Exhibit 10.7

 

Execution Version

Confidential

 

 

COLLABORATION AND LICENSE AGREEMENT

by and between

BIOGEN MA INC.

and

APPLIED GENETIC TECHNOLOGIES CORPORATION

July 1, 2015

 

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EXCHANGE COMMISSION.  TRIPLE ASTERISKS [***] DENOTE OMISSIONS.

 

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TABLE OF CONTENTS

 

1.

DEFINITIONS

1

 

 

 

 

2.

GOVERNANCE

19

 

2.1.

Joint Development Committee

19

 

2.2.

Joint Commercialization Committee

23

 

2.3.

Alliance Managers

24

 

2.4.

Other Committees

25

 

2.5.

General Authority

25

 

 

 

 

3.

INITIAL LICENSED PROGRAMS

25

 

3.1.

Control of Development

25

 

3.2.

Development Costs

26

 

3.3.

Development Diligence

28

 

3.4.

Subcontractors

29

 

3.5.

Conduct

29

 

 

 

 

4.

DISCOVERY PROGRAMS

30

 

4.1.

General

30

 

4.2.

Discovery Program License Grants

30

 

4.3.

Diligence

31

 

4.4.

Substitution of Discovery Programs

31

 

4.5.

Discovery Program Development Plans

32

 

4.6.

Development Costs

33

 

4.7.

Option Grant; Option Exercise

34

 

4.8.

Subcontractors

34

 

4.9.

Conduct

35

 

 

 

 

5.

LICENSE GRANTS

35

 

5.1.

Exclusive License from AGTC to Biogen

35

 

5.2.

Biogen Sublicensees

35

 

5.3.

Non-Exclusive License from Biogen to AGTC

35

 

5.4.

Enabling Licenses

35

 

5.5.

Retained Rights and Head Licenses

36

 

5.6.

Right of Reference

37

 

5.7.

No Implied Rights

37

 

5.8.

Exclusivity

37

 

5.9.

Right of Notification for [***]

39

 

 

 

 

6.

FINANCIAL TERMS

39

 

6.1.

Upfront Fees

39

 

6.2.

Limited Milestone Payments and Election of Financial Terms for the

Initial Licensed Products

39

 

6.3.

Cost Share Option

40

 

6.4.

Milestone/Royalty Option

40

 

6.5.

Financial Terms for Discovery Products

41

 

6.6.

Payment Adjustments

42

 

6.7.

Reports and Payments

44

 

 

 

 

7.

REGULATORY AFFAIRS; PHARMACOVIGILANCE

45

 

7.1.

Regulatory Affairs

45

 

7.2.

Pharmacovigilance

47

 

 

 

 

 

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8.

COMMERCIALIZATION

47

 

8.1.

Control of Commercialization Activities

47

 

8.2.

Commercialization Costs

49

 

8.3.

Commercial Diligence

49

 

 

 

 

9.

RECORDS AND AUDITS

49

 

9.1.

Research and Manufacturing Records

49

 

9.2.

Financial Records

49

 

9.3.

Audits

50

 

 

 

 

10.

REPORTS

50

 

10.1.

Development Reports

50

 

10.2.

Commercialization Reports

51

 

 

 

 

11.

TECHNOLOGY AND REGULATORY TRANSFERS

51

 

11.1.

Initial Technology Transfer

51

 

11.2.

Ongoing Technology Transfers

52

 

11.3.

Transfer of Materials

52

 

11.4.

Restrictions on Use and Transfer of Materials

52

 

11.5.

Regulatory Transfers

53

 

 

 

 

12.

MANUFACTURE AND SUPPLY

54

 

12.1.

Responsibilities

54

 

12.2.

Costs of Supply

54

 

12.3.

Requirements regarding Supply and Manufacture

55

 

 

 

 

13.

INTELLECTUAL PROPERTY

55

 

13.1.

Ownership of Intellectual Property

55

 

13.2.

Personnel Obligations

55

 

13.3.

Patent Representatives

55

 

13.4.

Filing, Prosecution and Maintenance of Patent Rights

57

 

13.5.

Enforcement of Patent Rights

60

 

13.6.

Infringement and Third Party Licenses

62

 

13.7.

Patent Term Restoration

63

 

13.8.

Recording

64

 

 

 

 

14.

CONFIDENTIALITY

64

 

14.1.

Confidentiality

64

 

14.2.

Authorized Disclosure

64

 

14.3.

SEC Filings and Other Disclosures

64

 

14.4.

Residual Knowledge Exception

65

 

14.5.

Restrictions on Material Non-Public Information

65

 

14.6.

Public Announcements; Publications

65

 

 

 

 

15.

REPRESENTATIONS AND WARRANTIES

66

 

15.1.

Representations and Warranties of Each Party

66

 

15.2.

Additional Representations and Warranties of AGTC

67

 

15.3.

Additional Covenant of Biogen

69

 

15.4.

Special Exceptions for Licensors Under Existing License Agreements

69

 

15.5.

JHU Disclaimer

70

 

15.6.

Duties of the Parties

70

 

15.7.

Representations by JHU

70

 

15.8.

Representation by Legal Counsel

70

 

15.9.

Disclaimer

71

 

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15.10.

No Guarantee of Success

71

 

 

 

 

16.

GOVERNMENT APPROVALS; TERM AND TERMINATION

71

 

16.1.

HSR Filing and Clearance

71

 

16.2.

Termination Upon HSR Denial

71

 

16.3.

Other Government Approvals

72

 

16.4.

Term

72

 

16.5.

Termination by AGTC

72

 

16.6.

Termination by Biogen

72

 

16.7.

Termination for Insolvency

73

 

16.8.

Effects of Termination

74

 

16.9.

Effects of Material Breach by AGTC in Lieu of Termination

77

 

16.10.

Termination of AGTC Third Party Agreements

77

 

 

 

 

17.

LIABILITY, INDEMNIFICATION AND INSURANCE

77

 

17.1.

No Consequential Damages

77

 

17.2.

Indemnification by Biogen

78

 

17.3.

Indemnification by AGTC

78

 

17.4.

Procedure

79

 

17.5.

Special Indemnification by Biogen of the Existing Licensors

79

 

17.6.

Insurance

80

 

 

 

 

18.

MISCELLANEOUS

80

 

18.1.

Assignment

80

 

18.2.

Change of Control of AGTC

81

 

18.3.

Force Majeure

81

 

18.4.

Correspondence and Notices

81

 

18.5.

Amendment

82

 

18.6.

Waiver

82

 

18.7.

Severability

82

 

18.8.

Descriptive Headings

83

 

18.9.

Export Control

83

 

18.10.

Governing Law

83

 

18.11.

Entire Agreement

83

 

 

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SCHEDULES AND EXHIBITS

Schedule 1.22-1 – AGTC Patent Rights for the Initial Licensed Products

Schedule 1.22-2 – AGTC Patent Rights for the Discovery Products

Schedule 1.23 – AGTC Platform

Schedule 1.40 – Biogen Patent Rights

Schedule 1.56– Clinical Candidate Designation Criteria

Schedule 1.212 – Product-Specific Patent Rights of AGTC

Schedule 3.1.3 – Biogen Step-In Events

Schedule 4.2.1 – Licensed Patent Rights for the Discovery Programs

Schedule 5.2 – Sublicensing Restrictions

Schedule 11.4 – Third Party Materials

Schedule 11.4.2 – [***] Restrictions

Schedule 15.1 – Mutual Disclosure Schedule

Schedule 15.2 – AGTC Disclosure Schedule

Schedule 15.2.7 – Existing License Agreements

Exhibit A-1 – Initial XLRS Development Plan

Exhibit A-2 – Initial XLRP Development Plan

Exhibit A-3 – Initial [***] Discovery Program Development Plan

Exhibit A-4 – Initial [***] Discovery Program Development Plan

Exhibit A-5 – Initial [***] Development Plan

Exhibit A-6 – Initial [***] Development Plan

Exhibit B – Co-Promotion Terms

Exhibit C – Financial Planning, Accounting and Reporting for the Cost Share
Product(s)

Exhibit D – Press Release

Exhibit E – Tax Matter Partnership Terms

 

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COLLABORATION AND LICENSE AGREEMENT

This Collaboration and License Agreement (the “Agreement”) is entered into as of
July 1, 2015 (the “Execution Date”), by and between Biogen MA Inc., a
corporation organized and existing under the laws of the Commonwealth of
Massachusetts and having a principal place of business at 250 Binney Street,
Cambridge, MA 02142 (“Biogen”) and Applied Genetic Technologies Corporation, a
corporation organized and existing under the laws of Delaware and having a
principal place of business at 11801 Research Drive, Suite D, Alachua, FL 32615
(“AGTC”). Biogen and AGTC may each be referred to herein individually as a
“Party” and collectively as the “Parties.”

WHEREAS, AGTC is a biotechnology company that has developed technology relating
to the identification, research, development and manufacture of gene therapy
products in ophthalmology and other indications;

WHEREAS, Biogen has extensive experience and expertise in the development and
commercialization of pharmaceutical products, and desires to acquire an
exclusive license and exclusive option rights in the Territory (as defined
below) to AGTC’s patents, patent applications, technology, know-how and
scientific and technical information in gene therapy;

WHEREAS, Biogen and AGTC wish to engage in collaborative development activities
under the Initial Licensed Programs (as defined below) regarding potential
Licensed Products (as defined below);

WHEREAS, Biogen and AGTC wish to collaborate on the conduct of the Discovery
Programs (as defined below) to engage in research regarding potential Discovery
Products (as defined below);

WHEREAS, subject to the terms of this Agreement, AGTC wishes to grant to Biogen,
and Biogen wishes to receive from AGTC, an exclusive license in the Field (as
defined below) in the Territory to research, develop, manufacture and
commercialize Licensed Products (as defined below); and

WHEREAS, subject to the terms of this Agreement, AGTC wishes to grant to Biogen,
and Biogen wishes to receive from AGTC, an exclusive option to receive an
exclusive license in the Field in the Territory to research, develop,
manufacture and commercialize Discovery Products (as defined below);

NOW THEREFORE, in consideration of the mutual promises and covenants set forth
below and other good and valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, the Parties hereby agree as follows:

1. DEFINITIONS.

Capitalized terms not otherwise defined herein shall have the following
meanings:

1.1. “1934 Act” has the meaning set forth in Section 14.5.

1.2. “AAV” means adeno-associated virus.

1.3. “AAV Product” means any product containing a recombinant AAV or AAV-based
vector that delivers one or more transgenes or portions thereof to a human or
animal subject.

1.4. “Abandoned Program” means any Discovery Program (i) which is a Terminated
Discovery Program and for which Biogen does not elect to reinstate as a
Discovery Program under Section 4.4.3, (ii) for which Biogen does not exercise
the Option pursuant to Section 4.7, (iii) the [***] Discovery Program in the
event the Non-Ophthalmology Discovery Program is designated in accordance with
Section 4.4.4 or (iii) for which Biogen terminates for convenience under Section
16.6.1.

1.5. “[***]” has the meaning set forth in Section 1.234.

1.6. “[***]” has the meaning set forth in Section 1.26.

1.7. “[***] Program” means the existing Development program of AGTC or its
Affiliates with respect to AAV Products targeting the [***].

 

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1.8. “Additional Biogen Activities” has the meaning set forth in Section 3.1.3.

1.9. “Additional Clinical Trial” has the meaning set forth in Section 3.2.2(c).

1.10. “Additional Taxes” has the meaning set forth in Section 6.8.2.

1.11. “Administration Costs” has the meaning set forth in Exhibit C.

1.12. “Affiliate” means, as of any point in time and for so long as such
relationship continues to exist with respect to any Person, any other Person
that controls, is controlled by or is under common control with such Person.  A
Person shall be regarded as in control of another Person if it (a) owns or
controls more than fifty percent (50%) of the equity securities of the subject
Person entitled to vote in the election of directors (or, in the case of a
Person that is not a corporation, for the election of the corresponding managing
authority); provided, however, that in such circumstance, the term “Affiliate”
shall not include subsidiaries or other entities in which a Person owns a
majority of the ordinary voting power necessary to elect a majority of the board
of directors or other governing board, but is subject to a contractual or other
restriction that causes such Person to be unable to elect such majority, until
such time as such restriction is no longer in effect; or (b) possesses, directly
or indirectly, the power to direct or cause the direction of the management or
policies of an such Person (whether through ownership of securities or other
ownership interests, by contract or otherwise).

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

1.14. “AGTC” has the meaning set forth in the preamble.

1.15. “AGTC Assays” means proprietary assays, and Know-How describing and Patent
Rights Covering the same, that are Controlled by AGTC or any of its Affiliates
as of the Execution Date or that come into the Control of AGTC or any of its
Affiliates during the Term that are (a) useful for determining [***] or the like
(b) actually used in a Collaboration Program and (c) disclosed to
Biogen.  Notwithstanding the foregoing, Schedule 1.23 sets forth the AGTC Assays
as of the Execution Date, and will be updated as set forth in Section 1.23.  For
clarity, actual use in a Collaboration Program for purposes of this definition
includes (i) a good faith belief by AGTC that a specific assay would be
necessary or useful in such Collaboration Program and (ii) disclosure by AGTC in
a discussion between the Parties regarding the potential use of such assay in
such Collaboration Program.

1.16. “AGTC Customer-Facing FTE” has the meaning set forth in Exhibit B.

1.17. “AGTC Improved Know-How” means any Know-How, other than Joint Know-How,
that is conceived, discovered, invented, created, made or reduced to practice or
tangible medium by or on behalf of AGTC or any of its Affiliates or Sublicensees
in the course of conducting activities under this Agreement, that constitutes an
improvement or enhancement to any Biogen Technology used in such Collaboration
Program.

1.18. “AGTC Improved Patent Right” means any Patent Right, other than a Joint
Patent Right, that claims or discloses any AGTC Improved Know-How that is
Invented by or on behalf of AGTC or any of its Affiliates or Sublicensees in the
course of conducting activities under this Agreement.

1.19. “AGTC Improved Technology” means the AGTC Improved Know-How and the AGTC
Improved Patent Rights.

1.20. “AGTC Indemnified Party” has the meaning set forth in Section 17.2.

1.21. “AGTC Know-How” means any Know-How, other than Joint Know-How, (a) that
(i) AGTC or any of its Affiliates Control as of the Execution Date, (ii) is
conceived, discovered, invented, created, made or reduced to practice or
tangible medium by or on behalf of AGTC or any of its Affiliates or Sublicensees
in the course of conducting activities under this Agreement, other than Program
Data for an Initial Licensed Product and, after the Option Exercise Date, for a
Discovery Product, or (iii) otherwise comes into the Control of AGTC or any of
its Affiliates during the Term, provided that, in the case of any Know-How under
this clause (iii) that comes into the Control of AGTC or its Affiliates through
a license to Third Party IP Rights, Biogen has elected to take a sublicense to
such Third Party IP Rights under Section 13.6.2(a) and (b) that is necessary or
useful for the Development, Manufacture, Commercialization or use of any
Licensed Product.  For clarity, AGTC Know-How includes all AGTC Improved
Know-How.

1.22. “AGTC Patent Right” means any Patent Right, other than a Joint Patent
Right, (a) that (i) AGTC or any of its Affiliates Control as of the Execution
Date or (ii) comes into the Control of AGTC or any of its Affiliates during the
Term, provided

 

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that, in the case of any Patent Right under this clause (ii) that comes into the
Control of AGTC or its Affiliates through a license to Third Party IP Rights,
Biogen has elected to take a sublicense to such Third Party IP Rights under
Section 13.6.2(a) and (b) claims or discloses any AGTC Know-How.  Schedule
1.22-1 sets forth the AGTC Patent Rights as of the Execution Date, and will be
updated on or prior to the Schedule Revision Date to include additional AGTC
Patent Rights filed between the Execution Date and the Schedule Revision Date,
if any.  Schedule 1.22-2, which will be prepared by AGTC and attached hereto in
accordance with Section 4.7, will set forth the AGTC Patent Rights which to
AGTC’s Knowledge Cover a Discovery Product as of the Option Exercise Date for
such Discovery Product.  Schedule 1.22-1 (and Schedule 1.22-2, as applicable)
shall be updated by the Patent Representatives on a semi-annual basis to include
additional Patent Rights, if any, that become AGTC Patent Rights after the
Schedule Revision Date. Any AGTC Patent Right that is not listed on Schedule
1.22-1 or Schedule 1.22-2, but is otherwise described in this Section 1.22,
shall still be considered an AGTC Patent Right hereunder.  For purposes of
clarity, AGTC Improved Patent Rights are included in the AGTC Patent Rights.

1.23. “AGTC Platform” means (a) the [***] Manufacturing Technology, (b) the
Capsid Optimization Technology, (c) AGTC Assays and (d) the Promoter
Technology.  Schedule 1.23 further describes the AGTC Platform as of the
Execution Date, and will be updated on or prior to the Schedule Revision Date to
include additional technologies and assays that become part of the AGTC Platform
after the Execution Date, if any.  In addition, Schedule 1.23 shall be updated
by the Patent Representatives on a semi-annual basis to include additional
technologies and assays, if any, that become part of the AGTC Platform after the
Schedule Revision Date.

1.24. “AGTC Technology” means the AGTC Know-How and the AGTC Patent Rights.

1.25. “AGTC Third Party Agreement” means any agreement between AGTC (or any of
its Affiliates) and any Third Party pursuant to which AGTC has acquired, or,
during the Term, acquires, Control of any of the AGTC Technology, including the
Existing License Agreements.

1.26. “[***] Discovery Program” means a program of Pre-Funded Discovery
Activities through Clinical Candidate Designation with respect to AAV Products
that deliver [***] for the diagnosis, treatment or prevention of [***],
conducted by either or both Parties in accordance with the [***] Discovery
Program Development Plan and the terms of this Agreement.

1.27. “[***] Discovery Program Development Plan” means the written plan for
Pre-Funded Discovery Activities for the [***] Discovery Program to be conducted
pursuant to this Agreement, as such written plan may be amended, modified or
updated by the JDC in accordance with the terms of this Agreement.  The initial
[***] Discovery Program Development Plan is attached hereto as Exhibit A-4.

1.28. “Alliance Manager” has the meaning set forth in Section 2.3.1.

1.29. “Antitrust Laws” has the meaning set forth in Section 16.1.

1.30. “Audited Party” has the meaning set forth in Section 9.3.1.

1.31. “Auditing Party” has the meaning set forth in Section 9.3.1.

1.32. “Available Program Notice” has the meaning set forth in Section 4.4.2.

1.33. “Available Programs” has the meaning set forth in Section 4.4.2.

1.34. “Bankruptcy Code” means the United States Bankruptcy Code (11 U.S.C. §101
et seq.), as amended from time to time, or any successor statute.

1.35. “Biogen” has the meaning set forth in the preamble.

1.36. “Biogen Customer-Facing FTE” has the meaning set forth in Exhibit B.

1.37. “Biogen Indemnified Party” has the meaning set forth in Section 17.3.

 

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1.38. “Biogen Know-How” means any Know-How, other than Joint Know-How, that (a)
(i) is conceived, discovered, invented, created, made or reduced to practice or
tangible medium by or on behalf of Biogen or any of its Affiliates or
Sublicensees in the course of conducting activities under this Agreement, (ii)
relates to one or more Licensed Products or the Development of any of the
foregoing and (iii) is necessary or useful for AGTC to perform AGTC’s
obligations under this Agreement in accordance with any Development Plan or (b)
is not Know-How defined in the foregoing subsection (a) and is Controlled by
Biogen as of the Execution Date or otherwise comes into the Control of Biogen
during the Term and that Biogen uses, subject to the provisions of Section
2.1.2(b)(vi), in the Development, Manufacture or Commercialization or use of the
Licensed Products.  For purposes of clarity, Biogen Platform Improvement
Know-How is included in the Biogen Know-How.

1.39. “Biogen Patent Challenge” has the meaning set forth in Section 16.5.2.

1.40. “Biogen Patent Right” means any Patent Right, other than a Joint Patent
Right, that (a) Biogen Controls as of the Execution Date or that comes into the
Control of Biogen during the Term, and (b) claims or discloses any Biogen
Know-How.  Schedule 1.40 sets forth the Biogen Patent Rights as of the Execution
Date, and will be updated on or prior to the Schedule Revision Date to include
additional Biogen Patent Rights filed between the Execution Date and the
Schedule Revision Date, if any. Schedule 1.40 shall be updated by the Patent
Representatives on a semi-annual basis to include additional Patent Rights, if
any, that become Biogen Patent Rights after the Schedule Revision Date, provided
that any Biogen Patent Right that is not listed on Schedule 1.40, but is
otherwise described in this Section 1.40 shall still be considered a Biogen
Patent Right hereunder.

1.41. “Biogen Platform Improvement Know-How” means any Know-How, other than
Joint Know-How, that is conceived, discovered, invented, created, made or
reduced to practice or tangible medium by or on behalf of Biogen or any of its
Affiliates or Sublicensees in the course of conducting activities under this
Agreement, that constitutes an improvement or enhancement to the AGTC Platform.

1.42. “Biogen Platform Improvement Patent Right” means any Patent Right, other
than a Joint Patent Right, that claims or discloses any Biogen Platform
Improvement Know-How that is Invented by or on behalf of Biogen or any of its
Affiliates or Sublicensees in the course of conducting activities under this
Agreement.

1.43. “Biogen Platform Improvement Technology” means the Biogen Platform
Improvement Know-How and the Biogen Platform Improvement Patent Rights.

1.44. “Biogen Product” has the meaning set forth in Section 8.1.3.

1.45. “Biogen Technology” means the Biogen Know-How and the Biogen Patent
Rights.

1.46. “BLA” means a Biologics License Application (as defined in 21 C.F.R. 600
et. seq.), NDA, MAA or substantially similar application or submission filed
with a Regulatory Authority in a country or group of countries, and any
amendments thereto.

1.47. “Budget” means (a) a Development Budget or (b) a Commercialization Budget,
as applicable.

1.48. “Business Day” means a day other than a Saturday, Sunday or bank or other
public holiday in New York, New York.

1.49. “Calendar Quarter” means the respective periods of three (3) consecutive
calendar months ending on March 31, June 30, September 30 or December 31, for so
long as this Agreement is in effect.

1.50. “Calendar Year” means any calendar year ending on December 31.

1.51. “Capsid Optimization Know-How” means all proprietary Know-How, other than
Joint Know-How, Controlled by AGTC or any of its Affiliates as of the Execution
Date or that comes into the Control of AGTC or any of its Affiliates during the
Term that (a) relates to design, optimization, generation or selection of AAV
capsids, where the AAV vector containing any such AAV capsid demonstrates
improved efficacy of AAV based gene therapy, (b) is actually used in a
Collaboration Program and (c) is actually disclosed to Biogen.  For clarity,
actual use in a Collaboration Program for purposes of this definition includes
(i) a good faith belief by AGTC that certain Know-How would be necessary or
useful in such Collaboration Program and (ii) disclosure by AGTC in a discussion
between the Parties regarding the potential use of such Know-How in such
Collaboration Program.

 

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1.52. “Capsid Optimization Patent Rights” means all Patent Rights, other than
Joint Patent Rights, Controlled by AGTC or any of its Affiliates as of the
Execution Date or that comes into the Control of AGTC or any of its Affiliates
during the Term that claim or disclose any Capsid Optimization
Know-How.  Notwithstanding the foregoing, Schedule 1.23 sets forth the Capsid
Optimization Patent Rights as of the Execution Date, and will be updated as set
forth in Section 1.23.

1.53. “Capsid Optimization Technology” means the Capsid Optimization Know-How
and the Capsid Optimization Patent Rights.

1.54. “cGMP” means current Good Manufacturing Practices as specified in the
United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent
laws, rules, or regulations of an applicable Regulatory Authority at the time of
manufacture.

1.55. “Change of Control” means, 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, or (b) a transaction or series of related
transactions in which a Third Party, together with its Affiliates, becomes the
beneficial owner of more than fifty percent (50%) of the combined voting power
of the outstanding securities of such Party, or (c) the sale or other transfer
to a Third Party of all or substantially all of such Party’s business or assets
relating to one or more Collaboration Programs.

1.56. “Clinical Candidate Designation” means, with respect to any Discovery
Program, the satisfaction by a clinical candidate in such Discovery Program of
each of the criteria set forth on Schedule 1.56, as such Schedule may be amended
by mutual agreement of the Parties.

1.57. “Clinical Study Report” means a report containing the results of a
Clinical Trial of a pharmaceutical product that is consistent in content and
format with applicable Law and regulatory guidance and with the guidelines of
the International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) on Structure and Content of
Clinical Study Reports.

1.58. “Clinical Trial” means a human clinical study conducted on sufficient
numbers of human subjects that is designed to (a) establish that a
pharmaceutical product is reasonably safe for continued testing, (b) investigate
the safety and efficacy of the pharmaceutical product for its intended use, and
to define warnings, precautions and adverse reactions that may be associated
with the pharmaceutical product in the dosage range to be prescribed or (c)
support Regulatory Approval of such pharmaceutical product or label expansion of
such pharmaceutical product.  Without limiting the foregoing, Clinical Trial
includes any FIH Trial or Pivotal Trial.

1.59. “[***]” has the meaning set forth in Section 1.7.

1.60. “Collaboration Program” means (a) the XLRS Program, (b) the XLRP Program
or (c) any Discovery Program, but excluding any Abandoned Program.

1.61. “Combination Product” means (a) any single product in finished form
containing as active ingredients both a Licensed Product and one or more other
pharmaceutically active compounds or substances (including, for the avoidance of
doubt, a transgene other than the transgene identified in the definition of such
Licensed Product), whether co-formulated or co-packaged (i.e., within a single
box or sales unit); or (b) any Licensed Product sold in combination with one or
more other products (such as devices) or services for a single invoice price; or
(c) any Licensed Product sold where the sale of the Licensed Product is only
available with the purchase of other products or services (such other
pharmaceutically active compounds or substances, or such other products or
services referred to in clauses (a) through (c) hereof, the “Other Components”).

1.62. “[***] Discovery Product” has the meaning set forth in Section 4.7.

1.63. “Commercial FTE Rate” means a rate to be agreed upon by the JCC in
accordance with Section 2.2.2(b)(ii), which rate shall be updated for each
Calendar Year to a rate as agreed by the Parties, commencing on January 1, 2017,
provided that, if the Parties cannot come to agreement with respect to such rate
in any given year, such rate shall be updated for such year in accordance with
the Consumer Price Index – All Urban Consumers, US City Average, All Items,
1982-84 = 100, published by the United States Department of Labor, Bureau of
Labor Statistics (or its successor equivalent index) over the twelve (12) month
period preceding January 1 of the applicable Calendar Year.

 

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1.64. “Commercialization Budget” means the written budget set forth in any
Commercialization Plan for Commercialization activities with respect to the
applicable Cost Share Product, as such written plan may be amended, modified or
updated in accordance with the terms of this Agreement.

1.65. “Commercialization Plan” means, with respect to any Cost Share Product,
the written plan for Commercialization activities for such Cost Share Product to
be conducted pursuant to this Agreement, which shall include, at a minimum,
Commercialization activities, Commercialization Budgets and associated
timelines, as such written plan may be amended, modified or updated in
accordance with the terms of this Agreement.

1.66. “Commercialize” or “Commercializing” means to market, advertise, promote,
distribute, offer for sale, sell, have sold, import, lease, export or otherwise
commercialize a product, to conduct activities, other than Development and
Manufacturing, in preparation for the foregoing activities, and to conduct
post-approval studies.  When used as a noun, “Commercialization” shall mean any
and all activities involved in Commercializing.

1.67. “Commercially Reasonable Efforts” means, with respect to each Party, the
efforts and resources typically used by biotechnology or biopharmaceutical
companies similar in size and scope to such Party and its Affiliates to perform
the obligation at issue, which efforts shall not be less than those efforts made
with respect to other products at a similar stage of development or in a similar
stage of product life, with similar developmental risk profiles, of similar
market and commercial potential, taking into account the competitiveness of the
market place, the proprietary position of the products, the regulatory structure
involved, Regulatory Authority-approved labeling, product profile, the
profitability of the applicable products (taking into account payments under
this Agreement), issues of safety and efficacy, the likely timing of the
product’s entry into the market, the likelihood of receiving Regulatory Approval
and other relevant scientific, technical and commercial factors.

1.68. “Competing Program” has the meaning set forth in Section 5.8.3(a).

1.69. “Competitive Infringement” has the meaning set forth in Section 13.5.4.

1.70. “Competitive Product” means, with respect to a Licensed Product, any AAV
Product that is Commercialized or used in the same indication and targeting at
least one of the same genes as such Licensed Product.

1.71. “Confidential Information” means, with respect to each Party, all Know-How
or other information, including proprietary information (whether or not
patentable) regarding or embodying such Party’s technology, products, business
information or objectives, that is communicated in any way or form by or on
behalf of the Disclosing Party to the Receiving Party or its permitted
recipients, on or after the Effective Date of this Agreement, whether or not
such Know-How or other information is identified as confidential at the time of
disclosure, provided that Know-How or other information not identified as
confidential by or on behalf of the Disclosing Party shall be deemed to be
Confidential Information of the Disclosing Party if the Receiving Party knows,
or should have had a reasonable expectation, that such Know-How or other
information communicated by or on behalf of the Disclosing Party is Confidential
Information of the Disclosing Party.  The terms and conditions of this Agreement
shall be considered Confidential Information of both Parties.  Notwithstanding
any provision of this Section 1.71 to the contrary, Confidential Information
does not include any (a) Joint Know-How or (b) Know-How or information that: (i)
was already known by the Receiving Party (other than under an obligation of
confidentiality to the Disclosing Party) at the time of disclosure by or on
behalf of the Disclosing Party; (ii) was generally available to the public or
otherwise part of the public domain at the time of its disclosure to the
Receiving Party; (iii) became generally available to the public or otherwise
part of the public domain after its disclosure to the Receiving Party, other
than through any act or omission of the Receiving Party in breach of its
obligations under this Agreement; (iv) was disclosed to the Receiving Party,
other than under an obligation of confidentiality, by a Third Party who had no
obligation not to disclose such information to the Receiving Party; or (v) was
independently discovered or developed by or on behalf of the Receiving Party
without the use of or access to any Confidential Information belonging to the
Disclosing Party.

1.72. “Continuing Party” has the meaning set forth in Section 13.4.2(c).

1.73. “Control” or “Controlled” means with respect to any intellectual property
right (including any Patent Right, Know-How or other data, information or
Materials), possession of the ability (whether by sole or joint ownership,
license or otherwise, other than pursuant to the license grants under this
Agreement) to grant, without violating the terms of any agreement with a Third
Party, a license, access or other right in, to or under such intellectual
property right.  Notwithstanding anything in this Agreement to the contrary, a
Party shall be deemed to not Control any Patent Rights or Know-How that are
owned or controlled by a Third Party described in the definition of “Change of
Control”, or such Third Party’s Affiliates, (a) prior to the closing of such
Change of Control,

 

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except to the extent that any such Patent Rights or Know-How were developed
prior to such Change of Control through the use of such Party’s technology, or
(b) after such Change of Control to the extent that such Patent Rights or
Know-How are developed or conceived by such Third Party or its Affiliates (other
than such Party) after such Change of Control without using or incorporating or
having access to such Party’s technology.

1.74. “Control Limitation Agreement” means any written agreement or arrangement,
other than an Existing License Agreement, executed by AGTC that has not been
disclosed to Biogen in Schedule 15.2 which provides for the use or license of
Technology by AGTC that would, but for limitations included in such agreement or
arrangement on the ability of AGTC to use or grant a license or sublicense to or
under such Technology, constitute AGTC Technology or that otherwise restricts
AGTC’s ability to use or license any Technology that would, but for such
restrictions, constitute AGTC Technology.

1.75. “Co-Promotion Agreement” has the meaning set forth in Section 8.1.4(a).

1.76. “Co-Promotion Option” has the meaning set forth in Section 8.1.4(a).

1.77. “Co-Promotion Product” has the meaning set forth in Section 8.1.4(a).

1.78. “Cost of Goods Sold” means, as to each Licensed Product or Material, the
fully burdened cost of such Licensed Product in final therapeutic form or
Material.  The fully burdened cost of each Licensed Product or Material will be
determined in accordance with U.S. GAAP as applied by the Party performing or
contracting for each stage of the Manufacturing process and will include direct
labor, material, product testing costs and allocable overhead.

1.79. “Cost of Sales” has the meaning set forth in Exhibit C.

1.80. “Cost Share Option” has the meaning set forth in Section 6.2.2.

1.81. “Cost Share Product” has the meaning set forth in Section 6.3.

1.82. “Cover,” “Covering” or “Covers” means, as to a product and Patent Rights,
that, in the absence of a license granted under, or ownership of, such Patent
Rights, the making, using, selling, offering for sale or importation of such
product would infringe such Patent Rights or, as to a pending claim included in
such Patent Rights, the making, using, selling, offering for sale or importation
of such product would infringe such Patent Rights if such pending claim were to
issue in an issued patent without modification.

1.83. “Customer-Facing Activities” has the meaning set forth in Exhibit B.

1.84. “Customer-Facing Activities Plan” has the meaning set forth in Exhibit B.

1.85. “Customer-Facing FTE” has the meaning set forth in Exhibit B.

1.86. “Data Package” means, with respect to any Discovery Program, all data,
research reports and other information that reasonably demonstrates satisfaction
of the criteria set forth on Schedule 1.56, which criteria may be amended from
time to time by the JDC, subject to Biogen’s final decision-making authority as
set forth in Section 2.1.4(c).

1.87. “Declining Party” has the meaning set forth in Section 13.4.2(c).

1.88. “Designation Notice” has the meaning set forth in Section 4.4.2.

1.89. “Develop” or “Developing” means to discover, research or otherwise develop
a product, including conducting non-clinical and clinical research and
development activities such as toxicology, pharmacology and other discovery
efforts, test method development and stability testing, process development,
formulation development, delivery system development, quality assurance and
quality control development, statistical analysis, clinical studies (including
pre-approval studies), regulatory affairs, pharmacovigilance and Regulatory
Approval and clinical study regulatory activities (including regulatory
activities directed to obtaining pricing and reimbursement approvals).  When
used as a noun, “Development” shall mean any and all activities involved in
Developing.

 

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1.90. “Development Budget” means the written budget set forth in any Development
Plan, as such written budget may be amended, modified or updated by the JDC in
accordance with the terms of this Agreement.

1.91. “Development Costs” means, as to each Licensed Product (or, if applicable,
any Discovery Program product candidate), the FTE Costs and other direct costs
actually incurred, excluding capital expenditures, to obtain the authorization
or have the ability to Manufacture, formulate, fill, ship and/or sell such
Licensed Product (or, if applicable, such Discovery Program product candidate)
in the Field in commercial quantities in the Territory.  Development Costs shall
include but are not limited to the cost of studies on the toxicological,
pharmacokinetic, metabolic or clinical aspects of such Licensed Product (or, if
applicable, such Discovery Program product candidate) conducted internally or by
individual investigators, or consultants necessary for the purpose of obtaining
or maintaining Regulatory Approval of such Licensed Product (or, if applicable,
such Discovery Program product candidate) in the Field by a Regulatory Authority
in a country of the Territory, and costs for preparing, submitting, reviewing or
developing data or information for the purpose of a submission to a Regulatory
Authority to obtain or maintain Regulatory Approval of such Licensed Product
(or, if applicable, such Discovery Program product candidate) in the Field in a
country of the Territory as well as costs of assay development and process
development scale-up and recovery (including plant costs).  Development Costs
shall include expenses for compensation, benefits and travel and other
employee-related expenses, as well as data management, statistical designs and
studies, document preparation, and other expenses associated with the clinical
testing program.  Development Costs that are to be paid solely by one but not
both of the Parties as set forth in Section 3.2 or Section 4.6 shall not be
included in the determination of Operating Profits (Losses) for the purposes of
Exhibit C.  For clarity, “Development Costs” include any costs incurred in
connection with the Pre-Funded Activities to the extent that such costs
otherwise meet the definition of “Development Costs” hereunder, including any
such costs intended to be covered by the R&D Pre-Funding.

1.92. “Development Plan” means (a) the XLRS Development Plan, (b) the XLRP
Development Plan or (c) any Discovery Program Development Plan, which shall
include at a minimum, Development activities, Development Budgets and associated
timelines for the applicable Collaboration Program for at least the next three
(3) years, or, if Biogen’s internal development plans for similarly situated
products are a shorter time period, such shorter time period. Development Plans
shall be updated annually on a rolling basis pursuant to Section 2.1.2(b)(i).

1.93. “Disclosing Party” has the meaning set forth in Section 14.1.

1.94. “Discovery Event Milestone Payment” has the meaning set forth in Section
6.5.2.

1.95. “Discovery Product” shall mean any AAV Product (a) that is generated by,
is derived from or is the subject of a Discovery Program for which Biogen has
exercised the Option in accordance with Section 4.7 and (b) with respect to
which, absent the license granted to Biogen in Section 5.1, the, Development,
Manufacture, Commercialization or use by Biogen as contemplated under this
Agreement would infringe a Valid Claim of the AGTC Patent Rights or the Joint
Patent Rights or misappropriate AGTC Know-How or Joint Know-How. For clarity,
“Discovery Product” includes any AAV Product that is generated by, is derived
from or is the subject of a Substitute Discovery Program that otherwise meets
the definition of a “Discovery Product”, but excludes any product generated by
or subject to an Abandoned Program.

1.96. “Discovery Program” means (a) the [***] Discovery Program, (b) the [***]
Discovery Program, (c) the Non-Ophthalmology Discovery Program, if applicable,
(d) the [***], (e) the [***] or (f) any Substitute Discovery Program, but
excluding any Abandoned Program.

1.97. “Discovery Program Development Plan” means (a) the [***] Discovery Program
Development Plan, (b) the [***] Discovery Program Development Plan, (c) any
Development Plan for the Non-Ophthalmology Discovery Program approved by the JDC
pursuant to Section 2.1.2(b)(ii), (d) the [***], (e) [***] or (f) any
Development Plan for a Substitute Discovery Program approved by the JDC pursuant
to Section 2.1.2(b)(ii).

1.98. “Discovery Program Substitution Date” has the meaning set forth in Section
4.4.2.

1.99. “Distribution Costs” has the meaning set forth in Exhibit C.

1.100. “Distributor” means any Third Party which purchases its requirements for
Licensed Product in a country from Biogen or its Affiliates or Sublicensees and
is appointed as a distributor to distribute, market and resell such Licensed
Product in such country, even if such Third Party is granted ancillary rights to
develop, package or obtain regulatory approvals of such Licensed Product in
order to distribute, market or sell such Licensed Product in such country.

 

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1.101. “Dollar” means the United States Dollar.

1.102. “[***]” means [***].

1.103. “[***]” means the [***] and the [***].

1.104. “[***]” means a program of Pre-Funded Discovery Activities through
Clinical Candidate Designation with respect to AAV Products that deliver [***],
which [***] shall be designated by the JDC in accordance with Section
2.1.2(b)(iii), for the diagnosis, treatment or prevention of [***], conducted by
either or both Parties in accordance with the [***] and the terms of this
Agreement.

1.105. “[***]” means a program of Pre-Funded Discovery Activities through
Clinical Candidate Designation with respect to AAV Products that deliver [***],
which [***] shall be designated by the JDC in accordance with Section
2.1.2(b)(iii), for the diagnosis, treatment or prevention of [***], conducted by
either or both Parties in accordance with the [***] and the terms of this
Agreement.

1.106. “[***] Development Plan” means the written plan for Pre-Funded Discovery
Activities for the [***] to be conducted pursuant to this Agreement, as such
written plan may be amended, modified or updated by the JDC in accordance with
the terms of this Agreement.  The initial [***] Development Plan shall be
prepared and approved by the JDC in accordance with Section 2.1.2(b)(ii) and
shall be attached hereto as, and shall supersede and replace, Exhibit A-5.

1.107. “[***] Development Plan” means the written plan for Pre-Funded Discovery
Activities for the [***] to be conducted pursuant to this Agreement, as such
written plan may be amended, modified or updated by the JDC in accordance with
the terms of this Agreement.  The initial [***] Development Plan shall be
prepared and approved by the JDC in accordance with Section 2.1.2(b)(ii) and
shall be attached hereto as, and shall supersede and replace, Exhibit A-6.

1.108. “[***]” means [***].

1.109. “Effect” has the meaning set forth in Section 1.179.

1.110. “Effective Date” means the later of (a) the Execution Date or (b) the HSR
Clearance Date.

1.111. “Event Milestone Payment” has the meaning set forth in Section 6.4.1.

1.112. “Execution Date” has the meaning set forth in the preamble.

1.113. “Existing License Agreements” means those certain license agreements as
may be amended from time to time listed on Schedule 15.2.7 (as such Schedule may
be updated in accordance with Section 15.2).

1.114. “Existing Licensors” means the licensors under the Existing License
Agreements.

1.115. “FD&C Act” means the United States Federal Food, Drug, and Cosmetic Act,
as amended, and the rules and regulations promulgated thereunder.

1.116. “FDA” means the United States Food and Drug Administration or any
successor agency thereto.

1.117. “Field” means the diagnosis, treatment or prevention of disease in humans
or animals in any and all indications.

1.118. “FIH Trial” means, with respect to a Licensed Product, the first Clinical
Trial of such Licensed Product.

1.119. “FIH Trial Completion” means, with respect to a Licensed Product, the
earliest of (a) [***] after database lock for the FIH Trial for such Licensed
Product after the last visit of the last subject in such FIH Trial for measuring
data for the primary endpoint for such FIH Trial, (b) (i) with respect to the
XLRS Product, [***] after the initial dosing of the last subject in the FIH
Trial for such Licensed Product or (ii) with respect to the XLRP Product, such
reasonable similar time period as mutually agreed by the Parties in writing
prior to the start of such FIH Trial or (c) [***] of the FIH Trial for such
Licensed Product, if applicable.

 

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1.120. “First Commercial Sale” means, with respect to any Licensed Product and
with respect to any country of the Territory, the first sale of such Licensed
Product by Biogen or an Affiliate or Sublicensee of Biogen to a Third Party in
such country after such Licensed Product has been granted Regulatory Approval by
the appropriate Regulatory Authority(ies) for Commercialization in such country.

1.121. “FTE Costs” means costs actually incurred by a Party in accordance with
the applicable FTE Rate.

1.122. “FTE Rate” means the R&D FTE Rate or the Commercial FTE Rate, as
applicable.

1.123. “GAAP” means United States generally accepted accounting principles,
consistently applied.

1.124. “GCP” means good clinical practices, which are the then current standards
for Clinical Trials for pharmaceuticals, as set forth in the FD&C Act or other
applicable Law, and such standards of good clinical practice as are required by
the Regulatory Authorities of the European Union and other organizations and
Governmental Authorities in countries for which the applicable Licensed Product
is intended to be developed, to the extent such standards are not less stringent
than United States GCP.

1.125. “Gene Therapy Product” means any product containing a virus-based vector
that delivers one or more transgenes to a human or animal subject.

1.126. “GLP” means the then-current good laboratory practice standards
promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58 or the
successor thereto, or comparable regulatory standards in jurisdictions outside
the United States.

1.127. “Governmental Authority” means any court, agency, department, authority
or other instrumentality of any national, state, county, city or other political
subdivision.

1.128. “Gross Sales” has the meaning set forth in Section 1.184.

1.129. “[***]” means [***].

1.130. “[***] Agreements” means the License Agreement, dated [***],  as amended
[***], by and between AGTC and [***], as may be further amended from time to
time, and the License Agreement, dated [***], as amended [***], by and between
AGTC and [***], as may be further amended from time to time.

1.131. “[***] Biological Material(s)” has the meaning set forth in Section
11.4.1(a).

1.132. “[***] Claims” has the meaning set forth in Section 17.5.4.

1.133. “[***] Indemnitees” has the meaning set forth in Section 17.5.4.

1.134. “[***] Product” has the meaning set forth in Section 11.4.1(a).

1.135. “[***] Virus” has the meaning set forth in Section 11.4.1(a).

1.136. “HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976,
as amended, and the rules and regulations promulgated thereunder.

1.137. “HSR Clearance Date” means the earliest date on which the Parties have
actual knowledge that all applicable waiting periods under the HSR Act with
respect to the transactions contemplated hereunder have expired or have been
terminated.

1.138. “HSR Filing” means a filing by Biogen and AGTC with the United States
Federal Trade Commission and the Antitrust Division of the United States
Department of Justice of a Notification and Report Form for Certain Mergers and
Acquisitions (as that term is defined in the HSR Act) with respect to the
matters set forth in this Agreement, together with all required documentary
attachments thereto.

 

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1.139. “[***] Manufacturing Know-How” means all proprietary Know-How, other than
Joint Know-How, Controlled by AGTC or any of its Affiliates as of the Execution
Date or that comes into the Control of AGTC or any of its Affiliates during the
Term that (a) relates to the production, manufacture, or expression of
recombinant AAV using an [***] helper virus, (b) is actually used in a
Collaboration Program and (c) is disclosed to Biogen.  For clarity, actual use
in a Collaboration Program for purposes of this definition includes (i) a good
faith belief by AGTC that certain Know-How would be necessary or useful in such
Collaboration Program and (ii) disclosure by AGTC in a discussion between the
Parties regarding the potential use of such Know-How in such Collaboration
Program.

1.140. “[***] Manufacturing Patent Rights” means all Patent Rights, other than
Joint Patent Rights, Controlled by AGTC or any of its Affiliates as of the
Execution Date or that comes into the Control of AGTC or any of its Affiliates
during the Term that claim or disclose any [***] Manufacturing Know-How.
Notwithstanding the foregoing, Schedule 1.23 sets forth the [***] Manufacturing
Patent Rights as of the Execution Date, and will be updated as set forth in
Section 1.23.

1.141. “[***] Manufacturing Technology” means the [***] Manufacturing Know-How
and the [***] Manufacturing Patent Rights.

1.142. “IND” means an Investigational New Drug Application submitted under the
FD&C Act, or an analogous application or filing with any analogous agency or
Regulatory Authority outside of the United States under any analogous foreign
Law for the purposes of obtaining permission to conduct human clinical studies.

1.143. “Indemnified Party” has the meaning set forth in Section 17.4.

1.144. “Indemnifying Party” has the meaning set forth in Section 17.4.

1.145. “Initial Licensed Product” means (a) the XLRS Product or (b) the XLRP
Product.

1.146. “Initial Licensed Program” means (a) the XLRS Program or (b) the XLRP
Program.

1.147. “Insolvency Event” has the meaning set forth in Section 16.7.

1.148. “Insolvent Party” has the meaning set forth in Section 16.7.

1.149. “Invented” means the act of invention by inventors, in accordance with
statutes and regulations regarding inventorship as established under United
States patent law, including case law, rules and guidelines associated
therewith. “Invent” or “Invents” have correlative meanings.

