quarterly” shall refer to a calendar quarter, except that the
first (1st) Quarter shall commence on the Effective Date and extend to the end
of the then-current calendar quarter and the last calendar quarter shall extend
from the first day of such calendar quarter until the effective date of the
termination or expiration of this Agreement.

1.131“Regeneron Co-Funding Product” shall mean (a)(i) with respect to the
Regeneron Target that is the subject of the Exercised Option, the Regeneron
Product developed under the

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Collaboration Agreement that is Directed to such Regeneron Target or (ii) with
respect to an Intellia Liver Target that is the subject of the Exercised Option
under Section 5.1(e) of the Collaboration Agreement and for which Regeneron is
designated as the Lead Party, [***].

1.132“Regeneron Co-Funding Product Invention” shall mean [***].

1.133“Regeneron Co-Funding Target” shall mean with respect to a Regeneron
Co-Funding Product, [***].

1.134“Regeneron Contributed IP” shall mean [***], that is Controlled by
Regeneron or its Affiliate.

1.135“Regeneron Contributed Technology” shall mean (a) technology that is
covered under the definition of Regeneron Contributed Technology in the
Collaboration Agreement and (b) technology Controlled by Regeneron or its
Affiliates [***].

1.136[***].

1.137“Regeneron Material Relationship” shall have the meaning ascribed to such
term in the Collaboration Agreement.

1.138“Regeneron Materials” shall mean Regeneron’s (or its Affiliate’s)
proprietary [***], that are used in the performance of this Agreement or the
Collaboration Agreement or otherwise included in the Regeneron Contributed
Technology.  [***].

1.139“Regeneron Materials Improvement” shall mean (a) any Intellectual Property
that is invented by or on behalf of either Party (solely or jointly with the
other) under this Agreement during the Term that constitutes or comprises an
improvement, enhancement or other modification to any Regeneron Materials [***],
including any such Intellectual Property that comprises a composition of, or any
method of using or making, Regeneron Materials [***], (b) any Patent Rights to
the extent within the Intellectual Property in the foregoing clause (a), [***].

1.140“Regeneron Mice” shall mean Regeneron’s proprietary, genetically modified
mice that are used in the performance of this Agreement or the Collaboration
Agreement, and any progeny or derivatives thereof shall constitute Regeneron
Materials Improvements.

1.141“Regeneron Option” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.142“Regeneron Option Exercise Notice” shall have the meaning ascribed to such
term in the Collaboration Agreement.

1.143“Regeneron Product” shall mean have the meaning ascribed to such term in
the Collaboration Agreement.

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

1.144“Regeneron Product Inventions” shall have the meaning ascribed to such term
in the Collaboration Agreement.

1.145[***].

1.146“Regeneron Target” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.147[***].

1.148“Region” shall mean such [***] or more countries that are grouped together
for purposes of Commercialization of a particular Co-Funding Product as
determined by the JCC.

1.149“Registration Filing” shall mean the submission to the relevant Regulatory
Authority of an appropriate application seeking Approval, and shall include any
IND or Marketing Approval application.

1.150“Regulatory Authority” shall mean any federal, national, multinational,
state, provincial or local regulatory agency, department, bureau or other
governmental entity anywhere in the world with authority over the activities
conducted under this Agreement or the development, manufacture, or
commercialization of products.

1.151“Regulatory Filings” shall mean regulatory applications, submissions,
dossiers, notifications, registrations, Approvals, or other filings made to or
with, or other approvals granted by, a Regulatory Authority that are necessary
in order to Develop, Manufacture or Commercialize a Co-Funding Product in a
particular country or regulatory jurisdiction.

1.152[***].

1.153[***].

1.154“Reserved Ex-Vivo Field” shall mean (a) modification of cells using
CRISPR-Cas where such modification is conducted ex vivo for the purpose of
[***], (b) modification of HSCs using CRISPR-Cas where such modification is
conducted ex vivo for the purpose of [***], and (c) modification of cells using
CRISPR-Cas for use in [***].

1.155“Shared Commercial Expenses” shall mean the sum of the following items, in
each case [***], including a U.S. Commercialization Plan, or Global
Commercialization Plan, [***], and to the extent that such items do not include
any costs included in Development Costs:

(a)[***];

(b)[***];

(c)Field Force Costs;

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(d)Out-of-Pocket Costs related to [***];

(e)Out-of-Pocket Costs related to [***];

(f)Out-of-Pocket Costs [***];

(g)Commercial Overhead Charge;

(h)Out-of-Pocket Costs related to [***];

(i)[***]; and

(j)[***].

[***].

1.156“Target” shall have the meaning ascribed to such term in the Collaboration
Agreement.

1.157“Technology Collaboration Inventions” shall have the meaning ascribed to
such term in the Collaboration Agreement.

1.158“Terminated Co-Funding Target” shall mean the Co-Funding Target for which
this Agreement is terminated in accordance with Article 16.

1.159“Terminated Co-Funding Products” shall mean all CPs that are Directed to a
Terminated Co-Funding Target that were formerly Co-Funding Products.

1.160“Third Party” shall have the meaning ascribed to such term in the
Collaboration Agreement.

1.161“Third Party Collaboration Agreement” shall have the meaning ascribed to
such term in the Collaboration Agreement.

1.162“Third Party License” shall mean any agreement between a Party and a Third
Party pursuant to which such Third Party grants a license to such Party with
respect to Intellectual Property of such Third Party that pertains to a
Co-Funding Product, which shall include the Intellia Existing Third Party
Agreements and New Intellia Platform Licenses.

1.163“Third Party License Payment” shall mean any payment due to any Third Party
under any Third Party License, including upfront payments, royalties, milestone
payments and any other payments.

1.164“UC Technology License” shall have the meaning ascribed to such term in the
Collaboration Agreement.

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

1.165“United States” or “U.S.” shall have the meaning ascribed to such term in
the Collaboration Agreement.

1.166“U.S. Commercialization Budget” shall mean the budget(s) for a particular
Contract Year developed by the Lead Party, reviewed by the JCC and JSC, and
approved by the JSC for the U.S. Commercialization Plan.

1.167“U.S. Commercialization Plan” shall mean for a Co-Funding Product, the
Country/Region Commercialization Plan for the United States developed by the
Lead Party in consultation with the Participating Party, reviewed by the JCC and
JSC, and approved by the JSC.

1.168“U.S. Export Control Laws” shall have the meaning ascribed to such term in
the Collaboration Agreement.

1.169The remaining capitalized terms used in this Agreement shall have the
meanings set forth in the following Sections of this Agreement:

Term

Section Reference

“Acquiring Party”

12.6(d)

“Agreement”

Preamble

“Alleged Party”

16.5(b)

“Alleging Party”

16.5(b)

“Breach Notice”

16.5(b)

“Caribou”

1.10

“Claim”

14.1(a)

“[***]”

9.3

“[***]”

4.11(a)

“Committees”

2.3(b)

“Competing Program”

12.6(d)

“Confidential Information”

13.1(a)

“Consultation Party”

10.2(d)(i)

“Covered Claim”

9.3(b)

“CRISPR-Cas Materials”

1.34

“Damages”

14.1(a)

“Disclosing Party”

13.1(a)

“Effective Date”

Preamble

“Election Notice”

16.14

“[***]”

12.6(c)

“Form of U.S. Co-Promotion Agreement”

4.11(c)

“Global Commercialization Budget(s)”

4.3(a)

“Global Development Budget(s)”

3.7(a)

“Healthcare Prescriber”

1.36

“Indemnified Party”

14.2(a)

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Term

Section Reference

“Indemnifying Party”

14.2(a)

“Intellia”

Preamble

“Intellia Indemnitees”

14.1(b)

“JCC”

2.3(b)

“JDC”

2.3(b)

“JFC”

2.3(b)

“JMC”

2.3(b)

“Joint CRISPR-Cas Improvements”

1.90(b)

“Lead Litigation Party”

10.4(b)(v)

“Marketing Guidelines”

2.6(b)(iii)

“Materials”

7.7(a)

“New Intellia Platform License”

7.3(c)

“Non-Acquiring Party”

12.6(d)(i)

“Participating Party Commitment Level”

4.11(a)

“Party” and “Parties”

Preamble

“[***]”

4.3(c)

“[***]”

3.7(c)

“Product Infringement”

10.4(a)

“[***]”

Schedule 9.2

“Receiving Party”

13.1(a)

“Redacted Agreement”

13.5(d)

“Regeneron”

Preamble

“Regeneron Agreements”

12.2(b) (Sub-Annex 1(A))

“Regeneron Indemnitees”

14.1(a)

“Responsible Party”

10.2(d)(i)

“SEC”

13.5(d)

“Subject Claim”

9.3(b)

“Subject Litigation”

16.14

“Term”

16.1

“Third Party Acquisition”

12.6(d)

“[***]”

4.11(b)

“Working Group”

2.3(b)

 

Article 2
AGREEMENT OVERVIEW AND COLLABORATION GOVERNANCE

2.1Lead Party and Participating Party.  For purposes of and subject to the terms
and conditions of this Agreement, the Lead Party with respect to the Co-Funding
Target and all Co-Funding Products Directed to such Co-Funding Target shall have
primary responsibility and decision-making authority with respect to the
Development, Commercialization and Manufacturing thereof and shall have the
rights and obligations allocated to it as more fully set

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REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

forth in this Agreement, and the Participating Party shall have the rights and
obligations allocated to it as more fully set forth in this Agreement.

2.2Modification of the Collaboration Agreement by this Agreement, Conflicts,
Drafting Principles; Incorporation by Reference.

(a)As contemplated by Section 5.4 of the Collaboration Agreement, this Agreement
supersedes the Collaboration Agreement solely with respect to the particular
Co-Funding Target and Co-Funding Products, as applicable, that is the subject of
this Agreement.  In the event there is any conflict between the provisions of
this Agreement and the provisions of the Collaboration Agreement as it relates
to the Co-Funding Target or a Co-Funding Product, as applicable, this Agreement
shall control.  Any dispute as to whether there is a conflict between the
provisions of this Agreement and the provisions of the Collaboration Agreement
shall be resolved in accordance with Section 2.9 and if applicable, Section
17.1(c) of the Collaboration Agreement (which is incorporated into this
Agreement in accordance with Section 17.1 of this Agreement).2

(b)[See Annex 1.]

There are instances where certain provisions of this Agreement are identical to
those provisions in the Collaboration Agreement and for purposes of brevity this
Agreement incorporates by reference the applicable terms of the Collaboration
Agreement.  In such cases, references to the term “Agreement” within such
provisions incorporated by reference shall be deemed to refer to this Agreement,
and unless otherwise expressly provided in this Agreement, each of the other
defined terms referenced therein shall be deemed to refer to the corresponding
defined term under this Agreement (e.g., Party, Term, Contract Year) and all
references to the terms “development”, “commercialization” and “manufacture” and
conjugations thereof within such provisions incorporated by reference shall be
deemed to refer to “Development”, “Commercialization” and “Manufacture” and
conjugations thereof respectively to the extent such terms refer to the
Development, Commercialization and Manufacture of the Co-Funding Products
contemplated herein (as context requires).

2.3Committees/Management.

(a)Joint Steering Committee.  The Parties have established a JSC pursuant to the
Collaboration Agreement which shall also oversee the activities of the Parties
under this Agreement.

(b)Committees.  In addition to the JSC, the Parties agree to establish, for the
purposes specified herein, a Joint Development Committee (the “JDC”), a Joint
Commercialization Committee (the “JCC”), a Joint Manufacturing Committee
(“JMC”), a Joint Finance Committee (the “JFC”) and such other committees or
sub-committees as the Parties deem appropriate.  The other Committees shall be
established by the JSC at the times determined appropriate by the JSC.  It is
understood that the Parties may wish to establish multiple Committees reporting
to the JSC, JDC, JFC and JCC with responsibility for different Co-Funding
Products.  The roles and responsibilities of each Committee are set forth in
this Agreement (or as may be determined by the JSC for Committees established in
the future and not described herein) and may be further designated by the
JSC.  From time to time, each

 

2 

  NTD:  This paragraph will be included in each Co-Co Agreement, as appropriate.

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REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Committee may establish working groups (each, a “Working Group”) to oversee
particular projects or activities, and each such Working Group shall be
constituted and shall operate as the Committee which establishes the Working
Group determines.  The JDC, JCC, JFC, JMC and JSC, and any other committees the
Parties establish pursuant to this Section 2.3, are the “Committees.”

(c)Decision Making.  Without limiting Section 2.9, the Committees shall have the
right to determine matters that are within their scope (as set forth in Section
2.2(d) of the Collaboration Agreement or Sections 2.4-2.8) or are otherwise
expressly allocated to such Committee as set forth in this Agreement.  The JSC
shall operate by consensus.  The Parties shall cause their respective
representatives on a Committee to use their good faith efforts to give due
consideration to the perspective of each Party’s representatives and to resolve
all matters presented to them as expeditiously as possible.  The representatives
of each Party shall have collectively one (1) vote on behalf of such Party;
provided that no such vote taken at a meeting shall be valid unless a
representative of each Party is present and participating in the vote.

(d)Membership.  Each of the Committees shall be composed of an equal number of
representatives appointed by each of Regeneron and Intellia.  Each Party may
replace its Committee members upon written notice (which may be via email) to
the other Party.  For clarity, Section 2.2(a) of the Collaboration Agreement
shall continue to apply to the JSC.

(e)Meetings.  Each Committee shall hold meetings at such times as the Parties
shall determine, but in no event less frequently than [***], commencing from and
after the time such Committee is established as provided herein.  All Committee
meetings may be conducted by telephone, video-conference or in person as
determined by the Co-Chairpersons; provided, however, that each Committee shall
meet in person at least [***].  Unless otherwise agreed by the Parties, all
in-person meetings of each Committee shall be held on an alternating basis
between Regeneron’s facilities and Intellia’s facilities.  Other representatives
of each Party or of Third Parties involved in the Development, Manufacture or
Commercialization of any Co-Funding Product (under obligations of
confidentiality) may be invited by the Committee co-chairs to attend meetings of
the Committees as nonvoting participants.  Each Party shall be responsible for
all of its own expenses of participating in the Committees.  Either Party’s
representatives on a Committee may call a special meeting of the applicable
Committee upon at least [***] Business Days’ prior written notice (which may be
via email), except that emergency meetings may be called with at least [***]
Business Days’ prior written notice (which may be via email).  For clarity,
Section 2.4(c) of the Collaboration Agreement shall apply to meetings of the JSC
with respect to this Agreement, except that the JSC shall continue to meet at
least [***], and more frequently as either Party may reasonably request, until
the expiration or termination of the Term of this Agreement.

(f)Authority.  Each Party shall retain the rights, powers and discretion granted
to it under this Agreement and each Committee shall have solely the powers
expressly assigned to it  (as set forth in Section 2.4 of the Collaboration
Agreement or Section 2.4-2.8) or are otherwise expressly allocated to such
Committee as set forth in this Agreement, and no

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Committee, including the JSC, shall have any power to amend, modify or waive
compliance with this Agreement.

2.4Joint Steering Committee.

(a)Additional Purpose.  In addition to and without limiting the responsibility
of the JSC under the Collaboration Agreement, the JSC shall have overall
responsibility for the oversight of the activities of the Parties under this
Agreement with respect to Co-Funding Products.  The JSC shall (i) review and
approve the overall strategy for an integrated worldwide Development program for
each Co-Funding Product, including the Manufacture of Co-Funding Products for
use in activities under the Plans and for the Commercialization of Co-Funding
Products worldwide; (ii) to review the efforts of the Parties in performing
their responsibilities under the Plans; and (iii) to oversee the Committees and
resolve matters referred by the other Committees to the JSC for decision-making
and approval as set forth in this Agreement or otherwise, and to resolve matters
on which such Committees are unable to reach consensus on.

(b)Additional Specific Responsibilities.  In addition to and without limiting
the duties of the JSC under the Collaboration Agreement, the JSC shall:

(i)annually review and approve the Global Development Plan(s) (including
reviewing and approving an updated Development Cost Forecast), Manufacturing
Plan(s), Global Commercialization Plan(s) and Country/Region Commercialization
Plan(s), including the U.S. Commercialization Plan(s), if any;

(ii)[***], review the efforts of the Parties in performing their respective
Development and Commercialization activities under the then-effective Plans;

(iii)approve the Product Trademark;

(iv)discuss the prospective or planned incorporation of any Intellectual
Property under a Third Party License that would trigger a Third Party License
Payment in connection with the Development, Commercialization or Manufacture of
a Co-Funding Product;

(v)review and discuss and agree to any proposal made by the Lead Party to
license Development, Commercialization or Manufacturing rights for any
Co-Funding Product to any Third Party [***];

(vi)attempt in good faith to resolve any disputes referred to it by any of the
Committees and provide a single-point of communication for seeking consensus
regarding key global strategy and Plan issues;

(vii)establish sub-committees of the JSC, as the JSC deems appropriate;

(viii)[See Annex 1]; and

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(ix)consider and act upon such other matters as are specifically assigned to the
JSC under this Agreement or otherwise agreed by the Parties.

(c)Information Sharing.  Each Party will share information with the JSC in a
timely manner concerning the progress of the Plans and, in any event, at least
[***] prior to each regular [***] meeting of the JSC, and in connection
therewith, each Party will provide to the JSC a written report (in electronic
form) summarizing in reasonable detail the material activities undertaken by
such Party in connection with such Plans since such Party’s most recent report.

2.5Joint Development Committee.

(a)Composition and Purpose.  The purpose of the JDC shall be (i) to advise the
JSC on the strategy for the worldwide Development of each Co-Funding Product;
(ii) to review and review and annual update and present to the JSC for approval
the Global Development Plan(s) (and related Global Development Budget(s)); and
(iii) to oversee the implementation of the Global Development Plan(s) and the
Development operational aspects of the activities of the Parties with respect to
Co-Funding Products as directed by the JSC.  The JDC shall be composed of at
least [***] of each Party; provided that the total number of representatives may
be changed upon mutual agreement of the Parties (so long as each Party has an
equal number of representatives).

(b)Specific Responsibilities.  In particular, the JDC shall be responsible for:

(i)reviewing and advising the JSC on the overall global Development strategy for
each Co-Funding Product developed by the Lead Party;

(ii)review and provide input on the draft Global Development Plan(s) and related
Global Development Budget(s) (including the Development Cost Forecast) prepared
by the Lead Party and the implementation thereof, as described in Sections 3.6
and 3.7, and submitting material decisions with respect thereto for final
approval by the JSC;

(iii)review and provide input on [***];

(iv)facilitating an exchange between the Parties of data, information, material
and results relating to the Development of Co-Funding Products;

(v)discussing [***];

(vi)overseeing, and discussing the [***] in connection with the Co-Funding
Products;

(vii)[***] for Co-Funding Products conducted under the Global Development
Plan(s); and

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(viii)considering and acting upon such other matters as specifically assigned to
the JDC under this Agreement or by the JSC.

2.6Joint Commercialization Committee.

(a)Composition and Purpose.  The purpose of the JCC shall be to develop and
propose to the JSC the strategy for the global Commercialization of Co-Funding
Products worldwide, to oversee the implementation of the Global
Commercialization Plans.  The JCC shall be composed of at least [***] of each
Party; provided that the total number of representatives may be changed upon
mutual agreement of the Parties (so long as each Party has an equal number of
representatives).

(b)JCC Responsibilities.  In particular, the JCC shall be responsible for:

(i)reviewing and advising the JSC on the overall global Commercialization
strategy for each Co-Funding Product;

(ii)review and provide input on the draft Global Commercialization Plan(s) and
related Global Commercialization Budget(s) and Country/Region Commercialization
Plan(s), and related Country/Region Commercialization Budget(s), including the
U.S. Commercialization Plan(s) and U.S. Commercialization Budget(s), prepared by
the Lead Party, as described in Sections 4.2 and 4.3 and submitting material
decisions with respect thereto for final approval by the JSC and the
implementation thereof; reviewing and validating latest annual budget estimates
for the current calendar year compared to the Global Commercialization Budget
and Country/Region Commercialization Budgets, including the U.S.
Commercialization Budgets, and submitting material decisions with respect
thereto for final approval by the JSC;

(iii)for each Co-Funding Product, [***];

(iv)review and provide input on [***];

(v)review and provide input on [***];

(vi)review and provide guidance on [***];

(vii)review and provide input on [***];

(viii)discussing the [***];

(ix)review and provide input on [***];

(x)review and provide input on [***];

(xi)[***];

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(xii)review and provide input on [***];

(xiii)discussing a [***]; and

(xiv)considering and acting upon such other matters as specifically assigned to
the JCC under this Agreement or by the JSC.

2.7Joint Finance Committee.  The JFC shall be responsible for accounting,
financial (including planning, reporting and controls) and funds flow matters
related to the profit and loss sharing relationship between the Parties with
respect to Co-Product under this Agreement, and submitting material decisions
with respect thereto for final approval by the JSC, including such specific
responsibilities set forth in Sections 3.7(b), 4.3(c), 9.7, and 9.10 and such
other responsibilities determined by the JSC or set forth in this
Agreement.  The JFC also shall respond to inquiries from the JDC, the JMC and
the JCC, as needed.

2.8Joint Manufacturing Committee.  Working with the JSC, JDC and JCC, as
appropriate, the Joint Manufacturing Committee shall be responsible for
overseeing Manufacturing activities, including reviewing the Manufacturing Plan
prepared by the Lead Party and any updates thereto and referring the foregoing
for approval by the JSC and overseeing the specific activities set forth in
Sections 8.6 and 8.7 and such other Manufacturing related activities determined
by the JSC or set forth in this Agreement, [***].  For process development
activities, the Joint Manufacturing Committee shall consult the appropriate
expert functions of both Parties or their Affiliates as appropriate.