1.150. “JHU” means Johns Hopkins University.

1.151. “JHU Inventors” has the meaning set forth in Section 17.5.3.

1.152. “Joint Commercialization Committee” or “JCC” has the meaning set forth in
Section 2.2.1.

1.153. “Joint Development Committee” or “JDC” has the meaning set forth in
Section 2.1.1.

1.154. “Joint Improved Know-How” means Joint Know-How that constitutes an
improvement or enhancement to any Biogen Technology.

1.155. “Joint Improved Patent Right” means any Patent Right that claims or
discloses any Joint Improved Know-How that is Invented jointly by or on behalf
of (i) on the one hand, AGTC or any of its Affiliates or Sublicensees and (ii)
on the other hand, Biogen or any of its Affiliates or Sublicensees, in each
case, in the course of conducting activities under this Agreement.

1.156. “Joint Improved Technology” means the Joint Improved Know-How and the
Joint Improved Patent Rights.

 

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1.157. “Joint Know-How” means Know-How that is conceived, discovered, invented,
created, made or reduced to practice or tangible medium jointly by or on behalf
of (i) on the one hand, AGTC or any of its Affiliates or Sublicensees and (ii)
on the other hand, Biogen or any of its Affiliates or Sublicensees, in each
case, in the course of conducting activities under this Agreement.

1.158. “Joint Patent Right” means any Patent Right that claims or discloses
Know-How that is Invented jointly by or on behalf of (i) on the one hand, AGTC
or any of its Affiliates or Sublicensees and (ii) on the other hand, Biogen or
any of its Affiliates or Sublicensees, in each case, in the course of conducting
activities under this Agreement.

1.159. “Joint Platform Improvement Know-How” means Joint Know-How that
constitutes an improvement or enhancement to the AGTC Platform.

1.160. “Joint Platform Improvement Patent Right” means any Patent Right that
claims or discloses any Joint Platform Improvement Know-How that is Invented
jointly by or on behalf of (i) on the one hand, AGTC or any of its Affiliates or
Sublicensees and (ii) on the other hand, Biogen or any of its Affiliates or
Sublicensees, in each case, in the course of conducting activities under this
Agreement.

1.161. “Joint Platform Improvement Technology” means the Joint Platform
Improvement Know-How and the Joint Platform Improvement Patent Rights.

1.162. “Joint Technology” means the Joint Know-How and the Joint Patent Rights.

1.163. “Know-How” means intellectual property, data, results, pre-clinical and
clinical protocols and study data, chemical structures, chemical sequences,
information, inventions, know-how, formulas, trade secrets, techniques, methods,
processes, procedures and developments, whether or not patentable; except that
Know-How does not include Patent Rights claiming any of the foregoing.  For
clarity, “Know-How” does not include any Materials.

1.164. “Knowledge” means, with respect to AGTC, the then, actual knowledge,
after inquiry of patent counsel, but without any other duty of inquiry, of the
Chief Executive Officer, Chief Financial Officer, Chief Medical Officer, Chief
Business Officer, Chief Scientific Officer and Senior Director – Process
Development, Senior Director – Research and Pre-Clinical Studies and any other
person performing substantially the same functions as any of the foregoing.

1.165. “Law” means any law, statute, rule, regulation, order, judgment or
ordinance of any Governmental Authority.

1.166. “Liability” has the meaning set forth in Section 17.2.

1.167. “Licensed Activities” has the meaning set forth in Section 13.6.1.

1.168. “Licensed Product” means (a) any XLRS Product, (b) any XLRP Product or
(c) any Discovery Product.

1.169. “Licensed Program” means (a) the XLRS Program, (b) the XLRP Program or
(c) any Discovery Program for which Biogen has exercised the Option in
accordance with Section 4.7.

1.170. “Limited Milestone Payment” has the meaning set forth in Section 6.2.1.

1.171. “MAA” means a Marketing Authorization Application for the applicable
Licensed Product under the centralized European procedure.

1.172. “Major EU Market Countries” means the following countries: [***].

1.173. “Major Market Countries” means the following countries: [***].

1.174. “Manufacture” or “Manufacturing” means activities directed to making,
producing, manufacturing, processing, filling, finishing, packaging, labeling,
quality control testing and quality assurance release, shipping or storage of a
product.

1.175. “Manufacturing Precedent Period” has the meaning set forth in Section
2.1.4(a)(v).

 

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1.176. “Manufacturing Technology Agreement” means the Manufacturing License and
Technology Transfer Agreement, executed by the Parties on even date herewith.

1.177. “Marketing Application” means an application, submitted to a Regulatory
Authority in any jurisdiction, for Regulatory Approval required in order to
Commercialize a product as a drug, including a BLA.

1.178. “Marketing Costs” has the meaning set forth in Exhibit C.

1.179. “Material Adverse Event” means, with respect to AGTC, an event,
occurrence, development or change (a) that occurs after the Execution Date and
prior to or on the HSR Clearance Date (each event, occurrence, development or
change that satisfies the criteria in this clause (a), an “Effect”) and (b) that
when taken together with all other Effects, has or would reasonably be expected
to have a material adverse effect on the AGTC Technology taken as a whole, the
Parties’ practice of the AGTC Technology taken as a whole and as contemplated by
this Agreement or the Development, Manufacture or Commercialization of Licensed
Products as contemplated by this Agreement, except for any Effect resulting from
(1) any change in applicable Law or the interpretation thereof other than any
change in regulations promulgated by the FDA or any other Regulatory Authority
or any change in the interpretation of any regulation promulgated by the FDA or
any other Regulatory Authority, (2) any event or change affecting the
pharmaceutical industry as a whole or the gene therapy industry in particular
that does not have a disproportionate effect on the practice of the AGTC
Technology taken as a whole and as contemplated by this Agreement or the
Development, Manufacture or Commercialization of Licensed Products as
contemplated by this Agreement, (3) any event or change affecting Biogen,
provided that such event or change is not caused by AGTC or (4) announcement of
entry into this Agreement.

1.180. “Materials” means any biological or chemical materials in each case, that
are necessary or useful to exploit the licenses granted to Biogen under this
Agreement including, but not limited to, cell lines (e.g.,  parental cell lines
and any non-commercially available cell lines or cell-based assays, for example,
the [***] and [***] cell lines [***], appropriate rep-cap-, gene of interest-
and any other related [***]  seed stocks, any material-, platform- or
product-specific reference materials including any platform or product-specific
assay controls and reagents that are not readily available as standard
commercial items.

1.181. “Medical Education Costs” has the meaning set forth in Exhibit C.

1.182. “Milestone/Royalty Option” has the meaning set forth in Section 6.2.2.

1.183. “NDA” means a New Drug Application (as more fully described in 21 C.F.R.
Parts 314 et seq. or its successor regulation).

1.184. “Net Sales” means, with respect to a Licensed Product in a country in the
Territory, the gross amount invoiced by Biogen, its Affiliates or Sublicensees
for the sale or other disposition of such Licensed Product in such country to
Third Parties (including Distributors, wholesalers and end-users) (“Gross
Sales”), less the following deductions (such deductions, collectively, “Sales
Returns and Allowances”):

(a) sales returns and allowances actually paid, granted or accrued on the
Licensed Product, including trade, quantity, prompt pay and cash discounts and
any other adjustments, including those granted on account of price adjustments
or billing errors;

(b) credits or allowances given or made for rejection, recall, return or wastage
replacement of, and for uncollectible amounts on, Licensed Product or for
rebates or retroactive price reductions (including Medicare, Medicaid, managed
care and similar types of rebates and chargebacks);

(c) taxes, duties or other governmental charges levied on or measured by the
billing amount for Licensed Product, as adjusted for rebates and refunds,
including without limitation pharmaceutical excise taxes (such as those imposed
on a Licensed Product by the United States Patient Protection and Affordable
Care Act of 2010 and other comparable laws), but which shall not include any
tax, duty, or other charge imposed on or measured by net income (however
denominated) or any franchise taxes, branch profits taxes, or similar tax; and

(d) charges for freight, customs and insurance directly related to the
distribution of the Licensed Product and wholesaler and Distributor
administration fees; and

 

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(e) other future similar deductions, taken in the ordinary course of business or
in accordance with GAAP and Biogen’s standard practices;

to the extent such deductions: (i) are reasonable and customary, (ii) included
in the gross invoiced sales price for the Licensed Product or otherwise directly
paid, allowed, accrued, or incurred by such Party, its Affiliates or
Sublicensees with respect to the sale of such Licensed Product (iii) applicable
and in accordance with standard allocation procedures, (iv) have not already
been deducted or excluded, (v) are incurred in the ordinary course of business
in type and amount consistent with good industry practice, and (vi) except with
respect to the uncollectible amounts and pharmaceutical excise taxes described
in subsections (b) and (c) above, are determined in accordance with, and as
recorded in revenues under, GAAP.  Net Sales shall not be imputed to transfers
of Licensed Product without consideration or for nominal consideration for use
in any Clinical Trial, or for any bona fide charitable, compassionate use or
indigent patient program purpose where Licensed Products are sold at or below
Cost of Goods Sold or as a sample.  For the avoidance of doubt, in the case of
any transfer of any Licensed Product between or among Biogen and its Affiliates
or Sublicensees for resale, Net Sales shall be determined based on the sale made
by such Affiliate or Sublicensee to a Third Party.

Notwithstanding the foregoing, in the event a Licensed Product is sold as a
component of a Combination Product in any country in the Territory in any
Calendar Quarter, Net Sales shall be calculated by multiplying the Net Sales of
the Combination Product (calculated in the same manner as set forth above as if
the Combination Product were a Licensed Product) in such country during such
Calendar Quarter by the fraction A/(A+B), where A is the average Net Sales of
the Licensed Product when sold separately in such country during such Calendar
Quarter and B is the average Net Sales of the Other Components included in the
Combination Product (calculated in the same manner as set forth above as if the
Other Components were Licensed Product) when sold separately in such country
during such Calendar Quarter.  In the event that no separate sales of the
Licensed Product or any Other Components included in a Combination Product are
made by Biogen, its Affiliates or Sublicensees in a country during a Calendar
Quarter in which such Combination Product is sold in such country, the average
Net Sales in the above described equation shall be replaced with reasonable good
faith estimate of the fair market value, as mutually determined by the Parties,
of the Licensed Product and each of the Other Components included in such
Combination Product.

1.185. “Non-Disclosing Party” has the meaning set forth in Section 14.6.4.

1.186. “Non-Ophthalmology Discovery Program” has the meaning set forth in
Section 4.4.4.

1.187. “Obligated Party” has the meaning set forth in Section 3.3.2.

1.188. “Operating Profit or Loss” or “Operating Profits (Losses)” has the
meaning set forth in Exhibit C.

1.189. “Option” has the meaning set forth in Section 4.7.

1.190. “Option Exercise Date” has the meaning set forth in Section 4.7.

1.191. “Option Exercise Period” has the meaning set forth in Section 4.7.

1.192. “Option Fee” shall have the meaning set forth in Section 6.5.1.

1.193. “Orphan Drug Designation” means a grant by the FDA of a request for
designation under Section 526 of the Federal Food, Drug, and Cosmetic Act as
amended by section 2 of the Orphan Drug Act (sections 525-528 (21 U.S.C.
360aa-360dd)) in the United States or any analogous grant by a Regulatory
Authority in any other country in the Territory.

1.194. “Orphan Drug Exclusivity” means, with respect to a Licensed Product, a
grant of a period of marketing exclusivity by a Regulatory Authority for such
Licensed Product in connection with an Orphan Drug Designation for such Licensed
Product.

1.195. “Other Components” shall have the meaning set forth in Section 1.61.

1.196. “Other Operating Income/Expense” has the meaning set forth in Exhibit C.

1.197. “Out-of-Pocket Costs” means, with respect to a Party, costs and expenses
paid by such Party to Third Parties (or payable to Third Parties and accrued in
accordance with GAAP), other than Affiliates or employees of such Party.

 

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1.198. “Party” or “Parties” has the meaning set forth in the preamble.

1.199. “Patent Costs” has the meaning set forth in Exhibit C.

1.200. “Patent Representative” has the meaning set forth in Section 13.3.1(a).

1.201. “Patent Rights” means the rights and interests in and to issued patents
and pending patent applications in any country, jurisdiction or region
(including inventor’s certificates and utility models), including all
provisionals, non-provisionals, substitutions, continuations,
continuations-in-part, divisionals, renewals and all patents granted thereon,
and all reissues, reexaminations, extensions, confirmations, revalidations,
registrations and patents of addition thereof, including supplementary
protection certificates, PCTs, pediatric exclusivity periods and any foreign
equivalents to any of the foregoing.

1.202. “[***] Agreement” means the [***] License Agreement, dated [***], as
amended June 30, 2015, by and between AGTC and [***], as may be further amended
from time to time.

1.203. “Person” means an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited liability
company, business trust, joint stock company, trust, incorporated association,
joint venture or similar entity or organization, including a government or
political subdivision or department or agency of a government.

1.204. “Pivotal Trial” means a human Clinical Trial of a Licensed Product which
is intended to be sufficient for obtaining Regulatory Approval, or is according
to 21 C.F.R. §312.21(c), as amended, or its equivalent, as appropriate, in
foreign jurisdictions.

1.205. “Post-Funding Development Activities” means, with respect to each Initial
Licensed Program, any activities related to the Development of an Initial
Licensed Product in such Initial Licensed Program under the applicable
Development Plan that are not Pre-Funded Activities.

1.206. “Preclinical Studies” means any preclinical pharmacokinetic, toxicology
or other study relating to one or more Licensed Products.

1.207. “Pre-Funded Activities” means (a) with respect to the XLRS Program, any
Development activities conducted under the XLRS Development Plan for the XLRS
Product [***] and (b) with respect to the XLRP Program, any Development
activities conducted under the XLRP Development Plan for a XLRP Product [***],
in each case ((a) and (b)), that are designated under the applicable Development
Budget to be funded by the R&D Pre-Funding.

1.208. “Pre-Funded Discovery Activities” means, with respect to any of the [***]
Discovery Program, the [***] Discovery Program, the Non-Ophthalmology Discovery
Program, if applicable, the [***], the [***] or any Substitute Discovery
Program, any Development activities that take place under and pursuant to a
Discovery Program Development Plan for such Discovery Program in accordance with
this Agreement.

1.209. “[***] Program” means, at any time, a research program being conducted
solely by or on behalf of AGTC in an indication or involving a gene target, for
which program AGTC has not (i) already granted rights to or entered into a fully
executed term sheet (which may be a non-binding term sheet) contemplating the
grant of rights to a Third Party that would preclude the granting of rights to
Biogen for such program as a Discovery Program to the extent contemplated by
this Agreement or (ii) begun [***] for purposes of selecting a candidate
comprising a [***] to use for such indication or involving such gene target.

1.210. “Price Approval” means, in any country where a Governmental Authority
authorizes reimbursement for, or approves or determines pricing for,
pharmaceutical products, receipt (or, if required to make such authorization,
approval or determination effective, publication) of such reimbursement
authorization or pricing approval or determination (as the case may be).

1.211. “Product-Specific Know-How” means all Know-How Controlled by a Party or
an Affiliate thereof, or jointly by the Parties or one of each of their
respective Affiliates, as of the Execution Date or during the Term that relates
exclusively to the composition, formulation or use of a Licensed Product or
methods of manufacture exclusively related to a Licensed Product, but excluding
Joint Platform Improvement Know-How and Biogen Platform Improvement Know-How.

1.212. “Product-Specific Patent Right” means all Patent Rights Controlled by a
Party or an Affiliate thereof, or jointly by the Parties or their respective
Affiliates, as of the Execution Date or during the Term that exclusively Covers
the composition,

 

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formulation or use of a Licensed Product or methods of manufacture exclusively
related to a Licensed Product, but excluding Joint Platform Improvement Patent
Rights and Biogen Platform Improvement Patent Rights.  Notwithstanding the
foregoing, Schedule 1.212 sets forth the AGTC Patent Rights that are
Product-Specific Patent Rights as of the Execution Date, and will be updated (i)
on or prior to the Schedule Revision Date to include additional AGTC Patent
Rights filed between the Execution Date and the Schedule Revision Date that are
Product-Specific Patent Rights as of the Effective Date, if any and (ii) on or
prior to the Option Exercise Date for each Discovery Program with respect to the
Discovery Product for which the Option is being exercised.  Schedule 1.212 shall
be updated by the Patent Representatives on a semi-annual basis to include
additional AGTC Patent Rights that are Product-Specific Patent Rights, if any,
that become AGTC Patent Rights after the Schedule Revision Date, provided that
any AGTC Patent Right that is not listed on Schedule 1.212, but is otherwise
described in this Section 1.212 and confirmed by the Patent Representatives to
be a Product-Specific Patent Right pursuant to Section 13.3, shall still be
considered a Product-Specific Patent Right hereunder.

1.213. “Product-Specific Technology” means the Product-Specific Know-How and the
Product-Specific Patent Rights.

1.214. “Program Data” means all preclinical and clinical data and results,
including all study databases, generated by either Party or both Parties or
their respective Affiliates, Subcontractors or agents in the course of
performance of their activities pursuant to the Licensed Programs (including
under any Development Plan).  For clarity, any such data with respect to a
Discovery Program generated prior to the Option Exercise Date in the course of
performance of activities pursuant to such Discovery Program (including under
the applicable Discovery Program Development Plan) shall be deemed “Program
Data” as of the Option Exercise Date with respect to such Discovery Program.

1.215. “Promoter Know-How” means all proprietary Know-How, other than Joint
Know-How, Controlled by AGTC or any of its Affiliates as of the Execution Date
or that comes into the Control of AGTC or any of its Affiliates during the Term
that (a) relates to the design, selection or sequence of nucleic acid signaling
sequences, inverted terminal repeats, long terminal repeats, introns, or
microRNA target sequences that the foregoing, when contained in an AAV vector,
demonstrate targeted expression of a recombinant AAV comprising a transgene to a
specific cell type or increased expression in a variety of cell types, (b) is
actually used in a Collaboration Program and (c) is disclosed to Biogen.  For
clarity, actual use in a Collaboration Program for purposes of this definition
includes (i) a good faith belief by AGTC that certain Know-How would be
necessary or useful in such Collaboration Program and (ii) disclosure by AGTC in
a discussion between the Parties regarding the potential use of such Know-How in
such Collaboration Program.

1.216. “Promoter Patent Rights” means Patent Rights, other than Joint Patent
Rights, Controlled by AGTC or any of its Affiliates as of the Execution Date or
that comes into the Control of AGTC or any of its Affiliates during the Term
that claim or disclose any Promoter Know-How.  Notwithstanding the foregoing,
Schedule 1.23 sets forth the Promoter Patent Rights as of the Execution Date,
and will be updated as set forth in Section 1.23.

1.217. “Promoter Technology” means Promoter Know-How and Promoter Patent Rights.

1.218. “R&D FTE Rate” means [***], which rate shall be updated for each Calendar
Year to a rate as agreed by the Parties, commencing on January 1, 2017, provided
that, if the Parties cannot come to agreement with respect to such rate in any
given year, such rate shall be updated for such year in accordance with the
Consumer Price Index – All Urban Consumers, US City Average, All Items, 1982-84
= 100, published by the United States Department of Labor, Bureau of Labor
Statistics (or its successor equivalent index) over the twelve (12) month period
preceding January 1 of the applicable Calendar Year.

1.219. “R&D Pre-Funding” has the meaning set forth in Section 6.1.

1.220. “Receiving Party” has the meaning set forth in Section 14.1.

1.221. “Regulatory Approval” means the technical, medical and scientific
licenses, registrations, authorizations and approvals (including approvals of
BLAs, supplements and amendments, pre- and post- approvals, pricing and third
party reimbursement approvals, and labeling approvals) of any Regulatory
Authority, necessary for the commercial manufacture, distribution, marketing,
promotion, offer for sale, use, import, export or sale of a pharmaceutical
product in a regulatory jurisdiction. For the sake of clarity, Regulatory
Approval shall not be achieved for a Licensed Product in a country until all
applicable Price Approvals and other Third Party reimbursement approvals have
also been obtained by Biogen or its designee for such Licensed Product in such
country.

 

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1.222. “Regulatory Authority” means, with respect to a country in the Territory,
any national (e.g., the FDA), supra-national (e.g., the European Commission, the
Council of the European Union, or the European Medicines Agency), regional,
state or local regulatory agency, department, bureau, commission, council or
other Governmental Authority involved in the granting of a Regulatory Approval
for pharmaceutical products in such country or countries.

1.223. “Research Period” means, with respect to any Discovery Program, the
period (a) starting (i) on the Effective Date, if such Discovery Program is the
[***] Discovery Program, the [***] Discovery Program, the Non-Ophthalmology
Discovery Program, if applicable, the [***] or [***] or (ii) on the Discovery
Program Substitution Date, if such Discovery Program is a Substitute Discovery
Program and (b) ending on the earlier of the date of Clinical Candidate
Designation for such Discovery Program or the date that such Discovery Program
becomes an Abandoned Program.

1.224. “Residual Knowledge” means knowledge, techniques, experience and Know-How
that are (a) included in any Confidential Information owned or Controlled by the
Disclosing Party and (b) retained in the unaided memory of any employee or
representative of the Receiving Party as part of a body of knowledge that is not
limited to such Confidential Information, after having authorized access to such
Confidential Information, provided that such employee or representative has not
accessed any written or electronic records or other embodiments of any
Confidential Information of the Disclosing Party for use of such Confidential
Information outside of this Agreement.  A person’s memory will be considered to
be unaided if the person (i) has not made any effort to memorize or assist the
recollection of the Confidential Information for the purpose of retaining and
subsequently using or disclosing it, (ii) is not relying on the external
records, documents or embodiments of the Disclosing Party’s Confidential
Information, or notes taken on the foregoing and (iii) is not knowingly
disclosing what such person knows to be the Confidential Information of the
Disclosing Party. In no event, however, will Residual Knowledge include any
knowledge, techniques, experience and Know-How to the extent (at any time, for
such time) within the scope of any Patent Right owned or Controlled by the
Disclosing Party.

1.225. “ROW Territory” means all countries in the Territory other than the
United States.

1.226. “Royalty Term” means with respect to any particular Licensed Product in
any particular country in the Territory, the period of time beginning on the
First Commercial Sale of such Licensed Product in such country and extending
until the latest of (a) the expiration of the last to expire of any Valid Claim
included in any AGTC Patent Right or Joint Patent Right in such country which
Valid Claim Covers the manufacture, use, sale, offer for sale or importation of
such Licensed Product in such country; (b) [***].

1.227. “[***]” has the meaning set forth in Section [***].

1.228. “RS-1” has the meaning set forth in Section 1.263.

1.229. “Sales Costs” has the meaning set forth in Exhibit C.

1.230. “Sales Milestone Payment” has the meaning set forth in Section 6.4.2.

1.231. “Sales Returns and Allowances” has the meaning set forth in Section
1.184.

1.232. “Schedule Revision Date” means the earlier of (a) the fifth (5th) day
following the HSR Clearance Date and (b) the day on or after the HSR Clearance
Date on which AGTC provides to Biogen either (i) AGTC’s supplemental or
additional schedules (if any) pursuant to the proviso in the first sentence of
Section 15.2, the agreed-upon updated schedules of AGTC Patent Rights, the AGTC
Platform and the Product-Specific Patent Rights of AGTC, if any, and a notice
that no further supplemental, additional or updated schedules will be provided
or (ii) instead of providing any such supplemental, additional or updated
schedules, a notice that no further supplemental, additional or updated
schedules will be provided.

1.233. “Specification” means a list of tests, references to analytical
procedures, and appropriate acceptance criteria which are numerical limits,
ranges, or other criteria for the tests described, which establishes the set of
criteria to which a drug substance, drug product, or materials at other stages
of its Manufacture or with respect to other drug substances, drug products or
materials should conform to be considered acceptable for its intended use.

1.234. “[***] Discovery Program” means a program of Pre-Funded Discovery
Activities through Clinical Candidate Designation with respect to AAV Products
that deliver [***] for the diagnosis, treatment or prevention of [***] disease,
conducted by either or both Parties in accordance with the [***] Discovery
Program Development Plan and the terms of this Agreement.

 

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1.235. “[***] Discovery Program Development Plan” means the written plan for
Pre-Funded Discovery Activities for the [***] Discovery Program to be conducted
pursuant to this Agreement, as such written plan may be amended, modified or
updated by the JDC in accordance with the terms of this Agreement.  The initial
[***] Discovery Program Development Plan is attached hereto as Exhibit A-3.

1.236. “[***]” has the meaning set forth in Section [***].

1.237. “Subcontractor” has the meaning set forth in Section 3.4.

1.238. “Sublicensee” means (i) with respect to Biogen or its Affiliate, a Third
Party, other than a Distributor, to whom Biogen or its Affiliate has, directly
or through multiple tiers, granted a right under the AGTC Technology or the
Joint Technology to make, use, develop, sell, offer for sale or import a
Licensed Product in a country or otherwise exercise its rights or perform its
obligations under this Agreement or any Development Plan, and (ii) with respect
to AGTC or its Affiliate, a Third Party, other than a Distributor, to whom AGTC
or its Affiliate has, directly or through multiple tiers, granted a right under
the Biogen Technology or the Joint Technology to exercise its rights or perform
its obligations under this Agreement or any Development Plan.

1.239. “Substitute Discovery Program” has the meaning set forth in Section
4.4.1.

1.240. “Substitution Notice” has the meaning set forth in Section 4.4.2.

1.241. “Sued Party” has the meaning set forth in Section 13.6.3.

1.242. “Tax Authority” has the meaning set forth in Section 6.8.1.

1.243. “Technology” means Know-How and Patent Rights.

1.244. “Term” has the meaning set forth in Section 16.4.

1.245. “Terminated Discovery Products” has the meaning set forth in Section
4.4.2.

1.246. “Terminated Discovery Program” has the meaning set forth in Section
4.4.2.

1.247. “Territory” means all countries of the world.

1.248. “Third Party” means any Person other than Biogen, AGTC or their
respective Affiliates.

1.249. “Third Party IP Rights” has the meaning set forth in Section 13.6.2(a).

1.250. “Third Party License” has the meaning set forth in Section 6.6.1(a).

1.251. “Third Party Payments” has the meaning set forth in Exhibit C.

1.252. “UAB” means The UAB Research Foundation.

1.253. “UAB Agreement” means the Non-Exclusive License Agreement with
Sublicensing Terms, dated January 19, 2006, as amended March 28, 2014 and June
29, 2015, as may be further amended from time to time, by and between AGTC and
UAB.

1.254. “UF/JHU Agreement” means the Standard Exclusive License Agreement With
Sublicensing Terms (also known as Agreement A3288), dated October 7, 2003, as
amended November 2004, February 25, 2009, March 30, 2010, December 17, 2013 and
July 1, 2015, as may be further amended from time to time, by and among AGTC,
UFRF and JHU.

1.255. “UFRF” means University of Florida Research Foundation, Inc.

1.256. “Valid Claim” means a claim of (a) an issued and unexpired patent, which
claim has not been revoked or held unenforceable, unpatentable or invalid by a
decision of a court or other governmental agency of competent jurisdiction,
which is not

 

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appealable or has not been appealed within the time allowed for appeal, and
which has not been abandoned, disclaimed, denied or admitted to be invalid or
unenforceable through reissue, re-examination or disclaimer or otherwise, or (b)
a patent application for a patent that has been pending less than [***] from the
earliest date on which such patent application claims priority and which claim
has not been cancelled, withdrawn or abandoned or finally rejected by an
administrative agency action from which no appeal can be taken.  If a claim of a
patent application that ceased to be a Valid Claim due to the passage of time
later issues, then it will again be a Valid Claim effective as of the issuance
of such patent.

1.257. “XLRP” means X-linked retinitis pigmentosa.

1.258. “XLRP Development Plan” means the written plan for Development activities
for the XLRP Product to be conducted pursuant to this Agreement, as such written
plan may be amended, modified or updated by the Joint Development Committee in
accordance with the terms of this Agreement.  The initial XLRP Development Plan
is attached hereto as Exhibit A-2.

1.259. “XLRP Product” means any Gene Therapy Product (a) that delivers [***] and
(b) with respect to which, absent the license granted to Biogen in Section 5.1,
the, Development, Manufacture, Commercialization or use by Biogen as
contemplated under this Agreement would infringe a Valid Claim of the AGTC
Patent Rights or the Joint Patent Rights or misappropriate AGTC Know-How or
Joint Know-How.  For clarity, “XLRP Product” includes any Gene Therapy Product
developed under the XLRP Program as a back-up product or other additional
pre-clinical product that otherwise meets the definition of a “XLRP Product”.

1.260. “XLRP Program” means the Development activities with respect to the XLRP
Product under the XLRP Development Plan, in accordance with the terms of this
Agreement.

1.261. “XLRS” means X-linked juvenile retinoschisis.

1.262. “XLRS Development Plan” means the written plan for Development activities
for the XLRS Product to be conducted pursuant to this Agreement, as such written
plan may be amended, modified or updated by the Joint Development Committee in
accordance with the terms of this Agreement.  The initial XLRS Development Plan
is attached hereto as Exhibit A-1.

1.263. “XLRS Product” means any Gene Therapy Product (a) that delivers a
retinoschisin-1 (“RS-1”) transgene (or any functional allelic, codon optimized
or other variant, fragment, derivative or modification thereof, in any form) and
(b) with respect to which, absent the license granted to Biogen in Section 5.1,
the, Development, Manufacture, Commercialization or use by Biogen as
contemplated under this Agreement would infringe a Valid Claim of the AGTC
Patent Rights or the Joint Patent Rights or misappropriate AGTC Know-How or
Joint Know-How.  For clarity, “XLRS Product” includes any Gene Therapy Product
developed under the XLRS Program as a back-up product or other additional
pre-clinical product that otherwise meets the definition of a “XLRS Product”.

1.264. “XLRS Program” means the Development activities with respect to the XLRS
Product under the XLRS Development Plan, in accordance with the terms of this
Agreement.

2. GOVERNANCE.

2.1. Joint Development Committee.

2.1.1. Composition.  As soon as practicable, but no later than thirty (30) days
following the Effective Date, the Parties shall form a joint development
committee (the “Joint Development Committee” or the “JDC”).  The JDC shall be
comprised of an equal number of representatives from each Party.  If mutually
agreed by the Parties on a case-by-case basis, the JDC may invite other
non-members to participate in the discussions and meetings of the JDC, provided
that the presence of such participants shall not be considered in determining
whether there is a quorum at the JDC.  Each Party shall notify the other Party
in writing of its initial representatives to the JDC, and may substitute one or
more representatives from time to time upon written notice to the other
Party.  A designated representative of Biogen will be the chairman of the JDC
until the end of the first full Calendar Year following the Effective Date, and
thereafter the chairman will be selected alternately, on an annual basis, by
AGTC or by Biogen.  The chairman shall be responsible for setting the agenda for
meetings of the JDC, with input from the other members, and for conducting the
meetings of the JDC.

2.1.2. Responsibilities.

 

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(a) General Responsibilities.  The JDC shall be responsible for oversight of (i)
Pre-Funded Activities and Post-Funding Development Activities with respect to
each Initial Licensed Program, including the Development Plans and corresponding
Development Budgets and timelines thereunder, each Party’s Development
activities, including pre-clinical work and IND-enabling studies for each
Initial Licensed Product and (ii) Pre-Funded Discovery Activities with respect
to each Discovery Program, including the Discovery Program Development Plans and
corresponding Development Budgets and timelines thereunder.

(b) Decision-Making Responsibilities.  In addition to the foregoing general
responsibilities and any other matters specified in this Agreement for
resolution by the JDC, the JDC shall in particular have the following
decision-making responsibilities:

(i) discuss, prepare and approve any Development Plan or Development Budget or
any amendment or modification to a Development Plan or Development Budget or
timelines or activities thereunder, [***], which amendments or modifications the
JDC shall be required to formally document on an annual basis as part of the
minutes of the meetings of the JDC,

(ii) discuss, prepare and approve the initial Development Plan and Development
Budget for the [***], the Non-Ophthalmology Discovery Program, if applicable,
and any Substitute Discovery Program,

(iii) designate the [***] Discovery Program within six (6) months of the
Effective Date,

(iv) if, under Section 3.2, the Parties share Development Costs for any Initial
Licensed Product that is not a Cost Share Product, develop and approve a
procedure for sharing of such Development Costs consistent with the procedures
set forth in Exhibit C,

(v) oversee and resolve the financial, budgetary and accounting issues which may
arise in connection with any Development Plan and the corresponding Development
Budget,

(vi) determine if (a) any AGTC Technology conceived, discovered, invented,
created, made or reduced to practice or tangible medium outside of a
Collaboration Program or (b) any Technology Controlled by Biogen that Biogen
desires to use in a Collaboration Program, in each case ((a) and (b)), that
comes into the Control of the applicable Party after the Effective Date, is to
be used in a Collaboration Program, if such use would require additional
Development activities or change the anticipated timing of any Pre-Funded
Activities, Pre-Funded Discovery Activities or Post-Funding Development
Activities under any Development Plan, subject to the provisions of Section
13.6.2(a) with respect to the use of any Technology that comes into the Control
of AGTC or its Affiliates during the Term through a license of Third Party IP
Rights, and

(vii) approve the matters contemplated by Exhibit C.

(c) Oversight.  In addition to the foregoing decision-making responsibilities,
the JDC shall have the following oversight responsibilities:

(i) oversee and review the activities under each Development Plan or Development
Budgets, including but not limited to timelines, thereunder,

(ii) manage the overall strategy for Development activities with respect to each
Collaboration Program under the Development Plans,

(iii) monitor the spending of the Parties under each Development Plan and
corresponding Development Budget,

(iv) oversee Manufacturing activities with respect to clinical supplies of
Licensed Product, including quality assurance and the selection of, and
technology transfer to, any Third Party contract organizations assisting with
such Manufacturing activities in accordance with this Agreement,

 

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(v) manage the technology transfer of AGTC Know-How and data from AGTC to Biogen
as described in Section 11.1, Section 11.2 and Section 11.3 or in any
Development Plan or that is otherwise reasonably requested by Biogen and
otherwise necessary or useful for Biogen to perform its obligations or exercise
its rights under this Agreement with respect to a Licensed Program, and

(vi) perform such other functions as may be appropriate to further the purposes
of this Agreement, in each case with respect to Development activities for the
Collaboration Programs, as mutually agreed in writing by the Parties.

The JDC, in its discretion, may establish subcommittees or working groups to
assist the JDC in carrying out the responsibilities of the JDC.  For clarity,
the JDC shall have no oversight authority over activities related to the
Commercialization of any Licensed Product or, except as expressly set forth
above, the Manufacture and supply of any Licensed Product required for
Commercialization.

(d) General.  The JDC shall conduct its responsibilities hereunder in good faith
and with reasonable care and diligence.

2.1.3. Meetings.

(a) Subject to this Section 2.1.3(a), the JDC shall meet in person or by
teleconference once per Calendar Quarter (or more often, as mutually agreed by
the Parties) on such dates and at such times and places as agreed to by the
members of the JDC, provided that the JDC shall meet promptly following FIH
Trial Completion with respect to any Initial Licensed Product.  Meetings of the
JDC shall be alternately hosted by the Parties, with the host determining
whether the meeting will be in person or by teleconference, provided that at
least one meeting hosted by each Party in each Calendar Year shall be in person
and the first in-person meeting shall be hosted by Biogen no later than sixty
(60) days from the Effective Date.  Each Party shall be responsible for its own
expenses relating to attendance at or participation in JDC meetings.

(b) Within ten (10) Business Days following each JDC meeting, the Party hosting
the meeting shall cause to be prepared and shall provide to the other Party a
draft of reasonably detailed written minutes describing all matters reviewed or
considered by the JDC and all determinations made and actions taken by the JDC
and a summary of the reasons therefor stated by the members at the meeting.  The
minutes of any meeting of the JDC must be finalized by approval of the members
of the JDC within fifteen (15) Business Days of the meeting.  The final minutes
shall include the relevant executed amendments to the Development Plans
reflecting the discussed and approved changes.  The minutes and the drafts of
any minutes shall be the Confidential Information of both Parties.

(c) Each Party shall submit to the JDC at least five (5) Business Days prior to
any meeting of the JDC all reports required to be submitted by such Party to the
JDC at such meeting under this Agreement.

2.1.4. Decision Making.  Each Party shall be entitled to cast one vote on
matters before the JDC.  For the transaction of business, a quorum consisting of
not less than one representative of each Party must be present at a meeting, and
each Party shall cause at least one representative of such Party to be present
at each such meeting.  Decisions of the JDC shall be made by unanimous approval,
provided that a quorum must be present for any decision to be made by the
JDC.  If the JDC is unable to reach agreement with respect to any decision
within the scope of its authority, such dispute shall be escalated to the
Alliance Managers for resolution.  If the Alliance Managers are unable to reach
agreement with respect to such decision within thirty (30) days of such
escalation, such dispute shall be escalated to the Chief Executive Officer of
each Party (or his/her nominee), and such Chief Executive Officers (or their
nominees, as applicable) will meet promptly to attempt to resolve the dispute by
good faith negotiations.  If these individuals are unable to resolve the dispute
within thirty (30) days of the request for such meeting, the matter shall be
decided [***]:

(a) Pre-Funded Activities for the Initial Licensed Programs.  [***] shall have
the final decision-making authority for all matters related to the conduct of
Pre-Funded Activities under any Development Plan for an Initial Licensed
Program, except that:

(i) if the matter relates to the use of any [***] Technology conceived,
discovered, invented, created, made or reduced to practice or tangible medium
outside of a Collaboration Program or any

 

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Technology Controlled by [***], in each case, in an Initial Licensed Program
where such use would require additional Development activities or change the
anticipated timing of any Pre-Funded Activities under any Development Plan as
described in Section 2.1.2(b)(vi), then Biogen shall have the final
decision-making authority if [***] determines, in its sole discretion, that (A)
with respect to any Initial Licensed Product, such [***] Technology or such
Technology Controlled by [***], as applicable, is necessary in order to Develop,
Manufacture, Commercialize or use such Initial Licensed Product or (B) with
respect to the XLRP Product, such [***] Technology or such Technology Controlled
by [***], as applicable, is useful in order to Develop, Manufacture,
Commercialize or use the XLRP Product;

(ii) if the matter is not described in clause (i) above and relates to the
addition of new Pre-Funded Activities to, or a change in the scope of, existing
Pre-Funded Activities under any Development Plan that would cause a change in
the applicable Development Budget, then the matter may only be decided by [***];
provided, however, that, if any Regulatory Authority recommends or suggests a
change to the FIH Trial for the XLRS Product (other than the matters described
below in Section 2.1.4(a)(iii)) in order to complete such FIH Trial or continue
the Development of the XLRS Product, and the Parties disagree on whether to
implement such change, [***] shall have the final decision-making authority,
subject to Section 3.2.2(a)(i);

(iii) with respect to a decision to conduct (A) a toxicology study with respect
to the XLRS Product at a higher dosage than prior studies or (B) an additional
arm in the FIH Trial for the XLRS Product, [***] shall have the final
decision-making authority, subject to Section 3.2.2(a)(i);

(iv) if Biogen exercises its step-in rights under Section 3.1.3 with respect to
an Initial Licensed Program, then [***] shall have the final decision-making
authority for all matters related to the conduct of Pre-Funded Activities for
such Initial Licensed Program in accordance with the Development Plan; and

(v) notwithstanding anything to the contrary in this Agreement, if the matter
relates to the Manufacture of an Initial Licensed Product, then [***] shall have
the final decision-making authority, provided that, if such matter would set a
regulatory precedent for Specifications for the Manufacture of AAV Products
during the period of time that Regulatory Approval for [***] has not been
obtained by either Party or their respective Affiliates or sublicensees or [***]
from the first Regulatory Approval achieved for such AAV Products, if earlier
(the “Manufacturing Precedent Period”), then such matter may only be decided by
[***].  For clarity, in the event of any requirement by a Regulatory Authority
with respect to the Manufacture of an Initial Licensed Product, the Parties
shall comply with such requirement and neither Party shall have final
decision-making authority.

(b) Post-Funding Development Activities for the Initial Licensed Programs.
Biogen shall have the final decision-making authority for all matters related to
the conduct of the Post-Funding Development Activities under any Development
Plan for an Initial Licensed Program, except that:

(i) if the matter relates to Post-Funding Development Activities for an Initial
Licensed Program for which AGTC has exercised the Cost Share Option, then the
matter (along with the Budget for such matter) may only be decided by [***]; and

(ii) notwithstanding anything to the contrary in this Agreement, if the matter
relates to the Manufacture of an Initial Licensed Product, then [***] shall have
the final decision-making authority, provided, however, that, if such matter
would set a regulatory precedent for Specifications for the Manufacture of AAV
Products during the Manufacturing Precedent Period, then such matter may only be
decided by [***]. For clarity, in the event of any requirement by a Regulatory
Authority with respect to the Manufacture of an Initial Licensed Product, the
Parties shall comply with such requirement and [***] shall have final
decision-making authority.

(c) Pre-Funded Discovery Activities. [***] shall have the final decision-making
authority for any matter that relates to a Discovery Program.

 

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Any decision made in exercising a Party’s final decision-making authority must
be consistent with the terms of this Agreement and within the scope of authority
delegated to the JDC under this Agreement, and any Development Costs associated
with the decisions set forth in this Section 2.1.4 shall be treated in
accordance with Section 3.2 or Section 4.6, as applicable.

2.1.5. Discontinuation of the JDC.  The JDC’s authority as set forth in this
Section 2.1 with respect to a Collaboration Program shall continue to exist
until the first to occur of (a) the Parties mutually agreeing to terminate the
JDC’s authority with respect to such Collaboration Program and (b) (i) with
respect to a Discovery Program, the earlier of (w) the Option Exercise Date, (x)
the end of the Option Exercise Period for such Discovery Program, (y) the date a
Discovery Program becomes a Terminated Discovery Program and (z) the date a
Discovery Program becomes an Abandoned Program, (ii) with respect to an Initial
Licensed Program for which AGTC has elected the Milestone/Royalty Option
pursuant to Section 6.2.2, the date that AGTC is no longer conducting any
substantial level of Development activities with respect to such Initial
Licensed Program or (iii) with respect to an Initial Licensed Program for which
AGTC has elected the Cost Share Option pursuant to Section 6.2.2, the later of
(x) completion of all Post-Funding Development Activities for such Initial
Licensed Program and (y) formation of the JCC; provided that, in all events, the
JDC shall cease to have oversight over activities with respect to a given
Initial Licensed Product when the First Commercial Sale of such Initial Licensed
Product has occurred.  The JDC shall disband when it ceases to have authority
over any Collaboration Program pursuant to the preceding
sentence.  Notwithstanding anything herein to the contrary, once the JDC ceases
to exist, the JDC shall have no further responsibilities under this Agreement
and Biogen shall have the right to solely decide, without consultation, any
matters previously within the authority of the JDC; provided, however, that any
decision requiring AGTC to perform any additional development activities will be
decided by mutual agreement of the Parties and any associated Development Costs
shall be treated in accordance with Section 3.2 or Section 4.6, as applicable.

2.2. Joint Commercialization Committee.

2.2.1. Composition.  No later than [***] prior to the anticipated First
Commercial Sale of any Cost Share Product and in any event no later than the
first filing of a Marketing Application for a BLA for such Cost Share Product,
the Parties shall form a joint commercialization committee (the “Joint
Commercialization Committee” or the “JCC”).  The JCC shall be comprised of an
equal number of representatives from each Party.  If mutually agreed by the
Parties on a case-by-case basis, the JCC may invite other non-members to
participate in the discussions and meetings of the JCC, provided that the
presence of such participants shall not be considered in determining whether
there is a quorum at the JCC.  Each Party shall notify the other Party in
writing of its initial representatives to the JCC, and may substitute one or
more representatives from time to time upon written notice to the other
Party.  A designated representative of Biogen will be the chairman of the JCC,
and Biogen may change this representative from time to time upon written notice
to AGTC.  The chairman shall be responsible for setting the agenda for meetings
of the JCC, with input from the other members, and for conducting the meetings
of the JCC.

2.2.2. Responsibilities.

(a) General Responsibilities.  The JCC shall be responsible for oversight of
Commercialization activities with respect to the Cost Share Products.

(b) Decision-Making Responsibilities.  In addition to the foregoing general
responsibilities and any other matters specified in this Agreement for
resolution by the JCC, the JCC shall in particular have the following
decision-making responsibilities with respect to the Cost Share Products:

(i) discuss and approve any Commercialization Plan or Commercialization Budget
or any amendment or modification to a Commercialization Plan or
Commercialization Budget, in each case, for any Cost Share Product, which
amendments or modifications the JCC shall be required to formally document on an
annual basis as part of the minutes of the meetings of the JCC,

(ii) determine the Commercial FTE Rate, which shall be consistent with Biogen’s
internal FTE rates for similar activities, and

(iii) approve the matters contemplated by Exhibit C.

 

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(c) Oversight.  In addition to the foregoing decision-making responsibilities,
the JCC shall have the following oversight responsibilities with respect to the
Cost Share Products:

(i) oversee and review the activities under the Commercialization Plan for each
Cost Share Product,

(ii) address the financial, budgetary and accounting issues which may arise in
connection with any Commercialization Plans and the corresponding Budget, and

(iii) perform such other functions as appropriate to further the purposes of
this Agreement with respect to Commercialization of the Cost Share Products, as
mutually agreed in writing by the Parties.

The JCC, in its discretion, may establish subcommittees to assist the JCC in
carrying out the responsibilities of the JCC.

(d) General.  The JCC shall conduct its responsibilities hereunder in good faith
and with reasonable care and diligence.

2.2.3. Meetings.

(a) Subject to this Section 2.2.3(a), after its formation in accordance with
Section 2.2.1, the JCC shall meet in person or by teleconference once per
Calendar Quarter (or more often, as mutually agreed by the Parties) on such
dates and at such times and places as agreed to by the members of the
JCC.  Meetings of the JCC shall be alternately hosted by the Parties, with the
host determining whether the meeting will be in person or by teleconference,
provided that at least one meeting hosted by each Party in each Calendar Year
shall be in person and the first in-person meeting of the JCC shall be hosted by
Biogen no later than sixty (60) days after the date that the JCC is formed in
accordance with Section 2.2.1.  Each Party shall be responsible for its own
expenses relating to attendance at or participation in JCC meetings.

(b) Within ten (10) Business Days following each JCC meeting, the Party hosting
the meeting shall cause to be prepared and shall provide to the other Party a
draft of reasonably detailed written minutes describing all matters reviewed or
considered by the JCC and all determinations made and actions taken by the JCC
and a summary of the reasons therefor stated by the members at the meeting.  The
minutes of any meeting of the JCC must be finalized by approval of the members
of the JCC within fifteen (15) Business Days of the meeting.  The minutes and
the drafts of any minutes shall be the Confidential Information of both Parties.