2.9[See Annex 1.]

2.10Resolution of Committee Disputes.

(a)Committee Disputes other than the JSC.  In the event there is a dispute at
the level of the JDC, JFC, JMC or JCC, the Parties, through such Committee, will
seek to resolve the dispute as promptly as possible, but no later than [***]
after a Party has delivered to the other Party a written request to resolve the
matter, and in the event that no resolution is reached at the JDC, JFC, JMC or
JCC, as applicable, such matter shall be promptly referred to the JSC.

(b)JSC Disputes.  Disputes at the JSC shall be resolved as follows:

(i)In the event that the JSC, after a period of [***] from the date a matter is
submitted to it for decision (including if the Parties are unable to agree on a
Plan (or amendment thereto), or any other matter that must be resolved by the
JSC), is unable to make a decision due to a lack of required unanimity, either
Party may require that the matter be submitted to the Executive Officers for a
joint decision by providing written notice to the other Party formally
requesting that the dispute be resolved by the Executive Officers and specifying
the nature of the dispute with sufficient specificity to permit adequate
consideration by such Executive Officers.

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(ii)If the dispute is referred to the Executive Officers, then the Executive
Officers shall diligently and in good faith attempt to resolve the referred
dispute within [***] after receiving such written notification or such longer
period of time as the Executive Officers may agree in writing.  All such
referred disputes shall require a joint decision of both Parties’ Executive
Officers.

(iii)If the Executive Officers cannot resolve such dispute within such [***] or
other agreed period, such dispute will be resolved as follows:

(A)[***];

(B)[***]; and

(C)[***];

(D)[***].

2.11Alliance Management.  Section 2.3 of the Collaboration Agreement is hereby
incorporated by reference into this Agreement, applied mutatis mutandis, except
that the Alliance Managers shall continue in their role until the expiration or
termination of the Term of this Agreement.

Article 3
DEVELOPMENT ACTIVITIES FOR CO-FUNDING PRODUCTS

3.1Development of Co-Funding Products.  [See Annex 1.]

3.2Existing Product R&D Programs and Associated Product R&D Plans.  [See Annex
1.]

(a)[See Annex 1.]

(b)[See Annex 1.]

3.3New Product R&D Programs and Associated Product R&D Plans.  [See Annex 1.]

 

3.4[See Annex 1.]

3.5Transition of Patent Prosecution Responsibilities.  [See Annex 1.]

3.6Preparation, Updates and Approval of Global Development Plans.

(a)With respect to each Co-Funding Product, the Lead Party in consultation with
the Participating Party shall prepare, and the JDC shall review and present a
Global Development Plan for approval by the JSC, and the JSC shall approve a
Global Development Plan for such Co-Funding Product, within

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

[***] after the Option Exercise Date.  [***], the Lead Party shall Develop the
Co-Funding Product in accordance with the development plan previously being used
by the Party developing such Co-Funding Product prior to the Option Exercise
Date.  An updated Global Development Plan for each Co-Funding Product will be
prepared by the Lead Party in consultation with the Participating Party,
reviewed by the JDC and presented by the JDC for approval by the JSC, and
reviewed and approved by the JSC, at least [***] prior to the end of each
Contract Year.  Each Global Development Plan will be reviewed and if necessary
updated by the Lead Party (with such update reviewed by the JDC and JSC and
approved by the JSC) not less frequently than once every [***].

(b)[See Annex 1.]

3.7Global Development Budgets.

(a)Approval.  Each Global Development Plan for a Co-Funding Product shall
include a related Global Development Budget and each Global Development Budget
shall be prepared, updated, reviewed and approved as part of the preparation,
update and approval of the Global Development Plan of which such Global
Development Budget is a part in accordance with this Agreement.  Amendments and
updates to any Global Development Budget shall not be effective without the
approval of the JSC.  [***].

(b)Changes.  If either Party reasonably anticipates that the costs of its
conducting, or having a Third Party conduct, any activity included in a Global
Development Budget will exceed the budgeted amount therefor, or if the costs of
conducting such activity do exceed the amount set forth in the Global
Development Budget, or if additional activities are required, such Party shall
notify the JSC and request a change to the applicable Global Development
Budget.  The JSC shall in good faith consider all such reasonable requests to
change the Global Development Budget.

(c)Budgets and Overages.  Each Party shall use Commercially Reasonable Efforts
to ensure that the actual costs associated with the performance of activities
allocated to it in the Global Development Plan for a Co-Funding Product for a
given Contract Year do not exceed [***] of the budgeted costs allocated to such
Party for such Contract Year as set forth in the budget.  [***].

3.8[See Annex 1.]

Article 4
COMMERCIALIZATION OF CO-FUNDING PRODUCTS

4.1Commercialization of Co-Funding Products.  Subject to the terms of this
Agreement, including Section 4.5, the Lead Party shall undertake
Commercialization activities with respect to Co-Funding Products pursuant to the
Global Commercialization Plans and such Commercialization activities shall be
under the general direction and oversight of the JCC and JSC.  Except as
otherwise agreed to by the Parties or explicitly set forth in this Agreement,
the JSC will assign responsibility for conducting all Commercialization
activities for a Co-Funding Product to the Lead Party.  The Lead Party shall use
Commercially Reasonable Efforts to Commercialize Co-Funding Products in
accordance with this Agreement and the applicable Plans, and each Party shall
use Commercially Reasonable Efforts to carry out the

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Commercialization activities assigned to it in Global Commercialization Plans
and Country/Region Commercialization Plans, including the U.S. Commercialization
Plans, in a timely manner, and in each case shall conduct all such activities in
compliance with Applicable Laws.  The Lead Party shall be responsible for
handling collection and receivables and recording and booking sales in each
country worldwide [***].

4.2Preparation, Updates and Approval of Global Commercialization Plans.  With
respect to each Co-Funding Product, a Global Commercialization Plan shall be
prepared by the Lead Party in consultation with the Participating Party, and the
JCC shall review and present to the JSC for approval, and the JSC shall approve
a Global Commercialization Plan [***].

4.3Global Commercialization Budget.

(a)Approval.  Each Global Commercialization Plan for a Co-Funding Product shall
include a related Global Commercialization Budget (each individually, a “Global
Commercialization Budget” and collectively, the “Global Commercialization
Budgets”) and each Global Commercialization Budget shall be prepared, updated,
reviewed and approved as part of the preparation, update and approval of the
Global Commercialization Plan of which such Global Commercialization Budget is a
part in accordance with this Agreement.  Amendments and updates to any Global
Commercialization Budget shall not be effective without the approval of the JSC.

(b)Changes.  If either Party reasonably anticipates that the costs of its
conducting, or having a Third Party conduct, any activity included in a Global
Commercialization Budget will exceed the budgeted amount therefor, or if the
costs of conducting such activity do exceed the amount set forth in the Global
Commercialization Budget, or if additional activities are required, such Party
shall notify the JSC and request a change to the applicable Global
Commercialization Budget.  The JSC shall in good faith consider all such
reasonable requests to change the Global Commercialization Budget.

(c)Budgets and Overages.  Each Party shall use Commercially Reasonable Efforts
to ensure that the actual costs associated with the performance of activities
allocated to it in the Global Commercialization Plan for a Co-Funding Product
for a given Contract Year do not exceed [***] of the budgeted costs allocated to
such Party for such Contract Year as set forth in the budget.  [***].

4.4Country/Region Commercialization Plans.  Each Country/Region
Commercialization Plan, including each U.S. Commercialization Plan, and all
updates and amendments thereto will be consistent with the Global
Commercialization Plan.  It is anticipated that each Country/Region
Commercialization Plan for a Co-Funding Product, including each U.S.
Commercialization Plan, will be prepared by the Lead Party for the Co-Funding
Product in consultation with the Participating Party, reviewed by the JCC and
JSC, and approved by the JSC, at least [***].  Such Country/Region
Commercialization Plan, including such U.S. Commercialization Plan, for each
subsequent Contract Year shall be updated by the Lead Party

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REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

in consultation with the JCC, reviewed by the JCC and JSC, and approved by the
JSC, at least [***].

4.5Commercialization Efforts; Sharing of Commercial Information.

(a)The Lead Party (through its Affiliates where appropriate) shall use
Commercially Reasonable Efforts to Commercialize Co-Funding Products in the
Field worldwide in accordance with the Global Commercialization Plans, the
Marketing Guidelines and, as applicable, the Country/Region Commercialization
Plan(s), including each U.S. Commercialization Plan.  Without limiting the
generality of the foregoing, [***] in accordance with Section 4.11, and subject
to Section 4.11 (1) the Participating Party shall use Commercially Reasonable
Efforts to perform the anticipated total Co-Promotion effort at the
Participating Party Commitment Level, and (2) the Lead Party shall use
Commercially Reasonable Efforts to perform the anticipated total Co-Promotion
effort above the Participating Party Commitment Level, in each case, with
respect to the Co-Funding Products in the Field in accordance with the approved
U.S. Commercialization Plan, consistent with the Global Commercialization Plan
and in accordance with all Applicable Laws.

(b)The Lead Party will provide the Participating Party with full access to
material information directly relating to the Commercialization of each
Co-Funding Product in the Field, [***].  Without limiting the foregoing,
beginning in the Quarter of the First Commercial Sale (i) in each Major Market
Country, the Lead Party will provide the Participating Party [***], with reports
of the activity within its field force in each such Major Market Country and
summarizing in reasonable detail other marketing and promotional activities
undertaken by the Lead Party, and (ii) with respect to the U.S., if the
Participating Party exercises its rights to Co-Promote a Co-Funding Product in
accordance with Section 4.11, the Participating Party will provide the Lead
Party, [***], with reports of the Participating Party’s Co-Promotion activity
within its field force in the United States, in each of (i) and (ii) which will
include reasonable data from reports created by a Party for its internal
management purposes.

4.6Promotional Materials.  The Lead Party will be responsible, [***], the Global
Commercialization Plan and the Country/Region Commercialization Plans (as
applicable), including the U.S. Commercialization Plans (as applicable), for the
creation, preparation, production and reproduction of all Promotional Materials
and for filing, as appropriate, all Promotional Materials with all Regulatory
Authorities in the world.  Without limiting Section 10.11, the JCC shall review
and comment on [***].

4.7Promotional Claims/Compliance.  Neither Party nor any of its Affiliates shall
make any medical or promotional claims for any Co-Funding Product other than as
permitted by Applicable Laws.  When distributing information related to any
Co-Funding Product or its use (including information contained in scientific
articles, reference publications and publicly available healthcare economic
information), each Party and its Affiliates shall comply with all Applicable
Laws and any applicable guidelines established by the pharmaceutical industry in
the applicable country.

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

4.8[***].

4.9Market Exclusivity Extensions.  [***].

4.10Post Marketing Approval Obligations.  Subject to the provisions of this
Agreement, the Lead Party shall comply with any post-Approval obligations with
respect to a Marketing Approval with respect to any Co-Funding Product in any
country, imposed by Applicable Law, pursuant to the Approvals or required by a
Regulatory Authority.

4.11The Participating Party’s Co-Promotion Option in the United States.

(a)Exercise of Co-Promote Option.  Subject to this Section 4.11, with respect to
the Co-Funding Target and all Co-Funding Products that are Directed to such
Co-Funding Target, in the event the Participating Party desires to Co-Promote a
Co-Funding Product in the United States, the Participating Party shall notify
the Lead Party of its decision regarding whether to Co-Promote such Co-Funding
Product in the United States no later than [***] (such notification, a
“Co-Promotion Exercise Notice”).  If the Participating Party does not timely
deliver to the Lead Party a Co-Promotion Exercise Notice by the deadline set
forth above, as applicable, the Participating Party’s right to Co-Promote such
Co-Funding Product in the United States shall immediately and permanently
expire.

(i)Detailing and Co-Promotion FTE Efforts.  The Participating Party shall
specify in its Co-Promotion Exercise Notice the [***]. Notwithstanding the
Participating Party’s exercise of its option pursuant to Section 4.11, the Lead
Party shall continue to be solely responsible for sales force training, unless
agreed otherwise by the JSC.

(ii)In the event the Participating Party, either directly or through or its
Affiliates, is not commercializing a product in the United States at the time of
the Participating Party’s election to Co-Promote a Co-Funding Product in
accordance with this Section 4.11(a), the Participating Party may only exercise
its election to Co-Promote such Co-Funding Product in the event the
Participating Party has an existing sales force in the United States at the time
of its election to Co-Promote such Co-Funding Product, [***].  On a Co-Funding
Product by Co-Funding Product basis, any costs incurred by the Participating
Party [***].

(iii)[***].

(b)Co-Promotion Agreement.  [***].

(c)[***].

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Article 5
CLINICAL AND REGULATORY AFFAIRS

5.1Regulatory Coordination.

(a)Subject to the terms of this Agreement, the Lead Party shall determine the
appropriate regulatory strategy with respect to Co-Funding Products, in
consultation with the Participating Party under the general direction and
oversight of the JDC, JCC, and JSC.  The Lead Party shall consult with the
Participating Party in the preparation of regulatory strategies and with respect
to all material regulatory actions, communications and Regulatory Filings for
Co-Funding Products worldwide.

(b)Regulatory Filings.

(i)The Lead Party shall be responsible for submitting and maintaining all such
Regulatory Filings and shall act as the point of contact for regulatory
communications with each applicable Regulatory Authority with respect to each
Co-Funding Product.  The Lead Party (or its designee) shall own all such
regulatory materials, including all INDs and Approvals with respect to
Co-Funding Products.  Without limiting the foregoing, the Lead Party will be
responsible for, and will use Commercially Reasonable Efforts in applying for,
obtaining and maintaining the applicable Approval or other Registration Filing
for each Co-Funding Product, subject to the oversight of the JSC.  The Lead
Party shall perform all such activities in accordance with the Plans and all
Applicable Laws.

(ii)[See Annex 1.]

(c)[See Annex 1.]

(d)The Parties shall [***].

(e)The Lead Party shall provide the Participating Party as promptly as
practicable with written notice and copies of any (i) draft and final Regulatory
Filings or other filings with, (ii) submissions [***] to and (iii) material
communications with, Regulatory Authorities pertaining to the Development and/or
Commercialization of a Co-Funding Product under the Plans, and shall afford the
Participating Party’s representatives an opportunity to review the foregoing
filings, submissions and correspondence (including all annual and periodic
safety reports for Co-Funding Products), [***].

5.2Labeling.  For each Co-Funding Product, [***].

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

5.3Regulatory Events.  Each Party shall keep the other Party informed, as soon
as possible but no later than the time period set forth below after notification
(or other time period specified below), of any action by, or notification or
other information which it receives (directly or indirectly) from, any
Regulatory Authority, Third Party or other Governmental Authority, which:

(a)raises any material concerns regarding the safety or efficacy of any
Co-Funding Product, for which the time period for informing the other Party will
be no later than [***]; or

(b)is reasonably likely to lead to a recall or market withdrawal of any
Co-Funding Product anywhere in the world, for which the time period for
informing the other Party will be no later than [***].

Information that shall be disclosed pursuant to this Section 5.3 shall include,
the following matters with respect to Co-Funding Products:

(i)Governmental Authority inspections or audits of Manufacturing, Development,
distribution or other facilities;

(ii)receipt of a complete response letter, refusal to file, warning letter or
similar communications issued by a Regulatory Authority; and

(iii)an initiation of any Regulatory Authority or other Governmental Authority
investigation, detention, enforcement action, seizure or injunction.

5.4Recalls and Other Corrective Actions.  Decisions with respect to any recall,
market withdrawal or other corrective action related to any Co-Funding Product
shall be made by the Lead Party, and the Lead Party shall make any such
decision, to the extent reasonably possible, in consultation with the
Participating Party.  In any event and without limiting the previous sentence,
[***].

Article 6
LICENSES

6.1Intellia License to Regeneron for Regeneron Co-Funding Products.  With
respect to Regeneron Co-Funding Products, Section 6.3 of the Collaboration
Agreement is hereby incorporated by reference into this Agreement in accordance
with Section 2.2(b), except all references to the IP Term shall be deemed to
refer to the IP Term as defined in this Agreement.  Notwithstanding the
foregoing, Intellia reserves the rights under the licenses granted under this
Section 6.1 to perform the activities designated to it under a Global
Development Plan, Global Commercialization Plan, and U.S. Commercialization
Plan, if applicable, and for the supply of Regeneron Co-Funding Products under
Section 8.2.

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

6.2Regeneron License to Intellia for Regeneron Co-Funding Products.  Regeneron
shall grant, and hereby grants, to Intellia a non-exclusive, worldwide license
under the Regeneron Contributed IP solely to the extent necessary for Intellia
to perform the activities designated to it under the applicable Global
Development Plan, Global Commercialization Plan, and U.S. Commercialization
Plan, if applicable, for such Regeneron Co-Funding Products and for the supply
of such Regeneron Co-Funding Products under Section 8.2.  Intellia may
sublicense the license granted under this Section 6.2 only in accordance with
Section 7.2(c) and only as necessary to enable permitted subcontractors to
perform such activities in accordance with Section 7.2(b).

6.3Regeneron License to Intellia for Intellia Co-Funding Products.  Regeneron
shall grant, and hereby grants, to Intellia a non-exclusive, worldwide,
sublicensable in multiple tiers (in accordance with Section 7.2(c)) license
under that portion of the Regeneron Contributed IP that Regeneron contributed in
connection with Intellia Co-Funding Products, to develop, make, have made, use,
sell, offer for sale, and import Intellia Co-Funding Products for use in the
Field. [See Annex 1.]

6.4Unblocking License.  [See Annex 1.]

6.5Intellia License to Regeneron for Intellia Co-Funding Products.  Intellia
shall grant, and hereby grants, to Regeneron a non-exclusive, worldwide license
under the Intellia Intellectual Property solely to the extent necessary for
Regeneron to perform the activities designated to it under the applicable Global
Development Plan, Global Commercialization Plan, and U.S. Commercialization
Plan, if applicable, for such Intellia Co-Funding Product.  Regeneron may
sublicense the license granted under this Section 6.5 only in accordance with
Section 7.2(c) and only as necessary to enable permitted subcontractors to
perform such activities in accordance with Section 7.2(b).

6.6Mutual License to Materials.  Each Party shall grant, and hereby grants, to
the other Party a non-exclusive, worldwide license under that portion of the
Materials provided pursuant to Section 7.7 for use in accordance with the
relevant Plan.

6.7Ex-Vivo Field.  With respect to Regeneron Co-Funding Targets, Section 6.5 of
the Collaboration Agreement is hereby incorporated by reference into this
Agreement in accordance with Section 2.2(b).

6.8[***].

6.9[***].

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Article 7
PERFORMANCE AND PERFORMANCE STANDARDS

7.1Licenses Generally; No Implied License.  Except as expressly provided for
herein, nothing in this Agreement grants either Party any right, title or
interest in and to the intellectual property rights, materials or Confidential
Information of the other Party (either expressly or by implication or
estoppel).  Except as expressly provided in this Agreement, neither Party will
be deemed by this Agreement to have been granted any license or other rights to
the other Party’s Patent Rights or Know-How, either expressly or by implication,
estoppel or otherwise.  With respect to Co-Funding Products for which Regeneron
is the Lead Party, the last sentence of Section 7.1 of the Collaboration
Agreement is hereby incorporated by reference into this Agreement in accordance
with Section 2.2(b).

7.2Performance Standards.

(a)Affiliates.  Each Party may carry out its obligations, and exercise its
rights, under this Agreement through its Affiliates, and in such case, the Party
carrying out such activities, or exercising such rights, through its Affiliate
absolutely, unconditionally and irrevocably guarantees to the other Party the
performance by such Party’s Affiliates in accordance with this Agreement,
including performance of responsibilities, liabilities, covenants, warranties,
agreements and undertakings of its Affiliates pursuant to this
Agreement.  Without limiting the foregoing, neither Party shall cause or permit
any of its Affiliates to commit any act (including any act or omission) which
such Party is prohibited hereunder from committing directly.  Each Party
represents and warrants to the other Party that it has licensed or will license
from its Affiliates the Patent Rights and Know-How Controlled by its Affiliates
that are to be licensed (or sublicensed) to the other Party under this
Agreement.

(b)Subcontracts.  Each Party may perform any of its obligations or exercise its
rights under this Agreement through one or more subcontractors; provided that
(i) [***]; (ii) the subcontracting Party remains responsible for the work
allocated to, and payment to, such subcontractors it selects to the same extent
it would if it had done such work itself and the non-subcontracting Party will
have the right to proceed directly against the subcontracting Party without any
obligation to first proceed against its subcontractor; (iii) [***]; and (iv) the
subcontractor agrees in writing to assign all inventions and intellectual
property developed in the course of performing any such work under this
Agreement, to the Party retaining such subcontractor (or to the other Party if
such inventions or intellectual property are to be assigned to such other Party
as required under this Agreement) and upon request to sign any documents to
confirm or perfect such assignment and to cooperate in the preparation and
prosecution of any such inventions.  [***].  To the extent any licenses are
granted under any subcontract agreements, such agreements will be subject to
Section 7.2(c).

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(c)Sublicensees.

(i)To the extent a license is sublicensable pursuant to the applicable license
grant hereunder, or is required in connection with a permitted subcontracting
pursuant to Section 7.2(b), the applicable Party may enter into sublicenses
under such licenses granted in this Agreement, but subject to compliance with
this Section 7.2(c) and the other applicable terms and conditions set forth in
this Agreement.  Any such sublicense agreement must be in writing and shall
require the sublicensee of a Party to comply with all applicable obligations of
such Party that are relevant to the sublicense granted, including the
confidentiality and non-use obligations set forth in Article 13.  [***].  With
respect to Co-Funding Products for which Regeneron is the Lead Party, the last
sentence of Section 7.2(c)(i) of the Collaboration Agreement is hereby
incorporated by reference into this Agreement in accordance with
Section 2.2(b).  The Lead Party shall promptly notify the Participating Party of
the grant of each such sublicense.

(ii)(A)With respect to any and all Other Co-Funding Agreement Inventions and
Joint Improvements or any other Intellectual Property that is invented and
jointly owned by the Parties under this Agreement, subject to the terms and
conditions of this Agreement, each Party shall have the right to grant
(sub)licenses (through multiple tiers) thereto for any purposes without the need
to seek consent from or account to the other Party (and, for clarity, neither
Party shall be required to obtain the consent of the other Party with respect to
such (sub)license anywhere in the world and, to the extent that such consent is
required in any country in the world, such consent is hereby granted); provided,
that, Regeneron shall only be permitted to grant a (sub)license with respect to
the [***]. [See Annex 1.]

(B)Notwithstanding the foregoing Section 7.2(c)(ii)(A), nothing in this Section
7.2(c)(ii)(B) shall in any way restrict, limit or prohibit or be deemed to
restrict, limit or prohibit either Party from soliciting, negotiating,
facilitating, executing or undergoing a Change of Control.

7.3Third Party Agreements.

(a)Intellia will be responsible for delivering all payments under the Intellia
Existing Third Party Agreements to the applicable Third Party counterparty
thereto.  The amounts of such payments shall be borne by the Parties pursuant to
Section 7.5.

(b)Following the Effective Date during the Term, Intellia or its Affiliates, in
its sole discretion (but subject to Section 7.4), may enter into new agreements
with Third Parties to license technologies or Intellectual Property from such
Third Parties, including pursuant to any Third Party Collaboration Agreements
(to the extent such technologies or Intellectual Property, as applicable, were
not licensed by Intellia or any of its Affiliates as of the Effective Date) (an
“Intellia Platform In-License”).

(c)Commencing on the Effective Date and continuing until the expiration of the
IP Term [***], if Intellia or its Affiliates enters into any Intellia Platform
In-License during such period that may be useful or necessary in connection with
the Development, Manufacture,

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Commercialization or use of a Co-Funding Product, then Intellia will provide
written notice of such license to the JSC, including a redacted copy of each
such Intellia Platform In-License (which may be redacted for information not
pertinent to this Agreement to the extent that such redactions do not reasonably
impair the JSC’s ability to evaluate whether it wants to include such Intellia
Platform In-License as a New Intellia Platform License under this Agreement), so
the JSC (subject to dispute resolution pursuant to Section 2.9) may elect
whether to include such license under this Agreement [***].

(d)[See Annex 1.]

(e)[***].

7.4Coordination of Third Party Intellectual Property Licensing.

(a)During the Term, if either Party (or its Affiliate) desires to obtain a
license to Intellectual Property of a Third Party for use in connection with the
Development, Commercialization or Manufacture of a Co-Funding Product (but not
for any broader use), then prior to entering into such license, the JSC shall
discuss in good faith and coordinate the licensing of such Intellectual
Property.  In the case of JSC approval [***].

(b)[See Annex 1.]

7.5Third Party License Payments.  Subject to [***], all Third Party License
Payments made by a Party in accordance with Section 7.3, Section 7.4, Section
7.12 (if applicable) [***] shall be included in the Profit Split and shared by
the Parties in accordance with their respective Co-Funding Percentages [***].

7.6Records.

(a)Records.

(i)Section 7.5(a)(i) of the Collaboration Agreement is hereby incorporated by
reference into this Agreement in accordance with Section 2.2(b) and all
references in such provisions to the Technology Collaboration and Technology
Collaboration Plan shall be deemed to refer to this Agreement and to the
applicable Plan, respectively.

(ii)[***].

(b)Record Keeping Generally.  Section 7.5(b) of the Collaboration Agreement is
hereby incorporated by reference into this Agreement in accordance with Section
2.2(b).

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

7.7Materials for Development Plans.

(a)Contributed Materials.  To facilitate the conduct of activities hereunder, a
Party shall provide the [***], collectively, “Materials”).  Except as is set
forth in the Product R&D Plan with respect to a Regeneron Co-Funding Product or
a Party agrees to provide Materials to the other Party as set forth in a Plan,
neither Party shall be obligated to provide any Materials to the other
Party.  Neither Party shall use the Materials of the other Party except in
accordance with a Plan.  All such Materials will remain the sole property of the
providing Party.  The receiving Party will (i) itself retain control of all such
Materials, (ii) use such Materials only in the fulfillment of obligations or
exercise of rights under this Agreement, (iii) not use such Materials or deliver
the same to, or for the benefit of, any Third Party, without the providing
Party’s prior written consent [***] and (iv) not use such Materials in research
or testing involving human subjects, without the providing Party’s prior written
[***].  The Materials supplied under this Section 7.7 are supplied “as is”, and
accordingly the receiving Party agrees to use prudence and appropriate caution
in the use, handling, storage, transportation and disposition and containment of
all such Materials, as not all of their characteristics may be known.  [***].

(b)Regeneron Mice.  Section 7.7(b) of the Collaboration Agreement is hereby
incorporated by reference into this Agreement in accordance with Section 2.2(b).

7.8Debarment.  Section 7.8 of the Collaboration Agreement is hereby incorporated
by reference into this Agreement in accordance with Section 2.2(b).

7.9No Use of Non-Controlled IP in Performance of Activities under this
Agreement.  Each Party hereby covenants to the other Party that in the course of
conducting its activities under this Agreement it will not use in or contribute
in the performance of activities under this Agreement, any material,
Confidential Information, Intellectual Property, or trademark that such
contributing Party knows (without any duty to inquire) misappropriates the
Intellectual Property of a Third Party.  The Parties acknowledge and agree that
this Section 7.9 is not intended to be, and shall not be deemed to be, a
covenant against non-infringement of Intellectual Property.

7.10Further Assurances and Transaction Approvals.  Section 7.10 of the
Collaboration Agreement is hereby incorporated by reference into this Agreement
in accordance with Section 2.2(b).

7.11[See Annex 1.]

7.12[See Annex 1.]

Article 8
CO-FUNDING PRODUCT MANUFACTURING

8.1Non-GMP Manufacture of Co-Funding Products.  [See Annex 1.]

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

8.2Supply for Product R&D Program or its Equivalent.  [See Annex 1.]

8.3Supply Beyond Pre-Clinical.

(a)On or before the later to occur of (i) [***] for a Co-Funding Product or (ii)
[***], the JMC shall discuss alternatives for the Manufacture and supply of
Co-Funding Products beyond pre-clinical supply, including Initiation of GLP
Toxicology Batch and GMP Manufacturing needed to support an IND, in each case,
for a Co-Funding Product.

(b)[See Annex 1.]

8.4[See Annex 1.]

8.5Clinical and Commercial Supply.  With respect to a Co-Funding Product, the
Lead Party will be responsible for and will use Commercially Reasonable Efforts
to adequately and timely Manufacture or have Manufactured the Clinical Supply
Requirements and Commercial Supply Requirements of Co-Funding Products worldwide
in accordance with the Manufacturing Plan and in accordance with Applicable
Laws, including applicable Good Practices.  The Lead Party will be responsible
for and will use Commercially Reasonable Efforts to perform the filling,
packaging, labeling and testing of the Clinical Supply Requirements and
Commercial Supply Requirements for Co-Funding Products for use under this
Agreement in accordance with Applicable Laws, including applicable Good
Practices.  The Parties through the JMC shall discuss in good faith the
Manufacture of Co-Funding Products, and reasonably cooperate with each other in
all such supply matters pertaining to the Co-Funding Products under this Article
8.

8.6Manufacturing Plans.  With respect to a Co-Funding Product, the Lead Party,
in consultation with the JMC, will develop and update as necessary, for each
Co-Funding Product, a Manufacturing Plan, which shall be reviewed and approved
by the JSC.  [***].  Each Manufacturing Plan shall set forth the [***].  The
Manufacturing Plan (including each annual update thereto) for a Co-Funding
Product shall be prepared by the Lead Party in consultation with the
Participating Party, reviewed by the JMC, presented to the JSC for approval, and
reviewed and approved by the JSC at least [***].  The Lead Party shall use
Commercially Reasonable Efforts to perform its responsibilities in accordance
with the approved Manufacturing Plans.  Upon the Participating Party’s written
request, the Lead Party shall provide the Participating Party with complete and
accurate copies of material Manufacturing-related records.

8.7[***].

Article 9
PAYMENTS

9.1Reimbursement for Past Expenses.  [See Annex 1.]

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

9.2Sharing of Profits and Development Costs from Co-Funding Products

.  Commencing on the Effective Date and continuing during the Term, on a
Co-Funding Product-by-Co-Funding Product basis, the Parties shall share Profits
and Development Costs and other costs equally for all Co-Funding Products
Directed to a Co-Funding Target as described in Schedule 9.2, subject to Section
9.3.

9.3[***].

(a) [***].

(b)[***] have been paid and releases have been granted concerning such Covered
Claims.

9.4Periodic Reports.  Intellia and Regeneron shall each prepare and deliver to
the other Party the periodic reports specified below:

(a)Within [***] in which the First Commercial Sale of any Co-Funding Product
occurs in any country in the world, the Lead Party shall deliver electronically
to the Participating Party a monthly detailed Co-Funding Product Net Sales
report, in each case with monthly and year-to-date sales in local currency and
in each country in which such Co-Funding Product is sold, such reporting
obligation to commence with the month in which the First Commercial Sale of any
Co-Funding Product occurs in any country;

(b)Within [***], the Lead Party and the Participating Party shall each provide
to the other Party a written report (in electronic form) summarizing the
material activities undertaken by such Party [***] in connection with each
Global Development Plan, together with a statement of Development Costs incurred
by such Party [***], which statement shall detail those amounts to be included
in the Development Payment Report for such [***];

(c)Within [***] in which the First Commercial Sale of any Co-Funding Product
occurs in any country in the world, the Lead Party shall deliver electronically
to the Participating Party a written report setting forth, on a
country-by-country basis for such [***], for each country, (i) the Co-Funding
Product Net Sales of each Co-Funding Product in local currency and in United
States Dollars, (ii) Co-Funding Product quantities sold and (iii) gross
Co-Funding Product sales and an accounting of the deductions from gross sales
permitted by the definition of Co-Funding Product Net Sales;

(d)Within [***], each Party that has incurred any Other Shared Expenses, Shared
Commercial Expenses or Cost of Goods Sold in that [***] shall deliver
electronically to the other Party a written report setting forth in reasonable
detail the Other Shared Expenses, Shared Commercial Expenses and/or Cost of
Goods Sold incurred by such Party in such [***] in the aggregate on a worldwide
basis and also on a Major Market Country-by-Major Market Country basis and on a
Co-Funding Product-by-Co-Funding Product basis, in local currency and in United
States Dollars, including whether any such expenses are also included in the
reports delivered pursuant to clause (e) below;

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(e)Within [***], the Lead Party shall provide to the Participating Party, in
electronic form, a Development Payment Report in respect of such [***],
combining the information reported by each Party pursuant to this Section 9.4(b)
and showing its calculations in accordance with Schedule 9.2 of the amount of
any payments to be made by the Parties hereunder for such [***] as contemplated
by this Section 9.4 [***] and, if applicable, providing for the netting of such
payments; and

(f)Within [***], the Lead Party shall deliver electronically to the
Participating Party a Profit Payment Report in respect of such [***], combining
the information reported by each Party pursuant to this Section 9.4(c)-(d) and
showing its calculations in accordance with Schedule 9.2 of the amount of any
payments to be made by the Parties hereunder for such [***] as contemplated by
this Section 9.4 [***] and, if applicable, providing for the netting of such
payments.

9.5Adjustments to FTE Rates.  Notwithstanding anything herein to the contrary,
upon the request of either Party, such request not to be delivered more than
once per Contract Year, the Parties shall meet to review the accuracy of an
applicable FTE rate in any country (e.g., Field Force FTE Rate, Development FTE
Rate, etc.).  The Parties agree to share reasonable supporting documents and
materials in connection with an assessment of the applicable FTE rate and to
determine in good faith whether to adjust the rate(s) in any country.

9.6Funds Flow.  The Parties shall make [***] Development True-Up and [***]
Profit True-Up payments as set forth in Schedule 9.2.  If the Lead Party is the
Party owing [***] Development True-Up or [***] Profit True-Up payment(s) based
on the calculations in the applicable Development Payment Report or Profit
Payment Report, it shall, subject to Section 9.10, make such payment to the
Participating Party within [***] after its delivery to the Participating Party
of such Development Payment Report or Profit Payment Report, as applicable and
receipt of an invoice therefor from the Participating Party.  If the
Participating Party is the Party owing the [***] Development True-Up or [***]
Profit True-Up payment(s) based on the calculations in the applicable
Development Payment Report or Profit Payment Report, it shall, subject to
Section 9.10, make such payment to the Lead Party within [***] after its receipt
of such Development Payment Report or Profit Payment Report, as applicable, from
the Lead Party and receipt of an invoice therefor from the Lead Party.  If
agreed between the Parties, the Parties may also net the collective payment(s)
due under the Development Payment Report and Profit Payment Report.  In the
event that the Third Party Licenses entered in compliance with this Agreement
reasonably require the payment of royalties or other amounts payable thereunder
(to the extent attributable to the Manufacture, Development and/or
Commercialization of Co-Funding Products) on a schedule other than the schedule
set forth in this Agreement for [***] Development True-Up or [***] Profit
True-Up payment(s), the Parties shall discuss in good faith an appropriate
schedule upon which the Party that is not party to such Third Party License
shall make such payment to the other Party or its designee, and the Parties
shall adjust the amounts payable for the next [***] Development True-Up or [***]
Profit True-Up payment(s) accordingly to credit such paying Party for its
pre-payment of any amounts under the Third Party Licenses.

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

9.7Invoices and Documentation.  The JFC shall propose and the JSC shall approve
the form of any necessary documentation relating to any Development Costs or
Profit Split payments hereunder so as to afford the Parties appropriate
accounting treatment in relation to any of the transactions or payments
contemplated hereunder.  Unless otherwise agreed by the JSC, the financial data
in the reports will include calculations in local currency and United States
Dollars.

9.8Payment Method and Currency.  Section 9.9 of the Collaboration Agreement is
hereby incorporated by reference into this Agreement.

9.9Taxes.  Section 9.10 of the Collaboration Agreement is hereby incorporated by
reference into this Agreement.

9.10Resolution of Payment Disputes.  In the event there is a dispute relating to
any payment obligations or reports hereunder, the Party with the dispute shall
have its representative on the JFC provide the other Party’s representative on
the JFC with written notice setting forth in reasonable detail the nature and
factual basis for such good faith dispute and the Parties, through the JFC, will
seek to resolve the dispute as promptly as possible, but no later than ten (10)
days after such written notice is received.  If the JFC is unable to resolve
such payment dispute within such period then the matter shall be referred to the
JSC.  The Parties agree that if there is a dispute regarding any payment amount,
only the disputed amount shall be withheld from the payment, and the undisputed
amount shall be paid within the applicable timeframes.

9.11Late Fee.  Section 9.12 of the Collaboration Agreement is hereby
incorporated by reference into this Agreement.

9.12Effect of Intellia Option Exercise.  If a Co-Funding Product constitutes a
Regeneron Co-Funding Product, then no milestone payments or royalties shall be
due or payable from Regeneron to Intellia under Article 9 of the Collaboration
Agreement with respect to such Regeneron Co-Funding Product [***].  For clarity,
Third Party License Payments (including pursuant to the Intellia Existing Third
Party Agreements) shall be included in the Profit Split and shared by the
Parties in accordance with their respective Co-Funding Percentages subject to
the other terms and conditions of this Agreement that relate to their inclusion
and allocation thereof.

9.13[See Annex 1.]

9.14[See Annex 1.]

Article 10
INTELLECTUAL PROPERTY

10.1Newly Created Intellectual Property.

(a)Ownership of Newly Created Intellectual Property.  Inventorship of
Intellectual Property invented through the performance of activities under this
Agreement shall be

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

determined in accordance with United States patent laws (regardless of where the
applicable activities occurred) and ownership of such Intellectual Property
shall follow inventorship.  Notwithstanding the previous sentence, all right,
title and interest in any [***], Regeneron Materials Improvements, Intellia
Materials Improvements, Co-Funding Product Inventions and [***], in each case,
shall be determined in accordance with the following terms and conditions:

(i)the Parties shall jointly own all [***];

(ii)Intellia shall solely own all Intellia Materials Improvements and Intellia
Co-Funding Product Inventions [***]; and

(iii)Regeneron shall solely own all Regeneron Materials Improvements and
Regeneron Co-Funding Product Inventions [***].

(b)[***].

(c)Treatment.  All Intellia Materials Improvements shall be treated as Intellia
Patent Rights or Intellia Know-How, as applicable, for purposes of this Article
10.  All Regeneron Materials Improvements shall be treated as Regeneron
Co-Funding Product Inventions for purposes of this Article 10.

(d)Invention Assignment; Assistance.  Section 10.1(d) of the Collaboration
Agreement is hereby incorporated by reference into this Agreement.

(e)Joint Ownership of [***].  The Parties shall each own an equal, undivided
interest in, and, subject to the other applicable provisions of this Agreement
[***], each Party shall otherwise enjoy an equal undivided right to exploit any
and all [***] including the right to use, practice and otherwise exploit for
research, development, manufacturing, commercialization and other purposes
(including to grant licenses or other similar rights under) the [***], without
the need to seek consent from or account to the other Party (and, for clarity,
neither Party shall be required to obtain the consent of the other Party with
respect to the exploitation thereof anywhere in the world and, to the extent
that such consent is required in any country in the world, such consent is
hereby granted).  The foregoing joint ownership rights shall not be construed as
granting, conveying or creating any license or other rights to any of the other
Party’s other intellectual property, unless otherwise expressly set forth in
this Agreement.  Subject to any licenses granted under this Agreement and
subject to the other applicable provisions of this Agreement [***] each Party
shall grant and hereby grants its consent to the other Party to exploit,
(sub)license, assign [***] where such consent is required under Applicable Law,
and further shall confirm the foregoing in writing at the other Party’s
reasonable request.  [***].

(f)Other Intellectual Property.  Section 10.1(f) of the Collaboration Agreement
is hereby incorporated by reference into this Agreement.

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(g)Employees and Consultants.  Section 10.1(g) of the Collaboration Agreement is
hereby incorporated by reference into this Agreement.

(h)Disclosure.  Each Party shall promptly disclose to the other Party all
Intellectual Property that (i) is invented by such Party, its employees, agents
and consultants pursuant to this Agreement and (ii) that is [***].

10.2Prosecution and Maintenance of Patent Rights.

(a)Intellia Patent Rights.  Intellia shall use Commercially Reasonable Efforts
to prepare, file, prosecute and maintain the Intellia Patent Rights [***] (and
as between the Parties, in the name of Intellia).  Intellia shall be solely
responsible for all fees and costs incurred for the preparation, filing,
prosecution and maintenance of such Intellia Patent Rights, [***].

(b)[***].  Intellia shall, through counsel it selects and, for Major Market
Countries, who has been approved by Regeneron (such approval not be unreasonably
withheld, conditioned or delayed), use Commercially Reasonable Efforts to
prepare, file, prosecute and maintain Patents and Patent Applications within
[***], all such Patents and Patent Applications shall be in the name of Intellia
and for [***], all such Patents and Patent Applications shall be jointly in the
names of both Intellia and Regeneron and Intellia shall bear the costs thereof,
[***].  For clarity, subject to Section 10.2(e), Regeneron shall not prepare,
file, prosecute or maintain Patents or Patent Applications that contain any
claims that claim only Intellia Co-Funding Product Inventions.

(c)Regeneron Co-Funding Product Inventions.  Regeneron shall use Commercially
Reasonable Efforts to prepare, file, prosecute and maintain Patents and Patent
Applications within Regeneron Co-Funding Product Inventions.  All such Patents
and Patent Applications shall be in the name of Regeneron [***].  For clarity,
subject to Section 10.2(e), Intellia shall not prepare, file, prosecute or
maintain Patents or Patent Applications that contain any claims that claim only
Regeneron Co-Funding Product Inventions.

(d)Consultation Rights.

(i)Each Party shall confer with and keep the other Party reasonably informed
regarding the status of such Party’s activities under Section 10.2(a), 10.2(b)
or 10.2(c), as applicable (the Party with primary responsibility under each such
Section, the “Responsible Party”, and the other Party, the “Consultation
Party”).  The Responsible Party shall have the following obligations with
respect to the filing, prosecution and maintenance thereof [***], as applicable,
including any action that would materially affect the scope or validity of
rights under any Patent Applications or Patents (such as substantially narrowing
or canceling any claim without reserving the right to file a continuing or
divisional Patent Application, abandoning any Patent or not filing or perfecting
the filing of any Patent Application in any country) and the Responsible Party
shall consider in good faith and discuss all reasonable comments thereto from
the Consultation Party.