(c) Each Party shall submit to the JCC at least five (5) Business Days prior to
any meeting of the JCC all reports required to be submitted by such Party to the
JCC at such meeting under this Agreement.

2.2.4. Decision Making.  Each Party shall be entitled to cast one vote on
matters before the JCC.  For the transaction of business, a quorum consisting of
not less than one representative of each Party must be present at a meeting, and
each Party shall cause at least one representative of such Party to be present
at each such meeting.  Decisions of the JCC shall be made by unanimous approval,
provided that a quorum must be present for any decision to be made by the
JCC.  If the JCC is unable to reach agreement with respect to any decision
within the scope of its authority, such dispute shall be escalated to the
Alliance Managers for resolution.  If the Alliance Managers are unable to reach
agreement with respect to such decision within thirty (30) days of such
escalation, such dispute shall be escalated to the Chief Executive Officer of
each Party (or his/her nominee), and such Chief Executive Officers (or their
nominees, as applicable) will meet promptly to attempt to resolve the dispute by
good faith negotiations.  If these individuals are unable to resolve the dispute
within thirty (30) days of the request for such meeting, Biogen shall have the
final decision-making authority; provided, however, that, if the matter relates
to the Manufacture of a Cost Share Product and would set a regulatory precedent
for Specifications for the Manufacture of AAV Products during the Manufacturing
Precedent Period, then such matter may only be decided by [***].  For clarity,
in the event of any requirement by a Regulatory Authority with respect to the
Manufacture of a Cost Share Product, the Parties shall comply with such
requirement and [***] shall have final decision-making authority.  Any decision
made by either Party in exercising its final decision-making authority must be
consistent with the terms of this Agreement.

 

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2.2.5. Discontinuation of the JCC. The JCC shall continue to exist until the
first to occur of (a) the Parties mutually agreeing to disband the JCC and (b)
the date that Biogen (or its Affiliate or Sublicensee) is no longer
Commercializing any Cost Share Product.

2.3. Alliance Managers.

2.3.1. Appointment.  Within thirty (30) days following the Effective Date each
Party will appoint (and notify the other Party of the identity of) a senior
representative of such Party having a general understanding of pharmaceutical
Development and Commercialization issues to act as its alliance manager under
this Agreement (each an “Alliance Manager”).  Each Party may replace its
Alliance Manager at any time by written notice to the other Party.

2.3.2. Specific Responsibilities.  The Alliance Managers may be, but shall not
be required to be, members of the JDC or the JCC.  The Alliance Managers will
serve as the primary contact point between the Parties for the Collaboration
Programs for the purpose of providing each Party with information on the
progress of Development and Commercialization of each Discovery Program and each
Licensed Product and shall have the following responsibilities:

(a) facilitating the flow of information and otherwise promoting communication,
coordination and collaboration between the Parties;

(b) coordinating the various functional representatives of each Party, as
appropriate, in developing and executing strategies and plans for the applicable
Discovery Program or the applicable Licensed Product;

(c) providing a single point of communication for seeking consensus both
internally within the respective Party’s organization and between the Parties
regarding key strategy and planning issues;

(d) assisting the integration of teams across functional areas;

(e) assisting the JDC and, if applicable, the JCC in identifying and raising
cross-Party and/or cross-functional disputes in a timely manner; and

(f) performing such other functions as requested by the JDC or, if applicable,
the JCC.

2.4. Other Committees.  The Parties may, by mutual agreement, form such other
committees or working groups as may be necessary or desirable to facilitate the
activities under each Collaboration Program, including the Development and
Commercialization of the Licensed Products.

2.5. General Authority.  Each of the JDC, the JCC and the Alliance Managers
shall have solely the powers expressly assigned to them in this Article 2 and
elsewhere in this Agreement.  None of the JDC, the JCC, any other committee or
working group or any Alliance Manager shall have any power to amend, modify or
waive compliance with or determine the other Party’s compliance with or breach
of this Agreement.  In conducting themselves on the JDC, the JCC or any other
committees or working groups and as Alliance Managers, and in exercising their
rights under this Article 2, all representatives of both Parties shall consider
diligently, reasonably and in good faith all input received from the other
Party, and shall use reasonable efforts to reach unanimity, where required, on
all matters before them.

3. INITIAL LICENSED PROGRAMS.

3.1. Control of Development.  The Parties will conduct all Development
activities for each Initial Licensed Program in accordance with the applicable
Development Plan for such Initial Licensed Program and this Section 3.1.  The
initial Development Plans for each Initial Licensed Program are attached hereto
as Exhibit A-1 and Exhibit A-2, respectively.  There shall be no Development
Plan (or corresponding Development Budget) for any Initial Licensed Program for
which (a) AGTC is no longer conducting any Development activities and (b) AGTC
has not exercised the Cost Share Option.  At such time as there is no
Development Plan for an Initial Licensed Program, (i) Biogen may conduct
Development activities for such Initial Licensed Program in its sole discretion,
subject to Section 3.3.1 and (ii) Biogen shall comply with the ongoing reporting
obligations set forth in Section 10.1.2.

 

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3.1.1. Development of the XLRS Product.  Subject to Section 3.1.3, AGTC will
have primary responsibility for Development of the XLRS Product until Regulatory
Approval in the United States in accordance with the XLRS Development
Plan.  AGTC shall promptly notify Biogen when the XLRS Product receives
Regulatory Approval in the United States.  Thereafter, Biogen will have sole
responsibility for the Development of the XLRS Product.

3.1.2. Development of the XLRP Product.  Subject to Section 3.1.3, AGTC will
have primary responsibility for Development of the XLRP Product until FIH Trial
Completion for the XLRP Product in accordance with the XLRP Development
Plan.  AGTC shall promptly notify Biogen when the XLRP Product achieves FIH
Trial Completion.  Within thirty (30) days of FIH Trial Completion, AGTC shall
provide to Biogen all Program Data from the XLRP Program that is not already in
Biogen’s possession, and, within thirty (30) days of Biogen’s receipt of such
Program Data, Biogen shall notify AGTC as to whether it elects to have primary
responsibility for the Development of the XLRP Product.  In the event that (a)
Biogen elects not to have primary responsibility for Development of the XLRP
Product, or (b) Biogen does not notify AGTC of its election within such thirty
(30) day period, then AGTC shall continue to use Commercially Reasonable Efforts
to Develop the XLRP Product in accordance with the XLRP Development Plan until
the XLRP Product receives Regulatory Approval in the United States, after which
Biogen will have primary responsibility for the Development of the XLRP Product,
provided that, if Biogen notifies AGTC prior to the receipt of a first
Regulatory Approval in the United States for the XLRP Product that Biogen
desires to take over Development activities for the XLRP Product, AGTC shall
transfer such Development activities to Biogen in a manner and on a timeline
reasonably determined by Biogen as sufficient to allow for an orderly transition
of such activities.

3.1.3. Biogen Step-In Rights.  Biogen shall have the right, but not the
obligation, to take over (a) all of AGTC’s unfinished Development activities
under any Development Plan for an Initial Licensed Product with [***] written
notice to AGTC upon occurrence of any of the events listed on Schedule
3.1.3.  In the event that Biogen properly exercises its right to take over any
of AGTC’s Development activities under any Development Plan pursuant to this
Section 3.1.3, AGTC shall have no further obligation to conduct such Development
activities; provided, however, that AGTC shall, at Biogen’s request, be
obligated to continue conducting any ongoing Clinical Trial under such
Development Plan through the completion of such Clinical Trial.  AGTC shall
transfer any such Development activities to Biogen in a manner and on a timeline
to reasonably allow for an orderly transition of such activities.  Within
forty-five (45)  days of the end of any Calendar Quarter in which Biogen has
incurred Development Costs in the course of performing Development activities in
accordance with any Development Plan under this Section 3.1.3, solely to the
extent such Development activities are Pre-Funded Activities or the Parties are
otherwise sharing the Development Costs for such Development activities under
Section 3.2.2(a)(iii), Biogen shall provide to AGTC a reasonably detailed
invoice of all or such portion of such Development Costs (which shall include a
determination of Biogen’s internal costs) that is the responsibility of AGTC
pursuant to Section 3.2, and AGTC shall make non-creditable, non-refundable
quarterly payments in accordance with the applicable Development Budget to
reimburse Biogen for any undisputed Development Costs payable by AGTC for such
Development activities within forty-five (45) days of receipt of such invoice
from Biogen.  In the event that Biogen exercises its step-in rights with respect
to an Initial Licensed Program under this Section 3.1.3 and the JDC determines
that it is necessary to conduct any activities not set forth in the Development
Plan for such Initial Licensed Program in order to complete the Pre-Funded
Activities set forth in such Development Plan (e.g., repeating a study or
performing back-up work on the applicable Initial Licensed Product), but in any
event, excluding an Additional Clinical Trial (such activities, the “Additional
Biogen Activities”), then the Parties shall share the Development Costs
associated with the Additional Biogen Activities equally in accordance with
Section 3.2.2(a)(iii) and thereafter the division of decision-making authority
set forth in Section 2.1.4(a)(iv) shall apply, as applicable, with respect to
any decisions regarding Development activities for such Initial Licensed
Program.

3.2. Development Costs.  The initial Development Budget for each Initial
Licensed Program is set forth in the initial Development Plans attached hereto
as Exhibit A-1 and Exhibit A-2, respectively.  Any Development Budget may be
amended or modified only by the JDC in accordance with the terms of this
Agreement.

3.2.1. General.  Subject to the provisions of Section 3.2.2(a), AGTC shall be
solely responsible for the payment of all Development Costs associated with the
Pre-Funded Activities conducted by either Party for each Initial Licensed
Program in accordance with the applicable Development Plan.  It is the intention
of the Parties that the applicable portion of the R&D Pre-Funding paid by Biogen
to AGTC in accordance with Section 6.1 will cover all Development Costs
associated with the Pre-Funded Activities as set forth in the applicable initial
Development Budget.  Subject to the provisions of Section 3.2.2(b), Section
3.2.2(c) and Section 3.2.2(d), if AGTC has exercised the Milestone/Royalty
Option with respect to an Initial Licensed Program, Biogen shall thereafter be
solely responsible for all Development Costs for such Initial Licensed
Program.  Within three (3) Business Days after the end of any Calendar Quarter
in which AGTC has incurred Development Costs in the

 

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course of performing Pre-Funded Activities or Post-Funding Development
Activities in accordance with any Development Plan, AGTC shall provide to Biogen
(a) a statement of actual Development Costs incurred for the first two (2)
months of such Calendar Quarter (which shall include a determination of AGTC’s
internal costs based on the R&D FTE Rate) and (b) a reasonable estimate of
Development Costs incurred in the third month of such Calendar Quarter (which
shall include an estimate of AGTC’s internal costs based on the R&D FTE
Rate).  Within thirty (30) days of the end of any such Calendar Quarter, AGTC
shall provide to Biogen a final report of such Development Costs and, with
respect to Development Costs incurred in the course of performing Post-Funding
Development Activities, a reasonably detailed invoice of such Development Costs
(which shall include a determination of AGTC’s internal costs based on the R&D
FTE Rate), and Biogen shall make non-creditable, non-refundable quarterly
payments in accordance with the applicable Development Budget to reimburse AGTC
for any undisputed Development Costs incurred in the course of performing
Post-Funding Development Activities within forty-five (45) days of receipt such
invoice from AGTC, provided that, if AGTC has exercised the Cost Share Option
with respect to any Initial Licensed Product, AGTC and Biogen shall share
responsibility for such Development Costs with respect to the Licensed Program
for such Initial Licensed Product in accordance with Section 6.3.

3.2.2. Budget Overages.

(a) Pre-Funded Activities.  For either of the Initial Licensed Programs, if the
Development Costs incurred in conducting any Pre-Funded Activity (including, for
the avoidance of doubt, reasonable costs incurred by Biogen in conducting
Pre-Funded Activities after exercising its step-in rights as set forth in
Section 3.1.3) exceed the budgeted amount for such Pre-Funded Activity as set
forth in the applicable Development Budget, then AGTC shall be solely
responsible for all such Development Costs in excess of such budgeted amount,
provided that, to the extent such excess Development Costs are caused by the
recklessness, negligence or intentional misconduct of Biogen or its Affiliates
or their respective Sublicensees or Subcontractors, then Biogen shall be solely
responsible for such Development Costs.  Notwithstanding the foregoing, except
to the extent such excess Development Costs are caused by the recklessness,
negligence or intentional misconduct of Biogen or its Affiliates or their
respective Sublicensees or Subcontractors, in which case Biogen shall be solely
responsible for such Development Costs, the following rules shall apply:

(i) If, prior to the completion of the Pre-Funded Activities for an Initial
Licensed Program, the JDC amends the Development Plan for such Initial Licensed
Program to include additional Development activities or change the scope of any
existing Pre-Funded Activities or if a Regulatory Authority requires such
additional Development activities or change in scope, and such amendment
requires an increase in Development Costs as set forth in the corresponding
amended Development Budget, then AGTC and Biogen shall share such increased
Development Costs equally, provided that AGTC shall bear [***] and Biogen shall
bear [***] of any Development Costs associated with conducting (A) a toxicology
study with respect to the XLRS Product at a higher dosage than prior studies or
(B) an additional arm in the FIH Trial for the XLRS Product, in each case if
determined by Biogen to be conducted pursuant to Section 2.1.4(a)(iii); and
provided, further, that with respect to any other change to the FIH Trial for
the XLRS Product, if a Party exercises its final decision-making authority under
Section 2.1.4(a)(ii) with respect to such change, such Party shall bear [***]
and the other Party shall bear [***] of the Development Costs associated with
such change.

(ii) Biogen shall bear [***] of such increased Development Costs to the extent
arising directly from the use in the XLRP Program of any AGTC Technology
conceived, discovered, invented, created, made or reduced to practice or
tangible medium outside of a Collaboration Program or any Technology Controlled
by Biogen under Section 2.1.2(b)(vi), solely to the extent that Biogen has
exercised its final decision-making authority under clause (B) of Section
2.1.4(a)(i) with respect to such use (unless and to the extent that such
increased Development Costs arise directly from the use in an Initial Licensed
Program of any Third Party IP Rights within the AGTC Technology or the
Technology Controlled by Biogen under Section 2.1.2(b)(vi), where AGTC has
violated any of the representations and warranties set forth in Section 15.2.13
or Section 15.2.14 with respect to such Third Party IP Rights, in which case
AGTC shall bear [***] of such increased Development Costs).

(iii) If, prior to the completion of the Pre-Funded Activities for an Initial
Licensed Program, Biogen exercises its step-in rights under Section 3.1.3 with
respect to such Initial Licensed Program and the JDC or a Regulatory Authority
determines that it is necessary to conduct any Additional Biogen

 

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Activities in order to obtain Regulatory Approval for the applicable Initial
Licensed Product, then, solely to the extent such Additional Biogen Activities
are not Pre-Funded Activities set forth in the initial Development Plan for such
Initial Licensed Program, AGTC and Biogen shall share equally the Development
Costs associated with such Additional Biogen Activities.  For the avoidance of
doubt, the provisions of this Section 3.2.2(a)(iii) shall apply in the case of
either (a) AGTC’s election of the Milestone/Royalty Option under Section 6.2.2
for such Initial Licensed Program or (b) AGTC’s election of the Cost Share
Option under Section 6.2.2 for such Initial Licensed Program.

(b) Post-Funding Development Activities.

(i) If the Development Costs for Post-Funding Development Activities for the
XLRS Program exceed the Development Costs budgeted for Post-Funding Development
Activities for the XLRS Program as set forth in the Development Budget for the
Initial Licensed Program attached hereto as part of Exhibit A-1 as of the
Effective Date, then (i) if AGTC has exercised the Milestone/Royalty Option for
the XLRS Program, then, (A) with respect to the Development Costs up to [***] or
less of the budgeted amount, Biogen shall bear [***] of such excess Development
Costs and (B) with respect to the Development Costs greater than [***] of the
budgeted amount, AGTC shall bear [***] and Biogen shall bear [***] of such
excess Development Costs, in accordance with the processes developed by the JDC
in accordance with Section 2.1.2(b)(iv), and (ii) if AGTC has exercised the Cost
Share Option for the XLRS Program, then the Parties shall equally share any
Development Costs that exceed the budgeted amount in accordance with Section
6.3.

(ii) If the Development Costs for Post-Funding Development Activities for the
XLRP Program prior to the Pivotal Trial exceed the Development Costs budgeted
for Post-Funding Development Activities for the XLRP Program as set forth in the
Development Budget for the XLRP Program attached hereto as part of Exhibit A-2
as of the Effective Date, then (i) if AGTC has exercised the Milestone/Royalty
Option for XLRP Program, then, (A) with respect to the Development Costs up to
[***] or less of the budgeted amount, Biogen shall bear [***] of such excess
Development Costs and (B) with respect to the Development Costs greater than
[***] of the budgeted amount, AGTC shall bear[***] and Biogen shall bear [***]
of such excess Development Costs, in accordance with the processes developed by
the JDC in accordance with Section 2.1.2(b)(iv), and (ii) if AGTC has exercised
the Cost Share Option for XLRP Program, then the Parties shall equally share any
Development Costs that exceed the budgeted amount in accordance with Section
6.3.  Notwithstanding the foregoing, if the Development Costs for the Pivotal
Trial and related or subsequent Post-Funding Development Activities (including
any extension studies) for the XLRP Product exceed the Development Costs for
such Pivotal Trial and related Post-Funding Development Activities as set forth
in the Development Budget for the XLRP Program attached hereto as part of
Exhibit A-2 as of the Effective Date, then (x) if AGTC has exercised the
Milestone/Royalty Option for the XLRP Program, Biogen shall bear [***] of such
excess Development Costs and (y) if AGTC has exercised the Cost Share Option for
the XLRP Program, the Parties shall equally share such excess Development Costs
in accordance with Section 6.3.

(c) Additional Clinical Trials.  If, following the completion of the Pre-Funded
Activities for an Initial Licensed Program, the JDC or any Regulatory Authority
determines that it is necessary, in order to obtain Regulatory Approval of an
Initial Licensed Product under such Initial Licensed Program, to re-perform or
conduct any additional Clinical Trial prior to a Pivotal Trial with respect to
such Initial Licensed Product (each, an “Additional Clinical Trial”), then the
Development Budget for such Initial Licensed Product shall be modified to
include the Development Costs of the Additional Clinical Trial and, if AGTC has
exercised the Milestone/Royalty Option with respect to such Initial Licensed
Program, AGTC shall share such Development Costs equally with Biogen unless, in
such event, AGTC notifies Biogen prior to any such Development Costs being
incurred that it elects to not share such Development Costs equally, in which
case, AGTC shall not be required to share any such Development Costs with
Biogen, and such election shall have the effect described in the final paragraph
of Section 6.4.1. For clarity, if AGTC has exercised the Cost Share Option with
respect to such Initial Licensed Program, the Parties shall share any
Development Costs under this Section 3.2.2(c) in accordance with the provisions
of Section 6.3.

 

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(d) Other Activities.  Notwithstanding anything to the contrary, in the event
that AGTC conducts any activities with respect to any Initial Licensed Program
that are not in accordance with a Development Plan for such Initial Licensed
Program and incurs excess Development Costs in connection therewith, Biogen
shall have no obligation to reimburse AGTC for any such excess Development
Costs.

3.2.3. Excess R&D Pre-Funding.  If any Initial Licensed Program is terminated
prior to completion of all Pre-Funded Activities for such Initial Licensed
Program, then any R&D Pre-Funding for Pre-Funded Activities under such Initial
Licensed Program that have not yet been undertaken shall be allocated toward
Development Costs payable by Biogen for other Collaboration Programs. [***]

3.3. Development Diligence.

3.3.1. Diligence Obligations.

(a) AGTC will use Commercially Reasonable Efforts to carry out the Development
activities allocated to it under Section 3.1 and the Development Plan for each
Initial Licensed Program.  Without limiting the foregoing, AGTC shall, in
particular, use Commercially Reasonable Efforts to (i) conduct the Pre-Funded
Activities and the Post-Funding Development Activities assigned to AGTC under
the XLRS Development Plan and to Develop the XLRS Product through Regulatory
Approval in the United States in accordance with the XLRS Development Plan and
(ii) conduct the Pre-Funded Activities and the Post-Funding Development
Activities assigned to AGTC under the XLRP Development Plan and to Develop the
XLRP Product through FIH Trial Completion in accordance with the XLRP
Development Plan.

(b) To the extent that such activities are the responsibility of Biogen in
accordance with this Agreement, Biogen will use Commercially Reasonable Efforts
to develop and seek Regulatory Approval for at least (1) one XLRS Product and
(2) one XLRP Product, in each case, in the Major Market Countries.

3.3.2. Exceptions to Diligence Obligations.  Notwithstanding any provision of
this Agreement to the contrary, the Party obligated to meet diligence
requirements (the “Obligated Party”) will be relieved from and will have no
obligation to undertake any efforts described in Section 3.3.1 with respect to
the Development of any Initial Licensed Product in the event that:

(a) either Party receives or generates any safety, tolerability or other data
reasonably indicating, as measured by the Obligated Party’s safety and efficacy
evaluation criteria and methodology, that an Initial Licensed Product is not
reasonably suitable, for safety reasons, for initiation or continuation of
Clinical Trials in humans; or

(b) the other Party materially breaches any of its Development or other
obligations under the Development Plans or this Agreement and such breach
impairs or limits the Obligated Party’s ability to perform its Development
activities under this Agreement; provided that, in such event, the Obligated
Party shall only be relieved of such obligations to the extent and for so long
as the other Party’s breach so impairs or limits the Obligated Party’s ability
to perform its Development activities under this Agreement.

3.4. Subcontractors.  Each Party may engage consultants, subcontractors, or
other vendors (each, a “Subcontractor”) to perform any work under the Initial
Licensed Programs; provided that, with respect to any Subcontractor of AGTC that
has not previously been engaged by AGTC within the two (2) years prior to such
proposed engagement, all such engagements by AGTC and any contracts related to
such engagements shall be subject to the prior written approval of Biogen, such
approval not to be unreasonably withheld; and provided, further, that in the
event AGTC elects to engage a Subcontractor to provide any service for which
Biogen possesses internal capabilities to perform such service, at a cost equal
to or less than such Subcontractor and on substantially similar terms (including
capability and timing), AGTC shall notify Biogen and Biogen shall determine
whether Biogen, at AGTC’s sole expense subject to cost sharing provisions
included in Section 3.2.2 and Section 6.3, to the extent set forth in the
applicable Development Budget, will provide such service to AGTC in accordance
with the applicable Development Plan.  Biogen shall reasonably consult with AGTC
with respect to the engagement of Subcontractors but shall be permitted to
engage Subcontractors without prior approval of AGTC.  Each contract between a
Party and a Subcontractor shall be consistent with the provisions of this
Agreement and shall include provisions, including intellectual property
provisions, adequate for the other Party to avail itself of the licenses granted
hereunder as though such Party had performed the contracted work, and AGTC
shall, unless otherwise agreed to by Biogen, ensure that all contracts entered
into between AGTC and Subcontractors to perform Manufacturing activities include
a

 

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provision allowing AGTC to freely assign such contract to Biogen at no cost to
either Party.  Each Party shall be responsible for the effective and timely
management of and payment of its Subcontractors.  The engagement of any
Subcontractor in compliance with this Section 3.4 shall not relieve the
applicable Party of its obligations under this Agreement or any Development
Plan.  Each Party shall be solely responsible for any taxes, including income,
withholding, payroll, VAT, sales tax or the like, that arise from the use of a
Subcontractor.  To the extent AGTC engages any Subcontractor to perform any
Manufacturing activities, AGTC shall notify Biogen of proposed substantive
interactions with any such Subcontractors material to a Initial Licensed Program
and shall use reasonable efforts to allow Biogen to participate in any such
interactions primarily related to an Initial Licensed Program if Biogen requests
such involvement, at Biogen’s cost and expense, provided that such reasonable
efforts and such participation do not cause undue delay to any Initial Licensed
Program.

3.5. Conduct.  Each Party shall, and shall require its Affiliates and
Subcontractors to, comply with all applicable Laws in their conduct of the
Development activities with respect to the Initial Licensed Programs, including
where appropriate cGMP, GCP and GLP (or similar standards) for the performance
of laboratory activities.

4. DISCOVERY PROGRAMS.

4.1. General.  During the Research Period, each Party will conduct research and
Development activities with respect to each Discovery Program in accordance with
the applicable Discovery Program Development Plan and the terms and conditions
of this Agreement.  There shall be no Development Plan (or corresponding
Development Budget) for any Discovery Program after the Research Period for such
Discovery Program.  At such time as there is no Development Plan for a Discovery
Program, if Biogen has exercised the Option for such Discovery Program pursuant
to the terms of Section 4.7, (i) Biogen may conduct Development activities for
such Discovery Program in its sole discretion, subject to Section 4.3.1 and (ii)
Biogen shall comply with the ongoing reporting obligations set forth in
Section 10.1.2.

4.2. Discovery Program License Grants.

4.2.1. Subject to the terms and conditions of this Agreement, during the
Research Period for a Discovery Program, AGTC, on behalf of itself and is
Affiliates, hereby grants to Biogen an exclusive, royalty-free, fully paid-up
license (exclusive even as to AGTC and its Affiliates except to the extent
necessary for AGTC to perform its obligations under this Agreement) under the
(a) Know-How that (i) AGTC or its Affiliates Control as of the Effective Date or
that comes into the Control of AGTC or its Affiliates during such Research
Period, (ii) relates to one or more product candidates under such Discovery
Program or the Development of any of the foregoing and (iii) is necessary or
useful for Biogen to perform Biogen’s obligations under this Agreement in
accordance with the applicable Discovery Program Development Plan for such
Discovery Program, (b) any Patent Right that (i) AGTC Controls as of the
Effective Date or that comes into the Control of AGTC during such Research
Period and (ii) claims or discloses any Know-How described in clause (a) of this
Section 4.2.1, (c) AGTC’s interest in the Joint Technology and (d) the Materials
transferred hereunder, in each case ((a) through (d)), solely to Develop, have
Developed, Manufacture and have Manufactured product candidates under such
Discovery Program in the Field in the Territory pursuant to the applicable
Discovery Program Development Plan for such Discovery Program.  Schedule 4.2.1
sets forth the Patent Rights licensed to Biogen under this Section 4.2.1 with
respect to each Discovery Program as of the Execution Date, and shall be updated
by the Patent Representatives in accordance with Section 13.3.1(a) to include
any additional Patent Rights licensed to Biogen under this Section 4.2.1 with
respect to each Discovery Program during the Research Period for such Discovery
Program.

4.2.2. Subject to the terms and conditions of this Agreement, during the
Research Period for a Discovery Program, Biogen, on behalf of itself and its
Affiliates, hereby grants to AGTC a non-exclusive, royalty-free, fully paid-up
license, under (a) any Know-How that (i) (x) is conceived, discovered, invented,
created, made or reduced to practice or tangible medium by Biogen, any of its
Affiliates or any of their respective employees, agents or independent
contractors in the performance of Biogen’s activities under this Agreement, (y)
relates to one or more product candidates under such Discovery Program or the
Development of any of the foregoing and (z) is necessary or useful for AGTC to
perform AGTC’s obligations under this Agreement in accordance with any Discovery
Program Development Plan or (ii) is not Know-How defined in the foregoing
subsection (i) and is Controlled by Biogen as of the Execution Date or otherwise
comes into the Control of Biogen during the Term and that Biogen designates, in
its sole discretion, under a Discovery Program Development Plan for use in
Pre-Funded Discovery Activities thereunder, (b) any Patent Right, other than a
Joint Patent Right, that (i) Biogen Controls as of the Effective Date or that
comes into the Control of Biogen during such Research Period and (ii) claims or
discloses any Know-How described in clause (a) of this Section 4.2.2 and (c)
Biogen’s interest in the Joint Technology, in each case solely

 

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to Develop, have Developed, Manufacture and have Manufactured product candidates
under such Discovery Program in the Field in the Territory pursuant to the
applicable Discovery Program Development Plan for such Discovery Program.

4.2.3. Subject to the restrictions set forth on Schedule 5.2, each Party shall
have the right to grant sublicenses of any and all rights granted to such Party
by the other Party under Section 4.2.1 or 4.2.2, as applicable, to one or more
of its Affiliates and to one or more Third Parties solely to the extent such
Affiliate or Subcontractor requires such a sublicense to carry out activities
consistent with the Discovery Program Development Plan.  Each such sublicense
shall be subject and subordinate to, and consistent with, the terms and
conditions of this Agreement and shall require such Sublicensee(s) to comply
with all applicable terms of this Agreement.

4.3. Diligence.

4.3.1. Diligence Obligations.

(a) During the Research Period for each Discovery Program that is not a
Terminated Discovery Program, each Party shall use Commercially Reasonable
Efforts to conduct the Pre-Funded Discovery Activities for such Discovery
Program as set forth in the applicable Discovery Program Development Plan
through Clinical Candidate Designation.

(b) With respect to any Discovery Program for which Biogen has exercised the
Option in accordance with Section 4.7, Biogen will use Commercially Reasonable
Efforts to develop and seek Regulatory Approval for at least one Discovery
Product for such Discovery Program in the Major Market Countries.

4.3.2. Exceptions to Diligence Obligations.  Notwithstanding any provision of
this Agreement to the contrary, the Obligated Party will be relieved from and
will have no obligation to undertake any efforts under Section 4.3.1 with
respect to the Development of any Discovery Product in the event that:

(a) either Party receives or generates any safety, tolerability or other data
reasonably indicating, as measured by the Obligated Party’s safety and efficacy
evaluation criteria and methodology, that a Discovery Product is not reasonably
suitable, for safety reasons, for initiation or continuation of Clinical Trials
in humans; or

(b) the other Party materially breaches any of its Development or other
obligations under the Development Plans or this Agreement and such breach
impairs or limits the Obligated Party’s ability to perform its Development
activities under this Agreement; provided that, in such event, the Obligated
Party shall only be relieved of such obligations to the extent and for so long
as the other Party’s breach so impairs or limits the Obligated Party’s ability
to perform its Development activities under this Agreement.

4.4. Substitution of Discovery Programs.

4.4.1. As of the Effective Date, the Discovery Programs are comprised of the
[***] Discovery Program, the [***] Discovery Program and the [***].  With
respect to any Discovery Program (or in the case the [***] Discovery Program is
substituted under Section 4.4.4, the Non-Ophthalmology Discovery Program), at
any time until the earliest of (i) the Option Exercise Date for such Discovery
Program, (ii) the end of the Option Exercise Period for such Discovery Program
or (iii) [***] from the Effective Date, Biogen may decide to terminate such
Discovery Program and to designate an alternative program as a Discovery Program
under this Agreement (such alternative program, a “Substitute Discovery
Program”), under the following conditions: (a) neither Biogen, nor its
Affiliates nor their respective sublicensees is engaged in researching,
Developing or Commercializing an AAV Product directed to the gene target that is
the subject of such Substitute Discovery Program, (b) Biogen shall have the
right to deliver a Substitution Notice and invoke the process set forth in
Section 4.4.2 for any reason during the period starting on the Effective Date
and ending [***] thereafter, provided that Biogen may only make such request
once in any [***], (c) Biogen shall have the right to deliver a Substitution
Notice and invoke the process set forth in Section 4.4.2 at any time upon
failure of a Discovery Program, as mutually determined by the Parties, even if
Biogen has previously delivered a Substitution Notice during the same twelve
month period and (d) Biogen may designate a Substitute Discovery Program no more
than twice in accordance with this Section 4.4.

4.4.2. In the event Biogen wishes to designate a Substitute Discovery Program,
Biogen shall notify AGTC of such desire, identifying the Discovery Program to be
terminated (the “Terminated Discovery Program”) and the corresponding

 

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products that are generated by or is the subject of such Discovery Program to be
terminated (the “Terminated Discovery Products”), and listing indications or
gene targets which Biogen is interested in pursuing (the “Substitution
Notice”).  Within thirty (30) days of receiving such Substitution Notice from
Biogen, AGTC shall deliver to Biogen a notice (the “Available Program Notice”)
including (a) a list of (i) all then-current [***] Programs in research or
development other than an Abandoned Program, and (ii) in AGTC’s sole discretion,
any other program that AGTC is researching or developing which AGTC desires to
research or develop with Biogen as a Discovery Program, and (b) an annotated
list identifying those indications or gene targets included in the Substitution
Notice [***] (such programs included in clauses (a) and (b), the “Available
Programs”) and shall provide Biogen, at Biogen’s request, any information in
AGTC’s possession regarding any such Available Program sufficient in AGTC’s
reasonable determination to allow Biogen to determine whether it wishes to
designate any Available Program as a Substitute Discovery Program. Biogen shall,
within thirty (30) days following receipt of the Available Program Notice,
designate any one Available Program as a Substitute Discovery Program (the
“Designation Notice”).  Effective as of the date of the Designation Notice, the
Terminated Discovery Program shall immediately cease to be a Discovery Program
hereunder and the program identified in the Designation Notice shall be a
Substitute Discovery Program (the “Discovery Program Substitution Date”).  On
the Discovery Program Substitution Date, subject to Section 4.5, the terms and
conditions of this Agreement applicable to Discovery Programs shall become
effective with respect to such Substitute Discovery Program.  The JDC shall
within fifteen (15) days after the Discovery Program Substitution Date discuss
in good faith and determine whether the Substitute Discovery Program shall be
subject to the milestones set forth in Category A, Category B or Category C of
Section 6.5.2, which may or may not be the same category of milestones as the
Terminated Discovery Program.

4.4.3. Provided that Biogen has not designated a Substitute Discovery Program
more than twice in accordance with this Section 4.4, with respect to a
Terminated Discovery Program, for a period of [***] months following the date of
the Substitution Notice, AGTC shall notify Biogen if it decides to continue,
either itself or through an Affiliate or Third Party, to Develop products under
a Terminated Discovery Program due to a discovery regarding such Terminated
Discovery Program.  If Biogen wishes to reinstate such Terminated Discovery
Program as a Discovery Program, subject to the terms and conditions of this
Agreement that applied to such Terminated Discovery Program before the
applicable substitution designation was made for such Terminated Discovery
Product, then Biogen shall notify AGTC of such desire within thirty (30) days
after receipt of such notice of continued development from AGTC. If Biogen
notifies AGTC that it does not wish to reinstate such Terminated Discovery
Program or if Biogen does not respond to such notice of continued development
from AGTC within such thirty (30) day period, such Terminated Discovery Program
shall be deemed to be an Abandoned Program and AGTC shall be free to develop
products under a Terminated Discovery Program, whether or not through an
Affiliate or Third Party.  Until such time that such Terminated Discovery
Program becomes an Abandoned Program, AGTC shall not extend to any Third Party a
right or license that would preclude AGTC from granting to Biogen the license
set forth in Section 4.2.1 for such Terminated Discovery Program.  For clarity,
Biogen may have more than three (3) total Discovery Programs as a result of the
provisions of this Section 4.4.3.

4.4.4. Notwithstanding the foregoing, the Parties acknowledge and agree that the
viability of the [***] Discovery Program may be dependent upon certain factors,
including the access to certain Third Party Technology.  The Parties intend to
make inquiries regarding such Third Party Technology to determine whether a
license to such Third Party Technology would be necessary or useful in order to
conduct the [***] Discovery Program.  If, following such inquiries, Biogen
determines that it does not wish to continue the [***] Discovery Program, the
Parties may agree to substitute an alternate non-ophthalmology program for the
[***] Discovery Program, without triggering the formal substitution process set
forth in this Section 4.4, but subject to criteria of availability of such
program as set forth in this Section 4.4.  Biogen shall use reasonable efforts
to make such determination during the three (3) month period following the
Execution Date, such determination period not to exceed four (4) months or as
mutually agreed between the Parties (such alternate non-ophthalmology program,
the “Non-Ophthalmology Discovery Program”). In the event of any disagreement
between the Parties regarding the substitution of an alternate program, Biogen
shall have the final decision-making authority with respect to whether or not
the [***] Discovery Program will be substituted, but not, for purposes of
clarity, whether a substituted program is an Available Program.  For clarity,
designation of the Non-Ophthalmology Discovery Program shall not count toward
Biogen’s two (2) opportunities to designate a Substitute Discovery Program under
clause (d) of Section 4.4.1.

4.5. Discovery Program Development Plans.  For each Discovery Program other than
a Substitute Discovery Program, the initial research and Development activities
to be conducted by AGTC with respect to such Discovery Program shall be set
forth in the initial Discovery Program Development Plan for such Discovery
Program.  The initial [***] Discovery Program Development Plan is attached
hereto as Exhibit A-3, and the initial [***] Discovery Program Development Plan
is attached hereto as Exhibit A-4.  The JDC shall discuss, prepare and approve
the initial [***] in accordance with Section 2.1.2(b)(ii) within three (3)
months of the Parties’

 

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mutual agreement on the gene targets for the [***] in accordance with Section
1.104.  Upon such approval by the JDC, the initial [***] Development Plan shall
be attached hereto as Exhibit A-5 and the initial [***] Development Plan shall
be attached hereto as Exhibit A-6.  With respect to the Non-Ophthalmology
Discovery Program, if applicable, promptly following the date such
Non-Ophthalmology Discovery Program is designated under Section 4.4.4, the JDC
shall discuss in good faith and mutually agree upon a Discovery Program
Development Plan for such Non-Ophthalmology Discovery Program covering
Development activities through Clinical Candidate Designation for such
Non-Ophthalmology Discovery Program, which Discovery Program Development Plan
shall be attached as Exhibit A-7 hereto. With respect to any Substitute
Discovery Program, promptly following the Discovery Program Substitution Date,
the JDC shall discuss in good faith and mutually agree upon a Discovery Program
Development Plan for such Substitute Discovery Program covering Development
activities through Clinical Candidate Designation for such Substitute Discovery
Program, which Discovery Program Development Plan shall be attached as Exhibit
A-8 (or Exhibit A-9, if applicable) hereto.  If the Parties are unable to agree
on a Discovery Program Development Plan for any Substitute Discovery Program
within thirty (30) days of Biogen’s selection of such Substitute Discovery
Program, then Biogen shall have final decision-making authority to determine the
remaining activities for which agreement has not been reached under such
Discovery Program Development Plan, subject to the provisions of Section
4.6.  The JDC shall review and update the Discovery Program Development Plans
and related Development Budgets on a quarterly basis, or more often as
necessary.

4.6. Development Costs.

4.6.1. R&D Pre-Funding.  Subject to the provisions of Section 4.6.3, AGTC shall
be solely responsible for the payment of all Development Costs associated with
AGTC’s Pre-Funded Discovery Activities through Clinical Candidate Designation
for each of the [***] Discovery Program, the [***] Discovery Program (or the
Non-Ophthalmology Discovery Program, if applicable), and the [***] in accordance
with the applicable Discovery Program Development Plan.  It is the intention of
the Parties that the applicable portion of the [***] will cover all Development
Costs associated with the Pre-Funded Discovery Activities through Clinical
Candidate Designation under the Discovery Program Development Plan for each of
the [***] Discovery Program, the [***] Discovery Program (or the
Non-Ophthalmology Discovery Program, if applicable) or the [***] as set forth in
the applicable Development Budget, but, for clarity, if such R&D Pre-Funding
does not fully cover such Development Costs, [***] will, subject to Section
4.6.2 with respect to Substitute Discovery Programs and Section 4.6.3, be
responsible for all such Development Costs required under each Discovery
Program.  Within three (3) Business Days after the end of any Calendar Quarter
in which [***] has incurred Development Costs in the course of performing
Pre-Funded Activities in accordance with any Discovery Program Development Plan,
[***] shall provide to [***] (a) a statement of actual Development Costs
incurred [***] (which shall include a determination of [***] internal costs
based on the R&D FTE Rate) and (b) a reasonable estimate of Development Costs
incurred [***] (which shall include an estimate of AGTC’s internal costs based
on the R&D FTE Rate) and, within thirty (30) days of the end of any such
Calendar Quarter, [***] shall provide to Biogen a final report of such
Development Costs.

4.6.2. Development Costs for Substitute Discovery Programs.  Within sixty (60)
days of the Discovery Program Substitution Date, AGTC shall, if applicable,
notify Biogen in writing of the aggregate Development Costs incurred by AGTC in
conducting the Pre-Funded Discovery Activities to date under the Discovery
Program Development Plan for the Terminated Discovery Program, and shall provide
Biogen with copies of records necessary to verify the foregoing.  In the event
that the aggregate Development Costs incurred by AGTC in conducting such
activities, if any, were less than the total amount of R&D Pre-Funding budgeted
for such Discovery Program, then the remainder of the R&D Pre-Funding budgeted
for such Discovery Program shall be used to fund the Development Costs
associated with the Pre-Funded Discovery Activities of AGTC under the Discovery
Program Development Plan for the applicable Substitute Discovery Program.  In
addition, any excess R&D Pre-Funding under Section 3.2.3 or Section 4.6.4 for a
terminated Collaboration Program shall also be used to fund such Development
Costs, to the extent necessary.  Biogen shall be responsible for any Development
Costs associated with the Pre-Funded Discovery Activities of AGTC under the
Discovery Program Development Plan for the applicable Substitute Discovery
Program as set forth in the applicable Development Budget, to the extent not
covered by such remainder of the R&D Pre-Funding from the Terminated Discovery
Program or any such other terminated Collaboration Program.  Any amounts owed to
AGTC by Biogen under this Section 4.6.2 shall be paid by Biogen to AGTC within
forty-five (45) days of receipt of an invoice from AGTC delivered within
forty-five (45) days after the end of each Calendar Quarter that provides
reasonable detail regarding such excess Development Costs.

4.6.3. Budget Overages.

(a) If, during the Research Period for any Discovery Program, any Development
Costs incurred by AGTC in conducting any activity set forth in the applicable
Discovery Program Development Plan for the [***] Discovery

 

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Program, the [***] Discovery Program (or the Non-Ophthalmology Discovery
Program, if applicable), the [***], the [***] or a Substitute Discovery Program
exceed the budgeted amount therefor as set forth in the applicable Development
Plan, then [***] shall be solely responsible for all Development Costs in excess
of the budgeted amount for such activity, provided that, to the extent such
excess Development Costs are caused by the recklessness, negligence or
intentional misconduct of [***] or its Affiliates or their respective
Sublicensees or Subcontractors, [***] shall be solely responsible for such
Development Costs.

(b) Notwithstanding the foregoing, if the JDC amends a Discovery Program
Development Plan to include additional activities or change the scope of any
existing activities or a Regulatory Authority requires that additional
activities be performed or a change in scope, with respect to a Discovery
Program, and such amendment requires an increase in Development Costs under the
corresponding Development Budget, then [***] shall pay such increased
Development Costs.

4.6.4. Excess R&D Pre-Funding.  If any Discovery Program is terminated prior to
completion of all Pre-Funded Discovery Activities for such Discovery Program,
then any R&D Pre-Funding for Pre-Funded Discovery Activities under such
Discovery Program that have not yet been undertaken shall be allocated toward
Development Costs payable by Biogen for other Collaboration Programs (including,
as applicable, for any Substitute Discovery Program as set forth in Section
4.6.2).  [***]

4.7. Option Grant; Option Exercise.  With respect to each Discovery Program,
AGTC hereby grants to Biogen an exclusive option during the Option Exercise
Period for such Discovery Program to obtain an exclusive license under the AGTC
Technology and AGTC’s interest in the Joint Technology to use, have used,
Develop, have Developed, Manufacture, have Manufactured, Commercialize, have
Commercialized, import, have imported, export and have exported Discovery
Products on the terms set forth in Section 5.1 (the “Option”).  Within fifteen
(15) days of Clinical Candidate Designation for any Discovery Program, AGTC
shall notify Biogen of such Clinical Candidate Designation and shall provide
Biogen with a Data Package for such Discovery Program.  If Biogen reasonably
believes that the Data Package is incomplete, it may notify AGTC of any such
deficiency, and AGTC will promptly provide to Biogen any additional information
reasonably requested by Biogen, provided that no additional Development
activities are required to provide such information. Biogen shall have the right
to exercise the Option at any time within ninety (90) days of Biogen’s receipt
of the Data Package, including any additional information reasonably requested
by Biogen pursuant to the preceding sentence, for a Discovery Program (the
“Option Exercise Period”), upon written notice to AGTC (the date that AGTC
receives such notice, the “Option Exercise Date”).  Effective immediately upon
payment of the Option Fee within sixty (60) days of the Option Exercise Date as
set forth in Section 6.5.1, with respect to any Discovery Program for which
Biogen has exercised an Option as set forth in this Section 4.7, (a) AGTC shall
and hereby does grant to Biogen the license set forth in Section 5.1 with
respect to the Discovery Products for such Discovery Program and (b) the Parties
shall update Schedule 1.22-2 hereto to include those Patent Rights set forth on
Schedule 4.2.1 with respect to the applicable Discovery Products and to reflect
any additional AGTC Patent Rights existing as of the Option Exercise Date.  For
clarity, upon exercise of the Option by Biogen, all terms and conditions of this
Agreement applicable to Licensed Products shall become effective with respect to
the applicable Discovery Products, provided that those terms and conditions of
this Agreement specifically applicable to Initial Licensed Products (e.g., the
Cost Share Option and the Co-Promotion Option) shall not apply to the applicable
Discovery Products.  Notwithstanding anything to the contrary, in the event that
the Parties mutually agree to incorporate [***] under the [***] into a single
clinical candidate that achieves Clinical Candidate Designation, then, if Biogen
desires to exercise the Option with respect to such clinical candidate, the
Option Fee shall be payable only once for such clinical candidate, and such
clinical candidate shall thereafter be deemed a “[***]”.

4.8. Subcontractors.  Each Party may engage Subcontractors to perform any work
under the Discovery Programs; provided that, with respect to any Subcontractor
of AGTC that has not previously been engaged by AGTC within the [***] prior to
such proposed engagement, all such engagements by AGTC and any contracts related
to such engagements shall be subject to the prior written approval of Biogen,
such approval not to be unreasonably withheld; and provided, further, that in
the event AGTC elects to engage a Subcontractor to provide any service for which
Biogen possesses internal capabilities to perform such service at a cost equal
to or less than such Subcontractor and on substantially similar terms (including
capability and timing), AGTC shall notify Biogen and Biogen shall determine
whether Biogen, at AGTC’s sole expense subject to cost sharing provisions
included in Section 4.6.3, to the extent set forth in the applicable Development
Budget, will provide such service to AGTC in accordance with the applicable
Development Plan.  Biogen shall reasonably consult with AGTC with respect to the
engagement of Subcontractors but shall be permitted to engage Subcontractors
without prior approval of AGTC, at Biogen’s sole expense.  Each contract between
a Party and a Subcontractor shall be consistent with the provisions of this
Agreement and shall include provisions, including intellectual property
provisions, adequate for the other Party to avail itself of the licenses granted
hereunder as though such Party had performed the contracted work.  Each Party
shall be responsible for the effective and timely management of and payment of
its Subcontractors. The

 

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engagement of any Subcontractor in compliance with this Section 4.8 shall not
relieve the applicable Party of its obligations under this Agreement or any
Development Plan. Each Party shall be solely responsible for any taxes,
including income, withholding, payroll, VAT, sales tax or the like, that arise
from the use of a Subcontractor.  To the extent AGTC engages any Subcontractor
to perform any Manufacturing activities, AGTC shall notify Biogen of proposed
substantive interactions with any such Subcontractors material to a Discovery
Program and shall use reasonable efforts to allow Biogen to participate in any
such interactions primarily related to a Discovery Program if Biogen requests
such involvement, at Biogen’s sole cost and expense, provided that such
reasonable efforts and such participation do not cause undue delay to any
Discovery Program.

4.9. Conduct.  Each Party shall, and shall require its Affiliates and
Subcontractors to, comply with all applicable Laws in their conduct of the
Pre-Funded Discovery Activities with respect to the Discovery Programs,
including where appropriate cGMP, GCP and GLP (or similar standards) for the
performance of laboratory activities.

5. LICENSE GRANTS.

5.1. Exclusive License from AGTC to Biogen.  Subject to the terms and conditions
of this Agreement and effective as of the Effective Date for the Initial
Licensed Products and as of the Option Exercise Date for the applicable
Discovery Product, AGTC, on behalf of itself and its Affiliates, hereby grants
to Biogen an exclusive license (exclusive even as to AGTC and its Affiliates
except to the extent necessary for AGTC to perform its obligations under this
Agreement), with the right to grant sublicenses through multiple tiers pursuant
to Section 5.2, under the AGTC Technology, AGTC’s interest in the Joint
Technology and the Materials transferred hereunder, to use, have used, Develop,
have Developed, Manufacture, have Manufactured, Commercialize, have
Commercialized, import, have imported, export and have exported Licensed
Products (which for purposes of clarity, consist of the Initial Licensed
Products and Discovery Products for which Biogen has exercised an Option in
accordance with Section 4.7) in the Field in the Territory.

5.2. Biogen Sublicensees.  Subject to the restrictions set forth on Schedule
5.2, Biogen shall have the right to grant sublicenses through multiple tiers to
one or more of its Affiliates and to one or more Sublicensees of any and all
rights granted to Biogen under this Agreement by AGTC, provided that in no event
may Biogen grant a sublicense, and Biogen shall use reasonable efforts to ensure
that none of its Affiliates or their respective Sublicensees grant a sublicense,
of any of the rights licensed under Section 5.1 with respect to an Initial
Licensed Product to any Person that is (i) Developing or Commercializing a
product targeting the same gene as such Initial Licensed Product if, at the time
that Biogen grants such sublicense, Biogen is Developing such Initial Licensed
Product or (ii) Commercializing a product targeting the same gene as such
Initial Licensed Product if, at the time that Biogen grants such sublicense,
Biogen is Commercializing such Initial Licensed Product in each case of (i) or
(ii), without AGTC’s prior written consent, which AGTC may give in its sole
discretion.  Each such sublicense shall be subject and subordinate to, and
consistent with, the terms and conditions of this Agreement. The engagement of
any Sublicensee in compliance with this Section 5.2 shall not relieve Biogen of
its obligations under this Agreement or any Development Plan.  Biogen shall
remain responsible for actions or omissions of its Sublicensees and Biogen’s
breaches under this Agreement that are caused by its Sublicensee’s breach of any
sublicense agreement (or delay caused by such breach). Biogen shall provide a
redacted copy of each sublicense to AGTC promptly following execution of such
sublicense.

5.3. Non-Exclusive License from Biogen to AGTC.  Subject to the terms and
conditions of this Agreement, during the Term, Biogen, on behalf of itself and
its Affiliates, hereby grants to AGTC a non-exclusive, royalty-free, fully
paid-up license in the Territory, with no right to grant sublicenses except as
permitted to Subcontractors under Section 3.4 or Section 4.8, under the Biogen
Technology and Biogen’s interest in the Joint Technology, solely to perform
Development activities as set forth in the Development Plans.

5.4. Enabling Licenses.

5.4.1. Joint Technology. Subject to the terms and conditions of this Agreement,
each Party, on behalf of itself and its Affiliates, hereby grants to the other
Party a non-exclusive, worldwide, royalty-free, fully paid-up, irrevocable
license, with the right to grant sublicenses through multiple tiers, under its
interest in the Joint Technology (other than the Joint Improved Technology), to
use, have used, Develop, have Developed, Manufacture, have Manufactured,
Commercialize, have Commercialized, import, have imported, export and have
exported products or processes, [***].

5.4.2. Enabling License from Biogen to AGTC.

 

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(a) Subject to the terms and conditions of this Agreement and effective as of
the Effective Date, Biogen, on behalf of itself and its Affiliates, hereby
grants to AGTC a non-exclusive, worldwide, royalty-bearing license, with the
right to grant sublicenses through multiple tiers, under the Biogen Platform
Improvement Technology to use, have used, Develop, have Developed, Manufacture,
have Manufactured, Commercialize, have Commercialized, import, have imported,
export and have exported Gene Therapy Products.

(b) If any Gene Therapy Product sold by AGTC, its Affiliates or Sublicensees is
Covered by a Valid Claim of a Biogen Platform Improvement Patent Right licensed
to AGTC under this Section 5.4.2 in the country in which such Gene Therapy
Product is made, used or sold, then on a country-by-country basis AGTC will pay
to Biogen a royalty at a rate to be agreed upon by the Parties of up to [***] of
net sales (as determined in accordance with Section 5.4.2(d) and calculated in
accordance with Section 1.184, which definition of Net Sales shall apply mutatis
mutandis to such calculation) of such Gene Therapy Product on a
country-by-country and Gene Therapy Product-by-Gene Therapy Product basis, until
the latest of (a) the expiration of the last to expire of any Valid Claim
included in any Patent Right licensed to AGTC under this Section 5.4.2 in such
country which Valid Claim Covers the manufacture, use, sale, offer for sale or
importation of such Gene Therapy Product in such country, (b) [***].

(c) Such royalties shall be paid in accordance with the provisions of Section
6.7, which shall apply mutatis mutandis to payments made by AGTC pursuant to
this Section 5.4.2, provided, however, that if AGTC licenses or has prior to the
Effective Date licensed, intellectual property rights from one or more Third
Parties, in either case, which intellectual property rights are necessary or
useful to, and are actually used at any time to, exercise the license under
Section 5.4.2(a), whether directly or through any AGTC Affiliate or Sublicensee,
then any royalties otherwise payable to Biogen under Section 5.4.2(b) shall be
reduced by [***] of the royalties paid to Third Parties pursuant to any such
Third Party licenses arising out of and directly attributable and
proportionately allocated to the exercise of the license under 5.4.2(a),
provided that in no event shall any royalty payable to Biogen under this Section
5.4.2 be reduced to less than [***] (unless the royalty rate determined under
Section 5.4.2(b) or Section 5.4.2(d) is less than [***], in which case no
royalty reduction will apply); provided, however, that any amounts paid under
such Third Party license that are not used to reduce a payment due hereunder as
a result of the foregoing limitations may be carried over to reduce subsequent
payments due under this Section 5.4.2.

(d) If the Parties are unable to agree upon the applicable royalty rate within
thirty (30) days of the commencement of discussions regarding such royalty rate,
then the Parties shall select a mutually agreed external neutral expert with
significant and relevant experience to decide upon a commercially reasonable
royalty rate of up to [***], which external neutral expert shall not have
previously served as an employee of either Party or, within the two (2) years
prior to the external neutral expert’s engagement by the Parties pursuant to
this Section 5.4.2, as a consultant or third party expert for either Party.  The
Parties shall cooperate with such external neutral expert to enable such
external neutral expert to reach a decision as quickly as possible.  The
decision of the external neutral expert shall be final, non-appealable and
binding on the Parties.  Biogen and AGTC shall share equally the costs and fees
of such external neutral expert regardless of the decision by the external
neutral expert.

5.4.3. Enabling License from AGTC to Biogen.  Subject to the terms and
conditions of this Agreement and effective as of the Effective Date, during the
Term, AGTC, on behalf of itself and its Affiliates, hereby grants to Biogen a
worldwide, royalty-free, perpetual, irrevocable license, with the right to grant
sublicenses through multiple tiers, under the AGTC Improved Technology and
AGTC’s interest in the Joint Improved Technology, to use, have used, Develop,
have Developed, Manufacture, have Manufactured, Commercialize, have
Commercialized, import, have imported, export and have exported any
products.  The license granted under this Section 5.4.3 shall be exclusive (even
as to AGTC and its Affiliates except to the extent necessary for AGTC to perform
its obligations under this Agreement) with respect to the Joint Improved
Technology and non-exclusive with respect to the AGTC Improved Technology,
provided that such license shall be exclusive with respect to the AGTC Improved
Technology to the extent required pursuant to any Third Party agreement of
Biogen.

5.5. Existing License Agreements.

5.5.1. The rights granted to Biogen, its Affiliates or Sublicensees under this
Agreement are subordinate to the terms and conditions of the Existing License
Agreements, including the coordination of prosecution or enforcement of Patent
Rights or other intellectual property rights under the applicable agreement.

 

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5.5.2. Biogen shall be entitled to grant a sublicense under its sublicense
rights in the [***] Agreements in conjunction with a license to technology owned
or controlled by Biogen that (a) is included in or useful for the making of
[***] Products and (b) is intended to be included in or used in the manufacture
of [***] Products by the Sublicensee. Biogen shall only be entitled to
sublicense its rights under each [***] Agreement on the terms set forth in in
Section 2.3 of such [***] Agreement.

5.5.3. It is understood that the United States Government (through any of its
agencies or otherwise) has funded research, [***] during the course of or under
which certain of the inventions of the AGTC Patent Rights licensed to AGTC under
Existing License Agreements were conceived or made. The United States Government
is entitled, as a right, under the provisions of 35 U.S.C. §202-212 and
applicable regulations of Title 37 of the Code of Federal Regulations, to a
non-exclusive, nontransferable, irrevocable, paid-up license to practice or have
practiced the inventions of such AGTC Patent Rights for governmental
purposes.  Any license granted to Biogen in this Agreement shall be subject to
such right.

5.5.4. Biogen shall include the following provisions in any sublicense to a
Sublicensee, revised as appropriate to apply to such Sublicensee as it applies
to Biogen, to the extent such AGTC Technology is sublicensed and to the extent
such provision applies to AGTC’s licensors of such AGTC Technology: 5.5,
8.1.6(b), 11.4, 14.2.4, 14.6.3, 15.1.8, 15.3, 15.4, 15.5, 15.6, 15.7, 17.2,
17.5, 17.6.2, 17.6.3, 18.1, 18.9 and 18.15.  The Parties acknowledge and agree
that in the event that any Technology is included in the licenses granted to
Biogen under this Agreement pursuant to Section 13.6.2(a), additional
obligations and restrictions may need to be included in this Agreement prior to
such Technology being included in such licenses.  Without limiting the
foregoing, upon Biogen’s election to take a sublicense under Section 13.6.2(a)
to any Technology, the Parties shall update Schedule 5.2 to include any
restrictions on Biogen’s right to sublicense such Technology.

5.6. Right of Reference.   AGTC hereby grants to Biogen a “Right of Reference”,
as that term is defined in 21 C.F.R. § 314.3(b) and any analogous regulation
outside of the United States, to any data Controlled by AGTC or its Affiliates
that is necessary or useful to Develop, Manufacture, Commercialize or use any
Licensed Product, and AGTC shall provide a signed statement to this effect, if
requested by Biogen, in accordance with 21 C.F.R. § 314.50(g)(3) (or any
analogous applicable Law recognized outside of the United States).

5.7. No Implied Rights.  Except as expressly provided in this Agreement, neither
Party shall be deemed to have granted the other Party any license or other right
with respect to any intellectual property of such Party.

5.8. Exclusivity.

5.8.1. Initial Licensed Programs.  On an Initial Licensed Program-by-Initial
Licensed Program basis, for so long as AGTC, Biogen or any of their respective
Affiliates or Sublicensees are (a) Developing  any Initial Licensed Product from
such Initial Licensed Program under this Agreement, (i) neither AGTC nor any of
its Affiliates shall work independently of this Agreement for itself or any
Affiliate or Third Party (including the grant of any license, option or other
right to any Third Party) with respect to the Development, Manufacture or
Commercialization of any Gene Therapy Product, and (ii) neither Biogen nor any
of its Affiliates shall work independently of this Agreement for itself or any
Affiliate or Third Party (including the grant of any license, option or other
right to any Third Party) with respect to the Development, Manufacture or
Commercialization of any Gene Therapy Product, or (b) Commercializing any
Initial Licensed Product from such Initial Licensed Program under this
Agreement, (i) neither AGTC nor any of its Affiliates shall work independently
of this Agreement for itself or any Affiliate or Third Party (including the
grant of any license, option or other right to any Third Party) with respect to
the Manufacture or Commercialization of any Gene Therapy Product, and (ii)
neither Biogen nor any of its Affiliates shall work independently of this
Agreement for itself or any Affiliate or Third Party (including the grant of any
license, option or other right to any Third Party) with respect to Manufacture
or Commercialization, of any Gene Therapy Product, in each case of (a) or (b),
that delivers (1) an RS-1 transgene [***], if such Initial Licensed Program is
the XLRS Program or (2) an [***] transgene [***], if such Initial Licensed
Program is the XLRP Program.

5.8.2. Discovery Programs.

(a) On a Discovery Program-by-Discovery Program basis for the [***] Discovery
Program, the [***] Discovery Program (or the Non-Ophthalmology Discovery
Program, if applicable), the [***], the [***] or any Substitute Discovery
Program, commencing at the start of the Research Period with respect to each
such Discovery Program and for so long as AGTC, Biogen or any of their
Affiliates or Sublicensees are (i) Developing any

 

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Discovery Product from such Discovery Program under this Agreement, neither AGTC
nor any of its Affiliates shall work independently of this Agreement for itself
or any Affiliate or Third Party (including the grant of any license, option or
other right to any Third Party) with respect to the Development, Manufacture or
Commercialization of any AAV Product, or (ii) Commercializing any Discovery
Product from such Discovery Program under this Agreement, neither AGTC nor any
of its Affiliates shall work independently of this Agreement for itself or any
Affiliate or Third Party (including the grant of any license, option or other
right to any Third Party) with respect to the Manufacture or Commercialization
of any AAV Product, in each case of (i) or (ii) that delivers (1) [***], with
respect to the [***] Discovery Program, 2) [***], with respect to the [***], (3)
[***], with respect to the [***], (4) [***], with respect to the [***], (5) if
the Non-Ophthalmology Discovery Program is designated in accordance with Section
4.4.4, [***], or (6) if Biogen selects a Substitute Discovery Program under
Section 4.4, [***], provided that, for any Abandoned Program, AGTC’s obligations
under this Section 5.8.2(a), as applicable, shall terminate immediately.

(b) On a Discovery Program-by-Discovery Program basis for the [***] Discovery
Program, the [***] Discovery Program (or the Non-Ophthalmology Discovery
Program, if applicable), the [***] Discovery Program or any Substitute Discovery
Program, commencing at the start of the Research Period with respect to each
such Discovery Program and ending upon the earliest of (i) the date that such
Discovery Program becomes a Terminated Discovery Program, (ii) the date that
Biogen exercises the Option with respect to such Discovery Program or (iii)
[***] years from the Effective Date or [***] years from the Discovery Program
Substitution Date with respect to the applicable Substitute Discovery Program,
neither Biogen nor any of its Affiliates shall, while Developing a product
candidate under such Discovery Program, work independently of this Agreement for
itself or any Affiliate or Third Party (including the grant of any license,
option or other right to any Third Party) with respect to the Development,
Manufacture or Commercialization of any AAV Product that delivers (a) [***],
with respect to the [***] Discovery Program, (b) [***], with respect to the
[***] Discovery Program, (c) [***], with respect to the [***], (d) [***], with
respect to the [***] (e) if the Non-Ophthalmology Discovery Program is
designated in accordance with Section 4.4.4, [***], or (e) if Biogen selects a
Substitute Discovery Program under Section 4.4, [***].

5.8.3. Competing Program; Change of Control.

(a) Notwithstanding the provisions of Section 5.8.1 and Section 5.8.2, if during
the Term either Party acquires a Third Party or a portion of the business of a
Third Party (whether by merger, stock purchase or purchase of assets) that is,
prior to such acquisition, engaged in researching, Developing or Commercializing
a Gene Therapy Product in XLRS or XLRP or an AAV Product in a Discovery Program
that would violate the provisions of Section 5.8.1 or Section 5.8.2 if conducted
by such Party (a “Competing Program”), such Party shall use Commercially
Reasonable Efforts to divest such Competing Program promptly following the
closing of such acquisition, and in any event shall complete such divestment
within one year after the closing of such acquisition; provided that such time
period shall be extended, and such Party shall not be in breach of this Section
5.8.3, if at the expiration thereof (and any extensions thereto) such Party
provides competent evidence of reasonable ongoing efforts to divest such
Competing Program; and provided, further, that such Party shall cease all
research, Development and Commercialization activities with respect to such
Competing Program if such Party has not completed such divestment within [***]
after the closing of such acquisition (it being understood that such Party may
thereafter continue its efforts to divest such asset).  During such divestment
period, the acquiring Party shall (i) segregate the Competing Program with the
Collaboration Programs, including, to the extent practicable, establishing
separate teams to conduct Development activities under the Collaboration
Programs and such Competing Program, and (ii) use good faith efforts to prevent
any Confidential Information relating to the applicable Collaboration Program
from being disclosed to, or used by, individuals performing Development
activities under such Competing Program.  For the avoidance of doubt, neither
Party nor its Affiliates may acquire a Competing Program on a standalone basis.

(b) In the event of a Change of Control of either Party during the Term, the
obligations of such Party under Section 5.8.1 and Section 5.8.2 shall not apply
to any Gene Therapy Product, with respect to XLRS or XLRP, or AAV Product, with
respect to a Discovery Program, that (i) is owned or controlled by a Third Party
described in the definition of “Change of Control” or its Affiliates prior to or
as of the closing of such Change of Control or (ii) becomes owned or controlled
by such Third Party or its Affiliates after the closing of such Change of
Control if such Gene Therapy Product or AAV Product, as applicable, is not
developed using any Know-How or with access

 

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to any Know-How, and is not Covered by any Patent Rights, that were Controlled
by such Party or licensed to such Party under this Agreement prior to the
closing of the Change of Control.

5.8.4. Other Programs.  Each Party understands and acknowledges that the other
Party may have present or future initiatives or opportunities, including
initiatives or opportunities with Third Parties, involving similar products,
programs, technologies or processes that may compete with a product, program,
technology or process covered by this Agreement.  Each Party acknowledges and
agrees that nothing in this Agreement other than the provisions of Section
5.8.1, Section 5.8.2 or Section 5.8.3 will be construed as a representation,
warranty, covenant or inference that either Party will not itself Develop,
Manufacture or Commercialize or enter into business relationships with one or
more Third Parties to Develop, Manufacture or Commercialize products, programs,
technologies or processes that are similar to or that may compete with any
product, program, technology or process covered by this Agreement, provided that
such Party will not use the other Party’s Confidential Information in breach of
this Agreement.

5.9. Right of Notification for [***].  AGTC shall notify Biogen of any upcoming
publication, presentation or press release regarding the [***] Program, which
information, for the avoidance of doubt, shall be AGTC’s Confidential
Information.  If, at any time during the Term, AGTC (a) seeks to grant any
rights to the [***] to any Third Party or (b) receives any written expression of
interest from a Third Party for the [***], then AGTC shall each such time
promptly (and, in any event, no later than five (5) Business Days following the
execution of a confidentiality agreement with any Third Party with respect to
such potential transaction) provide written notice to Biogen.  Thereafter, AGTC
shall consider in its sole discretion any timely proposal by Biogen to add the
[***] as a Licensed Program under this Agreement.  For the avoidance of doubt,
AGTC shall have no obligation to negotiate with or enter into any definitive
agreement with Biogen with respect to the [***].

6. FINANCIAL TERMS.

6.1. Upfront Fees.  Within fifteen (15) days after the Effective Date, Biogen
shall pay to AGTC a sum of Ninety-Four Million Dollars ($94,000,000), payable by
wire transfer of immediately available funds according to instructions that AGTC
shall provide, and shall be allocated as follows: (a) an upfront fee of [***] in
consideration of the licenses granted to Biogen for the XLRS Program, (b) an
upfront fee of [***] in consideration of the licenses granted to Biogen for the
XLRP Program, (c) an access fee in the aggregate amount of [***] in
consideration of the Options granted to Biogen under the Discovery Programs, (d)
pre-paid research and Development funding for the XLRS Program in the amount of
[***], (e) pre-paid research and Development funding for the XLRP Program in the
amount of [***] and (f) prepaid research and Development funding for the
Discovery Programs in the aggregate amount of [***] (the amounts in (d) through
(f), collectively, the “R&D Pre-Funding”).

6.2. Limited Milestone Payments and Election of Financial Terms for the Initial
Licensed Products.

6.2.1. Limited Milestone Payments.  In partial consideration for AGTC’s
development of the AGTC Technology, prosecution and maintenance of the AGTC
Patent Rights and the grant of rights hereunder, and regardless of the election
by AGTC under Section 6.2.2 below, Biogen shall pay AGTC the amounts set forth
below within forty-five (45) days of receipt of notice from AGTC of the first
occurrence of each event described below for each of the first XLRS Product and
the first XLRP Product to achieve such event (each, a “Limited Milestone
Payment”).

[***]

Each of the Limited Milestone Payments set forth above shall be payable one time
only for each of the XLRS Program and the XLRP Program (regardless of the number
of XLRS Products or XLRP Products with respect to which, or the number of times
with respect to any XLRS Product or XLRP Product, the specified event milestone
occurs).  No Limited Milestone Payments shall be payable for any subsequent XLRS
Product or XLRP Product regardless of the number of XLRS Products or XLRP
Products developed.  For clarification, if one XLRS Product or XLRP Product
replaces another XLRS Product or XLRP Product in development, such replacement
XLRS Product or XLRP Product, as applicable, shall only be subject to Limited
Milestone Payments that have not previously been triggered by one or more prior
XLRS Products or XLRP Products, as applicable.

6.2.2. AGTC Election.  With respect to each Initial Licensed Program, AGTC shall
have the right to elect either (a) to share Operating Profits or Losses equally
with Biogen and receive Limited Milestone Payments with respect to such Initial
Licensed Program (the “Cost Share Option”), in which case the provisions of
Section 6.3 shall apply and the provisions of Section 6.4 shall not apply with
respect to such Initial Licensed Program, or (b) to receive Event Milestone
Payments, Sales

 

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Milestone Payments and royalty payments with respect to such Initial Licensed
Program (the “Milestone/Royalty Option”), in which case the provisions of
Section 6.4 shall apply and the provisions of Section 6.3 shall not apply with
respect to such Initial Licensed Program.  AGTC may make such election with
respect to an Initial Licensed Program by written notice to Biogen at any time
during the period starting upon FIH Trial Completion for the Initial Licensed
Product from such Initial Licensed Program, and ending forty-five (45) days
after receipt from Biogen of the calculation of all Development Costs reasonably
incurred by Biogen which Biogen would expect to be reimbursed under Section 6.3
if AGTC exercised the Cost Share Option. In the event that AGTC fails to make an
election with respect to such Initial Licensed Program during the applicable
forty-five (45) day period, AGTC shall be deemed to have elected the
Milestone/Royalty Option for such Initial Licensed Program.  For clarity, (i)
after AGTC elects the Cost Share Option or the Milestone/Royalty Option for the
XLRS Program, then such election shall apply to all XLRS Products and (ii) after
AGTC elects the Cost Share Option or the Milestone/Royalty Option for the XLRP
Program, then such election shall apply to all XLRP Products.

6.3. Cost Share Option.  If AGTC exercises the Cost Share Option as set forth in
Section 6.2.2 for an Initial Licensed Program, then effective immediately on the
date that AGTC exercises the Cost Share Option in accordance with Section 6.2.2,
Biogen and AGTC shall equally share in Operating Profits or Losses for Initial
Licensed Products arising under such Initial Licensed Program (each, a “Cost
Share Product”) in the Territory as provided in Exhibit C.  In addition, no
later than sixty (60) days after AGTC exercises the Cost Share Option for an
Initial Licensed Program, AGTC shall reimburse Biogen for [***] of all
Development Costs reasonably incurred by Biogen prior to the exercise of the
Cost Share Option in the performance of activities in anticipation of the
continued Development of the applicable Cost Share Product(s).  Biogen shall
prepare and provide to AGTC a first draft of the tax partnership agreement
within twenty (20) days after AGTC’s exercise of the Cost Share Option and AGTC
shall provide any comments to Biogen within twenty (20) days of receipt of such
first draft.  The Parties shall work together, in good faith and consistent with
the terms of this Section 6.3 and Exhibit E, to finalize and execute the tax
partnership agreement within sixty (60) days after AGTC’s exercise of the Cost
Share Option.

6.4. Milestone/Royalty Option.  If AGTC exercises the Milestone/Royalty Option
as set forth in Section 6.2.2 for an Initial Licensed Program, then the
provisions of this Section 6.4 shall apply with respect to such Initial Licensed
Program.

6.4.1. Event Milestone Payments.  In partial consideration for AGTC’s
development of the AGTC Technology and the grant of rights hereunder, Biogen
shall pay AGTC the amounts set forth below within forty-five (45) days of the
first occurrence of each event described below for each of the first XLRS
Product and the first XLRP Product to achieve such event (each, an “Event
Milestone Payment”).

Table 6.4.1

[***]

Each of the Event Milestone Payments set forth above shall be payable one time
only for each of the XLRS Program and the XLRP Program (regardless of the number
of XLRS Products or XLRP Products with respect to which, or the number of times
with respect to any XLRS Product or XLRP Product, the specified event milestone
occurs). No Event Milestone Payments shall be payable for any subsequent XLRS
Product or XLRP Product regardless of the number of XLRS Products or XLRP
Products developed.  For clarification, if one XLRS Product or XLRP Product
replaces another XLRS Product or XLRP Product in development, such replacement
XLRS Product or XLRP Product, as applicable, shall only be subject to Event
Milestone Payments that have not previously been triggered by one or more prior
XLRS Products or XLRP Products, as applicable.

In the event that an XLRS Product or an XLRP Product bypasses an event milestone
and achieves a later event milestone, then upon achievement of the later event
milestone, Event Milestone Payments shall be payable both for the event
milestone achieved and any earlier event milestone that was bypassed, provided
that the provisions of this sentence shall not apply if the respective event
milestones are territory-based event milestones (i.e., event milestones (ii)
through (x) of Table 6.4.1) and relate to events occurring in different
territories (e.g., if an XLRS Product or an XLRP Product bypasses event
milestones (ii) and (iii) (which relate to events in the United States) and
achieves event milestone (iv) (which relates to events in the European Union),
the Event Milestone Payments for event milestones (ii) and (iii) shall not
become payable).  In the event that an XLRS Product or an XLRP Product achieves
more than one event milestone concurrently, then the Event Milestone Payments
associated with each such event milestone shall be payable concurrently.

 

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Notwithstanding anything to the contrary in this Agreement, if the JDC or any
Regulatory Authority determines that it is necessary, in order to obtain
Regulatory Approval of an Initial Licensed Product, to conduct any Additional
Clinical Trial with respect to such Initial Licensed Product, then all future
Event Milestone Payments for such Initial Licensed Product shall be reduced by
[***] of the amount otherwise payable; provided, however, that if AGTC has
elected to not share the Development Costs associated with such Additional
Clinical Trial equally with Biogen as described in Section 3.2.2(c), all future
Event Milestone Payments for such Initial Licensed Product shall be reduced by
[***] of the amount otherwise payable.

6.4.2. Sales Milestone Payments.  In addition to the Event Milestone Payments
described in Section 6.4.1, in consideration of the rights granted to Biogen
hereunder, and subject to the terms and conditions of this Agreement, Biogen
shall pay AGTC the following one-time payments (each, a “Sales Milestone
Payment”) when aggregate Net Sales of any XLRS Product or any XLRP Product, as
applicable, in a Calendar Year in the Territory first reach the respective
thresholds indicated below:

[***]

Biogen shall make any Sales Milestone Payment payable with respect to a Calendar
Year within sixty (60) days after the end of the applicable Calendar Quarter in
which such cumulative Net Sales for such Calendar Year were achieved, and such
payment shall be accompanied by a report identifying the applicable Initial
Licensed Products, the relevant countries, Net Sales of each Initial Licensed
Product for each such country, and the amount payable to AGTC under this Section
6.4.2.  In the event that more than one of the previously unmet sales milestones
are achieved in a Calendar Year with respect to XLRS Products or XLRP Products,
then all of the Sales Milestone Payments corresponding to the sales milestones
met in such year shall be owed to AGTC.

6.4.3. Royalty Payments.

(a) Royalties.  In consideration for the license granted to Biogen under Section
5.1, Biogen, on an Initial Licensed Product-by-Initial Licensed Product and
country-by-country basis shall, during the Royalty Term for such Initial
Licensed Product, pay to AGTC royalties on Net Sales from the sale of such
Initial Licensed Product in any Calendar Year as follows:

[***]

(b) Fully Paid-Up, Royalty Free License.  Following expiration of the Royalty
Term for any Initial Licensed Product in a country, no further royalties shall
be payable in respect of sales of such Initial Licensed Product in such country
and, thereafter the license granted to Biogen under Section 5.1 with respect to
such Initial Licensed Product in such country shall be a fully paid-up,
perpetual, exclusive, irrevocable, royalty-free license.

6.5. Financial Terms for Discovery Products.

6.5.1. Option Fee.  Within forty-five (45) days of the Option Exercise Date for
a Discovery Program, Biogen shall pay to AGTC an option fee in the aggregate
amount of [***] (the “Option Fee”).

6.5.2. Discovery Event Milestone Payments.  In partial consideration for AGTC’s
development of the AGTC Technology and the grant of rights hereunder, Biogen
shall pay AGTC the amounts set forth below within forty-five (45) days of the
first occurrence of each event described below for each of the first Discovery
Product in each of Category A, Category B and Category C to achieve such event
(each, a “Discovery Event Milestone Payment”).

Table 6.5.2

[***]

For purposes of this Section 6.5.2:

“Category A” means a Discovery Product in [***], such as [***].

 

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“Category B” means a Discovery Product in [***], such as [***].

“Category C” means a Discovery Product in [***], such as [***].

Each of the Discovery Event Milestone Payments set forth above shall be payable
one time only for each Discovery Program (regardless of the number of Discovery
Products under such Discovery Program with respect to which, or the number of
times with respect to any Discovery Product under such Discovery Program, the
specified event milestone occurs).  No Discovery Event Milestone Payments shall
be payable for any subsequent Discovery Product under the same Discovery
Program, regardless of the number of Discovery Products under such Discovery
Program developed.  If, as a result of Biogen’s exercise of the Option for [***]
or the designation of a Substitute Discovery Program under Section 4.4, there
are Discovery Products from more than one Discovery Program in any of Category
A, Category B or Category C, then the Discovery Event Milestone Payments set
forth under the applicable category shall be payable for the applicable
Discovery Product from each such Discovery Program to achieve the specified
event milestone.  Notwithstanding the foregoing, if Biogen exercises an Option
for a clinical candidate that is a [***] Discovery Product, then each Discovery
Event Milestone Payment shall be payable only once for such [***] Discovery
Product.  For clarity, if Biogen reinstates a Terminated Discovery Program
pursuant to Section 4.4.3, Biogen shall pay the applicable Discovery Event
Milestone Payments for both the reinstated Terminated Discovery Program and the
applicable Substitute Discovery Program on a going forward basis.

In the event that a Discovery Product bypasses an event milestone and achieves a
later event milestone, then upon achievement of the later event milestone,
Discovery Event Milestone Payments shall be payable both for the event milestone
achieved and any earlier event milestone that was bypassed, provided that the
provisions of this sentence shall not apply if the respective event milestones
are territory-based event milestones (i.e., event milestones (iii) through (xi)
of Table 6.5.2) and relate to events occurring in different territories (e.g.,
if a Discovery Product bypasses event milestones (iii) and (iv) (which relate to
events in the United States) and achieves event milestone (v) (which relates to
events in the European Union), the Discovery Event Milestone Payments for event
milestones (iii) and (iv) shall not become payable).  In the event that a
Discovery Product achieves more than one event milestone concurrently, then the
Discovery Event Milestone Payments associated with each such event milestone
shall be payable concurrently.

6.5.3. Royalty Payments.

(a) Royalties.  In consideration for the license granted to Biogen under Section
5.1, Biogen, on a Discovery Product-by-Discovery Product and country-by-country
basis shall, during the Royalty Term for such Discovery Product, pay to AGTC
royalties on Net Sales from the sale of such Discovery Product in any Calendar
Year as follows:

[***]

(b) Fully Paid-Up, Royalty Free License.  Following expiration of the Royalty
Term for any Discovery Product in a country, no further royalties shall be
payable in respect of sales of such Discovery Product in such country and,
thereafter the license granted to Biogen under Section 5.1 with respect to such
Discovery Product in such country shall be a fully paid-up, perpetual,
exclusive, irrevocable, royalty-free license.

6.6. Payment Adjustments.  With respect to any payments under Section 6.2.1,
Section 6.4 or Section 6.5, the following adjustments shall apply in all cases
subject to Section 6.6.4.

6.6.1. Third Party Agreements.

(a) Biogen Third Party Agreements.  If Biogen licenses during the Term or has
prior to the Effective Date licensed, intellectual property rights from one or
more Third Parties, in either case, which intellectual property rights are
necessary or useful to, and are actually used at any time to, Develop,
Manufacture, Commercialize or use any Licensed Product, whether directly or
through any Biogen Affiliate or Sublicensee (each, a “Third Party License”),
then any payments otherwise payable to AGTC under Section 6.2.1, Section 6.4 or
Section 6.5 with respect to such Licensed Product shall be reduced by [***] of
the payments paid to Third Parties pursuant to any such Third Party Licenses
(which, in the case of upfront payments, shall be allocated equitably by Biogen
in good faith and proportionately among the applicable Collaboration Programs
and other relevant programs of Biogen and its Affiliates) arising out of and
directly attributable to the Development, Manufacture, Commercialization or use
of

 

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any Licensed Product, provided that in no event shall any payment payable to
AGTC for any Licensed Product be reduced to less than [***] of the amount that
would otherwise be owed to AGTC for such Licensed Product as a result of the
application of this Section 6.6.1(a); provided, however, that any amounts paid
under a Third Party License that are not used to reduce a payment due hereunder
as a result of the foregoing limitations may be carried over to reduce
subsequent payments due under Section 6.2.1, Section 6.4 or Section 6.5.  In the
event that AGTC elects the Cost Share Option under Section 6.2.2 for an Initial
Licensed Program for which Biogen has carried-over amounts pursuant to the
preceding sentence, such carried-over amounts shall be shared by the Parties in
accordance with Section 6.3.  Notwithstanding anything to the contrary, in the
event that Biogen obtains a direct license from any licensor under an AGTC Third
Party Agreement upon termination of such AGTC Third Party Agreement pursuant to
Section 16.10, then, if AGTC had been paying all amounts due under such AGTC
Third Party Agreement prior to such termination, any payments otherwise payable
to AGTC under Section 6.2.1, Section 6.4 or Section 6.5 with respect to a
Licensed Product shall be reduced by [***] of the payments paid to Third Parties
pursuant to any such Third Party Licenses arising out of and directly
attributable to the Development, Manufacture, Commercialization or use of such
Licensed Product without any limitation described in this Section 6.6.1(a).

(b) AGTC Third Party Agreements.

(i) AGTC shall be solely responsible for all obligations (including any royalty
or other obligations that relate to the AGTC Technology) under the Existing
License Agreements and any other agreements with Third Parties that are in
effect as of the Effective Date.  [***]

(ii) Solely to the extent that Biogen elects to take a sublicense under Section
13.6.2(a) under any license to Third Party IP Rights that AGTC or any of its
Affiliates enters into during the Term, Biogen shall be responsible for any
payment obligations under the applicable AGTC Third Party Agreements arising out
of the Development, Manufacture, Commercialization or use of any Licensed
Product, provided that any upfront payments under such AGTC Third Party
Agreements shall be allocated [***].  AGTC shall be solely responsible for all
other obligations under any such AGTC Third Party Agreements.  With respect to
any amounts paid by Biogen pursuant to any AGTC Third Party Agreements under
this Section 6.6.1(b)(ii), Biogen may offset such amounts against payments due
to AGTC in accordance with Section 6.6.1(a), as if such AGTC Third Party
Agreements were Third Party Licenses thereunder.

(iii) In the event that the Royalty Term for any Licensed Product extends beyond
the tenth (10th) anniversary of the First Commercial Sale of such Licensed
Product solely because the manufacture, use, sale, offer for sale or importation
of such Licensed Product is Covered by a Valid Claim of an AGTC Patent Right
Controlled by AGTC under an AGTC Third Party Agreement that AGTC enters into
during the Term, then, for the remainder of the Royalty Term, any royalty
payments otherwise payable to AGTC under this Agreement with respect to such
Licensed Product shall be reduced to the amount of royalty payments, if any,
payable by AGTC to such Third Party pursuant to such AGTC Third Party Agreement
with respect to such Licensed Product. Notwithstanding anything to the contrary,
this Section 6.6.1(b)(iii) shall not apply in the event that the manufacture,
use, sale, offer for sale or importation of such Licensed Product is Covered by
a Valid Claim of an AGTC Patent Right Controlled by AGTC under an AGTC Third
Party Agreement that AGTC enters into during the Term, but for which AGTC
provided all or substantially all of the funding that contributed to the
invention Covered by such Valid Claim.

6.6.2. Competitive Products.  On a country-by-country and Licensed
Product-by-Licensed Product basis, in the event Competitive Products to such
Licensed Product are sold in a country in the Territory, any royalty otherwise
payable to AGTC under this Agreement with respect to Net Sales of such Licensed
Product in such country pursuant to Section 6.4.3 or Section 6.5.3 in all
subsequent Calendar Quarters shall be reduced by [***] if Biogen’s market share
during any two (2) consecutive Calendar Quarters, as measured in either Net
Sales or units sold of such Licensed Product, decreases by a total of [***] or
more of the average Net Sales or units sold of such Licensed Product in such
country averaged over the four (4) Calendar Quarters immediately prior to the
first sale of such Competitive Product in such country.

6.6.3. No Valid Claims; Orphan Drug Exclusivity.  On a country-by-country and
Licensed Product-by-Licensed Product basis, any royalty otherwise payable to
AGTC under this Agreement with respect to Net Sales of such Licensed Product in
such country shall be reduced by [***] at any time when (a) there is no Valid
Claim included in the AGTC Patent

 

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Rights or Joint Patent Rights in such country that Covers the Manufacture, use
or sale of such Licensed Product and (b) [***].

6.6.4. Reductions Cumulative; Royalty Floor; Event Milestone Floor.  The payment
reductions set forth in this Section 6.6 shall be applied on a cumulative basis;
provided, however, that, except as provided in Section 6.6.1(b)(iii), in no
event shall any royalty payment payable to AGTC under this Agreement for any
Licensed Product in a given Calendar Quarter be reduced to less than the royalty
payments payable by AGTC to Third Parties with respect to such Licensed Product
in such Calendar Quarter plus [***]; and provided, further, that in no event
shall any Limited Milestone Payment, Event Milestone Payment or Discovery Event
Milestone Payment payable to AGTC under this Agreement for any Licensed Product
be reduced pursuant to this Section 6.6 (or, with respect to Event Milestone
Payments, pursuant to the final paragraph of Section 6.4.1) to less than (a)
[***] of the amount otherwise payable to AGTC, if the applicable event milestone
relates to the FIH Trial or any earlier event for such Licensed Product; (b)
[***] of the amount otherwise payable to AGTC, if the applicable event milestone
relates to (i) the Pivotal Trial for such Licensed Product or (ii) the receipt
of Regulatory Approval in the United States for such Licensed Product, in the
case of clause (ii), solely to the extent that such Licensed Product is the
first Initial Licensed Product to receive Regulatory Approval in the United
States; provided, however, in each case ((i) and (ii)), that if AGTC has elected
to not share the Development Costs associated with such Additional Clinical
Trial equally with Biogen under Section 3.2.2(c), then the floor set forth in
this clause (b) shall be further reduced to [***] of the amount otherwise
payable to AGTC; or (c) [***] of the amount otherwise payable to AGTC, with
respect to any other event milestone for any Licensed Product (including, for
clarity, a Regulatory Approval event milestone for a Licensed Product that is
not the first Initial Licensed Product to receive Regulatory Approval in the
United States).

6.7. Reports and Payments.

6.7.1. Cumulative Royalties.  Any obligation to pay royalties under this
Agreement shall be imposed only once with respect to any sale of any Licensed
Product.

6.7.2. Royalty Statements and Payments.  Within sixty (60) days of the end of
each Calendar Quarter, at any time during the Term in which Biogen is making
royalty payments to AGTC for any Licensed Products under Section 6.4.3 or
Section 6.5.3, Biogen shall deliver to AGTC a report setting forth for the most
recently completed Calendar Quarter, the following information, on a Licensed
Product-by-Licensed Product, country-by-country and Territory-wide basis: (a)
Net Sales of each such Licensed Product, (b) the basis for any adjustments to
the royalty payable for the sale of any such Licensed Product and (c) the
royalty due hereunder for the sale of each such Licensed Product.  No such
reports shall be due for any such Licensed Product before the First Commercial
Sale of such Licensed Product.  The total royalty due for the sale of all such
Licensed Products during such Calendar Quarter shall be remitted at the time
such report is made.

6.8. Taxes and Withholding.

6.8.1. AGTC shall provide such information and documentation to Biogen as are
reasonably requested by Biogen that are necessary for Biogen to determine if any
withholding taxes apply to any payments to be made by Biogen to AGTC. Biogen
shall only make such withholding payments to the extent required by applicable
Law and shall subtract such required withholding payments that are actually paid
by Biogen to the appropriate Governmental Authority responsible for the
collection of such withholding tax (such a Governmental Authority, a “Tax
Authority”) from the payments due to AGTC. For avoidance of doubt, AGTC shall
not be responsible for any interest, penalties or additions to tax attributable
to Biogen’s failure to timely make any such required withholding payments.
Biogen shall promptly submit to AGTC appropriate proof of payment by Biogen to
the appropriate Tax Authority of the required withholding taxes.  At the request
of AGTC, Biogen shall give AGTC such reasonable assistance, which shall include
the provision of appropriate certificates of such deductions and withholding
payments made, together with other supporting documentation as may be required
by the relevant Tax Authority, to enable AGTC to claim exemption from such
withholding tax or to obtain a repayment thereof or a reduction thereof, and
shall provide such additional documentation from time to time as is reasonably
requested by AGTC in connection with any of the foregoing. Biogen shall use
commercially reasonable efforts to minimize any such withholdings.

6.8.2. Additional Taxes. The amount of any payment to be made by Biogen to AGTC
pursuant to this Agreement shall be increased for any sales, value added or
similar taxes (any such taxes, “Additional Taxes”) required to be collected by
AGTC from Biogen.  Biogen shall provide such information and documentation to
AGTC as are reasonably requested by AGTC for AGTC to determine the amount of any
Additional Taxes that apply to any payments to be made by Biogen to AGTC, and to
satisfy any applicable reporting obligations related to such Additional Taxes.

 

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6.8.3. The Parties agree that the provisions of this Section 6.8 shall also
apply to payments made by AGTC to Biogen, if any, under this Agreement, in which
case this Section 6.8 shall be read by replacing all references to “AGTC” with
“Biogen” and all references to “Biogen” with “AGTC.”

6.9. Currency.  All payments to be made by a Party to the other Party hereunder
shall be in immediately available funds via either a bank wire transfer, an ACH
(automated clearing house) mechanism, or any other means of electronic funds
transfer, at the payee Party’s election, to a bank account to be designated by
the payee Party in a notice at least ten (10) days before the payment is due.
All amounts payable and calculations under this Agreement shall be in United
States Dollars.  As applicable, Net Sales and any royalty deductions shall be
translated into United States Dollars at the exchange rate used by Biogen for
public financial accounting purposes in accordance with GAAP.  If, due to
restrictions or prohibitions imposed by national or international authority,
payments cannot be made as provided in this Article 6, the Parties shall consult
with a view to finding a prompt and acceptable solution, and Biogen will deal
with such monies as AGTC may lawfully direct.

6.10. Late Payments.  If a Party does not receive payment of any sum due to it
on or before the due date therefor set forth in this Agreement, simple interest
shall thereafter accrue on the sum due to the Party from the due date until the
date of payment at a per-annum rate of one percent (1%) over the then-current
prime rate reported in The Wall Street Journal or the maximum rate allowable by
applicable Laws, whichever is lower.

7. REGULATORY AFFAIRS; PHARMACOVIGILANCE.

7.1. Regulatory Affairs.

7.1.1. XLRS Product.

(a) AGTC will initially own all INDs and Orphan Drug Designations and related
documentation submitted to any Regulatory Authorities anywhere in the Territory
with respect to the XLRS Product, and the Marketing Application, related
documentation and initial Regulatory Approval in the United States with respect
to the XLRS Product, subject to Section 3.1.3.  AGTC will be primarily
responsible, in consultation with Biogen, for (a) all regulatory matters and
interactions with Regulatory Authorities relating to the conduct of Clinical
Trials for the XLRS Product worldwide including (i) overseeing, monitoring and
coordinating all regulatory actions, communications and filings with, and
submissions to, Regulatory Authorities with respect to the conduct of Clinical
Trials for the XLRS Product; (ii) interfacing, corresponding and meeting with
Regulatory Authorities with respect to the conduct of Clinical Trials for the
XLRS Product; (iii) submitting and maintaining all regulatory filings with
respect to Clinical Trials for the XLRS Product, other than any Marketing
Applications, and (iv) maintaining and submitting all records required to be
maintained or required to be submitted to any Regulatory Authority with respect
to Clinical Trials for the XLRS Product and (b) all other regulatory matters in
the United States through Regulatory Approval of the XLRS Product, including (i)
overseeing, monitoring and coordinating all regulatory actions, communications
and filings with, and submissions to, the FDA with respect to marketing
authorization for the XLRS Product; (ii) interfacing, corresponding and meeting
with the FDA with respect to the XLRS Product; (iii) submitting and maintaining
all regulatory filings with respect to the XLRS Product in the United States;
and (iv) maintaining and submitting all records required to be maintained or
required to be submitted to the FDA with respect to the XLRS Product, provided
that Biogen will have final decision-making authority with respect to any
decisions regarding the BLA for the XLRS Product, the content of the label for
the XLRS Product or post-marketing commitments with respect to the XLRS Product,
subject to Section 2.1.4(a)(v) or Section 2.1.4(b)(ii), as applicable.