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(ii)If either Party desires to file a patent application that discloses the
Confidential Information of the other Party (including Confidential Information
that is treated by this Agreement as the Confidential Information of both
Parties), within a reasonable period of time prior to the anticipated filing
date, a notice that specifies the Confidential Information to be disclosed
within such patent application shall be provided to the other Party and, upon
the request of the other Party, the filing Party shall be obliged at the other
Party’s discretion to either (A) remove the Confidential Information belonging
solely to the other Party [***] from such patent application or (B) provide the
other Party reasonably sufficient time [***] to file a Patent Application
claiming or otherwise covering such Confidential Information (including
Confidential Information that is treated by this Agreement as the Confidential
Information of both Parties), as applicable (unless any disclosure resulting
from such filing under this clause (B) is prohibited by any Third Party
obligations of such other Party, in which case this clause (B) shall not be
available and only clause (A) shall apply).  Confidential Information of
Regeneron includes the Regeneron Materials unless subject to the exceptions set
forth in Section 13.2.  Confidential Information of Intellia includes the
Intellia Materials unless subject to the exceptions set forth in Section 13.2.

(e)Step-In Rights.

(i)[***].

(ii)[***].

(iii)[***].

(iv)[***].

(v)[***].

(f)Regeneron Contributed IP.  As between the Parties, Regeneron shall have the
sole and exclusive right, in its discretion and at its expense, to prepare,
file, prosecute and maintain Patents and Patent Applications within the
Regeneron Contributed IP and Intellia shall have no right to do so.  For
clarity, any such costs and expenses shall be borne solely by Regeneron and
shall not be subject to sharing by the Parties in accordance with their
respective Co-Funding Percentages and shall not be treated as Other Shared
Expenses.

(g)Cooperation.  Section 10.2(g) of the Collaboration Agreement is hereby
incorporated by reference into this Agreement.

(h)Cooperative Research and Technology Enhancement Act.  Section 10.2(h) of the
Collaboration Agreement is hereby incorporated by reference into this Agreement.

10.3Administrative Patent Proceedings.

(a)Proceedings.  Each Party will notify the other within [***] after receipt by
such Party of information concerning the request for, or filing or declaration
of, any reissue, post-

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

grant review, inter partes review, derivation proceeding, supplemental
examination, interference, opposition, reexamination or other administrative
proceeding relating to [***].

(b)Product Infringement.  If any proceeding under Section 10.3(a) involves
Patents or Patent Applications involved in a Product Infringement under
Section 10.4, then notwithstanding the provisions of Section 10.3(a), any
decisions on whether to initiate or how to respond to such a proceeding, as
applicable, and the course of action in such proceeding, shall be made by the
Party controlling such Product Infringement action pursuant to Section 10.4 in
consultation with the other Party [***].

(c)Cost.  All Out-of-Pocket Costs incurred in connection with any proceeding
under Section 10.3(a) shall be borne solely by [***].

(d)Regeneron Contributed IP and Regeneron Materials Improvements.  As between
the Parties, Regeneron shall have the sole and exclusive right, in its
discretion and at its expense, to handle any reissue, post-grant review, inter
partes review, derivation proceeding, supplemental examination, interference,
opposition, reexamination or other administrative proceeding relating to (i)
Patents and Patent Applications within the Regeneron Contributed IP and (ii)
Patents and Patent Applications claiming or otherwise covering Regeneron
Materials Improvements.  For clarity, any such costs and expenses shall be borne
solely by Regeneron and shall not be subject to sharing by the Parties in
accordance with their respective Co-Funding Percentages and shall not be treated
as Other Shared Expenses.

10.4Third Party Infringement Suits.

(a)Product Infringement.  In the event that either Party or any of its
Affiliates becomes aware of an actual, anticipated, or suspected infringement or
misappropriation by a Third Party of (i) [***], or (ii) [***] (collectively (i)
and (ii), “Product Infringement”), the Party that became aware of the Product
Infringement shall promptly notify the other Party in writing of this actual or
suspected infringement and shall provide such other Party with all available
evidence in such Party’s possession (and that is not subject to a binding
contractual confidentiality obligation to a Third Party) supporting such actual
or suspected infringement.

(b)Lead Litigation Party.  The Parties will consult and cooperate fully in an
effort to determine a mutually agreeable course of action with respect to any
Product Infringement; provided, that:

(i)[***];

(ii)[***];

(iii)[***];

(iv)[***]; and

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(v)[***].

The Party initiating the litigations shall be referred to as the “Lead
Litigation Party”.  The Lead Litigation Party cannot require the non-Lead
Litigation Party to join in the suit, provided, however that [***].

(c)Costs.  All Out-of-Pocket Costs incurred in the connection with the
enforcement of a Product Infringement shall be borne [***] that is not the Lead
Litigation Party.

(d)Recoveries.  The amount of any recovery from any Product Infringement suit
shall first be used to pay each of the Party’s reasonable costs, including
attorneys’ fees, relating to such legal proceedings and the balance of any such
recovery shall be retained by the Lead Litigation Party; provided, however, that
with respect to any amounts of such recovery from any such Product Infringement
suit (other than those amounts used to pay a Party’s reasonable costs) that have
been awarded (as reimbursement for lost sales or lost royalties) of Co-Funding
Products, regardless of which Party is the Lead Litigation Party, such amounts
shall be included in the calculation of Profit Split in accordance with Section
9.2.

(e)Assistance.  In the event either Party initiates a proceeding pursuant to
this Section 10.4, without any effect as to who is the Lead Litigation Party
pursuant to the terms of Section 10.4(b), the other Party shall provide all
assistance reasonably requested by the Lead Litigation Party [***].

(f)Settlements; Admissions.  Section 10.4(f) of the Collaboration Agreement is
hereby incorporated by reference into this Agreement.

(g)Step-In Rights.  Section 10.4(g) of the Collaboration Agreement is hereby
incorporated by reference into this Agreement.

(h)Biosimilar Applications.  Section 10.4(h) of the Collaboration Agreement is
hereby incorporated by reference into this Agreement.

(i)Regeneron Contributed IP and Regeneron Materials Improvements.  As between
the Parties, Regeneron shall have the sole and exclusive right, in its
discretion and at its expense, to handle enforcement relating to the Regeneron
Contributed IP and Regeneron Materials Improvements.

10.5BPCIA and Biosimilar Applications.

(a)BPCIA Listings.

(i)With respect to Regeneron Co-Funding Products, Regeneron will have sole
decision-making authority with respect to the determination of which Intellia
Patent Rights or Patent Rights Controlled by Regeneron or its Affiliates to
submit to a Third Party that files a Biosimilar Application, or any other act of
patent information exchange or listing as required by the BPCIA or other similar
measure in any other country worldwide (provided that with respect

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

to Intellia Background Patent Rights, if such Patent Rights cover one or more
products of Intellia or its (sub)licensees, then any such determination shall
discussed in good faith by the Parties with respect to such Patent Rights);
provided, that to the extent permitted by Applicable Law, Regeneron shall confer
in good faith with Intellia regarding which, if any, such Intellia Patent Rights
are listed pursuant to 42 U.S.C. § 262(l)(3)(A) (or any successor legislation)
(or other similar measure in any other country worldwide), or otherwise included
in any litigation with such a Third Party applicant.

(ii)With respect to Intellia Co-Funding Products, Intellia will have sole
decision-making authority with respect to the determination of which Intellia
Patent Rights to submit to a Third Party that files a Biosimilar Application, or
any other act of patent information exchange or listing as required by the BPCIA
or other similar measure in any other country worldwide; provided, that to the
extent permitted by Applicable Law, Intellia shall confer in good faith with
Regeneron regarding which, if any, such Intellia Patent Rights are listed
pursuant to 42 U.S.C. § 262(l)(3)(A) (or any successor legislation) (or other
similar measure in any other country worldwide), or otherwise included in any
litigation with such a Third Party applicant.

(b)Biosimilar Applications.  Notwithstanding anything to the contrary herein, if
either Party receives a copy of a Biosimilar Application referencing a
Co-Funding Product or otherwise becomes aware that such a Biosimilar Application
has been submitted to a Regulatory Authority for marketing approval (such as in
an instance described in 42 U.S.C. §262(l)(9)(C)), such Party shall within [***]
notify the other Party.  The owner of the relevant Patent Rights shall then seek
permission to view the application and related confidential information from the
filer of the Biosimilar Application if necessary under 42 U.S.C.
§262(l)(1)(B)(iii).  If either Party receives any equivalent or similar
communication or notice in the United States or any other jurisdiction, either
Party shall within [***] notify and provide the other Party copies of such
communication to the extent permitted by Applicable Laws.  Promptly after
receiving notice of a Biosimilar Application referencing a Co-Funding Product or
any equivalent or similar communication or notice in the United States or any
other jurisdiction referencing a Co-Funding Product, the Parties shall enter
into an appropriate joint defense agreement.  Regeneron shall have the right to
be the Lead Litigation Party with respect to a Regeneron Co-Funding Product and
Intellia shall have the right to be the Lead Litigation Party with respect to an
Intellia Co-Funding Product.  A Party that is not the Lead Litigation Party in a
litigation shall consent to being joined in a litigation or being named as the
plaintiff in a litigation if such being joined or named as a plaintiff is
necessary to confer standing to bring the litigation or is otherwise necessary
for the pendency of the litigation, and in such instance the joined Party shall
provide reasonable cooperation and assistance to the Lead Litigation Party, and
all Out-of-Pocket Costs incurred by the joined Party in connection therewith
shall be shared by the Parties in accordance with their respective Co-Funding
Percentages and treated as Other Shared Expenses.

(c)Coordination.  With regard to issues related to potential Biosimilar
Applications referencing a Co-Funding Product, the Parties shall conduct and
maintain ongoing and regular communications between their legal/intellectual
property departments.

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

10.6Extensions and Other Protections.  The Lead Party shall have the sole right
to apply for supplementary protection certificates, patent term extensions,
patent term restorations or any other exclusivity, including as may be available
under the provisions of the Drug Price Competition and Patent Term Restoration
Act of 1984 (or comparable laws outside the United States of America), in
respect of a Co-Funding Product.  At the Lead Party’s reasonable request, the
other Party will provide reasonable assistance to the Lead Party in connection
with any such applications. [***].

10.7Patent Marking.  Each Party shall comply with the patent marking statutes in
each country in which a Co-Funding Product or Terminated Co-Funding Products, as
applicable, is made, offered for sale, sold or imported by such Party, its
Affiliates or sublicensees.

10.8Third Party Claims Related to [***].  If either Party or its Affiliates
shall learn of a Third Party claim, assertion or certification that the
activities under this Agreement infringe or otherwise violate the intellectual
property rights of any Third Party, then such Party shall promptly notify the
other Party in writing of this claim, assertion or certification.  As soon as
reasonably practical after the receipt of such notice, the Parties shall [***].

10.9Infringement of Third Party Patent Rights or Third Party Know-How.  If any
Co-Funding Product manufactured, used or sold by a Party, its Affiliates or
sublicensees becomes the subject of a Third Party’s claim or assertion of
infringement of a Patent Right or misappropriation of Know-How, the Party first
having notice of the claim or assertion shall promptly notify the other
Party.  Regeneron shall have the sole right, but not the obligation, to defend
any such Third Party claim or assertion of infringement of a Regeneron
Co-Funding Product.  Intellia shall have the sole right, but not the obligation,
to defend any such Third Party claim or assertion of infringement of an Intellia
Co-Funding Product.  The non-defending Party shall provide reasonable
cooperation and assistance to the defending Party.  Subject to Section 14.1, all
Out-of-Pocket Costs incurred by the defending Party in connection with a defense
against a Third Party claim or assertion pursuant to this Section 10.9 and by
the non-defending Party in connection with providing the assistance set forth in
the previous sentence [***].

10.10Product Trademarks.  The Lead Party shall exclusively own and be
responsible for, filing, prosecuting, protecting and maintaining the Product
Trademarks, including all enforcement and defense thereof.  All Out-of-Pocket
Costs incurred in the filing, prosecution and maintenance, enforcement and
defense of Product Trademarks pursuant to this Section 10.10 shall be shared by
the Parties in accordance with their respective Co-Funding Percentages and
treated as Other Shared Expenses.  The Participating Party shall provide all
assistance reasonably requested by the Lead Party in connection with the
maintenance, enforcement and defense of the Product Trademarks.

10.11Use of Corporate Names.  The Lead Party shall use Commercially Reasonable
Efforts to include the Participating Party’s name with [***] on materials
related to the Product (including package inserts, packaging, trade packaging,
internet pages, social media, samples and all Promotional Materials used or
distributed in connection with the Product), unless to do so

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

would be prohibited under Applicable Law; provided, in the case of multi-product
materials that refer to the Product as well as other (bio)pharmaceutical
products [***].  Each Party grants to the other Party (and its Affiliates) the
right, free of charge, to use [***].

10.12Third Party Rights.

(a)Notwithstanding the foregoing provisions of this Article 10, the Parties
acknowledge and agree that each Party’s rights and obligations with respect to
any Patent Rights under this Article 10 will be subject to the terms and
conditions of [***].

(b)[See Annex 1.]

(c)This Section 10.12 shall not apply to, and expressly excludes, the Patent
Rights licensed under any Third Party Collaboration Agreement.

Article 11
BOOKS, RECORDS AND INSPECTIONS; AUDITS AND ADJUSTMENTS

11.1Books and Records.  Section 11.1 of the Collaboration Agreement is hereby
incorporated by reference into this Agreement in accordance with Section
2.2(b).  Each Party shall keep its books of record and account to the extent
related to this Agreement in a readily available and organized form to allow an
independent auditor to verify the accuracy of all financial, accounting and
numerical information provided in a reasonably efficient manner.  To the extent
an audited Party is reasonably determined to not be in compliance with the
previous sentence, such audited Party shall be responsible for any additional
fees charged by the independent auditor to the auditing Party as a result of
additional time spent by the independent auditor assembling or organizing such
information.

11.2Audits and Adjustments.  Section 11.2 of the Collaboration Agreement is
hereby incorporated by reference into this Agreement.

11.3GAAP.  Section 11.3 of the Collaboration Agreement is hereby incorporated by
reference into this Agreement

Article 12
REPRESENTATIONS, WARRANTIES AND COVENANTS

12.1Joint Representations and Warranties.  Each Party hereto represents and
warrants to the other Party, as of the Effective Date, as follows:  (a) it is
duly organized, validly existing, and in good standing under the laws of its
jurisdiction of incorporation; (b) it has full corporate power and authority to
execute, deliver, and perform this Agreement, and has taken all corporate action
necessary to enter into, deliver, and perform this Agreement; (c) the execution
and performance by it of its obligations hereunder will not constitute a breach
of, or conflict with, its organizational documents nor any other material
agreement or arrangement, whether written or oral, by which it is bound or
requirement of Applicable Laws; (d) this Agreement is its legal, valid and
binding obligation, enforceable in accordance with the terms and conditions
hereof (subject to Applicable Laws of bankruptcy and moratorium); (e) such Party
is not prohibited by the terms of any agreement to which it is a party from
granting the licenses expressly to the other Party hereunder; (f) no broker,
finder or investment banker is entitled to any brokerage, finder’s

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

or other fee in connection with this Agreement or the transactions contemplated
hereby based on arrangements made by it or on its behalf; and (g) it has
obtained all necessary consents, approvals and authorizations of all
Governmental Authorities and other Persons required to be obtained by it as of
the Effective Date, as applicable, in connection with the execution, delivery
and performance of this Agreement.

12.2Additional Representations and Warranties of the Parties.

(a)By Intellia.  [See Annex 1.]

(b)By Regeneron.  [See Annex 1.]

12.3Covenants.

(a)Each Party hereby covenants to the other Party as follows:  (i) it will not
during the Term grant any right or license to any Third Party which would be in
conflict with the rights granted to the other Party under this Agreement, and
(ii) neither Party will use the Patent Rights, Know-How, materials, or
Confidential Information of the other Party outside the scope of the licenses
and rights granted to it under this Agreement.

(b)Intellia (on behalf of itself and its Affiliates) hereby further covenants to
Regeneron that it (and they) shall not assign, transfer, convey or otherwise
grant to any Person or otherwise encumber (including through lien, charge,
security interest, mortgage, encumbrance or otherwise) any rights to any
Intellia Know-How or Intellia Patent Rights, in any manner that would conflict
with, or would adversely interfere with, the grant of the rights or licenses
granted to Regeneron hereunder.

(c)Regeneron (on behalf of itself and its Affiliates) hereby further covenants
to Intellia that it (and they) shall not assign, transfer, convey or otherwise
grant to any Person or otherwise encumber (including through lien, charge,
security interest, mortgage, encumbrance or otherwise) any rights to any
Regeneron Know-How or Regeneron Patent Rights, in any manner that would conflict
with, or would adversely interfere with, the grant of the rights or licenses
granted to Intellia hereunder.

(d)[See Annex 1.]

12.4Compliance with Laws.  Section 12.5 of the Collaboration Agreement is hereby
incorporated by reference into this Agreement.

12.5Disclaimer of Warranties.  EXCEPT AS OTHERWISE SPECIFICALLY AND EXPRESSLY
PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR
WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, CONCERNING THE SUCCESS OR
POTENTIAL SUCCESS OF ANY ACTIVITIES PERFORMED UNDER ANY PLAN OR THE DEVELOPMENT,
COMMERCIALIZATION, MARKETING OR SALE OF ANY CO-FUNDING PRODUCT.  EXCEPT AS
EXPRESSLY SET FORTH HEREIN, EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF
NON-INFRINGEMENT, MERCHANTABILITY

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

AND FITNESS FOR A PARTICULAR PURPOSE.

12.6Exclusivity.  The Parties hereby agree as follows:

(a)Exception to Intellia Liver Exclusivity.  For clarity, nothing in
Section 12.7(a) of the Collaboration Agreement shall restrict or limit or
otherwise be deemed to restrict or limit Intellia’s rights under this Agreement
to research, develop, manufacture, commercialize or otherwise exploit Intellia
Co-Funding Products as a Lead Party in accordance with this Agreement or
Intellia’s rights under this Agreement to act as a Participating Party with
respect to Regeneron Co-Funding Products.

(b)Target Exclusivity.  [***].

(c)Change of Control of a Party.  [***].

(d)Other Acquisitions by a Party.  Notwithstanding Section 12.6(b), in the event
that a Party or its Affiliates acquire a Third Party or a portion of the
business of a Third Party (whether by merger, stock purchase, purchase of assets
or other means of acquiring ownership) (such Party, the “Acquiring Party” and
such acquisition, a “Third Party Acquisition”) that is, immediately prior to
such acquisition, conducting a research, development or commercialization
program that, if conducted by such Party at such time, would be a breach of such
Party’s exclusivity obligation in Section 12.6(b) (a “Competing Program”), the
Acquiring Party shall give the other Party express written notice thereof within
[***] after the closing of such Third Party Acquisition and furthermore the
Acquiring Party shall [***] after the closing of such Third Party Acquisition:

(i)[***];

(ii)[***]; or

(iii)[***].

(iv)[***].

Article 13
CONFIDENTIALITY

13.1Confidential Information.

(a)Each Party and its Affiliates (in such capacity, collectively, the “Receiving
Party”) shall keep confidential, and other than as provided herein, shall not
disclose, directly or indirectly, any proprietary or confidential information,
including any proprietary data, inventions, documents, ideas, information,
discoveries, or materials, Controlled by the other Party or its Affiliates (in
such capacity, collectively, the “Disclosing Party”), whether in tangible or
intangible form, including Regeneron Contributed IP and Intellia Know-How, that
is disclosed pursuant to this Agreement (the “Confidential Information”).

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(b)Each Party and its Affiliates shall use the Confidential Information of the
other Party and its Affiliates solely for the purpose of exercising its rights
and performing its obligations hereunder.

(c)Each Party covenants that neither it nor any of its respective Affiliates
shall disclose any Confidential Information of the other Party to any Third
Party except (i) to its directors, officers, employees, agents, consultants and
subcontractors to the extent necessary to perform such Party’s obligations, or
exercise such Party’s rights, hereunder, provided such directors, officers,
employees, agents, consultants, subcontractors or other Persons are subject to
confidentiality obligations applicable to such Confidential Information no less
strict than those set forth herein, (ii) as approved by the Disclosing Party
hereunder in writing, (iii) as set forth elsewhere in this Agreement, including
to subcontractors and sublicensees in accordance with Section 7.2, (iv) to file
or prosecute Patent Rights in accordance with this Agreement, (v) to prosecute
or defend litigation as permitted by this Agreement, (vi) to any Governmental
Authority or other Regulatory Authority in order to gain or maintain approval to
conduct clinical trials or to market Co-Funding Products, but such disclosure
may be only to the extent reasonably necessary to obtain such approvals (subject
to the applicable provisions of Article 3, Article 4, Article 5 and Article 8 as
and to the extent applicable), or (vii) as required by Applicable Law, valid
order of a court of competent jurisdictions, or other judicial or administrative
proceedings of any Governmental Authority requires to be disclosed, provided
that in the case of (v), (vi) or (vii) the Receiving Party gives the Disclosing
Party reasonable advance notice (if practical) of such required disclosure in
sufficient time to enable the Disclosing Party to seek confidential treatment
for such information, and provided further that the Receiving Party provides all
reasonable cooperation to assist the Disclosing Party to protect such
information and limits the disclosure to that information which is required by
Applicable Law to be disclosed, and also provided that, such information shall
still be treated as Confidential Information for all purposes other than
satisfaction of such disclosure requirement.