(b) Biogen will own all Marketing Applications and related documentation
submitted to any Regulatory Authority in the ROW Territory and the initial
Regulatory Approval in any country in the ROW Territory with respect to the XLRS
Product.  Biogen will be primarily responsible, in consultation with AGTC, for
all regulatory matters relating to marketing authorizations for the XLRS Product
in the ROW Territory, through Regulatory Approval, including (i) overseeing,
monitoring and coordinating all regulatory actions, communications and filings
with, and submissions to, Regulatory Authorities with respect to marketing
authorizations for the XLRS Product in the ROW Territory; (ii) interfacing,
corresponding and meeting with Regulatory Authorities with respect to matters
relating to marketing authorization for the XLRS Product in the ROW Territory;
(iii) submitting and maintaining all regulatory filings with respect to the XLRS
Product in the ROW Territory, other than those required to be maintained and
submitted by AGTC under Section 7.1.1(a); and (iv) maintaining and submitting
all records required

 

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to be maintained or required to be submitted to any Regulatory Authority with
respect to the XLRS Product in the ROW Territory, other than those required to
be maintained and submitted by AGTC under Section 7.1.1(a).  AGTC shall provide
Biogen with any information regarding the XLRS Program reasonably requested by
Biogen in order for Biogen to conduct the activities set forth in this Section
7.1.1(b), and shall provide reasonable support to Biogen with respect to such
activities upon Biogen’s request, including attending meetings and assisting
with responses to inquiries from Regulatory Authorities, and Biogen shall
reimburse AGTC for AGTC’s reasonable Out-Of-Pocket Costs associated with such
activities within forty-five (45) days of receipt of an invoice from AGTC for
such Out-Of-Pocket Costs.  Biogen will have final decision-making authority
regarding the Marketing Applications in the ROW Territory for the XLRS Product,
the content of the label for the XLRS Product and post-marketing commitments
with respect to the XLRS Product, subject to Section 2.1.4(a)(v) or Section
2.1.4(b)(ii), as applicable.

7.1.2. XLRP Product.

(a) AGTC will initially own all INDs, Orphan Drug Designations obtained prior to
FIH Trial Completion and related documentation submitted to any Regulatory
Authorities anywhere in the Territory with respect to the XLRP Product, subject
to Section 3.1.3. AGTC will be primarily responsible, in consultation with
Biogen, for all regulatory matters and interactions with Regulatory Authorities
relating to the conduct of Clinical Trials for the XLRP Product worldwide
through FIH Trial Completion, including (i) overseeing, monitoring and
coordinating all regulatory actions, communications and filings with, and
submissions to, Regulatory Authorities with respect to the conduct of the FIH
Trial for the XLRP Product; (ii) interfacing, corresponding and meeting with
Regulatory Authorities with respect to the conduct of the FIH Trial for the XLRP
Product; (iii) submitting and maintaining all regulatory filings with respect to
the FIH Trial for the XLRP Product and (iv) maintaining and submitting all
records required to be maintained or required to be submitted to any Regulatory
Authority with respect to the FIH Trial for the XLRP Product.

(b) Biogen will own all INDs, Marketing Applications and related documentation
submitted to any Regulatory Authority, any Orphan Drug Designations and all
Regulatory Approvals with respect to XLRP Products after the transfer in Section
11.5 upon FIH Trial Completion for the XLRP Product.  Biogen will be primarily
responsible, in consultation with AGTC (and, after FIH Trial Completion for the
XLRP Product, shall be solely responsible without consultation with AGTC), for
all regulatory matters relating to the XLRP Product, including (i) overseeing,
monitoring and coordinating all other regulatory actions, communications and
filings with, and submissions to, Regulatory Authorities with respect to the
XLRP Product; (ii) interfacing, corresponding and meeting with Regulatory
Authorities with respect to the XLRP Product; (iii) submitting and maintaining
all regulatory filings with respect to the XLRP Product, other than those
required to be maintained and submitted by AGTC under Section 7.1.2(a); and (iv)
maintaining and submitting all records required to be maintained or required to
be submitted to any Regulatory Authority with respect to the XLRP Product, other
than those required to be maintained and submitted by AGTC under this Section
7.1.2(a).  AGTC shall provide Biogen with any information regarding the XLRP
Program reasonably requested by Biogen in order for Biogen to conduct the
activities set forth in this Section 7.1.2(b), and shall provide reasonable
support to Biogen with respect to such activities upon Biogen’s request,
including attending meetings and assisting with responses to inquiries from
Regulatory Authorities, and Biogen shall reimburse AGTC for AGTC’s reasonable
Out-Of-Pocket Costs associated with such activities within forty-five (45) days
of receipt of an invoice from AGTC for such Out-Of-Pocket Costs.  Biogen shall
have final decision-making authority regarding Marketing Applications in the
Territory for the XLRP Product, the content of the label for the XLRP Product
and post-marketing commitments with respect to the XLRP Product, subject to
Section 2.1.4(a)(v) or Section 2.1.4(b)(ii), as applicable.

7.1.3. Participation.  Within five (5) Business Days after receipt by either
Party of any communication from a Regulatory Authority with respect to an
Initial Licensed Product (or such shorter time as necessary to allow the other
Party an opportunity to review if the time to respond to such communication is
less than five (5) Business Days), such receiving Party will provide the other
Party, through its Alliance Manager, with a brief written description of the
issues raised in such communication or, if such communication is a substantive
communication, a copy of such communication.  With respect to any such
communications or any filings and other submissions to a Regulatory Authority
with respect to an Initial Licensed Product, the receiving or filing Party will
allow the other Party a reasonable opportunity, taking into account the nature
and length of such communications, filings or submissions (but no less than ten
(10) Business Days in the case of significant filings if possible), to review
and comment on such Party’s proposed response, filings or submissions in advance
of the transmission of such response, filing or submission, and such receiving
or filing Party will reasonably consider all comments

 

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provided by the other Party in connection therewith, provided that, if such
filing or other submission relates to the XLRS Product and AGTC is the Party
making such filing or other submission, with respect to any comments by Biogen
regarding the BLA for the XLRS Product, the content of the label or
post-marketing commitments for the XLRS Product, AGTC shall have the obligation
to incorporate such comments into any such filing or submission.  Each Party
shall promptly provide the other Party with a complete copy of any filing or
submission actually submitted to a Regulatory Authority.  Each Party shall
provide the other Party with reasonable advance notice of any formal meeting or
teleconference with any Regulatory Authority with respect to an Initial Licensed
Product.  The Party having such formal meeting or teleconference shall permit
the other Party to have, at such other Party’s expense, a representative of such
other Party attend such formal meetings or teleconferences.  AGTC shall provide
Biogen with prompt written notice of (but in any event within ten (10) Business
Days) after the occurrence of the filing of any IND for the XLRP Product;
provided, however, that in all circumstances, AGTC shall inform Biogen of such
event prior to public disclosure of such event by AGTC.  Notwithstanding
anything to the contrary, AGTC shall have no further participation rights under
this Section 7.1.3 (including any rights to receive copies of regulatory
communications, filings or submissions) with respect to an Initial Licensed
Product if (a) AGTC is no longer conducting Development activities with respect
to such Initial Licensed Product and (b) AGTC has not exercised the Cost Share
Option for such Initial Licensed Product, subject to Section 2.1.4(a)(v) or
Section 2.1.4(b)(ii), as applicable.

7.1.4. Discovery Products.  Biogen will own all INDs, Orphan Drug Designations,
Marketing Applications and related documentation submitted to any Regulatory
Authority and all Regulatory Approvals with respect to the Discovery
Products.  Biogen will be solely responsible for all regulatory matters relating
to the Discovery Products, including (i) overseeing, monitoring and coordinating
all regulatory actions, communications and filings with, and submissions to,
Regulatory Authorities with respect to the Discovery Products; (ii) interfacing,
corresponding and meeting with Regulatory Authorities with respect to the
Discovery Products; (iii) submitting and maintaining all regulatory filings with
respect to the Discovery Products; and (iv) maintaining and submitting all
records required to be maintained or required to be submitted to any Regulatory
Authority with respect to the Discovery Products.

7.2. Pharmacovigilance.  Within one hundred and twenty (120) days following the
Effective Date (or as soon as reasonably practicable following such one hundred
and twenty (120) day period), the Parties shall enter into a written
pharmacovigilance agreement governing each Party’s respective obligations with
respect to allocation of responsibilities for reporting to the other Party and
appropriate Regulatory Authorities adverse events, complaints, and other
safety-related matters.

8. COMMERCIALIZATION.

8.1. Control of Commercialization Activities.

8.1.1. General.  As between the Parties, and subject to AGTC’s Co-Promotion
Option as set forth in Section 8.1.4 and the oversight of the JCC, as
applicable, in accordance with Section 2.2, Biogen shall have sole and exclusive
responsibility for and control of all aspects of Commercialization of the
Licensed Products, including: (i) developing and executing a commercial launch
and pre-launch plan, (ii) negotiating with applicable Governmental Authorities
regarding the price and reimbursement status of each Licensed Product; (iii)
marketing and promotion; (iv) booking sales and distribution and performance of
related services; (v) handling all aspects of order processing, invoicing and
collection, inventory and receivables; and (vi) providing customer support,
including handling medical queries and performing other related functions.

8.1.2. Commercialization Plan and Commercialization Budget.  At least [***]
prior to the anticipated First Commercial Sale of any Cost Share Product, Biogen
shall prepare an initial Commercialization Plan and Commercialization Budget for
the following [***] for such Cost Share Product and shall present such initial
Commercialization Plan and Commercialization Budget to the JCC for review and
approval.  Thereafter, Biogen shall amend and update the Commercialization Plan
and Commercialization Budget annually on a rolling basis for the following
[***].

8.1.3. Biogen Product.  Biogen shall have the sole right, either itself or
through its Affiliates or Sublicensees, to Commercialize the first Initial
Licensed Product to receive Regulatory Approval in the United States (the
“Biogen Product”), and such Initial Licensed Product shall not be subject to the
Co-Promotion Option.  Biogen shall have sole and exclusive responsibility for
and control of Commercialization of the Biogen Product.

 

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8.1.4. AGTC Co-Promotion Option.

(a) AGTC shall have an option (the “Co-Promotion Option”) to co-promote in the
United States the second Initial Licensed Product to receive Regulatory Approval
in the United States (such product for which AGTC has exercised the Co-Promotion
Option, the “Co-Promotion Product”), in accordance with this Section 8.1.4 and
Exhibit B.  AGTC may exercise its Co-Promotion Option by providing written
notice to Biogen no later than [***] days prior to the date anticipated for
receipt of Regulatory Approval for the second Initial Licensed Product to
receive Regulatory Approval in the United States, which date Biogen shall
communicate to AGTC no later than [***] days prior to the date anticipated for
receipt of such Regulatory Approval, and, in the event Biogen fails to so notify
AGTC in a timely manner in accordance with this Section 8.1.4(a), AGTC may
exercise the Co-Promotion Option within sixty (60) days of the date that Biogen
actually notifies AGTC of the date anticipated for receipt of such Regulatory
Approval.  No later than three (3) months after AGTC exercises its Co-Promotion
Option, AGTC and Biogen shall enter into a co-promotion agreement for the
Co-Promotion Product consistent with this Section 8.1.4 and Exhibit B
(“Co-Promotion Agreement”).

(b) Upon AGTC’s exercise of the Co-Promotion Option in accordance with this
Section 8.1.4, the Parties shall coordinate all sales efforts and field
activities with respect to the Co-Promotion Product in the United States under
the direction of Biogen, and such efforts and activities shall be more fully
described in the Co-Promotion Agreement.  Except for those rights expressly
granted to AGTC herein and in the Co-Promotion Agreement, Biogen shall have sole
and exclusive responsibility for and control of all aspects of Commercialization
of the Co-Promotion Product.

(c) AGTC may exercise the Co-Promotion Option regardless of whether AGTC has
exercised the Cost Share Option or the Milestone/Royalty Option with respect to
the Co-Promotion Product.  Solely in the event that AGTC has exercised the
Milestone/Royalty Option with respect to the Co-Promotion Product, AGTC shall be
responsible for all costs and expenses associated with AGTC’s co-promotion
activities, including the AGTC Customer-Facing FTEs, for the Co-Promotion
Product.  For clarity, if AGTC has exercised the Cost Share Option with respect
to the Co-Promotion Product, the costs and expenses associated with the Parties’
respective Customer-Facing FTEs for the Co-Promotion Product shall be shared by
the Parties in accordance with the provisions of Section 6.3.

(d) Notwithstanding anything to the contrary, upon any Change of Control of
AGTC, the Co-Promotion Option (if not yet exercised pursuant to Section
8.1.4(a)) or Co-Promotion Agreement, as applicable, shall terminate on the date
of such Change of Control or the closing of such acquisition, as
applicable.  If, on the date of such Change of Control or the closing of such
acquisition, as applicable, AGTC has exercised the Co-Promotion Option but the
Parties have not yet entered into the Co-Promotion Agreement, Biogen shall have
no further obligation to enter into a Co-Promotion Agreement.

(e) If AGTC does not exercise the Co-Promotion Option as set forth in this
Section 8.1.4, then Biogen shall have the sole and exclusive responsibility for
and control of Commercialization of both Initial Licensed Products.

(f) For clarity, AGTC shall have no right to exercise the Co-Promotion Option if
only one Initial Licensed Product receives Regulatory Approval in the United
States.

8.1.5. Discovery Products.  Biogen shall have the sole and exclusive
responsibility for and control of Commercialization of the Discovery Products.

8.1.6. Branding and Marks.

(a) Biogen shall select and own all trademarks and trade dress used in
connection with the Commercialization of any and all Licensed Products,
including all goodwill associated therewith.  Neither AGTC nor its Affiliates
shall use or seek to register, anywhere in the world, any trademarks which are
confusingly similar to any trademarks, trade names, trade dress or logos
developed by or on behalf of Biogen its Affiliates or Sublicensees in connection
with any Licensed Product. For purposes of clarity, AGTC have sole
responsibility for and shall be free to use any trademark, trade name, trade
dress or logos developed for the AGTC Platform, even if the Parties agree to use
such trademark, trade name, trade dress or logo on or with respect to a Licensed
Product.

 

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(b) Biogen shall apply patent markings that meet all requirements of U.S. law
Title 35 of United States Code, including without limitation, 35 U.S.C. §287,
with respect to all Licensed Products subject to this Agreement. Biogen shall
mark the Licensed Products sold in the United States with all applicable United
States patent numbers. All Licensed Products shipped to or sold in other
countries shall be marked in such manner as to conform with the patent laws and
practice of the country of manufacture or sale. Any Licensed Products subject to
Patent Rights under an Existing License Agreement that are sold or produced in
the United States shall be Manufactured substantially in the United States to
the extent required by applicable Law. Biogen shall take all reasonable action
necessary on its part as a licensee of any Patent Rights under an Existing
License Agreement to enable the Existing Licensors to satisfy their respective
obligations to the United States government under Title 35 of the United States
Code.

8.2. Commercialization Costs.  Subject to the provisions of Section 8.1.4(c),
Biogen shall be solely responsible for all costs associated with
Commercialization of the Licensed Products; provided, however, that if AGTC
exercises the Cost Share Option for an Initial Licensed Product as set forth in
Section 6.2.2, AGTC shall share such costs as set forth in Section 6.3.

8.3. Commercial Diligence.

8.3.1. Diligence Obligations.  Biogen shall use Commercially Reasonable Efforts
to Commercialize a given Licensed Product in each Major Market Country in the
Territory where Regulatory Approval is obtained for such Licensed Product, in
accordance with the terms of this Agreement and, if such Licensed Product is a
Cost Share Product, the Commercialization Plan for such Licensed Product. Solely
in the event that the Parties enter into a Co-Promotion Agreement, AGTC shall
use Commercially Reasonable Efforts to co-promote the Co-Promotion Product in
the United States in accordance with the provisions of the Co-Promotion
Agreement.

8.3.2. Exceptions to Commercial Diligence Obligations.  Notwithstanding any
provision of this Agreement to the contrary, the Obligated Party will be
relieved from and will have no obligation to undertake any efforts with respect
to the Commercialization of any Licensed Product in the event that:

(a) either Party receives or generates any safety, tolerability or other data
reasonably indicating, as measured by the Obligated Party’s safety and efficacy
evaluation criteria and methodology, that a Licensed Product is not reasonably
suitable, for safety reasons, for initiation or continuation of Clinical Trials
in humans; or

(b) the other Party materially breaches any of its obligations under the this
Agreement and such breach impairs or limits the Obligated Party’s ability to
perform its Commercialization activities under this Agreement; provided that, in
such event, the Obligated Party shall only be relieved of such obligations to
the extent and for so long as the other Party’s breach so impairs or limits the
Obligated Party’s ability to perform its Commercialization activities under this
Agreement.

9. RECORDS AND AUDITS.

9.1. Research and Manufacturing Records.  Each Party shall maintain, consistent
with its then-current internal policies and practices, and cause its Affiliates,
Sublicensees, employees and Subcontractors to maintain, consistent with its
internal policies and applicable Law, for [***], records and laboratory
notebooks, inventory, purchase and invoice records and Manufacturing records
with respect to the Licensed Products in sufficient detail and in a good
scientific manner appropriate for (i) inclusion in filings with Regulatory
Authorities, and (ii) obtaining and maintaining intellectual property rights and
protections, including Patent Rights.  Such records and laboratory notebooks
shall be complete and accurate in all material respects and shall fully and
properly reflect all work done, data and developments made, and results
achieved.  Each Party shall allow, and cause its Affiliates, Sublicensees,
employees and subcontractors to allow, the other Party, to the extent necessary
for such regulatory or intellectual property protection purposes, inspect or
copy such records, subject to redaction by such Party.

9.2. Financial Records.  Each Party shall keep and shall cause its Affiliates
and Sublicensees to keep complete and accurate books and accounts of record (i)
used for determination of Development, Manufacturing or Commercialization costs
and expenses incurred in connection with the performance of its activities and
obligations under this Agreement, and (ii) in connection with the sale of
Licensed Products, including without limitation, sales analysis, general
ledgers, financial statements, and tax returns, in each case, in accordance with
GAAP and such Party’s then-current accounting procedures and in sufficient
detail to permit accurate determination of all figures necessary for
verification of amounts to be paid under this Agreement or used in the
calculation of any

 

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cost sharing arrangement, including without limitation, royalties, Sales
Milestone Payments, amounts for Cost of Goods Sold.  Each Party shall, and shall
cause its Affiliates and Sublicensees to, maintain such records for a period of
at least six (6) years after the end of the Calendar Quarter in which they were
generated.

9.3. Audits.

9.3.1. Upon reasonable advance written notice by a Party (the “Auditing Party”)
and not more than once in each Calendar Year (except for cause), the other Party
(the “Audited Party”) and its Affiliates shall permit, and shall use reasonable
efforts to cause their Sublicensees to permit, the Auditing Party or licensors
of AGTC Technology (or an attorney or CPA of such licensor), or an independent
certified public accounting firm of internationally recognized standing,
selected by the Auditing Party and reasonably acceptable to the Audited Party,
to have access during normal business hours to such of the records of the
Audited Party and its Affiliates and, if applicable, their Sublicensees as may
be reasonably necessary to (a) verify the accuracy of the applicable royalty or
milestone payments hereunder, (b) verify the accuracy of any Development,
Manufacturing or Commercialization costs and expenses submitted to the other
Party for reimbursement or required for purposes of effecting or managing a cost
sharing arrangement under this Agreement or (c) verify the accuracy of any
financial information provided by the Audited Party to the Auditing Party under
Exhibit C, as applicable, in each case, for any year ending not more than
thirty-six (36) months prior to the date of such request.  No year may be
audited more than once, except for cause.  The accounting firm will enter a
confidentiality agreement reasonably acceptable to the Audited Party governing
the use and disclosure of the Audited Party’s information disclosed to such
firm, and such firm shall disclose to the Auditing Party only whether the
information provided by the Audited Party to the Auditing Party as described in
clauses (a) through (c) above was accurate, and the specific details concerning
any discrepancies, which information shall be Confidential Information of the
Audited Party.

9.3.2. Unless disputed by either Party in good faith, if such accounting firm
concludes that any payments paid by a Party to the other Party during the
audited period were more or less than the amount actually due, the underpaying
Party shall pay any additional amounts due, or the overpaid Party will refund
any amounts overpaid, as applicable, in each case plus interest as set forth in
Section 6.10, within forty-five (45) days after the date the written report of
the accounting firm so concluding is delivered to AGTC and Biogen.  The written
report will be binding on the Parties absent clear error.  The fees charged by
such accounting firm shall be paid by the Auditing Party; provided, however,
that if the audit results in a payment adjustment of more than five percent
(5%), then the Audited Party shall pay the reasonable fees and expenses charged
by such accounting firm.  The Auditing Party shall treat all financial
information disclosed by its accounting firm pursuant to this Section 9.3 as
Confidential Information of the Audited Party for purposes of Article 14 of this
Agreement.

9.3.3. In the event of a good faith dispute by either Party regarding the result
of an audit made pursuant to this Section 9.3, the Parties shall agree in good
faith on an alternative independent certified public accounting firm of
internationally recognized standing to perform a second audit.  If such audit is
requested by the Audited Party because the Audited Party was found by the
initial audit to have underpaid and the second audit confirms that the Audited
Party underpaid, then the Audited Party shall bear all costs associated with the
second audit.  If such audit is requested by the Auditing Party because the
Audited Party was found by the initial audit to have overpaid and the second
audit confirms that the Audited Party overpaid, then the Auditing Party shall
bear all costs associated with the second audit.  Notwithstanding the above, in
the event that the second audit confirms the findings of the first audit, the
requesting Party shall pay.  No over or under payment indicated by the initial
audit shall be payable in the event of a dispute until the second audit is
complete and such second audit shall be binding on the Parties, with any under
or over payment determined thereby, plus interest as set forth in Section 6.10,
being payable within forty-five (45) days after the date the written report of
the accounting firm so concluding is delivered to both Parties.

10. REPORTS.

10.1. Development Reports.

10.1.1. JDC Reports and Exchange of Information.  During the period of the JDC’s
authority under Section 2.1.5 with respect to any Collaboration Program, each
Party shall keep the JDC informed of the progress of its activities under each
Development Plan (and during any period in which AGTC is Manufacturing Licensed
Products under Article 12, its Manufacturing activities), including delivering
quarterly written updates of its progress under each Development Plan (and
Manufacturing activities, if applicable) to the JDC at least five (5) Business
Days in advance of each JDC meeting.  Any such updates delivered by AGTC shall
include, with respect to any Pre-Funded Activities or Pre-Funded Discovery
Activities, as

 

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applicable, under such Collaboration Program, (a) the number of FTEs employed
with respect to the applicable Collaboration Program, (b) the applicable FTE
rates of such FTEs and (c) detailed information with respect to any Clinical
Trials that AGTC is conducting for such Collaboration Program, including patient
enrollment information and information regarding Clinical Trial sites.  In
addition, each Party shall provide to the JDC at least ten (10) days in advance
of each JDC meeting, summaries of Program Data from such Collaboration Program
and any AGTC Technology (including AGTC Improved Technology) or Biogen
Technology (including Biogen Platform Improvement Technology), as applicable,
arising under such Collaboration Program.

10.1.2. Continuing Reporting Obligations.  After the JDC’s authority is
discontinued with respect to any Collaboration Program pursuant to Section
2.1.5, the Parties shall meet annually until the First Commercial Sale of a
Licensed Product under such Collaboration Program to discuss the ongoing
Development activities with respect to such Collaboration Program.  To the
extent practicable, the Parties will combine the annual meetings for some or all
such Collaboration Programs.  Such annual meetings may be in person or by
teleconference.  No later than December 31st of each Calendar Year until the
First Commercial Sale of a Licensed Product from each Collaboration Program,
Biogen shall provide to AGTC a report containing summaries of the following
items with respect to such Collaboration Program: (a) a status update with
respect to research, pre-clinical, clinical and CMC matters for such
Collaboration Program, (b) budget and timeline for the Development activities
for such Collaboration Program, (c) status of Development activities with
respect to the applicable development milestones for such Collaboration Program,
(d) changes in Development assumptions for such Collaboration Program due to new
information (e.g., new clinical data or feedback from a Regulatory Authority)
and (e) the plan for Development activities for such Collaboration Program for
the following year across all relevant functions. Biogen shall consider any
input it receives from AGTC regarding the Development activities performed under
a Collaboration Program in its sole discretion.

10.2. Commercialization Reports.

10.2.1. JCC Reports.  Biogen shall prepare and present to the JCC an initial
Commercialization Plan and Commercialization Budget for any Cost Share Product
in accordance with Section 8.1.2, and shall provide the JCC with updates to such
Commercialization Plan and Commercialization Budget in accordance with Section
8.1.2.  During such time as the JCC is in existence under Section 2.2, Biogen
shall keep AGTC reasonably informed, through the JCC, about the status of
Biogen’s Commercialization activities with respect to each Cost Share Product by
providing, on a quarterly basis, a summary of such activities conducted during
the prior Calendar Quarter.

10.2.2. Exchange of Commercialization Information.  With respect to (a) the
first Initial Licensed Product for which Biogen expects to receive Regulatory
Approval in the United States and (b) the second Initial Licensed Product for
which Biogen expects to receive Regulatory Approval in the United States, if
such Initial Licensed Product is a Co-Promotion Product, provided, in each case
((a) and (b)), that such Initial Licensed Product is not a Cost Share Product,
the Parties shall, subject to the last sentence of this Section 10.2.2, meet in
person or by teleconference to discuss Commercialization activities with respect
to such Initial Licensed Product once every [***] months during the period
starting twelve (12) months prior to anticipated First Commercial Sale of such
Initial Licensed Product in the United States and ending [***] months after
First Commercial Sale of such Initial Licensed Product in the United
States.  During each such meeting, the Parties shall discuss (i) developing and
executing a commercial launch and pre-launch plan for such Initial Licensed
Product, (ii) negotiating with applicable Governmental Authorities regarding the
price and reimbursement status of such Initial Licensed Product and (iii)
marketing and promotion plans and activities, in each case, with respect to such
Initial Licensed Product.  Notwithstanding the foregoing, this Section 10.2.2
shall not apply in the event that AGTC is not conducting a Pivotal Trial for or
commercializing any AAV Product during the period in which the Parties would
otherwise conduct the meetings described in this Section 10.2.2. Biogen shall
consider AGTC’s comments regarding Commercialization of any Initial Licensed
Product in its sole discretion.

11. TECHNOLOGY AND REGULATORY TRANSFERS

11.1. Initial Technology Transfer.  Within the time periods set forth in a
technology transfer plan to be agreed by the Parties within sixty (60) days
after the Effective Date, AGTC shall transfer to Biogen at AGTC’s sole expense
[***], to the extent not already transferred to Biogen under the Manufacturing
Technology Agreement, a true and complete copy as reasonably practicable of (a)
data embodying any AGTC Know-How and (b) other tangible embodiments of AGTC
Know-How, in each case ((a) and (b)), with respect to the Licensed Products
existing on the date of such transfer, in such format as Biogen may reasonably
request (including by download of digital files to a secure website or e-room
designated and controlled by Biogen, to which AGTC has equivalent access).

 

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11.2. Ongoing Technology Transfers.  The Parties shall conduct a transfer [***],
or more frequently at such time as (a) new material Program Data,
Manufacturing-related Development data, AGTC Technology or Biogen Technology, as
applicable, comes into a Party’s Control or (b) Biogen takes control of
Development activities, Manufacturing activities or regulatory activities with
respect to a Collaboration Program under any provision of this Agreement,
including under Section 3.1.3, Section 3.4, Section 4.7, Section 4.8 or Section
12.1, in each case ((a) and (b)), in accordance with a technology transfer plan,
to transfer to the other Party (i) if the transferee Party is Biogen, any
Program Data, Manufacturing-related Development data or any and all tangible
Know-How within the AGTC Technology (including AGTC Improved Technology and any
AGTC Technology that is necessary or useful to enable the Manufacture of a
Licensed Product), and (ii) if the transferee Party is AGTC, any and all
tangible Know-How within the Biogen Technology (including Biogen Platform
Improvement Technology) that is necessary for AGTC to exercise its rights or
perform its obligations under this Agreement, in each case ((i) and (ii)), to
the extent not already transferred to the transferee Party under this Agreement
or the Manufacturing Technology Agreement, and in such format as the transferee
Party may reasonably request (including, if the transferee Party is Biogen, by
download of digital files to a secure website or e-room designated and
controlled by Biogen, to which AGTC has equivalent access).  Further, each Party
shall make appropriate personnel available to the other Party at reasonable
times and places, including by telephone during normal business hours, and upon
reasonable prior notice for the purpose of assisting such other Party to
understand and use the applicable AGTC Technology or Biogen Technology for the
Development, Manufacture, Commercialization and use of Licensed Products in
accordance with this Agreement. Any activities under this Section 11.2 shall be
conducted at AGTC’s sole expense.

11.3. Transfer of Materials.  To facilitate the conduct of each Collaboration
Program, each Party shall provide any Materials required by the applicable
Development Plan to be transferred to the other Party and may provide to the
other Party certain other Materials.  Prior to the commencement by either Party
of any Development activities with respect to a Collaboration Program, the other
Party shall transfer to such Party, within a reasonable timeframe, all Materials
reasonably required and as set forth in the applicable Development Plan in order
to conduct such Development activities.  Prior to the commencement of
Manufacturing of any Licensed Product by Biogen, AGTC shall transfer to Biogen,
at Biogen’s request, any Materials specific to a Licensed Product and reasonable
quantities of Materials that are not specific to a Licensed Product but that are
used by AGTC or its Affiliates or Subcontractors in the Manufacture of such
Licensed Product that are necessary or useful to enable Biogen to practice its
license and rights under this Agreement.  Subject to Section 12.1.1 and Section
12.1.2, all Materials shall remain the sole property of the supplying Party,
shall be used only in the fulfillment of obligations or exercise of rights under
this Agreement and solely under the control of the receiving Party, shall not be
used or delivered by the receiving Party to or for the benefit of any Third
Party (other than a permitted Subcontractor) without the prior written consent
of the supplying Party, and, except with respect to any Materials provided by
one Party to the other Party hereunder for use in a Clinical Trial, shall not be
used in research or testing involving human subjects, unless expressly
agreed.  All Materials supplied under this Section 11.3 are supplied “as is”,
with no warranties of fitness for a particular purpose and must be used with
prudence and appropriate caution in any experimental work, since not all of
their characteristics may be known.  The transfer of Materials under this
Section 11.3 shall be conducted at AGTC’s expense.

11.4. Restrictions on Use and Transfer of Materials.   Schedule 11.4 sets forth
the Materials to which each of the following restrictions applies.  Upon the
transfer under Section 11.3 of any Third Party Materials not listed on Schedule
11.4, AGTC will notify Biogen of any restrictions applicable to such Materials.

11.4.1. [***] Biological Materials.

(a) Biogen acknowledges that all rights, title and interest in and to all
materials scheduled in the [***] Agreements, together with all progeny, mutants,
replicates and derivatives (modified or unmodified) thereof (collectively, the
“[***] Biological Material(s)”) shall be owned solely and exclusively by
[***].  For clarity, the [***] Biological Materials do not include (a) any virus
produced by AGTC, Biogen, or their respective Affiliates or sublicensees through
the use of the [***] Biological Materials, provided that such virus does not
contain any [***] Biological Materials or any functional portion or functional
fragment thereof (a “[***] Virus”) or (b) any product produced by a [***] Virus
(a “[***] Product”).

(b) Biogen acknowledges that AGTC is required to inform [***]of any [***]
Biological Material created by Biogen that is different from, and a modification
to, the [***] Biological Material listed in part (a) of Schedule 11.4.  Biogen
shall not use the [***] Biological Material other than in accordance with the
rights expressly granted by the applicable [***] Agreement. Biogen shall not
sell or otherwise transfer any [***] Biological Material to any Affiliate or
Third Party, except in connection with a sublicense granted in accordance with
the provisions of this Agreement.  The [***] Biological Material shall not be
used in humans. All of the [***] Biological Material is experimental in nature
and shall be used with prudence and appropriate caution since not all of their
characteristics

 

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are known. Biogen acknowledges that as between AGTC and [***], all right, title
and interest in and to all [***] Viruses, [***] Products, and any intellectual
property applying thereto or to the production thereof, shall be owned solely
and exclusively by AGTC.  For the avoidance of doubt, nothing herein prohibits
or is intended to prohibit the use of the [***] Products in humans.

(c) Except as expressly provided herein, nothing in this Agreement will be
construed to confer any ownership interest, license or other rights upon Biogen
by implication, estoppel or otherwise as to any technology, intellectual
property rights, products or biological materials of [***], or any other entity,
regardless of whether such technology, intellectual property rights, products or
biological materials are dominant, subordinate or otherwise related to any [***]
Biological Material or the other Materials listed in part (a) of Schedule 11.4.

(d) Biogen shall not enter into any agreement under which Biogen grants to or
otherwise creates in itself or any Affiliate or Third Party a security interest
in any [***] Agreement or its rights under any [***] Agreement and any such
security interest shall be null and void and of no legal effect. This limitation
shall apply to any [***] Biological Material or the other Materials listed in
part (a) of Schedule 11.4.

11.4.2. [***]. The use of any [***] listed on part (b) of Schedule 11.4 licensed
under the Agreement, dated [***], between AGTC and [***], as amended on [***],
and as may be further amended shall be subject to the following terms: (i)
Biogen shall only have the right to distribute and license the [***] and (ii)
shall be subject to the terms and conditions included in Schedule 11.4.2, which
terms and conditions allow for commercial use, despite references to “research
purposes only”.

11.4.3. [***]. Biogen acknowledges that any [***] listed on part (c) of Schedule
11.4 under the [***] Agreement, dated March 13, 2014 by and between [***] and
AGTC, shall at all times remain the property of [***]. With respect to such
[***], Biogen may transfer such [***] to its Affiliates or Third Parties to the
extent necessary for said Affiliates or Third Parties to Manufacture for Biogen
(i) AAV or (ii) the raw materials and components used in connection with the
preparation of AAV.  Biogen shall provide to AGTC written notification of the
identity of any such Third Party that receives such Materials from Biogen along
with a certification that such transfer is in compliance with this Section
11.4.3 within thirty (30) days of such transfer.

11.4.4. [***]. Biogen acknowledges and agrees that all direct derivatives and
modifications to the [***] listed on part (d) of Schedule 11.4 created by AGTC
or Biogen shall be the property of [***] and shall be considered Know-How under
[***] referenced in part (d) of Schedule 11.4, provided, however, that all other
materials, substances, modifications, cell lines, derivations, progeny created,
developed or produced by AGTC as a result of AGTC’s research or use of such
Know-How shall, as between AGTC and [***], be the property of AGTC, including
the intellectual property rights associated therewith.

11.5. Regulatory Transfers.

11.5.1. No later than thirty (30) days prior to the anticipated date of
Regulatory Approval for the XLRS Product in the United States, the Parties shall
finalize a mutually agreed regulatory transfer plan for the XLRS Product, which
shall include a timeline for execution of such transfer.  Thereafter, AGTC
shall, at AGTC’s expense, commence transfer to Biogen of ownership of the INDs
and Orphan Drug Designations and related filings and documentation for the XLRS
Product submitted to any Regulatory Authority in the Territory, and the
Marketing Application and related filings and documentation for the XLRS Product
submitted to the FDA and the initial Regulatory Approval for the XLRS Product in
the United States in accordance with such regulatory transfer plan, and shall
complete such transfer within ninety (90) days after the date of Regulatory
Approval for the XLRS Product in the United States, which time period may be
extended due to a delay caused by a Regulatory Authority; provided, however,
that with respect to any Orphan Drug Designations for the XLRS Product in the
ROW Territory, AGTC shall transfer such Orphan Drug Designations to Biogen no
later than  sixty (60) days after the dosing of the first subject in the Pivotal
Trial for the XLRS Product, which time period may be extended due to a delay
caused by a Regulatory Authority. Thereafter, Biogen will be the sole owner of
all INDs, Orphan Drug Designations, Marketing Applications, Regulatory Approvals
and related filings and documentation submitted to any Regulatory Authority
before, on or after the date of such transfer with respect to the XLRS Product
in all countries in the Territory, to the extent that Biogen was not already the
owner of any such INDs, Orphan Drug Designations, Marketing Applications,
Regulatory Approvals or related filings and documentation in any country in the
Territory.  Notwithstanding the foregoing, Biogen may request that AGTC continue
any ongoing Clinical Trials and, with respect to any associated regulatory
filings or

 

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documentation submitted to any Regulatory Authority with respect to any ongoing
Clinical Trial that AGTC is continuing at Biogen’s request at the time of such
transfer, AGTC shall not be obligated to transfer ownership of such regulatory
filings or documentation to Biogen until the completion of such Clinical Trial.

11.5.2. No later than thirty (30) days prior to the anticipated date of
completion of the Clinical Study Report for such FIH Trial, which Clinical Study
Report shall be prepared together by the Parties during the course of the
Clinical Trial, for the XLRP Product, the Parties shall finalize a mutually
agreed regulatory transfer plan for the XLRP Product under which AGTC shall, at
AGTC’s expense, commence transfer to Biogen ownership of all INDs, Orphan Drug
Designations and related filings and documentation submitted to any Regulatory
Authority, and the study database with respect to such FIH Trial, and shall take
all steps necessary to effectuate such transfer in accordance with such
regulatory transfer plan.  Thereafter, subject to AGTC’s rights under Section
16.8.1, Biogen will be the sole owner of all INDs, Orphan Drug Designations,
Marketing Applications, Regulatory Approvals and related filings and
documentation submitted to any Regulatory Authority before, on or after the date
of such transfer with respect to the XLRP Product in all countries in the
Territory, to the extent that Biogen was not already the owner of any such INDs,
Orphan Drug Designations, Marketing Applications, Regulatory Approvals or
related filings and documentation in any country in the Territory.

12. MANUFACTURE AND SUPPLY.

12.1. Responsibilities.

12.1.1. Initial Licensed Products.  AGTC shall be solely responsible for
Manufacturing clinical supply of each Initial Licensed Product, either itself or
through one or more Affiliates or Third Parties, in accordance with the
applicable Development Plan, until completion of the FIH Trial for such Initial
Licensed Product and any other Clinical Trial that the JDC or any Regulatory
Authority determines is required to be conducted prior to the Pivotal Trial for
such Initial Licensed Product. Thereafter, Biogen shall be solely responsible
for Manufacturing clinical supply of such Initial Licensed Product, either
itself or through one or more Affiliates or Third Parties, including the
Manufacture of clinical supply of the XLRS Product for use by AGTC in the
Pivotal Trial for the XLRS Product. Effective as of the date that Biogen becomes
responsible for Manufacture of an Initial Licensed Product in accordance with
this Section 12.1.1, AGTC shall, and hereby does, subject to the terms of the
Existing License Agreements as set forth in Section 11.4, transfer to Biogen
ownership of those portions of the master cell banks delivered to Biogen under
Section 11.3 and applicable viral seed stocks and/or master viral banks,
reagents and reference standards for such Initial Licensed Product, or, if AGTC
does not have ownership of the foregoing Materials, AGTC shall, and hereby does,
transfer to Biogen all of AGTC’s right, title and interest in and to such
Materials. Biogen shall be solely responsible for Manufacturing commercial
supply of the Initial Licensed Products, either itself or through one or more
Affiliates or Third Parties.  In the event that the Parties mutually agree that
either Party (or its Affiliate or Subcontractor) will Manufacture clinical
supply of any Initial Licensed Products for use by the other Party in Clinical
Trials or other Development activities conducted by such other Party under this
Agreement, the Parties will discuss in good faith and agree upon reasonable
terms, including quality assurance provisions, for such Manufacture and supply.

12.1.2. Discovery Products.  Biogen shall be solely responsible for
Manufacturing clinical and commercial supply of the Discovery Products, either
itself or through one or more Affiliates or Third Party Subcontractors.  In the
event that the Parties mutually agree that AGTC (or its Affiliate or Third Party
Subcontractor) will Manufacture clinical supply of any Discovery Products for
use by Biogen in Clinical Trials or other Development activities conducted by
Biogen under this Agreement, the Parties will discuss in good faith and agree
upon reasonable terms, including quality assurance provisions, for such
Manufacture and supply.  Biogen shall, subject to the terms and retained rights
included in the Existing License Agreements as set forth in Section 11.4, have
sole ownership of those portions of the master cell banks delivered to Biogen
under Section 11.3 and applicable viral seed stocks and/or master viral banks,
reagents and reference standards for such Discovery Product, or, if AGTC does
not have ownership of the foregoing Materials, AGTC shall, and hereby does,
transfer to Biogen all of AGTC’s right, title and interest in and to such
Materials .

12.2. Costs of Supply.  If, in accordance with Section 12.1.1, AGTC Manufactures
and supplies quantities of any Licensed Product other than a Cost Share Product
to Biogen, AGTC shall supply such quantities to Biogen at the Cost of Goods Sold
for such Licensed Product.  Biogen shall make all payments to AGTC on the
schedule and in accordance with the terms agreed upon by the Parties under
Section 12.1.1.  If, in accordance with Section 12.1.1, AGTC Manufactures and
supplies quantities of any Cost Share Product to Biogen, then the costs of such
Manufacture and supply shall be accounted for in the calculation of Operating
Profit or Loss as “Cost of Goods Sold” in accordance with the provisions of
Exhibit C.  With respect to quantities of the XLRS Product Manufactured by
Biogen and supplied to AGTC for use in the Pivotal Trial for the XLRS Product,
such quantities shall be supplied at

 

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no cost, if AGTC has exercised the Milestone/Royalty Option for the XLRS
Product.  If AGTC has exercised the Cost Share Option for the XLRS Product, then
the costs of such Manufacture and supply shall be accounted for in the
calculation of Operating Profit or Loss as “Cost of Goods Sold” in accordance
with the provisions of Exhibit C.

12.3. Requirements regarding Supply and Manufacture.  Each of the Parties agrees
that all supply and Manufacture of Licensed Products pursuant to this Agreement,
whether by a Party or a Third Party, shall, and shall require its Affiliates and
Subcontractors to, when required, comply with all applicable Laws, including
applicable cGMP.

13. INTELLECTUAL PROPERTY.

13.1. Ownership of Intellectual Property.

13.1.1. Invention Disclosure; Ownership of Inventions.  During the Term, each
Party shall notify the other Party within sixty (60) days of any inventions,
developments or discoveries that are made by its or its Affiliates’ employees,
agents or independent contractors in connection with their activities under this
Agreement.  Each Party shall own all right, title and interest in and to: (a)
any and all inventions, developments or discoveries made solely by its or its
Affiliates’ employees, agents or independent contractors in connection with
their activities under this Agreement; (b) any and all Patent Rights claiming
any invention, development or discovery described in clause (a) of this Section
13.1.1; and (c) any and all Know-How embodied by or in any invention,
development or discovery described in clause (a) of this Section
13.1.1.  Inventorship shall be determined in accordance with United States
patent laws.

13.1.2. Ownership of Joint Know-How and Joint Patent Rights.  The Parties shall
jointly own any Joint Technology, other than any Program Data.  Subject to the
grant of licenses under Section 5.1 and Section 5.4, the exclusivity provisions
of Section 5.8, the reversionary rights under Section 16.8.1 and the Parties’
other rights and obligations under this Agreement, each Party shall be free to
exploit Joint Patent Rights and Joint Know-How pursuant to the license grant set
forth in Section 5.4.1, including granting a license under such Joint Technology
without accounting to the other Party in accordance with Section 5.4.1.

13.1.3. Program Data.  As between the Parties, Biogen shall own all Program
Data, and such Program Data shall be the Confidential Information of
Biogen.  AGTC, on behalf of itself and its Affiliates, hereby agrees to and does
hereby assign to Biogen all of AGTC’s and its Affiliates’ right, title and
interest in and to the Program Data.  AGTC will, and will cause its Affiliates
to, execute and deliver all requested assignments and other documents, and take
such other actions as Biogen may reasonably request, in order to perfect and
enforce Biogen’s rights in the Program Data.  Except as expressly provided in
this Agreement, and except in the case AGTC elects to receive a license under
Section 16.8.1 in which case AGTC shall be free to publish, use or access any
Program Data for the applicable Collaboration Program, neither AGTC, its
Affiliates nor any Third Party may publish, use, access or cross reference any
Program Data without prior written consent from Biogen, which shall not be
unreasonably withheld, conditioned or delayed for any publication or
presentation regarding the AGTC Platform, generally.

13.2. Personnel Obligations.  Each employee, agent or independent contractor
(including all Subcontractors) of a Party or its respective Affiliates
performing work under this Agreement shall, prior to commencing such work, be
bound by invention assignment obligations, including: (i) promptly reporting any
invention, discovery, process or other intellectual property right; (ii)
presently assigning to the applicable Party or Affiliate all of his or her
right, title and interest in and to any invention, discovery, process or other
intellectual property; (iii) cooperating in the preparation, filing,
prosecution, maintenance and enforcement of any patent or patent application;
and (iv) performing all acts and signing, executing, acknowledging and
delivering any and all documents required for effecting the obligations and
purposes of this Agreement. It is understood and agreed that such invention
assignment agreement need not reference or be specific to this Agreement.

13.3. Patent Representatives.

13.3.1. Responsibilities; Decision-Making.

(a) Within thirty (30) days of the Effective Date, each Party will appoint a
patent representative as the point person to manage that Party’s review and
comment on (a) Patent Rights being prepared, filed, prosecuted and maintained
subject to the provisions in this Article 13 and (b) materials for publications,
subject to the provisions in Section 14.6 (the “Patent Representative”).  Each
Party shall be permitted to appoint a new Patent Representative

 

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upon written notice to the other Party.  The Patent Representatives will meet on
a regular basis at a frequency to be agreed from time to time by the Patent
Representatives, but no less than twice per year, and will (i) determine by
mutual agreement in accordance with the principles set forth in Section 13.3.2
whether intellectual property arising out of activities performed under the
Collaboration Programs are Product-Specific Technology, AGTC Improved
Technology, Joint Improved Technology, Joint Platform Improvement Technology or
Biogen Platform Improvement Technology, (ii) determine by mutual agreement, as
required under Section 13.4.2(a)(ii), whether any applicable AGTC Patent Right,
Joint Platform Improvement Patent Right or Biogen Platform Improvement Patent
Right contains at least one claim that Covers the Development, Manufacture,
Commercialization or use of any Licensed Product, (iii) determine by mutual
agreement whether intellectual property that comes into the Control of AGTC or
its Affiliates during the Term falls within the definition of the AGTC Platform,
(iv) determine by mutual agreement to update Schedule 1.22-1, Schedule 1.22-2,
Schedule 1.23, Schedule 1.40, Schedule 1.212 or Schedule 4.2.1, (v) coordinate
as reasonably necessary or useful to achieve the greatest degree of patent
coverage and to avoid creating potential issues in prosecution of the
Product-Specific Patent Rights and the applicable AGTC Patent Rights, Biogen
Patent Rights and Joint Patent Rights and (vi) facilitate the exchange of
information between the Parties in matters related to intellectual property. 

(b) In the event the Patent Representatives cannot reach an agreement on any
matter to be determined by the Patent Representatives pursuant to this Section
13.3 within thirty (30) days, such dispute shall be escalated to the Alliance
Managers for resolution.  Following such thirty (30)-day period, either Alliance
Manager may elect to obtain an opinion on such matter from an independent
outside patent counsel mutually agreed by the Patent Representatives, the costs
of which shall be borne equally by the Parties.  If either Alliance Manager
elects to obtain such an opinion, the Alliance Managers shall consider such
opinion, but such opinion shall not be binding on the Parties.  If the Alliance
Managers are unable to reach agreement with respect to such decision within
fifteen (15) days of (i) the date of escalation of the dispute, if neither
Alliance Manager elects to obtain an opinion of outside patent counsel or (ii)
receipt of the opinion of outside patent counsel, if an Alliance Manager elects
to obtain such an opinion, such dispute shall be escalated to the Chief
Executive Officer of each Party (or his/her nominee), and such Chief Executive
Officers (or their nominees, as applicable) will meet promptly to attempt to
resolve the dispute by good faith negotiations.  In the event that such dispute
is escalated to the CEOs (or their nominees, as applicable), the Alliance
Managers shall (x) obtain a non-binding opinion of independent outside patent
counsel as set forth in this Section 13.3.1(b), if they have not already
obtained such an opinion in accordance with this Section 13.3.1(b), and (y)
provide such opinion to the CEOs (or their nominees, as applicable) for their
consideration.

13.3.2. Classification of Technology.  The Patent Representatives shall adhere
to the following principles in conducting their activities and exercising their
decision-making authority as set forth in Section 13.3.1:

(a) For the purposes of this Agreement, all provisional patent applications
shall include at least one claim.

(b) Subject to the provisions of Section 1.212, a Patent Right shall be
classified by reference to its claim(s).  No Patent Right may be classified in
more than one of the following categories: Product-Specific Patent Rights, AGTC
Improved Patent Rights, Joint Improved Patent Rights, Joint Platform Improvement
Patent Rights and Biogen Platform Improvement Patent Rights; provided, however,
that an initial filing may be classified in more than one category if it
includes claims in more than one category, subject to the Parties’ obligations
under Section 13.3.2(c) with respect to subsequent amendments to such initial
filing.  With respect to any filing classified in more than one category under
the preceding proviso, the Party that made such filing shall have the right to
continue prosecution and maintenance of such filing until such time as the
Patent Representatives classify the applicable Patent Right in one category.

(c) The Parties shall use reasonable efforts to file the applicable Patent
Rights so that all claims under any such Patent Right are in no more than one of
the following categories (including, if necessary, amended any initial filing
such that all claims are in no more than one of such categories):
Product-Specific Patent Rights, AGTC Improved Patent Rights, Joint Improved
Patent Rights, Joint Platform Improvement Patent Rights and Biogen Platform
Improvement Patent Rights.

 

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13.4. Filing, Prosecution and Maintenance of Patent Rights.

13.4.1. Product-Specific Patent Rights.

(a) Biogen shall, at its own expense (subject to Section 13.4.1(d)), prepare,
file, prosecute and maintain any Product-Specific Patent Rights, in all
countries determined by Biogen.  Biogen shall keep AGTC advised on the status of
the prosecution of all patent applications included within such Product-Specific
Patent Rights and the maintenance of any issued patents included within such
Product-Specific Patent Rights.  Further, Biogen shall consult and reasonably
cooperate with AGTC with respect to the preparation, filing, prosecution and
maintenance of such Product-Specific Patent Rights, including: (i) allowing AGTC
a reasonable opportunity and reasonable time to review and comment regarding
such drafts before any applicable filings are submitted to any relevant patent
office or Governmental Authority; and (ii) reflecting any reasonable comments
offered by AGTC in any final filings submitted by Biogen to any relevant patent
office or Governmental Authority, to the extent such comments are intended to
prevent any detrimental effect on the prosecution and maintenance of any Patent
Rights owned or Controlled by AGTC, provided that Biogen does not reasonably
determine that such comments are detrimental to the prosecution, maintenance or
enforcement of any Patent Rights owned or Controlled by Biogen.

(b) If Biogen elects not to file a patent application included in such
Product-Specific Patent Rights in any country or elects to cease the prosecution
or maintenance of any such Product-Specific Patent Right in any country, then
Biogen shall provide AGTC with written notice immediately, but not less than
sixty (60) days before any action is required, upon the decision to not file or
continue the prosecution of such patent application or maintenance of such
Patent Right.  In the event Biogen has provided notice to AGTC as described in
the preceding sentence, Biogen shall permit AGTC, in AGTC’s sole discretion, to
file or continue prosecution or maintenance of any such Product-Specific Patent
Right in such country at AGTC’s expense, [***], and provided, further, that, if
AGTC has the right to file or continue prosecution or maintenance of such
Product-Specific Patent Right, AGTC shall consult with Biogen with respect to
the preparation, filing, prosecution and maintenance of such Product-Specific
Patent Rights, including: (i) allowing Biogen a reasonable opportunity and
reasonable time to review and comment regarding such drafts before any
applicable filings are submitted to any relevant patent office or Governmental
Authority, (ii) reflecting any reasonable comments offered by Biogen in any
final filings submitted by AGTC to any relevant patent office or Governmental
Authority to the extent such comments are intended to prevent any detrimental
effect on the prosecution and maintenance of any Patent Rights owned or
Controlled by Biogen, provided that AGTC does not reasonably determine that such
comments to be detrimental to the prosecution, maintenance or enforcement of any
Patent Rights owned or Controlled by AGTC and (iii) not taking any position with
respect to such Product-Specific Patent Right that would be reasonably likely to
adversely affect the scope, validity or enforceability of any of the other
Patent Rights being prosecuted and maintained by Biogen under this Agreement
without the prior written consent of Biogen, which consent shall not be
unreasonably withheld, conditioned or delayed.

(c) Notwithstanding anything to the contrary, if AGTC Controls any
Product-Specific Patent Rights pursuant to any Third Party agreement, then
Biogen shall have the rights set forth in this Section 13.4.1 with respect to
the prosecution and maintenance of such Product-Specific Patent Rights solely to
the extent that AGTC has such rights under such Third Party agreement and is
authorized to allow its sublicensees to take control over such rights.  If AGTC
has limited rights with respect to the preparation, filing, prosecution and
maintenance of such Product-Specific Patent Rights under such Third Party
agreement (e.g., review and comment rights or the right to control prosecution
and maintenance without the right to allow sublicensees to take control over
such rights) then AGTC shall, to the extent allowable, pass such rights through
to Biogen and permit Biogen to exercise such rights through AGTC with respect to
the preparation, filing, prosecution and maintenance of such Product-Specific
Patent Rights.

(d) Notwithstanding anything to the contrary, with respect to any
Product-Specific Patent Right that Covers or claims a Cost Share Product, the
Out-of-Pocket Costs incurred by either Party in connection with the preparation,
filing, prosecution and maintenance of such Product-Specific Patent Right under
this Section 13.4.1 shall be shared by the Parties in accordance with Section
6.3.

 

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13.4.2.Other Patent Rights.

(a) AGTC Patent Rights.

(i) As between the Parties, AGTC shall, at its own expense, prepare, file,
prosecute and maintain all AGTC Patent Rights (other than those which are
Product-Specific Patent Rights which, for clarity, shall be governed by Section
13.4.1 and AGTC Improved Patent Rights, which, for clarity, shall be governed by
Section 13.4.2(b)), Biogen Platform Improvement Patent Rights and Joint Platform
Improvement Patent Rights, in all countries determined by AGTC, after
consultation with Biogen.  AGTC shall keep Biogen advised on the status of the
prosecution of all patent applications included within such Patent Rights and
the maintenance of any issued patents included within such Patent
Rights.  Further, AGTC shall consult and reasonably cooperate with Biogen with
respect to the preparation, filing, prosecution and maintenance of such Patent
Rights, including: (i) allowing Biogen a reasonable opportunity and reasonable
time to review and comment regarding such drafts before any applicable filings
are submitted to any relevant patent office or Governmental Authority; and (ii)
considering in good faith any reasonable comments offered by Biogen in any final
filings submitted by AGTC to any relevant patent office or Governmental
Authority, to the extent such comments are intended to prevent any detrimental
effect on the prosecution and maintenance of any Patent Rights owned or
controlled by Biogen.

(ii) If AGTC elects not to file a patent application included in such AGTC
Patent Rights, Biogen Platform Improvement Patent Rights or Joint Platform
Improvement Patent Rights in any country or elects to cease the prosecution or
maintenance of any such Patent Right in any country, if any such Patent Right
contains at least one claim that Covers the Development, Manufacture,
Commercialization or use of any Licensed Product, as determined by the Patent
Representatives in accordance with Section 13.3.1, then AGTC shall provide
Biogen with written notice immediately, but not less than thirty (30) days
before any action is required, upon the decision to not file or continue the
prosecution of such patent application or maintenance of such patent.  In the
event AGTC has provided notice to Biogen as described in the preceding sentence,
AGTC shall permit Biogen, in Biogen’s sole discretion, to file or continue
prosecution or maintenance of any such Patent Right in such country at Biogen’s
expense, [***], and provided, further, that, if Biogen has the right to file or
continue prosecution or maintenance of such AGTC Patent Right, Biogen shall
consult with AGTC with respect to the preparation, filing, prosecution and
maintenance of such Patent Rights, including: (a) allowing AGTC a reasonable
opportunity and reasonable time to review and comment regarding such drafts
before any applicable filings are submitted to any relevant patent office or
Governmental Authority, (b) reflecting any reasonable comments offered by AGTC
in any final filings submitted by Biogen to any relevant patent office or
Governmental Authority and (c) not taking any position with respect to such
Patent Right that would be reasonably likely to adversely affect the scope,
validity or enforceability of any of the other Patent Rights owned or Controlled
by AGTC without the prior written consent of AGTC, which consent shall not be
unreasonably withheld.

(iii) Notwithstanding anything to the contrary, with respect to any AGTC Patent
Rights that contain at least one claim that Covers the Development, Manufacture,
Commercialization or use of any Licensed Product, if AGTC Controls any such AGTC
Patent Rights pursuant to any Third Party agreement, then AGTC shall have the
obligations and Biogen shall have the rights set forth in this Section 13.4.2(a)
with respect to the prosecution and maintenance of such AGTC Patent Rights
solely to the extent that AGTC has such rights under such Third Party agreement
and is authorized to allow its sublicensees to take control over such
rights.  If AGTC has limited rights with respect to the preparation, filing,
prosecution and maintenance of such AGTC Patent Rights under such Third Party
agreement (e.g., review and comment rights or the right to control prosecution
and maintenance without the right to allow sublicensees to take control over
such rights) then AGTC shall, to the extent allowable, pass such rights through
to Biogen and permit Biogen to exercise such rights through AGTC with respect to
the preparation, filing, prosecution and maintenance of such AGTC Patent Rights.

(b) Biogen Patent Rights.

(i) Biogen shall have the sole right, in Biogen’s sole discretion, at its own
expense, to prepare, file, prosecute and maintain all Biogen Patent Rights
(other than any Product-Specific Patent Rights within

 

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such Biogen Patent Rights which, for clarity, shall be governed by Section
13.4.1 and Biogen Platform Improvement Patent Rights, which, for clarity, shall
be governed by Section 13.4.2(a)), AGTC Improved Patent Rights and Joint
Improved Patent Rights, in any country determined by Biogen and Biogen shall
have no obligation to prosecute or maintain any such Patent Right.  Biogen shall
keep AGTC advised on the status of the prosecution of all patent applications
included within the AGTC Improved Patent Rights and the Joint Improved Patent
Rights and the maintenance of any issued patents included within such AGTC
Improved Patent Rights and the Joint Improved Patent Rights.  Further, Biogen
shall consult and reasonably cooperate with AGTC with respect to the
preparation, filing, prosecution and maintenance of such Patent Rights,
including: (i) allowing AGTC a reasonable opportunity and reasonable time to
review and comment regarding such drafts before any applicable filings are
submitted to any relevant patent office or Governmental Authority; and (ii)
considering in good faith any reasonable comments offered by AGTC in any final
filings submitted by Biogen to any relevant patent office or Governmental
Authority, to the extent such comments are intended to prevent any detrimental
effect on the prosecution and maintenance of any Patent Rights owned or
controlled by AGTC.

(ii) If Biogen elects not to file a patent application included in such AGTC
Improved Patent Rights or Joint Improved Patent Rights in any country or elects
to cease the prosecution or maintenance of any such AGTC Improved Patent Right
or Joint Improved Patent Right in any country, then Biogen shall provide AGTC
with written notice immediately, but not less than thirty (30) days before any
action is required, upon the decision to not file or continue the prosecution of
such patent application or maintenance of such patent.  In the event Biogen has
provided notice to AGTC as described in the preceding sentence, Biogen shall
permit AGTC, in AGTC’s sole discretion, to file or continue prosecution or
maintenance of any such AGTC Improved Patent Right or Joint Improved Patent
Right in such country at AGTC’s expense, [***], and provided, further, that, if
AGTC has the right to file or continue prosecution or maintenance of such AGTC
Improved Patent Right or Joint Improved Patent Right,  AGTC shall consult with
Biogen with respect to the preparation, filing, prosecution and maintenance of
such Patent Rights, including: (i) allowing Biogen a reasonable opportunity and
reasonable time to review and comment regarding such drafts before any
applicable filings are submitted to any relevant patent office or Governmental
Authority, (ii) reflecting any reasonable comments offered by Biogen in any
final filings submitted by AGTC to any relevant patent office or Governmental
Authority and (iii) not taking any position with respect to such Patent Right
that would be reasonably likely to adversely affect the scope, validity or
enforceability of any of the other Patent Rights being prosecuted and maintained
by Biogen under this Agreement without the prior written consent of Biogen,
which consent shall not be unreasonably withheld.

(c) Joint Patent Rights.  In the event the Parties make any Joint Know-How
(other than Product-Specific Know-How, Joint Platform Improvement Know-How and
Joint Improved Know-How), the Patent Representatives shall promptly meet to
discuss and determine whether to seek patent protection thereon.  Biogen shall
have the first right, but not the obligation, to prepare, file, prosecute and
maintain any Joint Patent Right (other than any Product-Specific Patent Rights
within such Joint Patent Rights which, for clarity, shall be governed by Section
13.4.1, Joint Platform Improvement Patent Rights which, for clarity, shall be
governed by Section 13.4.2(a) and Joint Improved Patent Rights, which, for
clarity, shall be governed by Section 13.4.2(b)) throughout the world using
patent counsel selected by Biogen and reasonably acceptable to AGTC. Biogen
shall give AGTC an opportunity to review the text of any application with
respect to such Joint Patent Right before filing, shall consult with AGTC with
respect thereto, and shall supply AGTC with a copy of the application as filed,
together with notice of its filing date and serial number.  Biogen shall keep
AGTC reasonably informed of the status of the actual and prospective patent
filings (including, without limitation, the grant of any Joint Patent Rights),
and shall provide advance copies of any official correspondence related to the
filing, prosecution and maintenance of such patent filings. AGTC shall reimburse
Biogen for fifty percent (50%) of the reasonable Out-of-Pocket Costs incurred by
Biogen in preparing, filing, prosecuting and maintaining such Joint Patent
Rights, which reimbursement will be made pursuant to invoices submitted by
Biogen to AGTC no more often than once per Calendar Quarter.  If either Party
(the “Declining Party”) at any time declines to share in the costs of filing,
prosecuting and maintaining any such Joint Patent Right, on a country by country
basis, the Declining Party shall provide the other Party (the “Continuing
Party”) with thirty (30) days’ prior written notice to such effect, in which
event, the Declining Party shall (i) have no responsibility for any expenses
incurred in connection with such Joint Patent Right after the end of such thirty
(30) day period and (ii) if the Continuing Party elects to continue prosecution
or maintenance, the Declining Party,

 

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upon the Continuing Party’s request, shall execute such documents and perform
such acts, at the Continuing Party’s expense, as may be reasonably necessary (A)
to assign to the Continuing Party all of the Declining Party’s right, title and
interest in and to such Joint Patent Right and (B) to permit the Continuing
Party to file, prosecute and maintain such Joint Patent Right.

13.5. Enforcement of Patent Rights.

13.5.1. Notice.  If either Biogen or AGTC becomes aware of any potential
infringement, anywhere in the world, of any issued Patent Right within the AGTC
Patent Rights, the Joint Patent Rights, or any Biogen Patent Rights that are
Product-Specific Patent Rights or Biogen Platform Improvement Patent Rights,
such Party will promptly notify the other Party in writing to that effect.  Any
such notice shall include any available evidence to support an allegation of
infringement by such Third Party.

13.5.2. Enforcement of Product-Specific Patent Rights, AGTC Improved Patent
Rights and Joint Improved Patent Rights.  Except as otherwise provided in this
Section 13.5.2, Biogen shall have the first right, but not the obligation, to
take action to obtain a discontinuance of infringement or bring suit against a
Third Party infringer of any Product-Specific Patent Right, AGTC Improved Patent
Right or Joint Improved Patent Right.  Biogen shall have the right to cause AGTC
to join Biogen as a party plaintiff to any such suit, at Biogen’s expense, where
such joinder is necessary for the enforcement of any such Patent Right.  If,
after ninety (90) days after the date of notice given pursuant to Section
13.5.1, Biogen has not obtained a discontinuance of infringement of any such
Patent Right, filed suit against any such Third Party infringer of such Patent
Right or provided AGTC with information and arguments demonstrating to AGTC’s
reasonable satisfaction that there is insufficient basis for the allegation of
such infringement of such Patent Right, then AGTC shall have the right, but not
the obligation, to bring suit against such Third Party infringer of such Patent
Right with Biogen’s prior written consent, which may be withheld in Biogen’s
sole discretion.  If such discontinuance, infringement or suit relates to a Cost
Share Product, then the Out-of-Pocket Costs incurred by the Parties in
connection with any action brought under this Section 13.5.2 shall be shared by
the Parties in accordance with Section 6.3.  In all other events, each Party
shall bear its own expenses in connection with any action taken by a Party
pursuant to this Section 13.5.2.  Any recovery obtained by either Party as a
result of any proceeding against a Third Party infringer shall be allocated as
follows:

(a) Except where the recovery relates to a Cost Share Product (in which event,
such recovery shall be shared by the Parties in accordance with Section 6.3),
such recovery shall first be used to reimburse each Party pro rata for all
litigation costs in connection with such litigation paid by that Party; and

(b) Except where the recovery relates to a Cost Share Product (in which event,
such recovery shall be shared by the Parties in accordance with Section 6.3),
Biogen shall retain [***] and AGTC shall retain [***] of the remaining portion
of any such recovery.

13.5.3. Enforcement of other Biogen Patent Rights.  Biogen shall have the sole
right, in its sole discretion, to take action to obtain a discontinuance of
infringement or bring suit against a Third Party infringer of any Biogen Patent
Right (other than any Product-Specific Patent Rights within the Biogen Patent
Rights which, for clarity, shall be governed by Section 13.5.2 and other than
any Biogen Platform Improvement Patent Right which, for clarity, shall be
governed by Section 13.5.4).

13.5.4. Enforcement of other AGTC Patent Rights, Joint Platform Improvement
Patent Rights and Biogen Platform Improvement Patent Rights.  Except as
otherwise provided in this Section 13.5.4, AGTC shall have the sole right, in
its sole discretion to take action to obtain a discontinuance of infringement or
bring suit against a Third Party infringer of any AGTC Patent Right (other than
any Product-Specific Patent Rights or AGTC Improved Patent Rights within the
AGTC Patent Rights which, for clarity, shall be governed by Section 13.5.2),
Joint Platform Improvement Patent Right or Biogen Platform Improvement Patent
Right.  AGTC shall have the right to cause Biogen to join AGTC as a party
plaintiff to any such suit, at AGTC’s expense, where such joinder is necessary
for the enforcement of any such Patent Right.  In the case of a Third Party
infringer developing, manufacturing or commercializing an AAV Product that is
competitive to a Licensed Product in the same indication and targeting the same
gene (a “Competitive Infringement”) of any such Patent Right, unless AGTC has
notified Biogen that it does not wish to bring such action or does not bring
such action within the period of time set by court decree, the Parties shall
jointly take action to obtain a discontinuance of infringement or bring suit in
a Competitive Infringement.  Alternatively, if AGTC has notified Biogen that it
does not wish to join such action or does not join within a period of time set
by court decree, Biogen may take such action without AGTC in which case Biogen
shall have the right to

 

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cause AGTC to join Biogen as a party plaintiff in such suit, at Biogen’s
expense, where joinder is necessary for enforcement of the Patent Right.  If the
infringement is a Competitive Infringement relating to a Cost Share Product,
then the Out-of-Pocket Costs incurred by the Parties in connection with any
action brought under this Section 13.5.4 shall be shared by the Parties in
accordance with Section 6.3.  In all other events, each Party shall bear its own
expenses in connection with any action taken by a Party pursuant to this Section
13.5.4.  Any recovery obtained by AGTC as a result of any proceeding that is not
a Competitive Infringement proceeding shall be retained by AGTC.  Any recovery
obtained by either Party as a result of any Competitive Infringement proceeding
against a Third Party infringer shall be allocated as follows:

(a) Except where the recovery arose out of a Competitive Infringement relating
to a Cost Share Product (in which event, such recovery shall be shared by the
Parties in accordance with Section 6.3), such recovery shall first be used to
reimburse each Party pro rata for all litigation costs in connection with such
litigation paid by that Party; and

(b) Except where the recovery arose out of a Competitive Infringement relating
to a Cost Share Product (in which event, such recovery shall be shared by the
Parties in accordance with Section 6.3), Biogen shall retain [***] and AGTC
shall retain [***] of the remaining portion of any such recovery.

13.5.5. Enforcement of other Joint Patent Rights.  Except as otherwise provided
in this Section 13.5.5, Biogen shall have the first right, but not the
obligation, to take action to obtain a discontinuance of infringement or bring
suit against a Third Party infringer in a Competitive Infringement of any Joint
Patent Right that is not a Product-Specific Patent Right, Joint Improved Patent
Right or Joint Platform Improvement Patent Right.  Biogen shall have the right
to cause AGTC to join Biogen as a party plaintiff to any such suit, at Biogen’s
expense, where such joinder is necessary for the enforcement of any such Joint
Patent Right.  If, ninety (90) days after the date of notice given pursuant to
Section 13.5.1, Biogen has not obtained a discontinuance of infringement of such
Joint Patent Right, filed suit against any such Third Party infringer of such
Joint Patent Right or provided AGTC with information and arguments demonstrating
to AGTC’s reasonable satisfaction that there is insufficient basis for the
allegation of such infringement of such Joint Patent Right, then AGTC shall have
the right, but not the obligation, to bring suit against such Third Party
infringer of such Joint Patent Right.  With respect to any infringement of a
Joint Patent Right that is not a Product-Specific Patent Right or Joint Platform
Improvement Patent Right, where such infringement is not a Competitive
Infringement, the Parties shall determine by mutual agreement (a) whether to
take action to obtain a discontinuance of infringement or bring suit against a
Third Party infringer and (b) which Party shall take control of such action or
suit.  If the infringement is a Competitive Infringement relating to a Cost
Share Product, then the Out-of-Pocket Costs incurred by the Parties in
connection with any action brought under this Section 13.5.5 shall be shared by
the Parties in accordance with Section 6.3.  In all other events, each Party
shall bear its own expenses in connection with any action taken by a Party
pursuant to this Section 13.5.5.  Any recovery obtained by either Party as a
result of any such proceeding against a Third Party infringer shall be allocated
as follows:

(a) Except where the recovery arose out of a Competitive Infringement relating
to a Cost Share Product (in which event, such recovery shall be shared by the
Parties in accordance with Section 6.3), such recovery shall first be used to
reimburse each Party for all litigation costs in connection with such litigation
paid by that Party; and

(b) Except where the recovery arose out of a Competitive Infringement relating
to a Cost Share Product (in which event, such recovery shall be shared by the
Parties in accordance with Section 6.3):

(i) if the recovery arose out of a Competitive Infringement proceeding, then
Biogen shall retain [***] and AGTC shall retain [***] of the remaining portion
of any such recovery; and

(ii) if the recovery arose out of any proceeding that is not a Competitive
Infringement proceeding, then the Parties shall share the remaining portion of
such recovery equally.

13.5.6. Settlements. With respect to any action, suit, proceeding or claim
involving a Patent Right under Section 13.5.2, Section 13.5.4 (solely in the
case of a Competitive Infringement) or Section 13.5.5, the enforcing Party shall
not consent to the entry of any judgment or enter into any settlement with
respect to such an action or suit without the prior written consent of the other
Party (which consent shall not unreasonably be withheld or delayed), provided
that, if such action or suit relates to the infringement of any Biogen Patent
Right that is a Product-Specific Patent Right, Biogen may consent to the entry
of any judgment or enter into a settlement with respect to such Biogen Patent
Right in Biogen’s sole discretion.

 

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13.5.7. Cooperation.  Each Party shall cooperate (including by executing any
documents required to enable the other Party to initiate such litigation) with
the other Party in any suit for infringement of any such Patent Right brought by
the other Party against a Third Party in accordance with Section 13.5.2, Section
13.5.4 or Section 13.5.5, and shall have the right to consult with the other
Party and to participate in and be represented by independent counsel in such
litigation.  Neither Party shall incur any liability to the other Party as a
consequence of such litigation or any unfavorable decision resulting therefrom,
including any decision holding any such Patent Right invalid or unenforceable.

13.6. Infringement and Third Party Licenses.

13.6.1. Infringement of Third Party Patents.  If the Development, Manufacture,
Commercialization or use of any Licensed Product, the practice of any AGTC
Patent Right or Joint Patent Right, or the exercise of any other right granted
by AGTC to Biogen hereunder (collectively, the “Licensed Activities”) by Biogen
or any of its Affiliates or Sublicensees is alleged by a Third Party to infringe
such Third Party’s Patent Rights or other intellectual property rights, the
Party becoming aware of such allegation shall promptly notify the other
Party.  Additionally, if either Party determines that, based upon the review of
any Third Party Patent Right or other Third Party intellectual property rights,
it may be desirable to obtain a license from such Third Party with respect
thereto so as to avoid any potential claim of infringement by such Third Party
against either Party or their respective Affiliates or Sublicensees, such Party
shall promptly notify the other Party of such determination and initiate
discussions to determine whether such a license is desirable.

13.6.2. Negotiating Third Party Licenses.

(a) Either Party shall have the right to obtain a license under one or more
Patent Rights or other intellectual property rights owned or controlled by a
Third Party that are necessary or useful to conduct the Licensed Activities
(collectively, “Third Party IP Rights”), provided that, (i) if AGTC is the
licensee, AGTC is granted a sublicensable license under such Third Party IP
Rights permitting AGTC and Biogen and their respective Affiliates and
sublicensees to practice such Third Party IP Rights in connection with the
Licensed Activities and the performance of any of its obligations or the
exercise of any of their respective rights under this Agreement, under terms and
conditions that, to the extent applicable to Biogen as a sublicensee of such
Third Party IP Rights, are not more onerous in any material respect on Biogen
than those contained in this Agreement and (ii) if Biogen is the licensee,
[***], to the extent applicable to AGTC as a sublicensee of such Third Party IP
Rights, are not more onerous in any material respect on AGTC than those
contained in this Agreement.  Upon entry into any such agreement, the
contracting Party shall promptly provide a copy of such agreement to the other
Party and, in the case where AGTC is the contracting Party, AGTC shall provide
Biogen with a proposed allocation of upfront payments contemplated by Section
6.6.1(b)(ii).  In the case of any such agreement entered into by AGTC, Biogen
may, but shall not be required to, at any time after Biogen receives such copy,
elect to take a sublicense to such Third Party IP Rights by notice to AGTC, and
thereafter Biogen’s payment obligations under Section 13.6.2(b) shall apply, and
the Know-How and Patent Rights included in such sublicense shall thereafter be
deemed AGTC Technology.

(b) The royalties payable under (a) any such agreement that Biogen enters into
with a Third Party or (b) solely to the extent that Biogen has elected to take a
sublicense under this last sentence of Section 13.6.2(a), any such agreement
that AGTC enters into with a Third Party, shall (i) reduce Biogen’s royalty
obligations under this Agreement as and to the extent provided in Section 6.6.1,
if the applicable Third Party IP Rights Cover or claim the Development,
Manufacture, Commercialization or use of any Initial Licensed Product for which
AGTC has exercised the Milestone/Royalty Option in accordance with Section 6.2.2
or any Discovery Product or (ii) be shared by the Parties in accordance with
Section 6.3, if the applicable Third Party IP Rights Cover or claim the
Development, Manufacture, Commercialization or use of any Initial Licensed
Product for which AGTC has exercised the Cost Share Option in accordance with
Section 6.2.2.

13.6.3. Third Party Infringement Suit.  If a Third Party sues Biogen or any of
Biogen’s Affiliates or Sublicensees (each Person so sued being referred to
herein as a “Sued Party”), alleging that the Licensed Activities of Biogen or
any of Biogen’s Affiliates or Sublicensees during the Term and pursuant to this
Agreement infringe or will infringe such Third Party’s Patent Rights, then, if
such suit is an indemnifiable claim under Section 17.3, such suit shall, at
Biogen’s election, be subject to the indemnification provisions of Article
17.  If Biogen does not seek and waives indemnification under Section 17.3 with
respect to such suit, or if such suit is not an indemnifiable claim, then Biogen
shall have the right to lead the defense of such suit and, upon Biogen’s request
and in connection with the Sued Party’s defense of any such Third Party
infringement suit, AGTC shall provide reasonable assistance to the Sued Party
for such defense.  Biogen shall keep AGTC

 

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reasonably informed with respect to any such suit involving an [***]
Manufacturing Patent Right, and shall consider AGTC’s comments with respect
thereto in good faith.  All activities under this Section 13.6.3 shall be
conducted at the expense of the Party taking any action pursuant to this Section
13.6.3, except that, if the Licensed Activities at issue relate to a Cost Share
Product, the Parties shall share any Out-Of-Pocket Costs incurred by either
Party in connection with such activities equally in accordance with Section 6.3.
With respect to any action, suit, proceeding or claim involving a Third Party
Patent Right under this Section 13.6.3, the Sued Party shall not consent to the
entry of any judgment or enter into any settlement that imposes a financial
obligation on AGTC, or that admits the infringement by AGTC and Biogen of such
Third Party Patent Rights or that limits the scope, validity, or enforceability
of any of the AGTC Patent Rights, without AGTC’s written consent, which consent
shall not be unreasonably withheld, conditioned or delayed.

13.6.4. Administrative Actions by Third Parties.  Each Party shall promptly
notify the other Party in the event of any administrative action involving any
AGTC Patent Right, Joint Patent Right or Biogen Patent Right of which it becomes
aware, including any nullity, revocation, reexamination, opposition,
interference, inter partes and post-grant review or compulsory license
proceeding.  AGTC shall have the first right, but no obligation, to defend
against any such action involving (a) an AGTC Patent Right that is not a
Product-Specific Patent Right, (b) a Joint Platform Improvement Patent Right or
(c) a Biogen Platform Improvement Patent Right, in each case, in its own name
and at its own expense.  Upon AGTC’s request, Biogen may, in its sole
discretion, consent to join, and will join if necessary under applicable Law, in
any such action at AGTC’s expense and cooperate with AGTC at AGTC’s
expense.  Biogen shall have the first right, but no obligation, to defend
against any such action involving (x) an AGTC Patent Right that is a
Product-Specific Patent Right or (y) a Joint Patent Right that is not a Joint
Platform Improvement Patent Right, and the sole right, but not the obligation,
to defend against any such action involving a Biogen Patent Right that is not a
Biogen Platform Improvement Patent Right, in each case, in its own name, and any
such defense shall be at Biogen’s expense, subject to AGTC’s indemnification
obligations under Article 17.  AGTC, upon Biogen’s request, may, in its sole
discretion, consent to join, and will join if necessary under applicable Law, in
any such action at Biogen’s expense and cooperate with Biogen at Biogen’s
expense.  If the Party having the first right to defend any action involving an
AGTC Patent Right, Joint Patent Right or Biogen Platform Improvement Patent
Right fails to defend against any such action within ten (10) days of notice
thereof, then the other Party shall have the right to defend such action, in its
own name, and any such defense shall be at such other Party’s expense.  In such
event, the Party having the first right to defend such action shall reasonably
cooperate, upon the other Party’s request, in any such action at the other
Party’s expense.  In the event of any administrative action under this Section
13.6.4 with respect to a Product-Specific Patent Right that Covers a Cost Share
Product, the Parties shall share any Out-Of-Pocket Costs incurred by either
Party in connection with such administrative action equally in accordance with
Section 6.3.

13.6.5. Paragraph IV Notices.  Each Party shall immediately give written notice
to the other of any certification of which it becomes aware filed pursuant to
any statutory or regulatory requirement in any country in the Territory similar
to 21 U.S.C. § 355(b)(2)(A)(iv) or § 355(j)(2)(A)(vii)(IV) (or any amendment or
successor statute thereto) claiming that any AGTC Patent Right, Joint Patent
Right or Biogen Platform Improvement Patent Right Covering any Licensed Product
is invalid or that infringement will not arise from the Development,
Manufacture, use or Commercialization in the Territory of such Licensed Product
by a Third Party.  Upon the giving or receipt of such notice, the provisions of
Section 13.5 with respect to division of enforcement responsibilities shall
apply, mutatis mutandis, with respect to any infringement action against such
Third Party.  In each case, the Party with the right to bring an infringement
action shall notify the other Party at least ten (10) days prior to the date set
forth by statute or regulation of its intent to exercise, or not exercise, this
right.  Any infringement action against a Third Party arising under this Section
13.6.5 shall be governed by the provisions of Section 13.5.  Without limiting
any provision of Section 13.5, in order to establish standing in connection with
any action under this Section 13.6.5, upon the request of the Party bringing the
action, the other Party shall reasonably cooperate in any such action at the
expense of the Party bring the action and shall timely commence or join in any
such action at the request and expense of the Party bringing the action.

13.7. Patent Term Restoration.  The Parties shall reasonably cooperate with each
other in obtaining patent term restoration in any country in the Territory under
any statute or regulation equivalent or similar to 35 U.S.C. § 156, where
applicable to the AGTC Patent Rights, Joint Patent Rights or Biogen Platform
Improvement Patent Rights.  If any election with respect to seeking such patent
term restoration is to be made in any country in the Territory, then if such
election is with respect to an AGTC Patent Right that is not a Product-Specific
Patent Right, Joint Platform Improvement Patent Right or Biogen Platform
Improvement Patent Right then AGTC shall make such election (including, without
limitation, by filing supplementary protection certificates and any other
extensions that are now or in the future become available) and if such election
is with respect to (a) a Product-Specific Patent Right or (b) a Joint Patent
Right that is not a Joint Platform Improvement Patent Right, then Biogen shall
make such election (including, without limitation, by filing supplementary
protection certificates and any other extensions that are now or in the future
become available).  In

 

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each case, the Party without the right to make such election shall abide by such
election and cooperate, as reasonably requested by the Party making such
election, in connection with the foregoing (including, without limitation, by
providing appropriate information and executing appropriate documents).

13.8. Recording.  If either Party deems it necessary or desirable for any reason
to register or record this Agreement or evidence of this Agreement with any
patent office or other appropriate Governmental Authority(ies) in one or more
jurisdictions in the Territory, the other Party shall reasonably cooperate to
execute and deliver to such Party any documents accurately reflecting or
evidencing this Agreement that are necessary or desirable, in such Party’s
reasonable judgment, to complete such registration or recordation.  The
registering or recording Party shall reimburse the other Party for all
reasonable Out-of-Pocket Costs, including attorneys’ fees, incurred by such
other Party in complying with the provisions of this Section 13.8.

14. CONFIDENTIALITY.

14.1. Confidentiality.  Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing, the Parties agree that, during the
Term and for [***] thereafter (or indefinitely with respect to trade secrets),
each Party (the “Receiving Party”) receiving any Confidential Information of the
other Party (the “Disclosing Party”) hereunder shall: (a) keep the Disclosing
Party’s Confidential Information confidential; (b) not publish, or allow to be
published, and shall not otherwise disclose, or permit the disclosure of, the
Disclosing Party’s Confidential Information in any manner not expressly
authorized pursuant to the terms of this Agreement; and (c) not use, or permit
to be used, the Disclosing Party’s Confidential Information for any purpose
other than as expressly authorized pursuant to the terms of this
Agreement.  Each Party shall be responsible for unauthorized disclosures by its
agents, directors, officers, employees, consultants, Affiliates and advisors,
and any other Third Party to whom such Party discloses such Confidential
Information, regardless of whether such disclosure to such Third Party was
permitted.  For the avoidance of doubt, (i) AGTC Technology shall be the
Confidential Information of AGTC, (ii) Biogen Technology shall be the
Confidential Information of Biogen and (iii) Joint Technology shall be the
Confidential Information of both Parties, with both Parties deemed to be the
Receiving Party.

14.2. Authorized Disclosure.  Notwithstanding the foregoing provisions of
Section 14.1, each Party may disclose Confidential Information belonging to the
other Party to the extent such disclosure is reasonably necessary to:

14.2.1. file or prosecute patent applications or regulatory filings as
contemplated by this Agreement;

14.2.2. prosecute or defend litigation;

14.2.3. exercise its rights and perform its obligations hereunder, provided that
such disclosure is covered by terms of confidentiality at least as restrictive
as those set forth herein;

14.2.4. allow such Party to comply with the terms and conditions of any
agreements with Third Party licensors of the AGTC Technology or the Biogen
Technology, as applicable, provided that such disclosure is covered by terms of
confidentiality at least as restrictive as those set forth herein or, with
respect to AGTC Technology licensed under an Existing License Agreement, those
set forth in the applicable Existing License Agreement disclosed in Schedule
15.2.7; and

14.2.5. comply with applicable Law.

In the event a Party shall deem it reasonably necessary to disclose Confidential
Information belonging to the other Party pursuant to this Section 14.2, the
Disclosing Party shall to the extent possible give reasonable advance written
notice of such disclosure to the other Party and take all reasonable measures to
ensure confidential treatment of such information.

14.3. SEC Filings and Other Disclosures.  Either Party may disclose the terms of
this Agreement (a) to the extent required to comply with applicable Law,
including the rules and regulations promulgated by the United States Securities
and Exchange Commission or any equivalent governmental agency in any country in
the Territory, (b) in connection with a prospective acquisition, merger or
financing for such Party, to prospective acquirers or merger candidates or to
existing or potential investors or financing sources and (c) to any sublicensee,
collaborator or potential sublicensee or permitted collaborator of such Party,
provided that, in the case of clause (b) or (c), prior to such disclosure each
such candidate, investor or financing source shall agree in writing to be bound
by obligations of confidentiality and non-use no less restrictive in scope than
those set forth in this Article 14; and provided, further, that in the case of
clause (a), such Party shall initially submit the redacted version of the
Agreement agreed to by the Parties in writing within ten (10) days after the
Execution Date with a request for confidential treatment of all of the redacted
portions of such attached

 

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Agreement.  With respect to any subsequent disclosure regarding this Agreement
by a Party as required to comply with applicable Law, including the rules and
regulations promulgated by the United States Securities and Exchange Commission
or any equivalent governmental agency in any country in the Territory (including
in response to comments from the Securities and Exchange Commission regarding a
request for confidential treatment), such Party shall provide a copy of the
intended disclosure to the other Party prior to filing of such disclosure, and
the other Party shall have five (5) Business Days (or in the case of a Current
Report on Form 8-K, two (2) Business Days) prior to the filing thereof to review
such disclosure and provide comments to such Party.  Such Party shall implement
all reasonable comments provided by the other Party within such period, it being
understood that each Party is solely responsible for the accuracy and
completeness of all SEC disclosures made by such Party.

14.4. Residual Knowledge Exception.  Notwithstanding any provision of this
Agreement to the contrary, and subject to the terms and conditions of any
pre-existing exclusive license granted by either Party to one or more Third
Parties, Confidential Information for the purpose of clause (c) of Section 14.1
will not include Residual Knowledge.  Any use made by the Receiving Party of
Residual Knowledge is on an “as is, where is” basis, with all faults and all
representations and warranties disclaimed and at its sole risk. Notwithstanding
the foregoing, nothing in this Section 14.4 shall (a) affect the obligations of
either Party with respect to confidentiality obligations of Confidential
Information under Article 14; (b) constitute, or be deemed to result in, a
license under any Technology or other intellectual property right; or (c) affect
any other rights or remedies a Party may have under this Agreement or otherwise.

14.5. Restrictions on Material Non-Public Information.  Each Party acknowledges
that it is aware that the United States securities laws prohibit certain Persons
who have received material, non-public information with respect to a public
company from purchasing or selling securities of that public company and from
communicating such information to any other Person under circumstances in which
it is reasonably foreseeable that such Person is likely to purchase or sell such
securities.  Each Party acknowledges that it is familiar with the United States
Securities Exchange Act of 1934, as amended, and the rules and regulations
promulgated thereunder (collectively, the “1934 Act”); and agrees that it will
neither use, nor cause or permit any person to use, any Confidential Information
in contravention of the 1934 Act, including Rule l0b-5 and Rule 14e-3
thereunder, or other applicable securities laws.

14.6. Public Announcements; Publications.

14.6.1. Coordination.  AGTC and Biogen will, from time to time and at the
request of the other Party, discuss the general information content relating to
this Agreement that may be publicly disclosed; provided, however, that Biogen
shall have no obligation to consult with AGTC with respect to any scientific
publication or public announcement concerning Biogen’s Development, Manufacture,
Commercialization or use of any Licensed Product (except as otherwise expressly
set forth in Section 14.6.4).

14.6.2. Announcements.  Except as may be expressly permitted under clause (a) of
Section 14.3, neither Party will make any public announcement regarding this
Agreement without the prior written approval of the other Party.  For the sake
of clarity, nothing in this Agreement shall prevent Biogen from making any
scientific publication or public announcement concerning Biogen’s Development,
Manufacture or Commercialization activities with respect to any Licensed Product
under this Agreement; provided, however, that, except as permitted under Section
14.2, Biogen shall not disclose any of AGTC’s Confidential Information in any
such publication or announcement without obtaining AGTC’s prior written consent
to do so and consult with AGTC if such scientific publication or public
announcement involves the AGTC Platform.  The Parties agree that the Parties
intend to jointly release the press release attached hereto as Exhibit D
following the Effective Date.

14.6.3. Use of Names.  Biogen shall not and shall ensure that its Affiliates and
Sublicensees shall not:

(a) use the name or insignia of [***] or the name of any [***] officers,
faculty, other researches or students, or any adaptation of such names, in any
advertising, promotional or sales literature, including any press release or any
document employed to obtain funds, without the prior written approval of [***];
this restriction shall not apply to any information required by law to be
disclosed to any governmental entity;

(b) use the names of UFRF, or the University of Florida, nor of any of either
institutions employees, agents or affiliates, nor the name of any inventor of
Patent Rights under any UFRF Existing License Agreement, nor any adaptation of
such names, in any promotional, advertising or marketing materials or any
similar form of publicity, or to suggest any endorsement by such entities or
individuals, without the prior written approval of UFRF in each case;

 

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(c) use the name of The Johns Hopkins University or the Johns Hopkins Health
System or any of its constituent parts, such as the Johns Hopkins Hospital or
any contraction thereof or the name of inventors in any advertising,
promotional, sales literature or fundraising documents without prior written
consent from an authorized representative of JHU; Biogen, Affiliates and
Sublicensees shall allow at least seven (7) business days’ notice of any
proposed public disclosure for JHU’s review and comment or to provide written
consent; and

(d) use [***] name, the name of any inventor of Patent Rights governed by the
[***] Agreement, or the name of [***] in any sales promotion, advertising or any
other form of publicity without the prior approval of [***], except as required
by Law; should Biogen be required by regulatory or legal requirements to
disclose the existence of this Agreement, any of the terms in the [***]
Agreement or the names of [***] or [***], [***] shall have thirty (30) days to
review (i) redaction of terms, including but not limited to royalty rates, and
milestone or other payments, and (ii) the manner in which the names of [***] or
[***] are used.

14.6.4. Publications.  During the Term, each Party shall submit to the other
Party (the “Non-Disclosing Party”) for review and approval any proposed
academic, scientific and medical publication or public presentation related to
any Collaboration Program, any Licensed Product or any activities conducted
pursuant to this Agreement (including under any Development Plan).  In both
instances, such review and approval will be conducted for the purposes of
preserving the value of the AGTC Technology and the AGTC Platform, the Biogen
Technology, the Joint Technology, the rights granted to each Party hereunder and
determining whether any portion of the proposed publication or presentation
containing the Non-Disclosing Party’s Confidential Information should be
modified or deleted.  Written copies of such proposed publication or
presentation required to be submitted hereunder shall be submitted to the
Non-Disclosing Party no later than thirty (30) days before submission for
publication or presentation.  The Non-Disclosing Party shall provide its
comments with respect to such publications and presentations within ten (10)
Business Days of its receipt of such written copy.  The review period may be
extended for an additional sixty (60) days in the event the Non-Disclosing Party
can demonstrate reasonable need for such extension including for the preparation
and filing of patent applications.  Notwithstanding anything to the contrary,
the Non-Disclosing Party may require that the other Party redact the
Non-Disclosing Party’s Confidential Information from any such proposed
publication or presentation.  AGTC and Biogen will each comply with standard
academic practice regarding authorship of scientific publications and
recognition of contribution of other parties in any publication.  For the sake
of clarity, Biogen’s obligation to submit any publication to AGTC for review and
approval under this Section 14.6.4 shall not apply to any publication which does
not contain AGTC’s Confidential Information or involve the AGTC Platform or
disclose any non-public information included in the AGTC Technology.