(d)Other [***] shall be Confidential Information of both Parties; provided that
the [***] may be utilized as provided in (c) above, as well as, the
following:  (i) used by either Party (or their respective subcontractors,
licensees or sublicensees) but not disclosed to Third Parties except as other
Confidential Information may be disclosed by the Receiving Party (a) as
expressly permitted herein (including through the publication procedures set
forth in Section 13.4) or (b) with the prior written consent of the other Party;
(ii) disclosed under commercially reasonable confidentiality terms and solely to
the extent reasonably necessary to any potential or actual investor, advisor,
lender, investment banker, financing partner, or acquirer; and (iii) disclosed
under confidentiality obligations at least as restrictive as, or substantially
the same as, those set forth herein (except with respect to the duration of such
obligations, which shall not be less than [***] from the date that the agreement
under which such information is disclosed), to any actual or prospective
subcontractor, licensee or sublicensee.  Notwithstanding the foregoing or
anything to the contrary contained herein, (A) (I) Regeneron Materials
Improvements, Know-How within the Regeneron Contributed Technology and Know-How
within the Regeneron Co-Funding Product Inventions to the extent solely owned by
Regeneron and (II) any other Confidential

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Information to the extent related to Regeneron Co-Funding Products or Regeneron
Co-Funding Targets, shall be the Confidential Information of Regeneron, and
(B)(I) Intellia Know-How [***], (II) Intellia Materials Improvements and
Know-How within the Intellia Co-Funding Product Inventions to the extent solely
owned by Intellia and (III) any other Confidential Information to the extent
related to Intellia Co-Funding Products or Intellia Co-Funding Targets, shall be
the Confidential Information of Intellia.

13.2Exceptions.  Section 13.2 of the Collaboration Agreement is hereby
incorporated by reference into this Agreement.

13.3Injunctive Relief.  Section 13.3 of the Collaboration Agreement is hereby
incorporated by reference into this Agreement.

13.4Publications.

(a)[***].  Subject to the prior written consent of the JSC and subject further
to Sections 13.4(b) and 13.4(c), either Party may issue publications in
scientific journals and make scientific presentations [***] with the order and
inclusion of Intellia and Regeneron authors to be agreed upon in accordance with
International Committee of Medical Journal Editors (ICJME) Standards or other
mutually agreed upon applicable standards and in compliance with any applicable
rules or policies of the publisher of such publication.

(b)Co-Funding Products, Co-Funding Targets and Co-Funding Product
Inventions.  Subject to Section 13.4(c), Regeneron shall have the sole right to
issue and control all publications in scientific journals and make scientific
presentations regarding [***], and to extent Intellia contributes to such
publication, the order and inclusion of Regeneron and Intellia authors to be
agreed upon in accordance with International Committee of Medical Journal
Editors (ICJME) Standards or other mutually agreed upon applicable standards and
in compliance with any applicable rules or policies of the publisher of such
publication..  Subject to Section 13.4(c), Intellia shall have the sole right to
issue and control all publications in scientific journals and make scientific
presentations regarding [***], and to extent Regeneron contributes to such
publication, the order and inclusion of Intellia and Regeneron authors to be
agreed upon in accordance with International Committee of Medical Journal
Editors (ICJME) Standards or other mutually agreed upon applicable standards and
in compliance with any applicable rules or policies of the publisher of such
publication.

(c)Review Rights.  If the JSC approves a publication under Section 13.4(a),
Regeneron intends to make a publication under the first sentence of Section
13.4(b) or Intellia intends to make a publication under the second sentence of
Section 13.4(b), the publishing Party shall provide the non-publishing Party an
advance copy of any such proposed publication prior to submission for
publication or disclosure.  The non-publishing Party shall have a reasonable
opportunity to (i) recommend any changes to prevent disclosure of its
Confidential Information (including any joint Confidential Information) and (ii)
file a Patent Application related to such Confidential Information, if any.  The
publishing Party shall remove any such Confidential

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Information, and shall not make any such publication if the non-publishing Party
requests a delay of up to [***] to enable it to file Patent Applications until
expiration of [***] period.

13.5Disclosures Concerning this Agreement.

(a)Press Releases.  The Parties do not intend to issue a press release
announcing the execution of this Agreement.  Excluding the first sentence, the
remainder of Section 13.5(a) of the Collaboration Agreement is hereby
incorporated by reference into this Agreement.

(b)Agreement Terms.  Except as required by a Governmental Authority or
Applicable Law (including the rules and regulations of any stock exchange or
trading market on which a Party’s (or its parent entity’s) securities are or
will be traded), or in connection with the enforcement of this Agreement,
neither Party (or their respective Affiliates) shall disclose to any Third
Party, under any circumstances, any terms of this [***] that have not been
previously disclosed publicly in accordance with this Article 13 without the
prior written consent of the other Party, which consent shall not be
unreasonably conditioned, withheld or delayed; except for disclosures thereof
pursuant to Section 7.3(e) of this Agreement or (i) to potential or actual
investors, advisors, lenders, investment bankers, financing partners, acquirers,
subcontractors, licensees or sublicensees that are bound by obligations of
confidentiality and nonuse substantially equivalent in scope to those included
herein with a term of at least [***] (but of shorter duration if customary in
connection with any disclosure to a potential or actual investor, advisor,
lender, investment banker or financing partner) or (ii) to Persons that are
identified in Section 13.1(c)(i) who are subject to the confidentiality
obligations specified therein; provided that, in the event of any such
disclosure to a Third Party who is a potential or actual investor, advisor,
lender, financing partner, acquirer, licensee or sublicensee (A) this Agreement
shall only be initially disclosed in the Redacted Agreement form to such Third
Party and its advisors and (B) after negotiations with any such Third Party have
progressed so that the Disclosing Party reasonably and in good faith believes it
will execute a definitive agreement with such Third Party within [***], this
Agreement may be disclosed in an unredacted form to such Third Party and its
advisors as and to the extent relevant to such Third Party [***].

(c)Communications General.  Any mechanisms and procedures established by the JSC
pursuant to Section 13.5(c) of the Collaboration Agreement to ensure coordinated
timely corporate communications relating to the Collaboration Agreement shall
also apply to this Agreement, including the Co-Funding Products.

(d)Publicly Traded Company.  Each Party acknowledges that the other Party, as a
publicly traded company, is legally obligated to make timely disclosures of all
material events relating to its business.  Therefore, the Parties acknowledge
that either or both Parties may be obligated to file a copy of this Agreement
with the United States Securities and Exchange Commission or its equivalent (the
“SEC”).  The Parties agree that the form of the redacted version of this
Agreement (the “Redacted Agreement”), which shall be mutually agreed by the
Parties in good faith within [***] of the Effective Date, may be used as its
filing (or submission) of this

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Agreement to the SEC, and the Parties shall cooperate with one another and use
reasonable efforts to obtain confidential treatment of confidential information
(including any information that constitutes a trade secret or a sensitive
commercial term), including with respect to any comments received from the SEC
with respect to the proposed redactions.  The Parties further agree that,
following the initial filing (or submission) of the Redacted Agreement, the
filing Party will (i) promptly deliver to the non-filing Party any written
correspondence received by the filing Party or its representatives from the SEC
with respect to such confidential treatment request and promptly advise the
non-filing Party of any other communications between the filing Party or its
representatives with the SEC with respect to such confidential treatment
request, allowing a reasonable time for the non-filing Party to review and
comment; (ii) upon the written request of the non-filing Party, request an
appropriate extension of the term of the confidential treatment period; and
(iii) if the SEC requests any changes to the redactions set forth in the
Redacted Agreement, to the extent reasonably practicable, not agree to any
changes to the Redacted Agreement without first discussing such changes with the
non-filing Party and taking the non-filing Party’s comments into consideration
when deciding whether to agree to such changes.  In addition, each Party will
provide the other Party with an advance copy of any securities filings in which
the Agreement is discussed or disclosed, in each case only to the extent
describing this Agreement or referencing the other Party, allowing a reasonable
time (but in no event less than [***]) for the other Party to review and
comment, and will reasonably consider and, to the extent permitted by a
Governmental Authority, or Applicable Law (including the rules and regulations
of any stock exchange or trading market on which a Party’s (or its parent
entity’s) securities are or will be traded), incorporate the other Party’s
timely comments thereon; [***].

Article 14
INDEMNITY

14.1Indemnity and Insurance.

(a)Intellia’s Indemnification Obligations.  Intellia will indemnify and hold
harmless Regeneron, its Affiliates and their respective officers, directors,
employees and agents (“Regeneron Indemnitees”) from and against all loss,
liabilities, damages, penalties, fines and expenses, including reasonable
attorneys’ fees and costs (collectively, “Damages”), incurred by any Regeneron
Indemnitee as a result of a Third Party’s claim, action, suit, settlement, or
proceeding (each, a “Claim”) against a Regeneron Indemnitee that arises out of
or results from:

(i)[***] of Intellia or any other Intellia Indemnitee(s) in its performance
under the Plans or other activity under this Agreement, including in connection
with the Development, Manufacture or Commercialization of any Co-Funding Product
in the Field; or

(ii)breach by Intellia of this Agreement (including the inaccuracy of any
representation or warranty made by Intellia in this Agreement);

in each case, except to the extent such Claim is subject to Regeneron’s
indemnification obligations under Section 14.1(b)(i) or (ii) below.

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(b)Regeneron’s Indemnification Obligations.  Regeneron will indemnify and hold
harmless Intellia, its Affiliates and their respective officers, directors,
employees and agents (“Intellia Indemnitees”) from and against all Damages
incurred by any Intellia Indemnitee as a result of a Claim against an Intellia
Indemnitee that arises out of or results from:

(i)[***] of any Regeneron or any other Regeneron Indemnitee(s) in its
performance under the Plans or other activity under this Agreement, including in
connection with the Development, Manufacture or Commercialization of any
Co-Funding Product in the Field; or

(ii)breach by Regeneron of this Agreement (including the inaccuracy of any
representation or warranty made by Regeneron in this Agreement);

in each case, except to the extent such Claim is subject to Intellia’s
indemnification obligations under Section 14.1(a)(i) or (ii) above.

(c)Product Liability.  [***].  Regeneron shall have the sole right, but not the
obligation, to defend any such Third Party product liability claim of a
Regeneron Co-Funding Product.  Intellia shall have the sole right, but not the
obligation, to defend any such Third Party product liability claim of an
Intellia Co-Funding Product.  The non-defending Party shall provide reasonable
cooperation and assistance to the defending Party.

14.2Indemnity Procedure.

(a)Notification.  The Party entitled to indemnification under this Article 14
(an “Indemnified Party”) shall notify the Party potentially responsible for such
indemnification (the “Indemnifying Party”) within [***] Business Days of
becoming aware of any Claim asserted or threatened in writing against the
Indemnified Party which could give rise to a right of indemnification under this
Agreement; provided, however, that the failure to give such notice shall not
relieve the Indemnifying Party of its obligations hereunder except to the extent
that such failure materially prejudices the Indemnifying Party.

(b)Control of Defense.  If the Indemnifying Party elects in writing to the
Indemnified Party that it will assume control of the defense of such Claim, the
Indemnifying Party shall have the right to defend, at its sole cost and expense,
such Claim by all appropriate proceedings, which proceedings shall be prosecuted
diligently by the Indemnifying Party to a final conclusion or settled at the
discretion of the Indemnifying Party; provided, however, that the Indemnifying
Party may not enter into any compromise or settlement unless (i) such compromise
or settlement includes as an unconditional term thereof, the giving by each
claimant or plaintiff to the Indemnified Party of a release from all liability
in respect of such claim; and (ii) the Indemnified Party consents to such
compromise or settlement, which consent shall not be conditioned, withheld or
delayed unless such compromise or settlement involves (A) any admission of legal
wrongdoing by the Indemnified Party, (B) any payment by the Indemnified Party
that is not indemnified hereunder or (C) the imposition of any equitable relief
against the Indemnified Party.  If the Indemnifying Party does not elect to
assume control of the defense of such Claim within [***] of its receipt of
notice thereof, or if the Indemnifying Party elects in

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

writing to the Indemnified Party to cease maintaining control of the defense of
such Claim, the Indemnified Party shall have the right, at the expense of the
Indemnifying Party, upon at least [***] Business Days’ prior written notice to
the Indemnifying Party of its intent to do so, to undertake the defense of such
Claim for the account of the Indemnifying Party (with counsel reasonably
selected by the Indemnified Party and approved by the Indemnifying Party, such
approval not unreasonably conditioned, withheld or delayed), provided, that the
Indemnified Party shall keep the Indemnifying Party apprised of all material
developments with respect to such Claim and promptly provide the Indemnifying
Party with copies of all correspondence and documents exchanged by the
Indemnified Party and the opposing party(ies) to such Claim.  The Indemnified
Party may not compromise or settle such Claim without the prior written consent
of the Indemnifying Party, such consent not to be unreasonably conditioned,
withheld or delayed.

(c)Indemnified Party’s Participation.  The Indemnified Party shall cooperate
with the Indemnifying Party in, and may participate in, but not control, any
defense or settlement of any Claim controlled by the Indemnifying Party pursuant
to this Section 14.2 and shall bear its own costs and expenses with respect to
such participation; provided, however, that the Indemnifying Party shall bear
such costs and expenses if counsel for the Indemnifying Party shall have
reasonably determined that such counsel may not properly represent both the
Indemnifying Party and the Indemnified Party (and the Out-of-Pocket Costs of the
Indemnified Party shall be shared by the Parties in accordance with their
respective Co-Funding Percentages and treated as Other Shared Expenses if the
Claim is covered by Section 10.9 or Section 14.1(c)).

(d)Defense Procedures For Damages that are Other Shared Expenses.  The
indemnification procedures in this Section 14.2 shall apply to Claims for which
each Party indemnifies the other Party for its Co-Funding Percentage subject to
Section 9.3(b) of all Damages under the terms of Section 10.9 and Section
14.1(c); provided that Regeneron shall be deemed to be the Indemnifying Party if
the Claim in Section 10.9 or Section 14.1(c) relates to a Regeneron Co-Funding
Product and Intellia shall be deemed to be the Indemnifying Party if the Claim
in Section 10.9 or Section 14.1(c) relates to an Intellia Co-Funding Product.

14.3Insurance.  During the Term and for a minimum period of [***] thereafter and
for an otherwise longer period as may be required by Applicable Law, each of
Regeneron and Intellia will (i) use Commercially Reasonable Efforts to procure
and maintain appropriate commercial general liability and product liability
insurance in amounts appropriate for the industry and considering the activities
being conducted or (ii) with respect to Regeneron as of the Effective Date, or
Intellia as such time as Intellia and its Affiliates have annual revenue in
excess of [***] (including after any Change of Control of Intellia), procure and
maintain adequate insurance by means of self-insurance in such amounts and on
such terms as are consistent with normal business practices of large
pharmaceutical companies in the life sciences industry.  Such insurance shall
insure against liability arising from this Agreement on the part of Regeneron or
Intellia, respectively, or any of their respective Affiliates, due to injury,
disability or death of any person or persons, or property damage arising from
activities performed in connection with this Agreement.  It is understood that
such insurance shall not be construed to create a limit of either Party’s
liability with respect to its indemnification obligations under Section 14.1 or
otherwise.  

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Any insurance proceeds received by a Party in connection with any Damages shall
be retained by such Party and shall not reduce any obligation of the other
Party.

Article 15
FORCE MAJEURE

Article 15 of the Collaboration Agreement is hereby incorporated by reference
into this Agreement.

Article 16
TERM AND TERMINATION3

16.1Term.  The “Term” of this Agreement shall begin on the Effective Date and
will expire with respect to all Co-Funding Products Directed to such Co-Funding
Target at such time as neither the Lead Party nor any of its Affiliates, nor any
of their respective sublicensees, is Developing, Commercializing and
Manufacturing (for purposes of Development or Commercialization) any Co-Funding
Product in the Field Directed to such Co-Funding Target anywhere in the world
under this Agreement (and such cessation of Development, Manufacturing and
Commercialization activities is acknowledged by the Lead Party in writing to be
permanent), unless this Agreement is earlier terminated in its entirety in
accordance with this Article 16, in which event the Term shall end on the
effective date of such termination.

16.2Termination for Insolvency.  Section 16.2 of the Collaboration Agreement is
hereby incorporated by reference into this Agreement.

16.3Termination of Co-Funding Target for which a Party is the Lead Party for
Convenience.  At any time, upon [***] advanced written notice, with respect to
all Co-Funding Products Directed to such Co-Funding Target, the Lead Party may
terminate this Agreement with respect to the Co-Funding Target and all
Co-Funding Products hereunder; provided, that, the Lead Party’s obligation to
use Commercially Reasonably Efforts to develop and commercialize Co-Funding
Products with respect to a given Co-Funding Target and such Co-Funding Products
shall continue during the [***] period following its delivery of such a notice
of termination with respect to such terminated Co-Funding Target in accordance
with this Agreement.

16.4Termination of Co-Funding Target by the Participating Party for Convenience.

(a)The Participating Party may terminate this Agreement, (i) at any time upon
[***] advanced written notice, (ii) within the first [***], pursuant to Section
3.2(b), (iii) [***]; or (iv) [***].

(b)With respect to termination under Section 16.4(a)(i) or Section 16.4(a)(ii),
the Participating Party shall continue to be responsible for its share
(applicable Co-Funding Percentage) of all Development Costs and Shared
Commercial Expenses incurred in connection with the Co-Funding Product in
accordance with the Global Development Budget set forth in the

 

3 

  NTD:  May be subject to further consideration by the parties as the draft
progresses.  In the final document, the termination scenarios will be included
in the sub-annexes depending on the category of Co-Funding Target.

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

last Global Development Plan approved by the JSC and in accordance with the
Global Commercialization Budget set forth in the last Global Commercialization
Plan approved by the JSC and the Country/Region Commercialization Budget set
forth in the last Country/Region Commercialization Plan approved by the JSC,
including the U.S. Commercialization Budget set forth in the last U.S.
Commercialization Plan, to the extent applicable, in each case prior to the
Participating Party’s notice of termination up until the effective date of
termination in accordance with this Section 16.4.

(c)With respect to termination under Section 16.4(a)(iii) or Section
16.4(a)(iv), the Participating Party shall continue to be responsible for its
share (applicable Co-Funding Percentage) of all Development Costs and Shared
Commercial Expenses incurred in connection with the Co-Funding Product in
accordance with the previously-approved Global Development Budget and in
accordance with the previously-approved Global Commercialization Budget and the
previously-approved Country/Region Commercialization Budget, including the
previously approved U.S. Commercialization Budget, to the extent applicable, in
each case prior to the Participating Party’s notice of termination up until the
effective date of termination in accordance with this Section 16.4.  [***].

16.5Breach of the Agreement.

(a)Either Party may terminate this Agreement in accordance with the remainder of
this Section 16.5, its entirety if, as applicable, the other Party commits a
material breach of this Agreement [***].

(b)In the event that one Party (the “Alleging Party”) believes that the other
Party (the “Alleged Party”) has committed a material breach, the Alleging Party
shall provide written notice (“Breach Notice”) to the Alleged Party describing
in an appropriate detail the nature of such material breach.

(c)The Alleged Party shall have [***] from its receipt of the Breach Notice to
cure such material breach; provided that if such breach is not curable within
the foregoing cure period, then such cure period will be extended for a period
of up to [***] (for a total cure period of [***]) if the Alleged Party prepares
and provides to the Alleging Party a reasonable written plan for curing such
breach and uses Commercially Reasonable Efforts to cure such breach in
accordance with such written plan.  In the event such breach is not cured within
such [***] period, as applicable, this Agreement or portion thereof, as
applicable, may be terminated immediately by the Alleging Party.

(d)In the event of a good faith dispute as to the existence or materiality of a
breach specified in such notice, including any good faith dispute as to payments
due under this Agreement, and the Alleged Party provides the Alleging Party
notice of such dispute within such [***] period, the cure period will be tolled
from the date the Alleged Party notifies the Alleging Party of such good faith
dispute and through the diligent resolution of such dispute in accordance with
the applicable provisions of this Agreement (provided that if such dispute
relates to payment, the cure period will only apply with respect to payment of
disputed amounts, and not with respect

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

to undisputed amounts).  It is understood and agreed that during the pendency of
such dispute, all of the terms and conditions of this Agreement will remain in
effect and the Parties will continue to perform all of their respective
obligations, and retain their respective rights, hereunder.  Termination will
become effective, if at all, following a final and conclusive determination
pursuant to 17.1(c) of the Collaboration Agreement (which is incorporated into
this Agreement in accordance with Section 17.1) that the Alleged Party committed
such material breach and failed to cure the same during the applicable cure
period.

16.6Termination for IP Challenge.  With respect to Co-Funding Products, Section
16.5 of the Collaboration Agreement is hereby incorporated by reference into
this Agreement in accordance with Section 2.2(b) and all references to Regeneron
Target or Regeneron Product therein shall be deemed to refer to the Co-Funding
Target and Co-Funding Product(s) respectively.

16.7Termination for Suspension of Development or Commercialization.  If during
the period after the Effective Date, the Lead Party elects to permanently
discontinue all Development, Commercialization and Manufacturing (for purposes
of Development or Commercialization) of all Co-Funding Products Directed to the
Co-Funding Target it shall provide written notice to the Participating Party
which will automatically be treated as the Lead Party’s submission of written
notice pursuant to Section 16.3 with respect to the Co-Funding Target.

16.8Effects of Termination of the Agreement where Regeneron is the Lead Party,
except if the Agreement is Terminated by Intellia pursuant to Section 16.4.

(a)If this Agreement is terminated by either Party with respect to a Co-Funding
Target for which Regeneron is the Lead Party for any reason other than by
Intellia pursuant to Section 16.4 then the following provisions of this Section
16.8(a) will apply, subject to Section 16.8(b):

(i)This Agreement shall terminate in its entirety with respect to such
Terminated Co-Funding Target and Terminated Co-Funding Products, including the
licenses granted to the Parties under [***].

(ii)Sections 16.7(c)-(l) of the Collaboration Agreement are hereby incorporated
by reference into this Agreement in accordance with Section 2.2(b) (including
all provisions in the Collaboration Agreement that are incorporated by reference
into such provisions), except that (A) references to the Terminated Regeneron
Target in such provisions shall be deemed to refer to the Terminated Co-Funding
Target and (B) Regeneron’s interest in and to the Converted CFP Inventions shall
be included within the Collaboration Reversion IP thereunder.  [***].