15. REPRESENTATIONS AND WARRANTIES.

15.1. Representations and Warranties of Each Party.  Except as may be disclosed
in Schedule 15.1, which may be updated within five (5) days following the HSR
Clearance Date, each of AGTC and Biogen hereby represents, warrants and
covenants to the other Party as of the Execution Date and the Effective Date as
follows:

15.1.1. it is a corporation duly organized, validly existing and in good
standing under the laws of the state of its incorporation;

15.1.2. it (i) has the requisite power and authority and the legal right to
enter into this Agreement and to perform its obligations hereunder, (ii) has the
requisite resources and expertise to perform its obligations hereunder and (iii)
has taken all requisite action on its part to authorize the execution and
delivery of this Agreement and the performance of its obligations hereunder;

15.1.3. this Agreement has been duly executed and delivered on behalf of such
Party, and constitutes a legal, valid, binding obligation, enforceable against
such Party in accordance with its terms;

15.1.4. it has obtained all necessary consents, approvals and authorizations of
all Governmental Authorities and other persons or entities required to be
obtained by such Party in connection with the execution and delivery of this
Agreement;

15.1.5. the execution, delivery and performance by such Party of this Agreement
and its compliance with the terms and provisions hereof does not and will not
conflict with or result in a breach of any of the terms and provisions of or
constitute a default under (i) a loan agreement, guaranty, financing agreement,
agreement relating to one or more Patent

 

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Rights or other agreement or instrument binding or affecting it or its property;
(ii) the provisions of its charter or operative documents or bylaws; or (iii)
any order, writ, injunction or decree of any court or Governmental Authority
entered against it or by which any of its property is bound;

15.1.6. it has not, and will not, after the Execution Date and during the Term,
grant any right to any Third Party that would conflict with the rights granted
to the other Party or would be inconsistent with its obligations hereunder;

15.1.7. neither it nor any of its Affiliates has been debarred by the FDA or is
the subject of a conviction described in Section 306 of the FD&C Act or is
subject to any similar sanction of other Governmental Authorities in the
Territory. Neither AGTC nor any of its Affiliates has used, in any capacity, any
Person who either has been debarred by the FDA, is the subject of a conviction
described in Section 306 of the FD&C Act or is subject to any such similar
sanction in their development programs for the Licensed Products.  Neither Party
shall engage, in any capacity in connection with this Agreement or any ancillary
agreements, any Person who either has been debarred by the FDA, is the subject
of a conviction described in Section 306 of the FD&C Act or is subject to any
such similar sanction.  Each Party shall inform the other Party in writing
promptly upon learning that it or any Person engaged by such Party or any of its
Affiliates who is performing services under this Agreement or any ancillary
agreements is debarred or is the subject of a conviction described in Section
306 of the FD&C Act, or, to such Party’s knowledge, if any action, suit, claim,
investigation or legal or administrative proceeding is pending or is threatened,
relating to the debarment or conviction of such Party, any of its Affiliates or
any such Person performing services hereunder or thereunder;

15.1.8. it shall at all times comply with all material Laws applicable to its
activities under this Agreement; and

15.1.9. each Party hereby agrees that until the expiration of six (6) months
after the expiration or termination of this Agreement, neither it nor any of its
controlled Affiliates will solicit to employ any of the officers or employees of
the other Party without obtaining the prior written consent of the other Party;
provided, however, that the foregoing shall not prohibit such Party from: (i)
publishing general job advertisements or similar notices that are not targeted
specifically at such Party’s employees or (ii) soliciting employees whose
employment with such Party has terminated not less than six (6) months prior to
such solicitation.

15.2. Additional Representations and Warranties of AGTC.  In addition to the
representations, warranties and covenants made by AGTC elsewhere in this
Agreement, except as disclosed in Schedule 15.2 as may be updated in accordance
with this Section 15.2, AGTC hereby represents, warrants and covenants to Biogen
(i) as of the Execution Date and the Effective Date (provided that AGTC may (1)
supplement any schedule referred to in this Section 15.2 or (2) add one or more
new schedules to this Section 15.2 with respect to the applicable representation
and warranty made as of the Effective Date in each case ((1) and (2)) within
five (5) days following the HSR Clearance Date, but any such supplement or new
schedule may only contain information arising after the Execution Date and may
not correct, modify or delete any information set forth in any such schedule on
the Execution Date) and (ii) with respect to any Discovery Program, as of the
Option Exercise Date for such Discovery Program, solely with respect to (a) AGTC
Technology, other than AGTC Technology or Joint Technology already disclosed to
Biogen under an existing Collaboration Program or through the Patent
Representatives (including Technology covered by the following representations
and warranties as of the Effective Date), that is necessary or useful to such
Discovery Program and (b) Existing License Agreements and Control Limitation
Agreements relating specifically to such Discovery Program, in each case ((a)
and (b)), as such AGTC Technology and agreements may be added to existing
schedules or set forth in new schedules to this Section 15.2:

15.2.1. the issued AGTC Patent Rights are, to AGTC’s Knowledge, valid and
enforceable patents. To AGTC’s Knowledge, no Third Party is infringing any such
Patent Rights in the Field. AGTC has not received written notice challenging the
extent, validity or enforceability of such Patent Rights (including by way of
example through the institution or written threat of institution of
interference, nullity, opposition, inter partes or post grant review or similar
invalidity proceedings before the United States Patent and Trademark Office or
any analogous foreign Governmental Authority);

15.2.2. (a) Schedule 1.22-1 contains a complete and correct list of all Patent
Rights owned or otherwise Controlled by AGTC or its Affiliates (and indicating
which entity owns or Controls each Patent Right and which are owned and which
are Controlled) that, to AGTC’s Knowledge, are necessary or that AGTC believes
to be useful for the Development, Manufacture, Commercialization or use of the
Initial Licensed Products and (b) Schedule 1.22-2, as of the Option Exercise
Date, contains a complete and correct list of all Patent Rights owned or
otherwise Controlled by AGTC or its Affiliates (and indicating with entity owns
or Controls each Patent Right and which are owned and which are Controlled)
that, to AGTC’s

 

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Knowledge, are necessary or that AGTC believes to be useful or the Development,
Manufacture, Commercialization or use of the Discovery Products;

15.2.3. it has, and to its Knowledge, its licensors have, complied in all
material respects with all applicable Laws, including, with respect to any
issued patents and pending patent applications (excluding United States
provisional patent applications), any disclosure requirements of the USPTO or
any other Governmental Authority, in connection with the filing, prosecution and
maintenance of the AGTC Patent Rights and it has, and to its Knowledge, its
licensors have, timely paid all filing and renewal fees payable with respect to
any AGTC Patent Rights for which it controls prosecution and maintenance;

15.2.4. it has obtained, or caused its Affiliates, as applicable, to obtain,
assignments from the inventors of all inventorship rights to the AGTC Patent
Rights that are owned by AGTC or such Affiliates and, to AGTC’s Knowledge, there
has been no failure on the part of any licensor of AGTC Patents Rights that are
licensed by AGTC to obtain assignments from the inventors of all inventorship
rights to such licensed Patent Rights, and to AGTC’s Knowledge, all assignments
of inventorship rights relating to the AGTC Patent Rights are valid and
enforceable, and the inventorship of the AGTC Patent Rights owned by AGTC, and,
to AGTC’s knowledge, of the AGTC Patent Rights licensed to AGTC, is properly
identified on each patent or patent application;

15.2.5. other than as expressly permitted by this Agreement, it shall not, and
shall cause its Affiliates not to (i) license, sell, assign or otherwise
transfer to any Person any AGTC Technology (or agree to do any of the foregoing)
or (ii) incur with respect to any AGTC Technology, any lien, encumbrance,
charge, security interest, mortgage, liability, grant of license to Third
Parties or other restriction (including in connection with any indebtedness), in
each case ((i) and (ii)), other than license grants to Third Parties that do not
breach or conflict with the rights and licenses granted to Biogen hereunder;

15.2.6. it has sufficient right, power and authority to grant all of the right,
title and interest in the licenses granted or to be granted to Biogen or
Biogen’s Affiliates under this Agreement;

15.2.7. there are no AGTC Third Party Agreements, other than the Existing
License Agreements expressly disclosed on Schedule 15.2.7, true and complete
copies of which have been provided to Biogen and, to AGTC’s Knowledge, other
than as disclosed on Schedule 1.22-1 or Schedule 1.22-2 or as set forth in such
Existing License Agreements, no Third Party has any right, title or interest in
or to, or any license under, any of the AGTC Patent Rights or AGTC Know-How;

15.2.8. except as provided in the Existing License Agreements and other than as
disclosed on Schedule 1.22-1 or Schedule 1.22-2, AGTC is the sole and exclusive
owner of the AGTC Patent Rights listed on Schedule 1.22-1 or Schedule 1.22-2,
all of which are free and clear of any liens, charges and encumbrances other
than licenses granted to Third Parties that do not breach or conflict with the
rights and licenses granted to Biogen hereunder;

15.2.9. to AGTC’s Knowledge, it has the right to use, and to permit Biogen,
Biogen’s Affiliates and Biogen’s Sublicensees to use, the AGTC Know-How for all
permitted purposes under this Agreement;

15.2.10. the AGTC Know-How is free and clear of liens, charges or encumbrances
other than licenses granted to Third Parties that do not breach or conflict with
the rights and licenses granted to Biogen hereunder;

15.2.11. it and its Affiliates have taken commercially reasonable measures
consistent with industry practices to protect the secrecy, confidentiality and
value of all AGTC Know-How that constitutes trade secrets under applicable Law
(including requiring all employees, consultants and independent contractors to
execute binding and enforceable agreements requiring all such employees,
consultants and independent contractors to maintain the confidentiality of such
AGTC Know-How) and, to AGTC’s Knowledge, such AGTC Know-How has not been used,
disclosed to or discovered by any Third Party except pursuant to such
confidentiality agreements and there has not been a breach by any party to such
confidentiality agreements;

15.2.12. except as provided in the Existing License Agreements, no AGTC
Technology existing as of the Execution Date or the Effective Date is subject to
any funding agreement with any government or governmental agency;

15.2.13. to AGTC’s Knowledge, the manufacture, use, sale, offer for sale, supply
or importation by AGTC or Biogen (or their respective Affiliates or
Sublicensees) of any Licensed Product does not and will not infringe any issued
patent of any Third Party.

 

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15.2.14. it has not received notice of any claims, and there are no judgments or
settlements against or owed by AGTC or, to AGTC’s Knowledge, any pending or
threatened claims or litigation, in each case relating to the AGTC Technology;

15.2.15. it and its Affiliates are, and shall remain, in compliance in all
material respects with any AGTC Third Party Agreements;

15.2.16. it will not without Biogen’s written consent, amend any AGTC Third
Party Agreement in a manner that materially adversely affects the rights granted
to Biogen hereunder or AGTC’s ability to fully perform its obligations
hereunder;

15.2.17. it will furnish Biogen with copies of all notices received by AGTC
relating to any alleged breach or default by AGTC that would give rise to a
termination right under AGTC Third Party Agreements no later than ten (10) days
after AGTC’s receipt thereof.  In the event AGTC does not resolve any such
alleged breach or default, it shall notify Biogen within a sufficient period of
time before the expiration of the cure period for such breach or default under
such AGTC Third Party Agreement such that Biogen, in its sole discretion, is
able to cure or otherwise resolve such alleged breach or default.  Biogen shall
have the right, but not the obligation, to cure or otherwise resolve any such
alleged breach or default, including making any required payments under such
AGTC Third Party Agreement on AGTC’s behalf.  If Biogen makes any payments to a
Third Party in connection with the cure or other resolution of such alleged
breach or default of AGTC, then, notwithstanding anything to the contrary in
this Agreement, Biogen may credit the full amount of such payments against any
royalties or other payments payable to AGTC pursuant to this Agreement;

15.2.18. it will promptly furnish Biogen with copies of all (i) amendments of
the AGTC Third Party Agreements and (ii) correspondence with or from licensors
under the AGTC Third Party Agreements to the extent material to Biogen or the
rights granted to Biogen or Biogen’s Affiliates under this Agreement;

15.2.19. all terms and conditions of the Existing License Agreements applicable
to Biogen in its role as a sublicensee or otherwise required to be included in
sublicense agreements under such Third Party Agreements are expressly set forth
in this Agreement;

15.2.20. neither AGTC nor any of its Affiliates are a party to or otherwise
subject to any Control Limitation Agreement with respect to any Technology that
would, but for such Control Limitation Agreement, be included in the rights
licensed or assigned to Biogen or its Affiliates pursuant to this Agreement with
respect to (a) the Initial Licensed Products, as of the Execution Date and the
Effective Date or (b) a Discovery Product, as of the Option Exercise Date for
such Discovery Product; and

15.2.21. there is no action, claim, demand, suit, proceeding, arbitration,
grievance, citation, summons, subpoena, inquiry or investigation of any nature,
civil, criminal, regulatory or otherwise, in law or in equity, pending or, to
AGTC’s Knowledge, threatened, with any judicial or arbitrative body against AGTC
or any of its Affiliates in connection with the AGTC Technology, the Discovery
Programs or the Licensed Products.

15.3. Additional Covenant and Representation of Biogen.

15.3.1. In addition to the representations, warranties and covenants made by
Biogen elsewhere in this Agreement, Biogen hereby covenants to AGTC that Biogen
shall not encumber, other than under sublicenses as expressly permitted under
this Agreement, or otherwise grant a security interest in, any of the AGTC
Technology to any Third Party.

15.3.2. Biogen represents and warrants that it will comply, and will ensure that
its Affiliates comply, with all local, state and international laws and
regulations relating to the [***] Biological Material and to the development,
manufacture, use, sale and importation of [***] Viruses and [***] Products.
Without limiting the foregoing, Biogen represents and warrants that it will
comply with all United States export control laws and regulations with respect
to [***] Biological Material and any [***] Viruses and [***] Products developed
or made through the use thereof.

15.4. Special Exceptions for Licensors Under Existing License
Agreements.  Notwithstanding anything to the contrary in this Agreement, nothing
in this Agreement shall be construed as:

 

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15.4.1. a warranty or representation by UFRF as to the validity or scope of any
right included in the AGTC Patent Rights licensed under the UF/JHU Agreement;

15.4.2. a warranty or representation that anything made, used, sold or otherwise
disposed of under the license granted in the UF/JHU Agreement will or will not
infringe patents of Third Parties;

15.4.3. an obligation to bring or prosecute actions or suits against Third
Parties for infringement of AGTC Patent Rights granted in the UF/JHU Agreement;

15.4.4. an obligation to furnish any Know-How not provided in AGTC Patent Rights
granted in the UF/JHU Agreement or any services other than those specified in
the UF/JHU Agreement; or

15.4.5. a warranty or representation by UFRF that it will not grant licenses to
others to make, use or sell products not covered by the claims of the AGTC
Patent Rights granted in the UF/JHU Agreement which may be similar and/or
compete with products made or sold by Biogen.

15.5. UFRF Disclaimer.  EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THE UF/JHU
AGREEMENT, UFRF MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND,
EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND VALIDITY OF PATENT RIGHTS
CLAIMS, ISSUED OR PENDING.  UFRFASSUMES NO RESPONSIBILITIES WHATSOEVER WITH
RESPECT TO USE, SALE, OR OTHER DISPOSITION BY BIOGEN, ITS SUBLICENSEE(S), OR
THEIR VENDEES OR OTHER TRANSFEREES OF PRODUCTS INCORPORATING OR MADE BY USE OF
INVENTIONS LICENSED UNDER SUCH AGREEMENT.

15.6. Duties of the Parties.  None of the licensors under the UF/JHU Agreement
are commercial organizations.  They are institutes of research and
education.  Therefore, such licensors have no ability to evaluate the commercial
potential of any AGTC Patent Rights or processes or other license or rights
granted in such Agreement. It is therefore incumbent upon Biogen to evaluate the
rights and products in question, to examine the materials and information
provided by such licensors, and to determine for itself the validity of any AGTC
Patent Rights or processes licensed under such Agreement, its freedom to
operate, and the value of any such AGTC Patent Rights or processes or other
rights granted.

15.7. Representations by JHU.  JHU has represented to AGTC that it has good and
marketable title to its interest in the inventions claimed under AGTC Patent
Rights licensed under the UF/JHU Agreement with the exception of certain
retained rights of the United States government, which may apply if any part of
the JHU research was funded in whole or in part by the United States
Government.  JHU does not warrant the validity of any patents or that practice
under such patents shall be free of infringement.  EXCEPT AS EXPRESSLY SET FORTH
IN THIS SECTION 15.7, BIOGEN, AND BIOGEN’S AFFILIATES AND SUBLICENSEE(S) AGREE
THAT THE AGTC PATENT RIGHTS LICENSED UNDER THE UF/JHU AGREEMENT ARE PROVIDED "AS
IS", AND THAT JHU MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO THE
PERFORMANCE OF SUCH LICENSED PRODUCT(S) AND LICENSED PROCESSES INCLUDING THEIR
SAFETY, EFFECTIVENESS, OR COMMERCIAL VIABILITY.  JHU DISCLAIMS ALL WARRANTIES
WITH REGARD TO SUCH PRODUCT(S) AND PROCESSES(S) LICENSED UNDER THE UF/JHU
AGREEMENT, INCLUDING, BUT NOT LIMITED TO, ALL WARRANTIES, EXPRESSED OR IMPLIED,
OF MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE.  NOTWITHSTANDING ANY
OTHER PROVISION OF THIS AGREEMENT, JHU ADDITIONALLY DISCLAIMS ALL OBLIGATIONS
AND LIABILITIES ON THE PART OF JHU AND INVENTORS, FOR DAMAGES, INCLUDING, BUT
NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL AND CONSEQUENTIAL DAMAGES, ATTORNEYS’
AND EXPERTS’ FEES, AND COURT COSTS (EVEN IF JHU HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS), ARISING OUT OF OR IN CONNECTION
WITH THE MANUFACTURE, USE, OR SALE OF THE PRODUCT(S) AND PROCESSES LICENSED
UNDER THIS AGREEMENT. BIOGEN, AND BIOGEN’S AFFILIATES AND SUBLICENSEE(S) ASSUME
ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY A PRODUCT AND/OR
PROCESS MANUFACTURED, USED, OR SOLD BY LICENSEE, ITS SUBLICENSEE(S) AND
AFFILIATED COMPANIES WHICH IS A LICENSED PRODUCT(S) OR LICENSED PROCESSES AS
DEFINED IN THE UF/JHU AGREEMENT.

15.8. Representation by Legal Counsel.  Each Party hereto represents that it has
been represented by legal counsel in connection with this Agreement and
acknowledges that it has participated in the drafting hereof.  In interpreting
and applying the terms and provisions of this Agreement, the Parties agree that
no presumption shall exist or be implied against the Party which drafted such
terms and provisions.

 

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15.9. Disclaimer.  THE FOREGOING WARRANTIES OF EACH PARTY ARE IN LIEU OF ANY
OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF
MERCHANTABILITY OR ANY IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE,
ALL OF WHICH ARE HEREBY SPECIFICALLY EXCLUDED AND DISCLAIMED.

15.10. No Guarantee of Success.  Biogen and AGTC acknowledge and agree that
nothing in this Agreement will be construed as representing any estimate or
projection of (a) the successful Development or Commercialization of any
Licensed Product under this Agreement, (b) the number of Licensed Products that
will or may be successfully Developed or Commercialized under this Agreement,
(c) anticipated sales or the actual value of any Licensed Products that may be
successfully Developed or Commercialized under this Agreement or (d) the
damages, if any, that may be payable if this Agreement is terminated for any
reason. Neither Party makes any representation, warranty or covenant, either
express or implied, that (i) it will successfully Develop, Manufacture,
Commercialize or, other than is expressly required under Section 3.3.1, Section
4.3.1 or 8.3.1, continue to Commercialize any Licensed Product in any country,
(ii) if Commercialized, that any Licensed Product will achieve any particular
sales level, whether in any individual country or cumulatively throughout the
Territory or (iii) other than is expressly required under Section 3.3.1, Section
4.3.1 and Section 8.3.1, that either Party will devote, or cause to be devoted,
any level of diligence or resources to Developing or Commercializing any
Licensed Product in any country, or in the Territory in general.

16. GOVERNMENT APPROVALS; TERM AND TERMINATION.

16.1. HSR Filing and Clearance.  Subject to the terms hereof, AGTC and Biogen
agree to cooperate and to use their respective reasonable best efforts to obtain
any government clearances or approvals, or expirations or terminations of
waiting periods, required for the consummation of the transactions contemplated
under this Agreement under the HSR Act, the Sherman Antitrust Act, as amended,
the Clayton Act, as amended, the Federal Trade Commission Act, as amended, and
any other federal, state or foreign law or, regulation or decree designed to
prohibit, restrict or regulate actions for the purpose or effect of
monopolization or restraint of trade (collectively “Antitrust Laws”), and to
respond to any government requests for information under any Antitrust Law.  The
Parties will consult and cooperate with one another, and consider in good faith
the views of one another, in connection with any analyses, appearances,
presentations, memoranda, briefs, arguments, opinions and proposals made or
submitted by or on behalf of any party hereto in connection with proceedings
under or relating to any Antitrust Law.  Biogen, in consultation with AGTC,
shall be entitled to direct any proceedings or negotiations with any
governmental entity relating to any of the foregoing, provided that it shall
afford AGTC and its counsel a reasonable opportunity to participate
therein.  Except as prohibited by applicable Law, each Party shall keep the
other party and/or its counsel informed of any substantive communication
received by such party from, or given by such party to any governmental entity,
in each case regarding any of the transactions contemplated hereby; and permit
the other party and/or its counsel to review any substantive communication given
by it to, and consult with each other in advance of any meeting or conference
with, any such governmental entity. Without limiting the generality of the
foregoing, each of AGTC and Biogen shall, within ten (10) days after the
Execution Date (or such later time as may be agreed to in writing by the
Parties) file with the United States Federal Trade Commission and the Antitrust
Division of the United States Department of Justice any HSR Filing required of
it under the HSR Act in the reasonable opinion of either Party with respect to
the transactions contemplated hereby.  The Parties shall cooperate with one
another to the extent necessary in the preparation of any such HSR Filing.  Each
Party shall be responsible for its own costs, expenses, and filing fees
associated with any HSR Filing; provided, however, that Biogen shall be solely
responsible for any fees (other than penalties that may be incurred as a result
of actions or omissions on the part of AGTC) required to be paid to any
governmental agency in connection with making any such HSR filing for
acquisitions by Biogen hereunder. In the event the United States Federal Trade
Commission or the United States Department of Justice seeks a preliminary
injunction under the HSR Act against AGTC and Biogen to enjoin the transactions
contemplated by this Agreement, Biogen shall have the first right, but not the
obligation, to defend against such preliminary injunction, at Biogen’s cost and
expense, in consultation with AGTC. If Biogen has not obtained a discontinuance
of such injunction within sixty (60) days of submitting the HSR Filing or if
Biogen does not to pursue such discontinuance, AGTC shall have the right, but
not the obligation, to take over such defense, at AGTC’s cost and expense, in
consultation with Biogen.

16.2. Termination Upon HSR Denial.  In the event that the Parties make an HSR
Filing under Section 16.1, this Agreement shall terminate (a) at AGTC’s option,
immediately upon notice to Biogen, in the event that the United States Federal
Trade Commission or the United States Department of Justice seeks a preliminary
injunction under the HSR Act against AGTC and Biogen to enjoin the transactions
contemplated by this Agreement, provided that Biogen is not pursuing a
discontinuance of such injunction under Section 16.1, (b) at the election of
either Party, immediately upon notice to the other Party, in the event that the
United States Federal Trade Commission or the United States Department of
Justice obtains a preliminary injunction under the HSR Act against AGTC and
Biogen to enjoin the transactions contemplated by this Agreement or (c) at the
election of either Party, immediately upon

 

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notice to the other Party, in the event that the HSR Clearance Date shall not
have occurred on or prior to one hundred eighty (180) days after the effective
date of the HSR Filing.

16.3. Other Government Approvals.  Each of AGTC and Biogen shall cooperate with
the other Party to make all registrations, filings and applications, to give all
notices and to obtain as soon as practicable all governmental or other consents,
transfers, approvals, orders, qualifications authorizations, permits and
waivers, if any, and to do all other things necessary or desirable for the
consummation of the transactions as contemplated hereby.

16.4. Term.  With respect to any Collaboration Program, the term of this
Agreement will commence (a) with respect to any Collaboration Program other than
a Substitute Discovery Program, on the Effective Date, or (b) with respect to a
Substitute Discovery Program, on the Discovery Program Substitution Date and, in
each case ((a) and (b)), shall extend on a Collaboration
Program-by-Collaboration Program, country-by-country, or product-by-product
basis, as applicable, unless this Agreement with respect to a Collaboration
Program, country or product under such Collaboration Program is terminated
earlier (in accordance with this Article 16 or with respect to a Discovery
Program, if earlier, on the date such Discovery Program becomes an Abandoned
Program), until the later of (i) with respect to each Licensed Product that is
not a Cost Share Product, the last to expire of any Royalty Term for such
Licensed Product in such country in the Territory or (ii) with respect to each
Cost Share Product, the date that Biogen is no longer Developing or
Commercializing such Cost Share Product in such country in the Territory (the
“Term”).

16.5. Termination by AGTC.

16.5.1. Termination for Breach by Biogen.  In the event that Biogen commits a
material breach of its obligations under this Agreement and such material breach
remains uncured for [***] days (or in the case of non-payment that constitutes a
material breach, [***] days), measured from the date written notice of such
material breach is given to Biogen, AGTC may, in its sole discretion, terminate
this Agreement either for cause in its entirety or on a Collaboration
Program-by-Collaboration Program or Licensed Product-by-Licensed Product basis
with respect to the Collaboration Programs or Licensed Products to which such
material breach directly relates, in each case, in one or more countries in the
Territory, at any time during the Term after such [***] day period (or [***] day
period in the case of non-payment), by giving written notice to Biogen;
provided, however, that if any breach other than non-payment is not reasonably
curable within [***] days and if Biogen is making a bona fide effort to cure
such breach, such termination shall be delayed for so long as Biogen is
continuing to make such bona fide efforts to cure such breach.  The cure period
shall be tolled pending resolution of any bona fide dispute between the Parties
as to whether any such material breach has occurred.

16.5.2. Termination for Biogen Patent Challenge. Except to the extent the
following under this Section 16.5.2 is unenforceable under the law of the
applicable jurisdiction where the applicable Patent Right is pending or issued,
in the event that Biogen or any of its Affiliates, individually or in
association with any other person or entity, initiates or assists in initiating
or continuing a determination that any Patent Right owned or Controlled by AGTC
is invalid or unenforceable or otherwise limit the scope of any such Patent
Right (a “Biogen Patent Challenge”) through any administrative, judicial or
other similar proceeding with respect to such Patent Right in a particular
jurisdiction, AGTC may either, at its sole discretion (i) [***] days’ prior
written notice to Biogen, unless such Biogen Patent Challenge is dropped within
such [***] day period; or (ii) elect, in lieu of termination, [***]. In any
event, Biogen shall reimburse AGTC for all costs incurred by AGTC, its
Affiliates or their respective sublicensees in connection with such Biogen
Patent Challenge upon written notice to Biogen.  Biogen will include the
obligations set forth in this Section 16.5.2 in any sublicenses of its rights
under this Agreement and shall use reasonable efforts to ensure its
Sublicensees’ compliance with such obligations, provided that AGTC shall have no
termination right under this Section 16.5.2 in the event of any failure by such
a Sublicensee to comply with such obligations, unless (a) Biogen has not
included such provision in the applicable sublicense and (b) such Sublicensee
individually or in association with any other person or entity, initiates or
assists in initiating or continuing a determination that any Patent Right owned
or Controlled by AGTC is invalid or unenforceable or otherwise limit the scope
of any such Patent Right.  AGTC will be a third party beneficiary of such
provisions in any sublicense agreement solely for the purpose of enforcing its
rights under such sublicense provisions directly.

16.6. Termination by Biogen.

16.6.1. Termination for Convenience.  At any time upon at least [***] days’
written notice to AGTC, Biogen may terminate this Agreement with respect to any
Initial Licensed Program, any Initial Licensed Product or any Discovery Program
during the Research Period for such Discovery Program, without cause, for any or
no reason, which termination shall be effective after the expiration of such
[***] day period.  At any time upon written notice to AGTC, Biogen may

 

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terminate this Agreement with respect to any Discovery Product for which Biogen
has exercised the Option, without cause, for any or no reason, which termination
shall be effective immediately upon receipt of such notice by AGTC.  In the
event any Discovery Program is terminated under this Section 16.6.1, such
Discovery Program shall be deemed to be an Abandoned Program.

16.6.2. Termination for Breach by AGTC.  In the event that AGTC commits a
material breach of its obligations under any or all Collaboration Programs or
with respect to any or all Licensed Products under this Agreement and such
material breach remains uncured for [***] days (or in the case of non-payment
that constitutes a material breach, [***] days), measured from the date written
notice of such material breach is given to AGTC, Biogen may, in its sole
discretion, terminate this Agreement either for cause in its entirety or on a
Collaboration Program-by-Collaboration Program or Licensed Product-by-Licensed
Product basis with respect to the Collaboration Programs or Licensed Products to
which such material breach directly relates, in each case, in one or more
countries in the Territory, at any time during the Term after such [***] day
period (or the applicable [***] day period), by giving written notice to AGTC;
provided, however, that if any breach other than non-payment is not reasonably
curable within [***] days and if AGTC is making a bona fide effort to cure such
breach, such termination shall be delayed for so long as AGTC is continuing to
make such bona fide efforts to cure such breach.  The cure period shall be
tolled pending resolution of any bona fide dispute between the Parties as to
whether any such material breach has occurred.

16.6.3. Termination Due to Material Adverse Event.  This Agreement will
terminate in its entirety if a Material Adverse Event has occurred and Biogen
provides notice of termination to AGTC within three (3) Business Days after the
Schedule Revision Date that such Material Adverse Event has occurred.

16.7. Termination for Insolvency.  To the extent permissible under applicable
Law, in the event that either Party makes an assignment for the benefit of
creditors, appoints or suffers appointment of an administrator, receiver or
trustee over all or substantially all of its property to which this Agreement
relates, files a petition under any bankruptcy or insolvency act or has any such
petition filed against it which is not dismissed within sixty (60) days of the
filing thereof (each, an “Insolvency Event” and the Party undergoing such
Insolvency Event, the “Insolvent Party”), then the other Party may terminate
this Agreement effective immediately upon written notice to Insolvent Party.  In
the event of a rejection of this Agreement by the Insolvent Party or any trustee
thereof under Section 365 of the Bankruptcy Code:

16.7.1. All rights and licenses now or hereafter granted by the Insolvent Party
to the other Party under or pursuant to this Agreement, including, for the
avoidance of doubt, the licenses granted under Sections 5.1, 5.3, 5.4 and
16.8.1, are, for all purposes of Section 365(n) of the Bankruptcy Code, licenses
of rights to “intellectual property” as defined in the Bankruptcy Code. Upon the
rejection of this Agreement by the Insolvent Party or any trustee thereof, the
Insolvent Party, for itself and any successors or assigns, including any
trustee, agrees that the other Party, as licensee of such rights under this
Agreement, shall retain and may fully exercise all of its rights and elections
under the Bankruptcy Code. The Insolvent Party shall, during the term of this
Agreement, create and maintain current copies of all intellectual property
licensed under this Agreement.  Each Party acknowledges and agrees that
“embodiments” of such intellectual property within the meaning of Section 365(n)
include, without limitation, laboratory notebooks, product samples and
inventory, research studies and data, all Marketing Applications and Regulatory
Approvals and rights of reference therein, of the AGTC Technology on the one
hand or the Biogen Technology and Program Data on the other hand, and in either
case, the Joint Technology.  If (i) a case under the Bankruptcy Code is
commenced by or against the Insolvent Party, (ii) this Agreement is rejected as
provided in the Bankruptcy Code, and (iii) the other Party elects to retain its
rights hereunder as provided in Section 365(n) of the Bankruptcy Code, the
Insolvent Party (in any capacity, including debtor-in-possession) and its
successors and assigns (including a trustee) shall:

(a) provide to the other Party all such intellectual property (including all
embodiments thereof) in the possession of the Insolvent Party on  terms agreed
by the Parties, promptly upon the other Party’s written request.

(b) not interfere with the non-insolvent Party’s rights under this Agreement, or
any agreement supplemental hereto, to such intellectual property (including such
embodiments), including any right to obtain such intellectual property (or such
embodiments) from another entity, to the extent provided in Section 365(n) of
the Bankruptcy Code.

16.7.2. All rights, powers and remedies of each Party provided herein are in
addition to and not in substitution for any and all other rights, powers and
remedies now or hereafter existing at law or in equity (including the Bankruptcy
Code)

 

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in the event of the commencement of a case under the Bankruptcy Code with
respect to the Insolvent Party.  The Parties agree that they intend the
following rights to extend to the maximum extent permitted by law, and to be
enforceable under Bankruptcy Code Section 365(n) upon any rejection of this
Agreement: the right of access on terms agreed by the Parties to any
intellectual property (including all embodiments thereof) of the Insolvent Party
which is necessary for the Manufacture, use, sale, import or export of Licensed
Products.

16.8. Effects of Termination.

16.8.1. Effects of Termination.

(a) Termination by AGTC for Cause of an Initial Licensed Program.

(i) In the event AGTC terminates this Agreement for cause with respect to any
Initial Licensed Program or Initial Licensed Product pursuant to Section 16.5,
then, with respect to such Initial Licensed Program or Initial Licensed Product
in such applicable countries, at AGTC’s election, (1) Biogen shall, and hereby
does, grant to AGTC an exclusive, royalty-bearing license, with the ability to
sublicense, under any Know-How and Patent Rights Controlled by Biogen or its
Affiliates that are necessary for, or useful for and were in use by, Biogen or
its Affiliates or Sublicensees in, the Initial Licensed Program or the
Development, Manufacture or Commercialization of the applicable Initial Licensed
Product at the time of such termination, to Develop, Manufacture, Commercialize
and use such Initial Licensed Product in the Field in the terminated
country(ies), (2) at Biogen’s expense, Biogen shall within thirty (30) days of
AGTC’s request, transfer or begin transferring all Marketing Applications and
Regulatory Approvals with respect to such Initial Licensed Product(s) to AGTC,
(3) at Biogen’s expense, Biogen shall within thirty (30) days of AGTC’s request,
diligently conduct a Know-How transfer to AGTC, including all relevant Program
Data, included in the license set forth in clause (1), (4) Biogen shall within
thirty (30) days of AGTC’s request, transfer a reasonable amount of such Initial
Licensed Product for clinical and commercial use, along with work in process for
such clinical and commercial supply to the extent practicable, requested by
AGTC, and AGTC shall reimburse Biogen for such Materials at Cost of Goods Sold
(provided that, if the terminated Initial Licensed Product is a Cost Share
Product, AGTC may subtract from such reimbursement any amounts already
reimbursed by AGTC to Biogen for such Materials), and (5) all other rights and
obligations of the Parties under this Agreement with respect to such Initial
Licensed Program or such Initial Licensed Product shall terminate, except that,
with respect to any terminated Initial Licensed Program, (a) Biogen’s
obligations under Section 5.8.1 shall continue for two (2) years after the
effective date of such termination under Section 16.5 and (b) the restrictions
on Biogen’s use, licensing, assignment and transfer of Joint Technology that
constitutes an improvement or enhancement to the [***] Manufacturing Technology
as set forth in Section 5.4.1 shall continue until the later of (i) five (5)
years from the effective date of termination with respect to such Initial
Licensed Program and (ii) the date that this Agreement has expired or terminated
with respect to both Initial Licensed Programs.

(ii) Effective upon AGTC’s election to obtain the license in Section
16.8.1(a)(i), Biogen hereby grants to AGTC a “Right of Reference”, as that term
is defined in 21 C.F.R. § 314.3(b) and any analogous regulation outside of the
United States, to any data Controlled by Biogen or its Affiliates that relates
to the terminated Initial Licensed Program or Initial Licensed Product, as
applicable, including without limitation applicable Program Data, any
Preclinical Studies or Clinical Trials or any Initial Licensed Product solely to
Develop, Manufacture and Commercialize the Initial Licensed Product with respect
to which this Agreement has been terminated, and Biogen shall provide a signed
statement to this effect, if requested by AGTC, in accordance with 21 C.F.R. §
314.50(g)(3) (or any analogous applicable Law recognized outside of the United
States).

(b) Termination by Biogen for Convenience of an Initial Licensed Program.

(i) In the event Biogen terminates this Agreement for convenience with respect
to any Initial Licensed Program or Initial Licensed Product pursuant to Section
16.6.1, with respect to such Initial Licensed Program or Initial Licensed
Product at AGTC’s election (1) Biogen shall, and hereby does, grant to AGTC an
exclusive, royalty-bearing license under any Know-How and Patent Rights
Controlled by Biogen or its Affiliates that are necessary for, or useful for and
were in use by, Biogen or its Affiliates or

 

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Sublicensees in, the Initial Licensed Program or the Development, Manufacture or
Commercialization of the applicable Initial Licensed Product at the time of such
termination, to Develop, Manufacture, Commercialize and use such Initial
Licensed Product in the Field in the Territory, (2) at Biogen’s expense, Biogen
shall within thirty (30) days of AGTC’s request, transfer or begin transferring
all Marketing Applications and Regulatory Approvals with respect to such Initial
Licensed Product to AGTC, (3) at Biogen’s expense, Biogen shall within thirty
(30) days of AGTC’s request conduct a Know-How transfer to AGTC, including all
relevant Program Data, included in the license set forth in clause (1), (4)
Biogen shall within thirty (30) days of AGTC’s request, transfer a reasonable
amount of such Initial Licensed Product for clinical and commercial use, along
with work in process for such clinical and commercial supply to the extent
practicable, requested by AGTC, and AGTC shall reimburse Biogen for such
Materials at Cost of Goods Sold (provided that, if the terminated Initial
Licensed Product is a Cost Share Product, AGTC may subtract from such
reimbursement any amounts already reimbursed by AGTC to Biogen for such
Materials), and (5) all other rights and obligations of the Parties under this
Agreement with respect to such Initial Licensed Program or such Initial Licensed
Product, including the Parties’ respective obligations under Section 5.8, shall
terminate, except that, with respect to any terminated Initial Licensed Program,
(a) [***] (ii) the date that this Agreement has expired or terminated with
respect to both Initial Licensed Programs and (b) Biogen’s obligations under
Section 5.8.1 with respect to such terminated Initial Licensed Program shall
continue until the date that is [***] days after the effective date of
termination.

(ii) Effective upon AGTC’s election to obtain the license in Section
16.8.1(b)(i), Biogen hereby grants to AGTC a “Right of Reference,” as that term
is defined in 21 C.F.R. § 314.3(b) and any analogous regulation outside of the
United States, to any data Controlled by Biogen or its Affiliates that relates
to the terminated Initial Licensed Program or Initial Licensed Product, as
applicable, including without limitation applicable Program Data, any
Preclinical Studies or Clinical Trials or to any Initial Licensed Product solely
to Develop, Manufacture and Commercialize the Initial Licensed Product with
respect to which this Agreement has been terminated, and Biogen shall provide a
signed statement to this effect, if requested by AGTC, in accordance with 21
C.F.R. § 314.50(g)(3) (or any analogous applicable Law recognized outside of the
United States).

(c) Termination of a Discovery Program; Abandoned Programs.  In the event either
Party terminates this Agreement with respect to any Discovery Program or any
Discovery Product pursuant to any provision of Section 16.5 or Section 16.6, or
in the event that any Discovery Program becomes an Abandoned Program hereunder,
except as otherwise expressly provided herein, all rights and obligations of the
Parties under this Agreement with respect to such Discovery Program or such
Discovery Product, including the Parties’ respective obligations under Section
5.8, shall terminate.

(d) Consideration for the Reversionary Licenses.  In consideration for either of
the licenses granted to AGTC with respect to an Initial Licensed Product
pursuant to Section 16.8.1(a) or Section 16.8.1(b), AGTC shall pay to Biogen a
royalty on Net Sales of such Initial Licensed Product (calculated in accordance
with Section 1.184, which shall apply mutatis mutandis to such calculation) on a
Calendar Quarter basis as follows: (i) such Net Sales shall be multiplied by the
applicable royalty rate set forth in Section 6.4.3(a); (ii) the reductions set
forth in  Section 6.6.1 (provided that the reductions set forth in Section 6.6.1
shall apply only with respect to Third Party royalty payments, and no other
Third Party payments), Section 6.6.2 and Section 6.6.3 shall be applied to the
amount set forth in clause (i), if applicable; and (iii) the amount set forth in
clause (ii) shall be multiplied by a percentage, as set forth in Table
16.8.1(d)-1 (in the case of a license granted under Section 16.8.1(a)) or Table
16.8.1(d)-2 (in the case of a license granted under Section 16.8.1(b)) below
based on the effective date of termination with respect to such Initial Licensed
Product and whether such Initial Licensed Product was a Cost Share
Product.  Such royalties shall be payable to Biogen on a country-by-country and
Initial Licensed Product-by-Initial Licensed Product basis, until the latest of
(a) the expiration of the last to expire of any Valid Claim included in any AGTC
Patent Right or Joint Patent Right that is issued or pending in such country as
of the effective date of termination, which Valid Claim Covers the manufacture,
use, sale, offer for sale or importation of such Initial Licensed Product in
such country, (b) [***].  The royalty floor set forth in Section 6.6.4 shall not
apply with respect to any Initial Licensed Product that AGTC is Commercializing
under this Section 16.8.1; provided, however, that in no event shall any royalty
payment payable to Biogen under this Section 16.8.1(d) for any Initial Licensed
Product in a given Calendar Quarter be reduced to less than the royalty payments
payable by Biogen to Third Parties with respect to such Initial Licensed

 

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Product in such Calendar Quarter plus [***].  In addition, AGTC shall be
responsible for any milestone payments payable by Biogen to Third Parties
arising out of the Development, Manufacture, Commercialization or use of such
Initial Licensed Product.  The provisions of Section 6.7, Section 9.2 and
Section 9.3 shall apply mutatis mutandis during such time as AGTC is
Commercializing an Initial Licensed Product under this Section 16.8.1. In the
event of a termination by AGTC for Biogen’s non-payment pursuant to Section
16.5.1, AGTC may credit the amount of the non-payment, together with interest
that accrued pursuant to Section 6.10 from the first and any subsequent payments
due to Biogen under this Section 16.8.1(d) until such amount is exhausted.

Table 16.8.1(d)-1

Consideration for the License under Section 16.8.1(a) (Termination by AGTC for
Cause of an Initial Licensed Program)

[***]

Table 16.8.1(d)-2

Consideration for the License under Section 16.8.1(b) (Termination by Biogen for
Convenience of an Initial Licensed Program)

[***]

(e) Termination for Cause by Biogen.  In the event Biogen terminates this
Agreement pursuant to Section 16.6.2 for cause, with respect to any
Collaboration Program or Licensed Product in any country in the Territory,
except as otherwise expressly provided herein, all rights and obligations of
each Party with respect to such Collaboration Program or Licensed Product in
such country shall cease, provided that AGTC’s obligations under Section 5.8.1
or Section 5.8.2, as applicable, with respect to the applicable Licensed
Program, shall survive for a period of [***] years from the effective date of
such termination.  In the event Biogen terminates this Agreement in its entirety
pursuant to Section 16.6.2 for cause, except as otherwise expressly provided
herein, all rights and obligations of each Party under this Agreement shall
cease, provided that AGTC’s obligations under Section 5.8.1 and Section 5.8.2
shall survive for a period of [***] years from the effective date of such
termination.

16.8.2. Sublicense Survival. In the event of any termination of this Agreement,
any permitted sublicense of either Party shall, at the applicable Sublicensee’s
option, survive such termination, provided that the Sublicensee is not in breach
of any of its obligations under such sublicense and provided, further, that, in
the case of a Sublicensee of Biogen, such Sublicensee has not initiated or
assisted in the initiation or continuation of any Biogen Patent Challenge.  In
order to effect this provision, at the request of the Sublicensee, the licensor
Party shall enter into a direct license with the Sublicensee on substantially
the same terms as the sublicense, provided that the licensor Party shall not be
required to undertake obligations in addition to those required by this
Agreement, and that the licensor Party’s rights under such direct license shall
be consistent with its rights under this Agreement, taking into account the
scope of the license granted under such direct license.

16.8.3. Accrued Rights.  Expiration or termination of this Agreement for any
reason shall be without prejudice to any right which shall have accrued to the
benefit of either Party prior to such termination, including damages arising
from any breach under this Agreement.  Expiration or termination of this
Agreement shall not relieve either Party from any obligation which is expressly
indicated to survive such expiration or termination.

16.8.4. Survival of Certain Provisions.  In addition to any other provisions
expressly stated in this Agreement to survive expiration or termination of this
Agreement, the following sections (and any other sections referenced therein for
the corresponding time periods set forth therein) of this Agreement shall
survive expiration or termination of this Agreement for any reason: Article 1,
Section 5.4, Section 5.5.3, Section 5.7,  Section 5.8.4, Section 6.7, Section
6.8, Section 6.9, Section 6.10, Article 9 (solely with respect to record-keeping
and audits of records for activities conducted under this Agreement prior to the
effective date of termination), Section 11.4, Section 13.1, Section 14.1 (for
the time periods set forth therein), Section 14.2, Section 14.3, Section 14.4,
Section 14.5, Section 14.6, Section 15.5, Section 15.7, Section 15.9, Section
15.10, Section 16.8, Section 17.1, Section 17.2 through Section 17.5 (solely
with respect to indemnification of claims arising from activities conducted
under this Agreement prior to the effective date of termination), Section 18.1
and Section 18.3 through Section 18.16.

 

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16.9. Effects of Material Breach by AGTC in Lieu of Termination.  
Notwithstanding anything to the contrary, in the event of any material breach by
AGTC of its obligations under this Agreement that remains uncured following the
applicable cure period under Section 16.6.2, Biogen may elect, in lieu of
terminating this Agreement in whole or in part as a result of such material
breach, (a) to convert the financial terms for any Cost Share Product to which
such material breach directly relates to the Milestone/Royalty Option and (b) to
reduce all further royalty and milestone payments payable by Biogen to AGTC
under this Agreement, for a Licensed Product to which such material breach
directly relates, as follows: (i) with respect to royalty payments payable for
such Licensed Product, on a country-by-country basis, for each Calendar Quarter
during the Royalty Term for such Licensed Product, (x) Net Sales of such
Licensed Product shall be multiplied by the applicable royalty rate set forth in
Section 6.4.3(a) or Section 6.5.3(a), as applicable; (y) the reductions set
forth in Section 6.6.1, Section 6.6.2 and Section 6.6.3 shall be applied to the
amount set forth in clause (x), if applicable; and (z) the amount set forth in
clause (y) shall be multiplied by a percentage, as set forth in Table 16.9 below
based on the date that the applicable cure period under Section 16.6.2 ends with
respect to such Licensed Product and whether such Licensed Product was a Cost
Share Product, and (ii) with respect to any further milestone payments payable
for Licensed Product, such milestone payments shall be equal to the milestone
payments otherwise payable to AGTC for such Licensed Product, multiplied by a
percentage, as set forth in Table 16.9 below based on the date that the
applicable cure period under Section 16.6.2 ends with respect to such Licensed
Product and whether such Licensed Product was a Cost Share Product.  The royalty
floor and event milestone floor set forth in Section 6.6.4 shall not apply with
respect to any Licensed Product for which Biogen has elected to reduce further
royalty and milestone payments under this Section 16.9, provided that, subject
to Section 6.6.1(b)(iii), in no event shall (i) any royalty payment payable to
AGTC under this Agreement for any Licensed Product in a given Calendar Quarter
be reduced to less than the royalty payments payable by AGTC to Third Parties
plus [***] with respect to such Licensed Product in such Calendar Quarter or
(ii) any milestone payment payable to AGTC under this Section 16.9 for any
Initial Licensed Product be reduced to less than the milestone payments payable
by AGTC to Third Parties for the applicable event milestone with respect to such
Initial Licensed Product.  In addition, Biogen shall be responsible for any
milestone payments payable by AGTC to Third Parties arising out of the
Development, Manufacture, Commercialization or use of such Licensed Product for
event milestones that do not correspond to any milestone payment under this
Agreement.  In the event of a termination by Biogen for AGTC’s non-payment
pursuant to Section 16.6.2, Biogen may credit the amount of the non-payment,
together with interest that accrued pursuant to Section 6.10 from the first and
any subsequent milestone or royalty payments due to AGTC under this Agreement
until such amount is exhausted.

Table 16.9

[***]

16.10. Termination of AGTC Third Party Agreements.  In the event that any AGTC
Third Party Agreement is terminated, so long as Biogen is not in default of any
obligation under this Agreement, Biogen shall have rights to obtain a direct
license to any such AGTC Third Party Agreement subject to the terms and
conditions as expressly set forth in such AGTC Third Party Agreement.

17. LIABILITY, INDEMNIFICATION AND INSURANCE.

17.1. No Consequential Damages.  Except with respect to liability arising from a
breach of Section 5.8 or Article 14, from any willful misconduct or
intentionally wrongful act, or to the extent such Party may be required to
indemnify the other Party under this Article 17, in no event will either Party
or any of its respective Affiliates, agents or representatives be liable under
this Agreement for any special, indirect, incidental or consequential damages,
whether in contract, warranty, tort, negligence, strict liability or otherwise,
including loss of profits or revenue suffered by either Party or any of its
respective Affiliates, agents or representatives.  Without limiting the
generality of the foregoing (a) “consequential damages” will be deemed to
include, and neither Party will be liable to the other Party or any of the other
Party’s Affiliates, agents, representatives or stockholders for, any damages
based on or measured by, any Event Milestone Payment due upon any unachieved
event milestone under Section 6.2.1, Section 6.4.1 or Section 6.5.2, any Sales
Milestone Payment due upon any unachieved annual Net Sales level under Section
6.4.2, any unearned royalties under Section 6.4.3 or Section 6.5.3,  or any
other unearned, speculative or otherwise contingent payments provided for in
this Agreement and (b) “consequential damages” will be deemed to include, and
neither Party will be liable to the other Party or any of the other Party’s
Affiliates or representatives for, any damages based on or measured by the other
Party’s, its Affiliates’ or its Sublicensees’ loss of projected or speculative
future sales of the Licensed Product(s).

 

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17.2. Indemnification by Biogen.  Biogen will indemnify, defend and hold
harmless AGTC, each of its Affiliates and each licensor of the AGTC Technology,
and each of its and its Affiliates’ or such licensor’s employees, officers,
directors, trustees and agents and inventors of AGTC Technology licensed under
the UAB Agreement (each, an “AGTC Indemnified Party”) from and against any and
all liability, loss, damage, expense (including reasonable attorneys’ fees and
expenses) and cost (collectively, a “Liability”) that the AGTC Indemnified Party
may be required to pay to one or more Third Parties resulting from or arising
out of:

17.2.1. any claims of any nature arising out of the Development, Manufacture,
Commercialization, consumption or use of any Licensed Product by, or on behalf
of, Biogen (other than by any AGTC Indemnified Party), or under the authority of
Biogen including without limitation death of or injury to any Person or out of
damage to property, other than claims for which AGTC is required to indemnify
Biogen pursuant to Section 17.3; or

17.2.2. the breach by Biogen of any of its representations, warranties,
covenants or obligations set forth in this Agreement;

except, in each case, to the extent such Liabilities are caused by the
recklessness, negligence or intentional misconduct of AGTC or any AGTC
Indemnified Party.  Notwithstanding anything to the contrary, if AGTC has
exercised the Cost Share Option with respect to an Initial Licensed Product, in
the event of any Third Party claim against AGTC, Biogen or any AGTC Indemnified
Party or Biogen Indemnified Party arising out of the Development, Manufacture,
Commercialization, consumption or use of the applicable Cost Share Product,
Biogen and AGTC will coordinate in defending such claim and will share any
Liabilities resulting from or arising out of such claim equally in accordance
with Section 6.3, except to the extent such claim is caused by the recklessness,
negligence or intentional misconduct of, or a breach of any representation or
warranty by, (i) AGTC or any AGTC Indemnified Party, in which case, AGTC shall
indemnify Biogen Indemnified Parties under Section 17.3 or (ii) Biogen or any
Biogen Indemnified Party, in which case Biogen shall indemnify the AGTC
Indemnified Parties under this Section 17.2.

17.3. Indemnification by AGTC.  AGTC will indemnify, defend and hold harmless
Biogen, its Affiliates, Sublicensees, Distributors and each of its and their
respective employees, officers, directors and agents (each, a “Biogen
Indemnified Party”) from and against any and all Liabilities that the Biogen
Indemnified Party may be required to pay to one or more Third Parties resulting
from or arising out of:

17.3.1. the breach by AGTC of any of its representations, warranties, covenants
or obligations set forth in this Agreement;

17.3.2. any claim that the practice of the [***] Technology to Develop,
Manufacture, Commercialize or use any Initial Licensed Product infringes or
misappropriates any issued patent or other proprietary right owned or possessed
by any Third Party, other than any such claim to the extent that (i) it is based
on the practice of the AGTC Technology in combination with Technology other than
AGTC Technology that is utilized in the Development, Manufacture,
Commercialization or use of any Initial Licensed Product as a result of Biogen’s
exercise of its final decision-making authority or (ii) it arises from Biogen’s
election not to take a license or sublicense to any Technology under Section
13.6.2(a); or

17.3.3. any claims of any nature arising out of the research, Development or
Manufacturing activities performed by AGTC with respect to any Collaboration
Programs prior to the Execution Date or any research, Development or
Manufacturing activities performed by AGTC hereunder during the Term, other than
claims for which Biogen is required to indemnify AGTC under Section 17.2;

except, in each case, to the extent such Liabilities are (i) caused by the
recklessness, negligence or intentional misconduct of Biogen or any Biogen
Indemnified Party or (ii) that Biogen has already recovered such Liabilities
under Section 3.2.2(a)(ii).  Notwithstanding anything to the contrary, if AGTC
has exercised the Cost Share Option with respect to an Initial Licensed Product,
in the event of any Third Party claim against AGTC, Biogen or any AGTC
Indemnified Party or Biogen Indemnified Party that the practice of the AGTC
Technology to Develop, Manufacture, Commercialize or use of the applicable Cost
Share Product infringes or misappropriates any issued patent or other
proprietary right owned or possessed by such Third Party, Biogen and AGTC will
coordinate in defending such claim and will share any Liabilities resulting from
or arising out of such claim equally in accordance with Section 6.3, except to
the extent such claim is caused by the recklessness, negligence or intentional
misconduct of, or a breach of any representation or warranty by, (i) AGTC or any
AGTC Indemnified Party, in which case, AGTC shall indemnify Biogen Indemnified
Parties under this Section 17.3 or (ii) Biogen or any Biogen Indemnified Party,
in which case Biogen shall indemnify the AGTC Indemnified Parties under Section
17.2.

 

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17.4. Procedure.  Each Party will notify the other Party in writing in the event
it becomes aware of a claim for which indemnification may be sought
hereunder.  In case any proceeding (including any governmental investigation)
shall be instituted involving any Party in respect of which indemnity may be
sought pursuant to this Article 17, such Party (the “Indemnified Party”) shall
promptly notify the other Party (the “Indemnifying Party”) in writing and the
Indemnifying Party and Indemnified Party shall meet to discuss how to respond to
any claims that are the subject matter of such proceeding.  The Indemnified
Party shall reasonably cooperate with the Indemnifying Party in defense of such
matter.  The Indemnifying Party, upon request of the Indemnified Party, shall
retain counsel reasonably satisfactory to the Indemnified Party to represent the
Indemnified Party and shall pay the fees and expenses of such counsel related to
such proceeding.  In any such proceeding, the Indemnified Party shall have the
right to retain its own counsel, but the fees and expenses of such counsel shall
be at the expense of the Indemnified Party unless (a) the Indemnifying Party and
the Indemnified Party shall have mutually agreed to the retention of such
counsel, (b) the named parties to any such proceeding (including any impleaded
parties) include both the Indemnifying Party and the Indemnified Party and
representation of both Parties by the same counsel would be inappropriate due to
actual or potential differing interests between them.  All such fees and
expenses shall be reimbursed as they are incurred.  The Indemnifying Party shall
not be liable for any settlement of any proceeding effected without its written
consent, but, if settled with such consent or if there be a final judgment for
the plaintiff, the Indemnifying Party agrees to indemnify the Indemnified Party
from and against any loss or liability by reason of such settlement or
judgment.  The Indemnifying Party shall not, without the written consent of the
Indemnified Party, effect any settlement of any pending or threatened proceeding
in respect of which the Indemnified Party is, or could have been, a party and
indemnity could have been sought hereunder by the Indemnified Party, unless such
settlement includes an unconditional release of the Indemnified Party from all
liability on claims that are the subject matter of such proceeding.

17.5. Special Indemnification by Biogen of the Existing Licensors.

17.5.1. Biogen shall, at all times during the term of this Agreement and
thereafter, indemnify, defend and hold UFRF, the Florida Board of Governors, the
University of Florida Board of Trustees, the University of Florida, and each of
their directors, officers, employees, and agents, and the inventors of the any
Patent Rights licensed to AGTC under the UFRF Existing License Agreements,
regardless of whether such inventors are employed by the University of Florida
at the time of the claim, harmless against all claims and expenses, including
legal expenses and reasonable attorneys’ fees, whether arising from a Third
Party claim or resulting from UFRF’s enforcing this indemnification clause
against Biogen arising out of the death of or injury to any person or persons or
out of any damage to property and against any other claim, proceeding, demand,
expense and liability of any kind whatsoever (other than patent infringement
claims) resulting from the production, manufacture, sale, use, lease,
consumption, marketing, or advertisement of Licensed Products or use of any
processes licensed hereunder or arising from any right or obligation of Biogen
hereunder.  Notwithstanding the above, UFRF at all times reserves the right to
retain counsel of its own to defend UFRF’s, the Florida Board of Governors’, the
University of Florida Board of Trustees’, the University of Florida’s, and the
inventor’s interests.

17.5.2. Biogen warrants that it now maintains and will continue to maintain
liability insurance coverage appropriate to the risk involved in producing,
manufacturing, selling, marketing, using, leasing, consuming, or advertising the
products subject to this Agreement.  Notwithstanding the foregoing, Biogen may
self-insure to the extent that it self-insures for its other products.

17.5.3. JHU and [***] who are employees of JHU (hereinafter “JHU Inventors”)
will have no legal liability exposure to Third Parties if JHU does not license
the Licensed Products and processes licensed under the UF/JHU Agreement, and any
royalties JHU and the JHU Inventors may receive is not adequate compensation for
such legal liability exposure. Furthermore, JHU and JHU Inventors will not,
under the provisions of the UF/JHU Agreement or otherwise, have control over the
manner in which Biogen or its Affiliates or its Sublicensees or those operating
for its account or Third Parties who purchase Licensed Products and processes
licensed under the UF/JHU Agreement from any of the foregoing entities, develop,
manufacture, market or practice the inventions of such Licensed Products and
processes. Therefore, Biogen, and its Affiliates and Sublicensees shall
indemnify, defend with counsel reasonably acceptable to JHU, and hold JHU, The
Johns Hopkins Health Systems, their present and former trustees, officers, JHU
Inventors, agents, faculty, employees and students harmless as against any
judgments, fees, expenses, or other costs arising from or incidental to any
product liability or other lawsuit, claim, demand or other action brought as a
consequence of the practice of said inventions by any of the foregoing entities,
whether or not JHU or said JHU Inventors, either jointly or severally, is named
as a party defendant in any such lawsuit and whether or not JHU or the JHU
Inventors are alleged to be negligent or otherwise responsible for any injuries
to persons or property.  Practice of the inventions covered by such Licensed
Products and processes, by an Affiliate or an agent or a Sublicensee or a Third
Party on behalf of or for the account of Biogen or by a Third Party who
purchases such Licensed Products and processes from Biogen, shall be considered
Biogen’s practice of said

 

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inventions for purposes of this Section 17.5.3.  The obligation of Biogen to
defend and indemnify as set out in this Section 17.5.3 shall survive the
termination of this Agreement or the UF/JHU Agreement, shall continue even after
assignment of rights and responsibilities to an Affiliate or Sublicensee, and
shall not be limited by any other limitation of liability elsewhere in this
Agreement or the UF/JHU Agreement.

17.5.4. Biogen shall indemnify, defend and hold harmless [***] and its current
and former directors, governing board members, trustees, officers, faculty,
medical and professional staff, employees, students, and agents and their
respective successors, heirs and assigns (collectively, the “[***] Indemnitees”)
from and against any claim, liability, cost, expense, damage, deficiency, loss
or obligation of any kind or nature (including reasonable attorneys’ fees and
other costs and expenses of litigation) by or owed to a Third Party, based upon,
arising out of, or otherwise relating to the activities of Biogen, its
Affiliates and Sublicensees under this Agreement, including any cause of action
relating to product liability concerning any product, process, or service made,
used, sold or performed pursuant to any right or license granted under this
Agreement (collectively, the “[***] Claims”); provided, however, that Biogen’s
indemnification obligations hereunder shall not apply to any [***] Claim to the
extent that it is attributable to the gross negligence or willful misconduct of
any [***] Indemnitee.

17.5.5. Biogen shall, at its own expense, provide attorneys reasonably
acceptable to [***] to defend against any actions brought or filed against any
[***] Indemnitee hereunder with respect to the subject of indemnity contained
herein, whether or not such actions are rightfully brought. Any [***] Indemnitee
seeking indemnification hereunder shall promptly notify Biogen of such [***]
Claim; provided that any failure of or delay in such notification shall not
affect Biogen’s indemnification obligation unless and to the extent such failure
or delay is materially prejudicial to Biogen. The [***] Indemnitees shall
provide Biogen, at Biogen’s expense, with reasonable assistance and full
information with respect to such [***] Claim and give Biogen sole control of the
defense of any [***] Claim. Neither Biogen nor [***] shall settle any [***]
Claim without the prior written consent of the other, which consent shall not be
unreasonably withheld.

17.6. Insurance.

17.6.1. Insurance Obligations of AGTC.  AGTC will maintain, at its cost,
reasonable insurance against liability and other risks associated with its
activities contemplated by this Agreement, provided that, if AGTC is engaged in
any Development activities with respect to the Licensed Products hereunder, AGTC
will maintain, in force from thirty (30) days prior to enrollment of the first
subject in a Clinical Trial, a Clinical Trials/product liability insurance
policy providing coverage of at least [***] per claim and [***] annually in the
aggregate, and provided, further, that, if AGTC exercises its Co-Promotion
Option, that such coverage is increased to at least [***] at least thirty (30)
days before Biogen initiates the First Commercial Sale of the applicable
Licensed Product.  AGTC will furnish to Biogen evidence of such insurance upon
request.

17.6.2. Insurance Obligations of Biogen.  Biogen, together with its Affiliates,
will maintain, at its cost, reasonable insurance against liability and other
risks associated with its activities contemplated by this Agreement, provided
that, at a minimum, Biogen will maintain, in force from thirty (30) days prior
to enrollment of the first subject in a Clinical Trial, a Clinical
Trials/product liability insurance policy providing coverage of at least [***]
per claim and [***] annually in the aggregate, and provided, further, that such
coverage is increased to at least [***] at least thirty (30) days before Biogen
initiates the First Commercial Sale of a Licensed Product.  Biogen will furnish
to AGTC evidence of such insurance upon request.  Notwithstanding the foregoing,
so long as (i) substantially all of Biogen’s equity securities remain publicly
traded on a nationally recognized stock exchange and (ii) Biogen or any
Affiliate of Biogen is researching, developing and commercializing Licensed
Products under this Agreement, Biogen may self-insure against liability and
other risks associated with its and its Affiliates’ activities under this
Agreement to the extent that it self-insures in respect of its other products,
but at a minimum will self-insure at levels that are consistent with levels
customarily maintained against similar risks by similar companies in Biogen’s
industry.

17.6.3. Upon request of AGTC or an Existing Licensor, Biogen will furnish to
AGTC or such licensor with a certificate of insurance of each product liability
insurance policy obtained.

18. MISCELLANEOUS.

18.1. Assignment.  Neither this Agreement nor any interest hereunder shall be
assignable by either Party without the prior written consent of the other Party,
except as follows: (a) either Party may, subject to the terms of this Agreement,
assign its rights and

 

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obligations under this Agreement by way of sale of itself or the sale of the
portion or substantially all of the portion of such Party’s business to which
this Agreement relates, through merger, sale of assets and/or sale of stock or
ownership interest, provided that such sale is not primarily for the benefit of
its creditors and (b) either Party may assign its rights and obligations under
this Agreement to any of its Affiliates, provided that the assigning Party shall
remain liable for all of its rights and obligations under this Agreement.  The
assigning Party shall promptly (and in any event within two (2) Business Days)
notify the other Party of any assignment or transfer under the provisions of
this Section 18.1. This Agreement shall be binding upon the successors and
permitted assigns of the Parties and the name of a Party appearing herein shall
be deemed to include the names of such Party’s successors and permitted assigns
to the extent necessary to carry out the intent of this Agreement.  Any
assignment not in accordance with this Section 18.1 shall be void.  Biogen shall
not assign this Agreement without the prior written consent of [***], except
that Biogen may assign this Agreement to an Affiliate or a successor in
connection with the merger, consolidation or sale of all or substantially all of
its assets or that portion of its business to which this Agreement relates;
provided, however, that any permitted assignee agrees in writing to be bound by
the terms of this Agreement.

18.2. Change of Control.

18.2.1. Notification.  Each Party shall notify the other Party in writing
promptly (and in any event within four (4) Business Days) following the entering
into of a definitive agreement with respect to a Change of Control of such
Party.

18.2.2. Effects of Change of Control of AGTC.  In addition to the applicable
effects of Section 5.8.3, if any, if during the Term AGTC undergoes a Change of
Control with respect to one or both Initial Licensed Programs, then upon the
closing of such Change of Control, on an Initial Licensed Program-by-Initial
Licensed Program basis:

[***]

Notwithstanding the foregoing, if during the Term AGTC undergoes a Change of
Control with respect to all Collaboration Programs, the effects set forth above
in paragraphs [***] shall apply with respect to all Collaboration Programs.

18.2.3. Effects of Change of Control of Biogen.  In addition to the applicable
effects of Section 5.8.3, if any, if during the Term Biogen undergoes a Change
of Control with respect to one or both Initial Licensed Programs, then upon the
closing of such Change of Control, on an Initial Licensed Program-by-Initial
Licensed Program basis:

[***]

Notwithstanding the foregoing, if during the Term Biogen undergoes a Change of
Control with respect to all Collaboration Programs, the effects set forth above
in paragraphs [***] shall apply with respect to all Collaboration Programs.

18.3. Force Majeure.  Each Party shall be excused from the performance of its
obligations under this Agreement to the extent that such performance is
prevented by force majeure (defined below) and the nonperforming Party as
promptly as practicable provides notice of the prevention to the other
Party.  Such excuse shall be continued so long as the condition constituting
force majeure continues and the nonperforming Party takes Commercially
Reasonable Efforts to remove the condition.  For purposes of this Agreement,
“force majeure” shall include conditions beyond the control of the Parties,
including an act of God, voluntary or involuntary compliance with, or change in,
any regulation, law or order of any government, omissions or delays in acting by
any Regulatory Authority or other Governmental Authority or from the other
Party, war, terrorism, civil commotion, riot, labor strike or lock-out,
unavailability of raw materials, embargo, epidemic, failure or default of public
utilities or common carriers, destruction of production facilities or materials
by fire, flood, earthquake, storm or like catastrophe.

18.4. Correspondence and Notices.

18.4.1. Ordinary Notices.  Subject to the provisions of Section 18.4.2,
correspondence, reports, documentation and any other communication in writing
between the Parties in the course of ordinary implementation of this Agreement
shall be delivered by hand, sent by registered or certified mail (return receipt
requested) postage prepaid or sent using a nationally recognized express courier
service, in each case to the employee or representative of the other Party who
is designated by such other Party to receive such written communication.

 

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18.4.2. Extraordinary Notices.  Any notice or notification required or permitted
to be provided pursuant to the terms and conditions of this Agreement
(including, without limitation, any notice of force majeure, breach,
termination, change of address, etc.) shall be in writing and shall be deemed
given upon receipt if delivered personally or by facsimile transmission (receipt
verified), five (5) days after deposited in the mail if mailed by registered or
certified mail (return receipt requested) postage prepaid, or on the next
Business Day if sent by overnight delivery using a nationally recognized express
courier service and specifying next business day delivery (receipt verified), to
the Parties at the following addresses or facsimile numbers (or at such other
address or facsimile number for a Party as shall be specified by like notice;
provided, however, that notices of a change of address shall be effective only
upon receipt thereof):

All correspondence to Biogen shall be addressed as follows:

Biogen MA Inc.

225 Binney Street

Cambridge, Massachusetts 02142

Attn:  General Counsel

Fax: (866) 546-2758

with a copy to:

Marc Rubenstein

Ropes & Gray LLP

Prudential Tower, 800 Boylston Street

Boston, MA 02199-3600

Telephone: 617-951-7826

Facsimile: 617-235-0706

All correspondence to AGTC shall be addressed as follows:

Applied Genetic Technologies Corporation

11801 Research Drive

Suite D

Alachua, Florida 32615

Attn: Larry Bullock, Chief Financial Officer

with a copy to:

Hemmie Chang

Foley Hoag LLP

Seaport West, 155 Seaport Boulevard

Boston, MA 02210-2600

Telephone: 617-832-1175

Facsimile: 617-832-7000

18.5. Amendment.  No amendment, modification or supplement of any provision of
this Agreement shall be valid or effective unless made in writing and signed by
a duly authorized officer of each Party.

18.6. Waiver.  No provision of this Agreement shall be waived by any act,
omission or knowledge of a Party or its agents or employees except by an
instrument in writing expressly waiving such provision and signed by a duly
authorized officer of the waiving Party.  The waiver by either of the Parties of
any breach of any provision hereof by the other Party shall not be construed to
be a waiver of any succeeding breach of such provision or a waiver of the
provision itself.

18.7. Severability.  If any clause or portion thereof in this Agreement is for
any reason held to be invalid, illegal or unenforceable, the same shall not
affect any other portion of this Agreement, as it is the intent of the Parties
that this Agreement shall be construed in such fashion as to maintain its
existence, validity and enforceability to the greatest extent permitted by
law.  In any such event, this Agreement shall be construed as if such clause of
portion thereof had never been contained in this Agreement, and

 

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(after negotiation by the parties) there shall be deemed substituted therefor
such provision as will most nearly carry out the intent of the Parties as
expressed in this Agreement to the fullest extent permitted by applicable law.

18.8. Descriptive Headings.  The descriptive headings of this Agreement are for
convenience only and shall be of no force or effect in construing or
interpreting any of the provisions of this Agreement.

18.9. Export Control.  This Agreement is made subject to any restrictions
concerning the export of products or technical information from the United
States of America or other countries which may be imposed upon or related to
AGTC or Biogen from time to time.  Each Party agrees that it will not export,
directly or indirectly, any technical information acquired from the other Party
under this Agreement or any products using such technical information to a
location or in a manner that at the time of export requires an export license or
other governmental approval, without first obtaining the written consent to do
so from the appropriate agency or other governmental entity. Specifically, each
Party understands that the Arms Export Control Act (AECA), including its
implementing International Traffic In Arms Regulations (ITAR) and the Export
Administration Act (EAA), including its Export Administration Regulations (EAR),
are some (but not all) of the laws and regulations that comprise the U.S. export
laws and regulations. Each Party further understands that the U.S. export laws
and regulations include (but are not limited to): (I) ITAR and EAR
product/service/data-specific requirements; (2) ITAR and EAR ultimate
destination-specific requirements; (3) ITAR and EAR end user-specific
requirements; (4) ITAR and EAR end use-specific requirements; (5) Foreign
Corrupt Practices Act; and (6) anti-boycott laws and regulations. Each Party
will comply with all then-current applicable export laws and regulations of the
U.S. Government (and other applicable U.S. laws and regulations) pertaining to
the patents and products licensed under the [***] Agreement (including any
associated products, items, articles, computer software, media, services,
technical data, and other information). Each Party certifies that it will not,
directly or indirectly, export (including any deemed export), nor re-export
(including any deemed re-export) such patents or products (including any
associated products, items, articles, computer software, media, services,
technical data, and other information) in violation of U.S. export laws and
regulations or other applicable U.S. laws and regulations.

18.10. Governing Law.  This Agreement, and all claims arising under or in
connection therewith, shall be governed by and interpreted in accordance with
the substantive laws of the State of Delaware, without regard to conflict of law
principles thereof.

18.11. Entire Agreement.  This Agreement, together with all related agreements
referenced herein, constitutes and contains the complete, final and exclusive
understanding and agreement of the Parties and cancels and supersedes any and
all prior negotiations, correspondence, understandings and agreements, whether
oral or written, between the Parties respecting the subject matter hereof and
thereof, including that certain Mutual Confidentiality Agreement between the
Parties dated May 27, 2014 which is hereby superseded and replaced in its
entirety as of the Effective Date, and any Confidential Information disclosed by
the Parties under such Mutual Confidentiality Agreement shall be treated in
accordance with the provisions of Article 14.

18.12. Independent Contractors.  Both Parties are independent contractors under
this Agreement.  Nothing herein contained shall be deemed to create an
employment, agency, joint venture or partnership relationship between the
Parties hereto or any of their agents or employees, or any other legal
arrangement that would impose liability upon one Party for the act or failure to
act of the other Party.  Neither Party shall have any express or implied power
to enter into any contracts or commitments or to incur any liabilities in the
name of, or on behalf of, the other Party, or to bind the other Party in any
respect whatsoever.

18.13. Counterparts.  This Agreement may be executed in two (2) counterparts,
each of which shall be an original and both of which shall constitute together
the same document.  Counterparts may be signed and delivered by facsimile, each
of which shall be binding when received by the applicable Party.

18.14. Interpretation.  Except where the context expressly requires otherwise,
(a) the use of any gender herein shall be deemed to encompass references to
either or both genders, and the use of the singular shall be deemed to include
the plural (and vice versa), (b) the words “include”, “includes” and “including”
shall be deemed to be followed by the phrase “without limitation,” (c) the word
“will” shall be construed to have the same meaning and effect as the word
“shall,” (d) any definition of or reference to any agreement, instrument or
other document herein shall be construed as referring to such agreement,
instrument or other document as from time to time amended, supplemented or
otherwise modified (subject to any restrictions on such amendments, supplements
or modifications set forth herein), (e) any reference herein to any Person shall
be construed to include the Person’s successors and assigns, (f) the words
“herein”, “hereof” and “hereunder”, and words of similar import, shall be
construed to refer to this Agreement in its entirety and not to any particular
provision hereof, (g) all references herein to Sections or Exhibits shall be
construed to refer to Sections or Exhibits of this Agreement, and references to
this Agreement include all Exhibits hereto, (h) the word “notice” shall mean
notice in writing (whether or not specifically stated) and shall include
notices, consents, approvals and other written communications contemplated under
this Agreement, (i) provisions that require that a Party, the Parties or any
committee hereunder “agree,” “consent”

 

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or “approve” or the like shall require that such agreement, consent or approval
be specific and in writing, whether by written agreement, letter, approved
minutes or otherwise (but excluding e-mail and instant messaging), (j)
references to any specific law, rule or regulation, or article, section or other
division thereof, shall be deemed to include the then-current amendments thereto
or any replacement or successor law, rule or regulation thereof, (k) any
definition of or reference to any agreement, instrument or other document herein
shall be construed as referring to such agreement, instrument or other document
as from time to time amended, supplemented or otherwise modified (subject to any
restrictions on such amendments, supplements or modifications set forth herein),
and (l) the term “or” shall be interpreted in the inclusive sense commonly
associated with the term “and/or.”

18.15. No Third Party Rights or Obligations.  No provision of this Agreement
shall be deemed or construed in any way to result in the creation of any rights
or obligation in any Person not a Party to this Agreement, provided that each
Person indemnified by either Party under Article 17 is an intended Third Party
beneficiary for the sole purpose of enforcing such indemnification.

18.16. Remedies Cumulative.  All rights and remedies of each Party under this
Agreement will be cumulative and non-exclusive of any other rights or remedies
available to such Party at law or in equity or provided for in this Agreement.

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

[Signature page follows.]

 

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IN WITNESS WHEREOF, duly authorized representatives of the Parties have duly
executed this Agreement to be effective as of the Effective Date.

 

BIOGEN MA INC.

 

APPLIED GENETIC TECHNOLOGIES CORPORATION

 

 

By_/s/ Douglas Williams__________________

 

 

By_/s/ Susan B. Washer_______________

Name:Douglas Williams, Ph.D.

Title: Executive Vice President, Research and Development

Name:Susan B. Washer

Title: President and CEO

 

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[Signature Page to Collaboration and License Agreement]

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SCHEDULE 1.22-1

AGTC PATENT RIGHTS FOR THE INITIAL LICENSED PRODUCTS

(i) AGTC Owned Patents

[***]

(ii) Co-Owned Patent Rights

[***]

(iii) In-licensed Patents

[***]

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SCHEDULE 1.22-2

AGTC PATENT RIGHTS FOR THE DISCOVERY PRODUCTS

[To be included as of the Option Exercise Date.]

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SCHEDULE 1.23

AGTC PLATFORM

The AGTC Platform is further described as follows:

1.  “[***] Manufacturing Patent Rights” has the meaning set forth in Section
1.140 and, as of the Execution Date, consists of the following Patent Rights:

(i) AGTC Owned Patents

[***]

(ii) Co-Owned Patent Rights

[***]

(iii) In-licensed Patents

[***]

2.   “Capsid Optimization Patent Rights” has the meaning set forth in Section
1.52 and, as of the Execution Date, consists of the following Patent Rights:

[***]

3.   “Promoter Patent Rights” has the meaning set forth in Section 1.216 and, as
of the Execution Date, consists of the following Patent Rights:

None as of the Execution Date.

4.   “AGTC Assays” has the meaning set forth in Section 1.15 and, as of the
Execution Date, consists of the following assays:

[***]

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SCHEDULE 1.40

BIOGEN PATENT RIGHTS

None as of the Execution Date.

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SCHEDULE 1.56

CLINICAL CANDIDATE DESIGNATION CRITERIA

[***] 

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SCHEDULE 1.212

PRODUCT-SPECIFIC PATENT RIGHTS OF AGTC

[***]

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SCHEDULE 3.1.3

BIOGEN STEP-IN EVENTS

[***]

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SCHEDULE 4.2.1

LICENSED PATENT RIGHTS FOR THE DISCOVERY PROGRAMS

1. [***] Discovery Program

    [***]

2. [***] Discovery Program I

    [***]

3. [***] Discovery Program II

    [***]

4. [***] Discovery Program

    [***]

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SCHEDULE 5.2

SUBLICENSING RESTRICTIONS

1. [***] Agreement

With respect to AGTC Technology sublicensed to Biogen pursuant to the [***]
Agreement, Biogen may grant further sublicenses to such AGTC Technology through
itself or its Affiliates to Third Parties, provided that each sublicense
agreement: (a) shall incorporate by reference the terms and conditions of the
[***] Agreement as set forth in this Agreement, (b) shall be consistent with the
terms, conditions and limitations of the [***] Agreement, (c) shall name [***]
and [***] as intended third party beneficiaries with respect to the
indemnification obligations of the Sublicensee, (d) shall include a prohibition
from further sublicensing the rights delivered thereunder, and (e) shall comply
with the applicable provisions of Section 5.5.4 of this Agreement.  Biogen
agrees to provide a copy of each executed sublicense agreement to AGTC for
delivery to [***] and [***] (which copy may be redacted for Biogen’s, its
Affiliate’s or any Sublicensee’s confidential information, for information
regarding intellectual property that is unrelated to the AGTC Patent Rights
licensed under the [***] Agreement or other confidential information not
necessary for [***] and [***] to ensure compliance with the [***] Agreement).
Notwithstanding anything to the contrary, Biogen and any Sublicensee shall be
free, without notice or consent, to engage distributors or to sublicense to
contractors or collaborators for the purpose of manufacturing, research,
development or any other purpose other than granting sublicense rights to
commercialize or sell Licensed Products to Third Parties, provided that the
provisions of this paragraph in this Schedule 5.2 shall be incorporated into
each such sublicense agreement.

2. [***] Agreement

With respect to AGTC Technology sublicensed to Biogen pursuant to the [***]
Agreement, Biogen may grant further sublicenses to such AGTC Technology through
itself or its Affiliates to Third Parties, provided that, in the case of Biogen
granting rights to commercialize or sell Licensed Products to a Sublicensee,
Biogen shall notify [***] of the identity of such Sublicensee within thirty (30)
days after the grant of such further sublicense.  Further, in the event Biogen
grants such a further sublicense of commercialization rights to a Sublicensee,
any such downstream sublicense agreement must require the Sublicensee to comply
with the terms of the [***] Agreement as set forth in this Agreement. For
clarity, any Sublicensee of Biogen shall be free, without notice or consent, to
engage distributors or to sublicense to contractors or collaborators for the
purpose of manufacturing.

 

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SCHEDULE 11.4

THIRD PARTY MATERIALS

(a)

[***] Biological Materials:

[***]

(b)

[***] Materials:

[***]

(c)

[***]

(d)

[***]

 

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SCHEDULE 11.4.2

[***]RESTRICTIONS

[***]

 

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SCHEDULE 15.1

MUTUAL DISCLOSURE SCHEDULE

(a) AGTC Disclosures

[***].

(b) Biogen Disclosures

[***]

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SCHEDULE 15.2

AGTC DISCLOSURE SCHEDULE

15.2.4

[***] 

15.2.20

[***]

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SCHEDULE 15.2.7

EXISTING LICENSE AGREEMENTS

UFRF Agreements

1. Standard Exclusive License Agreement With Know How - [***] Vectors License
(A12044), dated November 5, 2012, by and between AGTC and University of Florida
Research Foundation, Inc.

a.  Amendment - January 30, 2014

b. Amendment – June 30, 2015 (Omnibus Amendment)

2. Standard Non-Exclusive License Agreement (A10571), dated September 18, 2012,
by and between AGTC and University of Florida Research Foundation, Inc.

a. Amendment – June 30, 2015 (Omnibus Amendment)

UFRF/JHU Agreements

3. Standard Exclusive License Agreement With Sublicensing Terms (A3288), dated
October 7, 2003, by and among AGTC, University of Florida Research Foundation,
Inc. and Johns Hopkins University

a. Amendment - November 2004 (First Amendment)

b. Amendment - December 3, 2004 (Side Letter)

c. Amendment - February 25, 2009 (Second Amendment)

d. Amendment - March 30, 2010 (Third Amendment)

e. Amendment - December 17, 2013 (Fourth Amendment)

f. Amendment – July 1, 2015 (Omnibus Amendment)

4. [***] Agreement, dated March 13, 2014, by and among AGTC, University of
Florida Board of Trustees and Johns Hopkins University

a. Amendment – July 1, 2015 (Omnibus Amendment)

[***]Agreements

[***]

UAB Agreements

5. Non-Exclusive License Agreement with Sublicensing Terms [***], dated January
19, 2006, by and between AGTC and UAB Research Foundation

a. Amendment - March 28, 2014 (First Amendment)

b. Amendment – June 29, 2015 (Second Amendment)

c. Side Letter – June 29, 2015 (Request Letter)

[***] Agreements

[***]

[***] Agreements

[***]

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EXHIBIT A-1

INITIAL XLRS DEVELOPMENT PLAN

[***]

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EXHIBIT A-2

INITIAL XLRP DEVELOPMENT PLAN

[***]

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EXHIBIT A-3

INITIAL [***] DISCOVERY PROGRAM DEVELOPMENT PLAN

[***]

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EXHIBIT A-4

INITIAL [***] DISCOVERY PROGRAM DEVELOPMENT PLAN

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EXHIBIT A-5

INITIAL [***]DEVELOPMENT PLAN

[***]

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EXHIBIT A-6

INITIAL [***]DEVELOPMENT PLAN

[***]

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EXHIBIT B

CO-PROMOTION TERMS

[***]

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EXHIBIT C

FINANCIAL PLANNING, ACCOUNTING AND REPORTING FOR THE COST SHARE PRODUCT(S)

1. [***]

 

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EXHIBIT D

PRESS RELEASE

BIOGEN AND AGTC ENTER COLLABORATION TO DEVELOP GENE THERAPIES IN OPHTHALMOLOGY

Companies to advance a potentially transformative treatment approach for genetic
diseases of the eye

AGTC to receive $124M upfront, with potential future milestone payments and
royalties

AGTC to host conference call today at 8 a.m. EDT

CAMBRIDGE, Mass. & GAINESVILLE, Fla. – July 1, 2015 – Biogen (NASDAQ: BIIB) and
AGTC (NASDAQ: AGTC) today announced a broad collaboration and license agreement
to develop gene-based therapies for multiple ophthalmic diseases. The
collaboration will focus on the development of a portfolio of AGTC’s therapeutic
programs, including both a clinical stage candidate and a pre-clinical candidate
for orphan diseases of the retina that can lead to blindness in children and
adults. The agreement also includes options for early stage discovery programs
in two ophthalmic diseases and one non-ophthalmic condition, as well as an
equity investment in AGTC by Biogen and a license agreement for manufacturing
rights.

“With this collaboration, we hope to advance gene therapies to open
possibilities for patients who suffer from diseases that are well understood,
but have no adequate treatment,” said Olivier Danos, Ph.D., senior vice
president, cell & gene therapy at Biogen. “AGTC is an exceptional partner to
help us advance our gene therapy capabilities by targeting diseases of the eye –
an organ that provides an ideal setting for the localized, selective delivery of
gene-based therapies.”

“We expect this collaboration will further validate our novel adeno-associated
virus (AAV) gene therapy platform and support the development of new therapies
that may allow for transformative treatments for these rare inherited eye
diseases and other clinical indications,” added Sue Washer, president and CEO of
AGTC. “Biogen’s significant commitment to advancing gene therapies and
demonstrated success in developing innovative therapies to treat complex
diseases, combined with our proprietary manufacturing technology and extensive
gene therapy experience, makes this an ideal partnership.”

The lead development programs in the collaboration include a clinical candidate
for X-linked Retinoschisis (XLRS) and a pre-clinical candidate for the treatment
of X-Linked Retinitis Pigmentosa (XLRP).   XLRS, a disease affecting young males
beginning during the teenage years, can lead to serious complications such as
vitreous hemorrhage or retinal detachment during adulthood. XLRP usually causes
night blindness by the age of ten and progresses to legal blindness by an
individual’s early forties. Both conditions represent significant unmet needs
that may be addressed by replacing the single, faulty gene causing each disease.

Collaboration Overview

Biogen will make an upfront payment in the amount of $124 million to AGTC, which
includes a $30 million equity investment in AGTC at a price equal to $20.63 per
share and certain prepaid research and development expenditures. Biogen will be
granted a license to the XLRS and XLRP programs and the option to license
discovery programs for three additional indications at the time of clinical
candidate selection.

Under the collaboration, AGTC is eligible to receive upfront and milestone
payments exceeding $1 billion. This includes up to $472.5 million collectively
for the two lead programs, which also will carry royalties in the high single
digit to mid-teen percentages of annual net sales. In addition, Biogen will make
payments up to $592.5 million across the discovery programs, along with
royalties in the mid single digits to low teen percentages of annual net sales.

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Biogen obtains worldwide commercialization rights for the XLRS and XLRP
programs. AGTC has an option to share development costs and profits after the
initial clinical trial data are available, and an option to co-promote the
second of these products to be approved in the United States.  AGTC will lead
the clinical development programs of XLRS through product approval and of XLRP
through the completion of first-in-human trials. Biogen will support the
clinical development costs, subject to certain conditions, following the
first-in-human study for XLRS and IND-enabling studies for XLRP.  Under the
manufacturing license, Biogen will receive an exclusive license to use AGTC’s
proprietary technology platform to make AAV vectors for up to six genes, three
of which are in AGTC’s discretion, in exchange for payment of milestones and
royalties.

The transaction is subject to customary closing conditions, including the
expiration of the applicable waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976 in the United States, and is expected to
close in the third calendar quarter of 2015.

AGTC will host a live webcast presentation and conference call on [July # at
##:## a.m. EDT] to discuss the collaboration. The webcast can be accessed at
ir.agtc.com/events.cfm  or by dialing [(###) ###-#### (US) or (###) ###-####
(outside of the US)] fifteen minutes prior to the start of the call.  The
passcode is [######.]  The webcast will be archived on the AGTC website.

About Gene Therapy

Gene therapy is an evolving field of medicine in which faulty genes are
corrected in cells. Genes control heredity and provide the basic biological code
for determining a cell's specific functions. The most common form of gene
therapy involves using DNA that encodes a functional, therapeutic gene to
replace a defective gene. In gene therapy, the healthy copy of a defective gene
is packaged within a vector, a biological delivery mechanism which is used to
transport the genetic information into the diseased cells within the body. Once
the gene is delivered into the correct cell, a therapeutic protein is naturally
made by the cell from the therapeutic gene.

About Adeno-Associated Virus (AAV) Vectors

AAV vectors have emerged as an attractive approach for gene therapy since they
can deliver the genes for therapeutic proteins to accessible tissues in the
body. Several AAV gene therapy products are in late-stage clinical development,
and one product is approved in the EU.

About Biogen

Through cutting-edge science and medicine, Biogen discovers, develops and
delivers to patients worldwide innovative therapies for the treatment of
neurodegenerative diseases, hematologic conditions and autoimmune disorders.
Founded in 1978, Biogen is one of the world’s oldest independent biotechnology
companies, and patients worldwide benefit from its leading multiple sclerosis
and innovative hemophilia therapies. For product labeling, press releases and
additional information about the company, please visit www.biogen.com.

About AGTC

AGTC is a clinical-stage biotechnology company that uses its proprietary gene
therapy platform to develop products designed to transform the lives of patients
with severe diseases in ophthalmology. AGTC's lead product candidates focus on
X-linked retinoschisis, achromatopsia and X-linked retinitis pigmentosa, which
are inherited orphan diseases of the eye, caused by mutations in single genes
that significantly affect visual function and currently lack effective medical
treatments. AGTC is also using its gene therapy expertise to expand into disease
indications with large market opportunity such as wet AMD and other
ophthalmology and orphan indications.

Biogen Safe Harbor

This press release contains forward-looking statements, including statements
about the potential benefits and advancements that may be achieved through the
collaboration with AGTC and the expected timing of the closing the transactions.
These statements may be identified by words such as “believe,” “expect,” “may,”
“plan,” “potential,” “will” and similar expressions, and are based on Biogen’s
current beliefs and expectations. These statements involve risks and
uncertainties that could cause actual results to differ materially from those

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reflected in such statements. Risks and uncertainties that may cause actual
results to differ materially include, among others: uncertainty inherent in the
regulatory review process and satisfaction of other closing conditions relating
to the transactions; uncertainty regarding the ability to achieve the expected
benefits from the proposed collaboration, including as a result of risks and
uncertainties associated with drug development and commercialization, reliance
on third parties over which Biogen may not always have full control and other
risks associated with collaborations; and other risks and uncertainties that are
described in the Risk Factors section of Biogen’s most recent annual or
quarterly report filed with the Securities and Exchange Commission. Any
forward-looking statements speak only as of the date of this press release and
Biogen assumes no obligation to update any forward-looking statements, whether
as a result of new information, future events or otherwise.

AGTC Safe Harbor

This release contains forward-looking statements that reflect AGTC’s plans,
estimates, assumptions and beliefs.  Forward-looking statements include
information concerning the expected timing of the closing of the transactions
contemplated by the proposed collaboration, possible or assumed future results
of operations, business strategies and operations, preclinical and clinical
product development and regulatory progress, potential growth opportunities,
potential market opportunities and the effects of competition.  Forward-looking
statements include all statements that are not historical facts and can be
identified by terms such as "anticipates," "believes," "could," "seeks,"
"estimates," "expects," "intends," "may," "plans," "potential," "predicts,"
"projects," "should," "will," "would" or similar expressions and the negatives
of those terms. Actual results could differ materially from those discussed in
the forward-looking statements, due to a number of important factors. Risks and
uncertainties that may cause actual results to differ materially include, among
others: uncertainty inherent in the regulatory review process and satisfaction
of other closing conditions relating to the transactions; uncertainty regarding
the ability to achieve the expected benefits from the proposed collaboration,
including as a result of risks and uncertainties associated with drug
development and commercialization, reliance on third parties over which AGTC may
not always have full control and other risks associated with collaborations; and
other risks and uncertainties that are described under the heading "Risk
Factors" in AGTC’s Annual Report on Form 10-K for the fiscal year ended June 30,
2014, as filed with the SEC.  Given these uncertainties, you should not place
undue reliance on these forward-looking statements.  Also, forward-looking
statements represent management's plans, estimates, assumptions and beliefs only
as of the date of this release.  Except as required by law, we assume no
obligation to update these forward-looking statements publicly or to update the
reasons actual results could differ materially from those anticipated in these
forward-looking statements, even if new information becomes available in the
future.

###

CORPORATE AGTC CONTACT:

Larry Bullock

Chief Financial Officer

Applied Genetic Technologies Corporation

T: (386) 462-2204

lbullock@agtc.com

 

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EXHIBIT E

TAX MATTER PARTNERSHIP TERMS

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