(iii)Regeneron shall assign to Intellia all right, title and interest in the
Intellia Material Improvements within Co-Funding Product Inventions that solely
relates to the Terminated Co-Funding Products.  

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(b)If this Agreement is terminated by Regeneron pursuant to Section 16.5
(Breach), then, (i) this Agreement shall terminate in its entirety with respect
to such Terminated Co-Funding Target, and Terminated Co-Funding Products,
including the licenses granted to the Parties [***], and (ii) Regeneron may
elect (which election shall be made in writing by Regeneron no later than [***]
of such determination thereof and no later than the effective date of
termination of this Agreement) that the Collaboration Agreement (and all the
terms and conditions therein) shall be deemed to apply to such Terminated
Co-Funding Target and all Terminated Co-Funding Products that are Directed to
such Terminated Co-Funding Target, and upon such election, the Terminated
Co-Funding Target shall become a Regeneron Target and all associated Terminated
Co-Funding Products shall be deemed to be Regeneron Products [***].  It is
understood and agreed by the Parties that Regeneron may only Develop,
Manufacture or Commercialize CPs (including Terminated Co-Funding Products)
Directed to such Terminated Co-Funding Target by electing this option.  [***].

16.9Effects of Termination of the Agreement where Regeneron is the Lead Party if
the Agreement is Terminated by Intellia pursuant to Section 16.4.  Without
limiting any other legal or equitable remedies that either Party may have, if
this Agreement with respect to a Co-Funding Target for which Regeneron is the
Lead Party is terminated by Intellia pursuant to Section 16.4, then this
Agreement shall terminate in its entirety with respect to such Terminated
Co-Funding Target and Terminated Co-Funding Products, including the licenses
granted to the Parties under [***], and the Collaboration Agreement (and all the
terms and conditions therein) shall be deemed to apply to such Terminated
Co-Funding Target and all Terminated Co-Funding Products that are Directed to
such Terminated Target, and such Terminated Co-Funding Target shall be
considered a Regeneron Target and all Terminated Co-Funding Products shall be
deemed to be Regeneron Products.

16.10Effects of Termination of the Agreement where Intellia is the Lead Party,
except if the Agreement is Terminated by Intellia pursuant to Section 16.3 or
Section 16.7 or the Agreement is Terminated by Regeneron pursuant to Section
16.4.  If this Agreement with respect to a Co-Funding Target for which Intellia
is the Lead Party is terminated by either Party for any reason other than by
Intellia pursuant to Section 16.3 or Section 16.7 or by Regeneron pursuant to
Section 16.4 then the provisions of this Section 16.10 will apply:  

(a)This Agreement shall terminate in its entirety, including the licenses
granted under [***].

(b)Section 16.12(a) through 16.12(c) shall apply.

(c)Intellia shall assign to Regeneron all right, title and interest in the
Regeneron Material Improvements within Co-Funding Product Inventions that solely
relates to the Terminated Co-Funding Products, and such Regeneron Material
Improvements shall be deemed to be Regeneron Contributed IP for purposes of
Section 16.12(c).

16.11Effects of Termination of the Agreement where Intellia is the Lead Party if
this Agreement is Terminated by Intellia pursuant to Section 16.3 or Section
16.7.  With respect to Intellia Co-Funding Targets and Intellia Co-Funding
Products, without limiting any other legal

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

or equitable remedies that either Party may have, if this Agreement is
terminated by Intellia pursuant to Section 16.3 or Section 16.7, then the
provisions of this Section 16.11 will apply:

(a)This Agreement shall terminate in its entirety, including the licenses
granted under [***], and the Collaboration Agreement (and all the terms and
conditions therein) shall be deemed to apply to such Terminated Target and all
Terminated Co-Funding Products, and such Terminated Target shall be deemed to be
a Regeneron Target and the Terminated Co-Funding Products shall be deemed to be
Regeneron Products and Section 16.7(d)‑(l) of the Collaboration Agreement shall
apply mutatis mutandis so that Regeneron may assume development and
commercialization of Terminated Co-Funding Products as Regeneron Products
thereunder.  [***].

(b)Intellia shall assign to Regeneron all right, title and interest in the
Regeneron Material Improvements within Co-Funding Product Inventions that solely
relates to the Terminated Co-Funding Products.

16.12Effects of Termination of the Agreement where Intellia is the Lead Party if
this Agreement is Terminated by Regeneron pursuant to Section 16.4.  With
respect to Intellia Co-Funding Targets and Intellia Co-Funding Products, without
limiting any other legal or equitable remedies that either Party may have, if
this Agreement is terminated by Regeneron pursuant to Section 16.4, then the
provisions of this Section 16.12 will apply:

(a)This Agreement shall terminate in its entirety with respect to such
Terminated Co-Funding Target and all Terminated Co-Funding Products Directed to
such Terminated Target, including the licenses granted under [***].

(b)[***], all such Terminated Co-Funding Products shall be subject to the
payment by Intellia to Regeneron of royalties on Net Sales of such Terminated
Co-Funding Products at the rate set forth in the table below based on the stage
of the most advanced Terminated Co-Funding Product Directed to the applicable
Terminated Co-Funding Target and Regeneron’s Co-Funding Percentage, in each
case, as of the effective date of termination with respect to such Terminated
Co-Funding Target and Section 16.7(c)(v) of the Collaboration Agreement is
hereby incorporated by reference into this Agreement in accordance with Section
2.2(b) (including all provisions in the Collaboration Agreement that are
incorporated by reference into such provisions), [***].

Stage

Royalty Rate [***]

Royalty Rate [***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

(c)Effective upon the effective date of termination, Regeneron shall grant, and
hereby grants, to Intellia a perpetual, irrevocable, worldwide, sublicensable
through multiple tiers (in accordance with Section 7.2(c) of the Collaboration
Agreement applied mutatis mutandis), non-exclusive license under the [***] to
research, develop, make, have made, use, sell, offer for sale and import
Terminated Co-Funding Products for any and all uses in the Field.

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(d)Intellia shall assign to Regeneron all right, title and interest in the
Regeneron Material Improvements within Co-Funding Product Inventions that solely
relates to the Terminated Co-Funding Products, and such Regeneron Material
Improvements shall be deemed to be Regeneron Contributed IP for purposes of
Section 16.12(c).

16.13Participating Party’s Remedies in lieu of Termination.

(a)In the event that the Participating Party notifies the Lead Party in writing
that Lead Party has materially breached this Agreement such that the
Participating Party would have a right of termination pursuant to Section 16.5
as a result of such material breach (including the application of Section
16.5(b)) [***], then, in lieu of the Participating Party exercising such
termination right pursuant to Section 16.5, the Participating Party may elect to
enter into a new agreement using the form of this agreement with the relevant
provisions for the Co-Funding Product (which election shall be made in writing
by the Participating Party no later than [***] of such determination thereof);
provided, however, that if the Participating Party so elects to enter into a new
agreement, then with respect to such Co-Funding Target for which the Lead Party
has materially breached this Agreement and for all CPs that are Directed to such
Co-Funding Target, such Co-Funding Target and such CPs Directed thereto shall
become upon written notice delivered to such breaching Lead Party, (i) in the
case where Intellia is the breaching Lead Party, a Regeneron Co-Funding Target
and Regeneron Co-Funding Products or (ii) in the case where Regeneron is the
breaching Lead Party, Intellia Co-Funding Target and Intellia Co-Funding
Products, as applicable, and it shall be treated as if the breaching Lead Party
had terminated this Agreement pursuant to Section 16.3 and Section 16.11 or
Section 16.8(a) (as applicable) shall apply mutatis mutandis and the
Participating Party making such election to so enter into a new agreement shall
from and after such date be the Lead Party and the breaching Lead Party shall
thereafter be the Participating Party with respect to such Co-Funding Target and
all CPs Directed to such Co-Funding Target.  In connection with such changing
roles of the Lead Party and Participating Party in the new agreement, the
Parties agree that over a [***] to transfer all rights, obligations, commitments
and operations between the Parties to reflect the change in the Lead Party.  The
former Lead Party shall, as promptly as reasonably practicable, transfer all
Patent prosecution and maintenance responsibilities for Co-Funding Product
Inventions to the former Participating Party, including transferring all files
related to the prosecution and maintenance of such Patents to the former
Participating Party and at the request of the former Participating Party, make
appropriate personnel available to the former Participating Party to answer such
reasonable questions as the former Participating Party may have in connection
with the prosecution and maintenance of such Patents.  [***].  

(b) [***].

16.14Change of Control of the Participating Party.  In the event of a Change of
Control of the Participating Party during the Term, the Participating Party
shall deliver to the Lead Party written notice of the closing of such
transaction within [***] following such closing.  If, as of the closing of such
Change of Control of the Participating Party, the Lead Party or any of its
Affiliates is in litigation that is material to the Lead Party or its Affiliate,
or has initiated or received notice of a claim, action, suit, or proceeding, or
has sent or received a demand letter, that is reasonably likely to result in
litigation that is material to the Lead Party or its Affiliate, with the Third
Party

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

or its Affiliate (other than a Party or a Party’s Affiliates immediately prior
to the closing of such Change of Control) involved in such Change of Control of
the Participating Party (the “Subject Litigation”), then [***].

(a)[***].

(b)[***].

(i)[***];

(ii)[***];

(iii)[***];

(iv)[***];

(v)[***];

(vi)[***]; and

(vii)[***].

[***].

 

16.15Survival of Obligations.  Expiration or termination of this Agreement shall
not relieve the Parties of any obligation accruing prior to such expiration or
termination.  Any expiration or termination of this Agreement shall be without
prejudice to the rights of either Party against the other accrued or accruing
under this Agreement prior to expiration or termination.  Except for the
following provisions (which shall survive expiration or termination of this
Agreement), upon expiration or termination of this Agreement, the rights granted
to the Parties hereunder and obligations of the Parties hereunder shall
terminate, and this Agreement shall cease to be of further force or effect:  (I)
Section 2.2(a), Section 2.2(b), Sections 5.3 and 5.4 (until the Development and
Commercialization of the Co-Funding Products have been transferred to the Party
that will continue to be responsible for such Development and Commercialization
after termination of this Agreement), Section 7.1, Section 7.2(a), Section
7.2(c), Section 7.6 (for the period set forth therein), Section 7.7, Section
7.12(a) (only with respect to the incorporation of Section 7.12 of the
Collaboration Agreement), Section 9.4 and Section 9.6 (with respect to the final
Quarter of the Term), Section 9.8, Section 9.9, Section 9.10, Section 9.11,
Section 10.1, Section 13.1, Section 13.2, Section 13.3, [Section 16.8, Section
16.9, Section 16.10, Section 16.11, Section 16.12,]4 Section 16.15, and Section
16.16; (II) Sections 10.2, 10.3, 10.4, 10.6, 10.7, 10.8, and 10.9 solely with
respect to Intellectual Property covered by this Agreement that is jointly owned
by the Parties pursuant to the terms of this Agreement; and (III) Article 1 (to
the extent necessary to give effect to the other surviving provisions), Article
11, Article 14, Article 15, and

 

4 

NTD: To be updated in each Co-Co Agreement, as applicable.

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Article 17.  In addition, the other applicable provisions of Article 9 will
survive such expiration or termination of this Agreement to the extent required
to make final reimbursements, reconciliations or other payments incurred or
accrued prior to the date of termination or expiration or after such termination
or expiration with respect to Section 16.7 (including any milestone payments and
royalties that become due as a result of Section 16.7(i)).  For any surviving
provisions requiring action or decision by a Committee or an Executive Officer,
each Party will appoint representatives to act as its Committee members or
Executive Officer, as applicable.

16.16Return of Confidential Information.  Confidential Information disclosed by
the Disclosing Party, including permitted copies, shall remain the property of
the Disclosing Party.  Upon the expiration or termination of this Agreement, and
[***], the Receiving Party shall promptly return to the Disclosing Party or, at
the Disclosing Party’s request, destroy, all documents or other tangible
materials representing the Disclosing Party’s Confidential Information (or any
designated portion thereof) pertaining to the expired or terminated subject
matter and, if expressly requested in writing by the Disclosing Party, provide
the Disclosing Party with written certification of such destruction within
[***]; provided, that one (1) copy may be maintained in the confidential files
of the Receiving Party for the purpose of complying with the terms of this
Agreement; further provided that the Receiving Party may retain the Disclosing
Party’s Confidential Information that is necessary or useful for the practice of
any license from the Disclosing Party to the Receiving Party that survives
expiration or termination, as applicable.  [***].

Article 17
MISCELLANEOUS

17.1Governing Law; Dispute Resolution; Submission to Jurisdiction.  Section 17.1
of the Collaboration Agreement is hereby incorporated by reference into this
Agreement, except that the reference in Section 17.1(b) of the Collaboration
Agreement to Section 16.9 shall be deemed to refer to Section 16.14 of this
Agreement. For clarity, Section 17.1(b) of the Collaboration Agreement shall
apply to unresolved Financial Disputes.

17.2Waiver.  Section 17.2 of the Collaboration Agreement is hereby incorporated
by reference into this Agreement.

17.3Notices.  Section 17.3 (including Schedule 17.3) of the Collaboration
Agreement is hereby incorporated by reference into this Agreement.

17.4Entire Agreement.  The first sentence of Section 17.4 of the Collaboration
Agreement is hereby incorporated by reference into this Agreement.

17.5Amendments.  Section 17.5 of the Collaboration Agreement is hereby
incorporated by reference into this Agreement.

17.6Interpretation.  Section 17.6 of the Collaboration Agreement is hereby
incorporated by reference into this Agreement.

17.7Construction.  Section 17.7 of the Collaboration Agreement is hereby
incorporated by reference into this Agreement.

17.8Severability.  Section 17.8 of the Collaboration Agreement is hereby
incorporated by reference into this Agreement.

17.9Assignment.  Section 17.9 of the Collaboration Agreement is hereby
incorporated by reference into this Agreement.

17.10Successors and Assigns.  Section 17.10 of the Collaboration Agreement is
hereby incorporated by reference into this Agreement.

17.11Counterparts.  Section 17.11 of the Collaboration Agreement is hereby
incorporated by reference into this Agreement.

17.12Third Party Beneficiaries.  Section 17.12 of the Collaboration Agreement is
hereby incorporated by reference into this Agreement.

17.13Relationship of the Parties.  Section 17.13 of the Collaboration Agreement
is hereby incorporated by reference into this Agreement.

17.14Limitation of Damages.  Section 17.14 of the

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Collaboration Agreement is hereby incorporated by reference into this Agreement.

17.15Injunctive or Other Equity Relief.  Section 17.15 of the Collaboration
Agreement is hereby incorporated by reference into this Agreement.

17.16Non-Exclusive Remedies.  Section 17.16 of the Collaboration Agreement is
hereby incorporated by reference into this Agreement.

[Remainder of page intentionally left blank; signature page follows]

 

 

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

IN WITNESS WHEREOF, Regeneron and Intellia have caused this Agreement to be
executed by their duly authorized representatives as of the day and year first
above written.

 

REGENERON PHARMACEUTICALS, INC.

 

 

 

By

 

 

 

 

Name:

 

 

Title:

 

 

 

INTELLIA THERAPEUTICS, INC.

 

 

 

By

 

 

 

 

Name:

 

 

Title:

 

 

 

[Signature Page to [            ] Co-Development and Co-Promotion Agreement]

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Schedule 1.18

Co-Funding Target

 

 

Schedule 1.18

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Schedule 1.102

Manufacturing Cost

Manufacturing Cost as used in this Agreement shall be determined as provided in
this Schedule 1.102.

“Manufacturing Cost” means the [***].

(a)“Direct Costs” equals the sum of the following:

(i)[***].

(ii)[***].

(iii)[***].

(iv)[***].

(v)[***].

(b)“Indirect Costs” equals the sum of the following:

(i)[***].

(ii)[***].

[***]

 

 

1.

[***]

 

2.

[***]

 

3.

[***]

 

4.

[***]

 

5.

[***]

 

Schedule 1.102

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Schedule 9.2

[***]

[***]

Definitions:

As used in this Agreement, the following terms shall have the following
meanings:

“Total Development Costs” means the aggregate of Development Costs incurred by
both Regeneron and Intellia for a Co-Funding Product.

[***]

“Profits” in a [***] means for a particular Co-Funding Product the Co-Funding
Product Net Sales recorded by the Lead Party worldwide in the Quarter less the
sum of (a) Cost of Goods incurred by the Lead Party world-wide in the Quarter,
(b) Shared Commercial Expenses incurred by both Parties in the [***], and
(c) Other Shared Expenses incurred by both Parties in the [***].

“Lead Party [***] Expenses” is the sum of the amounts in (a), (b) and (c) in the
definition of Profits that are incurred by the Lead Party in a [***] for a
Co-Funding Product.  

“Participating Party [***] Expenses” shall be the sum of the amounts in (a),
(b) and (c) in the definition of Profits that are incurred by the Participating
Party in a [***] for a Co-Funding Product.

“Profit Split” for a Co-Funding Product means the product of (i) Profits in a
[***] worldwide, (ii) the Participating Party Co-Funding Percentage, and (iii)
-1.

“[***] Profit True-Up” for a Co-Funding Product means (i) the Profit Split minus
(ii) Participating Party Quarterly Expenses.

Examples

In all of the examples below, it is assumed that the Participating Party
Co-Funding Percentage is [***] for a given Co-Funding Product:

 

•

[***] Development True-Up for Co-Funding Product A Example:

 

Aggregate

Lead Party

Participating Party

Development Costs

[***]

[***]

[***]

Total Development Costs

[***]

 

 

 

[***] Development True-Up = [***]

[***]

In this example, [***] would be included in the Aggregate [***] True-Up for
Co-Funding Product A.

Schedule 9.2

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

 

•

[***] Development True-Up for Co-Funding Product B Example:

 

Aggregate

Lead Party

Participating Party

Development Costs

[***]

[***]

[***]

Total Development Costs

[***]

 

 

 

[***] Development True-Up = [***]
[***]

In this example, [***] would be included in the Aggregate [***] True-Up for
Co-Funding Product B.

 

•

[***] Profit True-Up Examples:

 

o

Co-Funding Product A:  Calculation of the Profit Split in a Quarter:

 

Aggregate

Lead Party

Participating Party

Co-Funding Product Net Sales

[***]

[***]

 

(-) Cost of Goods Sold

[***]

[***]

 

(-) Shared Commercial Expenses

[***]

[***]

[***]

(-) Other Shared Expenses

[***]

[***]

[***]

Profits

[***]

 

 

 

Profit Split = [***].

[***] Profit True-Up = [***]
[***]

In this example, [***] would be included in the Aggregate [***] True-Up for
Co-Funding Product A.

 

o

Co-Funding Product B Example:  Calculation of the Profit Split in a Quarter in
which there are no Co-Funding Product Net Sales:

 

Aggregate

Lead Party

Participating Party

Co-Funding Product Net Sales

[***]

[***]

[***]

Schedule 9.2

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(-) Cost of Goods Sold

[***]

[***]

[***]

(-) Shared Commercial Expenses

[***]

[***]

[***]

(-) Other Shared Expenses

[***]

[***]

[***]

Profits

[***]

 

 

 

Profit Split = [***].

Quarterly Profit True-Up = [***]
[***]

In this example, [***] would be included in the Aggregate [***] True-Up for
Co-Funding Product B.

 

•

Aggregate [***] True-Up Example:

[***]  Development True-Up for Co-Funding Product A[***]
[***] Development True-Up for Co-Funding Product B[***]
[***] Profit True-Up for Co-Funding Product A[***]
[***] Profit True-Up for Co-Funding Product B[***]
___
Aggregate [***] True-Up[***]

In this example, [***] would be payable by the Lead Party to the Participating
Party in accordance with the terms of Article 9 and this Schedule 9.2.

Combination Products.

In the event a Co-Funding Product is a Combination Product [***].

In the event a Co-Funding Product is a Combination Product [***].

 

 

Schedule 9.2

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SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

ANNEX 1

Provisions Specific to Categories of Products

This Annex is divided into four (4) sub-annexes.  The Sections set forth in
sub-annex (A), (B), (C) or (D) shall be inserted into the corresponding Sections
of this Agreement prior to execution for the applicable Co-Funding Target,
depending on whether the Co-Funding Target is:

(A)Regeneron Co-Funding Target where a Regeneron Target is the Co-Funding
Target;

(B)Regeneron Co-Funding Target where an Intellia Liver Target is the Co-Funding
Target;

(C)Intellia Co-Funding Target; or

(D)TTR.

For clarity, for each Co-Funding Target, only one of the four (4) above
sub-annexes shall apply.

 

 

 

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“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

SUB-ANNEX 1(A):

Regeneron Co-Funding Target where a Regeneron Target is the Co-Funding Target

1.17“Co-Funding Product” shall mean each Regeneron Co-Funding Product that is
Directed to the Co-Funding Target.

1.27“Converted CFP Inventions” means the Co-Funding Product Inventions which
become Other Co-Funding Product Inventions by operation of Section 10.1(a)(iii)
upon termination of this Agreement.

1.38

 

4.

[Intentionally Omitted]

1.44“Exercised Option” shall mean the Intellia Option, exercised by Intellia
under Section 5.2(c) of the Collaboration Agreement, in accordance with the
Collaboration Agreement, for the Target set forth on Schedule 1.44 of this
Agreement.

1.89“IP Term” shall mean that period, during the Term, commencing on the
Effective Date and continuing for [***] to such Co-Funding Target.

1.94“Lead Party” shall mean Regeneron.

1.115“Participating Party” shall mean Intellia.

2.2(b)There are instances where certain provisions of this Agreement only apply
to Regeneron Co-Funding Products and not to Intellia Co-Funding Products and
where such provisions were already set forth in the Collaboration Agreement with
respect to Regeneron Products.  In such cases, this Agreement incorporates by
reference the applicable terms of the Collaboration Agreement, except that
references to Regeneron Products in the applicable terms of the Collaboration
Agreement shall be deemed to refer to Regeneron Co-Funding Products and
references to the Collaboration Agreement in the applicable terms of the
Collaboration Agreement shall be deemed to refer to this Agreement.

2.4(b)(viii)[Intentionally Omitted]

2.9[Intentionally Omitted]

3.1Development of Co-Funding Products.  Subject to the terms of this Agreement,
the Lead Party shall undertake, and in accordance with Section 3.2 with respect
to a Regeneron Co-Funding Product, the Parties shall jointly undertake
Development activities with respect to Co-Funding Products unless otherwise
mutually agreed to in the Global Development Plan, and such Development
activities shall be under the general direction and oversight of the JDC and
JSC.  [***].  Except as set forth in Section 3.2 with respect to a Regeneron
Co-Funding Product or otherwise agreed to by the Parties in writing or
explicitly set forth in this Agreement, the JSC will assign responsibility for
conducting all Development activities for a Co-Funding Product to the

SUB-ANNEX 1 (A) -- 1

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Lead Party.  For clarity, with respect to a given Regeneron Product that
constitutes a Co-Funding Product under this Agreement, the diligence obligations
of Regeneron to develop and commercialize such Regeneron Product in
Sections 4.4(d) and 6.1(a) of the Collaboration Agreement shall be superseded
(from and after the Effective Date of this Agreement) by Regeneron’s diligence
obligations as a Lead Party for such Co-Funding Product under this Agreement,
[***].

3.2Existing Product R&D Programs and Associated Product R&D Plans.

(a)With respect to a Co-Funding Product that constituted a Regeneron Product
immediately prior the Effective Date of this Agreement, if a Product R&D Program
and an associated Product R&D Plan existed immediately prior to Option Exercise
Date for a Regeneron Product that becomes a Regeneron Co-Funding Product on
account of Intellia’s exercise of the Exercised Option, to the extent
applicable, such Product R&D Program and associated Product R&D Plan shall be
incorporated and made a part of the Global Development Plan for the relevant
Regeneron Co-Funding Product and Section 4.3(b), 4.4(a), 4.4(d), 4.4(e) and
4.6(b) of the Collaboration Agreement are hereby incorporated by reference into
this Agreement in accordance with Section 2.2(b).  [***].

(b)The Participating Party may terminate this Agreement with respect to the
Co-Funding Target and all Co-Funding Products Directed to such Co-Funding Target
any time [***].  Upon such termination, the Regeneron Option exercised in
conjunction with this Agreement shall no longer constitute one of the Regeneron
Options exercised by Regeneron under Section 5.1 of the Collaboration
Agreement.  For clarity, each Party shall be responsible for the costs incurred
under this Agreement through the date of termination in accordance with their
respective Co-Funding Percentages.

3.3[Intentionally Omitted]

3.4[Intentionally Omitted]

3.5[Intentionally Omitted]

3.6(b) [Intentionally Omitted]

3.8Intellia Technical Support Related to the Development of Regeneron Co-Funding
Products.  With respect to Regeneron Co-Funding Products, Section 6.1(b) of the
Collaboration Agreement is hereby incorporated by reference into this Agreement
in accordance with Section 2.2(b).  Costs incurred by Intellia in the conduct of
activities conducted pursuant to this Section 3.8 shall be shared by the Parties
in accordance with their respective Co-Funding Percentages and treated as Other
Shared Expenses.

SUB-ANNEX 1 (A) -- 2

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

5.1(b)(ii)Regeneron shall be responsible for all communications with Regulatory
Authorities in connection with Regeneron Co-Funding Products, with Intellia’s
support and input (which may include preparation by Intellia of [***]), which
support and input shall be provided by Intellia upon reasonable request by
Regeneron; provided, that, in connection with such support prior to commencing
such support, [***]. Costs incurred by Intellia in the conduct of the assistance
contemplated by the previous sentence shall constitute Development Costs and
shall be shared by the Parties in accordance with their respective Co-Funding
Percentages.

5.1(c)[Intentionally Omitted]

6.3 [Intentionally Omitted]

6.4In the event that either (a) the use, practice or exercise by Regeneron (or
any of its Affiliates or sublicensees) of any Intellia Intellectual Property in
accordance with the licenses expressly granted to Regeneron in accordance with
this Agreement or (b) the research, development, making, having made, use, sale,
offering for sale, or import by Regeneron  (or any of its Affiliates or
sublicensees) of a Regeneron Co-Funding Product [***] for use in the Field,
pursuant to, and in accordance with, this Agreement, would infringe or
misappropriate any Patent Right which is first Controlled by Intellia or its
Affiliates after the IP Term and which is not covered by the license grant in
Section 6.1, Intellia shall grant, and hereby grants, to Regeneron a
non-exclusive, royalty-free, worldwide, sublicensable in multiple tiers (in
accordance with Section 7.2(c) license under such Patent Right solely as
necessary to (i) use, practice and exercise the Intellia Intellectual Property
in accordance with the licenses expressly granted to Regeneron in accordance
with this Agreement and (ii) research, develop, make, have made, use, sale,
offer for sale, and import Regeneron Co-Funding Products for use in the Field in
accordance with this Agreement, and solely for such purpose. The foregoing
license under this Section 6.4 shall automatically terminate on a Regeneron
Co-Funding Target-by-Regeneron Co-Funding Target basis (and with respect to all
Regeneron Co-Funding Products Directed to such Co-Funding Target) simultaneous
with the termination of the license under Section 6.1 with respect to such
Regeneron Co-Funding Product.  [***].

7.2(c)(ii)[***].

7.3(d)[***].

7.4(b)With respect to the Regeneron Co-Funding Products, the second sentence of
Section 7.4(a) and Section 7.4(b) of the Collaboration Agreement are hereby
incorporated by reference into this Agreement in accordance with Section 2.2(b)
and any payments made by Regeneron in accordance Section 7.4(a) of the
Collaboration Agreement shall be considered Third Party License Payments and
shall be treated in accordance with Section 7.5.

7.11Ongoing Technology Update and Transfer Obligations.  With respect to the
Co-Funding Products, Section 7.11 of the Collaboration Agreement is hereby
incorporated by reference into this Agreement in accordance with Section
2.2(b).  Costs incurred by Intellia in the

SUB-ANNEX 1 (A) -- 3

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

performance of activities conducted pursuant to clause (c) of Section 7.11 of
the Collaboration Agreement shall be shared by the Parties in accordance with
their respective Co-Funding Percentages and treated as Other Shared Expenses.

7.12[Intentionally Omitted]

8.1Non-GMP Manufacture of Co-Funding Products.  With respect to the Regeneron
Co-Funding Products, Section 8.1 of the Collaboration Agreement is hereby
incorporated by reference into this Agreement in accordance with Section 2.2(b).

8.2Section 8.2 of the Collaboration Agreement is hereby incorporated by
reference into this Agreement in accordance with Section 2.2(b).  [***].

8.3(b)With respect to a Regeneron Co-Funding Product, the second and third
sentences of Section 8.3 of the Collaboration Agreement are hereby incorporated
by reference into this Agreement in accordance with Section 2.2(b).

8.4Manufacturing Process Technology Transfer.  With respect to the Regeneron
Co-Funding Products, [***].

9.1Reimbursement for Past Expenses.  Within [***] after the Effective Date of
this Agreement, the Party that exercised the Exercised Option, as applicable,
shall pay to the other Party an amount equal to [***].

9.13Effect of Amendment of the UC Technology License.  [***].

9.14Treatment of Certain Payments for Sharing of Profits and Development Costs
for Regeneron Co-Funding Products.  With respect to Regeneron Co-Funding
Products [***].

10.12(b)In the event that Regeneron is not fully able to enjoy any rights
granted Regeneron under this Article 10 as a result of the provisions of this
Section 10.12, then Intellia shall use diligent efforts to afford and allow
Regeneron to exercise and enjoy such rights to the maximum extent possible under
the applicable Third Party agreement (but Intellia shall not be required to
amend or otherwise modify any such agreement, or make any payments to such Third
Party), [***].

12.2Additional Representations, Warranties and Covenants of the Parties.

(a)[Intentionally Omitted]

SUB-ANNEX 1 (A) -- 4

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(b)

(i)Except as set forth on Schedule 12.2(b)(i), Regeneron additionally hereby
represents and warrants to Intellia, as modified by any exceptions to such
representations and warranties applied mutatis mutandis to the subject matter of
the Intellia Option as set forth in the Option Package for the Co-Funding Target
and Co-Funding Products, that as of the Option Exercise Date:

(1)There are no claims, judgments or settlements against or owed by Regeneron
(or any of its Affiliates) and no pending or, to Regeneron’s knowledge,
threatened (in writing) claims or litigation, in each case, to which Regeneron
(or its Affiliates,) is a party or threatened (in writing) party relating to the
Regeneron Contributed IP or otherwise challenging Regeneron’s ownership or
control of the Regeneron Contributed IP, in each case, with respect to the
foregoing, solely with respect to the Co-Funding Products (such Regeneron
Contributed IP, the “CFP Regeneron Contributed IP”);

(2)Schedule 12.2(b)(i)(2)(A) sets forth a true, correct and complete list of
Patent Rights within the CFP Regeneron Contributed IP existing as of the Option
Exercise Date, in each case, with respect to the foregoing, solely with respect
to the Co-Funding Products (the “CFP Regeneron Patent Rights”).  To the
knowledge of the individuals listed on Schedule 12.2(b)(i)(2)(B) (without any
duty to inquire), the CFP Regeneron Patent Rights exist and are not invalid or
unenforceable, in whole or in part;

(3)Regeneron solely owns all CFP Regeneron Contributed IP; and Regeneron
Controls all of the CFP Regeneron Patent Rights;

(4)Schedule 12.2(b)(i)(4) sets forth a true, correct and complete list of all
agreements pursuant to which Regeneron has in-licensed, or otherwise obtained
rights to, CFP Regeneron Contributed IP (the “Regeneron Agreements”);

(5)Regeneron is not aware of any claim made in writing against it asserting the
invalidity, misuse, unregisterability, unenforceability or non-infringement of
any of the CFP Regeneron Patent Rights;

(6)Neither Regeneron nor any of its Affiliates is or has been a party to any
agreement with the U.S. federal government or an agency thereof pursuant to
which the U.S. federal government or such agency provided funding for the
development of the CFP Regeneron Contributed IP;

(7)Neither Regeneron nor any of its Affiliates has received any written
notification from a Third Party that the use of any CFP Regeneron Contributed IP
infringes or misappropriates the Patent Rights or Know-How owned or controlled
by such Third Party;

SUB-ANNEX 1 (A) -- 5

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(8)The CFP Regeneron Contributed IP is not subject to any liens or encumbrances
or other grants in favor of any Third Party that conflicts with the rights or
licenses granted to Intellia under this Agreement;

(9)To the knowledge of the individuals listed on Schedule 12.2(b)(i)(9) [***],
the conception, discovery, development or reduction to practice of CFP Regeneron
Contributed IP has not constituted or involved misappropriation of Intellectual
Property or rights of any Person; and

(10)Regeneron has a right and license to use the Patent Rights that are licensed
to Regeneron (directly or indirectly) under each of the Regeneron Agreements on
a worldwide basis, and Regeneron is granting a sublicense to such Patent Rights
to Intellia for use on a worldwide basis, in each case, with respect to the
foregoing, solely with respect to the Co-Funding Products.

(ii)With respect to each of the Regeneron Agreements (as may be amended from
time to time), Regeneron hereby represents and warrants as of the Effective
Date, and covenants during the Term, to Intellia that:

(1)Sections 12.4(a)(i) and (ii) of the Collaboration Agreement (as applied
mutatis mutandis) are hereby incorporated by reference into this Agreement in
accordance with Section 2.2(b), in each case, with respect to the foregoing,
solely with respect to the Co-Funding Products; and

(2)Regeneron shall fulfill all of its material obligations, including its
payment obligations, under the Regeneron Agreements, with respect to the
Co-Funding Products.

12.3(d)Covenants.

(i)With respect to the Regeneron Co-Funding Products under this Agreement,
[***].

(ii)Section 12.4 of the Collaboration Agreement is hereby incorporated by
reference into this Agreement in accordance with Section 2.2(b).  

 

 

SUB-ANNEX 1 (A) -- 6

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

SUB-ANNEX 1(B):

Regeneron Co-Funding Target where an Intellia Liver Target is the Co-Funding
Target

1.17“Co-Funding Product” shall mean each Regeneron Co-Funding Product that is
Directed to the Co-Funding Target.

1.27“Converted CFP Inventions” means the Co-Funding Product Inventions which
become Other Co-Funding Product Inventions by operation of Section 10.1(a)(iii)
upon termination of this Agreement.

1.38

 

4.

[Intentionally Omitted]

1.44“Exercised Option” shall mean the Regeneron Option exercised by Regeneron
under Section 5.1(e) of the Collaboration Agreement, in each case, in accordance
with the Collaboration Agreement, for the Target set forth on Schedule 1.44 of
this Agreement.

1.89“IP Term” shall mean that period, during the Term, commencing on the
Effective Date and continuing for [***] such Co-Funding Target.

1.94“Lead Party” shall mean Regeneron.

1.115“Participating Party” shall mean Intellia.

2.2(b)There are instances where certain provisions of this Agreement only apply
to Regeneron Co-Funding Products and not to Intellia Co-Funding Products and
where such provisions were already set forth in the Collaboration Agreement with
respect to Regeneron Products.  In such cases, this Agreement incorporates by
reference the applicable terms of the Collaboration Agreement, except that
references to Regeneron Products in the applicable terms of the Collaboration
Agreement shall be deemed to refer to Regeneron Co-Funding Products and
references to the Collaboration Agreement in the applicable terms of the
Collaboration Agreement shall be deemed to refer to this Agreement.

2.4(b)(viii)[Intentionally Omitted]

2.9[Intentionally Omitted]

3.1Development of Co-Funding Products.  Subject to the terms of this Agreement,
the Lead Party shall undertake, and in accordance with Section 3.2 with respect
to a Regeneron Co-Funding Product the Parties shall jointly undertake,
Development activities with respect to Co-Funding Products unless otherwise
mutually agreed to in the Global Development Plan, and such Development
activities shall be under the general direction and oversight of the JDC and
JSC. [***].  Except as set forth in Section 3.2 with respect to a Regeneron
Co-Funding Product or

SUB-ANNEX 1 (B) -- 1

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

otherwise agreed to by the Parties in writing or explicitly set forth in this
Agreement, the JSC will assign responsibility for conducting all Development
activities for a Co-Funding Product to the Lead Party. For clarity, with respect
to a given Regeneron Product that constitutes a Co-Funding Product under this
Agreement, the diligence obligations of Regeneron to develop and commercialize
such Regeneron Product in Sections 4.4(d) and 6.1(a) of the Collaboration
Agreement shall be superseded (from and after the Effective Date of this
Agreement) by Regeneron’s diligence obligations as a Lead Party for such
Co-Funding Product under this Agreement, [***].

3.2Existing Product R&D Programs and Associated Product R&D Plans.

(a)[Intentionally Omitted]

(b)The Participating Party may terminate this Agreement with respect to the
Co-Funding Target and all Co-Funding Products Directed to such Co-Funding Target
[***].  Upon such termination, the Regeneron Option exercised in conjunction
with this Agreement shall no longer constitute one of the Regeneron Options
exercised by Regeneron under Section 5.1 of the Collaboration Agreement.  For
clarity, each Party shall be responsible for the costs incurred under this
Agreement through the date of termination in accordance with their respective
Co-Funding Percentages.

3.3New Product R&D Programs and Associated Product R&D Plans.  In the event
Regeneron exercises the Exercised Option to an Intellia Liver Target and
Regeneron is the Lead Party for such Target, upon Regeneron’s written request,
Intellia shall perform certain activities for Regeneron under the Global
Development Plan for such Regeneron Co-Funding Product, if Intellia has agreed
to perform similar types of activities for Regeneron under a Product R&D Program
and an associated Product R&D Plan for a Regeneron Product under the
Collaboration Agreement (e.g., guide RNA and repair template design,
optimization, and in vitro validation; in vitro functional assays; and
development of non-viral systems for liver delivery; and the generation of
CRISPR-Cas Materials and nanoparticle formulations for in-vivo proof of concept
studies).  [***].

3.4Transition of Research and Development Activities for Regeneron Co-Funding
Products that were formerly Intellia Liver Products.  If the Co-Funding Target
constitutes an Intellia Liver Target for which Regeneron is the Lead Party,
Intellia shall, as promptly as reasonably practicable, [***].  The costs
incurred by Intellia in the conduct of transition activities conducted pursuant
to this Section 3.4 in accordance with the plan and cost estimate provided by
Intellia pursuant to the previous sentence shall be treated as Development Costs
and shared by the Parties in accordance with their respective Co-Funding
Percentages.

3.5Transition of Patent Prosecution Responsibilities.  After Regeneron’s
exercise of the Exercised Option for an Intellia Liver Product Directed to an
Intellia Liver Target for which Regeneron is designated as the Lead Party,
Intellia shall, as promptly as reasonably practicable, transfer all Patent
prosecution and maintenance responsibilities for Intellia Liver Product
Inventions to Regeneron, including transferring all files related to the
prosecution and maintenance

SUB-ANNEX 1 (B) -- 2

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

of such Patents to Regeneron and at the request of Regeneron, make appropriate
personnel available to Regeneron to answer such reasonable questions as
Regeneron may have in connection with the prosecution and maintenance of such
Patents.

3.6(b)[Intentionally Omitted]

3.8Intellia Technical Support Related to the Development of Regeneron Co-Funding
Products.  With respect to Regeneron Co-Funding Products, Section 6.1(b) of the
Collaboration Agreement is hereby incorporated by reference into this Agreement
in accordance with Section 2.2(b).  Costs incurred by Intellia in the conduct of
activities conducted pursuant to this Section 3.8 shared by the Parties in
accordance with their respective Co-Funding Percentages and shall be treated as
Other Shared Expenses.

5.1(b)(ii)Regeneron shall be responsible for all communications with Regulatory
Authorities in connection with Regeneron Co-Funding Products, with Intellia’s
support and input (which may include preparation by Intellia of [***]), which
support and input shall be provided by Intellia upon reasonable request by
Regeneron; provided that, in connection with such support prior to commencing
such support, [***]. Costs incurred by Intellia in the conduct of the assistance
contemplated by the previous sentence shall constitute Development Costs and
shall be shared by the Parties in accordance with their respective Co-Funding
Percentages.

5.1(c)With respect to Regeneron Co-Funding Products that were formerly Intellia
Liver Products, Intellia shall license, transfer, provide a letter of reference
with respect to, or take other action necessary to make available the relevant
Registration Filings and Approvals to and for the benefit of Regeneron, or
otherwise to allow Regeneron to Develop and Commercialize Regeneron Co-Funding
Products as set forth in this Agreement.

6.3 [Intentionally Omitted]

6.4In the event that either (a) the use, practice or exercise by Regeneron (or
any of its Affiliates or sublicensees) of any Intellia Intellectual Property in
accordance with the licenses expressly granted to Regeneron in accordance with
this Agreement or (b) the research, development, making, having made, use, sale,
offering for sale, or import by Regeneron  (or any of its Affiliates or
sublicensees) of a Regeneron Co-Funding Product [***] for use in the Field,
pursuant to, and in accordance with, this Agreement, would infringe or
misappropriate any Patent Right which is first Controlled by Intellia or its
Affiliates after the IP Term and which is not covered by the license grant in
Section 6.1, Intellia shall grant, and hereby grants, to Regeneron a
non-exclusive, royalty-free, worldwide, sublicensable in multiple tiers (in
accordance with Section 7.2(c)) license under such Patent Right solely as
necessary to (i) use, practice and exercise the Intellia Intellectual Property
in accordance with the licenses expressly granted to Regeneron in accordance
with this Agreement and (ii) research, develop, make, have made, use, sale,
offer for sale, and import Regeneron Co-Funding Products for use in the Field in
accordance with this Agreement, and solely for such purpose. The foregoing
license under this Section 6.4 shall automatically terminate on a Regeneron
Co-Funding Target-by-Regeneron Co-Funding Target

SUB-ANNEX 1 (B) -- 3

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

basis (and with respect to all Regeneron Co-Funding Products Directed to such
Co-Funding Target) simultaneous with the termination of the license under
Section 6.1 with respect to such Regeneron Co-Funding Product.  [***].

7.2(c)(ii)[***].

7.3(d)[***].

7.4(b)With respect to Regeneron Co-Funding Products, the second sentence of
Section 7.4(a) and Section 7.4(b) of the Collaboration Agreement are hereby
incorporated by reference into this Agreement in accordance with Section 2.2(b)
and any payments made by Regeneron in accordance Section 7.4(a) of the
Collaboration Agreement shall be considered Third Party License Payments.

7.11Ongoing Technology Update and Transfer Obligations.  With respect to
Regeneron Co-Funding Products, Section 7.11 of the Collaboration Agreement is
hereby incorporated by reference into this Agreement in accordance with Section
2.2(b).  Costs incurred by Intellia in the performance of activities conducted
pursuant to clause (c) of Section 7.11 of the Collaboration Agreement shall be
shared by the Parties in accordance with their respective Co-Funding Percentages
and treated as Other Shared Expenses.

7.12[Intentionally Omitted]

8.1Non-GMP Manufacture of Co-Funding Products.  With respect to Regeneron
Co-Funding Products, Section 8.1 of the Collaboration Agreement is hereby
incorporated by reference into this Agreement in accordance with Section 2.2(b).

8.2With respect to a Regeneron Co-Funding Product that is Directed to a
Co-Funding Target that was an Intellia Liver Target to which Regeneron exercised
the Exercised Option (for which there is no Product R&D Program), Intellia shall
manufacture (or have manufactured) the quantities of Co-Funding Products
(including its components) that are necessary to perform the pre-clinical
activities under the Global Development Plan and Section 8.2 of the
Collaboration Agreement is hereby incorporated by reference into this Agreement
in accordance with Section 2.2(b), except that the references to the Product R&D
Program shall be deemed to refer to the Global Development Plan.  [***].

8.3(b)With respect to a Regeneron Co-Funding Product, the second and third
sentences of Section 8.3 of the Collaboration Agreement are hereby incorporated
by reference into this Agreement in accordance with Section 2.2(b).

8.4Manufacturing Process Technology Transfer.  With respect to Regeneron
Co-Funding Products, [***].

SUB-ANNEX 1 (B) -- 4

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

9.1Reimbursement for Past Expenses.  Within [***] after the Effective Date of
this Agreement, the Party that exercised the Exercised Option, as applicable,
shall pay to the other Party an amount equal to [***].

9.13[***]

9.14Treatment of Certain Payments for Sharing of Profits and Development Costs
for Regeneron Co-Funding Products.  

(a)With respect to Regeneron Co-Funding Products, [***] the following amounts:  

(i) [***]; and

(ii) [***].  

(b)[***].

10.12(b)In the event that Regeneron is not fully able to enjoy any rights
granted Regeneron under this Article 10 as a result of the provisions of this
Section 10.11, then Intellia shall use diligent efforts to afford and allow
Regeneron to exercise and enjoy such rights to the maximum extent possible under
the applicable Third Party agreement (but Intellia shall not be required to
amend or otherwise modify any such agreement, or make any payments to such Third
Party), [***].

12.2Additional Representations, Warranties and Covenants of the Parties.

(a)Except as set forth on Schedule 12.2(a)(1), Intellia additionally hereby
represents and warrants to Regeneron, as modified by any exceptions to such
representations and warranties applied mutatis mutandis to the subject matter of
the Regeneron Option as set forth in the Option Package for the Co-Funding
Target and Co-Funding Products, that as of the Option Exercise Date:

(i)There are no claims, judgments or settlements against or owed by Intellia (or
any of its Affiliates) and no pending or, to Intellia’s knowledge, threatened
(in writing) claims or litigation, in each case, to which Intellia (or its
Affiliates, or, to its or their knowledge, any of the counterparties to the
Option Exercise Intellia Existing Third Party Agreements) is a party or
threatened (in writing) party relating to the Intellia Intellectual Property or
otherwise challenging Intellia’s ownership or control of the Intellia
Intellectual Property (such Intellia Intellectual Property, the “CFP Intellia
IP”);

(ii)Schedule 12.2(a)(1)(ii)(A) sets forth a true, correct and complete list of
Patent Rights within the CFP Intellia IP existing as of the Option Exercise
Date, (the “CFP Intellia Patent Rights”).  To the knowledge of the individuals
listed on Schedule

SUB-ANNEX 1 (B) -- 5

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

12.2(a)(1)(ii)(B) [***], the CFP Intellia Patent Rights exist and are not
invalid or unenforceable, in whole or in part;

(iii)Intellia solely owns all CFP Intellia IP, except for such CFP Intellia IP
that Intellia Controls pursuant to the Option Exercise Intellia Existing Third
Party Agreements, and Intellia Controls all of the CFP Intellia Patent Rights;

(iv)Schedule 12.2(a)(1)(iv) sets forth a true, correct and complete list of all
agreements with Third Parties pursuant to which Intellia has in-licensed, or
otherwise obtained rights to, any Intellectual Property related to activities
hereunder, including CRISPR-Cas, Targets, delivery technologies and CPs (the
“Option Exercise Intellia Existing Third Party Agreements”);

(v)Intellia is not aware of any claim made in writing against it asserting the
invalidity, misuse, unregisterability, unenforceability or non-infringement of
any of the CFP Intellia Patent Rights;

(vi)Neither Intellia nor any of its Affiliates is or has been a party to any
agreement with the U.S. federal government or an agency thereof pursuant to
which the U.S. federal government or such agency provided funding for the
development of the CFP Intellia IP;

(vii)Neither Intellia nor any of its Affiliates has received any written
notification from a Third Party that the use of any CFP Intellia IP infringes or
misappropriates the Patent Rights or Know-How owned or controlled by such Third
Party;

(viii)The CFP Intellia IP is not subject to any liens or encumbrances or other
grants in favor of any Third Party that conflicts with the rights or licenses
granted to Regeneron under this Agreement;

(ix)To the knowledge of the individuals listed on Schedule 12.2(a)(1)(ix)
(without any duty to inquire), the conception, discovery, development or
reduction to practice of CFP Intellia IP has not constituted or involved
misappropriation of Intellectual Property or rights of any Person; and

(x)Intellia has a right and license to use the Patent Rights that are licensed
to Intellia (directly or indirectly) under Option Exercise Intellia Existing
Third Party Agreements on a worldwide basis, and Intellia is granting a
sublicense to such Patent Rights to Regeneron for use on a worldwide basis, in
each case, with respect to the foregoing, solely with respect to the Co-Funding
Products hereunder;

(b)[Intentionally Omitted]

12.3(d)Covenants.

(i)With respect to the Regeneron Co-Funding Products under this Agreement,
[***].

SUB-ANNEX 1 (B) -- 6

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(ii)Section 12.4 of the Collaboration Agreement is hereby incorporated by
reference into this Agreement in accordance with Section 2.2(b), except that any
references to the Intellia Existing Third Party Agreements shall be deemed to
refer to the Option Exercise Intellia Existing Third Party Agreements.

 

 

 

SUB-ANNEX 1 (B) -- 7

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

SUB-ANNEX 1(C):

Intellia Co-Funding Target

1.17“Co-Funding Product” shall mean each Intellia Co-Funding Product that is
Directed to the Co-Funding Target.

1.27[Intentionally Omitted]

1.38

 

4.

[Intentionally Omitted]

1.44“Exercised Option” shall mean the Intellia Option exercised by Intellia
under Section 5.2(c) of the Collaboration Agreement, in accordance with the
Collaboration Agreement, for the Target set forth on Schedule 1.44 of this
Agreement.

1.89[Intentionally Omitted]

1.94“Lead Party” shall mean Intellia.

1.115“Participating Party” shall mean Regeneron.

2.2(b)[Intentionally Omitted]

2.4(b)(viii)[***];

2.9[***].

3.1Development of Co-Funding Products.  Subject to the terms of this Agreement,
the Lead Party shall undertake, Development activities with respect to
Co-Funding Products unless otherwise mutually agreed to in the Global
Development Plan, and such Development activities shall be under the general
direction and oversight of the JDC and JSC.  [***].  Except as otherwise agreed
to by the Parties in writing or explicitly set forth in this Agreement, the JSC
will assign responsibility for conducting all Development activities for a
Co-Funding Product to the Lead Party.

3.2Existing Product R&D Programs and Associated Product R&D Plans.

(a)[Intentionally Omitted]

(b)The Participating Party may terminate this Agreement with respect to the
Co-Funding Target and all Co-Funding Products Directed to such Co-Funding Target
[***].  Upon such termination, the Intellia Option exercised in conjunction with
this Agreement shall no longer constitute one of the Intellia Options exercised
by Intellia under Section 5.2 of the Collaboration

SUB-ANNEX 1(C) -- 1

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Agreement.  For clarity, each Party shall be responsible for the costs incurred
under this Agreement through the date of termination in accordance with their
respective Co-Funding Percentages.

3.3[Intentionally Omitted]

3.4[Intentionally Omitted]

3.5[Intentionally Omitted]

3.6(b)[Intentionally Omitted]

3.8[Intentionally Omitted]

5.1(b)(ii)[Intentionally Omitted]

5.1(c)[Intentionally Omitted]

6.3[***].

6.4Subject to the terms and conditions of this Agreement (including Section 6.1
and Section 12.6), Regeneron shall grant, and hereby grants, to Intellia a
non-exclusive, worldwide, sublicensable through multiple tiers (in accordance
with Section 7.2(c), provided that such sublicense shall not require the prior
written consent of Regeneron), royalty-free and fully paid-up (subject to
Section 7.12) license under Patents Rights and Know-How Controlled by Regeneron
solely to the extent necessary (and with respect to any Patent Rights, on a
claim-by-claim basis) to use, practice and otherwise exploit the applicable
Regeneron Contributed Technology [***] for the research, development, making,
having made, using, selling, offering for sale and importing of Intellia
Co-Funding Products.

7.2(c)(ii)[Intentionally Omitted].

7.3(d)To the extent that any milestones or royalties under a New Intellia
Platform License are attributable to one or more Co-Funding Products (as opposed
to amounts attributable to other products or activities) [***].

7.4(b)[Intentionally Omitted]

7.11Ongoing Technology Update and Transfer Obligations.  Without limiting the
last sentence of Section 6.3, [***].  Costs incurred by Regeneron in the
performance of activities conducted pursuant to clause (b)(ii) of this Section
7.11 shall be shared by the Parties in accordance with their respective
Co-Funding Percentages and treated as Other Shared Expenses.

7.12Regeneron Contributed IP.  With respect to Co-Funding Products for which
Intellia has a license to Regeneron Contributed IP pursuant to Section 6.3:

SUB-ANNEX 1(C) -- 2

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(a)Section 7.12 of the Collaboration Agreement is hereby incorporated by
reference into this Agreement in accordance with Section 2.2(b) and any payments
made by Intellia to Regeneron in accordance with Section 7.12 of the
Collaboration Agreement shall be considered Third Party License Payments
hereunder and treated in accordance with Section 7.5 of this Agreement.

(b)In the event that any Regeneron Contributed IP (or other Intellectual
Property licensed by Regeneron to Intellia hereunder) [***] with respect to the
Co-Funding Products hereunder, (1) Regeneron will provide prompt written notice
thereof to Intellia, and (2) unless Regeneron is already undertaking such
efforts for itself and Intellia, Regeneron will provide reasonable assistance to
Intellia in Intellia’s efforts to obtain rights to such Intellectual Property
Rights consistent with the rights (including scope) granted by Regeneron to
Intellia under this Agreement pertaining to the Co-Funding Products hereunder.

8.1Non-GMP Manufacture of Intellia Co-Funding Products.  With respect to
Intellia Co-Funding Products, Intellia will be responsible for the non-GMP
Manufacture and supply of Intellia Co-Funding Products to support the research
and pre-clinical development of Intellia Co-Funding Products.

8.2Intellia shall manufacture (or have manufactured) the quantities of
Co-Funding Products (including its components) that are necessary to perform the
pre-clinical activities under the Global Development Plan and the first sentence
of Section 8.2 of the Collaboration Agreement is hereby incorporated by
reference into this Agreement in accordance with Section 2.2(b), except that the
references to the Product R&D Program shall be deemed to refer to the Global
Development Plan (or the Option Package for such Co-Funding Product prior to
approval of such Global Development Plan).  [***].

8.3(b)[Intentionally Omitted]

8.4[Intentionally Omitted]

9.1Reimbursement for Past Expenses.  Within [***] after the Effective Date of
this Agreement, Regeneron shall pay to Intellia an amount equal to [***].

9.13[***]

(a)[***]; or

(b)[***]

SUB-ANNEX 1(C) -- 3

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

9.14Treatment of Certain Payments for Sharing of Profits and Development Costs
for Intellia Co-Funding Products.  

(a)With respect to Intellia Co-Funding Products, [***] the following amounts:  

(i) [***]; and

(ii) [***].  

(b)[***].

10.12(b)[Intentionally Omitted]

12.2Additional Representations, Warranties and Covenants of the Parties.

(a) (i)Except as set forth on Schedule 12.2(a)(i), Intellia additionally hereby
represents and warrants to Regeneron, as modified by any exceptions to such
representations and warranties applied mutatis mutandis to the subject matter of
the Regeneron Option as set forth in the Option Package for the Co-Funding
Target and Co-Funding Products, that as of the Option Exercise Date:

(1)There are no claims, judgments or settlements against or owed by Intellia (or
any of its Affiliates) and no pending or, to Intellia’s knowledge, threatened
(in writing) claims or litigation, in each case, to which Intellia (or its
Affiliates, or, to its or their knowledge, any of the counterparties to the
Option Exercise Intellia Existing Third Party Agreements) is a party or
threatened (in writing) party relating to the Intellia Intellectual Property or
otherwise challenging Intellia’s ownership or control of the Intellia
Intellectual Property (such Intellia Intellectual Property, the “CFP Intellia
IP”);

(2)Schedule 12.2(a)(i)(2)(A) sets forth a true, correct and complete list of
Patent Rights within the CFP Intellia IP existing as of the Option Exercise
Date, (the “CFP Intellia Patent Rights”).  To the knowledge of the individuals
listed on Schedule 12.2(a)(1)(ii)(B) [***], the CFP Intellia Patent Rights exist
and are not invalid or unenforceable, in whole or in part;

(3)Intellia solely owns all CFP Intellia IP, except for such CFP Intellia IP
that Intellia Controls pursuant to the Option Exercise Intellia Existing Third
Party Agreements; and Intellia Controls all of the CFP Intellia Patent Rights;

(4)Schedule 12.2(a)(i)(4) sets forth a true, correct and complete list of all
agreements with Third Parties pursuant to which Intellia has in-licensed, or
otherwise obtained rights to, any Intellectual Property related to activities
hereunder, including CRISPR-Cas, Targets, delivery technologies and CPs (the
“Option Exercise Intellia Existing Third Party Agreements”);

SUB-ANNEX 1(C) -- 4

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(5)Intellia is not aware of any claim made in writing against it asserting the
invalidity, misuse, unregisterability, unenforceability or non-infringement of
any of the CFP Intellia Patent Rights;

(6)Neither Intellia nor any of its Affiliates is or has been a party to any
agreement with the U.S. federal government or an agency thereof pursuant to
which the U.S. federal government or such agency provided funding for the
development of the CFP Intellia IP;

(7)Neither Intellia nor any of its Affiliates has received any written
notification from a Third Party that the use of any CFP Intellia IP infringes or
misappropriates the Patent Rights or Know-How owned or controlled by such Third
Party;

(8)The CFP Intellia IP is not subject to any liens or encumbrances or other
grants in favor of any Third Party that conflicts with the rights or licenses
granted to Regeneron under this Agreement;

(9)To the knowledge of the individuals listed on Schedule 12.2(a)(i)(9) [***],
the conception, discovery, development or reduction to practice of CFP Intellia
IP has not constituted or involved misappropriation of Intellectual Property or
rights of any Person; and

(10)Intellia has a right and license to use the Patent Rights that are licensed
to Intellia (directly or indirectly) under the Option Exercise Intellia Existing
Third Party Agreements on a worldwide basis.

(ii)With respect to the agreements set forth on Schedule 12.2(a)(1)(iv) (as may
be amended from time to time (the “Intellia Agreements”), Intellia hereby
represents and warrants as of the Effective Date, and covenants during the Term,
to Regeneron that:

(1)Sections 12.4(a)(i) and (ii) of the Collaboration Agreement (as applied
mutatis mutandis) are hereby incorporated by reference into this Agreement in
accordance with Section 2.2(b), in each case, with respect to the foregoing,
solely with respect to the Co-Funding Products except that any references to the
Intellia Existing Third Party Agreements shall be deemed to refer to the Option
Exercise Intellia Existing Third Party Agreements.  [***]; and

(2)Intellia shall fulfill all of its material obligations, including its payment
obligations, under the Option Exercise Intellia Existing Third Party Agreements,
with respect to the Co-Funding Products under this Agreement.

12.3(d)[Intentionally Omitted]

 

 

 

SUB-ANNEX 1(C) -- 5

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

SUB-ANNEX 1(D):

TTR

1.17“Co-Funding Product” shall mean each Co-Funding Product that is Directed to
the Initial Co/Co Target.

1.27[Intentionally Omitted]

1.38

 

4.

[***].

1.44“Exercised Option” shall mean the Regeneron Option exercised by Regeneron
under Section 5.1(e) of the Collaboration Agreement in accordance with the
Collaboration Agreement, for the Initial Co/Co Target, as such term is defined
in the Collaboration Agreement.

1.89[Intentionally Omitted]

1.94“Lead Party” shall mean Intellia.

1.115“Participating Party” shall mean Regeneron.

2.2(b)[Intentionally Omitted]

2.4(b)(viii)[***];

2.9[***].

3.1Development of Co-Funding Products.  Subject to the terms of this Agreement,
the Lead Party shall undertake, Development activities with respect to
Co-Funding Products unless otherwise mutually agreed to in the Global
Development Plan, and such Development activities shall be under the general
direction and oversight of the JDC and JSC.  [***].  Except as otherwise agreed
to by the Parties in writing or explicitly set forth in this Agreement, the JSC
will assign responsibility for conducting all Development activities for a
Co-Funding Product to the Lead Party.

3.2[Intentionally Omitted]

3.3[Intentionally Omitted]

3.4[Intentionally Omitted]

3.5[Intentionally Omitted]

SUB-ANNEX 1(D) -- 1

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

3.6(b)Schedule 5.1(e)(iii) of the Collaboration Agreement shall be deemed to be
the initial Global Development Plan for the Initial Co/Co Target until updated
by Intellia and reviewed and approved by the JSC.

3.8[Intentionally Omitted]

5.1(b)(ii)[Intentionally Omitted]

5.1(c)[Intentionally Omitted]

6.3[***].

6.4Subject to the terms and conditions of this Agreement (including Section 6.1
and Section 12.6), Regeneron shall grant, and hereby grants, to Intellia a
non-exclusive, worldwide, sublicensable through multiple tiers (in accordance
with Section 7.2(c)), provided that such sublicense shall not require the prior
written consent of Regeneron), royalty-free and fully paid-up (subject to
Section 7.12) license under Patents Rights and Know-How Controlled by Regeneron
solely to the extent necessary (and with respect to any Patent Rights, on a
claim-by-claim basis) to use, practice and otherwise exploit the applicable
Regeneron Contributed Technology [***] for the research, development, making,
having made, using, selling, offering for sale and importing of Intellia
Co-Funding Products.

7.2(c)(ii)[Intentionally Omitted].

7.3(d)[***].

7.4(b)[Intentionally Omitted]

7.11Ongoing Technology Update and Transfer Obligations.  Without limiting the
last sentence of Section 6.3, [***].  Costs incurred by Regeneron in the
performance of activities conducted pursuant to clause (b)(ii) of this Section
7.11 [***].

7.12Regeneron Contributed IP.  With respect to Co-Funding Products for which
Intellia has a license to Regeneron Contributed IP pursuant to Section 6.3:

(a)Section 7.12 of the Collaboration Agreement is hereby incorporated by
reference into this Agreement in accordance with Section 2.2(b) and [***].

(b)In the event that any Regeneron Contributed IP (or other Intellectual
Property licensed by Regeneron to Intellia hereunder) is [***] with respect to
the Co-Funding Products hereunder, (1) Regeneron will provide prompt written
notice thereof to Intellia, and (2) unless Regeneron is already undertaking such
efforts for itself and Intellia, Regeneron will provide reasonable assistance to
Intellia in Intellia’s efforts to obtain rights to such Intellectual Property
Rights consistent with the rights (including scope) granted by Regeneron to
Intellia under this Agreement pertaining to the Co-Funding Products hereunder.

SUB-ANNEX 1(D) -- 2

--------------------------------------------------------------------------------

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

8.1Non-GMP Manufacture of Co-Funding Products.  With respect to Intellia
Co-Funding Products, Intellia will be responsible for the non-GMP Manufacture
and supply of Intellia Co-Funding Products to support the research and
pre-clinical development of Intellia Co-Funding Products.

8.2Intellia shall manufacture (or have manufactured) the quantities of
Co-Funding Products (including its components) that are necessary to perform the
pre-clinical activities under the Global Development Plan and the first sentence
of Section 8.2 of the Collaboration Agreement is hereby incorporated by
reference into this Agreement in accordance with Section 2.2(b), except that the
references to the Product R&D Program shall be deemed to refer to the Global
Development Plan.  [***].

8.3(b)[Intentionally Omitted]

8.4[Intentionally Omitted]

9.1Reimbursement for Past Expenses.  [***].  The Lead Party provided to the
Participating Party invoices totaling [***] to be paid by the Participating
Party [***].  

9.13[***].  [***] Payments under this Agreement, and as between the [***].

9.14Treatment of Certain Payments for Sharing of Profits and Development Costs
for Co-Funding Products.  With respect to Intellia Co-Funding Products, in the
event that Intellia (or its Affiliate or sublicensee) is required to make any
upfront, annual or other license fees, milestone or royalty payments to a Third
Party as a result of a license (or other right) granted to Intellia (or its
Affiliate or sublicensee) by such Third Party under such Third Party’s
Intellectual Property or otherwise in connection with any settlement with such
Third Party [***].

12.2Additional Representations, Warranties and Covenants of the Parties.

(a)[Intentionally Omitted]

 

(b)

(i)[***].

(ii)Intellia shall fulfill all of its material obligations, including its
payment obligations, under the Intellia Existing Third Party Agreements, with
respect to the Intellia Co-Funding Products under this Agreement.

12.3(d)[Intentionally Omitted]

 

 

SUB-ANNEX 1(D) -- 3